Relocation of the European Medicines Agency Bucharest Smart Agency in a vivid European city

emabucharest.ro

Relocation of the European Medicines Agency 1

Mihai Tudose Prime Minister of Romania

“Back in 2007, when Romania became a member of the EU, it assumed a trajectory designed to set the premises for dynamic perspectives of unhesitating development on all levels. Now, in 2017, the objectives set back then are ripe for picking. Therefore, a constructive perspective on EU’s future also means fully tapping into the potential of Member States, such as Romania. This potential relies on compelling capabilities, diverse resources, unwavering willingness and profound commitment towards further enhancing the EU project.

This is why Bucharest deserves to host the European Medicine Agency. Thanks to the steady pace of economic and societal progress, as well as to the promising economic projections, Romania enjoys the status of an attractive and favourable setting for EMA’s future operations. Bucharest provides accessible and growing infrastructure, modern headquarters, convenient family opportunities or adequate healthcare facilities. This mix of advantages paves the way to further economic and social development in Bucharest and Romania, to the benefit of the EMA operations and its mission to safeguard the health of EU’s citizens. The speed and pace of Romania’s progress on all stages, ever since its accession to the EU, act as triggers to yield over time better results in achieving a high degree of convergence with EU’s prosperity.

Amid the current business climate and the promising expectations, I pledge with confidence for Bucharest as a friendly, cost-effective and fitting option to relocate EMA. Having said that, the EMA and its staff will find in Romania and in Bucharest not only professional relocation solutions aimed to accommodate their needs, but also innovative, research and development oriented industries, as well as promising life science initiatives. Bucharest reconciles modern with classic, lively reputation with calm getaways, cost effectiveness with high living standards. That is why, all the requirements in place for the continuity and successful performance of EMA meet up in Bucharest. The Romanian Government is looking forward to cooperating in making this transition a success.” Mission statement “A smart Agency in a vivid European city”

4 Relocation of the European Medicines Agency Romania is strongly committed to turn its candidacy for the relocation of the European Medicines Agency/EMA into a positive outcome. Romania truly deserves this constructive institutional development, which would allow for its increased contribution to the fulfilment of the EU political objectives, acting in the interest of the EU and its citizens.

Moreover, since Bucharest provides state-of-the-art premises, good logistics and has a proven record of field expertise, EMA’s efficient continuation of operations could only be a natural transition to a new, safe and welcoming EU capital with high development perspectives. Thus, Romania’s candidacy highly responds to the need of ensuring a cost- effective relocation process, as well as to the objective of optimising administrative costs at EU level.

Besides, ever since its 2007 accession to the EU family, Romania has proven its pro-European drive and the bedrock of its society and political actorship relies on the strong attachment to European values and principles. Nevertheless, Romania is amongst the few Member States that do not yet host an European agency.

Relocation of the European Medicines Agency 5 Since its 2007 accession, Romania has demonstrated its clear and steady pro-European orientation and its full commitment towards deepening the EU project. Furthermore, Romania Executive is a pillar of stability in the region and has a unique geostrategic position in the Black Sea area.

Summary Although Romania is among the few EU countries which still do not host any EU agency, here are the main reasons which reflect Romania’s readiness Starting with the second half of 2016, the Romanian and commitment towards offering to the EMA a Government, together with regional and local new home in Bucharest. stakeholders, have been working to set up a representative package for the relocation of the Bucharest, the capital city of Romania, aims at European Medicines Agency (EMA) to Bucharest. becoming one of the European regional hubs Our approach to EMA relocation is a flexible and for business and tourism and it represents an seamless transition for the EMA and its staff to a important centre for higher education. Taking country with a high potential for development, into consideration the achievement of such goals, located within one of the most interesting regions local development programs are integrated with in the EU - Central and Eastern Europe. the European strategy that aims at providing the appropriate environment for sustainable The CEE (Central and Eastern Europe) tends economic growth. to become one of the most attractive regions One of the strong points of Bucharest’s in terms of active economic growth and highly communications infrastructure are the skilled people, contributing in a representative widespread optic fibre networks, leading to manner to the scientific environment of the EMA superior internet access and data transmission with national leading researchers, students and rates, the foundation of the future Gigabit society. professors, with scientific collaboration between Bucharest’s NetCity project, the underground the healthcare system, the academic sector and infrastructure for optic fibre, is an innovative the industry. project and one of the largest investments in Enjoying stable and reliable macro-economic the city’s communications infrastructure, in line outlooks, Romania, the 7th largest country in the with the European socio-economic development EU in terms of population, ranks first in the EU in policy for local communities. terms of economic growth (5.7%), more than double the EU average (2.4%). Romania offers attractive Bucharest hosts several public data centres of conditions for Foreign Direct Investments, thus a European dimension, able to assure optimal sustaining an economy that generates new jobs collocation and/or operation of equipment, at a steady pace, which relies on a multicultural including back-up and disaster recovery services, environment with a high percentage of language as well as high capacity connections with European skilled citizens. and global content and connectivity providers.

6 Relocation of the European Medicines Agency Two public internet interexchange points function nearby possibilities to work at blue chip tenants in Bucharest, ensuring strong connectivity with in the area. ISPs active at national level as well as with global carriers; this is helpful in providing reliability and The Campus provides a private kindergarten and redundancy of communication paths. the after-school “Junior School”, as well as onsite amenities such as bank branches, pharmacy, the largest gym / spa in Bucharest, as well as a 1.1. State-of-the-art premises large variety of restaurants offering local and in Bucharest as future EMA international cuisine, a supermarket and several coffee shops. headquarters Within walking distance, there are some four star Romania offers state-of-the-art premises for hotels with a total of 606 rooms: the Caro Hotel the future headquarters of the EMA, including (184 rooms), the Cristal Hotel (74), the Phoenicia attractive financial arrangements for the Lease Hotel (348 rooms). Nearby, new hotels are under Contract. The modern real estate concept presents development, with a potential of another 150 an integrated new concept of work and life in one rooms. of the most active parts of Bucharest, the capital EMA’s headquarters can be easily reached from city. the airport in less than 16 minutes. Bucharest The proposed EMA building is part of a real estate Municipality could provide a direct line of integrated project of the Global Worth as developer. transportation between the EMA premises and The project perfectly balances a new concept of the destinations required by its personnel, all office spaces, which combines high technical and around Bucharest, including on the route from/ environmentally friendly specifications, green to the International Henri Coandă Airport. areas and a dedicated commercial component, as well as dwellings. A conference centre completes the mix, providing the infrastructure for a continuous learning process for companies and 1.2. Bucharest - A vivid European city, employees alike. a safe and cost-efficient place to work and live The total Gross Building Area is 36,740.80 sqm with a total office rent area of 27,431.43 sqm. Bucharest offers safe and excellent working and The location is also endowed with highest IT&C living conditions in an open, friendly and welcoming and mobile technologies, some of the best in the environment. With a population of almost 2 million world and 1st in the EU at the end of 2016. The inhabitants, Bucharest, the capital of Romania, is state-of-the-art IT&C of the building and the the 6th largest city in the European Union, after area would make it particularly well equipped to London, Berlin, Madrid, Rome and Paris. Well- provide assistance for the IT requirements of the connected and accessible, Bucharest serves as EMA. the economic, political and social hub of Romania. Close to the EMA building, the Campus residential Bucharest is very well positioned geographically, complex offers 435 spacious dwellings to rent offering swift access within 2 hours by car, to the or buy. Also, family members of EMA staff have Carpathian Mountains, the unique Danube Delta –

Relocation of the European Medicines Agency 7 the second largest and best preserved of Europe’s deltas – and the impressive Black Sea. Bucharest is one of the safest EU capitals (with less than 1% criminality rate per 100.000 inhabitans), providing a safe place to work and live for its citizens. It has never been a target for terrorist attacks. Romanian citizens perceive as low the risk to national security. The cost of living in Romania – especially in Bucharest – is approximately 50% lower when compared to other EU major cities (Vienna, London, Berlin, Paris) and at least 12% cheaper than other city capitals in the region (Prague, Warsaw or Budapest). Compared to London, the monthly rent price for an excellent IT&C equipped office building in Bucharest is 3 times lower. A new home city cannot be ‘at home’ without proper housing facilities – Bucharest means convenient living costs and high quality of life for expats, including cost efficient housing facilities. Over the past years, the real estate market has experienced a major expansion trend, hence the moderate buying costs and convenient rental prices.

Bucharest is also a place with a rich mix of strong traditional culture, theatres, opera, as well as a large and diverse network of museums completing the picture of a vivid and attractive city. Citizens, expats and visitors of Bucharest are familiar with recreational activities, ranging from traditional “shopping arcades”, cinemas, parks and public gardens, thermal spa facilities or various types of restaurants. Bucharest also offers excellent IT&C services at a high quality/price ratio, as Romania ranks first among European countries with the highest average peak internet connection speed and the communication services tariffs are among the lowest in Europe (Q3, 2016).

8 Relocation of the European Medicines Agency professional healthcare services, Bucharest offers 1.3. Bucharest - connectivity, easy the largest labour market in the country, enjoying access, diversity and tailor made a dynamic and diverse business environment with soaring competitiveness indicators. Bucharest approaches provides a well developed Business Services Sector (BSS), hosting the headquarters of Bucharest Henri Coanda International Airport multinational corporations, consulting companies provides over 220 daily direct and connecting or international law firms, offering a large range of flights to-and-from all EU Member States. employment possibilities for families and partners Bucharest has direct and connecting flights to of the EMA staff. 84 European destinations in 29 countries, out of which direct flights to 23 EU capital cities. Comprehensive and high-quality healthcare services in over 50 public hospitals in Bucharest, TAROM national airline company is ready to as well as a wide range of privately operated clinics provide for excellent corporate commercial and hospitals may ensure proper medical care offers to EMA staff and visting experts within its for EMA employees and their families. Insurance entire domestic and international network, at costs are generally covered by the Romanian competitive fares. government, which guarantees access to public The airport can be reached from downtown in less healthcare services for all. Besides, citizens can than 30 minutes and from the EMA headquarters opt for private insurance arrangements, which in less than 16 minutes by means of public bear accessible costs and provide access to a wide- transportation. range of services in public or private institutions. The city’s public transportation network comprises 4 well-connected, secure and accessible subway lines, as well as an extensive 1.5. Excellent education facilities for network of public bus, trolley bus and tram EMA employees’ children transportation. Tickets can be purchased at one of the lowest prices in the EU. Bucharest Bucharest offers a wide range of educational offers friendly bike rental facilities and cycling institutions for all ages, from nurseries, infrastructure with major expansion prospects. kindergartens, secondary schools, high schools and universities, teaching in foreign languages. The educational system in Bucharest has evolved 1.4. Plentiful accommodation taking into consideration the labour market and its modern needs, offering a diverse range of modern Bucharest offers a wide range of accomodation curricula and specialities, some of them in foreign to ease experts’ and delegates’ travel experience languages. - with over 140 hotels and 10.000 hotel rooms Several nurseries operate in Bucharest, offering ranging from exclusive to mid-range, major education in English, German, Finish and other international hotels being present in the city. With languages. Over 450 public primary and secondary plenty of employment possibilities for families schools operate in Bucharest, out of which over 30 and partners of the EMA staff and access to schools - from pre-school to high school - feature

Relocation of the European Medicines Agency 9 international profiles. Apart from the scenarios provided in the In Bucharest, there are 27 public and private EMA/336490/2017 MB document, Romania is ready universities, offering 75 Bachelor programmes to cope with the risk of possible EMA staff shortage in English, French and German, while 84 master due to the relocation. The National Agency for programmes are offered mainly in English. Medicines and Medical Devices is a reliable, active Doctoral studies may be organized in an partner of the European Medicine Agency, with international language as well. Higher education highly-skilled professionals. It is worth mentioning is free for top students admitted to undergraduate that Romania ranks tenth as to number of EMA’s degrees in public universities. employees.

1900 high skilled persons are ready to cope with a 1.6. Smooth transition for staff and possible 25% EMA staff shortage - 300 persons from their families the National Agency for Medicines and Medical Devices and 1,600 professors from all Universities of The Romanian proposal is based on the relevant Medicines and Pharmacy in Romania. This year, the EMA management Board decisions and EMA’s Agency has signed a partnership agreement with the Operations and Relocation Preparedness Task Force most prestigious medical university in Bucharest, (ORP) created to ensure a smooth transition through the “Carol Davila” University, to ensure EMA smooth a well-organized process, offering a professional business continuity, in case of a risk of personnel approach to relocation assistance, mechanisms and shortage. procedures. With over 170,000 highly-skilled young potential employees yearly, out of which 10,000 medical, It is based on risk control and management aimed dental and pharmacy students in Bucharest, the at mitigation of risks through arrangements for Romanian market offers concrete possibilities in the continuation and/or resumption of essential line with EMA principles to engage young persons services and ultimately return to “business as usual” in working activities or in a constant dialogue and in the shortest time possible. interaction in a mutually beneficial manner.

The Romanian Ministry of Health will put in place, Romania ranks high globally in terms of number of immediately after the decision to relocate EMA to medical school graduates – 36 graduates for every Bucharest, an operational Department of Support 100,000 population, whereas the United States have Relocation Services (DSRS) in order to support 6.5 graduates and the UK, 9.3 graduates for every relocation of EMA’s activities, experts and their 100,000 population. families, from UK to Romania. Romania has internationally recognised expertise The purpose is to relocate EMA with least breaks and tradition in the field of medicine and pharmacy for work and life. With the support of the Romanian education, with more than 70% of foreign students Embassy to the UK, the Romanian Ministry of Health studying medicine and pharmacy here. Furthermore, shall assist EMA staff and their families, thus ensuring the Romanian software and IT services sector relies a smooth and seamless transition. on highly skilled human capital recognised as such at international level.

10 Relocation of the European Medicines Agency researchers with tremendous contribution to the 1.7. The Romanian National Agency for development of a wide range of medicine and Medicines and Medical Devices has pharmacy fields. The most representative and brilliant researchers, some of them Nobel Prize an exceptional track record in modern laureates, are: medicinal product regulation - George Emil Palade, Romanian Nobel Prize The National Agency for Medicines and Medical laureate, for physiology and medicine awarded in Devices (NAMMD) is a reliable, active partner of 1974. He is considered to be the father of modern the European Medicine Agency. Romania ranks cell biology. tenth as to number of EMA employees. - Cornelius Giurgea has revolutionized encephalo- neuro-psycho-tropic therapy by discovering and It is worth mentioning that Romania has a long and substantiating the concept of a new therapeutic uninterrupted history of modern pharmaceutical (pharmacological) class in neuroscience - market regulators. nootropic medication. Its first representative is piracetam (DCI) - Nootropil® (UCB) - generation I. For over 50 years, the National Agency for - Ana Aslan, who developed Gerovital, vitamin H3, Medicines and Medical Devices (NAMMD) has patented in 30 countries since 1952. That same represented the medicinal product regulatory year, she established the first geriatric institute authority in Romania. in the world, the Geronto-Geriatrics National The current mission of the Agency includes Institute Dr. Ana Aslan, that represented a model authorizing the place on the market of good for other countries, through both clinical care and quality, safe and effective human medicines, as research. well as authorizing the conduct of clinical trials - Nicolae Paulescu, the true discoverer of insulin and the clinical trial sites in Romania; safety in 1921, secreted by the pancreas, which Paulescu supervision of medicinal products for human use, originally called “pancreine”. In his studies, through inspection and pharmacovigilance. As of he found out that the hormone regulating the 2014, the NAMMD is also the national competent metabolism of carbohydrates is equally involved authority in the field of medical devices and in lipid metabolism and parotids. The hormone assessment based on scientific criteria adopted Paulescu discovered has also been shown effective through national legislation in force of medical in reducing hyperglycemia and in the treatment technologies for inclusion into the national of diabetes. healthcare insurance system.

1.9. Strong perspectives of present 1.8. Recognised Romanian tradition Romanian R&D in the medicine and and expertise in the field of medicine pharmacy fields and pharmacy Nowadays, Romania is a country with high Romania has a long lasting tradition in medical perspectives in the research and development and pharmaceutical research, with bright talented area, counting more than 30,000 people working

Relocation of the European Medicines Agency 11 in research fields, out of which 18,000 highly are a new type of interstitial cells, discovered skilled researchers. by the famous “telocytes group in Bucharest”, Most of the public hospitals in Bucharest have created by Laurentiu M. Popescu, with possible research departments and clinical training centres implications in the transmission of signals that belonging to the universities of medicine and initiate regeneration. In 2012, telocytes became pharmacy. In Bucharest, there are 1,600 medical an internationally registered brand. The most university teaching staff and around 10,000 active countries in telocytes research are: China, medical, dental and pharmacy students. Italy, Spain, Germany, Belgium, Singapore or the USA. The role of telocytes is today only surmised, Here are some of the relevant research projects in but most likely, their still unknown functions are the Bucharest Ilfov Region: closely correlated with the particularities of their - ELI-NP: The most advanced research facility in structure. the world, focusing on the study of photonuclear - Romania is the first country in Europe in physics and its applications is placed in Romania terms of telemedicine. The national telemedicine (at only 12 km from Bucharest) – the Extreme network includes two command centres, at the Light Infrastructure - Nuclear Physics (ELI-NP). Floreasca Hospital in Bucharest and the Clinical The infrastructure will create a new European Emergency Hospital of Târgu Mureș and 56 laboratory for a broad range of sciences covering hospitals in 19 counties. Thus, doctors at the two frontier fundamental physics, new nuclear command centres provide medical support in real physics and astrophysics as well as applications in time to any of the hospitals in the country and nuclear materials, radioactive waste management, pursue the patient’s vital signs. material science and life sciences. - The „Victor Babes” National Institute - Telocytes

12 Relocation of the European Medicines Agency Chapters

1. Host country – ROMANIA 4.6. Secure life for EMA staff, families and children 2. Host city – BUCHAREST 4.7. Comprehensive and high-quality healthcare I. Assurance that the Agency can be set up on site and take services, public and/or private 25 up its functions at the date of the UK’s withdrawal from the V. Business continuity 74 European Union 5.1. Recognised Romanian tradition and expertise in the 1. Intelligent building in a dynamic market field of medicine and pharmacy 1.1. Real estate market in Bucharest 5.2. Strong perspectives of present Romanian R&D in the 1.2. Proposed EMA Office location medicine and pharmacy fields 1.3. IT&C system of the building 5.3. Business continuity – Romanian approach 1.4. Proposed financial arrangements for the building 5.4. Enabling staff to relocate with their families II. The accessibility of the location 40 5.5. Covering the possible risk of 25% staff shortage 2.1. Enabling scientific experts from all EU and third 5.5.1. National responsabilities to support EMA staff coutries to meet at EMA in Bucharest- Accessibility of the relocation and possible staff shortages new EMA location 5.5.2. International recognised medical and pharmacy 2.1.2. Major international airport Romanian universities providing highly skilled young 2.1.3. Excellent public transport links from the airport graduates to downtown Bucharest 5.5.3. Recruiting temporary IT staff at short notice 2.1.4. Means of transportation in the city 5.6. Time-plan for EMA relocation 2.1.5. Taxi transportation VI. Geographical spread 92 2.1.6. Bicycle Rental 2.1.7. Other transportation means connecting Bucharest Annexes to EU cities Annex 1 – Romania – general facts and figures 2.2. Accommodation for experts and delegates Annex 2 - High quality of life, culture and leisure III. Adequate facilities for children of EMA staff Annex 3 - Other communication systems 50 3.1. Strong educational system Annex 4 – Financial arrangements - CONFIDENTIAL 3.2. Bucharest’s offer Annex 5 - The 12 public universities in Bucharest offering 3.2.1. Nursery and kindergarten foreing language programmes 3.2.2. Primary school and secondary school Annex 6 - The National Agency for Medicines and 3.2.3. Higher education schools Medical Devices activities at EMA level IV. Appropriate access to the labour market, social Annex 7 – Cooperation agreement between NMMDA and 59 security and medical care for families the “Carol Davila“ University of Medicine and Pharmacy 4.1. Brief overview of the Romanian labour market of Bucharest 4.2. How to find a job 4.3. Self-employment 4.4. Romanian Social Assistance Policy 4.5. Employment for families and partners of the EMA staff

Relocation of the European Medicines Agency 13 List of abbreviations

EMA European Medicines Agency

RMoH Romanian Ministry of Health

NAMMD National Agency for Medicines and Medical Devices

EU European Union

CE European Council

BPO/SSC Business Process Outsourcing/ Shared Service Centre

BSS Business Service Sector

BRP Business Relocation Plan

ARCP Action Relocation Continuity Plan

ESRT EMA Support Relocation Team

RSRT Romanian Support Relocation Team

RSRP Romanian Support Relocation Plan

DSRS Department of Support Relocation Services

RTL Romanian Team Leader

LT L London Team Leader

PS - RSRP Project Schedule

RS Relocation Specialist

ANOFM National Agency for Employment

14 Relocation of the European Medicines Agency Host Country Romania

• An EU member for 10 years already; • A strong pro-European Member State, profoundly attached to EU values and principles which has constantly proved its openness and dedication to the European project; • The 7th EU largest country in terms of population; • A multicultural country that hosts various ethnic and religious groups • The 2nd longest EU terrestrial external border; • The largest EU harbour at the Black Sea; • Romania – a country that ranks first as economic performance (5.7%), more than double the EU average (2.4%); • 4th in the EU 28 as lowest level of income tax - 16% income tax and 3rd place in the EU 28 - 19% VAT; • Enjoys stable and reliable macro-economic outlooks, propitious and friendly investment climate; • A country expats and travellers often consider a place of their own, seamlessly blending into a modern European lifestyle; • A multicultural country with high openness for ethnic groups, religion and gender, where one can safely live and work. • Although Romania has an outstanding tradition in multilateral diplomacy, as an EU Member State it does not host any EU agency.

Relocation of the European Medicines Agency 15 Romania - an active presence in Resuscitation and Extrication - SMURD has a international organisations – significant recognized role in the international healthcare elements system, thus Romania being one of the co-organisers of an event in May 2013, dedicated to the launch of Romania has an outstanding tradition in multilateral the WHO Global Alliance for Care of the Injured. diplomacy, with highest professional standards In the past three years, Romania’s delegation to the set by the Romanian prominent diplomat Nicolae World Health Assembly has been an EU and EURO Titulescu, who was twice the President of the League (region) burden-sharer of a resolution, together of Nations – in 1930 and 1931. His legacy has been with Austria and Monaco, on poliomyelitis. inspirational for many generations of diplomats and ambassadors, who served Romania at the UN, Currently, there are 84 diplomatic missions in EU or other international organisations, as great Romania and 13 international organisations have professional and intellectual models. permanent missions in Bucharest. No European Since December 1955, Romania has been a member agency is currently located in Romania. This prompts of the United Nations. Its presence in various bodies us to emphasize that accommodating an EU agency of the UN entitles it to be a part of the decision in Romania would meet the objective set in the -making process within the world organisation that Conclusions of the December 2003 EU meeting influences the international situation at global level at the level of Heads of State or Government and and in proximal geographical areas. confirmed in 2008 that observing a geographical spread of the agencies’ seats at the level of the entire Romania is a founder member of the World Health European Union is desirable. Organisation – WHO (1948) and, over the years, has had good cooperation with this esteemed Romania – a clear economic outlook organization. After 1989, the WHO has been the main partner of Romania in the field of the public health Romania continues its consistent positive economic and supported the reform of healthcare system. trend over the past few years. 2016 was an exceptional In May 2004, Romania was elected member of the year for the Romanian economy, as headline growth WHO Executive Board for a three years mandate accelerated to 4.8%. Furthermore, Romania posts (represented by the minister of health). It is currently highest Q1 2017 economic growth rate in the EU – presenting a renewed candidature for the same 5.6%. position for another three years mandate starting Recently, the Eurostat has confirmed that Romania with May 2018. registered the highest increases in May industrial production (14.6 percent) in the EU and the second Romania has been particularly active within the WHO highest quarterly increases in industrial production framework and has co-initiated or joined significant in the EU (3.5 percent). initiatives in this area. Thus, in May 2007, at the World Health Assembly, delegations from Romania In Romania1, the level of taxation is attractive in terms and Thailand co-introduced a draft resolution on of the single rate of income tax of 16%. Romania healthcare systems: emergency-care systems, the ranks 4th in the EU 28 on the lowest level of income first-ever resolution on emergency care services. tax, after Bulgaria with 10% and the Czech Republic The Romanian Mobile Emergency Service, for 1 National Prognosis Committee, Romanian Ministry of Public Finance, 2017

16 Relocation of the European Medicines Agency and Hungary, with single rates of 15 %. Depending on the number of employees, a special tax rate for SMEs applies - 1% to 3% - for micro-enterprises. Dividents are taxed at 5% final withholding. At the same time, the consumption tax rate is 19% of the standard VAT rate. Romania ranks 3rd in the EU 28, after Luxembourg, with 17%, Malta, with 18% and at the same level of 19% with Germany and Cyprus. Romanian reduced VAT rates for some categories of goods and services contained in Annex III of VAT Directive 2006/112/EC, to mention the relevant ones, are:

• Foodstuff: 9% • Water Supply: 9% • Pharmaceutical products: 9% • Medical equipment for disabled persons: 9% • Books: 5% • Restaurant and catering services: 9% • Social housing: 5-6%

Indicator 2011 2012 2013 2014 2015 2016 2017

GDP growth 1,1 0,6 3,5 3,1 3,9 4,8 5,2

GDP per capita (euro) 6618 6660 7217 7549 8072 8604 9279

Industrial production growth 7, 5 2,4 7, 8 6,1 2,7 1,7 5,4

Household consumption 1,0 0,8 2,6 4,2 5,9 7, 5 7, 3

Current Account (% of GDP) -4,9 -4,8 -1,1 -0,7 -1,2 -2,3 -2,4

Net FDI (% of GDP) 1,4 1,6 1,9 1,6 2,2 2,4 2,5

Budget deficit (% of GDP) -4,2 -2,5 -2,5 -1,72 -1,35 -2,4 -2,96

Inflation rate (end of year) 3,1 5,0 1,6 0,8 -0,9 -0,5 1,9

Inflation rate (yearly average) 5,8 3,3 4,0 1,1 -0,6 -1,6 1,1

Average exchange rate 4,24 4,46 4,42 4,44 4,44 4,49 4,49

Unemployment rate registered 5,2 5,4 5,7 5,4 5,0 4,8 4,3

Budget deficit (ESA) % of GDP -5,4 -3,7 -2,1 -1,4 -0,8 -3,0 -2,9

Relocation of the European Medicines Agency 17 • The 6th largest city in the European Union, after London, Berlin, Madrid, Rome and Paris. • Lively, well-connected and accessible, it serves as the economic, political and social hub of Romania. • The concentration of the largest labour market in Host City the country, with a dynamic and diverse business Bucharest environment with soaring competitiveness indicators. • A heaven for expats. There are great tips on friendly Mobile Apps, designed to maximize the Bucharest experience.

Location: Southern Romania is today a bustling metropolis. Elevation: 55-90 m (190-295 ft) Size: City of Bucharest - 228 sq.km (88 sq. miles); Romanian legend tells that the city of Bucharest was Metropolitan area – 1,521 sq.km (587 sq. miles) founded on the banks of the Dambovita River by a Inhabited since: 500 BC shepherd named Bucur, whose name literarily means First documented: 1459 AD “Joy”. His flute playing reportedly dazzled the people Population: 1,883,425 million as of 2011 Census and his hearty wine from nearby vineyards endeared him to the local traders, who gave his name to the In Bucharest, three elements express the city’s place. specific identity: Bucharest, the capital city of Romania aims at 1. Its architecture - what people, in their option, becoming one of the European regional hubs for have considered valuable for decades and which business and tourism and an important centre continues to be the décor of the city today. for higher education. Taking into consideration the achievement of such goals, local development 2. The urban landscape - resulting from the merging programs are integrated with the European strategy of all the floods and voids in an area, colors, that aims at providing the appropriate environment vegetation, heights and construction materials of for a sustainable economic growth. which the buildings that shine in the sun are built. The local strategy is focused on five goals: 3. The contexture of the streets - which gives us employment, research, education, poverty direction, momentum and adventure. eradication and energy – climate.

In historical areas, the three elements form urban harmonies that express a specific identity. Known for its wide, tree-lined boulevards, glorious Belle “Today’s Bucharest is a lively city with Époque buildings and a reputation for the high life remarkable Belle Époque buildings and a (which in the 1900s earned its nickname of “Little reputation for high life” -TeBe Paris”), Bucharest, Romania’s largest city and capital,

18 Relocation of the European Medicines Agency Bucharest is a bargain. In just few European countries there are affordable houses like in Romania. Even more important, Romania is growing rather rapidly, so there is upside potential. For investors with exposure to Romania, the gross rental yields are good with low to moderate risk. A new home city cannot be ‘at home’ without proper housing facilities – Bucharest means convenient living costs and high quality of life for expats. Over the past years, the real estate market has experienced a major expansion trend, hence the moderate buying costs and convenient rental prices.

To support the Europe 2020 Strategy, an economic governance system has been established, aimed • at coordinating political actions at European and • national level. The Europe 2020 Strategy suggests • the signing of territorial pacts that can contribute • to eliminating disparities and lending a territorial • dimension and responsibility. • A total of 28 capitals of the European Union, including • Bucharest, welcome the European Union’s initiative • of giving way to direct dialogue by conferring these • cities the status of partners by ratifying the “Smart, • sustainable and inclusive growth: EU Capital Cities • – essential partners for Europe 2020” declaration at • Brussels. This declaration marks the passing to a new • level of cooperation in Europe. • At present, Bucharest is the most sustainable town • in Romania with highly skilled employees working • for both national and multinational industries, • mainly characterised by high competition. The life • quality of the Bucharest population and also of the • region has improved year by year due to the city’s • investments in transport and traffic for passages, • parking lots, the water and sewage network, public • lighting, schools and hospitals, theatres and parks. • • • Housing market and living standards in • Bucharest for EMA staff and their families • • Characteristics of the Bucharest housing market: • • Buying costs are moderate in Romania • • Moderate to good rental yields in Bucharest • • Romanian law is pro-landlord • • Risks: currency risk

Relocation of the European Medicines Agency 19 TRANSACTION COSTS2

Who Pays?

Stamp duty 0.50% - 3% buyer

Notary fee 0.44% - 2.20% buyer

Registration fee 0.50% - 2% buyer

3% buyer Real Estate Agent´s Fee 3% seller

Costs paid by buyer 4.44% - 10.20%

Costs paid by seller 4% - 6%

ROUNDTRIP TRANSACTION COSTS 8.44% - 16.20%

As shown in the Table above, houses and apartments are not expensive in Bucharest, at an average of 1,500 euro per square metre (sq. m.), purchase price: • a 120 sq.m. apartment in Bucharest will cost around 190,000 euro • a 70 sq.m. apartment in Bucharest will cost around 106,000 euro

Assumptions for price calculation: • Prices primarily represent very well-kept apartments. • We have used the “useful area” instead of the “built area” computed for sq.m. prices because apartments situated in old residential buildings were included.

Moderate to good rental yields in Bucharest:

COST (€) PRICE/SQ.M. (€) BUCHAREST - flats3 YIELD (p.a.) TO BUY MONTHLY RENT TO BUY MONTHLY RENT

70 sq. m. 106,050 552 6.24% 1,515 7.88

120 sq. m. 190,920 966 6.07% 1,591 8.05

20 Relocation of the European Medicines Agency High quality of cultural life, entertainment and leisure

Citizens, expats and visitors of Bucharest are no strangers to recreational activities ranging from traditional “shopping arcades”, cinemas, parks and public gardens, thermal spa facilities, or various types of restaurants offering unforgettable culinary experiences. Bucharest hosts 36 museums and public art collections, 2 opera institutions, 23 dramatic theatres, 1 Musical Theatres, Operetta, 1 Puppet Theatres / Animation and 3 Philarmonics.

The Cultural Scene of Bucharest

Bucharest’s cultural life is a rich mix of strong traditional culture, represented by a performing arts sector - theatre, opera, dance and music - as well as a large and diverse network of museums and mass culture, represented by an increasing number of open air festivals, concerts and events and a rapidly developing contemporary arts scene (for details, see Annex 2 –Bucharest, Culture and Leisure). Moreover, there is a growing number of cultural operators from the entrepreneurial sector. These include, besides the traditional areas of cultural industries such as multimedia, cinema, audiovisual, music, publishing, cinema, the more edgy domains of video games, interactive media, design, craftsmanship, architecture etc. Based on recent evaluation of the creative economy sector in Romania, Bucharest is the national leader in cultural entrepreneurship.

The arts and culture sector has different types of cultural structures, each with its own organisational, economic and artistic characteristics: municipal and national cultural institutions, independent organisations and private ones. Although all equally important as part of the cultural ecosystem of the city, they are in fact separate phenomena.

The Bucharest cultural institutions of European fame are: The National Peasant’s Museum — a member of the International Council of Monuments and Sites ICOMOS and the 1996 European Museum of the Year; the Bulandra Theatre — a member of the European Theatre Union since 1992; the Bucharest National Theatre — a founding member of the New European Theatre Action NETA network; the Romanian Youth Cultural Centre — a member of the European Federation of National Youth Orchestras.

The European presence is also felt in the numerous cultural events organised in cooperation with the cultural institutes of other EU states. The French Institute is one of the several cultural agencies promoting foreign culture in Romania, through its network of institutes and cultural centres located in the main cities. The German Goethe Institute, the Italian (Vito Grasso) and Spanish (Cervantes) institutes and the Hungarian Cultural Centre, just to name a few of the cultural institutes present in Bucharest, support cultural life through seminars, conferences, festivals, concerts, exhibitions etc, by funding a variety of independent projects and supporting various programmes and projects, along with public and non-public institutions.

Relocation of the European Medicines Agency 21 Excellent IT&C for an excellent future of Gigabit society

• Romania ranks first among European countries with the highest average peak internet connection speed (Q3, 2016). • Bucharest is the largest start-up hub in the country with over 130 start-ups and the home of many tech companies and VC firms as well as universities focused on technology, engineering and software development. • The Romanian IT&C market has a consolidated value of over 5 bln. EUR, contributing to the dynamic evolution of the GDP. • Communication services tariffs are among the lowest in Europe, ensuring a high quality/ price ratio. • Mobile voice and data services tariffs are between 2 EUR/month and 9 EUR/month. • Fixed internet tariffs do not exceed 11 EUR/month for services with speeds up to 1000 Mbps through optic fibre. • Convenient and reliable mobile and data subscriptions are commonplace for those who live in Romania, as they enjoy some of the most competitive prices for telecommunications in the EU. 1 Among the lowest communications Internet speed in Bucharest services costs in Europe

1

119Mbps 106Mbps No.1 11Euro/Month 9Euro/Month Internet service Voice and data services Average download Average upload Maximum internet maximum cost maximum cost speed speed speed in EU in 2016 (speeds up to 1000 Mbps through optic fibre)

The Romanian IT&C market has a consolidated value of over 5 bln. EUR, contributing to the dynamic evolution of the GDP. A number of widely established communication services and connectivity providers as well as local players of regional dimension currently provide services in Bucharest. Some of the names are Orange, Vodafone, Telekom, RCS & RDS, UPC, Euroweb, GTS Telecom and Prime Telecom. The range of services provided is large, covering “traditional” services such as fixed and mobile telephony, internet access,

22 Relocation of the European Medicines Agency broadcasting and video&data transmission as well as added value-services including security or IT support. There are 4 operators providing mobile communications with national coverage: Orange, Vodafone, Telekom, RCS & RDS, ensuring a highly competitive environment for service provision. All have 100% coverage over the city with state-of-the-art 3G and 4G technologies such as HSDPA, HSUPA, LTE and LTE Advanced, helping them sustain high data transfer rates.

The extensive high capacity mobile coverage is doubled by the introduction of advanced service features such as VoLTE – high quality of the voice service and simultaneous voice and high capacity data transfer or WiFi calling – extending indoor mobile coverage via WiFi access.

Romania has already started preparing for 5G, which will add increased transfer capacity and wider range of services. The NRA has launched a public consultation regarding the competitive selection procedure related to award of additional radio frequencies, aiming to allocate them as soon as feasible, to be available for the rollout of 5G mobile networks.

One of the strong points of Bucharest’s communications infrastructure is the wide spread of optic fibre networks, leading to superior internet access and data transmission rates, the foundation of the future Gigabit society. Bucharest’s NetCity project, the underground infrastructure for optic fibre, is an innovative

Relocation of the European Medicines Agency 23 project and one of the large investments made in the city’s communications infrastructure, in line with the European socio-economic development policy for local communities.

Bucharest hosts several public data centres of European dimension, able to assure optimal collocation and/or operation of equipment, including back-up and disaster recovery services, as well as high capacity connections with European and global content and connectivity providers. Two public internet interexchange points operate in Bucharest, ensuring strong connectivity with ISPs active at national level as well as with global carriers; this is helpful in providing reliability and redundancy of communication paths.

From the perspective of the costs related to provision of communication services, due to the increased competitiveness of the Romanian market, the tariffs of communication services are among the lowest in Europe, ensuring a high quality/price ratio. Thus, on the retail level, usual tariffs for mobile voice and data services are between 2 EUR/month and 9 EUR/month, while usual tariffs for fixed internet do not exceed 11 EUR/month for services with speeds up to 1000 Mbps through optic fibre.

Regarding the quality of the internet access service, international studies place Romania at the top of the world’s high-speed internet. Thus, according to the latest “State of the Internet” connectivity report conducted by the American group Akamai, for the first quarter of 2017, Romania ranked second among European countries with the highest average peak internet connection speed. The average peak speed in Romania was 95 Mbps in the first quarter of this year, up 15% over the same period of 2016. These data are also confirmed by the measurements made using the speed measurement application made available to users by the NRA, Netograf.ro. According to it, in the first quarter of 2017 the average download speed for fixed internet in Bucharest registered 119 Mbps and the average upload speed 106 Mbps. At the same time, the average download speed for mobile internet was 34 Mbps and the average upload speed was 14 Mbps.

It should also be added that fixed internet is provided by the main companies offering services in Bucharest at speeds between 500 and 1000 Mbps. The other communication systems ( WiFi, phone communication, post ) are presented in Annex 3.

• Deliveries of retail, logistic and office spaces stood at 956,000 square meters in 2016, up by 88 percent compared to 2015, marking the best year for the Romanian real estate market since 2008. • Second cheapest office rental rate in the EU - on average 18 €/sqm41

4 2016 EHL study

24 Relocation of the European Medicines Agency In terms of geographical distribution, the highest contributors to the stock are Floreasca-Barbu Vacarescu (42% of total deliveries), Dimitrie Pompeiu (26% of total deliveries) and the Central West Assurance that the Agency can Area (24% of total deliveries). In total, these zones be set up on site and take up accounted for 92% of the total deliveries in the its functions at the date of UK’s market. These areas have developed considerably in the post-crisis years as accessibility, transportation withdrawal from the Union and proximity to amenities started to rank higher in tenants’ requirements. Across all real estate sectors, approximately 60 % of facilities were built in Bucharest and around the capital. 1. IntelligentI building in a dynamic market Demand6 1.1 Real estate market in Bucharest Total take-up in the market for 2016 reached 369,000 sqm, up by 52% compared to the previous year. IT and The year 2016 was one of significant increase in all BPO/SSC were the main drivers behind this expansion segments of the real estate market, apart from office and accounted for a total of 50% of transactions. In space located outside of Bucharest, a segment that fact, we estimate that more than 20,000 people were had already seen record deliveries in 2015. hired in these sectors during 2016, which would mean that IT and BPO/SSC are on their way to becoming Supply52 the largest employers in Bucharest, outpacing employment in retail trade. The stock of modern office spaces in Bucharest has reached 2.1mn sqm, after registering new deliveries Demand for office buildings has been the strongest of 230,000 sqm during 2016. In fact, the volume of in already established areas such as: Floreasca Barbu new deliveries marks the fastest pace of expansion Vacarescu (13% of total demand), Dimitrie Pompeiu since 2009 and is 112% more than the yearly average (17%) and the Central West part of the city (24%). of deliveries in the post-crisis period. By all means, Bucharest office market is shifting gears. One of the Regarding the area between Calea Floreasca and explanations for this increased volume of deliveries Barbu Vacarescu, the demand is starting to outpace is the focus on large projects (with GLAs larger than the volume of office space on offer, as the vacancy 25,000 sqm), which accounted for 60% of the total rate continues to decrease rapidly. volume of deliveries in 2016. At the same time, there Looking at the broader market, it is clear that tenants is an increase in the number of pre-lease transactions continue to have the upper-hand. Net take-up during in the market. During 2016, pre-leased transactions 2016 reached 166,600 sqm, which covers 73% of the accounted for 82,100 sqm (up by 200% compared to area delivered to the market in the same period. It the post-crisis average). is expected that supply will outpace demand during 2017, which will invariably increase competition in the market. 5,6 Colliers market Report, 2017

Relocation of the European Medicines Agency 25 Hewlett-Packard, Honeywell, Idea Bank, JTI, 1.2. Proposed EMA Office location Lavalin, Luxoft, NBG Group, Nestle, Netherland’s Embassy, Procter&Gamble, Saipem, Stefanini, Benefits of the offered location: Xerox. • Globalworth Campus is the number one spot • Has all legal construction permits and complies in Dimitrie Pompeiu Boulevard, in terms of both with Romanian construction regulations which business and leisure. It is close to the Herastrau require, as essential conditions for buildings: Park, the largest park in Bucharest, to top well- mechanical resistance and stability, operational known music clubs, restaurants and other modern safety, fire safety, hygiene, health and environment, amenities. noise protection and sustainable use of natural • Access to a full suite of service providers for the resources. initial implementation phase in case of encountered • Brand-new building to be completed by the end limitation or deliver a full working new EMA building of 2017, with state-of-the-art IT&C infrastructure, in time: accross the street, Regus type services served by local and international well known are offered on Dimitrie Pompeiu 5-7 and Dimitrie providers. Pompeiu 9-9A, only in exceptional cases there • Attractive financial arrangement for the Lease are delays in time building delivery or relocation Contract. process. • Energy Efficiency: the technical and legal characteristics of the building meet the construction standards for Green Buildings such as BREEAM Excellent. • No other office space development in Bucharest balances work and life so clearly as the modern concept offered by the Globalworth Campus. 10’ 15’ 16’ • Residential complex at walking distance, with more To To To than 400 dwellings to rent or buy. Government City Centre Airport • Excellent access: The airport is located aprox.12 km away and can be reached in 16 min. DESCRIPTION OF THE LOCATION • Family members have nearby possibilities to work Address: 4-6 Dimitrie Pompeiu Boulevard, for some of the selected blue chip tenants in 1st District. Situated in the Northern part of the capital city of Romania, Bucharest, the area: DB Schenker, Deutsche Bank, Deutche with excellent access to all types of Telekom, EFG Eurobank, eValue, Genpact GFK, transports: subway, tramway, car, bycicle.

26 Relocation of the European Medicines Agency Globalworth Campus is located at the heart of the most dynamic business district in Bucharest. The new up- and-coming Floreasca – Dimitrie Pompeiu area is situated in the northern part of the city, in the traditional corporate zone of the Romanian capital. With a rich history in attracting and retaining blue chip tenants such as Honeywell, Deutsche Bank or Hewlett Packard, Bayer, Abbott, Sanofi, Merck, Dimitrie Pompeiu has risen to prominence as one of the first choices for multinationals in Bucharest.

A state-of-the-art development, the real estate project Globalworth Campus perfectly balances office, retail and other supporting amenities. The project effortlessly brings in a new concept of office spaces, which combines high technical and environmentally friendly specifications, green areas and a dedicated commercial component and residential. A conference centre completes the mix, providing the infrastructure for a continuous learning process for companies and employees alike.

The Globalworth Campus is an integrated real estate project and is the result of the convergence of commercial excellence and modern hardscapes softened by green areas and water features. There are numerous opportunities for relaxation or network building in the project’s bistros, cafes, or shopping areas.

Relocation of the European Medicines Agency 27 Campus facilites: The Campus enjoys a large variety of restaurants offering local and international cuisine as well as several coffee shops (including Paul, Starbucks or similar). The onsite amenities include the largest gym/spa in Bucharest (Worldclass), a supermarket (Mega Image), bank branches, private kindergarten and after shool „Junior School”, pharmacy (Sensiblu) etc. Globalworth Residence: Upground Towers is a modern residential compound located within walking distance from Globalworth Campus. With a height regime (GF+16F), GLA (sqm) 58,913 comprising 571 units, the project offers for sale and for renting 435 spacious apartments (on average 120 sqm per dwelling), with underground parking spaces for 617 vehicles.

Nearby facilities: Retail: A short journey west of the property lies Promenada Mall, a 36,000 sqm shopping centre catering to the needs of the individuals working in the area. Hotel accomodation: 5-15 walking minutes distance from the Dimitrie Pompeiu building location there are some 4 star hotels with a total of 606 rooms: the Caro Hotel (184 rooms), the Cristal Hotel (74) , the Phoenicia Hotel (348 rooms). New hotels are under development such as the Europa Royal on Dimitrie Pompeiu Boulevard.

CAMPUS PROPERTY DESCRIPTION The project perfectly blends in office, retail and other functions in an 88,000 sqm GLA (Gross Lettable Area) development. Built in 2 phases, Globalworth Campus will incorporate the latest technologies and flawless functionality, in order to deliver the very best of office experiences. With a 2,400 sqm floor plate, the development will have a 320 employee floor efficiency and a 1 to 80 parking ratio. It will be anchored by a 3,000 sqm retail gallery and a 720 seat conference centre which, combined with its unique running trail, will make it the focal point of Bucharest’s new CBD. At the end of the construction, Globalworth Campus aims to achieve a BREEAM Excellent certification.

28 Relocation of the European Medicines Agency TECHNICAL DESCRIPTION OF THE PROPOSED EMA BUILDING Building at a glance:

Building management system with full control Dedicated chiller backed up by generator of the equipment and billing system for for server rooms utilities, parking with controlled access Sprinkler system in all common Four pipes independent HVAC system with fan-coils mounted on the ceiling Easy orientation by proper signalling of the 2.8m clear height with built-in HVAC systems, parking, entrances, lobbies, common spaces, elevators and exits

Emergency generator for the vital systems and common areas of the building ALL COMMON AND TECHNICAL AREAS USE Telecom and internet services MODERN SYSTEMS THAT COMBINE HIGH 24h/7 days security and safety PERFORMANCE AND EASY Control access and video surveillance system MAINTENANCE WITH ADEQUATE STANDARDS AND ARCHITECTURE

Interior hydrants and sprinkler system

Efficiently organized areas with very few waste of common spaces Public announcement system Central lobbies and staircases efficiently

partitioning and the decorating of the Energy-saving heating plant requirements of each tenant (boilers with condensation)

Energy saving Air Handling Units with heat recovery and free cooling High performance solar control panes with advanced thermal insulation properties (SGG Cool-Lite ST 120)

Relocation of the European Medicines Agency 29 The project is designed to incorporate the latest workspace technologies. Globalworth Campus has a flexible layout all the while implementing state-of-the-art technology. The property can accommodate multiple tenant requirements, on site facilities and activities. The proposed building is Tower 2 on the Site Plan below and is part of the already mentioned integrated development project, “Globalworth Campus” consisting of : 3 Class A office buildings; one Conference Hall for 720 seats, parking – under and on the ground parking lots, commercial spaces, green spaces and within walking distance, the residential complex with more than 400 dwellings.

SITE PLAN

ACCESS

TOWER 3 CONFERENCE 2S + P + 12E + Th FIRE TRUCK ACCESS UNDERGROUND HALL CAR ACCESS UNDERGROUND COVERED WITH GREEN AREAS CAR ACCESS

ACCESS

TOWER 2 FIRE TRUCK 2S + P + 12E + Th ACCESS UNDERGROUND CAR ACCESS ACCESS ACCESS ACCESS

FIRE TRUCK ACCESS TOWER 1 2S + P + 12E + Th

PIPERA FIRE TRUCK ACCESS

PUBLIC PUBLIC ACCESS ACCESS

DIMITRIE POMPEIU BLVD.

30 Relocation of the European Medicines Agency STRUCTURAL SYSTEM FEATURES This office building is located in the northern part of Bucharest, with a height of maximum 60m. The structure has two basement levels, ground floor, 12 floors and one technical floor.

It is a well-balanced, reinforced concrete structural system, with a central shear wall tube and ductile frames. The structural system will allow large openings and provide maximum flexibility for interior design and partitioning.

Seismic resistance: The building is designed for a ground acceleration of 0,24g, in accordance with Romanian Legislation regarding such type of building.

The total Gross Building Area is 36,740.80 sqm with a total office area of 27,431.43 sqm.73

Total rentable area Floor Gross Building Area (sqm) (sqm) Technic Floor 250.00 0.00 12 Floor 2,265.90 2,215.09 11 Floor 2,265.90 2,215.09 10 Floor 2,265.90 2,215.09 9 Floor 2,265.90 2,215.09 8 Floor 2,265.90 2,215.09 7 Floor 2,265.90 2,215.09 6 Floor 2,265.90 2,215.09 5 Floor 2,265.90 2,215.09 4 Floor 2,265.90 2,215.09 3 Floor 2,265.90 2,215.09 2 Floor 2,265.90 2,215.09 1 Floor 2,265.90 2,215.09 Lobby 1,529.00 695.45 -1 Floor 3,885.50 79.89 -2 Floor 3,885.50 74.99 TOTAL 36,740.80 27,431.43

7 Based on BOMA measurements. Apart from the rented offices, the final rented surface consists also from the added underground car park (about 7.500 sqm), the reception and commercial spaces.

Relocation of the European Medicines Agency 31 6 high speed elevators servicing the office tower and two basement elevators Four pipe HVAC system with a fresh air supply of 7.5 mc / h / sqm

Highly flexible fit-out

Openable windows

Clear height of 2.8m

Floor loads: ceiling supplied with chillers and boilers. The system allows flexibility to distribute heating and cooling Romanian legal provisions are aligned with the loads in the building as per tenant requirements and Eurocode and the design floor loads for offices are: also allows heating and cooling at the same time for - LIVE LOAD: 3.00kN/sqm the intermediate seasons of spring and autumn. - Special loads are taken into consideration for the The boilers will be made of stainless-steel with design of technical rooms – live loads of 7.50 kN/ pressurized fireplace, mounted on a chassis, m2 (specific area designated for this purpose on the connected in cascade, using the benefit of condensing current floor with an area of max 5% of the total floor technology for better efficiencies and will produce rentable area). thermal agent, by LowNOX modulated burner, functioning with natural gas. MECHANICAL & ELECTRICAL FEATURES The cooling plant consists of two air-cooled chillers (2 screw chillers) and one drycooler. The cooling plant HVAC SYSTEM DESCRIPTION is capable of supplying proper cooling agent to the tenant terminal units to assure cooling needs in winter Heating and cooling: time by means of freecooling using the drycooler. Heating and cooling of the building is achieved with a 4 Additional to these chiller units, the buildings provides pipe system with fan coils placed above the suspended a dedicated chiller for IT equipment cooling that will

32 Relocation of the European Medicines Agency be able to run in winter conditions (it’s equipped with exhaust, access control and anything else required low ambient kit) to assure the base cooling of small IT by local laws and regulation. UPS will be available for rooms. uninterrupted operation of the fire detection and HVAC PARAMETERS (DRAFT) access control. Provisions will be available for the tenants to install their own UPS. External design conditions: Winter: temperature -15°C Lighting Design: Winter: relative humidity 90% Summer: temperature +35°C For the office areas, high class lighting fixtures are Summer: relative humidity 38% used, designed for mounting into ceiling grids (600 x Internal design conditions: 600 mm), with florescent tubes and electronic ballast. Winter: temperature +22°C±2°C Decorative lighting of various types plus recessed Winter: relative humidity 30% - 50% lighting will be used for reception areas, lobbies and Summer: temperature +24°C±2°C other common spaces. Summer: relative humidity 40%-60% Design Occupancy: The lights for the common areas are controlled by Open space: 1 person/6 mp (for max 80% of carpet BMS double with motion sensors and in the office area) area are controlled by traditional switches and by Meeting rooms: 1 person/3mp (for max 20% of carpet light sensors (first row near the façade) based on area) green accreditation requirements. Fresh air: 7.5mc/h/mp (carpet area) The interior lighting is designed with the following ELECTRICAL SYSTEM DESCRIPTION parameters (average lighting Em) General offices: 500 lux at 0.8m Electrical supply distribution: Lift lobbies: 250 lux at 0.0 m Toilets & staircases: 150 lux at mirror / at 0.0 m for The electrical power is distributed from the main staire case electrical panel through vertical electrical bus bars Storage rooms & parking: 100 lux at 0.0 m providing flexibility and allowing easy match with specifications and power requirements of every client. SANITARY SYSTEM FEATURES

Generators&UPS: Hot and cold water; sewage and drainage: Preparation of hot water is done through the locally The building is provided with 2 back-up generators placed boilers. All toilets are equipped with high working in parallel and synchronized that can sustain quality sanitary objects, all with incorporated water the vital systems of the building as per local legal tank “type Geberit”. All taps are provided with motion requirements. The electrical back-up supply will be sensors for reduced water consumption. All the designed to cover the following: emergency lighting, fixtures will have low flow or low flush feature. 30% of the lighting of the building, 2 plugs per person For sewage and rain water drainage systems, high in the office areas (assuming occupancy of 1person quality PE are used to ensure durability and noise per 8sqm), fire detection system, pumping stations for reduction. sprinklers and hydrants, emergency elevators, smoke

Relocation of the European Medicines Agency 33 Hydrants and sprinklers: Building management system: Fire protection of the building is achieved through hydrants, dry risers and dual layer sprinkler systems The building is provided with automated building that are covering all offices and common areas. management system that integrates and monitors the building systems and controls the energy consuming BUILDING’S SECURITY FEATURES systems such as heating and cooling, generators, pump stations, emergency systems, AHU. Access control: The access control system in the building is provided CCTV with turnstiles at the reception area ensuring The building common areas and exteriors are restricted access to office areas. The system is monitored through video surveillance system with

modular. All technical spaces are access-controlled latest technology cameras placed on all entrances, and secured and evacuation staircases are open only ramps, basements, exterior etc. with high area in emergency. coverage and very detailed information that is stored A special security control room, close to the lobby in NVR devices. The CCTV system complies with the entrance, will be put in place for the access control EDP (28 days retention capacity). system and CCTV system control office. According to the EMA requirements provision of Fire detection alarm: natural or build barriers shall be placed in the building A fully addressable fire detection system will perimeter. be available, with battery back-up in all areas in

34 Relocation of the European Medicines Agency accordance to fire legislation in force. The free floor heights are set as follows: Public address system: - Ground Floor - minimum 4.30m - Floors and office For the efficiency and operation of the building a areas: minimum 2.80m modern public address system is installed in all public areas for all kind of announcements. Raised floor: For the accommodation of under floor cabling and TELEPHONE AND INTERNET PROVIDERS floor boxes, raised floor will be provided for all office Access for all local telephone and internet providers areas. Raised floor will be medium duty, H=15cm will be available in the building by means of two calcium sulphate incombustible as per requirements connections to the NetCity network. The building has of local legislation. UPS power for all technical rooms, able to support all IT equipment for 60 minutes. Lifts: The building has the technical posibility for IT network The building is provided with 8 lifts as follows: in all offices and meeting rooms with 2 connections - 6 high speed lifts of 24 persons (1800kg) capacity for for each workstation for redundancy. WiFi on all floors the office tower, out of which 2 are for firefighters in throughout the premises. emergency cases, speed 2.5m/s - 2 lifts exclusive for the parking levels (1, 2) FINISHES & ARCHITECTURE FEATURES - the lifts are low voltage, to assure energy efficiency Building envelope: of the building. All office spaces are provided with natural light as all the building is surrounded with curtain wall façade. Entrance/ground floor: The curtain wall is designed to build a more sustainable The main lobby of the office building is easily accessible and low-energy building using semi-structure high from a large platform connected with Dimitrie thermo-insulation Aluminium system at the same Pompeiu Boulevard and George Constantinescu Street time insuring maximum resistance to wind loads. through a large entrance with revolving door and two The system selected is modular, the most suitable adjacent escape doors. This space is also accessible by for high rise buildings that allows quick installation, two escape doors on the secondary façade, in direct easy maintenance and durability. The glass used is relation with the green spaces and the interior street sun reflective in order to ensure maximum thermo- of the ensemble. insulation and improved thermal coefficient at the Depending on the tenants’ requests, the main lobby maximum extent. Materials used: modular facade will be furnished with modern high quality materials: Schuco UCC 65 SG; glass: Saint Gobain Cool Lite ST special lighting, large ceramic/ glass panels and 120. metalic perforated panel - cladding on the walls, high quality ceramic on the floor, elegant reception front Ceiling finishes&free floor height: desk, all the security requirements. Suspended ceiling system with tiles 600x600mm The Ground Floor of the building could accommodate in the office space with normal level of acoustic different dedicated spaces, according to the final absorption and attenuation and variable sizes for specification, with different access door from those of common space with high level of acoustic absorption the lobby. The areas between the exterior sidewalks and attenuation. and the interior parking or car routes are covered with green grass and trees.

Relocation of the European Medicines Agency 35 Tenant facilities: On each floor, the common spaces are provided with two groups of restrooms and one restroom for disabled persons. There is a waste management system in place with recycling system throughout the building. There is provision for one kitchenette on each floor with direct access from the office areas with totally independent ventilation system. There is an area dedicated for server/storage/archive room on each floor with direct access from the office areas and with all the requested provisions (increased loading capacity, provisions for cooling from separate chiller). The lighting of the common spaces as well as the water supply from sink taps are provided with motion sensors, energy efficient, equipped with low flow equipment. Additional fire security through dual layer sprinkler system is provided. The parking area has a specialy equiped area for bicycles for sole use for : 100 spaces, 7 showers, 2 changing rooms. Provisions for the disabled: The building is equipped with all necessary items for disabled persons: - There is one toilet for disabled persons on each floor; - There are special parking places dedicated to disabled persons; - The access in the building is easy as the Ground Floor level is connected with the exterior level through a dedicated ramp. EXTERIOR The exterior of the building meets a nice environmental landscape with great access organization both for car access and for pedestrians, lots of green areas, benches etc. There is easy access from Dimitrie Pompeiu Blvd as well as from George Constantinescu Street. Car access is controlled with barriers. The exterior lighting offers nice exterior environment and safety. GREEN CERTIFICATION The building is designed and constructed to be one of the most environmentally friendly buildings in Bucharest. The project boasts with being one of the buildings in Romania candidate for achieving BREEAM Excellent Certification. This target was set from the design stage with high end furnishings, façade and installations and using innovative design solutions. ACCESS TO THE BUILDING In time, the Central Business District of Bucharest (further mentioned as CBD) has evolved from Victoriei Square (now considered old CBD), to the current location due to the development of new and modern logistics, especially easy access to all means of transportation. Among multinational companies relocated to the same area, we can mention: Honeywell, Vodafone, Bayer, Orange, Schnider, Carrefour etc. Globalworth Campus and the porposed Tower 2 EMA building is located only 3 metro stops away from Victoriei Square and is easily accessible by over-the-ground means of public transportation (trams 5 and 16). The Pipera metro station sits directly in front of the property, while car access is via Dimitrie Pompeiu Boulevard. The Campus also celebrates sustainable and green commute options, offering secure bike storage, changing rooms and lockers.

36 Relocation of the European Medicines Agency The underground transportation map

PIPERA GLOBALWORTH CAMPUS Promenada Mall M

Herastrau Park

Aviatorilor Triumph Arch LEGEND Romanian Piaţa Victoriei Government EDUCATIONAL

LANDMARK BUILDINGS

RETAIL Bucharest University of Economic Studies PARK Piaţa Romană Romanian Athenaeum

Bucharest National Theatre

University of Bucharest Universitate

OLD CITY CENTER

Unirea Shopping Center The Palace of Parliament

Piaţa Unirii

Tineretului Tineretului Park

Sun Plaza Mall M2 Metro Line

Piaţa Sudului

HIGH STANDARD MEETING FACILITIES Apart from the specific meeting requirements for the EMA building, the Globalworth Campus offers a 720 seat conference hall, one of the highest standard meeting facilities. The conference hall is a sound proof space with state-of-the-art equipment such as: audio and video recording facilities, input for laptop, equipment to generate broadcast, UPS power and cetral air conditioning system. Special security arrangements will be put in place considering the client’s requirements.

Relocation of the European Medicines Agency 37 1.3. IT&C of the building

• Excellent telecommunications network with high capacity digital network provided using two secured underground connections viaMetropolitan Network (Netcity8).4The network can support any speed transfer. • Connectivity: mobile cellular communications of the building, including Internet access, are covered by

indoor 4G signal repeaters; superfast broadband fixed and Wi-Fi Internet access are also available via optic fibre in-house wiring and indoor Wi-Fi access network. We can also provide indoor wireless network coverage for LAN infrastructure. • International (and local) IT provision of Data Centre facilities is supported by at least 5 different IT providers of Tier 3 or above data centres in Bucharest (i.e. IBM, CloudFlare, M247, Telekom, Omnilogic, StarStorage, etc.). They can provide a main and a backup data centre for disaster recovery, both to be accessed from the EMA premises via a fast high volume Internet access fibre connection. • Minimum two Tier 3 data centres (with collocation options) in geographically independent locations (power grid, flood zones). • Green energy standards ISO 14001, 50001 are available and subject to the EMA selection process of suppliers for the data centre. • Security&operational standards ISO 27001, 9001, SSAE16, PCI-DSS: most suppliers are fully compliant with mentioned standards, the suppliers’ selection process will consider the mentioned standards. • Ideally, Microsoft ExpressRoute & Direct Connect connectivity: the mentioned requirement is on request at

8 NetCity is the Bucharest City Hall project to help digitize the capital city of Romania. It provides for the transfer of underground cables within the project area (final projected length of around 1,400km)

38 Relocation of the European Medicines Agency Microsoft. The building is located 200 m away from the two most important Romanian neutral collocation centres, NX Data 1 and NX Data 2. They can provide direct circuit connections, considering Microsoft has the mentioned service. Other 5 data centres are located within 800 m. • Adequate carrier infrastructure, both for campus, data centre and home working facilities (may require selection of Tier 1 carriers): two internal optic fiber rings and two different underground entrances, secured, for providers. Each entrance comes from a different street, from different points of the metropolitan undergrounded network. • Ability to cater for a disaster recovery site requirement in a geographically independent location (power grid, flood zones) from the main campus: the location has the possibility to implement such a requirement, based on more detailed EMA specifications.

1.4. Proposed financial arrangements for the building

In Annex 4 to the present document, subject to confidentiality, are presented the main commercial terms proposed for the Lease Contract. The information and prices are subject to final arrangements with EMA representatives. Apart from the Lease Agreement, the mentioned Annex 4 includes also the Romanian Goverment’s commitment to support the EMA.

Relocation of the European Medicines Agency 39 time electronic display, accessibility for passengers with disabilities) – fare for 2-trips: approx. 1.1 € Competitive taxi services - Average Taxi Fare: 0.45 €/km Extensive network of public bus, trolley bus and tram The accessibility transportation – fare for one-trip: approx. 0.30 €. of the location 2.1.1. Major international airport hub serving all EU Member States (MSs) in maximum 3-4 hours flight time, with high 2.1. Enabling scientific experts from all EU flight frequency and carrier choice. MemberII States to meet at EMA in Bucharest Major international airport hub – Henri Coanda • International Henri Coanda Airport provides Airport Bucharest (OTP) located at 12 km from EMA multiple daily flight connections which will allow headquartes and serving all EU Member States EMA experts and visitors to travel to-and-from within 3-4 hours flight time, with over 220 direct all EU Member States to Bucharest and connecting flights per day • Perspectives to relaunch direct long haul services from Bucharest to destinations in North The Henri Coanda International Airport will be America and Asia, operated by the Romanian national air carrier, TAROM connected to the existing Metro network, by • Excellent corporate commercial offers completion of Line VI running from Bucharest - provided by TAROM, in its entire domestic and Otopeni - Henri Coandă International Airport, the international network, at competitive fares Line providing for a transport capacity of 50,000 • Within 3-4 hours flight time, direct or connecting passengers/hour/direction. regular flights operating from the “Henri Coanda” International Airport Bucharest to 84 European destinations in 29 countries, out of which 23 Special dedicated line of transportation for EMA European capital cities. staff and delegates There are non-stop flights to Bucharest from most major The Municipality, through the Autonomous Public European cities and in the Middle-East and connecting Entity for Transportation, can provide, using its own flights from the United States, Canada, Australia and New means of transportation, a special dedicated line Zealand through various European and Middle Eastern of transportation between the new EMA location Hubs. Apart from international air carriers, Romania’s and the destinations required by its personnel, all national air carrier TAROM has concluded commercial around Bucharest, including on the route from/to agreements with major airlines in Europe and the Middle East. On top of that, due to its recent shift in strategy, the International Henri Coandă Airport. TAROM is negotiating the opportunity of re-launching its direct long haul services from its Hub in Bucharest to There are 4 well-connected, secure and accessible destinations in North America and Asia, with a possible subway lines with modern trains and stations start of operations from 2018. provided with safety and comfort facilities (waiting

40 Relocation of the European Medicines Agency The information below shows flight frequency and carrier choice for EU capital cities. Average N r. Number of direct/ price in Euro City Carrier crt. connecting flights/day (for economy class) 1. Amsterdam 14 KLM, TAROM, LOT, LUFTHANSA 60 - 200

2. Athens 5 TAROM, AEGEAN AIRWAYS, RYANAIR, BULGARIA AIR 33 - 141 TAROM, BLUE AIR, GERMANWINGS, AUSTRIAN, AIR SERBIA, 3. Berlin 9 LUFTHANSA, SWISS, KLM, EUROWINGS 63 - 256 4. Brusselles 5 TAROM, BLUE AIR, LOT, KLM, LUFTHANSA 57 - 200

5 Budapest 3 TAROM, WIZZ AIR 32 - 286

6. Copenhagen 10 SAS, AUSTRIAN, LOT, LUFTHANSA, 66 - 210

7. Dublin 7 BLUE AIR, RYANAIR, LUFTHANSA, KLM, BRITISH AIRWAYS 41 - 277

8. Helsinki 6 BLUE AIR, LUFTHANSA, KLM 107 - 242

9. Larnaca 3 TAROM, BLUE AIR, WIZZAIR 47 - 283

10. Lisbon 9 BLUE AIR, TAP PORTUGAL, WIZZAIR, AIR FRANCE, LUFTHANSA, KLM, 73 - 324 TAROM, BRITISH AIRWAYS, RYANAIR, SWISS, LUFTHANSA, KLM, 11. London 9 AUSTRIAN 84 - 407 12. Madrid 8 TAROM, WIZZAIR, BLUE AIR, LURTHANSA, KLM, AUSTRIAN 42 - 205

13. Malta 3 WIZZAIR, AUSTRIAN, AIR MALTA, TAROM 82 - 195

14. Oslo 7 BLUE AIR, LUFTHANSA, KLM, AUSTRIAN, RYANAIR 101 - 381

15. Paris 4 TAROM, AIR FRANCE, AIR EUROPE, VUELING AIRLINES, 59 - 377 16. Prague 2 AUSTRIAN, LUFTHANSA 63 - 186 1 7. Rome 4 TAROM, BLUE AIR, LUFTHANSA, TURKISH AIRLINES 38 - 151 18. Sofia 2 TAROM, 47 - 223

1 9. Vienna 7 TAROM, LUFTHANSA, LOT, AUSTRIAN 62 – 192

20. Stockholm 8 SAS, LOT, AUSTRIAN, LUFTHANSA 58 – 166 21. Warsaw 3 TAROM, LOT 57 – 210 22. Zagreb 3 CROATIA AIRLINES, AUSTRIAN, LUFTHANSA 102 - 452

23. Riga 3 LUFTHANSA, AEROFLOT, LOT 91 - 212

24. Tallin 6 LOT, LUFTHANSA, AIR BALTIC, KLM, AEROFLOT 82 - 294

25. Vilnius 6 KLM, LOT, RYANAIR, WIZZAIR, AIRBALTIC AUSTRIAN, LUFTHANSA 91 – 182 AUSTRIAN, LUXAIR, LUFTHANSA, KLM, AIR FRANCE, TAROM, 26. Luxemburg 10 RYANAIR 93 - 234 2 7. Ljubljana 6 ADRIA AIRWAYS, LUFTHANSA, AUSTRIAN, SWISS, 111 – 492

28. Bratislava 7 LUFTHANSA, AUSTRIAN LOT, TAROM, 59 - 199

TOTAL 220 -----

Relocation of the European Medicines Agency 41 • Henri Coanda International Airport95 (OTP) approximately 40 minutes. A roundtrip ticket costs Henri Coandă Airport is located 18 km (11 miles) from 7.00 Lei (about 1.56 Euro at the exchange rate of 1 downtown Bucharest. Most international flights Euro=4.50 lei). arrive at Henri Coandă (Otopeni) Airport. Airport facilities include ATM, currency exchange By train: Henri Coanda Express Trains offer daily office, Taxi Desk and cell phone rentals. Major car service from Balotesti (0.5 miles from the airport) to rental companies have offices located on the arrivals/ the main train station (Gara de Nord) with one stop baggage claim level. at Mogosoaia. Trains run hourly from 5:56 a.m. to Domestic Flights: Scheduled domestic flights from/ 9:00 p.m. The journey from the airport to the main to Cluj-Napoca (CLJ), Iasi (IAS), Oradea (OMR), Satu train station takes about one hour and 10 minutes. Mare (SUJ), Sibiu (SBZ) and Timisoara (TSR) also One-way ticket costs 6 Lei (about 1.34 Euro at the depart from/ arrive to Henri Coandă Airport. exchange rate of 1 Euro=4.50 lei). Transfer from Direct airlink with European capital cities: Within 3-4 Balotesti train station to the International Arrivals hours flight time, direct, regular flights operate from Terminal is included10.6 the “Henri Coanda” International Airport Bucharest, to 84 European destinations in 29 countries, out of Railway connection which 23 EU capital cities For better railway connections with the Henri Coanda International Airport, the General Transport Master • Baneasa Airport Plan of Romania also includes a project related to Baneasa Airport, located 8,5 Km (six miles) from achievement of the railway connection between the downtown Bucharest, is the second airport in North Railway Station and the Henri Coanda Airport, Bucharest, mostly used for private planes, or sport running 19.6 km in length and estimated at 97.15 activities million Euro. Currently, the CFR Călători company operates 34 daily 2.1.2. Excellent public transport links from trips from the “Henri Coandă” Bucharest International airports to downtown Bucharest Airport to the North Station in Bucharest, combined with transshipment by road transport (using CFR • Transportation between Henri Coandă Călători owned vehicles) to the “PO Otopeni Airport” International Airport and city centre hub. • Bucharest city centre can be reached by bus, taxi To facilitate travellers’ access from the airport to the or train connections, directly from the airport trains, transfer minibuses are boarded at the 1st floor bridge, the international arrivals area, where the By taxi - Cheap taxi fares, with rates/km starting ticket stand is also located. from 1.39 RON to 3.50 RON (the equivalent of 0.31 eurocents to 0.78 eurocents at the exchange rate of Express trains run according to the following hourly 1Euro=4,50 lei). timetable: Airport - Bucharest North Station: first trip 05:44 to By bus: Connections with the city centre and the 19:59, the last trip; main train station are ensured by two express Bucharest North Station - Airport: first trip 05:40 to buses, 780 and 783. The journey to downtown takes 19:50, last trip (37 trips in total).

9 Henri Coandă (1886–1972), aviation pioneer and inventor of the jet engine 10 Tickets can be purchased at the CFR booth International Arrivals Terminal

42 Relocation of the European Medicines Agency From the Bucharest North Railway Station, in Bucharest is the high level of security for the connections to all city areas are provided by both people. Passenger security in the Bucharest subway metro and public transport, ensuring night-time is high standard and comprises video surveillance routes as well. of passenger flows (CCTV), security personnel for Bus transportation between Baneasa airport and access to the paltforms and security personnel in city centre the subway trains. Bus #131 and #783 to downtown Bucharest Bus #205 and #780 to the main train station (Gara The Plan for Sustainable Urban Mobility 2016 – de Nord) 2030 for the Bucharest – Ilfov Region is a strategic The express bus system is more useful for reaching development document that uses a software, IT destinations outside the city centre, as only a few application, for simulating and planning transports express buses actually pass through the centre and aims at meeting the mobility needs of the people itself. Two- or 10-journey tickets, as well as monthly and businesses in this area in order to improve the passes, are available for these buses. quality of life, at the same time contributing at reaching European targets regarding environment protection Car Rental and energy efficiency. Thus, the development vision of All major international and local car rental companies the Plan is to build an efficient, integrated, sustainable are represented in Romania’s capital city. On average, and safe transportation system promoting economic, the car rental per day in Bucharest is 20 lei or about social and territorial development and providing a 4.45 Euro. good quality of life. The Autonomous Transportation Enterprise of Bucharest (RATB), entity under the subordination of 2.1.3. Means of transportation in the capital Bucharest Municipality, provides public transportation city and has a total fleet of 1,929 units formed of buses, trolleybuses and trams and 155 routes. There is a bus route that provides a permanent link between the • Bucharest’s public transportation network centre of the city and the International Henri Coandă includes: subway, bus, trolley bus and tram Airport. • 4 well-connected, secure and accessible subway lines with modern trains and stations provided There are four subway lines (M1, M2, M3 and M4). with safety and comfort facilities (waiting time Subway stations are indicated with the letter “M” (blue, on a white board). At present, the fifth main electronic display, accessibility for passengers with line, M5, is under construction and has a length of 6.5 disabilities) – fare for 2-trips: approx. 1.1 € km and 10 stops. • Competitive taxi services - Average Taxi Fare: 0.45 At the end of 2022, the Henri Coanda International €/km Airport will be connected to the existing Metro • Extensive network of public bus, trolley bus and network, by completion of Line VI running from tram transportation – fare for one-trip: approx. Bucharest - Otopeni - Henri Coandă International Airport, the Line providing for a transport capacity of 0,30 € 50,000 passengers/hour/direction. • Of utmost importance for public transportation

Relocation of the European Medicines Agency 43 month unlimited pass: 70 Lei (about 15.6 Euro) - The metro provides fast, proper and economical unlimited rides/calendar month transportation and maintains its market share. The number of passengers transported by metro is Access in all 51 stations is provided by 100 elevators about 20% of the total number of those using public and through special gates that allow use by people transport, whereas the length of the metro network with physical disabilities as well. Also, all cabin trains is approximately 4% of the total public transport are equipped for people with disabilities, children and network of Bucharest. The Romanian metro is placed elderly persons. in the first half of the ranking of European countries, displaying an obvious upward trend in that respect. The subway operates from 5:00am until 11:00pm. RATB maps can be found at stands near bus and tram Subway fares (at the exchange rate of 1 Euro=4.50 lei): stops or online at http://www.ratb.ro/eng/index.php 2-trip metro card: 5 Lei (about 1.1 Euro) 10-trip metro card: 20 Lei (about 4.5 Euro ) Starting with 2007, the RATB has introduced low floor 1-day unlimited pass: 8 Lei ( about 1.78 Euro) - tram carriages and Euro 4 Mercedes Citaro buses. unlimited rides during one day 7-day unlimited pass: 25 Lei (about 5.56 Euro) - unlimited rides during one week To find the best options for point to point public

3h

2h

44 Relocation of the European Medicines Agency Bucharest › • Alghero • Alicante • Amman • Amsterdam • Antalya • Athens • Barcelona • Bari • Basel – Mulhouse • Beirut • Belgrade • Berlin • Bilbao • Billund • Birmingham • Bologna • Bordeaux • Bristol • Brussels • Budapesta • Castellon • Catania • Chisinau • Cologne-bonn • Copenhagen • Doha • Doncaster-sheffield • Dortmund • Dubai • Dublin • Duesseldorf • Eindhoven • Florence • Frankfurt • Geneva • Glasgow • Hamburg • Hannover • Helsinki • Irakleion • Istanbul • Kiev • Lamezia terme • Larnaca • Liege • Lisbon • Liverpool • London • Lyon • Madrid • Malaga • Malmo • Malta • Milan • Moscow • Munich • Naples • Nice • Nuremberg • Oslo • Palermo • Paris • Perugia • Pescara • Pisa • Prague • Pune • Rome • Sofia • Stockholm • Stuttgart • Tel aviv-yafo • Tenerife • Thessaloniki • Turin • Valencia • Venice • Verona • Vienna • Warsaw • Zagreb • Zaragoza • Zurich

Oslo Helsinki Stockholm

Billund Malmo Moscow Copenhagen Glasgow Doncaster Sheffield Dublin Liverpool Hamburg Birmingham Berlin Amsterdam Warsaw Dortmund Hannover London Eindhoven Bristol Frankfurt Brussels Dusseldorf Liege Cologne Bonn Kiev Prague Nuremberg Stuttgart Munich Vienna Paris Basel - Mulhouse Zurich Chisinau Geneva Budapesta Verona Zagreb Bordeaux Lyon Milan Venice Turin Bologna Bucharest Florence Belgrade Pisa Bilbao Nice Rome Perugia Pescara Sofia

Zaragoza İstanbul Madrid Bari Barcelona Alghero Naples Thessaloniki Castellon Lamezia Terme Lisbon Valencia Athens Palermo Alicante Catania Antalya Malaga Malta Larnaca Heraklion Beirut

Tel Aviv Amman Tenerife

Relocation of the European Medicines Agency 45 transportation or to locate a street in Bucharest, there is a free Internet option: www.transporturban.ro/en. Buses, trams and trolley buses operate between 5:00am and 11:59pm.

Tickets/cards must be purchased beforehand and validated upon boarding. Tickets or passes can be purchased at any stand displaying the RATB logo (The Autonomous Transportation Enterprise of Bucharest). Travellers may be required to show the validated ticket/card during the trip.

Bus / tram / trolley bus fares11:7 magnetic travel card (electronic wallet): 3.70 Lei (Euro 0.82) one-trip ticket or one-trip-fare: 1.30 Lei (Euro 0.30) day pass: 8.0 Lei (Euro 1.78) week pass: 17.0 Lei (Euro 3.78) two-week pass: 25.0 Lei (Euro 5.56) month pass: 50 Lei (Euro 11.20)

Tickets are interchangeable for the bus, tram and trolley bus, with the exception of express buses.

11 Exchange rate used is: 1Euro = 4.50 lei 46 Relocation of the European Medicines Agency

2.1.4. Taxi transportation

Numerous taxi companies operate in the city at one of the lowest fares in Europe.

2017 Average Taxi Fares in Euro, in some EU cities12:8

No City Taxi start Taxi 1 km Range 10 Km

1. Bucharest 0.45 0.45 4.95

2. Budapest 1.46 0.91 10.56

3. Vienna 3.85 2.18 25.65

4. Berlin 3.90 2.00 23.90

5. Amsterdam 3.95 2.18 25.75

6. Milan 5.00 1.09 15.90

7. Tallin 2.50 0.50 7.50

8. Lille 5.00 1.90 24.00

2.1.5. Bicycle rental

Friendly bike rental facilities and cycling infrastructure with major expansion prospects The General Council of Bucharest has passed a project for construction of 42 bicycle circuits in Bucharest, besides those already existing.

All major cities in Romania, including Bucharest, have their local or national bicycle rental companies. On average the bicycle rental per day in Bucharest is between 5 lei and 80 lei, or 1.12 euro and 17.78 euro at 1 euro = 4.50 lei.

For the first time in Bucharest, the first automatic stations for renting bicycles have been launched, I’Velo Urban. These bicycles will provide better mobility for the citizens, being placed in the most important places in Bucharest, on the routes with the highest inflow of public transportation travellers. The automatic bike- sharing stations are: Piața Universității, Piața Revoluției, Piața Romană, Piața Victoriei, Piața Charles de Gaulles, Kaufland Barbu Văcărescu, near the subway stations.

12 https://www.numbeo.com/taxi-fare/in

Relocation of the European Medicines Agency 47 At the same time, according to the Master Plan of 2.1.6. Other transportation means General Transport in Romania, preparation of a range connecting Bucharest to EU cities of projects for high-speed railway, successive schedule and rail services are starting this year, including a set of projects and investments related to both the The Romanian railway network covers the entire railway and railway services, in order to capitalize on country, with 10,632 km length of routes and a the socio-economic potential of certain development 19,868 km developed length. In 2011, the Romanian regions in Romania. railway network was the eighth largest network in the European Union. The Romanian railway network The proposed project package aims to increase has a density of 533.5 km / 1,000,000 inhabitants, the attractiveness of rail passenger transport (with exceeding the European Union average of 429.4 km immediate favourable effects for freight transport), by network per million inhabitants. decreased journey time, increased safety and comfort, as well as by introducing certain railway services. The The national company operates several trains railway-directed projects and investment package providing direct connections to the following will be implemented for railway sectors with a higher European cities: Vienna, Budapest, Istanbul, Chişinău, potential for attracting passengers and serving Sofia and Tessaloniki. Connection trains are provided economically and socially attractive areas. to the other European cities.

48 Relocation of the European Medicines Agency There are a number of concessionary fares for passengers travelling by train, local buses or inter-county buses. For example, in Bucharest, the following persons are exempt from fares: children under the age of 7, war veterans, persons with disabilities and all categories of pensioners. High school and university students attending day classes benefit from discounts of 50% of the monthly transport card. In the case of train transport on SNCFR trains, primary and secondary school students, as well as full-time university students at public universities or at accredited private universities benefit from 50% discounts for ‘regio’ train fares in second class, whereas pensioners benefit from 6 one-way second-class tickets at a 50% discount for ‘regio’ and ‘interregio’ train fares in second class. Private railway companies also offer discounts of 50% on fares for pupils/students/pensioners. Several international bus companies operate regular transport to most EU countries destinations.

2.2. Accomodation for experts and delegates

Convenient accommodation for delegates and experts in over 140 hotels and 10.000 hotel rooms ranging from exclusive to mid-range

Bucharest offers a range of hotels to ease travel experience of experts or delegates in order to maximize their productivity at the EMA headquarter. The price boundaries are consistent with the offered services and number of stars. The star system in Bucharest is consistent with the European one, with major international hotels present in the City. The table below shows all Bucharest hotels ranked by stars, including number of rooms and number of beds.

Bucharest Hotel Industry In Numbers as of March 2017139 HOTEL STARS NUMBER OF HOTELS NUMBER OF ROOMS NUMBER OF BEDS

5 stars 10 1,940 3,854

4 stars 49 5,092 9,968

3 stars 56 2,235 4,364

2 stars 20 807 1,499

1 star 5 297 566

TOTAL 140 10,371 20,251

Hotel accommodation: 5-15 minutes walking distance from the Dimitrie Pompeiu’s building location, there are some 4 star hotels with a total of 606 rooms: the Caro Hotel (184 rooms), the Cristal Hotel (74) , the Phoenicia Hotel (348 rooms). New hotels are under development such as, the Europa Royal on Dimitrie Pompeiu Boulevard.

13 Source: 2017, Ministry of Tourism monitoring system.

Relocation of the European Medicines Agency 49 tongues (Bulgarian, German or Hungarian); • 6 private schools in Bucharest registered as operating according to the rules and principles of different education systems (3 UK, FR, EL, US); • Higher education offer in Bucharest is free for top Facilities students admitted to undergraduate degrees in Adequate facilities for public universities; • 12 public universities and 15 private universities, children of EMA staff offering 50 Bachelor programmes in English, 17 Bachelor programmes in French, 8 Bachelor programmes in German; 3.1. Strong Educational System • 84 Master programmes offered mainly in English; III • Doctoral studies are in Romanian, with the • The Romanian educational system is based on possibility to be organized in an international strong European traditions and a multilingual language as well, upon student’s request. environment of education for both children and adults; • It has evolved taking into consideration the labour A high percentage of language skilled market and its modern needs, offering a diverse citizens. 97% of Romanian high school range of modern curricula and specialities; students study two or more foreign • Education in Romania is based on a free-tuition, languages. The predominant languages are egalitarian system; English, French, German and Spanish, yet • EU-recognition of diplomas; initiatives for teaching Japanese, Nordic • Bucharest offers a wide range of educational languages or the entire Latin language institutions for all ages, from nurseries, family (Spanish, Italian, French) exist. kindergartens, secondary schools and high schools; • Over 450 public primary and secondary schools, while over 30 schools (from pre-school to high- school) feature international profiles. In most of those schools, the language used is English, although international schools with German, French, Spanish and other non-EU languages also operate in Bucharest; • 3 public schools with education provided in mother

50 Relocation of the European Medicines Agency In order to match the needs of the EMA staff and their families, the Romanian proposal presents its international school offer for the children of the EMA staff.

Education in Romania is based on a free-tuition, egalitarian system. Access to free education is guaranteed by Article 32 of the Romanian Constitution, based on one of the main humanitarian European principles formulated by Immanuel Kant in the 18th Century: proclaim the natural dignity and inherent worth of all human beings. Education is regulated and enforced by the Ministry of National Education. Each step has its own form of organization and is subject to different laws and directives.

The national educational system: • has open character, allowing for the mobility of pupils, by transfer from one school unit/form/field of study/pathway to another; • has pluralistic character (public or private schools, in educational alternative systems such as Step by Step, Waldorf, Freinet, Montessori etc.) and provides schooling methods in the official state language (Romanian), in the native languages of pupils from national minorities or in languages of international circulation.

3.2. Bucharest offer

“We express our commitment to ensure that all the requests on the schooling of the 648 EMA’s staff children are met in due time and confirms the availability of the international, private and public schools from Bucharest to enroll the children.” -The Romanian Ministry of National Education

3.2.1. Nurseries and kindergartens (age group 0-3 years and 3-6 years)

Early childhood (0-6 years old) education includes before preschool level (0-3 years) and preschool (3-6 years) and is organized in younger/toddler group, middle group and pre-schoold proper group.1411 Before preschool early education can take place in nurseries, kindergartens and day care centres, public or private, according to the same educational content and in compliance with the same national standards.

Preschool education is conducted in kindergartens and schools (public or private) with pre-school education forms, according to the same curriculum and following the same national standards.

Children are organized, on a regular basis, by homogeneous age groups.

14 Guide for enrollment in kindergarten (ARACIP - 2016)

Relocation of the European Medicines Agency 51 The table below gives examples of private kindergartens in Bucharest with teaching languages other than Romanian.

Teaching language, No Name of the school Adress Status other than Romanian

Accredited 1 The Educational „Lauder - Reut” 1 5 I u l i u B a r a s h S t , s e c t o r 3 , English By MEN

Accredited German, as a native 2 ”FRIDOLIN” Kindergarten 9-13 Făgăraș Street, Sector 1 By MEN language

Accredited German, as a native 3 Adiwelt Kindergarten S t r . E l e n a C u z a n r . 5 5 – 5 7, s e c t o r 4 By MEN language

Accredited 4 "SOS Satul Copiilor" Kindergarten Calea Floreasca nr. 165, sector 1 English By MEN

Municipiul București, str. Răsăritului Accredited 5 Primary School ”Romania-Finish” Finish nr. 59 By MEN

Str. Lt. col.C-tin Marinescu nr.17, Accredited 6 „Happy Planet Kids” Kindergarten English sector 6 By MEN

Accredited 7 "Olga Gudynn International School" Kindergarten Str. Băneasa Ancuța nr. 8, sector 2 English By MEN

Accredited 8 „Sfântul Andrei ” Kindergarten Str. Bulgăruş nr. 44, sector 5 English By MEN

Accredited 9 King s Oak British International School Str. Petre S. Aurelian nr 66, sector 1 English By MEN

Accredited 10 Verita International School Bd. Dacia nr 79, sector 1 English By MEN

With a flexible payment system, the average yearly costs/child in private kindgergartens are: for a half day nursery – an average of 6,000 euro/year; for a full day nursery – an average of 7,800 euro/year.

3.2.2. Primary and secondary school

Compulsory schooling usually starts at age 6, with the “preparatory school year” (clasa pregătitoare), which is mandatory for enrolment in the first grade. In Romania, high school starts in the 9th grade and generally takes 4 years to complete; vocational high schools take 5 years. Public institutions do not charge tuition fees and offer scholarships to students with

52 Relocation of the European Medicines Agency academic merit or/and underprivileged.

The Romanian secondary education system includes: • National colleges: the most prestigious, well equipped and internationally-connected secondary-school institutions in Romania; • Economic and technical colleges: both offer academic programs geared towards technical/service industry training; • High schools: usually a high school’s name is indicative of its academic focus: theoretical high schools, economic high-schools etc.; • School groups: two schools that have teamed up, generally a high school offering technical or service industry programs and a School of Arts and Trades Schooling is d until the tenth grade (Lower Secondary), which corresponds to the age of sixteen or seventeen.

The school educational cycle ends in the twelfth grade (Upper Secondary), when students graduate the baccalaureate.

Relevant public schools in Bucharest teaching in languages other than Romanian In Bucharest, there are public schools where teaching is in Bulgarian, German or Hungarian, as mother tongues, education being offered from pre-school to high-school.

Public Schools teaching in Bulgarian, German and Hungarian

No School Name Teaching regime/program

1 Goethe National German College (from pre-school to high school) German, mother tongue

2 Ady Endre Theoretical High School Bucharest (from pre-school to high school) Hungarian, mother tongue

3 Hristo Botev Theoretical High School ( from primary to high school) Bulgarian, mother tongue

Relocation of the European Medicines Agency 53 Bilingual education is offered in English, French, German, Italian, Spanish and Portugues in a number of public schools in Bucharest, presented in the table below.

List of public schools providing bilingual education divided by Bucharest administrative districts according to the rules and principles of the Romanian education system

District School Name Level Teaching regime/program

1 National College "I.L.Caragiale" Upper Secondary English - Bilingual

1 National College "I.L.Caragiale" Upper Secondary German - Bilingual

1 National College "Ion Neculce" Upper Secondary Italian - bilingual

1 National College "Sfântul Sava" Upper Secondary English - Bilingual

1 High School "Alexandru Vlahuţă" Upper Secondary German - Bilingual

1 High School "Nicolae Iorga" Upper Secondary English - Bilingual

1 Bilingual High School "Miguel de Cervantes" Upper Secondary Spanish - bilingual

2 National College “Şcoala Centrală” Upper Secondary French - bilingual

2 National College "Cantemir Vodă" Upper Secondary English - Bilingual

2 National College "Iulia Haşdeu" Upper Secondary English - Bilingual

2 National College "Iulia Haşdeu" Upper Secondary Spanish - bilingual

2 National College "Spiru Haret" Upper Secondary English - Bilingual

2 National College Bilingv "George Coşbuc" Upper Secondary English - Bilingual

2 High School Bilingv "Ita Wegman" Upper Secondary German - Bilingual

3 High School "Dante Alighieri" Upper Secondary Italian - bilingual

4 National College "Ion Creangă" Upper Secondary English - Bilingual

6 National College "Elena Cuza" Upper Secondary English - Bilingual

6 High School "Eugen Lovinescu" Upper Secondary Portuguese - bilingual

Additionally, there are a number of private international schools teaching in English, French, Greek or German.

54 Relocation of the European Medicines Agency International Private Schools in Bucharest

No School Name Teaching regime/program

1 International British School of Bucharest English - Bilingual

2 Bucharest Beirut International School Lebanese, English

3 The American International School of Bucharest English

4 The British School of Bucharest English

5 Lycée Français Anna de Noailles French

6 Verita International School English

7 „Athena” Helenic School Greek

8 King's Oak British International School English

English 9 The Mark Twain International School IBO Educational Programme

English 10 EUROPEAN SCHOOL OF BUCHAREST IBO Educational Programme

There are a number of private schools with teaching language in English or German:

Name of the school Level of education Teaching language, other than Romanian

Primary education English language

The Lauder- Reut Educational Complex Secondary education English language

High-school education The bilingual program - English language

Primary School „FRIDOLIN” Primary education German, as a native language

Secondary School „FRIDOLIN” Secondary education German, as a native language

Primary education German, as a native language Secondary School ”Zeppelin Schule” Secondary education German, as a native language

Relocation of the European Medicines Agency 55 Some of these international private schools are registered as operating according to the rules and principles of different education systems (EU Countries mainly):

Private schools in Bucharest according to the rules and principles of different education systems (EU Countries mainly)

Name of the Education documents Address Educational system Curricula school issued by the school

Lycée Français Curriculum corresponding Diplôme national du brevet, Șos. București-Ploiești, The education system Anna de to the educational system Diplôme du baccalauréat nr. 160A, DN1 of the French Republic Noailles of the French Republic general.

The educational Curriculum of the Graduation diplomas, Şcoala Elena Str. Parfumului nr. 9, system in the Republic educational system in the Education certificates „Athena” sector 3 of Greece Hellenic Republic Transfer certificate

The educational Curriculum corresponding The British Str. Erou Iancu Nicolae system in the United to the educational system Cambridge University (CIE) School of nr. 42 - 42A, Oraşul Kingdom of Great of the United Kingdom of CIE-IGCSE, EDEXCELL-IGCSE/ Bucharest Voluntari, Pipera Britain and Northern Great Britain and Northern GCSE, Edexcel-AiDA Ireland Ireland

The educational Curriculum corresponding The Portfolio of diplomas system in the United to the educational system International Şos. Gării Căţelu nr 1 R, (Cambridge IGCSE, Kingdom of Great of the United Kingdom of School of sector 3 Cambridge AL) on the Britain and Northern Great Britain and Northern Bucharest passing of specific exams Ireland Ireland

Graduation of diploma The educational Curriculum corresponding and portfolio of diplomas International system in the United to the educational system (Cambridge Checkpoint, Str. Agricultori nr. 19 A British School Kingdom of Great of the United Kingdom of Cambridge IGCSE, -25, sector 2 of Bucharest Britain and Northern Great Britain and Northern Cambridge AS, Cambridge Ireland Ireland AL) on the passing of specific exams

The educational system in the Curriculum corresponding United States of to the educational system The American Diploma for graduation of an America Primary in the United States of International Şos. Pipera-Tunari, No US High-School Years Programme America IBO Primary years School of 196, Orașul Voluntari, International Baccalaureate of IBO (PYP), Middle programe, IBO Middle Bucharest, LLC Diploma Years Programme of Years Programme, IBO IBO (MYP), Diploma Diploma Programe Programme of IBO (DP)

The average costs of studies in private educational system in Bucharest are: for primary school – an average of 9,955 euro/year; for secondary education – an average of 11,000 euro/year for tuition only. As for the payment system, is flexible like the other mentioned forms of education.

56 Relocation of the European Medicines Agency There are 12 public universities in Bucharest and 3.2.3 Higher education degrees 15 private universities, offering 50 Bachelor’s programmes in English, 17 Bachelor’s programmes Passing the Baccalaureate exam is a prerequisite for in French, 8 Bachelor’s programmes in German. admission to higher education. Students apply to a As regards the Master’s degrees, for the academic school or department within a university. Admissions year 2017-2018, in Bucharest there are 84 Master’s usually depend on one’s Baccalaureate grade and programmes offered mainly in English. Doctoral yearly GPA in secondary education, the student’s studies are in Romanian with the posibility to also score in the university-organized admissions exam, be organized in an international language, upon an interview and more (usually a mix of the above). students’ request. Should a student decide to continue her/his studies Most Bachelor’s programs in Romania take 3 years to in Bucharest, it is worth mentioning that, while complete. However, some programs take longer to maintaining academic standards, tuition and living complete, for example those in some technical fields, costs for students are low. medicine and architecture. A brief description of the 12 public universities in Master’s programs (MA) take 2 years beyond Bucharest offering foreing languages programmes is the Bachelor’s degree. Master’s programs are a available in Annex 5. prerequisite for admission to PhD programs. PhD programs usually take 3 years to complete. Equivalence of diplomas in Romania Under special circumstances, the duration of study The National Centre for Recognition and Equivalence may be extended by 1 or 2 years. of Diplomas (NCRED), member of the ENIC- NARIC networks of National Centres for academic The European Credit Transfer System (ECTS) is information and recognition abroad, recognizes compulsory in Romanian universities. For each year education documents of pre-university level acquired of study, the student receives 60 ECTS (slightly abroad, through evaluating and establishing the level, more if they take on, say, all electives instead of just the field/specialization, in relation to the Romanian picking the compulsory amount; also if they take educational system, in keeping with international teacher training modules), an average of 30 ECTS norms and good practices in the field of recognition. per semester. The undergraduate program will have from 180 to 240 ECTS and the MA program from 90 Subsequently to evaluation, the NCRED may to 120 ECTS. recognize the level, the field of studies and/or the specialization, automatically or by taking equivalency Romanian students are eligible for the Erasmus + examinations or other compensatory measures. With program and can study for one or two semesters at the aim to implement the compensatory measures, a wide range of universities in the European Higher the NCRED collaborates with the County School Education Area. Education is free for top students Inspectorates and with the School Inspectorate of admitted to undergraduate degrees at public Bucharest Municipality. universities. By law, these top students are waived This procedure is implemented for the continuation the tuition fees for a BA, an MA and a PhD. of studies in Romania, as well as for access to the labour market.

Relocation of the European Medicines Agency 57 The NCRED recognizes education documents that prove graduation of XI-XII grades and graduation from upper-secondary studies at Baccalaureate level, from professional schools and the post-secondary schools.

Starting with 2015, by Minister Decree no. 5268/2015, files submitted for validation of the study periods carried out abroad and within education-providing organizations, corresponding to an educational system from another country (grades I-X), are received and evaluated by the local School Inspectorates.

The NCRED recognizes educational activities in Romania corresponding to an education system from another country. Aiming at maintaining the right to free practice for bearing a regulated profession in Romania, the NCRED recognizes (in keeping with the 2005/36/CE Directive) diplomas acquired within EU member-states, within the European Economic Area and within the Swiss Confederation, which give access to regulated professions, wherever the regulatory acts concerning the profession do not require otherwise.

58 Relocation of the European Medicines Agency Appropriate Access Access to the labour market, social security and medical care for both children and spouses/ partners

IVThe cost of living in Romania – especially in Bucharest – is approximately 50% lower compared to other important western cities in EU Member States (Vienna, London, Berlin, Paris) and at least 12% cheaper than other capitals of CEE countries (Prague, Warsaw or Budapest).15 According to the structure of total consumption expenditure in the first quarter of 2016, housing and water, electricity and natural gas accounted represent 19.6 % of household consumption. Other household expenses cover leisure and culture (3.1 %), transportation (5.9 %), healthcare (5.3 %), communications (5.1 %), clothing and footwear (5.2 %), home furnishings and maintenance (4.5 %), etc.

Bucharest offers the largest labour market in the country, with a dynamic and diverse business environment with soaring competitiveness indicators. All branches of industry are present in the Bucharest-Ilfov region, as this is the main industrial agglomeration in the country. In the past few years, the workforce has reoriented massively towards the services sector, which at present is the main contributor to this region’s economy. This region also has the fastest growth rates in sectors such as the building and real estate sector. Other highly dynamic sectors are the retail, distribution and management sectors. The economic environment in this region is highly attractive, as a result of direct investments, the existing institutional structure, a skilled workforce and a communications system.

15 Source: Invest Romania RelocationRelocation ofof thethe EuropeanEuropean MedicinesMedicines AgencyAgency 59 4.1 Brief overview of the Romanian labour market

The main types of enterprises present on the labour market are companies - limited liability companies (SRL), joint-stock companies (SA), partnerships (SNC), simple partnerships (SCS), joint- stock partnerships (SCA), sole traders (PFA) and family associations. The main categories of employers are multinational companies, profit/non-profit state-owned companies, private companies and NGOs. According to the 2016 Coface CEE Top 500 Companies study, the largest companies in Romania in terms of turnover are: Automobile Dacia SA, OMV Petrom Marketing SRL, OMV Petrom SA, Rompetrol Rafinare SA, Kaufland România, Rompetrol Downstream SRL, British American Tobacco Trading SRL, Lukoil Romania SRL, Carrefour România SA, EON Energie România SA and Transgaz SA. The main types of employment contract are contracts which may be fixed-term or permanent, with full-time or part-time working hours. Certain jobs require specific qualifications and/or experience.

Romanian labour market – ANOFM key figures (as of 1 January 2016) • active population - 8 776 800 persons; • 54.1 % men and 45.9 % women in the total active population; • most employees work in the services sector (3,100,200 people); • 1,821,800 persons are employed in the industrial and construction sectors; • the employment rate of the working age population (15-64 years old) was 61.8 %, with a higher rate for men (70.0 %, compared to 53.4 % for women).

Bucharest labour market – ANOFM key figures (as of 1 January 2016) • active population - 1,533,700 persons (44.4 % of the country’s total population); • unemployment rate (as on 31 December 2016) - 1.4 % – the lowest at national level (only 20 600 unemployed per- sons); • the employed population tends to have a high level of training and qualifications; • the main economic sector in which the population is employed is the services sector (71.3 %), followed by industry and the construction sector (26.2 %), while agriculture accounts for only 2.4 %. Services generate the largest num- ber of jobs.

60 Relocation of the European Medicines Agency providers (Romanian or from other EU/EEA countries) 4.2. How to find a job of specialised services aimed at stimulating the labour market. The list of private providers of employment Jobseekers who are EU or EEA citizens have free access services authorised to operate on the domestic market to the Romanian labour market. Nationals of other can be found on the individual websites of the county Member States of the European Union are employed employment agencies. in the same conditions as Romanian nationals and have to complete all the employment formalities. It is recommended that sufficient time be allowed between 4.3. Self-employment the signing of the individual employment contract and the start of work at the Romanian employer, so as to Natural persons who are EU/EEA citizens may carry enable the EU national to complete all the required out business activities in Romania, as follows: as sole formalities. traders, individually and on a self-employed basis; as entrepreneurs owning an individual undertaking; as Interested persons may contact and register with members of a family enterprise, in accordance with one of the 41 employment agencies in the counties or the national legislation in this area. in Bucharest, or with one of the 70 local employment agencies spread throughout the country. Sole traders and individual or family enterprises may be authorised to carry out business activities in any County agencies provide information, counselling field, trade or profession, with the exception of those and mediation services for jobseekers or unemployed governed by special laws, but they must be residents persons, as well as information and mediation services in Romania. Registration in the Trade Register and for potential employers. The services offered are free of an operating permit are mandatory. Sole traders charge. carrying out independent business activities are

A database is available, at both county and national level, containing all the jobs offered by Romanian employers, who are required by law to declare all their vacancies to the National Employment Agency (ANOFM). Job vacancies can be found under the ‘Locuri de muncă’ (Jobs) section on the ANOFM’s website. Details of the vacancies are displayed in Romanian.

EU/EEA citizens who are unemployed persons receiving unemployment benefits in another EU/EEA state and who are seeking a job in Romania may export their unemployment benefits (for a maximum period of 3 to 5 months), provided that they register as jobseekers with the county employment agency covering the area where they have established their residence in Romania. On the national labour market there are also private

Relocation of the European Medicines Agency 61 regarded as self-employed. Self-employment status refers to the right to benefit from the public pension scheme and other social insurance schemes, the social healthcare insurance system and the unemployment insurance system, in accordance with relevant laws.

Sole traders may not employ other persons on the basis of individual employment contracts to carry out the activities for which the legal authorisation for self-employment has been obtained. Owners of individual undertakings may employ other persons under an individual employment contract, may collaborate with other sole traders, with other owners of individual undertaking, with representatives of a family enterprise or with other legal persons. Family enterprises have two or several members of the same family. Members of a family enterprise are insured under the state social insurance system (pensions, unemployment and healthcare).

4.4. Romanian Social Assistance Policy

The Romanian law of social assistance, respectively Law no.292/2011, stipulates that social assistance benefits are granted to all categories in vulnerable situations, without discrimination.

The right to social assistance measures is guaranteed for all Romanian citizens, as well as to citizens of other countries, stateless persons and any other person who has acquired a form of protection and resides in Romania, without any discrimination.

Social assistance benefits granted in Romania are financial transfers granted for:

• family and children (family benefits); • preventing poverty and social exclusion risk (means tested benefits); • persons with special needs (disability benefits); • other types of benefits and facilities (emergency aids).

4.5. Employment possibilities for families and partners of the EMA staff Foreign nationals are mostly employed in the Business Services Sector (BSS), the headquarters of multinational corporations, consulting companies or international law firms; were at the end of 2016, BSS foreign employees, around 150,000 persons, 20% increase over 2015.

BSS centres provide IT, HR, Finance & Accounting, Marketing, Legal, Research & Analysis and R&D services in a multitude of different languages to all parts of the world.

62 Relocation of the European Medicines Agency Top employers in the BSS sector:

OMV PETROM SA, Kaufland Romania SCS, Auchan Romania SA, Carrefour Romania SA. Mega Image SRL, Addeco Human Reources SRL, Telekom Romania Communication SA, Romania Hipermarche SA, Metro Cash & Carry SRL, Lugera&Makler SRL, Mercer, Accenture, GSK, Pfizer, Novartis, Abbvie, Abbott, Roche, MSD, Merk, Microsoft Romania, IBM Romania, Daimler Benz Romania.

Major consulting companies:

Ernst & Young, Accenture, Deloitte, KPMG, PwC, McKinsey, BCG, Roland Berger, Colliers, Cushman & Wakefield

Major international law firms:

Allen & Overy LLP, Martinez-Echevarría, Perez & Ferrero Lawyers, Squire Sanders, White & Case, Dessewffy, Dávid and Partners Law Office, Rokas Law Firm, Eversheds Sutherland, DLA Pipers Dinu SCA, Dentons, Wolf Theiss, Noerr Finance&Tax SRL, Clifford Chance, Kinstellar SCA, Leroy&Asociates.

Relocation of the European Medicines Agency 63 4.6. Secure life for the EMA staff, families and children

Bucharest is one of the safest EU capitals (with less than 1% criminality rate per 100,000 inhabitants) providing a safe place to work and live for its citizens.

It has never been a target for terrorist attacks, being very well placed in the international ranking statistics - 0.2 score in the Political Stability and Absence of Terrorism index by the World Bank (2015).

According to the EB-86 Standard Eurobarometer, published in November 2016, Romanian citizens perceive as low the risk to national security referring to the main indicators, namely criminality, immigration and terrorism.

The level of the terrorist alert is BLUE-CAUTION (level 2 of 5). The European Medicines Agency and its staff shall benefit from the privileges and immunities established in Protocol (No 7) to the EU Treaties.

Romania is committed to other possible complementary provisions in a headquarters agreement specifying the detailed provisions with regard to application of the protocol.

Preserving privileges and immunities – first level of security for EMA staff in Bucharest

The European Medicines Agency and its staff shall benefit from the privileges and immunities established in Protocol (No 7) on the privileges and immunities of the European Union no. C 83/266 published in the Official Journal of the European Union on March 30, 2010, enjoying the usual immunities and inviolabilities provided by this Protocol. Similar measures as those adopted for other European or international organisations’ branches based in Romania would be applied. According to the Protocol, national staff working for the European Medicines Agency shall enjoy only functional immunities and privileges.

The Ministry of Foreign Affairs (MFA) ensures the application of provisions of the above mentioned Protocol, thus the Agency and its staff only has to register with the Protocol Directorate in order to benefit from these privileges and immunities. One of the responsibillities of the EMA Human Resources Department in Bucharest will be registration of EMA staff with the MFA.

Upon a final decision regarding the future location of the European Medicines Agency, Romania is committed to other possible complementary provisions in a headquarters agreement specifying the detailed provisions with regard to application of the protocol.

64 Relocation of the European Medicines Agency Safe life for EMA staff in Bucharest – national security and stability

Romania is a pillar of stability in the region and has a unique geostrategic position in the Black Sea area, in the present context, able to set up a security platform in the Black Sea, the Balkans, Central Asia and the Middle East area. Guaranteeing the safety of citizens, protecting their rights and fundamental freedoms represent national objectives, besides those that define and outline Romania’s strategic credibility, at international level.

The present system of public order and national security in Romania has proved its viability, being appreciated as one of the most efficient in Europe, the criminal phenomenon being very well managed by the Romanian authorities.

Internally, a high level of security and safety is maintained, the existing crimes being on a downward trend over the past 4 years, this way reaching the lowest value of the last 10 years.

Citizen safety is at the highest level. Criminal behaviour is kept under control, with no special events registered.

Crime prevention activities carried out by Romanian authorities are targeted largely towards issues that citizens consider priorities for improvement of safety problems. In the prevention area, special attention is paid to the education environment.

Relocation of the European Medicines Agency 65 The rate of serious violent crime, is low (only 0.2% of all notified offences) and it is not characterized by severe forms of manifestation.

According to the EB-86 Standard Eurobarometer, published in November 2016, the population of ROMANIA perceives as low the risk to national security, referring to the main indicators, namely criminality, immigration and terrorism.

The same study appreciates that Romanian citizens did not consider criminality as one of the main factors that could affect them individually, this being only on the 12th place of 15. One of the study conclusion mentions that Romanian citizens do not consider criminality one of the major problems that concern them, this perception being widely due to the increase of citizens’ safety.

The results registered as regards the constant decrease of crime at national level is also due to the excellent cooperation of law enforcement institutions with similar international agencies, namely the INTERPOL, the EUROPOL and the US law enforcement agencies.

Against the background of the restricting law regarding arms and ammunition, Romania efficiently manages this issue, not registering significant incidents affecting the safety of citizens or disturbing public order and safety.

The activities developed for preventing crime around education areas are in compliance with the objective assumed in the “National Strategy of public order and safety 2015 - 2020”, regarding the creation of a safe environment for education, by constantly involving competent institutions in increasing the degree of safety within the education institutions.

Starting with July 2016, a new common national action plan has been implemented for increasing the degree of safety of students and teachers, as well as for preventing juvenile delinquency within and around pre-university education units.

The dynamic of traffic accidents has recorded lower figures, scoring lower than foreseen by Romania to its European partners according to the European Road Safety Action Programme.

Regarding the prevention and countering terrorism, efficient coordination of law enforcement agencies from the National System for Prevention and Terrorism Countering, based on concrete measures, allowed early warning identification of any form of (self) radicalisation or intentions to support or execution of terrorist attacks on national territory, the level of the terrorist alert being BLUE-CAUTION (level 2 of 5).

On the grounds of terrorist attacks multiplying, raising of their scale and diversity of attack patterns, the need has been highlighted for identification of adequate answers for limitation of this phenomenon,

66 Relocation of the European Medicines Agency irrespective of manifestation form. In this regard, Romania has proposed to set up an International Court Against Terrorism, designed as an International Penal Law Organism, which should have as main goal deterring terrorism acts and conviction of perpetrators, wherever the crime may have been commited.

In regard of countering trafficking of human beings, according to the Annual Report of the US State Department, published in June 2017, Romania has made increasing efforts to enforce the rule of law, cooperation with NGO’s and developing their financial mechanisms. In this regard, Romania ranked 2nd of 4 tiers. Against the European trend of evolution with regard to migration, especially on the Western Balkans route, in result of implementation of the mechanisms for countering illegal migration and illegal staying, the illegal migration phenomenon is efficiently dealt with by the Romanian authorities, ranking low in relative numbers.

Although not yet full a Member of the Schengen area, Romania currently applies most of the provisions of the Schengen acquis and acts as a de facto Schengen member with a significant contribution to EU internal security, responsibly and efficiently managing over 2000 km of external border of the European Union.

Romania fulfils all technical criteria for joining the Schengen Area, having succesfully completed evaluation of the 7 fields of interests (police cooperation, data protection, consulates, maritime, air and land borders, SIS/SIRENE), as also ackonowledged at EU level (the EU Council).

Excellent IT&C systems for an excellent future of Gbit society One of the strong points of Bucharest’s communication infrastructure is the wide spread of optic fibre networks, leading to superior internet access and data transmission rates, the foundation of the future Gigabit society. Bucharest’s NetCity project, the underground infrastructure for optic fibre, is an innovative project and one of the large investments made in city’s communication infrastructure, in line with the European socio-economic development policy for local communities.

Bucharest hosts several public data centres of European dimension, able to assure optimal collocation and/or operation of equipment, including back-up and disaster recovery services, as well as high capacity connections with European and global content and connectivity providers. Two public internet interexchange points operate in Bucharest ensuring strong connectivity with ISPs active at national level as well as with global carriers; this is helpful in providing reliability and redundancy of communication paths.

From the perspective of costs related to provision of communication services, due to the increased competitiveness of the Romanian market, tariffs of communication services are among the lowest in Europe, ensuring a high quality/price ratio. Thus, on the retail level, usual tariffs for mobile voice and data services are between 2 EUR/month and 9 EUR/month, while usual tariffs for fixed internet do not exceed 11 EUR/ month for services with speeds up to 1000 Mbps through optic fibre.

Relocation of the European Medicines Agency 67 Regarding the quality of the internet access service, international studies place Romania at the top of the world’s high-speed internet. Thus, according to the latest “State of the Internet” connectivity report conducted by the American group Akamai, for the first quarter of 2017, Romania ranked second among European countries with the highest average peak internet connection speed. The average peak speed in Romania was 95 Mbps in the first quarter of this year, up 15% over the same period of 2016.

These data are also confirmed by the measurements made using the speed measurement application made available to users by the NRA, Netograf.ro. According to it, in the first quarter of 2017 the average download speed for fixed internet in Bucharest registered 119 Mbps and the average upload speed 106 Mbps. At the same time, the average download speed for mobile internet was 34 Mbps and the average upload speed was 14 Mbps.

It should also be added that fixed internet offers of the main providers offering services in Bucharest usually mention connections at speeds between 500 and 1000 Mbps.

4.7. Comprehensive and high-quality healthcare services, public and/or private

Health insurance costs are generally covered by the Romanian government, which guarantees access to public healthcare services for all.

Besides, citizens can opt for private insurance schemes, which bear accessible costs and provide access to a wide-range of services in public or private institutions.

There are currently over 50 public hospitals in Bucharest, as well as a wide range of private operated clinics and hospitals.

Hospital infrastructure development is a major priority in Romania, as there are several ongoing initiatives to fund the construction and equipment of new and existing facilities.

Access to healthcare is guaranteed by Article 34 in the Constitution of Romania, which specifies that the state is obliged “to guarantee the sheltering of healthcare”. Every citizen of Romania is entitled to cost-free, unrestricted medical procedures, as established by a physician. Citizens of the European Union have the right to free emergency medical assistance.

Romania offers benefits of an universal healthcare system. The state finances primary, secondary and tertiary healthcare. Public health campaigns are financed by the Government of Romania. The Ministry of Health of Romania is required to manage and supervise the public healthcare sector.

The Romanian healthcare system has turned from a centralized model, in which healthcare providers were directly employed by the Romanian Ministry of Health (RMoH), to a contract model in which healthcare providers in the healthcare system are independent and in contractual relationships with the insurance fund.

68 Relocation of the European Medicines Agency The RMoH is responsible for providing preventive accelerators for cancer treatment services at both the individual and population level. • Funding the 15 percent increase of the At local level, preventive activities are organized healthcare system salaries and supervised by the District Public Healthcare Authorities. Facilities and equipment

For 2017, the budget allocated for the healthcare Healthcare services in Romania have evolved during sector is 33. 8 billion lei (approx. 800 million euro) the past few years and especially since the country or 4.15% of GDP, with 3.5 billion lei (78 million euro) joined the European Union in 2007. The government more than in 2016, plus 3. 9 billion lei (80 million has been taking strict measures to ensure that all euro), commitment appropriations. citizens have access to healthcare facilities and services. It is also securing and deploying funds to Main objectives funded for 2017 are: improve the current state of healthcare in Romania, • Compensated and free medicines (155.5 million in both the private and public systems, so as to euro additionally allocated) continue the improvement of healthcare systems. • Construction of regional hospitals and providing each county hospital with a tomography The Ministry of Health regulates the healthcare computer sector in Romania. The governmental bodies in • Purchase of mandatory vaccines for children Romania are working towards setting up quality (172 million euro) management system in the healthcare sector, to • Providing seven hospitals with linear review the standards of healthcare facilities.

Relocation of the European Medicines Agency 69 A National Agency for Quality Control in the Healthcare Sector was set up in 2015 by the Government of Romania to determine, through standardization, quality assurance and continuous quality improvement of healthcare services, patient safety, healthcare services assessment and accreditation of healthcare facilities and change of the organizational culture for implementing the quality management system. The entire process is meant to ensure the international recognition of the quality of Romanian healthcare services.

In 2014, the Romanian Government signed an Agreement with the World Bank for the approval of 250 million-euro for the purpose of improving the infrastructure of the healthcare system in the country, such as modernization of healthcare facilities, improvement of healthcare governance bodies and fight diseases such as cancer. Additionally, a new metropolitan hospital is planned to be built by the local Administration of Bucharest, with a total number of 2000 beds.

In 2016, according to the National Statistics Institute, there were 366 public hospitals and 201 private hospitals in Romania.

Since 2008, the number of private hospitals has increased over four times. Overall, the total number of hospitals increased by 15% between 2008 and 201716.2

In 2017, the Romanian Ministry of Health has approved a total number of 119,579 beds funded by the state (public and private), of which more than 20,331 beds were in Bucharest.

Currently, Bucharest has a considerable number of hospitals comprising all specializations, intensive care units and outpatient cabinets for all sections, with highly specialized staff and top performance medical equipment. We can mention the university hospitals Floreasca Emergency University Hospital, the Bucharest University Emergency Hospital and the Fundeni Clinical Institute, facilities comprising more than 800 beds, the Coltea Hospital, all with highly specialized medical teams with European and worldwide recognition.

Bucharest offers excellent public childcare facilities such as the paediatric Hospitals-Marie Curie and Grigore Alexandrescu, with a capacity of 500 and 400 beds respectively, alongside with specialized departments for paediatric care within each public hospital in the capital, as well as a number of 9 public maternities, most of them recently modernized through state funds or European and World Bank funds.

Romania is the first country in Europe in terms of telemedicine. The national telemedicine network includes two command centres, at the Floreasca Hospital in Bucharest and the Clinical Emergency Hospital of Târgu Mureș and 56 hospitals. Thus, doctors at the two command centres provide medical support to any of the hospitals in the country and pursue the patient’s vital signs in real time.

There is also a large number of private operated clinics and hospitals, all with experienced and trained staff, the annual growth rate of the private medical services market being approximately 12 percent.

16 National Institute of Statistics, 2017

70 Relocation of the European Medicines Agency The private system is attractive to expats, as these hospitals boast the very latest, state-of-the-art equipment and technology and have modern facilities. Most medical staff in private facilities can communicate fluently in English.

Prices for private healthcare in Romania are significantly lower than in other European countries orin the United States, with the total cost of treatment less than half of the cost of treatment alone in many countries. Thus, Bucharest is becoming more and more attractive for medical tourism, especially in niche specializations (e.g. dentist treatment).

In 2015, Fiscal legislation was amended so as to stimulate private insurance benefit packages for the private sector. As such, the deductibility thresholds for expenses incurred on behalf of an employee in relation to voluntary pension schemes (i.e. EUR 400/year/employee) and for expenses for voluntary healthcare insurance premiums (i.e. EUR 250/year/employee) have been eliminated; these expenses are to be taxed at the level of the employer, with the threshold being EUR 400/year/employee for each type.

There is a high number of private hospitals and networks, such as: Monza, Sanador, Regina Maria, Ponderas, Metropolitan, Neolife, Medlife, Polisano, Oncofort, Medicover, West Eye Hospital, Pelicanul. The top five players on the private healthcare services market, Medlife, Regina Maria, Medicover, Sanador and Gral, had a total business of about 1.3 billion lei (288 million euro) in 2015, according to public available data. At a total level, the medical services market amounts to about 6 billion lei (about 1,35 bn. euro), according to the same public source.

The Regina Maria Private Healthcare Network, one of the two largest private healthcare networks in Romania, offers 33 polyclinics (16 in Bucharest), 4 hospitals (3 of which in Bucharest-Euroclinic, Ponderas, Baneasa Hospital), 8 Medical Centres and over 180 partner clinics across the country, 1,700 medical staff, 22 medical specialities.

The Life Memorial belonging to the MedLife medical network, represents an investment of 17 million euro, the unit having 150 beds. The hospital, which spans an area of 12,500 square meters, comprises an operator block consisting of 5 operating rooms, an IC section, as well as obstetrics-gynecology, neonatology, surgery, internal diseases, cardiology, oncology and paediatrics. Apart from the Life Memorial, MedLife also owns two more hospitals: a paediatric hospital in Bucharest and another in Arad, operated in collaboration with the Genesys Medical Clinic in Arad. Currently, the MedLife network includes 9 hyperclinics, 8 medical analysis laboratories, 28 general medical centres and 7 monodisciplinary centres. Since 2010, MedLife has also operated a pharmacies network, PharmaLife. With a total area of 23,000 square meters and a capacity of 402 beds, the Sanador Hospital includes all the medical and surgical specialties and is unique from this point of view on the Romanian market. The hospital is serviced by 7 lifts, it has 125 paid parking spaces in the 3 basements. Parking is managed by Parc Med Logistics.

Relocation of the European Medicines Agency 71 In Romania, Medicover has a network of 19 clinics in Bucharest and Timisoara, Cluj-Napoca, Constanta, Iasi, Ploiesti, Brasov, Galati, Pitesti and a general hospital - the Medicover Hospital located in Bucharest. The network offers integrated services: complete outpatient care, the first provider in Romania to introduce the concept of healthcare subscription. The Medicover Hospital in Romania includes all departments: outpatient, day hospital and a wide range of medical and surgical specialties.

The Synevo, part of the Medicover Group, is the largest and most advanced laboratory network in Romania, present in 11 countries, with over 80 laboratories and over 400 harvesting centres. The central laboratory was in Bucharest and claimed an investment of 10 million euro

Dental care According to the National Institute of Statistics, the number of private dental clinics in Bucharest has increased by 27%, reaching 2,894 in 2015 and it continues to expand.

The pharmaceutical industry in Romania is prosperous, with an average revenue of aprox. 2 billion euro per year.

The value chain in the pharmaceutical industry has increased significantly in the past decade in all segments, contributing with over 1% to the GDP. There are 43 production plants, 5 packaging plants and 8 manufacturers of substances.

In 2014, Romania’s market size increased by a full 6.8 % to EUR 2.76 billion with Romanians purchasing OTCs to the tune of some EUR 755 million in the final quarter alone, reflecting an 11.8% year-on-year rise, according to market research conducted by Cegedim. 1,051 pharmacies are located in Bucharest with the approval of the Ministry of Health.

Emergecy care: one of the best in Europe

Emergency care is available free for everyone including those without state healthcare insurance. However, once the condition is stabilized there is need for proof of the insurance status. Emergency treatment is provided at patient’s emergency rooms in all hospitals, which are open non-stop all year round.

The Emergency Healthcare Information System (EHCIS) in Bucharest provides information about the whole activity of Dispatch Emergency Ambulance Service and Emergency Admissions of the 7 Hospitals providing emergency healthcare in Bucharest over a MAN (Metropolitan Area Network). The data are registered in the ORACLE database on the central server. The client/server architecture assures real time communication among all these locations. The system works 7 days/week, 24 hours/day.

72 Relocation of the European Medicines Agency The SMURD is an emergency rescue service, one of the top in Europe. The first SMURD unit was created in 1990, in Târgu Mureș, a city in the centre of Romania and an important medical centre. In October 1996, the service received legal recognition under the Military Firemen Corps Law no.121.

Now the SMURD is a complementary service, with bases covering many parts of the country, still expanding. It deals with the worst emergency cases, all in a very good collaboration with the regular Ambulance Service (Serviciul de Ambulanţă). Also, HEMS (helicopter emergency medical system) was enforced in six cities (Târgu Mureș, Bucharest, Iaşi, Arad, Craiova and Constanţa), while in other cities the system is only ambulance based. Depending on the situation, police and army helicopters are also used. The emergency system used by this service is based on the European 112 emergency phone number, now also used in Romania for all the emergencies (police, firefighters, ambulance). Altogether (including the fleet of the Internal Affairs and SMURD), Romania has a fleet of 32 aircraft equipped for medical emergencies.

Pharmaceutical sector in Romania

Based on turnover,the biggest player in distribution of drugs is Mediplus. The company is part of the A&D Pharma group, founded in 1994, which also controls the network of pharmacies Sensiblu. The Mediplus logistic network consists of 10 regional warehouses and a national logistics centre.

Over-the-counter and prescription medicines

All citizens are entitled to receive financial aid for prescriptions, regardless of their financial status. The only required condition is contribuition to the National Healthcare Insurance House.. Any medicine (except for generic medicines) can be obtained with a discount. The discount is obtained by getting a medical prescription. The deduction is made right at the paying point and pharmacies further obtain their money back from the Ministry of Healthcare. Furthermore, there are medicines given out for free. Medicines for diseases included in National Healthcare Programs are free for anyone, regardless of their financial status. Diseases usually covered are chronic diseases. Starting with July 2012, all prescriptions have to be issued in digital format only.

Relocation of the European Medicines Agency 73 Business Continuity

V5.1. Recognised Romanian tradition and expertise in the field of medicine and pharmacy

Research conducted by Romanian specialists has had tremendous contribution to the development of a wide range of medicine and pharmacy fields, such as: - the first treaty of bacteriology in the world - the Pathological Histology Atlas of the Nervous System - the discovery of insulin - the first geriatric institute in the world - improving age-related dystrophic disorders - the revolution of encephalo-neuro-psycho-tropic therapy, by discovering and substantiating the concept of a new therapeutic (pharmacological) class in neuroscience - the discovery of humoral and cellular immunity - the lack of sensitivity and immunity of the body against scarlet fever. - the great Romanian experience on massive cholera vaccination in 1913 - the setting up of ophthalmology procedures with a wide international spread - introducing high rachianesthesia and new techniques in the surgery of uterine cancer, the sympathetic nerve and hernias. - among the founders of modern infra-microbiology

The Romanian Nobel prize winner in the field of physiology and medicine (1974), George Emil Palade (1912-2008) is considered the father of modern cell biology.

74 Relocation of the European Medicines Agency Carol Davila (1828-1884) and Nicholas Kretzulescu (1812-1900) are the main founders of Romanian medical education - the Medical Society (1857), the Red Cross Society (1876), the Society of Natural Sciences (1876) - as well as of two medical magazines.

Victor Babes (1854-1926) was a physician, professor, academician, member of the Academy of Medicine in Paris, an officer of the Legion of Honour, the founder of the Romanian school of microbiology. In 1885, in collaboration with Andre Victor Cornil, he conducted the first treaty of bacteriology in the world, laying the foundations of modern sciences and, in 1892, together with Gheorghe Marinescu and Paul Blocq, he published a Pathological Histology Atlas of the Nervous System. His research has led to discoveries in a wide range of fields, such as tuberculosis, leprosy, rabies vaccination and serotherapy of diphtheria, the discovery of novel microorganisms, with classification of an entire class of parasites, in 1900, at the International Congress of Zoology in London, called the Babesia.

Ioan Cantacuzino (1863-1934) was the founder of the Romanian school of experimental immunology and pathology, a internationally recognized physician, microbiologist, professor, academician, member of the Paris Academy of Sciences, Doctor Honoris Causa of the Universities of Lyon, Brussels, Montpellier, Athens and Bordeaux. He is the author of fundamental works on phagocytic functions in animal behaviour, electrophysiological phenomena role in immune mechanisms, on discovery of humoral and cellular immunity, lack of body sensitivity and immunity against scarlet fever. He created the notion of immunity by contact and set up cholera vaccination, called the Cantacuzino Method, still used today. The massive cholera vaccination in 1913 made him known as the Great Romanian experience. In 1921, he legally founded The Institute for Serums and Vaccines Dr. I. Cantacuzino, still operating today.

The Romanian Ophthalmology School was founded by Nicolae Manolescu (1850-1910), who set up a series of procedures with a wide international spread after presentation at the International Congress of Medicine in Lisbon.

Thoma Ionescu (1860-1926), surgeon and anatomist, professor in Bucharest and Paris, honorary member of the Romanian Academy, one of the founders of the Romanian School of Surgeons and Topographic Anatomy. Founder, in 1897, of the Surgery Society and the Surgery Journal he was recognized for the great merit of introducing high rachianesthesia and new techniques in the surgery of uterine cancer, the sympathetic nerve and hernias.

Relocation of the European Medicines Agency 75 In the field of physiology, one may also mention Ioan Athanasiu (1868-1926), one of the founders of modern Romanian physiology and author of several articles on the scientific bases of physical education, professor and correspondent member of the Romanian Academy.

An exceptional personality was Constantin Levaditi (1874-1953), born in Galati and naturalized in France, one of the founders of modern infra-microbiology. Graduate of the Faculty of Medicine in Bucharest, he was an honorary member of the Romanian Academy and the French Academy of Medicine.

Nicolae Paulescu (1869-1931), the true discoverer of insulin, secreted by the pancreas and originally called “pancreine” by Paulescu. In his studies he found that the hormone regulating the metabolism of carbohydrates is equally involved in lipid metabolism and parotids. The hormone discovered by Paulescu has also been shown effective in reducing hyperglycemia and in the treatment of diabetes.

A totally exceptional name is Ana Aslan (1897-1988), academician, specialist in gerontology. From procaine, an important substance in improving age-related dystrophic disorders, she developed Gerovital, vitamin H3, patented in 30 countries since 1952. That same year, she established the first geriatric institute in the world, Geronto- Geriatrics National Institute Dr. Ana Aslan, that would represent a model for other countries for both clinical care and research.

George Emil Palade (1912-2008), a Romanian Nobel Prize laureate for physiology and medicine in 1974, considered the father of modern cell biology, and received the National Medal of Science of the United States of America in 1986.

Prof. dr. Cornelius Giurgea (1923, Bucharest - 1995 Brussels) has revolutionized encephalo-neuro-psycho- tropic therapy, by discovering and substantiating the concept of a new therapeutic (pharmacological) class in neuroscience - nootropic medication (nootropics, memory and cognitive enhancers, anti-hypoxic agents, cerebral metabolism activators, smart drugs). The first representative such medicine is piracetam (DCI) - Nootropil® (UCB) - generation I.

A cyclic derivative of gamma amino butyric acid (GABA) - amino acid neurotransmitter from the brain, piracetam - due to lack of toxicity, outstanding efficacy and wide use is produced in many countries around the world and registered (®) under over 50 names, of which the most popular are: Nootropil®, Braintop®, Cerebroforte®, Gabacet®, memo Puren®, Nootrop®, Normabrain®, Piracebral®, Psychoton®, Sinapsan®.

76 Relocation of the European Medicines Agency 5.2 Strong perspectives of present Romanian R&D in medicine and pharmacy

A country with high perspectives in the research and development area, Romania counts more than 30,000 people working in research fields, out of which 18,000 highly skilled researchers. The Extreme Light Infrastructure - Nuclear Physics (ELI-NP), the most advanced research facility in the world, focusing on the study of photonuclear physics and its applications, is placed in Romania (only 12 km outside Bucharest). The infrastructure will create a new European laboratory with a broad range of sciences covering frontier fundamental physics, new nuclear physics and astrophysics as well as applications in nuclear materials, radioactive waste management, material sciences and life sciences. The “Victor Babes” National Institute - the “telocytes group in Bucharest” has discovered a new type of interstitial cells - the telocytes, with possible implications in transmission of signals initiating regeneration. Romania is the first country in Europe in terms of telemedicine.

Most public hospitals in Bucharest have research departments and clinical training centres belonging to the universities of medicine and pharmacy.

In Bucharest, there are 1,600 medical university staff and around 10,000 medical, dental and pharmacy students. ELI-NP - a very high intensity laser system, with two 10 PW laser arms able to reach intensities of 1023 W/ cm2 and electrical fields of 1015 V/m, is going to be the most advanced research facility in the world, focusing on the study of photonuclear physics and its applications and the most brilliant tunable gamma-ray beam. Situated in Magurele, only 12 km from downtown Bucharest, the users of the ELI-NP facility benefit from all infrastructure and services provided within the metropolitan area. The “Victor Babes” National Institute – The “telocytes group in Bucharest”, created by Laurentiu M. Popescu, has discovered a new type of interstitial cells, the telocytes, with possible implications in transmission of signals that initiate the regeneration.In 2012, telocytes became an internationally registered brand. Studies published in prestigious international journals (indexed by ISI) highlighted Romania’s contribution to the the international scientific community. Today, telocytes are recognized in more than 40 laboratories on the five continents. The most active countries in telocyte research are: China, Italy, Spain, Germany, Belgium, Singapore or the USA.

Nowadays, studies carried out at the Department of Cell Biology, Molecular and Histology of the Bucharest Medical and Pharmacy University, in collaboration with the Fudan University and Shanghai Regeneration and Aging Laboratory in China, intend to decipher the function of these cells. As a result of this collaboration, the genomic and proteomic characterization of telocytes isolated from the lungs has been obtained and further evidence of their regenerative potential cells has been provided. In collaboration with Fudan University, the book entitled “Telocytes: connecting cells” has been published by the renowned Springer publisher including the contributions of 30 laboratories around the world.

Relocation of the European Medicines Agency 77 Today, the role of telocytes is only surmised, but their yet unknown functionas are most likely closely correlated with the particularities of their structure. Therefore, there are projects funded by the Executive Agency for Higher Education, Research, Development and Innovation Funding (UEFISCDI) that aim to discover the functions of telocytes by developing bioinformatics and information processing systems. It is very important to determine the constitutive properties of the telocytes for the study of the signalling mechanisms between them and the surrounding cells, with possible implications in the transmission of signals that initiate the regeneration.

Exemples of R&D Centres in Romania: • Centre for Gene and Cellular Therapies in the Treatment of Cancer (OncoGen), Timisoara • Institute of Cellular Biology and Pathology “Nicolae Simionescu” • Institute for Macromolecular Chemistry “Petru Poni”, Iasi

Major R&D regional centres in Romania: 1. Renault Technology Romania, Bucharest 2. Regional R&D Center Ixia (IT), Bucharest 3. Cisco Academic Training Regional Center, Bucharest 4. Regional R&D Center Renault, Titu 5. Regional R&D Center Continental (IT), Timisoara 6. Regional R&D Center Siemens, Cluj-Napoca

Romania is the first country in Europe in terms of telemedicine. The national telemedicine network includes two command centers, at Floreasca Hospital in Bucharest and Clinical Emergency Hospital of Târgu Mureș and 56 hospitals in 19 counties. Thus, doctors at the two command centers provide medical support in real time to any of the hospitals in the country and pursue the patient’s vital signs.

5.3. Business Continuity – Romanian approach

The Romanian candidacy offers a professional approach to relocation assistance, mechanisms and procedures, based on the hypothesis that EU Council’s decision is favorable to Romania. Immediately after the decision for the EMA relocation to Bucharest, the Romanian Ministry of Health (RMoH) will put in place an operational department of Support Relocation Services (DSRS) in order to support relocation of activites, experts and their families from the UK. The purpose is to relocate the EMA with least brakes.

78 Relocation of the European Medicines Agency During the relocation process of an organization, the most important element is the continuity of the main activities so that both employees and clients can be assured that the core activities are carried out continuously and the risks of interruption are controlled and at minimum levels.

The proposed EMA business relocation is based on a risk control management mitigated by the arrangements in place for the continuation and/or resumption of essential services and ultimately returns to business as usual. (Phase 1 of the EMA Brexit Preparedness Business Continuity Plan approved at the management Board Meeting). The Romanian approach considers the relevant EMA management Board decisions and EMA’s Operations and Relocation Preparedness Task Force (ORP) created to ensure a smooth transition of the organization through a well-organized process.

From the organizational point of view, the following three components are essential: 1. Overall Management 2. Coordination 3. Implementation

1. EMA Governance: - Establishes authority and responsibility for the ORP dealing with the final and approved EMA Brexit Preparedness Business Continuity Plan , Employee policy document for relocation and a final Communication Plan of support internal and external communication in the relocation process. - Approves and selects a well known relocation company that will develop and implement the Business Relocation Plan (BRP) and Action Relocation Continuity Plan (ARCP) accordingly; the required services should be developed considering the risks and scenarios identified in the final or updated version of the EMA Brexit Preparedness Business Continuity Plan. - Approves the Space Plan to be developed, BRP and the ARCP and the EMA Support Relocation Team (ESRT).

Since all resources cannot be replaced immediately, a Business Relocation Plan (BRP) and the Action Relocation Continuity Plan (ARCP) should be endorsed/approved by the EMA Board members with final estimates. The ARCP includes the needed resources (budget, equipment and people) in hours, days and weeks following the beginning of the relocation process.

Business Relocation Plan requires high-level detail planning. Relocating EMA office needs the protection of the business from unplanned events that may arise during office relocation (comprising people, IT&C resources, documents, office space, furniture and equipment). Romania is fully engaged to develop a Space planning document immediately after the Council’s decision with respect to the next EMA stop in order to support too the BRP and ARCP.

The Business Relocation Plan (BRP) and the Action Relocation Continuity Plan (ARCP) should be as practical and flexible as possible to allow effetive regional and local adaptation to minimize potential EMA’s exposure

Relocation of the European Medicines Agency 79 to business gaps and to mitigate the risks.

2. Relocation team’s coordination and competences: - Deals with exceptional situations and events, such as the international relocation of the European Medicine Agency, in its capacity as European regulator. Always focuses on coordination and control of people and resources. - Tests, plans, measures and arrangements among Relocation Teams for better coordination for the relocation. - Ensures implementation of the BRP and ARCP by providing availability of critical services and assets and of any other service or asset when warranted by a possible threat during the implementation of the ARCP. - Allocates executive responsibility for managing the relocation. It is advisable to select and appoint a leader to take overall project management responsibility and appoint representatives in each three proposed relocation teams to liaise with the leader. Also, it is important to prepare checklists of responsibilities for team members, so everyone is aware of key dates and tasks. - As the Relocation Teams’ main offices should be considered, at first, the present EMA headquarters in London. It is considered that in case of an event, the risks and their mitigation would be properly managed from the current premises on a case-by-case basis. At the current EMA premises, special arrangements will be made for the necessary rooms equiped with the required IT&C and support staff (i.e. secretary, assistant for the TL etc.). When 80% of the relocation is finalized, the EMA relocation team should gradualy move to the new premises. The EMA Support Relocation Team (further refered as ESRT) and The Romanian Support Relocation Team (further refered as RSRT) will be revoked when the underlying activities take place as before („business as usual“). Relocation Teams: - Relocation team from a well known, reliable relocation company: to ensure an effective relocation process, services are outsourced to a well-known relocation company who can develop, test and implement a Business Relocation Plan (BCP) and an Action Relocation Continuity Plan (ARCP) on EMA’s behalf. We consider that the EMA’s core business

80 Relocation of the European Medicines Agency teams and other process teams, with the Romanian Support Relocation Team (RSRT) are not in the position to allocate sufficient professional resources to support an international relocation process with no or limited interruptions; it is not their core business. The risks of such relocation should be mitigated by an outsourced specialized company offering a professional relocation team supported by the EMA and the Romanian Support Relocation Teams. - The Romanian Support Relocation Team (RSRT): is coordinated by a professional Romanian Team Leader (RTL), hired by the Romanian Ministry of Health with professional experience and expertise in business relocation. Details of the RSRT coordination and competences are presented in section 5.3; - The EMA Support Relocation Team (ESRT): the main knowledge support from the EMA team is provided by: Architect, IT Business Continuity Leader, Business Continuity Facilities &Vendors Leader and Business Continuity Human Resource Leader under the co-ordination of a London Team Leader (LTL). The team is supported by heads of line managers for business-specific changes during the tests or relocation activities; 3. Implementation of the relocation deals: - Provides support for space planning, involving architect and/or installation engineers; - The relocation company undertakes the development of the BRP and ARCP; - Implementation of the approved relocation BRP and ARCP; - Coordinates its relocation with the ESRT and RSRT support teams; - Monitoring of activities and continuous review and control of critical actions during relocation; - Approval of resources needed in the hours, days and weeks following the beginning of the relocation process (i.e. supplementary resources in special circumstances, level of approval etc). The development of the BRP and ARCP will consider maintaining EMA essential activities during relocation, based on principles and methodology of the approved EMA Preparedness Business Continuity Plan. This way, the EMA can continue to provide customers with the

Relocation of the European Medicines Agency 81 right level of service with minimal disruption. a Romanian Team Leader (RTL), with relevant professional experience and expertise in business The implementation phase of the approved ARCP relocation and a team of 6 key experts (RS) to support comprises all the planned relocation activities the EMA relocation process. The DSRS shall be under which are under the responsibility of the selected the direct responsibility of the General Secretary of relocation company that shall coordinate its steps the Romanian Ministry of Health (RMoH). with the support of the EMA and the Romanian Support Relocation Teams (ESRT and RSRT). The main responsibilities of the RomanianTeam Leader (RTL) are: - To support the whole relocation process, with The next section gives information about the emphasis on experts and their families; Romanian support for EMA relocation to Bucharest, in terms of people and organizations involved in - Support the space planning of the new building, order to offset possible risks of EMA staff shortages if the case; and other potential relocation events. - To ensure that staff responsibilities are met as for time and quality; - Select the best method of internal and external communication considering how the RTL will 5.4. Enabling staff to relocate with their distribute information to management, staff and families service providers and how often; - Agree together with his/her counterpart in London the target dates and timeline of activities; The Romanian Support Relocation Plan (RSRP) aims to support the EMA relocation of activities and staff - Develop together a project schedule with own with their families. staff and in agreement with the London counterpart; The Romanian Ministry of Health (RMoH) shall put - Coordinate all resources and assign in place, immediatley after the decision to relocate responsibilities: resource people to be responsible the EMA to Bucharest, an operational Department for certain tasks, as well as sector service providers of Support Relocation Services (DSRS) in order to and contractors, in case of need. support relocation of activities and experts and The RTL develops a comprehensive document their families, from UK. The purpose is to relocate called “Romanian Support Relocation Plan - Project EMA with at least breaks for work and life. Schedule” and coordinates its tasks together with A web page is created with a full range of necessary the London-based teams. The document shall information, such as: accommodation, schooling for prioritise support tasks with the aim to ensure work the whole range of educational levels for EMA staff’ continuity for the EMA in the relocation process. children; employment possibilities; taxes and other To achieve the operational objective of the “Romanian fiscal information, means of transportation etc. Support Relocation Plan - Project Schedule” (PS) the The organizational strucuture of the DSRS comprises following tasks are envisaged:

82 Relocation of the European Medicines Agency 1. Cross-cultural training in advance of EMA staff moving to Bucharest: 2 months prior to the relocation process, the EMA staff moving to Romania may be offered training by Romanian trainers on topics such as specific customs, language, habits&behaviours, social norms etc. Responsibile: Trainers in cross-cultural aspects from the DSRS in the RmoH with support from the Risk Management Expert (on insurance issues) 2. Develop a local Romanian plan for internal and external communication coordinated with the EMA communication plan in the UK with the goal to support employees and provide them with information on essential location aspects such as house prices, schools and colleges, medical facilities, local stores, culture and sports. Also the plan informs customers of the relocation dates and arrangements for delivery during the transition period; it sets the potential benefits of the move in terms of improved customer service. It provides customers and suppliers with essential location information including address, telephone and other contact details. Periodically informs customers, experts and suppliers of the relocation. Explains how and where to obtain services during the move to Romania. A special English language Call Centre is put in place to better communicate with experts or clients. At the same time, a group of RS (2 to 3 persons) shall be established, with support of the Romanian Embassy in the UK, to assist EMA staff, their families and business in the process of relocation from UK. Responsible: EMA London teams and the Romanian RSRT 3. Specific support for other EMA relocation activities: space planning support offered to the Romanian Developer, if the case. Responsible: ESRT and RSRT 4. Experts and family installation in their new dwellings. Tasks to be followed: 1) The project schedule shall be coordinated with the London Teams in order to determine their final sequences, duration and assigned support. 2) About 100 temporary hotel apartments/ rooms shall be made available for the EMA staff. Temporary stay for the staff and families will be correlated with the move of their personal belongings. 3) The RTL shall assign a RS for each expert/group of experts and family/families in order to support the EMA staff in case of international moving disruptions. On arrival in Romania, staff members shall be provided the contact of the assigned RS. 4) The RS shall support the EMA expert/group of experts in identifying appropriate dwellings according to the needs of the expert and their family. 5) On a case-by-case basis, the RS shall identify a list of tasks, with start and finish dates, for each

Relocation of the European Medicines Agency 83 particular relocation of each/group of EMA staff and their families. 6) The RTL and RS should agree with key stakeholder on the sequences, duration and assigned responsibilities. 7) Regular meetings provided in the project schedule for the entire project relocation to update the schedule and responsibilities: develop a contact sheet for all meeting attendees; distribute agendas of the meetings in advance. 8) Final move of EMA staff in their new living places Feedback to RS from EMA staff. Responsible: Relocation Specialists (RS) from the Department of Support Relocation Services (DSRS) in the RMoH and London Teams.

84 Relocation of the European Medicines Agency Established set of competences of the Relocation Support specialists ( RS) assisting the relocation process of EMA staff and their families are:

DSRS staff to assist EMA staff and families

- Supports the relocation with the outsourced selected company Relocation - Assists EMA staff and their familyes in the relocation process Specialist - Follow up activities. Real Estate - Supports the finding of the right location and space for specific needs. Specialist - Support and advise the staff and their families in their decision to rent or buy a living place.

Construction specialists are speifically assigned to: Construction - Provide support for coordination on space planning, office facilities and parking Expert / Architect - Provide support for construction oversight of new dwellings, renovations and upgrades.

IT&C Specialists - Assists EMA staff in arranging for the installation of low voltage telephone, data and video wiring Delivery and other IT&C services needed in their new facilities.

Risk Management - Identifies and mitigates risks and provides support for additional insurance coverage Expert - Provides expertise on safety measures, ergonomics, emergency preparedness etc.

Trainers on cross- - Conducts training on specific customs, beliefs, languages, dress, habits&behaviour, ideology and cultural themes social norms.

5.5. Covering the possible risk of 25% staff shortage

5.5.1. National responsibilities to support EMA staff relocation and possible staff shortages

The National Agency for Medicines and Medical Devices (NAMMD) is a reliable, active partner of the European Medicines Agency Romania ranks tenth EMA employees.

Romania is ready to cope with the risk of a possible EMA staff shortage due to the relocation. In 2017, the Agency has signed a partnership agreement with the most prestigious medical university in Bucharest, the “Carol Davila” University to ensure EMA smooth business continuity, in case of a possible risk of personnel shortage.

The total highly skilled persons, to support an EMA 25% staff loss scenario, are 1,900 (300 persons from the NAMMD and 1,600 proffessors from all universities of medicines and pharmacy in Romania).

Relocation of the European Medicines Agency 85 The NAMMD and the Romanian Ministry of Health As of 2014, the NAMMD is also the national have full capacity to serve as a quick reference competent authority in the field of medical devices to cope with a possible risk of staff loss due to and of assessment based on scientific criteria relocation. Apart from the scenarios foreseen in adopted by national legislation in force of medical the EMA/336490/2017 MB document, Romania technologies for inclusion into the national provides its support for the possible loss of staff healthcare insurance system. and assures that this can be mitigated with aid of NAMMD personnel, which could replace shortly the One important point to note is increased critical position holders from EMA vacancies, until involvement of NAMMD specialists in activities of the hiring process of new employees is finalized. committees and working groups of the European Medicines Agency’s (EMA) and of the Heads of This is supported by the following facts: Medicines Agencies (HMA) (Annex 6). Romania has a long and uninterrupted history of modern pharmaceutical market regulators. For over 50 years, the National Agency for Medicines and Medical Devices (NAMMD) has represented the medicinal regulatory product authority in Romania.

It was the first institution in Romania to comply with the modern definition of a medicines regulatory authority, where main responsibilities were: authorisation and registration of medicinal products, yearly development of the Product Index, complex control of medicinal products manufactured nationally and abroad, pharmaceutical inspection, development of the Romanian Pharmacopoeia and its Supplements, development of national standards and reference materials etc.. The Romanian Pharmacopoeia has been considered a reference worldwide for many years.

The current mission of the Agency includes assessment of dossiers for authorisation for the marketing of good quality, safe and effective human medicines, assessment of dossiers for authorisation of conduct of clinical trials in Romania and of clinical trial sites; surveillance of human medicinal product safety in therapeutic circuit through inspection and pharmacovigillance.

86 Relocation of the European Medicines Agency In the context of the Brexit process, the NAMMD will also have to cope with this challenge without disregarding achievement of its current mission. In that respect, it is worth highlighting that, at EU, EMA and HMA committees and working groups’ level, aiming to create a frame of work allowing for coordinated approach to smooth transfer of UK responsibilities to the Member States remaining in the European Economic Area, the NAMMD will be directly involved in taking over redistributed responsibilities assigned. NAMMD specialists assigned as representative participants in these committees and working groups constantly prove their expertise in their area of competence through direct and ever more active involvement in the work of the respective committee / working group.

In 2017 the NAMMD has signed a partnership agreement with the most prestigious medical university in Bucharest “Carol Davila” University to ensure smooth EMA business continuity, in case of a possible risk of personnel shortage. Also, the agreement is an exemple of NAMMD cooperation with the relevant local actors (Annex 7). The total number of highly skilled persons, able to support the EMA in case of 25% staff loss scenario, is 1,900 (300 persons from the NAMMD and 1,600 proffessors from all universities of medicines and pharmacy in Romania).

5.5.2. International recognised medical and pharmaceutical Romanian universities providing highly skilled young graduates

Romania ranks highl globally, in terms of number of medical school graduates - 36 graduates for every 100,000 population. By comparison, the United States have 6.5 graduates and the UK, 9.3 graduates. Bucharest counts for more than 1,600 medical university staff and around 10,000 med- ical, dental and pharmacy students. 14,000 specialists in medicine and pharmacy trained in Romanian medical universities are currently working in other EU countries. More than 70% of foreign students studying in Romania (5.678) are enrolled in univer- sities of medicine and pharmacy.

Bucharest is a university centre with a long-lasting tradition – 12 public universities and 15 private universities, overall 159 faculties supply the market with highly skilled young people.

In the 2012 QS World University Rankings, the University of Bucharest was ranked in the Top 700 universities of the world. There is a constant increase of foreign students enrolled in its universities.

Relocation of the European Medicines Agency 87 Students enrolled in the medical and support areas in Bucharest for 2016-2017 educational year:

Total graduates LMPhD Bucharest No17 Areas of study Bachelor’s Master’s PhD (end education 2016)

1 Mathematics 105 63 39 3

2 Physics 126 41 55 30

3 Chemistry 66 31 26 9

4 Chemical engineering 210 108 98 4

5 Computer Science 362 234 127 1

6 Computers and information technology 621 437 170 14

7 Cybernetics, statistics and economic informatics 755 440 309 6

8 Veterinary medicine 228 220 0 8

9 Pharmacy (sectoral, 5 years) 267 266 0 1

10 Pharmacy (general, 3 years) 0 0 0 0

11 Medicine (sectoral, 6 years) 876 863 0 13

12 Medicine (sectorial, 4 years) 151 71 80 0

13 Medicine (general, 3 years) 29 29 0 0

14 Dental Medicine (sectoral, 6 years) 275 275 0 0

15 Dental Medicine (general, 3 years) 44 44 0 0

1 With over 170,000 highly-skilled young potential employees yearly, the Romanian market offers concrete possibilities in line with EMA principles to engage young persons in working activities or in constant dialogue and interaction in a mutually beneficial manner (e.g: young science researcher that could develop or support scientific opinions; inclusion of the views of young patients/consumers and their carers, wherever it may be appropriate).

Early involvement of young people in this kind of European regulatory Agency has proved to have a positive impact. On one hand, it fuels the Agency with young and very flexible highly-skilled work force adapted to short or long term assignments, with modern views of the global labour market. The freshness of their approach could be benefic for the constant improvement of the Agency, adapting it to future changes or market requirements.

17,18 Source: January 2017, Ministry of National Education, Monitoring System

88 Relocation of the European Medicines Agency Data regarding the students enrolled in Bachelor’s, Master’s and PhD programmes in the universities of Bucharest for the educational year 2016-2017:

Of which

Students enrolled Total number of in the Universities students in 18 Of which of Bucharest Bucharest Post graduate Preparatory Total number of Post graduate medical stud- year of Roma- students (BMPhD) programmes ies nian language Bachelor Master PhD

1. Romanian stu- 175.454 169.609 124.938 36.952 7.719 4.495 21 1.329 dents

2. Other EU Member States 766 710 563 49 98 10 46 students

3. Non-UE stu- 4.783 4.254 3.331 674 249 218 311 dents

4. Total students other EU and 5.549 4.964 3.894 723 347 228 357 0 non-EU (2+3)

5.5.3.Recruiting temporary IT staff at short notice

Due to the high number of public and private universities (159 faculties in 27 universities), Bucharest offers a wide range of possibilities for short notice recruitment of multilingual temporary staff.

The Bucharest IT market is mainly supplyed by the Politechnic University, University of Bucharest (Mathematics & IT Faculty), the Academy of Economic Studies (Cybernetics Faculty) and a range of new entry private universities which provide for key skills in infrastructure (i.e. systems, middleware); IT architecture (i.e.: security, software); systems development (i.e. developers, testers); management (i.e. project, ITSM).

Ability to recruit highly skilled IT and data management human resources (contractors):

The Romanian software and IT services sector relies on its highly-skilled human capital, recognised at international level. Romania ranks 4th worldwide in terms of medals obtained in all times International IT Scholar Competition - 99 medals in total, out of which 28 gold medals, 45 silver medals and 26 bronze medals.

Relocation of the European Medicines Agency 89 It is estimated that the software and IT services industry will generate more than 3% of Romania’s GDP in the next 3 years, provided the industry manages to leverage and compensate for a legacy education system and keep a low rate of highly IT skilled foreigners (especially from Ukraine, Bulgaria, Serbia etc.) who might be attracted to the country.

On the mid-term, the trend of increasing the value added to IT services provided from Romania is visible, while still focusing on growing the junior workforce, On the longer term, Romania’s positioning is expected to consolidate as a target market for higher value-added services, R&D centres and significant domestic market projects that would include high-end solutions and technologies.

Strong international IT providers (people&skills&accessibility)19162

The local private market is concentrated around multinationals. For 2017, there are clear signs of an increasing local IT market maturity, increasingly educated IT managers/CIOs, as well as top executives. The types of solutions and IT tools required show growing interest in business-oriented technologies, with lower TCO and faster ROI. Looking at the ownership structure of the software and IT services companies in Romania, it results that strategic investors (IT corporations) and entrepreneurs have been the most active during the past 10 years. Investment funds and “business angels” are increasingly visible on the market, analyzing different opportunities to enter the capital of high-potential local IT companies.

Distribuition of IT companies in Romania

2.3% 5% 2.4% 46.4%

6.4%

6.5%

12.1% 18.8%

București Cluj Timiș Iași Brașov Bihor Dolj Alții

19 Source: “Software & IT Services in Romania - 2017 “commissioned by ANIS Romania

90 Relocation of the European Medicines Agency Based on the number of employees and turnover, the first 5 IT companies in Bucharest and Romania are multinationals such as Oracle, IBM, Ericsson Telecommunications, Microsoft, Atos IT Solutions and Services.

More than 75% of the companies in the field are located in areas with university centres and have attracted foreign investments in recent years: 46.4% in Bucharest, 12.1% in Cluj, 6.5% in Timis, 6.4% in Iasi and 5% in Brasov.

5.6. 2018 TIME-PLAN FOR EMA RELOCATION

Timing Key Milestones Responsibility November 2017 CE decision on the new seat for the EMA EU Council in another EU member state December 2017 Space planning in accordance with Responsible arhitect working with/for detailed EMA requirements and Romani- EMA an regulations in construction: structure& enclosure of the building. December 2017 Base-building construction completed Romanian Developer Dec. 2017-Jan. 2018 Tender for selection and approval European Medicine Agency (EMA) desig- of the relocation company. Signing of the nated staff contract with the relocation company. EMA and Romanian Developer Lease contract approval by the MB and signing of contract. Feb.-March 2018 Business Relocation Plan and Action Con- Relocation company and EMA tinuity Relocation Plan: development and approval Jan.-Feb.2018 New building: space design based on de- Romanian Developer as per Contract tailed space planning schedule Phase I: Fit-out works’ completion: Romanian Developer as per contract March-May 2018 Phase I: first 6 floors, basement and schedule Phase II: ground floor Support: RTL, LTL June-August 2018 Phase II: remaining floor spaces

May- June 2018 Testing, commission and preparation for LTL, RTL and Relocation Company the move June 2018 Early access by services after phase I, fit- Relocation Company out work completion. Support: RTL, LTL

July-Sept. 2018 Staff moves: first phase based on planned Relocation Company staff move. Support: RTL, LTL Sept.-Nov.2018 Staff moves: second phase, after phase Relocation Company II fit-aut works completion and based on Support: RTL, LTL planned staff move. December 2018 First committee meeting (CVMP) at the EMA new Bucharest location. December 2018 Formal change of EMA address EMA

Relocation of the European Medicines Agency 91 Geographical Spread

VIAfter 10 years of EU membership, Romania is among the few EU countries not yet hosting any EU agency. During the 10 years of EU membership, Romania has demonstrated its full commitment towards deepening the EU project and promoting European values, fundamental principles and objectives set out during this period. Romania has a clear and steady pro-European orientation, as also shown by the results of Eurobarometer surveys issued on the EU public support in MS countries. Romania is a pillar of stability in the region and has a unique geostrategic position in the Black Sea area, able in the present context to set up a security platform in the Black Sea, Balkans, Central Asia and Middle East area. Romania’s strong commitment towards the EU is supported by good economic perspectives. This is exemplified by the fact that 2016 was an exceptional year for the Romanian economy, as headline growth accelerated to 4.8%. Romanian economy is expected to continue growing in the current year. Romania provides a favorable location, a friendly investment climate as an attraction tool for investors worldwide. Romania remains very well positioned to attract new investments due to its historical support for its high level of education. As an important player in the region, Romania has an economic impact due to its crucial structural shift in the economy: the emergence of the BPO/SSC and IT sector as powerhouse for growth and employment. Output in the sector has increased by 12% during 2016, making it the second contributor to GDP expansion after consumer spending and ahead of industrial production. Furthermore, the sector has consistently recorded growth rates above 7% p.a. during the past five years. The two reasons to consider Romania as a regional potential hub in the service sectors are: i) demand for services is expanding at a global level and ii) Romania has a significant potential for development in this area.

92 Relocation of the European Medicines Agency At global level, multinational companies have seen an increased benefit from constructing Shared Service Centres as a means to reduce costs and are set to continue implementing these solutions as key components of a new business model. The CEE region has been at the forefront of this boom, with Romania closely following up, as it currently employs approximately 100,000 people in the SSC/BPO sector. Furthermore, the prominence of the already existing companies should help boost demand not only during 2017, but also in the years ahead. Bucharest, the capital city of Romania, aims at becoming one of the European regional hubs for business and tourism and an important centre for higher education. Taking into consideration the achievement of such goals, local development programs are integrated with the European strategy that aims at providing the appropriate environment for sustainable economic growth. The Bucharest local strategy is focused on five goals regarding employment, research, education, poverty eradication and energy – climate. Criminal behavior is kept under control, up to now, no special events having been registered. Citizen safety has been highest over the past ten years. Crime prevention activities carried out by the Romanian authorities are targeted largely towards issues that citizens consider priorities for improvement of safety problems in the towns where crime occurs most frequently. In the prevention area, special attention is paid to the education environment. Finally, in choosing Romania as the next stop for the EMA, it is important to stay focused on benefits offered to the European people, in a dynamic world in real time, by a country with: 1. European tradition 2. Minor Brexit impact on the National economic stability2019163 3. An important geostrategic regional hub 4. Skilled population 5. Friendly social, economic and cultural conditions 6. State-of-the-art IT&C technologies 7. Secure life 8. European excellent and affordable living condition Accommodating the European Medicines Agency in Bucharest would meet the objective set out in the Conclusions of the December 2003 EU meeting at the level of Heads of State or Government and confirmed in 2008, that observing a geographical spread of the agencies’ seats at the level of the entire European Union is desirable.

20 2016 Report, Romanian Ministry of Economy: Romania’s total exports and imports to the EU, at the end of 2016, ammounted to EUR 95.029 billion, out of which EUR 4.027 billion (4.23%) represented trade relations with the UK

Relocation of the European Medicines Agency 93 Vote Romania for EMA

94 Relocation of the European Medicines Agency Annex 1 Religious affiliation: Eastern Orthodox (including all sub-denominations) 86.5%, Protestant (various denominations including Reformed and Pentecostal) Romania – country general fact and figures 5.1%, Roman Catholic 4.6%, other (includes Muslim) 0.4%, none or atheist 0.2%, unspecified 0.1%. Official Name: Romania Form of State: Romania is a semi-presidential democracy based on a bicameral Parliament: Location: (Southeastern) Central Europe the Chamber of Representatives or „Chamber of Climate: Temperate, four distinct seasons Deputies” (Camera Deputatilor) and the Senate (Senat). All members of the legislature are directly elected. Time Zone: GMT + 2 Under the semi-presidential system, the president is Official Language: Romanian responsible for foreign and defense policy. Area: 92,043 sq. miles (238,391 sq. km) Legal system: Constitution of 1991 amended and Flag: Three vertical stripes: blue, yellow and red. completed by the Law No. 429/2003 on the revision of the Constitution of Romania. Capital: Bucharest (București) Electoral System: Universal direct suffrage over Currency: Leu the age of 18. Parties must win at least five percent Population: Based on the latest United Nations of the national vote to gain representation in the estimates, the current population of Romania1 is Parliament. Organizations of citizens belonging to 19,270,127 as of Monday, April 3, 2017 or, 3.9% from the national minorities, which fail to obtain the number total EU population, equivalent to 0.26% of the total of votes for representation in Parliament, have the world population. Romania population ranks number right to one Deputy seat each, under the terms of 59 in the list of UN countries (and dependencies) by the electoral law. Citizens of a national minority are population and 7th in The EU. entitled to be represented by one organization only. National Elections: Fall 2019 (presidential), Fall 2020 (parliamentary) Largest cities2: Bucharest (1,883,425), Iasi (322,000), Cluj Napoca (309,000), Timisoara (303,000), Constanta Head of State: President of the Republic, currently (298,000), Craiova (295,000), Galati (286,000), Brasov Mr. Klaus Werner Iohannis (elected on November 16, (275,000), Ploiesti (224,000), Braila (205,000), Oradea 2014). Romania’s president can serve two consecutive (196,400). Romania’s population lives in 320 cities and five-year terms. towns and 12,956 villages, with 61.3% of the Romanian National Government: The government is led by population in urban areas (11,785,372 people in 2017). the Prime Minister, nominated by the political party Ethnic groups: Romanian 83.04%, Hungarian 6.5%, - or political alliance - with parliamentary majority, Rroma 3.3%, Ukrainian 0.3%, German 0.2%, other approved by the President of Romania and confirmed 0.7%, unspecified 5.9%. by the Parliament.

1 Source: Worldometers (www.Worldometers.info). Elaboration of data by United Head of the Government: the Prime Minister, currently Nations, Department of Economic and Social Affairs, Population Division. Mr. Mihai Tudose (appointed on June 26, 2017). 2 2011 Romanian Census

Relocation of the European Medicines Agency 95 Main political parties, represented in Romania’s o Moderately Free 60 - 69.9; Parliament following the December 11, 2016 elections: o Mostly Unfree 50 to 59.9; and Social Democratic Party (PSD), National Liberal Party (PNL), The Union for Romania (USR), Democratic Union o Repressed 0 - 49.9. of Hungarian Ethnics in Romania (UDMR), Liberal- Democratic Alliance (ALDE), Popular Movement Party The Romanian score is better compared to other, (PMP). more advanced economies in the EU. Romania 65.60 Slovenia 60.60 Local Administration: Forty-one County Councils (Consiliul Judeţean) and the Bucharest capital city . Portugal 65.10 Croatia 59.10 Romania is a member state of the European Union (EU) and North Atlantic Treaty Organization (NATO), France 62.30 Greece 53.20 apart from being member of all major international organizations. Italy 61.20

Religions in Romania

Orthodox Romano-Catholic Romania: Economic growth competiveness index is Reformed Pentecostal 4.324 Greek-Catholic

Muslim Unitarium The Growth Competitiveness Index (GCI) aims Old Rite Christian Synod-Presbyterian Lutheran Evangelic to quantify the quality of the macroeconomic environment, the state of country public institutions and its level of technological readiness. Higher competitiveness scores are more desirable: - Very High 5.51 to 7 - High 4.51 to 5.50 Source: Romanian 2002 Census - Moderate 3.51 to 4.50

Romania: Economic freedom rating is 65.663 - Low - 3.01 to 3.50 Scores are from 0 to 100, higher scores are more - Very Low 0 to 3.00 desirable i.e. more conducive to economic growth. The Romania 4.32 Cyprus 4.23 lower the score, the greater the level of government interference in the economy and the less economic Bulgaria 4.32 Slovak Rep. 4.22 freedom a country enjoys. Slovenia 4.28 Croatia 4.07 o Free 80 - 100; o Mostly Free 70 - 79.9; Hungary 4.25 Greece 4.02

3 Source: The Heritage Foundation and the Wall Street Journal 4 Source: World Economic Forum

96 Relocation of the European Medicines Agency Romania: Taxes on residents is -10,16%5 The percentage of gross earnings given up in tax, including any social security contributions. Calculated for a single worker without children, earning 100 % of the average wage, for selected countries.

Ireland 10.09% Slovak Rep. -13.80%

Malta -10.09% Slovenia -13.80%

Romania -10.40% Lithuania -14.21%

Czech Rep. -11.12% Croatia -14.21%

Hungary -12.62% Estonia -14.25%

Poland -12.84% Germany -14.42%

Bulgaria -13.11 % Sweden -14.58%

Luxembourg -13.11% Belgium -14.66%

Latvia -13.22% Netherlands -15.16%

Spain -13.23% Austria -15.23%

Portugal -13.73% Denmark -15.73%

Ratio/Capital city Bucharest Average salary (Euro/month) 572

Rent for a studio (Euro/month) 150

Hotel room (3 stars) (Euro/day) 45

Utilities (Euro/month) 70

Gasoline (Euro/liter) 1.1 Urban transport ticket (Euro) 0.6

5 Source: OECD Tax Database

Relocation of the European Medicines Agency 97 and Sites ICOMOS and the 1996 European Museum Annex 2 of the Year; Bulandra Theatre — a member of the European Theatre Union since 1992; Bucharest National Theatre — a founding member of New European Theatre Action NETA network; Romanian High quality of life, culture and leisure Youth Cultural Centre — a member of the European Federation of National Youth Orchestras. The Cultural Scene of Bucharest Bucharest’s cultural life is a rich mix of strong The European presence is also felt in the numerous traditional culture, represented by a performing arts cultural events organised in cooperation with the sector - theatre, opera, dance and music - as well as cultural institutes of other EU states. The French a large and diverse network of museums and a mass Institute is one of the several cultural agencies culture, represented by an increasing number of promoting foreign culture in Romania, through its open air festivals, concerts and events and a rapidly network of institutes and cultural centres located in developing contemporary arts scene. Moreover, the main cities. The German Goethe Institute, the there is a growing number of cultural operators Italian (Vito Grasso) and Spanish (Cervantes) institutes from the entrepreneurial sector. These include, and the Hungarian Cultural Centre, just to name a besides the traditional areas of cultural industries few of the cultural institutes present in Bucharest such as multimedia, cinema, audiovisual, music, are supporting the cultural life through seminars, publishing, cinema, the more edgy domains of video conferences, festivals, concerts, exhibitions etc, by games, interactive media, design, craftsmanship, funding a variety of independent projects and support architecture, etc. Based on recent evaluation of the various programmes and projects, along with public creative economy sector in Romania, Bucharest is the and non-public institutions. national leader in cultural entrepreneurship. Bucharest has the highest number of Art Universities The arts and culture sector has different types of in the country (seven), with more than 7,000 art cultural structures, each with its own organisational, students. In recent years, there have been some economic and artistic characteristics: municipal successful attempts to improve the collaborative and national cultural institutions, independent aspects of the, otherwise, traditional institutions with organisations and private ones. Although they are all research and experiment platforms. equally important as part of the cultural ecosystem of Some notable examples are the Centre for the city, they are in fact separate phenomena. Electroacustic Music and Multimedia at the National The independent sector’s rapid growth over the past Music University, which works with cuttingedge 15 years is also the result of the annual incorporation technologies in aural and visual arts and the CINETIC of a high number of young arts graduates coming international research centre in creative technologies from all over the country, making it the most active at the University of Theatre and Film. and innovative part of the local cultural scene. The Bucharest diverse networks of museums and public libraries produce more than half of the city’s The Bucharest cultural institutions with European cultural output, comprising theatre, dance and music recognition are: The National Peasant Museum — a performances, as well as exhibitions, conferences and member of the International Council of Monuments arts driven education events.

98 Relocation of the European Medicines Agency Bucharest’s Cultural Infrastructure6 coins, books, maps, engravings, paintings, arms and Libraries Number furniture to old traditional costumes. Among the most

National Libraries 3 valuable exhibits are the document attesting for the first time the name of the city of Bucharest, issued by Specialized Libraries 58 Vlad Tepes in 1459 and a sword set in precious stones School Libraries 264 that belonged to Prince Constantin Brancoveanu Libraries of Academic Institutions 28 (1688-1714). Museums and Public Art Collections 36 Theatres, Show and Concert Companies • George Enescu National Museum Dramatic Theatres 23 Address: 141 Calea Victoriei Opera Institutions 2 Musical Theatres, Operetta 1 The museum, housed in the Cantacuzino Palace, Puppet Theatres / Animation 1 displays documents and various objects that belonged Philarmonics 3 to the great Romanian composer and violinist George Enescu (1881-1955), including a Bach music Popular Orchestras 1 collection he received as a gift from Queen Elisabeth Artistic Ensembles 13 of Romania. A world-class violinist, Enescu studied Cultural Centres 7 at the Vienna Conservatory, where he met German Cinemas 17 composer Johannes Brahms and where he also Circus 1 gave his first concerts. In Paris, Enescu graduated Cultural Heritage from the French Conservatory in 1899. His best- Historic monuments 2.651 known works, the Romanian Rhapsodies, earned him Treasure Goods 12.191 national and international fame. In 1936, his Oedipe tragic opera premiered in Paris and Enescu was awarded the French Legion of Honor award for the Museums composition. A member of the Romanian Academy and corresponding member of the Institute of France, • Art Collections Museum George Enescu was the teacher of renowned violinist Address: 111 Calea Victoriei Yehudi Menuhin. Every two years, the Romanians Founded in 1978, the Art Collections Museum, a celebrates the maestro by hosting the George Enescu branch of the National Art Museum, houses private International Classic Music Festival. collections donated over the course of time. Collections include European as well as Oriental art works.

• Bucharest History & Art Museum Address: 2 I.C.Bratianu Boulevard Housed in the neoclassical Sutu Palace (1834), the museum features some 300,000 artifacts, from

6 Data provided by the National Institute for Statistics, the National Institute for Cultural Research and Training, the National Institute for Heritage

Relocation of the European Medicines Agency 99 icons, furniture, photographs and films build up a complete picture of Romanian folk culture. In one • Cotroceni Palace & Museum of the galleries, you can see a wooden church and in Address: 1 Geniului Street another, a wooden peasant house. Four more wooden churches stand in the outdoor museum area. In 1996, A former royal residence built between 1679 and 1681 the museum was named European Museum of the by Prince and ruler Serban Cantacuzino, the palace Year. Visitors can buy regional handcrafts and textiles was home to King Carol I, who made important in the museum’s extensive gift shop. changes in its architecture. At the end of the 19th century, Heir-to-the-Crown Ferdinand ordered the • National Art Museum partial demolition of the palace, which was later Address: Calea Victoriei 49-53 reconstructed by French architect Paul Gottereau in neoclassical style. In 1977, Nicolae Ceausescu Romania’s leading art museum was founded in 1948 transformed it into an official guesthouse with the to house the former Royal Collection, which included addition of a new wing. Romanian and European art dating from the 15th to After 1990, the old wing of the palace became a the 20th century. Located in the neoclassical former museum. The Oriental Hall, the Norwegian Hall and Royal Palace, set amid a wealth of historic buildings the Queen’s Chamber are almost unchanged from such as the Romanian Athenaeum, Kretzulescu Church the original design and are worth visiting. Very and the Hotel Athenee Palace-Hilton, the museum important collection of medieval art also can be seen here. Nowadays he new wing serves as the seat of the Romanian Presidency.

• Museum of the Romanian Peasant Address: Sos. Kiseleff 3

Opened in 1906, the museum features the richest folk art collection in Romania, with over 90,000 artifacts that trace the colorful and diverse cultural life of the Romanian people. The Pottery Collection includes some 18,000 items, representative of the most important pottery centres in the country. The oldest ceramic item found in the museum bears the currently exhibits over 100,000 works divided into inscription 1746. Equally impressive, the Costume two major sections. Its National Gallery features the Collection comprises almost 20,000 traditional folk works of major Romanian artists, including Grigorescu, costumes, some dating from the beginning of the Aman and Andreescu. There is also a roomful of early 19th century, giving visitors insight into the styles and Brancusi sculpture, such as you won’t find anywhere traditions of the Romanian peasants. else, demonstrating how he left his master, Rodin, behind in a more advanced form of expression. The displays dip into all aspects of life in the Romanian countryside. Exhibits of agricultural tools, carpets, The European Gallery, comprising some 15 rooms,

100 Relocation of the European Medicines Agency Bucharest’s newest museum, the MNAC, as it is often called by museum-goers, displays works of Romania’s contemporary artists as well as many temporary exhibits by international artists. The museum is housed in a wing of the Palace of Parliament, the space which would have served as Nicolae and Elena Ceausescu’s private apartment (where just the bathroom occupied 680 square feet, while the adjoining boudoir was three times that size).

• Theodor Pallady Museum displays little-known art gems from the likes of El Address: Str. Spatarului 22 Greco, Monet, Rembrandt, Renoir, Breughels (father and son) Cezanne and Rubens. If you only have time Housed in the beautifully restored Melik house, to visit one gallery, make it the Romanian one. It is built around 1750 by the rich Armenian Hagi Kevork the most complete collection of Romanian works of Nazaretoglu and currently, the oldest house in art in the country and quite possibly, the world. Bucharest, the museum features six Pallady paintings, a couple of his sketches and various other art objects. • National History Museum Zambaccian Museum (Muzeul Zambaccian) Address: Calea Victoriei 12 Address: Str. Zambaccian 21A Housed in a 1900s neoclassical building that once The museum possesses the private art collection served as the city’s main post office, the museum of Krikor Zambaccian (1889-1962). Names such as offers a great introduction to the exciting history of Andreescu, Grigorescu, Luchian, Pallady and Tonitza Romania. Spread throughout 41 rooms, the exhibits are famous in Romania, albeit less known outside recount the country’s development from prehistoric the country, but the works, mainly following the times to the 20th century. The highlight is the Impressionist school, are of the highest quality. There National Treasury Hall where visitors can enjoy a are also several small sculptures that complement dazzling display of some 3,000 gold items, including the canvases. Although Zambaccian was a big patron jewelry and valuable Neolithic artifacts. of the art of his home country, he also collected Among the displays are the 12 pieces of the 4th century European works from artists such as Cezanne, Renoir, Pietroasele Treasure Collection. First presented at Delacroix, Corot, Derain, Matisse, Pissaro, Bonnard, the 1867 World’s Fair in Paris, it was considered the Utrillo and Picasso. The museum preserves the most valuable treasure collection in the world (the initial display as it was conceived by the art collector tomb of Tutankamon had not yet been discovered). himself. One year later, the collection was displayed at the Second Annual International Exhibition in London and in 1872, at the International Exhibition in Vienna.

• National Museum of Contemporary Art Performing Arts Address: Calea 13 Septembrie 1, entrance E4 Bucharest’s performing art sector is historically

Relocation of the European Medicines Agency 101 strong with the National Theatre at its core. Its diverse presentations. networks of theatre, dance and music performances produce more than half of the city’s cultural output, • National Jewish Theatre as well as exhibitions, conferences and arts‑driven Address: Str. Dr. Iuliu Barasch 15 education events. The Jewish Theatre offers performances in Yiddish, Hebrew and Romanian (translation into Yiddish and Bucharest has numerous drama theatre and concert Hebrew available). venues. Tickets can be purchased on-line or directly at the venue’s box office. • The Comedy Theatre The vibrant cultural life is also supported by a great Adress: 2 Sf. Dumitru Street number of foundations implementing artistic and Sala Nouă: 11 Sf. Vineri Street cultural projects. These projects have led to the creation of an independent artistic scene, especially With a repertoire dedicated to comic genre in its as regards theatre, visual arts, contemporary dance, rich diversity, from Shakespeare, Chekhov and Gogol a scene that becomes more and more visible to the boulevard comedy, theater of the absurd and black public. comedy, Comedy Theater is unique in Romania. In the 60s the Comedy Theater went through a period Theatre performances are very popular in Romania of artistic synchronization with global theatrical and for most shows tickets sell-out within hours. movement, as evidenced by Nations Theater Award While most theatre productions are performed for “Best National Participation” made in Paris in in Romanian, sometimes, it is possible to find 1963 with the play “Rhinoceros” by Eugène Ionesco, performances in German or English at various small directed by Lucian Giurchescu, followed by “Shadow” theatres.There are 16 major theatres in Bucharest by Evghenii Svartz and “Troilus and Cressida” by offering performances for all ages. William Shakespeare, both directed by David Esrig, the The theatre season closes during the summer, from last one also getting the award for best performance. July to September, although some small student and underground theatres do remain open. • Odeon Theatre Address: Cal. Victoriei, 40-42 The notable theatres in Bucharest are: The Odeon Theatre, located in a splendid building • National Theatre which is a historical monument which centenary Address: Blvd Nicolae Balcescu 2 was celebrated in 2011, has been invited to be part of the Black Sea Route, within the project called The Three auditoriums host professional domestic and European Route of Historical Theatres. foreign plays by a broad selection of both classical and contemporary Romanian playwrights. The theatre’s This new route was launched on March 3rd, Great Hall (Sala Mare), hosts the grand productions, 2017, at a press conference that took place at the while the Amphitheatre (Sala Amfiteatru) shows National Theatre in Iași. Among the participants smaller productions and TV shows and the Studio were representatives of the theatres that are part of Hall (Sala Atelier) gets a mix of lower-key shows and the Black Sea Route and also members of Perspectiv

102 Relocation of the European Medicines Agency – The European Association of Historical Theatres, located in Berlin, the originator of this pan-European project, brought to life with the support of the European Union’s Culture Programme.

• Bulandra Theatre Address: 1Schitu Măgureanu Bulevard

The Bulandra Theatre was founded in 1947 as Teatrul Municipal; its first director was Lucia Sturza Bulandra, one of the leading Romanian stage actresses of her generation.

Since 1991, the Bulandra Theatre has been a member of the Union of European Theatres, which was founded in March 1990. The theatre currently has two stages, located about 1.5 kilometers apart from one another, Symphonic Music Sala Izvor (renovated 2002) near the Dambovita River, not far from the southwest corner of Cismigiu Garden • The Romanian Athenaeum and Sala Toma Caragiu(renovated 2003), about half a Address: 1 Benjamin Franklin Street kilometer southeast of Piata Romana, just east of the Gradina Icoanei park. The work of French architect Albert Galleron, who also designed the National Bank of Romania, the Athenaeum was completed in 1888, financed Opera & Ballet almost entirely with money donated by the general public. One of the preeminent public fundraising • National Opera & Ballet campaigns ever in Romania, the “Give a penny for Address: Mihail Kogalniceanu Boulevard 70 – 72 the Athenaeum” campaign saved the project after The city’s artistic life stood up to its Parisian nickname the original patrons ran out of funds. With its high in the 1930s and today, is as vibrant as ever. The Opera dome and Doric columns, the Athenaeum resembles House, completed in 1953, is worth visiting, not only an ancient temple. for its brilliant performances but also for the lavish The lobby has a beautifully painted ceiling decorated interior design. The world-renowned Romanian in gold leaf, while curved balconies cascade in ringlets Opera performs in Romanian as well as Italian and off a spiral staircase.A ring of pink marble columns German. You will be able to enjoy the classic repertoire is linked by flowing arches where elaborate brass - Puccini, Verdi, Rossini, Mozart -, innovative lanterns hang like gems from a necklace. Inside the staging, lavish costumes, seasoned performers and concert hall, voluptuous frescoes cover the ceiling choreographers. The Romanian National Ballet also and walls. Renowned worldwide for its outstanding performs in this theatre. Performances are held acoustics, it is Bucharest’s most prestigious concert Wednesday through Sunday evenings, except during hall and home of the Romanian George Enescu July and August. Philharmonic.

Relocation of the European Medicines Agency 103 Festivals & Events Entertainment Over the past 20 years, Bucharest has hosted a large number of festivals. Industry professionals promoted Cinemas an increasing number of film festivals in response to Foreign movies are generally shown in the original the dramatic decrease of the 1990s in film audiences language with Romanian subtitles. Current film and the lack of an European film distribution network. listings are available online www.sapteseri.ro Independent events and festivals such as Bucharest Design Week (20,000 visitors) and visual arts fair Art Circus Safari (19,000 visitors in 2015) have educated and Bucharest Globus Circus drawn new audiences, while network‑type events Address: Aleea Circului 1 such as the White Nights format have proven to be the most popular. Built in 1960, the enormous, permanent big-top circus is the centrepiece of a small but lovely park. With Music festivals seating for more than 3,500 spectators, Bucharest’s One of the country’s most important and popular circus continues to host excellent performances, put music events is the George Enescu International on by both local and touring companies. Festival, held in honour of the famous Romanian composer George Enescu. The first official opening day of the festival took place on September 4th 1958, merely three years after George Enescu’s passing, thus marking the official debut of the most important

104 Relocation of the European Medicines Agency Relocation of the European Medicines Agency 104 international musical manifestation hosted. Each edition brings to Bucharest some of the world’s most famous musicians worth mentioning Yehudi Menuhin, Sviatoslav Richter, Ion Voicu, Valentin Gheorghiu, Rostropovich performed on the stages of the Athenaeum, the Palace Hall and the Radio House and the most recent edition of the Enescu Festival (30 August – 20 September 2015, Bucharest) brought on stage George Enescu’s works by record-breaking German violinist David Garrett, San Francisco Symphony Orchestra (Pulitzer Prize for Music), or Israel Philharmonic Orchestra under Zubin Mehta. Conceived as a yearly event, Bucharest Jazz Festival is intended to be the major jazz event of Romania’s Capital, aiming to become fully integrated in the national and European contexts. Placing a strong accent on supporting the local Romanian jazz scene, Bucharest Jazz Festival is also a bridge for world class jazz and a platform for the latest trends in contemporary jazz.

Launched in 2006, the SoNoRo International Chamber Music Festival brought chamber music to the forefront of Romanian cultural life and included the Romanian musical scene in a network of high-profile European festivals. In addition to regular partnerships with festivals in Italy, Latvia, Germany, England, Israel and Japan, SoNoRo has performed in some of the most famous halls in the world, such as Wigmore Hall in London, Konzerthaus in Vienna, YMCA in Jerusalem and Carnegie Hall in New York.

Contemporary art and design Bucharest hosts every year the Romanian Design Week Festival, as a city highly promoting creative industries. Staged every year in May, Romanian Design Week is a 10-day festival that promotes design as a pad for cultural, social and economical growth. Events and showcases focus on product and industrial design, furniture, graphics, fashion, architecture and interior design. The main exhibition includes, every year, over 150 projects of more than 100 designers, design and architecture studios. A board of curators selects the participants of the main exhibition, gathering under the same roof the best creative work developed by Romanian designers, artists and architects. The festival’s international flair is reinforced by the introduction of a guest country. Up until now, these have included Netherlands (2014) and Denmark, Finland, Island, Norway and Sweden with a common project (2015).

The Art Safari Pavilion, organized by the Arts Society Cultural Centre Foundation, is an annual event devoted both to Romanian and regional art, with an emphasis on its recent developments. Designed to offer a comprehensive presentation of Romanian art, Art Safari features a wide range of artworks from heritage art to contemporary art. Over 100 galleries, museums and cultural institutions attend the event, mostly Romanian, along with participants from other countries.

Book fairs Another very important event is the Gaudeamus International Book and Education Fair, which gathers a very impressive number of publishing houses, as well as visitors. The Gaudeamus Fair is part of the READING Program initiated and organized by Radio Romania since 1994. Some of the highlights of the 2016 edition are: 125,000 visitors, 300 exhibitors from five countries: Romanian and foreign publishing houses, book distribution agencies, educational institutions, professional associations, cultural and educational non- governmental organizations, museum, libraries, 850 accompanying events – book launches, book signing

Relocation of the European Medicines Agency 105 sessions, professional debates and forums, creative workshops etc.

Film Festivals Awarded by the most important international film festivals, the Romanian New Wave films influenced the number and reputation of the film festivals. Bucharest International Film Festival is a competitive festival dedicated to feature films only; is organized by Charta Foundation. The objective of the festival is to promote international independent film, supporting the production and distribution of Romanian film as well. The festival aims to create a platform forthe international cinema industry.

The anim’est International Animation Film Festival, established in 2006, has become Bucharest’s most loved film festival and a recognized event on the international animation scene. The festival’s programme consists of six competitive sections (international feature film, international short film, Romanian film, student film, video, Minimest), the Mozaic section – presenting the hottest animation short & feature animations in international film festivals and also special sections & retrospectives dedicated to important animation studios, directors, film schools and festivals. Workshops, masterclasses, special parallel events, concerts and parties open to the festival guests and audience. The anim’est Trophy is presented every year to one of the films competing in the short film competition.

One World Romania is the biggest documentary festival dedicated to human rights in Romania and which presents cutting edge films addressing urgent political and social issues confronting today’s Europe. Starting 2017, One World will curate a special section within the festival, consisting of film showcases and collaboration programmes between documentary filmmakers and activists, providing a solid base for highly debated subjects such as the European refugee crisis, political views in the Orient, corruption and future world scenarios. Parallel, One World Association organises the educational programme One World Romania at School, which aims to introduce human rights debates and documentary film screenings in high schools from Bucharest.

Les Films de Cannes à Bucarest came into being in 2010 at the initiative of director Cristian Mungiu, with the support of Thierry Frémaux, General Delegate of the Cannes Film Festival. Their idea generated a trend, the festival spreading as far as Buenos Aires in 2014, under the name of Semana de Cine del Festival de Cannes.

Street festivals B-FIT in the Street!, the only international street theatre festival in Bucharest, is organised by ARCUB, the Cultural Centre of the Bucharest Municipality. During the festival, Bucharest becomes a fantastic setting, inhabited by unexpected characters blending in the crowd and interacting with the passers-by. Austria, Spain, UK, Germany and Italy were some of the countries that attended the 2016 edition of B-FIT in the Street!, an event with various dumb shows, circus, comedy, dance, acrobatics, street music and parades.

The Bucharest International Light Festival Spotlight restores public space to its traditional role as a set up for the rituals of communication by treating the architectural dimension of the city as a living structure

106 Relocation of the European Medicines Agency that auto generates. Artists and architects working with light are challenged to use the rich symbolism of Romanian folklore and translate it into digital art collaborative projects, to explore the superposition of spaces, experiment with the architectural dimension of the city as media carrying connections, rather than as static object and eventually use the public space of the city as a temporary museum.

Another interesting street festival held in Bucharest is called Femei pe Matasari (Women on Matasari) and brings together creative projects in the area of theater, music and fashion. The name comprehensively covers the event’s ideology: taking place in and around Matasari Street, organised by women, it’s designed to showcase local arts and culture groups through live music, fashion and theatre. The name of the street reminds of the old craft of working with silk (matase is the Romanian word for silk, matasar was the person working with silk).

Drawing huge number of persons, The European Night of Museums, the White Night of Galleries, as well as the White Night of Cultural Institutes has become a landmark for celebrating culture across the continent and these events have proven spectacularly popular in Bucharest.

The festival schedule during the year: • George Enescu Music Festival (September- every two years), the biggest international event • Masters of Lyrical Art (March) • Easter Gifts National Arts & Crafts Fair (April) • ‘Next’ International Film Festival (April) • Bucucuresti International Film Festival (B-EST IFF) (April) • Bucharest International Jazz Competition (May) • Bucharest International Music Festival ‘EuropaFest’ (May) • ‘GayFest’ Gay Pride Festival (June) • OstFest Music Festival - (June) • Rock The City - Music Festival (June) • B’ESTFEST top international dance, indie and world music acts (July) • ‘Proms of Delight’ - The Romanian Symphony Orchestra at Bucharest’s National Art Museum (August) • ‘Little Paris’ International Music Festival - (August) • International Festival of Radio Ensembles “RadiRo” (September) • Romania Tennis Open - an ATP event (September) • Romanian National Theatre Festival (October) • ‘Kinofest’ - cutting-edge short films and new media (October) • St Nicholas Fair at Bucharest’s Museum of The Romanian Peasant (December) • Winter Gifts Arts & Crafts Fair - Museum of the Romanian Peasant (December)

Relocation of the European Medicines Agency 107 extracted from 3 km deep, 1,800 parking spaces, 1,200 Healthy Leisure trees planted outdoors, 500 palms and exotic plants, the largest retractable roof with a front opening of Nearby Attractions: 36 meters without pillars, the water is extracted at 85 degrees Celsius, coated, cooled and changed once Nature, outdoor activities for adults and children - in 4 hours. The building uses mostly thermal energy bike ride, climbing courses in the trees, horse riding, supply. airsoft, archery or paintball - , relaxation and fun are ideally melt in some adventure parks which are also • Snagov Monastery very easy to access from Bucharest. Balotesti, Comana Where: 41 km (25 miles) north of Bucharest and Cernica are close to the city and well known for Access: car, bus, taxi the tourits they attract for a day or even a night stay over in the forest. In 1458 - more than one hundred years after the church was built (1364) - Romanian prince Vlad Tepes • Therme Bucharest, the largest thermal water park (Vlad the Impaler) added thick defending walls and in Europe a dungeon. A plaque on the floor inside the church Where: 10 Km North of Bucharest marks the grave with the presumed remains of the Access: car, taxi, Therme buses world-known count. The monastery is located on an island on lake Snagov and can be accessed on a Located in the Balotesti village, Therme Bucharest pedestrian bridge or by boat. is the perfect place to bring the entire family for fun and recreation, bringing together the wonders of nature and the convenience of modern lining in an exceptional setup. It is the largest thermal park in Sports Europe, with a covered area of 30,000 sq. meters and a total of 250,000 sq. m. It has palm trees, pools at 33 Football is the most widely followed sport in Bucharest, degrees Celsius and operates 365 days. with the city having numerous club teams, some The total capacity is 4000 visitors at the same time, of them being known throughout Europe: Steaua, pools are fueled exclusively by thermal waters Dinamo, or Rapid.

108 Relocation of the European Medicines Agency Arena Națională, a new stadium inaugurated on 6 Trophy international tennis tournament, which is September 2011, hosted the 2012 Europa League included in the ATP Tour. The outdoor tournament Final and has a 55,600-seat capacity, making it one is hosted by the tennis complex BNR Arenas. of the largest stadiums in Southeastern Europe. Sport clubs have formed for ice hockey, rugby union, Rugby games are held in different locations, but the basketball, handball, water polo and volleyball. The most modern stadium is Arcul de Triumf Stadium, majority of Romanian track and field athletes and which is also home to the Romanian national rugby most gymnasts are affiliated with clubs in Bucharest. team. Other Romanian turistic attractions with starting The Athletics and many Gymnastics National point in Bucharest Championships are held in Bucharest at the Polyvalent Hall, which is also used for other indoor Parks & Gardens sports such as volleyball and handball. • Cismigiu Garden The largest indoor arena in Bucharest is the Address: Regina Elisabeta Boulevard Romexpo Dome with a seating capacity of 10,000. It Designed in 1845 by the German landscape is used for tennis, boxing and kickboxing. architect Carl Meyer, the garden opened to the Every year, Bucharest hosts the BRD Năstase Țiriac public in 1860. The name, Cismigiu, comes from the

Relocation of the European Medicines Agency 109 Turkish cismea, meaning “public fountain.” More For an overview of the park, take a ride around than 30,000 trees and plants were brought from the lake on the ferry or rent your own boat. The the Romanian mountains, while exotic plants were park is also home to the Village Museum. The area imported from the botanical gardens in Vienna. surrounding the park holds even greater treasures. Cismigiu is Bucharest’s oldest park and a great place The streets between Bulevardul Mircea Eliade and to stroll and enjoy a break from the hectic city. Set Soseaua Kiseleff contain extraordinarily beautiful amid green lush lawns and winding paths, the park houses in architectural styles ranging from 19th offers a lake with rowboat rentals, a beer garden, a century neoclassical to 20th century art nouveau playground for children, a chess area for amateurs and modern luxury villas. and plenty of park benches for relaxing and people- watching. Painted Churches

• Botanical Garden • Voronet Monastery Address: Sos. Cotroceni 32 (across from Cotroceni Small but extremely beautiful, the Voroneţ Monastery Palace) was nicknamed the Oriental Sistine Chapel and the shade of blue that permeates the wall paintings is The huge greenhouses are open Tue, Thu, Sat, Sun, famous all over the world. 9am - 1pm. Opened in 1891, the garden features over 5,000 Close to the city Gura Humorului, the Voroneţ varieties of plants from Romania and around the Monastery is one of the few historic religious world. establishments which has, for the most part, retained its original form. The garden also encompasses a beautiful building Most of the interior paintings date from the reign in the Brancovenesc architectural style, housing the of Stephen the Great. The exterior paintings were Botanical Garden Museum. Here, you can peruse added later, during the reign of Petru Rareş, Stephen manuscripts, old botanical research devices and the Great’s son. a collection of artifacts made of vegetal materials. The church was extended and painted on the outside Locals treat the gardens as a park and on warm by metropolitan Grigore Roşca, in 1547. afternoons, you may see more young lovers than The church’s artworks are considered the best plants. representation of Moldavian feudal art. Three months, three weeks and three days. That i • Herastrau Park how long it took to build Voronet, perhaps Moldovia’s Address: 32 Soseaua Kiseleff most precious jewel. The church of Voroneţ Monastery was included in Spread over some 400 acres, from the Arch of the UNESCO World Heritage List in 1993. Triumph to the Banesa Bridge, the park is home to numerous attractions, including a boat rental • Sucevița Monastery complex, tennis courts and fairground. In the ”Învierea Domnului” Church of Suceviţa Monastery summertime, many terraces open up on the shores It was founded by metropolitan Gheorghe Movilă of the lake. and ruler Ieremia Movilă. The church was painted during 1596-1602.

110 Relocation of the European Medicines Agency Built in the 16th century and combining Gothic and Byzantine artistic elements with the style established during the reign of Stephen the Great and that of the wooden churches of the Maramureş area, Suceviţa has a special value, being included in the UNESCO World Heritage List in 2010. (Year of construction: 1582. Suceviţa Commune, Suceava County).

• Moldovita Monastery ”Buna Vestire” Church of Moldoviţa Monastery It was built by ruler Petru Rareş, near an ancient foundation of Alexandru cel Bun. The interior and exterior paintings in Moldoviţa Monastery’s church date back to 1537. Moldoviţa’s exterior paintings are true masterpieces whose remarkable preservation over the centuries has left their splendour undimmed by time. The church of Moldoviţa Monastery was included in the UNESCO World Heritage List in 1993. (Year of construction: 1532. Vatra Moldoviţei Commune, Suceava County)

• Horezu Monastery Horezu - UNESCO monument The ensemble of the Monastery of Horezu is situated in a picturesque landscape of the sub-Carpathian wooded hills and in the proximity of the Romanilor stream. It is the most important foundation of the Cantacuzene Prince Constantin Brancoveanu, the ruler of the Romanian principality of Wallahia between 1688 -1714.

The catholicon of the Monastery of Horezu, dedicated to Saints Constantine and Helena, was built between 1690-92 and the interior decoration was completed two years later by the work of the Greek artist Constantinos, who founded the school of mural and icon painters of Hurezi. The Horezu Depression was in 2008 designated a `European Destination of Excellence’, along with 19 other destinations in Europe, as part of the European Destinations of Excellence project, whose themes were tourism and hidden local heritage. Launched by the European Commission, the project was implemented by national tourism authorities in each participating country.

Sfânta Ana - the only volcanic lake Sfânta Ana is Romania’s only volcanic lake. It lies in the Harghitei Mountains, on the left bank of the Olt River near Tuşnad.

At 946 m, the lake occupies the bottom of an extinct volcano, named Ciomatu, from the volcanic massif Puciosu, of which 1,301m summit was the location of the most recent volcanic eruption in the Carpathians and indeed Central Europe, several thousand years ago. Almost circular, it is 620m long and 460m wide at its widest point, has a surface of 0.2 km2 and a maximum depth of 7m. With no springs feeding it, the lake is replenished only by rain and its water’s purity comes close to that of distilled water, containing only 0.0029ml minerals per liter. Extremely poor in oxygen, the lake permits no animal life.

Relocation of the European Medicines Agency 111 A reserve on account of its natural, geological, floral and wildlife riches, Sfânta Ana Lake is linked to Băile Tuşnad resort by tourist paths and a road.

Bukovina - a country of painted monasteries, impressive landscapes, old traditions, decency and hospitality. Small churches or real fortresses, lofty or well behaved, located in past mysterious places, enhance the charm of the landscape.

Speaking of Bukovina, one instantly thinks about great masterpieces of the painters of the Middle Ages: Voroneț with the impressive Judecata de Apoi (“Doomsday”), Pătrăuți with graceful “Cavalcade of Emperor

Constantine the Great”, Moldovița with the unique “Siege of Constantinople”, Probota with ecumenical councils and the gorgeous “Pantocrator” dominating majestically the drum tower, Suceviţa with its “Ladder of Virtues” or Arbore with St. Marina, reprinting a new way of “Cavalcade of Emperor Constantine the Great” and the Gothic canopy of the founder.

Among the many masterpieces existing in Bucovina, eight have received international recognition from UNESCO:

• “Beheading of St. John the Baptist” Church - Arbore • Church “Ascension of St. Cross” - Pătrăuți • Moldovița Monastery • Humor Monastery • Voroneț Monastery

112 Relocation of the European Medicines Agency • “St. John the New” Suceava • Probota Monastery • Danube Delta

Danube Delta - Part of UNESCO Natural Heritage Danube Delta, with an area of 5,800 square kilometers, is the second largest and best preserved of the European deltas and is mostly located in Romania.

It was included in the UNESCO World Heritage in 1991.

Earlier, Jacques-Yves Cousteau, a key figure of the 20th century, had made a television film, in four episodes and the intervention of the famous French was crucial in the decision to classify the Danube Delta as a Biosphere Reserve in Romania. The Danube Delta Biosphere Reservation The Danube Delta Biosphere Reservation is the third-richest biosphere reservation in the world in terms of biodiversity, after Australia’s Great Barrier Reef and Ecuador’s Galapagos Islands.

It is home to more than 7,000 known species of plants and animals known and, scientists believe, still more as yet unknown.

This feature of the Danube River is the only delta in the world with biosphere reservation status. Its area accounts for 2.5% of Romania’s surface and is the third largest delta in Europe, after those of the Volga and the Kuban and it is the 22nd largest in the world.

It shelters the largest compact area of reed beds on the planet and supports 30 types of ecosystem. Thanks to all these factors, the Danube Delta is a unique treasure of the planet’s natural heritage.

Besides the actual delta’s 3510 km2, Danube Delta Biosphere Reservation’s other remarkable features includes the Razim – Sinoe complex of lakes (1145 km2), the Black Sea beach strip (1030 km2), the Danube riverbank between Cotul Pisicii and Isaccea (13 km2) and the Danube flood-meadow between Isaccea and Tulcea (102 km2 ).

Dacian Fortresses

Dacian Fortresses - UNESCO’s Cultural World Heritage The fortified complex also known as Dacian fortresses in Orăştie Mountains, is located in the central and western sector of the geographic unit with the same name, concentrated around the river known as Apa Oraşului (Grădiştea river), which springs from Godeanu Mount and flows into the Mureş river at Orăştie.

Scattered along the many valleys of the mount, arrayed on high platforms, on natural or artificial terraces varying in altitude from 500 to 950 m, we can find here a number of habitats, most of them fortified, having

Relocation of the European Medicines Agency 113 characteristics and shapes of a surprising consistence, dominating the access ways and the main habitat, Sarmizegetusa, from the top of Grădiştea Hill (a branch of Godeanu Mount), at 1200 m altitude. The series of fortresses and defence towers of Sarmizegetusa start with the main access way to the capital of the Dacian kingdom, which ascended from Mureş Valley upstream to the river Apa Grădiştei, defended at the bottleneck point of the valley by the fortresses at Costeşti-Cetăţuie and Costeşti-Blidaru, as well as by the system of towers and small fortifications, such as Făeragul or Cetăţuia Înaltă. Built in the 1st centuries B.C. and A.D. under Dacian rule, these fortresses show an exceptional and unusual fusion of military and religious architectural techniques and concepts from the classical world and the late European Iron Age. The six defensive works, the nucleus of the Dacian Kingdom, were conquered by the Romans at the beginning of the 2nd century A.D.; their extensive and well-preserved remains stand in spectacular natural surroundings and give a dramatic picture of a vigorous and innovative civilization.

The Dacian civilization, as we know it today due to the systematic research undertaken by Romanian archaeologists, reveals the exceptional historical value (the concept of fortified mountains) and exceptional aesthetical value (the remarkable suggestion of the sacred and impenetrable space of the divine) of the fortresses from the Orăștie Mountains: a grandiose, imposing architecture which used refined decorative effects, a monumental architecture carved in stone, wood and as well other materials (clay, for example). The sophisticated rhythm of the columns of the sanctuaries, the dwelling towers located at the highest places of the fortresses, in perfect resonance with the spirit of the natural environment, single out this ancient civilization, faithful to its interior spirit and traditional materials. Sarmizegetusa Regia Fortress on Grădiştei Hill Sarmizegetusa Regia Fortress was the capital of pre-Roman Dacia, reaching its peak during the reign of Decebal and is the largest of the Dacian fortifications.

Located on the top of a cliff, at 1,200 metres altitude, the stronghold was the strategic centre of the Dacian defensive system of Orăştiei Mountains and consisted of six fortresses. The stronghold, a quadrilateral formed of massive blocks of stone (murus dacicus), is estimated to have been built in the 3rd-2nd centuries BC, being located on an area of approximately 30,000 square metres.

114 Relocation of the European Medicines Agency Relocation of the European Medicines Agency 114 GTS Telecom, part of GTS Central Europe Annex 3 and owned by Deutsche Telekom AG is one of the main infrastructure-based provider Other communication systems of telecommunications services in Romania and is positioned as a quality leader in the WiFi / Getting Online communications segment for medium and large Bucharest offers numerous WiFi hotspots and companies. The company is one of the founding many are free. Usually, all you will need is a members RoNIX (Romanian Network for Internet password (divulged to you when you order eXchange) and is certified ISO 9001, ISO 14001, something) though in many venues in Old Town or OHSAS 18001 and ISO 27001. in Metro you can simply sit down and start surfing GTS provides national and international transport away. solutions for data, voice, internet access, cloud services and collocation in its own data centres in Bucharest free Wi-Fi /HotSpots imply public Bucharest. spaces & parks: The company operates an extensive Ethernet - Piata Universitatii (University Square) at La and MPLS network built on a resilient fiber optic Biblioteca (The Library); infrastructure. - Orange Concept Shop at Calea Victoriei; - Orange Studio at Piata Victoriei (Victoriei Orange Romania is the brand under which France Square); Telecom provides mobile, Internet and television - Parcul Herastrau (Herastrau Park) at Gradina services. The France Telecom Group is one of Japoneza (The Japanese Garden); the world’s leading telecoms services with over - Expres Olimp at Bulevardul Iuliu Maniu 1 – 3 183 million customers on five continents. Orange - Lacul Tei at Strada Inginerilor; Romania has implemented a quality management - Strandul Moghioros at Moghioros Pool system certified according to ISO 9001. - Most Cafés, Restaurants and Clubs With the 4G Orange Network, it is possible to - Shopping Malls: Carrefour Orhideea Mall, access the information you need and send large CityMall, Auchan – Titan files faster than ever. In addition, you can make - Fast Food Restaurants: McDonalds (All McDonalds video conferencing or Full HD video streaming in Bucharest), K F C (all KFC), Pizza Hut, easier and for children quick access to online Pizza Maxx (splaiul Independentei 290 - Complex games. Starting with May 2017, Orange Romania Regie),WiFi hotspots in the Old Town Bucharest offer for the first time, 4G coverage in all cities in (Centrul Vechi). Romania.

Telecommunication Vodafone Romania is the first company that The city is well-served by a modern landline and implemented the GSM network in Romania in mobile network (4 mobile phone operators at April 1997. Also the first operator to launch 3G national level). The telecom system in Bucharest services on the Romanian market in April 2005 and has a reliable and modern communication then the superior level of HSDPA 3G broadband infrastructure with the following main operators: performance. In October 2012,Vodafone Romania is the first operator that launched the first 4G

Relocation of the European Medicines Agency 115 mobile data network in Romania. at sender’s location of choice. The handover takes For three consecutive years, Vodafone Romania place at sender’s location of choice, date and time have been certified P3 Communications as “The being established by the sender also. Most Powerful Mobile Network in Romania”. This service implies preliminary communication Vodafone Romania was the first telecom company between the sender and the final addressee in Romania certified according to ISO27001 regarding the time of the arrival. by KPMG UK in 2005, renewed certification in Collecting and processing operations are simplified 2014. ISO27001 is the most recognized standard thanks to processes informatization. for information security. The company is also Returning undistributed mail items at sender’s certified ISO 22301 Certification - Business location of choice. Mail items are being monitored Continuity Management; ISO 9001 Certification through the entire techological flow using the - Quality Management; ISO 14001 certification - Track & Trace system. Environmental management. Express services: Postal Services & Telephone Offices of Poșta Română, the national postal Prioripost Business – addressed to companies operator, are spread throughout the city, with that use direct sales (multilevel marketing); direct the central post office (Romanian: Oficiul Poștal marketing companies that manage monthly a București 1) located at 12 Matei Millo Street. Public significat number of mail items; companies that telephones are located in many places and are use the mail order channel or other categories of operated by Telekom Romania, a subsidiary of alternative commerce. Deutsche Telekom and successor of the former monopoly Romtelecom. Prioripost - fixed insured value - the service Post offices display a postal horn symbol and the addresses both to individuals and legal persons, word Posta. the delivery being distributed within the express Main Post & Telephone Office mail system - PRIORIPOST. It is a fast and Address: Str. Matei Millo 10 (off Calea Victoriei) convenient system to send financial and fiscal Open: Mon. - Fri. 7:30am - 8 pm; Sat. 8 am - 2 pm; documents or reports to public institutions (tax Closed Sun. on income statements, balance sheets, wages tax Telephoning Bucharest from Abroad statements, VAT deduction sheets, VAT refund International Access Code +40 (country code) + 21 applications etc.). or 31 (area code) + telephone number (seven digit number). Prioripost – invoices - this service ensures Poșta Română provide solutions specially tailored collection, transportation and delivery of mail for businesses needs, whether it’s about sending items containing documents (invoices, waybills) parcels, express services, e-commerce solutions, or Prioripost merchandise items that circulate direct marketing, flyers distribution, money orders accompanied by invoices and/ or waybills.The or printing solutions. service also ensures the return of signed and stamped fiscal documents to the sender and other Special delivery: specific services. Collecting, processing and delivery of postal parcels

116 Relocation of the European Medicines Agency Annex 4

Financial arrangements for the EMA building

CONFIDENTIAL INFORMATION, TO BE SUBMITTED SEPARATELY

Relocation of the European Medicines Agency 117 Romania and the setting of its new institutional Annex 5 structure and culture, during the second half of the 19th century. The 12 public universities in Bucharest offering foreing languages programmes 4. The University of Agronomic Sciences and - a brief description - Veterinary Medicine of Bucharest (USAMV B, for its acronym in Romanian) is the result 1. The University POLITEHNICA of Bucharest of the academic, scientific and administrative is the oldest and most prestigious engineering process supported by great names of Romanian school in Romania, with a tradition of more than agronomic education and science, which began 190 years made possible by the efforts of some of with the first Agronomic School in Romania (The the greatest Romanian professors. Its specificity Pantelimon School), established 163 years ago. relies in creating knowledge through research The fields of study covered by USAMV B are: and technological innovation, as well as through Agronomy, Biology, Forestry, Horticulture, Animal its implementation by means of education Science, Veterinary Medicine, Food Engineering, and professional training at a European level. Civil Engineering, Environmental Engineering, University POLITEHNICA of Bucharest welcomes Geodetic Engineering, Biotechnologies, foreign applicants, offering a number of 20 B.Sc. Applied Engineering Sciences, Engineering and and 25 M.Sc. programs taught in English, French Management, Engineering and Mmanagement or German. in Agriculture and Rural Development. USAMV B currently operates seven (7) faculties in Bucharest, 2. The Technical University of Civil Engineering two (2) branches across the country and fifteen of Bucharest is a technical university that trains (15) departments. higher education specialists in the fields of civil engineering, building services engineering, 5. The University of Bucharest is one of the oldest mechanical engineering/technological institutions of higher education in Romania, hence equipment and machines, environmental it bears the responsibility and the duty to be a engineering, geodesic engineering, management pioneer and a model of academic integrity. In its and engineering and systems engineering.The 150 years of existence, the University of Bucharest Technical University of Civil Engineering of has gained solid national and international Bucharest includes seven faculties, of which six prestige, being the first Romanian academic provide tuition in Romanian and one in foreign institution in the QS World University Rankings. languages (English and French). In addition, there The University of Bucharest offers numerous is a Department of Foreign Language Studies. study programmes, from Bachelor Degress to PhD programmes, as well as other academic 3. The “Ion Mincu” University of Architecture programmes, such as Erasmus and long life and Urbanism in Bucharest is the oldest and learning. The University constantly collaborates most important academic institution in this field with more than 100 prestigious universities from in Romania. It continues a long tradition of local 40 different countries. The degrees granted by the architectural higher education, the foundation University of Bucharest are recognized in most of which is closely linked with the rise of modern countries in the world.The University of Bucharest

118 Relocation of the European Medicines Agency covers the fields of Human and Social Sciences, by attending Bachelor’s, Master’s, Doctoral and Natural Science and Engineering, Exact Sciences Postdoctoral study programs. In addition, ASE (Mathematics and Computer Science) and offers organizes continuing training programs, teacher numerous undergraduate, graduate and PhD training programs, postgraduate programs, as study programmes, as well as numerous other well as MBA and EMBA study programs. ASE has higher postgraduate programmes. The degree 12 Faculties, whose nealry 22,000 students can granted by the University of Bucharest after final attend study programs in Romanian, English, examinations is recognised all over the world French or German: 24 Bachelor’s programs, 87 and recommends graduates as being thoroughly Master’s programs, Doctoral studies in 10 fields trained in the field of study of their choice. and more than 145 postgraduate continuing education programs. 6. “Carol Davila” University of Medicine and Pharmacy Bucharest (CDUMO) is the first 8. National University of Physical Education and University of medicine and pharmacy from Sports (UNEFS) develops 5 study programs for the Romania, that enjoys today a well deserved prestige bachelor university cycle and 7 study programs and recognition in national and international for the master university cycle. academic environment, a true leader of the Romanian medical education. 9. National University of Political Studies and At 160 years of existence, the fundamental Public Administration (SNSPA) is a public higher objective of CDUMP is to accelerate the efforts to education institution, which includes all three transform the institution into a University of elite cycles of education: bachelor, master, doctorate. worldwide, one of the top 500 universities of the SNSPA has a complex portfolio of 9 undergraduate world. programs, 52 master programs and 4 doctoral The University proposes a high quality education, schools. SNSPA underlie a wide range of academic focused on student, a continuous improvement of activities: research, academic education, the educational process through modern teaching postgraduate education, the projects realized methods, fair didactic relationships with students, in SNSPA with transnational partners, students’ encouraging initiative, creativity, dialogue and activity, teachers’ and researchers’ activity, library effective and active involvement of students in the endowment, academic management activity. educational process both in theory and practice. 10. National University of Music Bucharest is 7. The Bucharest University of Economic Studies a Romanian professional institution of higher in Bucharest is a research intensive university that education, research and music creation, founded organizes study programs and scientific research in 1864. in the fields of Economic Sciences, Administrative National University of Music Bucharest has two Sciences, Sociology and Humanities. ASE is faculties focused on higher music education considered the most important economic higher process: education institution from Romania and one • Faculty of Musical Performance (all classical of the most renown economic universities in instruments and singing) South‐Eastern Europe. Students are offered • Faculty of Composition, Musicology and Music the opportunity to pursue a full academic path Pedagogy (composition, musicology, music

Relocation of the European Medicines Agency 119 pedagogy, orchestral and choir conducting, jazz- pop music and sacred music) Annex 6 The research and advanced research are organized within the frame of a Doctoral School, a Post- The National Agency for Medicines and Medical Doctoral Institute and a Research, Innovation and Devices in support of EMA relocation to Bucharest Information Unit. The National Agency for Medicines and Medical 11. The National University of Arts (UNArte) in Devices (NAMMD) is the national authority Bucharest is an establishment of education and competent in the fields of medicine, medical artistic creation, rated Highly Trustworthy by devices and health technology assessment. The ARACIS subsequent to the institutional evaluation, current mission of the Agency includes assessment which includes study programs accredited for the of dossiers for authorisation for marketing of ranking field “Visual Arts”. good quality, safe and effective human medicines, The University comprises the Faculty of Fine assessment of dossiers for authorisation of Arts, which includes the Departments of conduct of clinical trials in Romania and of clinical Painting, Graphic Arts, Sculpture, Photo-Video- trial sites; surveillance of human medicinal product Computerized Image Processing and the Master’s safety in therapeutic circuit through inspection program Education through Visual Arts; the and pharmacovigilance. As of 2014, the NAMMD Faculty of Decorative Arts and Design, with the has also the national competent authority in the Departments of Design. Fashion – fashion design, field of medical devices and assessment based on Mural Art, Textile Arts – textile design, Ceramics- scientific criteria adopted by national legislation Glass-Metal, Scenography and Artistic Event; the force of medical technologies for inclusion the Faculty of Art History and Theory, which organizes national healthcare insurance system. the study programs of Art History and Theory and Conservation and Restoration. One important point to note is increased involvement of NAMMD specialists, since 2016, in 12. The National University of Theatre and Film activities of committees and working groups of I.L. Caragiale (UATC) begun its activity in 1834, as the European Medicines Agency’s (EMA) and of the first theatre FACULTY IN Romania within the the Heads of Medicines Agencies (HMA). Philharmonic School. Since 1990, the Academy of Theatre and Film In the context of the Brexit process, the NAMMD has undergone a continuous reform process. will also have to cope with this challenge without New specializations have been added, such as disregarding achievement of its current mission. Audiovisual Communication and Multimedia: In this respect, it is worth highlighting that, at EU, Sound-Editing (both at the Film Faculty), Puppets- EMA and HMA committees and working groups Marionettes, Choreography and Scenography (at level, aiming to create a frame of work allowing for the Theatre Faculty). The number of students has coordinated approach to smooth transfer of UK gone up, while the curricula and study programs responsibilities to the Member States remaining have been continuously improved and diversified. in the European Economic Area, the NAMMD will be directly involved in taking over redistributed responsibilities assigned. NAMMD specialists

120 Relocation of the European Medicines Agency assigned as representative participants in these July 2016; committees and working groups constantly prove their expertise in their area of competence • Romania’s activity (March 2016 – June 2017) through direct and ever more active involvement in the EMA Committee for Orphan Medicinal in the work of the respective committee / working Products (COMP), based on reports prepared by group. the assigned NAMMD representative:

Special emphasis should be placed on the fact 1. 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N- that, in case of EMA relocation to Bucharest, {4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]- the expertise of the NAMMD staff, of its highly phenyl}-2-oxo-acetamide (F901318) for treatment qualified specialists particularly, will allow conduct of invasive aspergillosis (orphan designation no. of activities formerly performed by certain EMA EU/3/16/1738, on 14 October 2016); staff members who might decide not to relocate. 2. N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol- 5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide A few concrete examples of involvement in the (CM4620) for treatment of acute pancreatitis scientific work of the European Network are (orphan designation no. EU/3/16/1783, on 18 highlighted in what follows: November 2016); 3. Udenafil for treatment of functional single • Regarding the centralised procedures with RO ventricle congenital heart disease (orphan already assigned as co-rapporteur, rapporteur designation no. EU/3/16/1807, on 12 December or peer-review, to be started in the next period: 2016); 4. Fluticazon propionate for treatment of 1) Co-rapporteurs for pegfilgrastim – bio similar eosinophilic esophagitis (orphan designation no. (application 10.4). Nomination May 2017; EU/3/16/1815, on 12 January 2017); 2) Co-rapporteurs for Ioflupane (123I) - CIS bio 5. Synthetic composition of Trans-cinnamic international (IOFLUPANE (123I)), generic of aldehyde, Trans-2-methoxy-cinnamaldehyde, DATSCAN of Amersham (application generic 10.1) Cinnamyl acetate, Linalool, Beta-caryophyllene, Nomination March 2017; Cineol and Benzyle benzoate (CTCLBCB) for 3) Rapporteurs for Tadalafil Mylan (application treatment of invasive aspergillosis (not granted generic 10.1), following resuming of the orphan designation after assessment and bioequivalence study and return to the EMA with presentation; withdrawal of application by the related documentation; sponsor in December 2016); 4) Peer-review in the multi-national team (RO/ 6. Emeramide for prophylaxis of mercury toxicity SE) – Cerepro (SITIMAGENE CERADENOVEC), (orphan designation no. EU/3/17/1864, on 20 (Advance therapy medicinal product – Application April 2017); complete 8.3 new active substances). Nomination 7. Tripotassium citrate monohydrate and potassium April 2017; hydrogen carbonate for treatment of renal distal 5) Peer-review in the multi-national team (RO/NO) tubular acidosis (orphan designation granted by – Voretigene Neparvovec (voretigene neparvovec), the COMP in June 2017, official designation by the (Advance therapy medicinal product – Application European Commission pending); complete 8.3 new active substance). Nomination 8. Retinol for treatment of retinopathy of

Relocation of the European Medicines Agency 121 prematurity (orphan designation granted by the work, the NAMMD has managed 8 PSUSA COMP in June 2017 official designation by the procedures so far, 2 other procedures being in European Commission pending); progress, as follows: 9. L-citrulline for treatment of cardiopulmonary In 2015 – 1 PSUSA procedure for tenonitrozole. by-pass (assessed in June, requesting In 2016 – 5 PSUSA procedures: supplementations in the presentation stage); - Asparaginase PSUSA/00003161/201508 10. Emeramide for treatment of (17.12.2015 - 14.04.2016); Neurodegeneration with brain iron accumulation - Hexoprenaline sulphate (assessment report for July 2017); PSUSA/00003170/201508 (17.12.2015 - 14.04.2016); 11. Synthetic composition of Trans-cinnamic - Chlorquinaldol (vaginal tablet)/promestriene aldehyde, Trans-2-methoxy-cinnamaldehyde, PSUSA/00009272/201509 (15.01.2016 - 13.05.2016); Cinnamyl acetate, Linalool, Beta-caryophyllene, - Bilastine PSUSA/00003163/201603 Cineol and Benzyle benzoate (CTCLBCB) for (02.06.2016 - 29.09.2016); treatment of invasive mucomycosis (under - N(2)-L-alanyl-L-glutamine validation); PSUSA/00003158/201603 (04.08.2016 - 12. Film-coated fibrinogen in albumin spheres for 01.12.2016). treatment of radiotherapy - induced skin ulcers (under validation). In 2017 - 2 completed PSUSA procedures for midodrine and chlorquinaldol (vaginal tablet)/ • Regarding the Paediatric Committee (PDCO), promestriene. since 2012, work has consisted in assessment of Currently, one procedure is in progress for 50 Paediatric Investigation Plans (PIP), of which bilastine and a new one is to be started soon, for 9 assessments are currently in progress. lantahnum.

At the same time, 4 paediatric work-sharing • As regards participation of NAMMD procedures have been completed, where RO acted representatives in the Committee for Advanced as rapporteur. Therapies:

• In the Committee for Medicinal Products Romanian CAT members have been involved in for Human Use (CHMP), Romania was a co- preparation of 25 scientific recommendations rapporteur in a review procedure based on Art on classification of advanced therapy medicinal 31 for Tolperisone in September 2012 and co- products (ATMPs), in 21 CAT Clinical Reports to rapporteur la in a review procedure for Raxone the Scientific Advice Working Party and in drafting (idebenone) in 2013. groups of scientific guidelines on investigational ATMPs, GCP specific aspects for investigational • As an observer, as of June 2016, in the CHMP ATMPs. Biostatistics Working Party Romania has been distributed 5 scientific advice applications for • Concerning participation in work of the determination of statistic problems. Committee on Herbal Medicinal Products (HMPC), Romania has been a rapporteur for 6 • As regards EMA-coordinated pharmacovigilance monographs:

122 Relocation of the European Medicines Agency - Camellia sinensis (L.) Kuntze, non fermentatum folium- final; - Ricinus communis L., oleum – final; - Harpagophytum procumbens DC and/or Harpagophytum zeyheri Decne, radix – final; - Piper methysticum G. Forst., rhizome – now in the post - public consultation stage; - Calendulae flos – work in progress; - Species amarae – work in progress.

Romania is a peer-review for one monograph: POLYPODIUM VULGARE L., RHIZOMA – work in progress

• As regards work in the CHMP Quality Working Party (QWP), here are the titles of the scientific guidelines, reflection papers and concept papers developed with Romania’s participation during 2013- 2017

2013

- Revision of the Guideline EMA/CHMP/CVMP/QWP/99738/2013, “Process Validation”; - Revision of the Guideline CHMP/CVMP/QWP/199250, “Setting Specifications for Related Impurities in Antibiotics”; - Revision of the Guideline EMA/CHMP/QWP/811210/2009, “Real Time Release Testing”; - Revision of the Guideline EMEA/CHMP/CVMP/QWP/17760/2009 Rev 2, “Use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations”; - Revision of the Guideline EMA/CHMP/QWP/911254/2011, “Quality of Transdermal Patches”; - Revision of the Guideline EMA/492713/2012, “Quality of Oral Modified Release Products”.

2014

- Participation in revision of the Guideline EMA/CHMP/CVMP/QWP/BWP/70278/2012 Rev. 1, “Process Validation”; - Participation in conclusion of the EMA reflection paper EMA/448443/2014 on requirements for selection and justification of starting materials for the manufacture of chemical active substances; - Participation in conclusion of the EMA reflection paper CHMP/CVMP/QWP/136250/2014 on the use of cocrystals and other solid-state forms of active substances in medicinal products; - Participation in conclusion of the EMA document EMA/334808/2014, Template for the qualified person’s declaration concerning GMP compliance of active of active substance manufacture, The QP declaration template; - Participation in revision of the Guideline EMEA/CHMP/CVMP/QWP/17760/2009 Rev 2, on the use of Near Infrared Spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations; - Participation in revision of the Guideline EMA/CHMP/CVMP/QWP/441071/2011 Rev 2, on stability testing for applications for variations to a marketing authorisation; - Participation in conclusion of the EMA concept paper on the establishment of a guideline on the selection of sterilisation processes for drug products;

Relocation of the European Medicines Agency 123 - Participation in conclusion of the EMA to the Chemical and Pharmaceutical Quality reflection paper EMA/HMPC/95714/2013 on Documentation Concerning Investigational microbiological aspects of herbal medicinal Medicinal Products in Clinical Trials”; products and traditional herbal medicinal - Participation in conclusion Of the EMA products; Guideline EMA/CHMP/QWP/608924/2014, - Participation in revision of the EMA Guideline “Quality of Transdermal Patches”; EMA/CHMP/QWP/608924/2014 on quality of - Participation in conclusion of the EMA transdermal patches; reflection paper EMA/448443/2014 on - Participation in revision of the EMA Guideline requirements for selection and justification of EMA/CHMP/QWP/428693/2013 on quality of starting materials for the manufacture of chemical oral modified release products; active substances; - Participation in conclusion Of the EMA Guideline EMA/CHMP/QWP/428693/2013 2015 (approved in 2015), “Quality of Oral Modified Release Products”; - Participation in conclusion of the EMA - Participation in conclusion of the reflection paper EMA/CHMP/QWP/104223/2015, EMA reflection paper CHMP/CVMP/ “Chemical Structure and Properties Criteria to QWP/136250/2014 on the use of cocrystals and be Considered for the Evaluation of New Active other solid-state forms of active substances in Substance (NAS) Status of Chemical Substances”; medicinal products. - Participation in conclusion of the EMA reflection paper CHMP/CVMP/ 2016 QWP/284008/2015, “Use of Cocrystals of Active Substances in Medicinal Products”; - Participation in conclusion of the EMA reflection - Participation in proofing of the draft paper EMA/CHMP/QWP/104223/2015, Guideline, “Chemistry of Active Substances” EMA/ “Chemical Structure and Properties Criteria to CHMP/QWP/96664/2015; Be Considered for the Evaluation of New Active - Participation in proofing of the draft Substance (NAS) Status of Chemical Substances”; Guideline, “Manufacture of the Finished Dosage - Participation in conclusion of the EMA Form” CHMP/QWP/245074/2015; draft Guideline EMA/CHMP/CVMP/QWP/ - Participation in proofing of the draft BWP/850374/2016, “Sterilisation of the Medicinal Guideline, “Q 3 D Impurities: Guideline on Product, Active Substance, Excipient and Primary Elemental Impurities” CHMP/ICH/353369/2013, Container”; in the CHMP Quality Working Party - Participation in conclusion of the EMA - Participation in conclusion of the EMA Guideline EMA/CHMP/ICH/83812/2013 on concept paper /CHMP/QWP/558185/2014, ICH M7 Assessment and control of DNA reactive “Development of e Guideline on Quality and (mutagenic) impurities in pharmaceuticals to limit Equivalence of Topical Products”; potential carcinogenic risk”; - Participation in conclusion of the EMA concept - Participation in conclusion of the EMA concept paper EMA/CHMP/QWP/126334/2015, “Need paper EMA/CHMP/QWP/126334/2015, “Need for Revision of the Guideline on the Requirements for revision of the guideline on the requirements

124 Relocation of the European Medicines Agency to the chemical and pharmaceutical quality immediate release products; documentation”; - Participation in conclusion of the EMA reflection • In the CHMP Name Review Satellite Group paper EMA/CHMP/QWP/104223/2015, (NRG), the NAMMD has taken part in development “Chemical Structure and Properties Criteria to of the EMA Guideline EMA/CHMP/287710/2014 Be Considered for The Evaluation of New Active – Rev. 6 on the acceptability of names for human Substance (NAS) Status of Chemical Substances”; medicinal products processed through the - Participation in proofing of the draft Guideline, centralised procedure “Chemistry of active substances” EMA/CHMP/ NAMMD endeavours to be directly involved QWP/96664/2015”; in addressing the new challenges that will be - Participation in conclusion of the EMA reflection supported by additional, highly skilled human paper Dissolution specification for generic resources. In this context, it is worth mentioning oral immediate release products, “Dissolution that, starting 2016, efforts have been made specification for generic oral immediate release to increase the capacity of human resources products”; allocated to the Agency through collaboration - Participation in conclusion of the EMA reflection with the medical and pharmacy institutions in paper CHMP/CVMP/QWP/284008/2015, “Use Romania, as a measure designed to facilitate the of Cocrystals of Active Substances in Medicinal undertaking of responsibilities redistributed by Products”; Brexit and assumed by the Agency in the event - Participation in conclusion of the EMA reflection of EMA relocation to Bucharest. The partnership paper EMA/CHMP/QWP/BWP/661488/2016, with the most prestigious medical university “Development of a Guideline on Quality in Bucharest is a proof of practical cooperation Requirements of Medicinal Products Containing among the relevant local actors in support of the a Device Component for Delivery or Use of the smooth relocation, in case of human resource risk. Medicinal Product”. The NAMMD will carry out the additional work in all its areas of competence, in line with the new 2017 procedural guidelines adopted at EU27 level.

- Guideline on the selection of sterilisation processes for active substances, drug products and primary packaging (Human and Veterinary); - Guideline on Manufacture of the Finished Dosage Form; - Guideline on Drug Device Combinations; - Guideline on quality of water for pharmaceutical use; - Guideline on the pharmaceutical quality of inhalation and nasal products; - Reflection Paper on Quality aspects of medicines for older people; - Reflection Paper on Dissolution specification for

Relocation of the European Medicines Agency 125 Annex 7

126 Relocation of the European Medicines Agency

Relocation of the European Medicines Agency

The Ministry of Health of Romania

Address: 1-3 Cristian Popişteanu Street, Sector 1, Postal Code 010024, Bucharest

Telephone: +4021 3072 500 +4021 3072 600

Website: www.ms.ro

The National Agency for Medicines and Medical Devices

Address: 48 Aviator Sanatescu Street, Sector 1, Postal Code 011478, Bucharest

Telephone: +4021 317 11 00 +4021 317 11 01

Website: www.anm.ro emabucharest.ro