GAREN MIKIRDITSIAN CHIEF EXECUTIVE OFFICER DEAR INVESTOR, DEVELOPMENT Pharmaceutical production is one of the fastest growing sectors of the Armenian economy: over the 2012-2015 period the annual growth rate of the Pharmaceutical FOUNDATION OF sector represented 18% and its share in Armenia’s GDP grew by 2.5 times over the past 8 years. ARMENIA The Pharmaceutical sector is an important part of Armenia’s economy, has great growth potential and as such has been declared a priority sector of the economy by the Government of the Republic of Armenia. A strong scientific school, the ambition of private enterprises, support of the private sector by the Government of Armenia, and assistance of donor organizations have been the most important factors contributing to the growth of Armenia's Pharmaceutical sector.

Armenia's Pharmaceutical sector is open for investment, and the Development Foundation of Armenia (DFA) has deemed it essential to have an updated source of information about the sector's recent development and the capabilities of the companies involved within the sector. The Guide provides this information, and we are confident it will be of great value to investors, pharmaceutical companies and to consumers alike.

The Development Foundation of Armenia is Armenia’s National Authority for Investment, Export and Tourism. It provides in depth services to foreign investors including the provision of requisite information on Armenia’s business climate, investment opportunities and relevant legislation, ground support in organizing site visits for investors, management of post-visit support, assistance with investment project implementation, business introductions, as well as liaison with governmental institutions. The DFA also provides after-care investment services to investors already established in Armenia.

The DFA assists Armenia based businesses in expanding export volumes and diversifying export markets through promotion of Armenia made products at international trade fairs, assisting companies in increasing the level of export readiness, providing them with financial assistance within the scope of specific governmental programs and organizing trade fairs showcasing export products to international buyers and distributors.

We trust this Pharmaceutical Guide will provide you with a good understanding of Armenia's Pharmaceutical sector and lay the ground for your increased involvement in one of the most promising sectors of the Armenian economy.

SINCERELY YOURS, GAREN MIKIRDITSIAN CHIEF EXECUTIVE OFFICER DEVELOPMENT FOUNDATION OF ARMENIA WHY ARMENIAN PHARMACEUTICAL SECTOR? EU GMP STANDARDS THE FASTEST ADOPTED IN 2010 GROWING FULL IMPLEMENTATION PHARMACEUTICAL OF GMP AND OTHER GXP STANDARDS BY THE SECTORS IN THE CIS END OF 2019

TAX FREE STRONG SCIENTIFIC REGIMES FOR AND R&D POTENTIAL HIGHLY SKILLED AND RESIDENTS OF WELL EDUCATED THE FEZ WORKFORCE LOW WAGES FAVORABLE AND ENERGY BUSINESS ENVIRONMENT AND COSTS IN THE EFFECTIVE SUPPORT REGION INSTITUTIONS SIMPLE RECOGNITION OLD TRADITIONS PROCEDURE AND RICH FOR MEDICINES EXPERIENCE IN THE REGISTERED IN THE FINE CHEMICAL EU, USA OR JAPAN INDUSTRY

OPEN AND HIGH COMPETITIVE 3,000 YEARS PHARMACEUTICAL MARKET OF HISTORY EXPORT-ORIENTED IN HERBAL PHARMACEUTICAL INDUSTRY MEDICINE 46 45 44 43 32 32 31 28 16 14 13 12 10 9 7 6 (EAEU) Eurasian EconomicUnion Volumes Market Structure and GrowthExport Performance EXPORT MARKETS Market Structure Growth Performance PHARMACEUTICAL WHOLESALEANDRETAIL Sub-sectors Competitive Niche Snapshot Industry Growth Performance PHARMACEUTICAL MANUFACTURING Standards Introduction oftheGXP Sector ataGlance Armenia’s Pharmaceutical Market Regional Pharmaceutical Market Global Pharmaceutical Introduction 98 93 92 90 89 87 84 82 81 77 76 76 75 65 50 48 47 Research Institutes Education, Skillsand Labor Costs HUMAN RESOURCES ABBREVIATIONS USEFUL CONTACTS Intellectual Property Sales Pharmaceutical Manufacturing Pharmaceutical Medicinal Products State Registrationof State Administration Legislation Policyand Pharmaceutical QUALITY CONTROL REGULATORY ENVIRONMENTAND and CompetitiveAdvantages Investment Opportunities Foreign Investments Investment Environment INVESTMENT ENVIRONMENT R&D INSTITUTES PHARMACEUTICAL ANDBIOTECHNOLOGY

TABLE OF CONTENTS GENERAL OVERVIEW 6

INTRODUCTION Armenia's pharmaceutical sector has Opportunities exist for manufacturing been one of the country's most dynamic low-volume medicines that larger sectors over the last decade, becoming producers find uneconomical to produce, increasingly relevant to the Armenian as well as herbal medicines. While economy. This fact is widely based upon investors need to carefully consider the qualifications of its personnel and many factors, this guide should give the driven innovation and research. The readers enough background information pharmaceutical sector has become a to assess the investment potential and strategic sector for growing the Armenian enable them to move forward quickly. economy due to both its growing export potential and investment attraction. This sector-specific guide supplements “Investment Guide  Armenia 2016,” Over the past 10 years, the Armenian which provides general information pharmaceutical sector's production about the attractive Armenian volume has grown from about one million investment environment and business USD in 2005 to 15 million USD in 2015, procedures. This guide provides with an annual growth rate of about 20% a detailed review of the Armenian over the past five years. pharmaceutical industry's performance, regulatory environment and state More than half of the Armenian policy. The aim of this guide is to pharmaceutical sector's total production highlight industry potential and recent is exported. Exports of Armenian performance, backed by quantitative pharmaceutical products have grown and qualitative data. The guide also an average of 20% per year, and showcases competitive advantages continued growth is expected due to and opportunities in investment, rising incomes, state policy and the and provides details on investment introduction of international standards. incentives.

Armenia’s domestic market may be At the end of the guide, the contact small, but Armenia offers easy access details of support institutions are to surrounding and fast-growing CIS provided to assist with gathering countries and other major emerging further information about the Armenian markets, including the Middle East. pharmaceutical industry. ■

MAIN MACROECONOMIC INDICATORS, 2011-2015 2011 2012 2013 2014 2015 Gross Domestic Product (USD billion) 10.1 9.9 10.4 11.6 10.5 Gross Domestic Product per capita (USD) 3,102 3,290 3,447 3,852 3,504 Gross Domestic Product real growth, % 4,7 7.2 3.5 3.6 3.0 Industry 13.5 7.0 6.8 2.7 5.2 Agriculture 13.7 9.5 7.6 7.2 11.7 Construction -12.5 3.3 -8.1 -4.3 0.3 Services 5.0 6.5 3.6 7.8 2.7 PHARMACEUTICAL Inflation (year-end) 4.7 3.2 6.6 4.6 -0.1 Budget balance (% of GDP) -3.0 -1.6 -1.7 -1.9 -4.6 SECTOR IS A Investment (USD million) 816.3 751.8 597.4 612.9 811.8 incl. FDI (USD million) 631.4 567.4 271.2 404.3 180.5 STRATEGIC SECTOR Exports FOB (USD million) 1,329.5 1,380.2 1,480.0 1,547.3 1,486.9 Imports CIF (USD million) 4,151.4 4,261.2 4,476.8 4,424.4 3,254.0 FOR THE ARMENIAN USD/AMD exchange rate (average) 372.5 401.8 409.6 415.9 477.9 ECONOMY SOURCE: NSS, MINISTRY OF FINANCE OF RA GLOBAL Historically, medicines were trillion by 2017. Absolute growth is prepared by physicians and later by expected to be USD 211-241 billion, PHARMACEUTICAL apothecaries, but today’s medicines compared to USD 228 billion over the typically are the products of the previous five years (using variable MARKET collaboration between university exchange rates) (see Figure 1). research scientists and private Oncology is the leading therapeutic corporations. The modern-era of class; other focus areas include pain medicine discovery and development management, diabetes, hypertension, began in the 19th century with mental health, and respiratory issues. scientists learning how to isolate and purify medicinal compounds Global pharmaceutical sales and developing methods for mass- exemplify the international spread production. of medical technology resulting from highly intensive Research and Advances in science and technology Development (R&D) that is occurring are bringing the research-based in exporting countries. In general, pharmaceutical industry into an the pharmaceutical industry is exciting new era for pharmaceutical the sector with the highest ratio of product development. Research R&D investment. According to the methods are evolving and improving, 2015 EU Industrial R&D Investment creating much promise for the Scoreboard, the Pharmaceuticals advancement of medicine. & Biotechnology sector ranks number one with a share of 19.2% The current global pharmaceutical of total business R&D expenditure market shows constant growth in worldwide, with an annual growth production, sales and profitability. rate of 4.1% since 2011. The largest The demand for medicines constantly number of companies involved grows despite the political and in pharmaceutical R&D in 2015 - economic forces that have the half of the world's activity - were opposite effect on other markets. concentrated in the U.S. where R&D costs are expected to reach about According to “IMS Health Consulting”, USD 91 billion in 2016. Twenty-six FIGURE 2. GEOGRAPHICAL STRUCTURE an international analytical company, percent of companies involved in OF THE R&D SEGMENT OF THE GLOBAL global pharmaceutical sales reached pharmaceutical R&D are in European PHARMACEUTICAL MARKET (BASED ON USD 959 billion in 2012 and USD 1 countries (see Figure 2). ► NUMBER OF COMPANIES INVOLVED IN trillion in 2014 and exceed USD 1.17 PHARMACEUTICAL DRUG R&D)

1% FIGURE 1. GLOBAL SPENDING AND GROWTH, 2008-2017 15%

4% $211-241Bn 4%

3% 50% $228Bn 5%

15%

$1,170- 3% $959Bn $731Bn USA 1,200Bn Europe France Japan Central and South America/Africa Germany UK Canada 2007 2008-2012 2012 2013-2017 2017 Pacific Rim SOURCE: MEDICINE PRODUCERS AND SOURCE: IMS MARKET PROGNOSIS, SEPTEMBER 2015 IMPORTERS UNION OF ARMENIA GENERAL OVERVIEW 8

FIGURE 3. GLOBAL SPENDING OF GERENICS, 2012-2017

2012 2017

Developed

72% 16% 12% USD 622Bn 67% 21% 12 % USD 650-680Bn

Developing

31% 58% 11% USD 224Bn 26% 63% 11 % USD 370-400Bn

Rest of the world

57% 27% 16% USD 120Bn 52% 31% 17% USD 125-155Bn

World 61% 27% 12% USD 965Bn 52% 36% 12% USD 1,170-1,200Bn

Brand Generic Other

SOURCE: IMS HEALTH THOUGHT LEADERSHIP, SEPTEMBER 2015

The research-based pharmaceutical to account for 63% of the developing industry greatly contributes to the market by the end of 2017 (see Figure world economy, having become a 3). Revenues from generics in 2016 robust economic pillar of industrialized are expected to reach USD 400–430 nations, and is increasingly becoming billion, approximately 70% of which an important sector in the developing will be outside of developed markets. world. It creates employment (direct, indirect, and induced), The biotechnology segment’s total increases imports and exports, revenue reached USD 263 billion in generates spending on research and 2015, representing a 12% increase development, and builds technological over the previous five years. The vast capacity. It is also the foundation for majority of revenue is generated in the existence of the generics industry. the European Union and the United States; however, the industry's major Though original brand-name players have recently reported slower pharmaceutical products (those with growth rates for US sales compared patents for approximately 20 years) with other parts of the world. This accounted for nearly two-thirds of trend is expected to continue over the global spending in 2012, the generic next five years as standards of living market has increased significantly and healthcare access improve in over the past decade. Generics emerging nations, such as India, China are growing much faster than the and Brazil. During the next five years, protected sector and are a much the industry is anticipated to continue larger slice of the pharmaceutical to prosper; according to the Deloitte market than ever before. As some report, “2014 Global Life Sciences patents are set to expire this year Outlook”, revenue is forecasted to in developed markets, that share reach USD 407.3 billion in 2018, with is expected to rise. Generics will average annual growth over the next continue to grow and are expected five years at 9.2%. ■ REGIONAL There are three leading geographic CIS countries also have a large centers within the global pharmaceutical potential for the development of their PHARMACEUTICAL market: North America, Western Europe pharmaceutical sectors. Global and and Japan. In 2006 these markets regional economic integration along with MARKET collectively accounted for 73% of market the removal of trade barriers have created volume. By 2012, that collective share of additional opportunities for manufacturers the market dropped to 71%. That year, in the CIS, including Armenia which has North America accounted for 38% of one of the fastest growing pharmaceutical world pharmaceutical sales, compared sectors. The fine chemical industry, which with 24% for Europe (European Union encompasses medicine production, and non-EU countries). According to has been a prominent part of the IMS data, the U.S. market accounted for Armenian economy for decades; in the 62% of sales of new medicines launched 1980s, the chemical sector accounted from 2007 to 2011, compared with 18% for approximately 10% of Armenian in Europe. manufacturing.

According to research by the International A new wave of pharmaceutical Federation of Pharmaceutical Wholesalers, development began in the mid-1990s there are significant disparities between when Armenia's economy experienced growth rates in developed and emerging an upturn as it gained macroeconomic markets, based on each groups’ capacity stability and sustained economic to bounce back from economic crisis. growth. It was during this period that Armenia received its first foreign Emerging economies such as Brazil, investments in its pharmaceutical China and India show rapid growth in the industry. pharmaceutical market and in research, leading to a gradual migration of activities Over the last decade, Armenia’s from Europe to these fast-growing markets. pharmaceutical industry has become one In 2015, the Brazilian and Chinese markets of its most dynamic economic sectors. grew by 17% and 22% respectively, Exports of medicinal products accounted compared to an average market growth of for 54% of output in 2015, whereas the -0.9% for the European markets and -1.3% average annual export growth rate has for the U.S. market. been 24% since 2003. ■

TOP 10 GLOBAL PHARMACEUTICAL CORPORATIONS RANKING BASED ON SALES (2015) GLOBAL PHARMACEUTICAL SALES BY Ranking Company Name Country Sales (USD Million) REGION - 2015 1 Novartis AG Switzerland 47,101 8% 2 Pfizer Inc. United States 45,708 8% 3 Roche Holding Ltd. Switzerland 39,120 41% 4 Sanofi France 36,437 20% 5 Merck & Co. Inc. United States 36,042 6 Johnson & Johnson United States 32,313 7 GlaxoSmithKline PLC United Kingdom 29,580 23% 8 AstraZeneca United Kingdom 26,095 North America 9 Gilead Sciences, Inc. United States 24,474 Europe (EU+Non-EU) Asia 10 Takeda Ltd. Japan 20,446 Japan Latin America

SOURCE: IMS HEALTH, 2015 SOURCE: IMS HEALTH GENERAL OVERVIEW 10

ARMENIA’S Armenia's pharmaceutical market market volume is considerably lower PHARMACEUTICAL experiences the major development compared to those of more developed trends of the global pharmaceutical countries, it has significant growth SECTOR AT A market. Although RA's pharmaceutical potential. ■ GLANCE Industry Players Production Type • 19 licensed manufacturers • Tablets • 25 pharmaceutical product importers/ • Capsules wholesalers and 1,273 retailers • Ointments • 41 retail companies which have more than two • Suppositories drugstores • Suspensions • 47 representatives of foreign pharmaceutical • Syrups companies (21 registered country offices) • Solutions for injection including intravenous • 1,688 pharmacies (2016) the turnover of which infusion solutions is more than USD 160 million (2015) • Eye Drops • Herbal extracts and tinctures Market Size Workforce • USD 14.2 million local pharmaceutical • 5,800 employees in the pharmaceutical sector production (2015) {{ 600 in production (2015) • USD 95.5 million imports (2015), of which {{ 4,200 in retail (2015) {{ USD 9.4 million from CIS countries {{ 1,000 in wholesale (2015) {{ USD 78.8 million from EU • Average gross monthly salary (2015) {{ USD 39.6 million from other countries {{ 239 USD in production • USD 7.8 million exports (2015) of which {{ 180 USD in retail {{ USD 4.5 million to CIS countries {{ 285 USD in wholesale {{ USD 3.3 million to other countries

Market Growth R&D, Academia and Associations • 20% average annual growth rate in local • ISO certified state-of-the-art laboratories pharmaceutical production (2009-2015), • 8 R&D institutions • 19.3% average annual growth rate in local • 8 universities and 4 colleges providing production export (2009-2015) degree programs in pharmaceutical-related • 7% average annual growth rate in imports disciplines. (2009-2015) • The Medicine Producers and Importers Union which contributes to the development of Armenia’s pharmaceutical industry Major Export Markets Regulation & Standards Russia, Georgia, Turkmenistan, Uzbekistan, • No pharmaceutical pricing regulations Ukraine, Belarus. • Law on Medicine • Various related laws and regulations • Three GMP-certified companies and several ISO-certified companies Registered Drugs Foreign Investment 4,572 drugs were registered in Armenia (in 2015) Liqvor, Yerevan Chemical-Pharmaceutical Firm, of which: PharmaTech • 6.3% were locally produced • 31.13% were produced in countries of the EU • 18.53% were produced in countries of the CIS • 14.08% were produced in other countries

Competitive advantages • High market growth in both domestic and major export markets • Old traditions and rich experience in the fine chemical industry • Highly educated workforce, increased every year with new graduates from Armenia’s internationally-recognized universities • State-of-the-art research and testing laboratory facilities with cutting-edge equipment and highly skilled staff, • Commitment of producers to introduce Good Manufacturing Practice (GMP) and other international standards • Government commitment to further develop a GMP certifying agency and support for the development of Armenian pharmaceutical sector • Favorable business environment and investment opportunities INJECTIONS AND EYE DROPS PREPARATION ROOM ACCORDING TO EU GMP STANDARDS; LIQVOR PHARMACEUTICAL COMPANY GENERAL OVERVIEW 12

INTRODUCTION Armenia adopted EU GMP standards All producers made the necessary OF THE GXP on November 25, 2010 under the technological investments. As a result, Decree of the Government of Armenia one local producer, Liqvor, obtained STANDARDS No. 1603-N “On the Approval of Rules GMP certification in 2013, issued by the of Good Manufacturing Practice”, Ministry of Health of Armenia based on thereby laying the foundation for the the inspection report of the Scientific production of medicines in compliance Center of Drug and Medical Technology with the highest international standards. Expertise (SCDMTE). Arpimed is the To make the process go smoothly, for second company that obtained GMP the first time in the history of Armenia certification (2014), issued by the a memorandum of cooperation was Ministry of Health of Armenia. Company signed between the Government Pharmatech achived GMP Certification of the RA and medicine producers, at the end of 2015. Other producers which approved the Action Plan for continue investing in equipment, Pharmaceutical/Biotechnology Sector infrastructure and personnel in order to Development 2012-2015. achieve compliance and obtain GMP certification by the end of 2019. The Government granted the request of producers to be given a few In parallel with the introduction of the years to conform their production GMP standards, a GMP inspectorate to GMP requirements. All Armenian was established within the SCDMTE. pharmaceutical companies are Now the SCDMTE not only reviews, tests ALL ARMENIAN currently working on the implementation and registers individual pharmaceutical of the GMP standards, which is products, but also issues GMP PHARMACEUTICAL scheduled to be completed no later certification for the manufacturing than 2019. The companies have process itself. To that end the inspectors COMPANIES WILL step-by-step guidance and follow- received training by leading international up Corrective and Preventive Action specialists and participated in joint ACHIEVE GMP (CAPA) plans for GMP compliance. inspections in Europe. Several local producers received CERTIFICATION BY tailored mentoring from international In 2012 the SCDMTE applied for the consultants on the implementation of pre-accession for the membership to the THE END OF 2019 their CAPA plans. Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co- operation Scheme (PIC/S) in order to achieve automatic recognition by the PIC/S countries (the EU, the U.S., Japan, Singapore, and others). This will make it possible to export locally – produced Armenian medicines not only to developing countries such as in the CIS and Africa – where at least some government GMP certification is required – but also to developed countries.

The Government of Armenia continues to introduce GxP standards in the country's pharmaceutical sector. The Government will announce the adoption of Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Storage Practice (GSP), Good Pharmacy Practice (GPP) and other GxP standards by the end of 2017. ■ PHARMACEUTICAL MANUFACTURING 15-32 PHARMACEUTICAL MANUFACTURING 14

GROWTH The Armenian pharmaceutical industry 52%, was exported), an increase of PERFORMANCE has presented a remarkable growth in 27.2% over 2014. Like production, the the past five years, boosted by sales export of pharmaceutical products in the domestic and external markets, from Armenia has grown at a brisk with a significant growth of investment pace over the past five years, with an in the sector. It is one of the fastest average annual growth rate of 20%. growing economic sectors of Armenia, the average growth of which has Armenia's pharmaceutical sector has exceeded growth in the manufacturing great growth potential. According industry as a whole and the overall to the “Export-Led Industrial Policy” national economy. In particular, the strategy of Armenia, the Government pharmaceutical industry has grown named the pharmaceutical industry from AMD 5.1 billion (USD 14.4 million) as one of the strategic sectors to be in 2014 to AMD 7.0 billion (USD 15.0 boosted in the period between 2010 million) in 2015, with an average annual and 2020. The long-term goal of this growth rate of 20% (see Figure 4). strategy is to form new “export driver” sectors by expanding not only current According to the RA’s National export potential, but also those with Statistical Service (NSS), major export potential. Through this pharmaceutical production strategy the Government intends to (in comparable prices) was increase the production of medicine approximately AMD 7.0 billion in from USD 8 million in 2010 to USD 75- 2015, 25.1% higher than 2014’s 100 million in 2020. During the same numbers (see Figure 5). Finished span, exports are expected to expand product realization totaled AMD 6.7 from USD 5 million in 2010 to USD 45- billion (out of which 3.5 billion, about 50 million by 2020 (see Table 1). ■

FIGURE 4. LOCAL PRODUCTION OF MEDICINE (AMD MILLION)

8000

7000

6000

5000

4000 6,768.1 7,050.0 3000 5,167.6 2000 3,977.3 3,329.9 3,540.8 1000

0 2010 2011 2012 2013 2014 2015

SOURCE: NSS OF THE RA; 2016 TABLE 1. MEDIUM-TERM TARGETS FOR PRODUCTION GROWTH

2010 2015 2020

Production USD 8 mil. USD 15-17 mil. USD 75-100 mil.

Exports USD 5 mil. USD 8-10 mil. USD 45-50 mil.

No. of employees 550 900-950 1,600-1,800

How to achieve the 2011-2015 2016-2020 targets? • GMP certification of Armenian • International recognition producers of Armenian GMP • Investing in the development of certificates industrial capacities • Transform packaging • Establishing new financing tools for process to medicine export production • Expand packaging process • Negotiate with TNCs to • Attracting orders from TNCs to establish or outsource Armenia production • If necessary, establish a new free economic zone Capacity building • Strengthen cooperation between n.a. manufacturers and educational institutions • Support the GXP Centre of Excellence in developing and conducting training courses SOURCE: MINISTRY OF ECONOMY, PHARMACEUTICALS AND BIOTECHNOLOGIES SECTOR STRATEGY 2011-2020 THE ARMENIAN

FIGURE 5. MANUFACTURING GROWTH PER YEAR (%) PHARMACEUTICAL

35% INDUSTRY HAS EXPERIENCED 30% REMARKABLE 25% GROWTH OVER THE

20% PAST FIVE YEARS

15% 29,9% 25,1% 10% PHARMACEUTICAL 17,4% PRODUCTION WAS 5% 10,0% 10,0% APPROXIMATELY AMD 3,7% 0% 7.0 BILLION IN 2015, 2010 2011 2012 2013 2014 2015 WITH GROWTH OF SOURCE: NSS OF THE RA; 2016 25.1% OVER 2014 PHARMACEUTICAL MANUFACTURING 16

INDUSTRY There are 19 licensed pharmaceutical manufacturing also exists to a limited SNAPSHOT companies in Armenia (See Table 2), extent. three of which produce significant volumes. In 2015, these three The main dosage forms produced by companies provided 70% (10.5 million Armenian pharmaceutical companies are: USD) of the total turnover of all local • Tablets producers and 11.2% of the total • Capsules turnover of Armenia's pharmaceutical • Ointments market as a whole (USD 134 million). • Suppositories The pharmaceutical industry is one of • Suspensions only a few export-oriented industries • Syrups in Armenia. Considering there are so • Solutions for injection including few GMP-certified producers, that the intravenous infusion solutions sector exports 52% of its production is • Eye Drops a clear indicator of its export capacity. • Herbal extracts and tinctures The key foreign markets for Armenian pharmaceutical companies are in the Product quality is a high priority of CIS, and predominantly Central Asian Armenian manufacturers. Therefore, most countries (Uzbekistan, Kazakhstan, raw materials and chemical compounds Turkmenistan, and Tajikistan). Armenian used in production are bought from EU companies also compete successfully and US suppliers. in the Georgian, Belarusian, Russian and Ukrainian markets. The industry is in the process of introducing and implementing international Local manufacturers mainly specialize quality standards (GxP standards). Two in production of generics, although a Armenian pharmaceutical producers have few produce branded products. Most of already been successfully audited and these generic medicines are included have been awarded a GMP certificate by in the list of essential medicines of the the Ministry of Health of the Republic of Republic of Armenia. Locally produced Armenia. All Armenian pharmaceutical generic products cost 10-30% less companies are planning to achieve than imported alternatives. Contract GMP certification before 2019, and ►

EXPORTS OF MEDICINAL PRODUCTS FROM ARMENIA ACCOUNTED FOR 52% OF THE ARMENIAN PHARMACEUTICAL SECTOR'S OUTPUT IN 2015 “PHARMA-ARMENIA 2013”; THE 5TH INTERNATIONAL PHARMACEUTICAL COMPETITIVENESS CONFERENCE PHARMACEUTICAL MANUFACTURING 18

are investing in technology in order to To promote the development of improve product quality and meet GMP the knowledge-based economy in requirements. Armenia the first Free Economic Zone (FEZ) was opened on August To ensure fair competition and promote 1, 2013. The FEZ is in the territory ethical practices in the marketing of where RAO Mars CJSC and the pharmaceutical products, Armenia's Yerevan Scientific Research Institute pharmaceutical manufacturers have of Mathematical Machines are located developed “The Code of Marketing and specializes in the production and Practice for the Pharmaceutical export of innovative technology and Industry in Armenia”. The Code takes R&D, including pharmaceuticals and into account the: realities of marketing biotechnology (For more information practices; the need for a complete about FEZ, please visit www.fez.am or set of rules regulating marketing “Investment Guide  Armenia 2016.”). practices; contemporary means The FEZ provides ample of incentives PRODUCT QUALITY of promotion and communication, to residents of the zone. In particular, including advertisements and the residents of the FEZ are exempt from all IS A HIGH PRIORITY internet; cooperation with healthcare taxes except the payroll taxes: professionals; and general trends in • profit tax - 0% FOR ARMENIAN ethical regulation found in Europe • VAT - 0% and globally, particularly the “Code of • import customs duties - 0% PHARMACEUTICAL Practice” developed by the International • export customs duties - 0% Federation of Pharmaceutical • dividend taxes - 0% MANUFACTURERS Manufacturers and Associations. • real estate and property taxes - 0%. ■ TABLE 2. LIST OF PHARMACEUTICAL PRODUCERS OF ARMENIA

Name of the # Address Phone number and e-mail Company 127/21 Arshakunyats Avenue, 1 Alex Grig Phone: 0007, Yerevan (+374 10) 490606

62 Tbilisyan Highway, 3109, Phone: 2 Alfa Pharm (+374 10) 465092 Gyumri E-mail: [email protected] 26 Azatutyan Avenue, 0037, Phone: 3 Armenicum+ (+374 10) 548001 Yerevan E-mail: [email protected] Phone: (+374 222) 21703 Building 19, 2-nd microdistrict, 4 Arpimed E-mail: [email protected] 2204, Abovyan, Kotayq Marz [email protected] Phone: 5 Arsanit Town Masis, Ararat Marz (+374 10) 522673 E-mail: [email protected] 1/1, 33 Manandyan Street, Phone: 6 Bio-Chem (+374 10) 425679 0046, Yerevan E-mail: [email protected]

Phone: 24 apt., 10 Hrachya Nersisyan (+374 10) 673929 7 Esco-Pharm Street, 0014 Yerevan (+374 10) 673903 E-mail: [email protected]

1st block, Davidashen, 0054, Phone: 8 Esculap (+374 55) 405603 Yerevan, E-mail: [email protected] 1 Gortsararneri Street, Artashat, Phone: 9 Hagenas (+374 10) 466466 Ararat Marz E-mail: [email protected]

10 Leykoalex 27 Fuchiki Street, 0048, Yerevan Phone: (+374 10) 350303

7/9 Kochinyan Street, 0089, Phone: 11 Liqvor (+374 60) 378800 Yerevan E-mail: [email protected] 1 Gortsaranain Street, 12 Lizin Phone: Charentsavan, Kotayk Marz (+374 94) 496939

Phone: (+374 93) 080880 22 Gorcaranayin, Masis station, 13 Medical Horizon E-mail: [email protected] Masis, 0802, Ararat Region [email protected] Nor Kharberd, Ararat Marz, 14 NOKI Phone: 0817, (+374 10) 285153

Phone: 15 PharmaTech 111 Raffi Street, 0064, Yerevan (+374 10) 741410 E-mail: [email protected] Nor Geghi, Nairi, Kotayq Marz, 16 Shirinyan Brothers 2411 The Institute of RESIDENTS OF THE Fine Organic 26, Azatutian Avenue, 0014, Phone: 17 (+374 10) 288334 Chemistry after L. Yerevan E-mail: [email protected] FEZ SPECIALIZING Mnjoyan Phone: (+374 10) 627410 IN PHARMACEUTICAL Yerevan Chemical- 6 Acharyan Street, 2nd lane, (+374 10) 613470 18 Pharmaceutical Yerevan, 0040 E-mail: [email protected] AND BIOTECHNOLOGY Firm [email protected] R&D ARE EXEMPT 100/5 Artashesyan Street, 0086, Phone: 19 Dioksid (+374 93) 202428 Yerevan E-mail: [email protected] FROM ALL TAXES PHARMACEUTICAL MANUFACTURING 20

Arpimed, which was established Many of Arpimed’s products are in 2001 by European specialists, currently in the registration stages in manufactures solid, semisolid and liquid several countries: medicines, prophylactic and medicinal • Russia preparations used in dentistry, antiseptic • Kazakhstan and disinfecting solutions, diagnostic • Kyrgyzstan preparations and cosmetics. The • Georgia company produces over 150 types of • Egypt medicines in the form of tablets, capsules, • Jordan oral and topical solutions, injectable solutions and ointments, which are used in Arpimed follows international ARPIMED LTD different branches of medicine (cardiology, standards for quality management neurology and psychiatry, endocrinology, system ISO 9001:2008 and Good gastroenterology, stomatology, and Manufacturing Practice standards. The CONTACTS others). Sixty-five percent of Arpimed’s company was certified by Germany's Contact Person: products are included in the list of TÜV Rheinland and France's AB Vachagan Ghazaryan, Essential Medicines of the Republic of Certification companies in 2013. In General Director Armenia. 2014, the company was awarded Address: a GMP certificate by one of PIC/S Building 19, 2-nd The quality of Arpimed’s imported raw country. Arpimed was also officially microdistrict, Abovyan, materials, intermediate and finished certified in accordance with the Good Kotayk marz, 2204, Armenia products is controlled in the Quality Manufacturing Practice standards by Phone: Control Laboratory, using state-of-the-art the Ministry of Health of the Republic (+374 222) 21703 devices. of Armenia (July 2014). Arpimed's E-mail: equipment is imported from [email protected] Arpimed exports approximately 30-35% world-renowned companies like [email protected] of its product. The company’s main ROTA (Germany), Telstar (India), Website: export markets are: Millipore (France), PamPac ACG www.arpimed.am • Belarus (India), Liotechnic (Italy), and others. Number of employees: • Ukraine 90 • Georgia Arpimed's advantages include diversified • Uzbekistan production and the existence of current • Kyrgyzstan assets. ■ EU GMP COMPLIANT INJECTION PRODUCTION LINE; ARPIMED PHARMACEUTICAL COMPANY PHARMACEUTICAL MANUFACTURING 22

Liqvor Pharmaceuticals, which was pharmaceutical products to meet founded in May 1991, was the first the unique demands of the region's private company in Armenia producing consumers. finished medicines. In its 23 years of existence, Liqvor has demonstrated The company was officially certified stable and dynamic growth. In 2005 in December 2013 in accordance the EBRD became a shareholder of with Good Manufacturing Practice the company and together with the standards, guaranteeing that its Government of the RA has implemented production meets international quality an investment project. standards.

LIQVOR CJSC Liqvor produces a wide range of Liqvor's quality management system intravenous and intramuscular injection includes the Control and Quality solutions for various therapeutic Assurance Department, which uses CONTACTS purposes. Liqvor's main focus is on the modern analytical and microbiological Contact Person: production of contemporary ophthalmic laboratories to control all incoming Sergey Matevosyan, medicines, which currently include 14 materials and ensure the quality of all General Director pharmacological groups. finished products. Address: 7/9 Kochinyan Street, The main export markets of the The company is a member of the Yerevan, 0089, Armenia company are: Chamber of Commerce of the Republic Phone: • Russia of Armenia. It is one of the founders of (+374 60) 378800 • Belarus the Medicine Producers and Importers E-mail: • Moldova Union of Armenia. [email protected] • Georgia Website: • Uzbekistan Liqvor's new plant meets EU GMP www.liqvor.com • Kazakhstan international standards for sterile Number of employees: • Tajikistan pharmaceutical production and 106 • Kyrgyzstan. guarantees long-term innovations. With its new plant, the company will be able The company plans to continue to increase production of modern and expanding its exports to offer a competitive medicines to fill its product wide range of modern and effective portfolio. ■ MULTI-STAGE WATER DISTILLER, LIQVOR PHARMACEUTICAL COMPANY PHARMACEUTICAL MANUFACTURING 24

Esco-Pharm LLC is the successor The company is in the process of of the manufacturing line of Esculap conforming its production to EU GMP LLC, founded in 1998. In 2011 standards and is preparing for GMP ESCO-PHARM LLC Esculap LLC was divided into certification. A quality assurance system two separate companies: one for is in place, including production and manufacturing, and the other for retail/ quality control practices. The quality CONTACTS wholesale trade. of active and adjuvant ingredients, Contact Person: packaging materials, and intermediate Ashot Gasparyan, Director Esco-Pharm currently produces and final products is controlled for Address: almost 60 types of non-sterile each batch and is in compliance with 24 apt., 10 Hrachya Nersisyan products, including ointments and international pharmacopeia requirements. Street, Yerevan, 0014, creams, liquids, tinctures, oils, Armenia powders, skin care products, and Esco-Pharm's production is compatible Phone: others. with other local and imported production, (+374 10) 673929 and is known for its high quality. The (+374 10) 673903 Esco-Pharm's products are in company offers lower prices for the E-mail: high demand in the Armenian same quality as imported products. The [email protected] pharmaceutical market. company continuously upgrades its Website: Several products are also in the production facilities in order to maintain www.escopharm.am process of being registered in the the high quality of its production and Number of employees: Russian Federation, Georgia and to be in line with market development 32 Uzbekistan. trends. ■ TINCTURE PRODUCTION LINE, ESCO- PHARM PHARMACEUTICAL COMPANY PHARMACEUTICAL MANUFACTURING 26

PharmaTech CJSC is a UK-owned PharmaTech has been GMP-certified pharmaceutical manufacturing since 2015 and continuously upgrades company based in Yerevan. The its production facilities in order to PHARMATECH CJSC company specializes in the production meet the increasing demand for of intravenous solutions, producing its products in Armenia and export 70 different solutions. PharmaTech's markets. The installation of European CONTACTS production capacity far exceeds Modular Equipment was carried Contact Person: Armenia's requirements, and many out by IPM (France) in accordance Vahan Arushanyan, Director products are already registered with GMP standards in one of the Address: and distributed in Georgia and CIS region's most advanced building 111 Raffi Street, Yerevan, countries. About 35% of the company's complexes managed by Cambridge 0064, Armenia production is exported, which is Pharmaceuticals of London. Phone: expected to increase to 55% within the PharmaTech finished the process of (+374 10) 741410 next three years. installing facilities for aseptic filling E-mail: and packaging of solid doses in 2015. [email protected] PharmaTech CJSC also imports and Installation of small-volume parenterals Website: distributes pharmaceutical products of is planned for 2017. PharmaTech also www.pharmatech.am leading companies GlaxoSmithKline, has a highly-equipped, ambient and Number of employees: MSD, Octapharma, and Eurodrug. temperature-controlled warehousing 50 system. PharmaTech was certified on November 23, 2000 by the Quality Management The company plans to increase Institute for quality management system the range of its IV products, launch ISO 9002:1994. On November 9, production of eye-drops and solid 2004, the Swiss certification company form medicines, organize contract SGS certified the quality system for manufacturing and packaging for third the design and manufacturing of their parties and provide services for the intravenous solutions as meeting both design, installation and organization of GMP and ISO 9001:2000 standards. production. ■

Bio-Chem LTD was established in 1991. and Central Asian countries. It is the first and only national scientific- industrial enterprise in Armenia that Raw materials are imported from world- produces more than 30 types of renowned suppliers such as German BIO-CHEM LTD skin and hair care cosmetics, dental companies Cognis, Clariant, and Drom; materials, antiseptic and disinfecting Belgian companies Goodrich and Dow solutions. Bio-Chem LTD is one of Corning; French company General CONTACTS leading companies in the region that Aromatics; English company Croda; Contact Person: is involved in the development of and others. Ashot Avetisyan, Director cosmetic products formulas and the Address: manufacturing of cosmetic goods. The The company is in the process of 1/1, 33 Manandyan Street, company produces cosmetics for both introducing EU GMP requirements for Yerevan, 0046, Armenia professional and personal use, and for the production of dental materials and Phone: both men and women. dentistry medicines, and modernizing (+374 10) 425679 its production facilities. E-mail: [email protected] The company currently exports its products Website: www.biochem.am to Georgia under the brand name Nica. The company's priority is to attract Number of employees: Other possible markets are USA, Russia, consumers with high-quality products 30 Iran, Uzbekistan and other Middle Eastern and affordable prices. ■ Medical Horizon was established in • Georgia 2006 and its first product was released • Kazakhstan to the market in January 2008. During this period, the plant was designed and One of Medial Horizon's basic constructed in accordance with GMP strategies is to establish a standards. As Armenia's most recently representation in Uzbekistan. The established pharmaceutical company, company is conducting marketing Medical Horizon has gained a stable, research for the purposes of registering continuously growing share of the in and exporting to Central Asia and MEDICAL Armenian pharmaceutical market. CIS countries. HORIZON LTD Medical Horizon is the only Armenian Medical Horizon is constantly improving pharmaceutical company that produces its production skills and technical suppositories. The company also equipment to meet GMP standards, and CONTACTS produces oral drops, syrups and is working to obtain a GMP certificate Contact Person: suspensions, liquids, and personal of conformity in 2017. The company's Shahe Kasis, Director hygiene products. Currently the quality control conforms to United Address: company produces 15 names of States Pharmacopoeia (USP) and 22 Gorcaranayin, products in 34 different dosage forms British Pharmacopoeia (BP) standards. Masis station, Masis, and strengths. Ararat marz, 0802, Armenia Medical Horizon's competitive Phone: The main export markets of Medical advantages are its quality, price policy, (+374 93) 080880 Horizon are: compliance of its marketing strategy E-mail: [email protected] • Uzbekistan which ethical norms, and constant Website: www.medicalhorizon.am • Ukraine development. ■ Number of employees: 28

Yerevan Chemical-Pharmaceutical The company has a number of Firm OJSC, the successor to Yerevan cooperation offers from companies Chemical-Pharmaceutical Plant, was from Belarus, Kazakhstan, Tajikistan founded in 1967. Its first products, and Kyrgyzstan. However, its ability including 10 different pharmaceutical to take advantage of these offers products, were released in 1968. In is being postponed due to limited 1969 the company began producing production capacity. The company is non-sterile bandages of various currently expanding its ties with the YERCHDF OJSC sizes, as well as tablets. In the late Russian Federation and Republic of 1970s, the company released 56 Uzbekistan. pharmaceutical products in different CONTACTS dosage forms: injections, tablets, and The company began the construction Contact Person: bandages. of a new plant meeting GMP Siraz Matevosyan, Director standards in 2012 to expand the Address: Yerevan Chemical-Pharmaceutical Firm production capacity. 6 Acharyan Street, 2-nd Lane, OJSC is the largest pharmaceutical Yerevan, 0040, Armenia company producing injectable Yerevan Chemical-Pharmaceutical Phone: medicines. In 2013 the company Firm OJSC's main area of focus is (+374 10) 627410, produced 107 different medicines, on the production of generics, which (+374 10) 613470 34 of which were for injection. Every are in high demand in the former E-mail: [email protected] year the company expands its range Soviet Union republics due to the [email protected] of products, including introducing new company's affordable prices and Number of employees: generic medicinal products. good reputation. ■ 182 PHARMACEUTICAL MANUFACTURING 28

COMPETITIVE Armenia’s competitive strength in the unusually extensive encyclopedic NICHE pharmaceutical sector comes from pharmacopeia providing details of 3,000 years of history, evidenced by a more than 3,700 medicines, arranged SUB-SECTORS high level of medical arts development in alphabetical order in Armenian and in ancient Armenia. Armenian folk five other languages. medicine included flora, fauna and inorganic materials. Ancient authors including Herodotus, Strabo, Xenophon, Tacitus and Ibn Armenian historians Movses Sina mentioned curative plants of the Khorenatsi, Pavstos Buzand, Lazar Armenian flora in their descriptions of Parpetsi and Thovma Ardsruni have Armenia. compiled important information on the practice of medicine in ancient Three pharmaceutical niches in which Armenia. Armenian physicians of the Armenia has competitive advantages Middle Ages studied ancient medicine and strong development potential are and scrutinized the achievements (1) herbal medicine production and of folk medicine. Davit Anhaght, a (2) research and development (R&D) famous Armenian philosopher of the and (3) development and production of Middle Ages who lived at the end of active pharmaceutical ingredients. the 5th century A.D. and beginning of the 6th century A.D., in his work “Definitions of Philosophy”, discussed HERBAL MEDICINE PRODUCTION questions of anatomy, biology and One of Armenia's most promising pharmacology. Anania Shirakatsi, development directions providing an eminent Armenian astronomer competitive advantages both in who lived in the 7th century A.D., local and foreign markets is phyto- was greatly interested in theoretical pharmaceuticals. This is mainly based and practical problems of medicine. on local herbs cultivated and collected Mekhitar Heratsi, a famous Armenian from different regions of Armenia. physician from the 12th century A.D., Armenian medicine, with its 3,000-year was the founder of medieval Armenian history, has created a rich treasury of medicine and played the same role natural medicaments. Medicine is an in the history of Armenian medicine inseparable part of ancient Armenian as Hippocrates did for Greek, Galen culture; its roots are embedded for Roman, and Ibn Sina for Arabic deep in the past. Over the years, its medicine. practitioners continuously collected and recorded an expanding body of One of the most brilliant figures information on therapeutics for use of Armenian medical science in in the daily medical care of ordinary the Middle Ages was Amirdovlat people. Amasiatsi (Amirdovlat of Amasia, 15th century A.D.). In his books In ancient times, medicinal herbs of “Usumn bzhshkutyan” (The Study of the Armenian highland were well- Medicine, 1459), “Ogut bzhshkutyan" reputed, and were exported to the East ARMENIAN MEDICINE, (The Benefits of Medicine), “Girk and to several countries in the West. ramkakan” (Popular Handbook, 1474) Ancient and Arabian writers such WITH ITS 3,000- and other works he dealt with human as Herodotus, Strabo, Xenophanes, anatomy, hygiene, diagnosis and Tacitus, Pliny the Elder, Dioscorides. YEAR HISTORY, HAS pharmacology. In the 25 chapters of Galen, Ibn Sina and al-Biruni, when “Akhrapatin” (Pharmacology, 1459) discussing Armenia, mentioned its A RICH TREASURY Amasiatsi described various medicines natural medicinal plants. and their therapeutic properties. His OF NATURAL most important and best known book Currently a number of Armenian is “Angitats Anpet” (Useless to the manufacturers (mainly small and MEDICAMENTS Ignorant, 1478-1482), which is an medium-size enterprises) specialize ► in the production of natural and was the USSR's leading center of herbal medicines and dietary pharmaceutical development and substances from medicinal, spicy production. The first Armenian and aromatic herbs. These include pharmaceutical company, Yerevan Khazaros, Antaram Phytotherapeutic Chemical Pharmaceutical Plant, had Cooperative, Zara Akunts-Natural started production of ten different Products, A. Ashotyan, and Fito- medical preparations a year after its pharm, among more than 15 registered founding in 1967. legal entities specializing in cultivation/ harvesting of medicinal herbs and/ After becoming independent, or production of herbal medicine. Armenia inherited a quite ramified These companies mainly produce and developed network of research herbal substances, teas, extracts, and education institutions distributed lotions, gels, topical creams and oils, among academic, university and ointments, powder-derived medicines branch/enterprise sectors. and dietary substances. They are engaged in primary and secondary The development of a knowledge- production and sell not only in the based economy that promotes R&D domestic market, but also export their and innovation is a core long-term products all over the world. strategic objective of the Government of Armenia. On February 17, 2011 the Global demand for medicinal herbs Government approved the “Concept and plants is currently growing and, Paper on the Initial Strategy of the according to Global Industry Analysts, Formation of Innovation Economy.” Inc, it is expected to reach close to Rich research and educational USD 118 billion by 2017. With over traditions, along with skilled human 2500 varieties of medicinal herbs resources, played an important role in and berries growing wild in its high attracting numerous global technology mountainous regions, Armenia has a firms to establish their branches and competitive advantage in the area of R&D centers in Armenia over recent herbal medicine production. years. THERE ARE OVER Through investment in R&D, cultivation, The National Center of Innovation and processing and marketing, there Entrepreneurship, operating under 2,500 VARIETIES are opportunities to increase sales the Ministry of Economy, plays an (both quantities and varieties) of raw important role in the implementation OF MEDICINAL medicinal herbs and herbal medicines, of Armenia's innovation policy. The and to expand export markets. Center implements innovative and HERBS AND BERRIES entrepreneurship processes, and supports the realization of innovative GROWING IN RESEARCH AND DEVELOPMENT IN ARMENIA ideas and projects. It also provides Product innovation in pharmaceuticals scientific-technical information and ARMENIA involves a uniquely long and costly library services. R&D process, typically divided into discovery and development. Discovery Armenia's pharmaceutical industry of a pharmaceutical product includes has strong scientific and R&D basic science and research on potential, which can be developed ARMENIA'S disease physiology, identification and with the improvement of inter-cluster validation of disease targets in a body, relations among R&D, production PHARMACEUTICAL identification and optimization of drug and educational institutions. There candidates, and pre-clinical testing. are 8 scientific research institutes INDUSTRY HAS undertaking research in the R&D was one of Armenia's core pharmaceutical and related areas (a STRONG SCIENTIFIC economic sectors before the collapse full list is available in pages 66-70 of this of the USSR. For 15 years Armenia guide). ► AND R&D POTENTIAL PHARMACEUTICAL MANUFACTURING 30

DEVELOPMENT AND PRODUCTION OF ACTIVE biotransformation, enzymatic PHARMACEUTICAL INGREDIENTS hydrolysis; Armenia has a rich tradition in science • Clinical results (cellular level) for and technology, with qualified personnel novel cardioactive hormones, and and wage rates that are very competitive new metal-containing proteins in the region. In pharmaceutical R&D and enzymes for treatment of and production Armenia has a special neurodegenerative diseases. niche in the area of development of active pharmaceutical ingredients Armenia's strong scientific and R&D (APIs). In Soviet times, six R&D institutes potential and research experience in and all R&D facilities within the state API development have served to attract universities, with more than 5,000 investments in this sector. In particular, specialists, were actively involved in the Swiss-based AZAD Pharmaceutical development of APIs, which were used Ingredients, a leading developer of in production of medicines throughout non-infringing APIs with a presence the entire Soviet Union. These institutes in the Armenian market since 2005, in continue to operate today, though with cooperation with the Institute of Organic limited capacity. They have developed Chemistry and with the support of the and patented new APIs and have Armenian Government, is setting up a implemented groundbreaking research in laboratory for the reproduction of API various areas: formulas. • APIs for treatment of cardiovascular, neuropsychic, and With further investment in R&D and infectious diseases and malignant marketing, there is strong potential tumors; for increasing the development and • New amino acid technologies: establishing the production of APIs in microbiological synthesis, Armenia. ■ PHARMACEUTICAL WHOLESALE AND RETAIL 33-44 PHARMACEUTICAL WHOLESALE AND RETAIL 32

GROWTH The pharmaceutical industry is one of the market is characterized by its openness PERFORMANCE most profitable industries in the world, and high competitiveness. The number of and has large development potential pharmaceutical wholesale-retail structures in Armenia. Though the Armenian in Armenia has significantly increased pharmaceutical market is highly dominated over the past 10 years. According to data by imports, it has grown dramatically, from from the Ministry of Health, over 1,600 approximately USD 93.5 million in 2009 to licenses for the right to engage in the USD 129 million in 2015, with an average pharmaceutical retail industry have been annual growth of 10%. These statistics issued since 2002, with an annual average are based on the value of pharmaceutical growth rate of 30%. imports plus the value of locally produced medicines sold in Armenia (see Figure 6). Pharmaceutical wholesalers supply products to both the public and private The pharmaceutical market is a complex sectors. The vast majority of the market market, given the great variety of is made up of commercial private stakeholders, significant involvement purchases (pharmacies and pharmacy of the government and high degree of kiosks). A small portion of medicine regulation aimed at achieving different consumption in 2015 consisted of public objectives. The Armenian pharmaceutical procurements (1.2%). ■

FIGURE 6. ARMENIA’S PHARMACEUTICAL MARKET (USD MILLION)

140 120 100 80 60 40 20 0 2010 2011 2012 2013 2014 2015 Imports Local sales of locally produced medicine SOURCE: NSS OF THE RA, MINISTRY OF FINANCE OF THE RA; 2016

MARKET Armenia's pharmaceutical industry four years, with an average annual is represented by three major groups growth rate of 6.8% from 2009 to STRUCTURE of business entities: manufacturers, 2015. Imports accounted for about importers/distributors and pharmacies. 86% of local pharmaceutical sales in There are 19 local manufacturing Armenia in 2015. companies (2016), as well as 47 foreign firm representatives and more than The main imported product of the 1700 pharmacies. pharmaceutical sector is medicine, representing by 84% (USD 108.4 Pharmaceutical imports are greater million) of the total import of the sector than exports, creating a negative in 2015. Other relevant imported trade balance. The total value of products are human and animal blood, imports of pharmaceutical products wadding, gauze, bandages and similar was USD 129.1 million in 2015, with articles and other pharmaceutical 17% growth over 2014. In general, products, which are 9.7%, 1.3% and imports of pharmaceuticals to 2.8%, respectively, of pharmaceutical Armenia have grown over the past imports. ► TABLE 3. TOP 10 PHARMACEUTICAL RETAIL CHAINS IN ARMENIA (BASED ON NUMBER OF PHARMACIES) 1 Alfa Pharm 6 Armfarm 2 Natali Pharm 7 Pharmdom 3 Esculap 8 Amikus 4 Gedeon Richter pharmacy JV 9 Asteria 5 Ritm Farm 10 Levon Lamara SOURCE: MINISTRY OF HEALTH OF THE RA; 2016

TABLE 4. TOP 10 IMPORTERS OF PHARMACEUTICALS IN ARMENIA (BASED ON USD IMPORTS IN 2015) 1 Natali Pharm 6 Alfa pharm import 2 Alfa Pharm 7 Esculap 3 Vaga Pharm 8 Deghabaza Yerevan 4 Richter Lambron 9 Argo Pharm 5 PharmaTech 10 Amikus SOURCE: MINISTRY OF HEALTH OF THE RA; 2016 FIGURE 7. IMPORT OF PHARMACEUTI- CAL PRODUCTION BY REGION (2015, As shown in Figure 7, imports are In recent years, pharmacies have been USD THOUSAND) coming from a diverse range of faced with increasing competition. 5 8.5 countries, although the majority (72%) Pharmacies try to compete not only 5.5 is from European countries. In 2015 by reducing prices of medicines and 9 Armenia imported pharmaceutical expanding their assortment, but also by products from 68 countries. Germany increasing business hours (the majority 9 leads in import numbers, accounting up to 24 hours), and offering free for 15.3%, followed by Switzerland consultations. (10.8%), France (10.7%), the US and

Russia (5.5% each). In 2015, there were 23 companies in 63 Armenia that imported pharmaceuticals on

The Armenian pharmaceutical a commercial basis. 55% of all commercial CIS Other Europe wholesale and retail market is very imports in 2015 were imported by the EU USA Asia/Australia Other competitive. As of February 2016, there three largest companies: Natali Pharm, were 25 pharmaceutical importers, and Alfa Pharm and Vaga Pharm. (see Table 4 more than 1,700 pharmacies. for the list of top 10 importers.) ■ SOURCE: NSS OF THE RA; MINISTRY OF FINANCE OF THE RA; 2016 The Armenian pharmaceutical TOP 10 COUNTRIES IMPORTING PHARMACEUTICALS TO market is based on developed retail ARMENIA (BASED ON USD IMPORTS IN 2015) pharmacy chains. There are around

1,700 pharmacies and pharmacy 3.7% kiosks in Armenia, which are prevalent 3.8% 15.6% in almost all cities and even rural 3.9% THE ARMENIAN areas of Armenia (approximately one 4.6% drugstore for every 1,900 people). PHARMACEUTICAL

These pharmacies are owned by 1,278 4.7% companies, but only 41 of them have 10.6% MARKET IS more than two drugstores. The largest 5.0% pharmacy chains are Alfa Pharm, Natali CHARACTERIZED 5.2% Pharm and Esculap, with a combined 9.6% total of 212 shops. The other seven Germany Russian Federation Italy BY ITS OPENNESS companies among the top ten retail United States Netherlands France Hungary United Kingdom chains (in terms of number of shops) Slovenia Switzerland AND HIGH own and operate fewer than 20 retail outlets (see Table 3). SOURCE: MINISTRY OF FINANCE OF THE RA; 2016 COMPETITIVENESS PHARMACEUTICAL WHOLESALE AND RETAIL 34

Natali Pharm was founded in 1998 • Cardiovascular medicines; and is one the largest importers of • Gastrointestinal medicines; medicines and medical supplies in • Antiallergics; Armenia. The company constantly • Analgesics and antipyretics, expands its range of imported drugs non-steroidal anti-inflammatory to satisfy market demands and keep medicines. up with market developments. The NATALI PHARM LLC organization follows GDP standards. Natali Pharm’s development strategy for Natali Pharm has a fully re-equipped the coming year is to expand its range pharmaceutical warehouse, which of imported medicines and medical CONTACTS provides faster and more accurate supplies. Contact Person: deliveries. Ruzanna Maghakyan Main advantages of the company are Address: Natali Pharm cooperates with more than following: 2/2, Tichina 3rd Lane, 60 leading pharmaceutical companies, • Up-to-date distribution center Yerevan, 0065, Armenia such as Roche, Les Laboratories In 2011 Natali Pharm fully re- Phone: Servier, Novartis Consumer, Novartis equipped its drug warehouse with (+374 10) 720620 Pharma, Teva, Abbott, Sandoz, a conveyor from Austrian-company E-mail: Polpharma, Bayer Consumer, Bayer Shafer, enabling it to provide faster [email protected] Pharma, Nizhpharm, B. Braun, Nipro and more accurate delivery of Website: and others. customer orders. www.natalipharm.am • Large network and reach Number of employees: The company imports about 8000 The company operates more than 450 pharmaceutical products of the 60 pharmacies in Yerevan and other following types: regions of Armenia, which provide • Anti-infective medicines; high-quality customer service. ■ DRUG WAREHOUSE FULLY RE-EQUIPPED ACCORDING TO GDP STANDARDS; NATALI PHARM PHARMACEUTICAL WHOLESALE AND RETAIL 36

Since its establishment in 1996, medicines; Alfa-Pharm has been successfully • Medicines for newborns; engaged in the import, wholesale • Medicines affecting the respiratory and retail of medicines in Armenia, system; ALFA PHARM CJSC occupying a leading position in • Multivitamins and minerals; Armenia’s pharmaceutical market. • Diagnostic tools.

The company’s shareholders Alfa Pharm’s central distribution CONTACTS are the European Bank for area is equipped with a Contact Person: Reconstruction and Development state-of-the-art, computer-controlled Ara Poghosyan, (EBRD) and founders with many conveying storage system, which Marketing manager years of experience in the Armenian meets all applicable quality control Address: pharmaceutical market. requirements for storage, handling 1/68 Shirak Street, Yerevan, and release of medicines. The 0043, Armenia The company has direct delivery from storage capacity allows timely and Phone: 100 leading European, Russian, U.S., accurate delivery of products to over (+374 10) 465092 Indian and CIS manufacturers, such 600 pharmacies and 150 medical E-mail: as Les Laboratories Servier, Sanofi- institutions. [email protected] Aventis, Abbott, Berlin-Chemie AG, Website: Novartis Consumer, Bayer Consumer, The company’s development strategy www.alfapharm.am Hoffman-La Roche, Astellas Pharma for the coming years is to expand Number of employees: Europe, AstraZeneca and others. its pharmacy chain in the territory of 600+ Armenia. The company imports about 4500 pharmaceutical products of the Main advantages of the company are following types: following: • Analgesics and antipyretics, • High-quality medicine from top non-steroidal anti-inflammatory manufacturers medicines; The company has direct delivery • Antiallergics; from more than 100 leading • Antidotes and other substances international manufactures. used in poisoning; • Qualified personnel • Antiepileptic medicines; Employees undergo continuous • Anti-infective medicines; education and training to • Immunosuppressives and provide high quality customer medicines used in palliative care; service. • Antiparkinson medicines; • Up-to-date distribution center • Oncology medicines; The company’s distribution center • Medicines affecting the blood; has been developed by the • Cardiovascular medicines; Austrian company Shafer and • Dermatological medicines; meets Good Storage Practice • Antiseptics; (GSP) standards. An automated • Diuretics; system allows fast and accurate • Gastrointestinal medicines; service to 600 pharmacies and • Hormones, other endocrine medical institutions. medicines and contraceptives; • The largest pharmacy chain • Ophthalmological medicines; Alfa Pharm is one of the largest • Medicines for mental and pharmaceutical retail chains in behavioural disorders; Armenia, operating 120 pharmacy • Uterine stimulants and relaxants; outlets in almost all of the regions • Children's otolaryngology in Armenia. ■ ALFA PHARM PHARMACY IN YEREVAN PHARMACEUTICAL WHOLESALE AND RETAIL 38

The Armenian-Hungarian joint-venture Richter-Lambron imports about 1,500 Richter-Lambron LTD was founded in pharmaceutical products of the 1998 by the Hungarian pharmaceutical following types: plant Gedeon Richter and Armenian • Cardiovascular medicines; company Lambron-Pharmimpex LTD. • Anti-seizure, anti-epileptic The latter has been engaged in the medicines; Armenian pharmaceutical market since • Non-opioid analgesics, RICHTER- 1994 and is ranked among the ten best non-steroidal anti-inflammatory and largest importing companies in medicines; LAMBRON Armenia. The company also owns and • Gastrointestinal medicines; operates 22 pharmacies located in • Antiallergics and medicines used in JV LTD Yerevan and the surrounding regions. anaphylaxis; • Contraceptives; Richter-Lambron’s partners are well- • Anti-infective medicines; known producers such as Gedeon • Medicines affecting the respiratory CONTACTS Richter, Krka, Sanofi-Aventis, system; Contact Person: Egis, Janssen Pharmaceuticals, • Hormones, other endocrine Armen Davtyan, Boehringer Ingelheim, Sopharma, GM medicines including diabetes Founder/Director Pharmaceuticals, LMP, Piere Fabre, medications. Ruben Astvatsatryan, Biopharm, Biosola, MPI Pharmaceuticals, Founding Director Sebapharma, Arabia Diamond Tex, Main advantages of the company are Address: Waritex, Abbott Products Operation AG, existence of: 22/14 Parpetsi Street, Berlin Chemie and others. • Streamlined purchasing system Yerevan, 0002, Armenia They use direct sales agreements Phone: The company meets European product with leading European medicine (+374 10) 531500 standards, ensuring all necessary producers. E-mail: conditions are met for the storage of • State-of-the-art equipment [email protected] pharmaceuticals, cosmetics and hygiene They use high-quality logistics for Website: items. There are special cold rooms for medicine storage. www.lambronpharm.am storage of product groups with different • Streamlined delivery service Number of employees: temperature requirements, and a special Good conditions (specialists, 73 bunker for the storage of psychotropic transportation, and high-quality and narcotic drugs. The company’s paperwork) for fast delivery of warehouse is equipped with advanced medicinal products to technology. customers ■ RICHTER LAMBRON JV PHARMACY IN GYUMRI PHARMACEUTICAL WHOLESALE AND RETAIL 40

Esculap was established in 1996 registration, marketing and promotion. and today is considered as one of the leading wholesale and retail Esculap imports about 680 pharmaceutical companies in Armenia, pharmaceutical products of the following ESCULAP LTD cooperating with many famous types: European pharmaceutical companies. It • Cadiovascular medicines; owns and operates 25 pharmacies. • Anti-infective medicines; CONTACTS • Analgesics and antipyretics; Contact Person: Esculap has direct distribution • Oncology medicines; Gagik Grigoryan, with many leading international • Medicines used to affect the nervous General Director pharmaceutical companies, such system; Address: as Sanofi-Aventis (France), Astellas • Gastrointestinal medicines; 17/2, 1st block, Davtashen, Europe, Pfizer (USA), UCB Pharma • Dermatological medicines. Yerevan, 0054, Armenia (Belgium), Novartis Group (Switzerland), Phone: Media Pharm (Switzerland), Zentiva Esculap’s development strategy for (+374 55) 405603 (Slovakia), Alkaloid AD (Macedonia), the coming years is to increase direct E-mail: Medial (Switzerland) and others. The imports by starting new partnerships, [email protected] company has exclusive distribution with and to expand its pharmacy chain as Website: Alkaloid AD (Macedonia), ReplekFarm much as possible. www.esculap.am (Macedonia), Intas Pharmaceuticals, Number of employees: Plethico, and the Himalaya Drug Co. Competitive advantages of the company 125 (India). In addition to distributing of are its sustainable development, highly pharmaceutical products in Armenia, professional services and management the company also organizes their autonomy. ■ Amikus LTD was founded in 1997 as The company plans also to expand the a medicine retailer and now is one number of partner organizations and its of Armenia’s major pharmaceutical pharmacy chain. AMIKUS importers. The company has established strong links with drug Amikus imports more than 140 manufacturers from Switzerland, medicinal products of the following France, Germany, Finland, Hungary, types: and Slovenia. Amikus also is the • Gastrointestinal medicines; AMIKUS LTD exclusive importer of Wockhardt (India), • Medicines affecting the blood; KIN (Spain) and Medgamal (Russia). • Cardiovascular medicines; The company also produces patient • Antiallergics; CONTACTS care products. • Anti-infective medicines; Contact Person: • Medicines affecting the respiratory Naira Kerobyan Together with the pharmaceutical system; Address: wholesale and retail, the company also • Antiparkinson medicines; 33/1 Manandyan, Yerevan, produces preparations for patient care • Hormones; 0046, Armenia (such as sterile bandages, cupping • Medications for skin conditions; Phone: glasses, accessories for processing • Diuretics; (+374 10) 428801 vaginal cavities, syringes etc.). • Anti-diabetes medicines; E-mail: • Analgesics and non-steroidal anti- [email protected] Recently the company began the inflammatory medicines; Website: construction of a new production • Ophthalmic medicines; www.amikus.am facility, meeting GMP standards. • Oncology medicines; Number of employees: • Vitamins. ■ 85-120

Argo-Pharm LTD was founded Currently the company imports 25 in 1997 and is one of the largest types of medicinal products, cosmetics, medicine importers in Armenia. In dietary supplements and medical 2011 it founded the 36.6 Pharmacies devices. chain. The company’s main goal is to maintain and expand its position in It specializes in the import of the the market. It continuously expands following types of products: ARGO-PHARM LTD its list of imported medicines to meet • Analgesics and antipyretics, demand and stay in line with market non-steroidal anti-inflammatory developments. medicines; CONTACTS • Medicines affecting the respiratory Contact Person: Argo-Pharm LTD follows Good system; Armen Tigranyan Distribution Practice (GDP) • Gastrointestinal medicines; Address: standards and cooperates with • Cardiovascular medicines; 60 Griboedov Street, Yerevan, leading pharmaceutical companies • Anti-infective medicines; 0051, Armenia such as Pharmstandart, Biosintez, • Psychotropic medicines; Phone: Master Lek, RBHC, Help and others. • Immunomodulatory medicines. ■ (+374 10) 237210 (+374 10) 282860 E-mail: [email protected] [email protected] Website: www.argo.am Number of employees: More than 20 PHARMACEUTICAL WHOLESALE AND RETAIL 42

AMIKUS PHARMACY IN YEREVAN EXPORT MARKETS 45-48 EXPORT MARKETS 44

EXPORT Armenia’s pharmaceutical industry has importance of boosting pharmaceutical GROWTH blossomed over the past decade into export has been reflected in the an export-oriented economic sector. Pharmaceutical/Biotechnology PERFORMANCE This shows the growth of the sector and sector action plan adopted by the quality of the production. Government. Moreover, a large number of highly profitable original According to the National Statistical brand medicines produced by top Service of the Republic of Armenia, manufacturers are due to lose patent exports of locally-produced protection, providing opportunities pharmaceuticals amounted to USD 9 for generic manufacturers to begin million in 2015, 12% above 2014 (See production of these off-patent medicinal Figure 8). The pharmaceutical industry products. It is therefore expected that is still a very small export industry, by 2020, Armenia's pharmaceutical comprising only 0.5% of Armenia's total exports will increase by USD 75-100 export volume. But it is one of the fastest million. growing export industries, increasing by an average of 20% annually The main product exported from the between 2010 and 2015, reflecting the pharmaceutical sector is medicine, strengthening of the industry. representing 82.7% of the total export of the sector in 2015, with 9.4% growth Today, exports account for 52% of over 2014. Other relevant exported Armenia's pharmaceutical output. products are human and animal blood, This export growth shows the and wadding, gauze, bandages and importance of external markets to similar articles, which are 11.7% and place the production of the Armenian 3.7%, respectively, of pharmaceutical pharmaceutical industry. The exports. ■

FIGURE 8. TOTAL EXPORTS OF PHARMACEUTICAL PRODUCTION 2010-2015 (USD THOUSAND)

10000 9,064.5 9000 8,039.3 FIGURE 9. EXPORT OF ARMENIAN 8000 7,815.3 PHARMACEUTICAL PRODUCT BY 6,887.7 REGION, 2015 7000

2 6000 5,790.3 5,022.8 5000

36 4000

57 3000

2 2000 3 1000

CIS EU 0 Asia 2010 2011 2012 2013 2014 2015 Georgia Other

SOURCE: MINISTRY OF FINANCE OF THE SOURCE: NATIONAL STATISTICAL SERVICE OF THE RA; 2016 RA; 2016 MARKET In 2015, Armenia exported locally • Consumers in CIS countries have produced medicine to 25 countries. As a general awareness of Armenian STRUCTURE shown in Figure 12, 58% of Armenian products and thus it is easier to exports go to CIS countries, 37% to compete in these countries, even AND VOLUMES Georgia, 3% to EU countries and 2% to with well-known international other countries, mainly USA, Japan and producers. Korea (See Figure 9). The biggest exporters are Liqvor, In 2015 exports to the CIS countries Yerevan Chemical-Pharmaceutical Firm, equaled USD 5,862 thousand, and Arpimed. These three companies representing an annual growth rate together accounted for approximately of 18%. Export to other countries in 70% of Armenian’s total pharmaceutical 2015 equaled USD 3,683 thousand, exports in 2015 (see Figure 10). representing an annual growth rate of 7%. The last figure shows that the Almost all Armenian producers plan to volume of exports into CIS countries expand their export markets. Primary has risen. This is due to: target markets are CIS countries, • Common use of Russian language particularly those whose markets and free trade agreements with CIS are not yet penetrated. However, as countries; Armenian pharmaceutical companies • Historical links with these countries, have implemented GMP standards in resulting in local producers their production, attractive markets for establishing good relations and Armenian pharmaceutical producers partnerships with these countries’ will also include the EU, Middle East/ distributors; and, North Africa, and Asia. ■

EXPORT TREND OF ARMENIAN PHARMACEUTICAL PRODUCTION TO CIS AND NON-CIS COUNTRIES (USD THOUSAND)

7000

6000 5,862 FIGURE 10. EXPORT OF PHARMACEUTICAL PRODUCTS BY 4,968 COMPANY (2015) 5000 4,505

4000 3,706 3,683 24% 3,434 3,310 3,442 3,182 33% 3000 2,703 2,320 2,356 1% 3% 2000

10% 1000 24% 5%

0 Liqvor Arpimed 2010 2011 2012 2013 2014 2015 Pharmatech YerCPhF CIS countries Non-CIS countries Vitamax Bio-Chem Other SOURCE: MEDICINE PRODUCERS AND SOURCE: NSS OF THE RA, MINISTRY OF FINANCE OF THE RA; 2016 IMPORTERS UNION OF ARMENIA; 2016 EXPORT MARKETS 46

EURASIAN On December 2, 2015 the Republic of and legal entities; a common market ECONOMIC Armenia joined the Eurasian Economic within the Eurasian Economic Union; the Union (EAEU) in accordance with an elimination of unjustified restrictions on UNION (EAEU) agreement governing pharmaceuticals the pharmaceutical and medical market; and medical products, which had been the enhancement of competitiveness adopted by the EAEU on December of pharmaceutical and medical goods 23, 2014. The agreement sets out produced in EAEU member states; and the common principles and rules for creation of optimal conditions for the the circulation of drugs and medical global market. products within the Eurasian Economic Union. As a result of becoming a party to the EAEU agreements, Armenia will have The agreement ensures: the Republic coordinated policies and increased of Armenia's economic cooperation; safety, efficiency and quality, as well as expansion of trade and economic guarantees to prevent consumers from ties; safe, effective and quality being misled, thereby creating trust in medicines; availability of medical the mutual interests of consumers and products; protection of the environment; sellers of pharmaceuticals and medical safeguarding of property of individuals products. ■ HUMAN RESOURCES 49-66 HUMAN RESOURCES 48

LABOR COSTS The Government of Armenia According to data published on envisions Armenia becoming January 1, 2016, the total number a producer of high-value and of people employed in Armenia's knowledge-intensive goods and pharmaceutical sector is around services with creative human 5,800. The vast majority (~4,200) are capital at its core. The highly employed on the retail side of the educated workforce, increasing sector. every year with new graduates from Armenia's internationally recognized Wages in Armenia are comparatively universities that have close lower than wages in other countries of educational cooperation with well- the region and Western and Eastern known Western universities, is one of Europe, with an average monthly wage the key advantages of the Armenian of USD 405 in 2015 (See Figure 11). pharmaceutical sector. Average monthly wages (as of Armenia’s pharmaceutical industry 1 January 2015) in Armenia's employs a high percentage of pharmaceutical sector (USD 261) professionals and technicians. In are in line with the overall national 2016, about 27% of employees in the average monthly wages (USD 302). pharmaceutical industry belonged to In 2015, the average monthly salary a technical-professional class. Due for pharmaceutical production jobs to recent significant technological was USD 299; for retail jobs, USD 216; investments in the sector and and for wholesale jobs, USD 312. The specialized training, it is expected average annual remuneration received that the percentage of technicians by the pharmaceutical industry and professionals employed in the employees has grown rapidly, with Armenian pharmaceutical industry growth rate estimated at 34% from 2009 will grow in coming years. to 2016. ■

FIGURE 11. AVERAGE MONTHLY SALARY IN ARMENIA AND SEVERAL COUNTRIES, 2015 (USD)

6,000

5,000

4,000

3,000

ARMENIA'S 2,000

HIGHLY EDUCATED 1,000 WORKFORCE IS 0 ONE OF THE KEY ADVANTAGES OF ITS PHARMACEUTICAL SECTOR SOURCE: MEDICINE PRODUCERS AND IMPORTERS UNION OF ARMENIA THE ANNUAL PHARMA CAREER FAIR, SEPTEMBER 2014 HUMAN RESOURCES 50

EDUCATION, SKILLS Armenia’s long history of educational infrastructure and standards are the AND RESEARCH excellence has resulted in a skilled and Yerevan State Medical University after qualified workforce. Literacy is almost M. Heratsi, Yerevan State University, INSTITUTES 100% and Armenia has one of the Russian-Armenian University and highest percentages of graduates in National Polytechnic University of the former Soviet Union. Human capital Armenia. development is an essential part of the country’s industrial growth policy, Twelve state and private universities with education seen as an incentive and colleges in Armenia offer an for progress. There are currently 26 education in pharmacy, some of which public and 41 private universities in confer master's degrees and PhD's. Armenia. The Armenian education The Faculty of Chemistry at Yerevan system participates in the Bologna State University offers bachelor's process and complies with international programs and master's programs standards. There is a continuing trend in pharmaceutical chemistry and of rising standards in Armenia's higher pharmacy. The Faculty of Pharmacy education institutions. at Yerevan State Medical University (YSMU) offers bachelor's and master's Eight public and private universities degrees in general pharmacy. (higher education institutions) Specializations, i.e., clinical studies, in Armenia offer degrees in are provided at the post-master's pharmaceutical disciplines. The leading stage. The Department of Chemical universities in terms of reputation, Technologies and Environmental ►

TEN PUBLIC AND PRIVATE HIGHER EDUCATION INSTITUTIONS IN ARMENIA OFFER DEGREES IN PHARMACEUTICAL DISCIPLINES THE GXP CENTRE OF EXCELLENCE Engineering at National Polytechnic The GXP Centre of Excellence University of Armenia offers bachelor's was established in 2009 by the and master's degree programs in Medicines Producers and Importers chemical technology of medicinal Union of Armenia, with the aim of substances. The Institute for training Armenian pharmaceutical Mathematics and High Technology at manufacturers and distributors in the Russian-Armenian University offers international best practice standards. majors in medical biochemistry and pharmacy. The Centre also provides consultancy services that assist companies to Students in their final years of study achieve compliance with international undertake internships in pharmaceutical production and distribution companies. The majority of graduates standards. It is the only center in who study pharmaceutical-related the region offering well-organized specializations in higher education training courses developed by institutions find jobs in pharmaceutical experienced international experts in companies and pharmacies, and a small appropriate fields that is approved number find jobs in hospitals or clinics. by the RA Ministries of Health and Economy. The quality of pharmaceutical skills among the workforce is solid in terms The courses and seminars cover of education. All pharmaceutical various professional topics and are companies attach great importance open to both foreign and Armenian to employees undergoing specific citizens. Upon completion, trainees professional or pharmacy-related are granted a state certificate. training. The Medicines Producers and Importers Union has founded a special 1. General GxP Training Courses: training center for the pharmaceutical • EU Guide for Good Manufacturing industry: the GXP Centre of Excellence. Practice (GMP) Pharmaceutical manufacturers and big • GMP principles retail companies also provide in-house • SOP Development and training for newly hired specialists. Documentation • Good Distribution Practice (GDP) UNIVERSITIES: • Good Laboratory Practice (GLP) • Yerevan State Medical University • Good Clinical Practice (GCP) after M. Heratsi • Qualified Person • Yerevan State University THE GXP CENTRE OF • National Polytechnic University of 2. Special Topic Training Courses: Armenia • Sterile Production EXCELLENCE IS THE • Russian-Armenian University • Validation & Qualification • Yerevan Medical Institute after • Factory Design & HVAC ONLY CENTER IN THE Mehrabyan • Effective Audits • University after Saint Teresa • Regulatory Affairs REGION OFFERING • Yerevan Haybusak University • Critical Cleaning & Validation • University of Traditional Medicine WELL-ORGANIZED 3. General Management Training COLLEGES: Courses: TRAINING COURSES • Yerevan State Basic Medical College • Middle Management • Yerevan State Medical College • Pharmaceutical Marketing APPROVED BY THE RA Erebuni • Medical Representative • Grigoris Medical-Humanities College • HR Systems & Appraisal MINISTRY OF HEALTH • L. Orbeli Medical College • Export Marketing ■ AND MINISTRY OF ECONOMY HUMAN RESOURCES 52

Yerevan State University was founded conducted by more than 1,580 highly in 1919 and has more than 100,000 qualified specialists and experts (206 graduates. Currently, more than 18,000 professors, 557 associate professors, students study in 19 faculties of YSU 378 assistants and 447 lecturers). 39 and four faculties in the regional academicians of the National Academy campus, with more than 100 general of Sciences of Armenia and 26 associate and professional departments. members of the National Academy of Science (NAS) of Armenia are also Since 1995, the university has involved in YSU's educational process. introduced a two-level qualification YEREVAN STATE system, with bachelor's and master's Pharmaceutical-related education degrees. In 2007, the European Credit is provided in the Department of UNIVERSITY (YSU) Transfer and Accumulation System was Pharmaceutical Chemistry of the introduced in all master's programs, Faculty of Chemistry, which was and a year later in bachelor's programs. founded in 1998.

CONTACTS According to data available as The Department conducts laboratory Contact Person: of January 1, 2013, YSU runs 60 and practical training at the Ashot Saghyan, bachelor's, 130 master's and 70 doctoral Departments of Pharmaceutical Head of Department of programs that involve nearly 18,000 Chemistry, Ecological Chemistry and Pharmaceutical Chemistry students. The educational process is Magistracy Chemistry. ► Address: 1 Alek Manukyan, Yerevan, NUMBER OF ADMITTED AND GRADUATED STUDENTS 0025, Armenia Admitted Graduated Phone: (+374 60) 710402 2013 2014 2015 2013 2014 2015 E-mail: Total 12,296 10,039 11,671 14,168 14,874 13,315 [email protected] Department of Pharmaceutical Website: Chemistry of the Faculty of 62 204 107 48 185 133 www.ysu.am Chemistry Number of employees: 1,588 NUMBER OF ADMITTED AND GRADUATED STUDENTS OF DEPARTMENT OF PHARMACEUTICAL CHEMISTRY Admitted Graduated Year Bachelor Master PhD Bachelor Master PhD 2011 14 - - - - - 2012 73 36 - 47 - - 2013 62 39 - 48 - - 2014 124 80 - 127 58 - 2015 79 29 - 74 59 -

NUMBER OF ADMITTED AND GRADUATED ARMENIAN AND FOREIGN STUDENTS IN PHARMACEUTICAL-RELATED SPECIALIZATIONS Admitted Graduated Year Armenian Foreigners Armenian citizens Foreigners citizens 2011 10 4 55 2 62 (5 year education) 2012 66 7 6 (5 year education) 47 (bachelor) 2013 58 4 48 - 2014 121 3 51 - 2015 79 2 53 - The Department teaches the following the Bologna Process has been fully major specialties: fundamentals of introduced in the department. In 2011, pharmacology, clinical pharmacology, two-year programs for master's degrees molecular biology, clinical biochemistry, were developed, which comply with chemistry of natural compounds, international standards and are licensed biotechnology, pharmacogenetics, by the Ministry of Health of Armenia. pharmacokinetics, engineering enzymology, pharmacopeia analysis, The Department of Pharmaceutical technology of medical preparation Chemistry cooperates closely with production (pharmaceutical and well-known research institutes and industrial), pharma-chemistry, companies abroad, including the A. pharmacognosy, toxicological Nesmeyanov Institute of Organoelement chemistry, organization and economy of Compounds RAS (Russia), Institute of pharmaceutics and others. Human Brain RAS (Russia), Karolinska University Hospital (Sweden), Acros Since 2010, the European Credit Organics Company (Belgium), Paris-Sud Transfer System in harmony with University (France) among others. ■ HUMAN RESOURCES 54

The Yerevan State Medical University and 504 associate professors. Seven was founded in 1930, an independent academicians of the NAS RA are extension of the medical department of also involved in YSMU's educational the Yerevan State University, which was process. established in 1919. Approximately six thousand students study under seven The Faculty of Pharmacy conducts the faculties (General Medicine, Public following educational programs: Health, Stomatology, Pharmacy, Military Medicine, Postgraduate and Continuing • Bachelor of Pharmacy – four-year Education). YSMU has more than 100 undergraduate course academic departments. More than • Master of Pharmacy – two-year 1,200 foreign students are enrolled. course YEREVAN STATE • Diploma Specialist Program (for In the 2005-06 academic year, the foreigners) - pharmacist. MEDICAL University introduced a two-level education system in order to meet Education in the Faculty of Pharmacy UNIVERSITY international education standards. is conducted in Armenian, Russian, and English. Students specialize in (YSMU) The educational process is conducted medicines technology, pharmaceutical by more than 1,100 highly qualified management, pharmaceutical specialists, including 171 professors chemistry, or clinical pharmacology. ► CONTACTS Contact Person: Bagrat Yenokyan, Dean of the Pharmacy Faculty Address: 2 Koryun Street, Yerevan, 0025, Armenia Phone: (+374 10) 582532 E-mail: [email protected] Website: www.ysmu.am Number of employees: 3,079 Pharmaceutical-related departments is “Research on natural and are: synthetic origin compounds’ anti-inflammatory and analgesic • Department of Drug Technology activity.” (one professor, two associate professors, four assistants including • Department of Pharmacognosy one PhD): The Department of (three associate professors, three Drug Technology’s main research assistants): The Department of involves the development of Pharmacognosy’s research is technological processes and study “Pharmacognostic research of the of pharmacological activity of RA flora.” biologically active ingredients from herbal materials. • Department of Clinical Pharmacology (one professor, • Department of Pharmaceutical two associate professors, six Management (three associate assistants): The Department of professors, 11 assistants): The Clinical Pharmacology’s research Department of Pharmaceutical is “Pharmacological correction Management’s main research of cardiac-cerebral-vascular is related to regulations in the diseases.” sphere of pharmaceuticals and increasing economic accessibility of • Department of Organic Chemistry medicines. (one professor, five associate professors, two assistants including • Department of Pharmacy one PhD): The Department of (four associate professors, four Organic Chemistry’s research is assistants): The Department of “Biological activity of natural and Pharmacy’s main research topic synthetic origin porphyrins.” ►

NUMBER OF ADMITTED AND GRADUATED STUDENTS

Admitted Graduated 2013 2014 2015 2013 2014 2015

Total 1,713 949 1026 1,119 557 771 Faculty of Pharmacy 104 112 100 47 11 49 (Bachelor) Faculty of Pharmacy 43 32 11 33 40 30 (Master) Faculty of Pharmacy 13 4 4 3 4 6 YSMU'S (Foreigners) PHARMACEUTICAL- NUMBER OF ADMITTED AND GRADUATED STUDENTS OF PHARMACEUTICAL-RELATED FACULTIES

Admitted Graduated RELATED Year Bachelor Master PhD Bachelor Master PhD EDUCATIONAL - 2011 10 38 2 47 5 (degreed 2 PROGRAMS ARE specialist) 2012 118 31 2 37 32 1 PROVIDED IN 2013 104 41 1 47 33 1 2014 112 32 1 11 40 1 ARMENIAN, ENGLISH 2015 100 11 1 49 30 1 AND RUSSIAN HUMAN RESOURCES 56

• Department of Pharmacology in the areas of medical education and (two professors, five associate healthcare with medical universities professors, eight assistants of different countries and international including one PhD): The development organizations. Foreign Department of Pharmacology’s exchange programs with universities research is “Pharmacological and health organizations enable YSMU correction of ischemic brain injury.” students and postgraduates to have a short clinical practice in top foreign YSMU has established close relations clinics and medical institutions. ■

NUMBER OF ADMITTED AND GRADUATED ARMENIAN AND FOREIGN STUDENTS

Admitted Graduated Year Armenian citizens Foreigners Armenian citizens Foreigners 2011 1,333 377 534 244 2012 712 323 704 118 2013 1,460 253 1,002 117 2014 741 208 495 62 2015 840 186 638 133 The National Polytechnic University of 1. General Chemistry and Armenia (NPUA) is the successor to Chemical Processes the Yerevan Polytechnic Institute that 2. Chemical Technologies was founded in 1933. From its 78 years 3. Environmental Protection and of existence, the University has nearly Biotechnology 115,000 graduates. Education is provided in several Presently, NPUA has over 10,000 specialties, such as Chemical students under 19 faculties, with four Technology of Pharmaceuticals and training programs of vocational, higher Biotechnology, among others. The and post-higher professional education, faculty has a modern, fully-equipped conferring junior specialist, bachelor, laboratory for biological synthesis of NATIONAL master and researcher degrees. The active substances. regular academic staff of the University POLYTECHNIC exceeds 1,000, most of whom have Competitive advantages of the earned Candidate or Doctor of Science University are: UNIVERSITY OF degrees. • All academic programs of NPUA are periodically reviewed to keep ARMENIA (NPUA) The University's specializations include up with changes in labor demand CONTACTS all main areas of engineering and and economic priorities; Contact Person: technologies, with 44 bachelor and 39 • The University has developed Artashes Tadevosyan, master specializations in Engineering, quality assurance principles based Dean of the Chemical Industrial Economics, Engineering on the standards of the European Technologies and Environ- Management, Applied Mathematics Association for Quality Assurance in mental Engineering Faculty and Sociology. Higher Education; and, Address: • The University has a leading role in 105 Teryan Street, Yerevan, The Faculty of Chemical Technologies the reformation of Armenia’s higher 0009, Armenia and Environmental Engineering is the education system. NPUA was the first Phone: main department providing education higher education institution in Armenia (+374 10) 524629 in pharmaceutical-related fields. The to introduce two-level and three-level (+374 10) 567968 faculty has three departments: higher education systems.► E-mail: [email protected] Website: NUMBER OF ADMITTED AND GRADUATED STUDENTS www.seua.am Number of employees: Admitted Graduated 1,000+ 2013 2014 2015 2013 2014 2015 Total 1,618 1,053 1,035 2,326 1,934 1,921 Faculty of Chemical Technologies and Envi- 30 27 21 79 57 32 ronmental Engineering

NUMBER OF ADMITTED AND GRADUATED STUDENTS OF PHARMACEUTICAL-RELATED FACULTIES Admitted Graduated Year Bachelor Master PhD Bachelor Master PhD 2011 10 8 1 36 9 - 2012 16 10 - 28 10 1 2013 16 11 2 33 7 - 2014 27 18 - 30 16 - 2015 21 14 - 17 16 - HUMAN RESOURCES 58

It implemented the European Credit many of the world’s leading universities Transfer System in harmony with the and research centers. The University Bologna Process. is a member of European University Association, Mediterranean Universities SEAU has also developed an extended Network, and Black Sea Universities network of cooperation that includes Network. ■

NUMBER OF ADMITTED AND GRADUATED ARMENIAN AND FOREIGN STUDENTS Admitted Graduated Year Armenian citizens Foreigners Armenian citizens Foreigners 2011 435 38 2,337 52 2012 1,871 46 2,493 44 2013 1,559 59 2,305 21 2014 1,002 51 1,896 38 2015 988 47 1,880 41

THE FACULTY OF CHEMICAL TECHNOLOGIES AND ENVIRONMENTAL ENGINEERING HAS A MODERN, FULLY-EQUIPPED LABORATORY FOR BIOLOGICAL SYNTHESIS OF ACTIVE SUBSTANCES The Russian-Armenian University is a Mathematics and High Technology: unique institution in the region and a • Medical Biochemistry and brilliant example of integration in the Biotechnology field of education. RAU was established • General and Pharmaceutical through an agreement between the Chemistry Governments of the Republic of Armenia • Bioengineering, Bioinformatics and RUSSIAN- and Russian Federation (RF) on August Molecular Biology 29, 1997. Despite its short existence, ARMENIAN RAU has already become the leading Students are trained in the following educational and scientific center in specialties: UNIVERSITY (RAU) Armenia. • Medical Biochemistry (6 years) • Bioengineering and Bioinformatics CONTACTS The University has five institutes: (5 years) Contact Person: Mathematics and High Technology; • Pharmaceutical (5 years) Gevorg Danagulyan, Economics and Business; Law and Prof. of department of Politics; Human Sciences; and Media, The following majors in the field of General and pharmaceutical Advertising and Film. Students are medical biology are offered for PhDs: chemistry trained in 31 chairs by highly qualified • Organic Chemistry (RF) Roza Kasababova, specialists. Training is offered in almost • Biochemistry (RF) RAU Academic secretary all branches of modern science and • Organic Chemistry Address: humanities, at both bachelor and master • Bioorganic Chemistry 123 Hovsep Emin Street, levels. • Zoology Yerevan, 0051, Armenia • Biophysics Phone: Pharmaceutical education is provided • Molecular and Cellular Biochemistry (+374 10) 277052 in the following chairs of the Institute of • Biochemistry ► (+374 10) 260745 Fax: NUMBER OF ADMITTED AND GRADUATED STUDENTS (+374 10) 221463 E-mail: Admitted Graduated [email protected] Website: 2013 2014 2015 2013 2014 2015 www.rau.am Total 757 805 808 638 563 508 Number of employees: 1. Pharmaceutical 6 11 8 – – 3 643 2. Medical Biochemistry 9 10 12 16 15 12 3. Bioengineering and 4 5 2 6 5 3 Bioinformatics Number of post-graduates (pharmaceutical-related specializations) 1. Organic Chemistry 1 1 1 1 – 1 2. Biochemistry 2 1 2 1 1 1

NUMBER OF ADMITTED AND GRADUATED ARMENIAN AND FOREIGN STUDENTS IN THREE PHARMACEUTICAL- RELATED SPECIALIZATIONS Admitted Graduated Year Armenian citizens Foreigners Armenian citizens Foreigners 2011 6 7 20 2 2012 18 11 17 5 2013 15 4 16 6 2014 17 9 15 5 2015 13 9 14 4 HUMAN RESOURCES 60

The above-mentioned majors have • Institute of Biology, Leiden University appropriate technical base and • Technische Universität laboratories: Braunschweig, • Laboratory of General Chemistry • Universität Erlangen, Lehrstuhl für • Laboratory of General Biology, Pharmazeutische Biologie Zoology and Botany • USA, CA, Institute for Molecular • Laboratory of Cellular Engineering Medicine • Laboratory of Nature Protection • USA Ann Arbor, University of • Laboratory of Analytical Michigan Biochemistry • Czech Republic, Masaryk University • Laboratory of Biotechnology • Poland, Bureau of Chemical Substances Management In the field of medical biology, RAU cooperates with a number of leading RAU also cooperates with leading foreign universities and institutions, research centers in Armenia (NAS including: Institute of Molecular Biology, Institute • Moscow State University after of Fine Organic Chemistry of Scientific- Lomonosov Technological Center of Organic and • Zoology Institute of the Academy of Pharmaceutical Chemistry, Virusology Science of Poland and Epidemiology Institute, Institute • Institut für Informatik Humboldt- of Medical Genetics Center), enabling Universität zu Berlin students to gain practical knowledge • Institute for Pharmaceutical Biology, and skills with the help of qualified Philipps-Universität Marburg professionals. ► THE MAIN BUILDING OF THE RUSSIAN- ARMENIAN UNIVERSITY HUMAN RESOURCES 62

Students specializing in medical • RAU students are awarded with biology regularly travel to Russia, Russian Federation and Armenian Poland, USA, Germany and Czech diplomas; THE CHAIRS OF Republic through exchange programs, • Postgraduate studies at RAU where they receive training at the are accredited and licensed by MEDICAL BIOCHEMISTRY above-listed universities and conduct the Russian Federation and the joint scientific research in scientific Republic of Armenia; AND BIOTECHNOLOGY, research centers. • RAU’s future graduates have an opportunity to continue their AND BIOENGINEERING The university has the following education in higher education advantages: institutions in Russia and other AND BIOINFORMATICS • With its scientific schools, countries; strong reputation, and history • One of the priorities of the OF THE RUSSIAN- of achievements, RAU attracts University is the integration of the youth of the region with the the Armenian Diaspora. The RAU ARMENIAN UNIVERSITY promise of a high-quality higher has become the alma mater for education; students from CIS and other ARE THE ONLY ONES • Joint degree programs with the countries. ■ leading technological universities OF THEIR KIND IN and companies of Russian Federation. ARMENIA LIST OF OTHER HIGHER EDUCATION INSTITUTIONS PROVIDING EDUCATION IN THE PHARMACEUTICAL AND BIOTECHNOLOGY FIELDS

University Pharmaceutical- Key courses/pharmaceutical- related departments related programs

Yerevan Medical Institute after Pharmacy History of Pharmacy Mehrabyan (www.armmed.am) Biochemistry Established in 1996, it provides Organic Chemistry higher and secondary education in Pharmaceutical Chemistry the fields of the dentistry, pharmacy, Pharmacognosy midwifery science, nursing care, Drug technology dental mechanic science, cosmetics.

Medical University after Saint Pharmaceutical Teresa (www.sterezameduni.com) Founded in 1992, it teaches not only the principles of medical education, but practical skills and psychological-pedagogical capacities.

Yerevan Haybusak University Pharmacy Pharmaceutical Chemistry (www.haybusak.org) Pharmacology Established in 1991, it offers both Pharmaceutical technologies full-time and part-time instruction, Biotechnology master courses, trainings, PhD Pharmacognosy courses and post-graduate courses Clinical pharmacology in Medicine.

University of Traditional Medicine Traditional Medicine Medical-Biology (www.unitradmed.com) Complementary Traditional Medicine Founded in 1991, it is unique in and Alternative Prophylactic Medicine the region and aims to restore Medicine traditional medicine in parallel with contemporary medicine, taking into consideration centuries-old practices of Armenian and eastern folk medicine. HUMAN RESOURCES 64

MEDICAL LIBRARY OF THE RAU PHARMACEUTICAL AND BIOTECHNOLOGY R&D INSTITUTES 67-76 PHARMACEUTICAL AND BIOTECHNOLOGY R&D INSTITUTES 66

Armenia historically has strong of ampoules, tablets and capsules. scientific research institutes that still In addition to its scientific research operate today. Two of these are the activities, the Institute produces two Institute of Fine Organic Chemistry and types of own original medicines, the Institute of Molecular Biology, which Gangleron and Ditilin, which are operate under the National Academy marketed locally and in CIS countries. of Sciences of the Republic of Armenia and play a key role in the development Other pharmaceutical products of Armenia’s pharmaceutical sector. developed at the Institute are: Subecholine (respiratory stimulant), The Institute of Fine Organic Chemistry Arpenal (bronchial asthma, gastro- INSTITUTE OF after L. Mnjoyan was founded in 1955. duodenal ulcers and Parkinsonism), It specializes in the development of Quateron (stenocardia, gastro-duodenal FINE ORGANIC efficient drugs for the treatment of ulcers and hypertension), Mesphena cardio-vascular, neuro-psychic and (hyperhidrosis, gastro-duodenal, CHEMISTRY infectious diseases, malignant tumors, bronchial asthma), Fubromegan and for use in surgical practice. (peptic and duodenal ulcers, bronchial AFTER asthma), Nalecin (typhoid fever, It is equipped with technology dysentery), Espenal (stenocardia, L. MNJOYAN and production facilities for bronchial asthma), Puphemid (epilepsy pharmaceuticals, laboratories for of various etiology), and Tiodine biological and chemical studies, and (radiculitis, neuritis, polyneuritis). CONTACTS an herbal laboratory. The Institute has Contact Person: 22 laboratories, eight groups and three With its scientific potential and well- Dr. Vigen Topuzyan establishments. equipped laboratories, the Institute Address: plays a core role in meeting the R&D 26 Azatutian Avenue, Production capacity allows the Institute needs of Armenia’s pharmaceutical Yerevan, 0014, Armenia to manufacture medicine in the form industry. ■ Phone: (+374 10) 288334 E-mail: [email protected] Website: www.stcopc.sci.am Number of employees: 295 The Institute of Molecular Biology is one of and has high sensitivity and specificity. the most active and dynamically growing Athletes, pilots, military officers and scientific research institutes in Armenia. truck drivers are potential customer It was founded in 1966 to encourage groups for this product. the development of molecular biology in 4. New cyclic amino acid derivatives Armenia. The research conducted at IMB possessing immunomodulatory in the twentieth century was significant in and antioxidant activities have been elucidating the structural and functional synthesized and tested. These organization of nucleic acids, proteins, compounds reduce mortality and cells, and organelles. enhance recovery after ionizing radiation and can be considered as Research at IMB focuses on the potential radioprotective agents. INSTITUTE OF investigation of regulatory mechanisms 5. Standardized cell culture screening of cell activity and its alterations in a systems have been established MOLECULAR number of pathologic conditions including for in vitro assessment of cyto- and auto-immune, auto-inflammatory, genotoxic effects of physiologically BIOLOGY (IMB) cerebrovascular, infectious, oncological, active compounds and potential drugs and psychiatric disorders. Special attention in different cell populations. is paid to mediators of the immune and CONTACTS signal transduction systems. The research Currently, IMB is implementing pilot Contact Person: is conducted using experimental animal production technology for immune Arsen Arakelyan, models, cell cultures, computer modeling stimulating antiviral preparation, aimed at Director and clinical samples. the development of production technology Address: and testing of new biologically active 7 Hasratian Street, Yerevan, Today IMB has 14 scientific-research preparation for prevention of infectious 0014, Armenia units (one scientific department, eight disease in cattle and poultry (foot-and- Phone: laboratories, three independent research mouth disease, Newcastel disease). (+374 10) 281626, groups, two interdisciplinary laboratories), (+374 10) 282622 and two educational units. IMB’s laboratories are equipped with E-mail: modern instruments such as PCR [email protected], IMB has 132 employees, including 15 with machines, a real-time PCR machine, DNA [email protected] DrSc degrees and 52 with PhDs. Forty- sequencer, patch clump, microplate reader, Website: four percent of IMB employees are young and fluorescent microscope. www.molbiol.sci.am researchers aged 35 and younger. In 2007- Number of employees: 2013, 71 bachelor’s and master’s students IMB maintains a collection of DNA samples 132 and 26 PhD students studied/trained of healthy subjects and patients with under the supervision of IMB scientists and various diseases, as well as a cell culture received degrees. collection and animal house. IMB is also connected to the ArmGrd and EuroGrid In the last three years, IMB has conducted high-throughput computing systems. the following pharmaceutical-related research activities: IMB has a strategy for 2010-2020 to 1. Computer 3D models for µ-, δ- and develop further in the following directions: κ morphine receptors have been • Genomics and “Armenian genome” created. These models can be used for project; investigating morphine and morphine- • Cell Biology, pathological processes like compounds interactions, as well as modeling; in drug design. • Molecular, cellular immunology, immune 2. A new interferon-stimulating response mechanisms of disorders; polyoxometalate compound with • Investigation of irregularities in signaling, antiviral activity has been developed effector system, biochemical cascades; and tested. and, 3. A test system for early diagnosis of • Information biology, bioinformatics, overtraining syndrome (OTS) has been biological statistics, molecular developed. It is reliable, non-invasive, modeling. ■ PHARMACEUTICAL AND BIOTECHNOLOGY R&D INSTITUTES 68

INSTITUTE OF SCIENTIFIC The Institute of Biochemistry The Scientific and Production Center BIOCHEMISTRY was founded in 1961. The main AND “Armbiotechnology”, which was scientific focus of the institute established in 2010, specializes AFTER is biochemistry of brain – PRODUCTION in biotechnology and bio-organic neurochemistry. The institute chemistry. It has three institutes: H. BUNIATIAN has 9 laboratories serving CENTER Institute of Biotechnology, Institute of the scientific research of the “ARMBIO- Microbiology and Center of Microbial Academy of Sciences system Depository. The center has 14 and universities, with modern TECHNOLOGY” laboratories where research activities CONTACTS equipment and highly qualified are conducted in the following fields: Director: specialists. • Development of methods and Dr. Samvel G. Chailyan technologies for production of Address: The main fields of research CONTACTS biologically active substances, 5/1, Paruir Sevak activity in the institute are: Director: study of basic problems of modern Street, Yerevan • Biochemistry of novel D.Sc. Ashot Saghyan microbiology and deposition of 0014, Armenia cardioactive hormones Address: new prospective microorganisms Phone: and specific proteins of 14 Gyurjyan Street, of research and production (+374 10) 281840 hypothalamus and atrium; Yerevan, 0056, significance; (+374 10) 281951 • Immunomodulators of the Armenia • Solutions for urgent biotechnological E-mail: brain; Phone: problems in the fields of medicine, [email protected] • Neurohormonal regulation (+374 10) 654180 pharmacology, agriculture and [email protected] of cyclic nucleotides E-mail: food industry, geology and nature Website: and neurotransmitters [email protected] protection; www.aab.sci.am biosynthesis; [email protected] • Fulfillment of applied scientific • Biochemistry of new metal- [email protected] researches in the field of containing proteins and Website: biotechnology directed at the enzymes in the brain and www.armbiotech.am development of production other organs; and, technologies for biologically active • Cardioactive hormones' substances; and, influence on diseases of • Development of new highly effective cardioactive system. methods and techniques for: {{ Simultaneous measurement and The institute has established prediction of nanoparameters of close scientific connections with numerous processes occurring the Institute for Neurochemistry in cells (microorganisms, and Drug Addiction in New cells of plants, mammals and York (also known as the Center insects) in suspension cultures for Neurochemistry), UK Royal {{ Control of processes Society; Institute of Physiological occurring in single cells Chemistry of Tubingen University; of suspension culture to Free University in Berlin; Max increase the productivity of Plank Institute of Neurobiology biotechnological processes, as (Germany); and, A. N. Bach well as processes using strain- Institute of Biochemistry, among producers with low productivity. others. INSTITUTE MOLECULAR The Institute of Organic Established in 1994, the Molecular OF ORGANIC Chemistry of Scientific- STRUCTURE Structure Research Center of Scientific Technological Center of Organic - Technological Center of Organic and CHEMISTRY and Pharmaceutical Chemistry RESEARCH Pharmaceutical Chemistry specializes was established in 1935. It in the research of molecular structure is specialized in the organic CENTER by physical chemistry methods (X-Ray synthesis and polymer chemistry. Structural Analysis, NMR-, IR-, UV-, CONTACTS Main research areas of the Mass-Spectroscopy, Chromatography). Director: institute are the: The Center has four laboratories, two Gagik V. Hasratyan • Investigation of methods CONTACTS groups and 34 employees, including Address: of functionalization of Director: one with DrSc degree and 11 with PhD’s. 26, Azatutian unsaturated molecules for Dr. Suren S. Mamyan Avenue, Yerevan, the construction of low- Address: The Center conducts research in the 0014, Armenia molecular bioregulators; 26, Azatutyan following fields: Phone: • Construction of low-molecular Avenue, Yerevan, • Structure determination of (+374 10) 283521 natural bioregulators, 0014, Armenia organic compounds by various (+374 99) 900520 aromatic and organoleptic Phone: physicochemical methods; E-mail: materials, aromatizators and (+374 10) 287423 • Structural investigations of [email protected] other molecules; E-mail: pyrrolidine derivatives possessing Website: • Synthesis and study of [email protected] antiviral properties; www.stcopc.sci.am oxygen, phosphorus Website: • The study of interaction of and nitrogen containing www.msrc.am biologically important gas unsaturated compounds and molecules with sublimed layers of polymers with a complex of metalloporphyrins and the creation properties; of stable layers with selective co- • Elaboration of scientific ordination ability; and, principles for synthesis and • 3D structure determination of application of polymeric biological and organic molecules by materials, composites and NMR spectroscopy in liquid crystals their application; and, and weakly-oriented environments. • Development of modern methods for synthesis of chemicals necessary for scientific research and organization of its production. PHARMACEUTICAL AND BIOTECHNOLOGY R&D INSTITUTES 70

ARMENIAN INSTITUTE OF The Armenian Institute of Applied Institute of Hydroponics Problems After INSTITUTE Chemistry (ARIAC) is a successor HYDROPONICS G. S. Davtyan was founded in 1947 and to the Soviet Institute of Specialty is specialized in the soilless production of OF APPLIED Chemicals and High-Purity PROBLEMS plants using industrial methods. The main Reagents that was established research topics of the institute are the: CHEMISTRY in 1975. ARIAC provides a large AFTER G.S. • Development of biotechnology for (ARIAC) number of services from contract DAVTYAN a number of valuable little-tonnage, manufacturing to syntheses route rare and endangered medicinal, development and manufacturing aromatic, dye-bearing and tree- facility design. It combines shrub plant soilless production CONTACTS chemical synthesis experience • Studies of physiological; Address: with scientific know-how to create CONTACTS biochemical, pharmacochemical Artashat highway one-stop manufacturing on- Director: and radiochemical and other 5/2, Yerevan, 0053, demand solutions. Kh. S. Mairapetyan peculiarities of crops grown under Armenia Address: soilless conditions; Phone: ARIAC is one of leading 108 Noragyugh, • Development of biotechnologies for (+374 95) 340831 manufacturers of various fine Yerevan, 0082, some agricultural and other crop E-mail: chemicals, intermediates and Armenia planting material production by [email protected] reagents. Phone: combination of in vitro method and Website: (+374 10) 565162 hydroponics; and, www.ariac.info Currently, the major classes of (+374 10) 563015 • Introduction of rare and organic compounds available on E-mail: endangered plants with valuable both laboratory and commercial [email protected] adaptogen properties to Armenia scales include: and investigation of their soilless • Heteroatom-containing cultivation feasibility. organic compounds of various functionality, such The Institute is able to provide organic as alcohols, carbonyl mass of herbs grown in their laboratories, compounds, carboxylic which allows the phyto-pharmaceuticals acids, nitro compounds, industry to reduce the costs of herb amines, alkyl halides; cultivation and collection as well as • Sulfur- and phosphorus- receive adequate quality as required to containing chemicals; synthesize medicine from these herbs. • Metal-organic compounds; • Heterocyclic compounds; • Composition materials; and, • Biologically active compounds and means, such as diagnostic kits, solutions for dialysis and antiseptic formulations.

ARIAC also produces raw materials for the pharmaceutical industry.

The Institute has customers in chemical manufacturing, biochemical research, pharmaceutical and scientific research in Europe, the Americas, Japan and other countries. FMD K&L Europe is part of Fountain FMD K&L is experienced in the following Medical Group, which is a multinational therapeutic areas: Contract Research Organization • Outsourcing offering services to the pharmaceutical, • Peripherial vascular biotechnology, and medical device • Immune industries in the field of clinical research • Dermatology and trials worldwide. The company • Nephrology is specialized in Data Management, • Opthalmology Biostatistics, Statistical Programming, • Osteoporosis CDISC compliant eSubmission, Drug • Hematology Safety, Medical and Regulatory Affairs. • Adiposis FMD K&L continuously strive to raise the • Respiratory FMD K&L EUROPE standard of excellence through accuracy • Medical Device and efficiency. This results in high quality • Oncology output to get client’s drug or medical • Gout CONTACTS product approved faster and to improve the • Hepatosis Contact Person: lives of patients. • Cardiovascular Kirit Velani • Inflammatory Head of Operations Company’s experts include a wide range • Infectious Address: of PhD level team members that are in the • Diabetes 11 Kalents street, Yerevan, forefront of any project regardless of the • Gastroenterology 0033, Armenia size or scope. • Neurology ■ Phone: (+374 99) 916454, (+374 60) 541515, Ext 1500 E-mail: [email protected] Website: www.fountain-med.com Number of employees: 64 PHARMACEUTICAL AND BIOTECHNOLOGY R&D INSTITUTES 72

Darmantest Laboratories (DTL) is a Board of the company, which is in full contract research organization (CRO) compliance with US FDA and EMA specializing in Bio-Equivalence, Bio- regulatory guidelines, to approve and Availability and Bio-Similar studies for monitor all aspects of DTL’s studies. the pharmaceutical industry. DARMANTEST DTL's research and provided services DTL was established in 2009 and is list includes: LABORATORIES managed by American and Armenian • Pilot or Pivotal Studies; professionals whose goal is to offer a • Beginning-to-end study LLC high quality of service at a reasonable management; cost. • Study design; • Protocol preparation; With its primary client being an • Method development and CONTACTS American generic pharmaceutical validation; Contact Person: manufacturer, at present DTL • IRB Submissions; Berj Bahtiarian, conducts pilot and pivotal studies for • Subject recruitment and Director single or multi-dose pharmaceutical screening; Address: products in full compliance with ICH • Clinical study; 6/1 Abelyan Street, Yerevan, GCP, GLP and GDP, and especially • Study monitoring; 0038, Armenia U.S. FDA (U.S. Food and Drug • Analytical, statistical & data Phone: Administration) and EMA (European management; (+374 10) 347599 Medicines Agency) regulatory • Pharmacokinetics and bio- E-mail: guidance. To date, DTL is the only statistical services using [email protected] laboratory within the region that WinNonlin and SAS; Website: is entirely GLP, GCP and GDP • Final study report; www.pharmatestlabs.com compliant. • Strict adherence to quality Number of employees: assurance; and, 20, plus additional, DTL has three divisions: Analytical • Nutritionist preparation of special temporary contractors Laboratory, Clinical Research Center, diets. and Quality Assurance and Statistical Departments. Quality assurance oversight includes: • Ongoing and impromptu internal Quality control is conducted by the audits; independent Quality Assurance • Strict adherence to standard Department with both regularly operating procedures (SOP’s); scheduled and impromptu audits, and • Ensuring compliance with document control. regulatory guidelines; • Review & audit of clinical activities DTL’s Clinical Research Center can and data; house up to 65 study subjects, has • Document control; and, a self-contained intensive care unit, • Responsibility for corrective action and a large community and dining and preventive action. room with all the amenities for a comfortable stay for both male and DTL is in the process of adding female study subjects. another ~450 square meters to its facility in anticipation of expected DTL IS THE ONLY The mainstay of the Analytical growth over the next few years. The Laboratory is the AB Sciex API 4100 projected growth for the next five LABORATORY IN LC/MS/MS. Additional state-of-the- years, which is already in process, is art equipment includes the Agilent to double the size of the laboratory THE REGION THAT IS 1290 UHPLC, as well as other Waters and staff and add additional HPLC’s. equipment in order to increase ENTIRELY GLP, GCP productivity and the number of annual Protocols are submitted to a fully studies. The company has prepared a AND GDP COMPLIANT independent Institutional Review business development plan that ► includes developing additional The company has assembled a business with generic pharmaceutical young, energetic and motivated manufacturers from the U.S., Europe, team which is not afraid to develop Middle East and CIS region. new and different approaches. DTL’s staff is fluent in English, Armenian, In order to achieve and maintain its Russian, Farsi, Arabic and French, competitive edge, DTL is: and can prepare reports and/ • Continually upgrading techniques or documentation in any of these and procedures; languages. • Ensuring the scientific validity of work; and, DTL is also as competitive as possible • Creating benchmarks to shape the in the cost of studies and completing future of the company. studies in a timely manner. ■ PHARMACEUTICAL AND BIOTECHNOLOGY R&D INSTITUTES 74

The FDA Lab is equipped with state- near the laboratory, which is in line with all of-the-art facilities operated by highly requirements of Good Clinical Practice. qualified specialists. The laboratory is certified in ISO 17025. “FDA Lab” The Tobacco Quality Laboratory has FDA LAB consists of four laboratories: the ability to determine the nicotine • Food Safety Analysis content, carbon monoxide content (CO) ANALYTICAL Laboratory; in dry smoke, water and tar content, • Drug Quality and Bioequivalence content of residual chloro-organic and LABORATORY Analysis Laboratory; dithiocarbamate compounds in tar. • Microbiological Analysis Laboratory; and, The Microbiological Laboratory • Tobacco Analysis performs the following types of analysis: CONTACTS Laboratory. • Pharmaceutical microbiology; and, Contact Person: • Sanitary microbiology: food Elen Lopoyan The company’s laboratories provide safety analyses in compliance Address: a wide range of services. The Food with microbiological parameters, 1 Building, 6th Street, Safety Laboratory has the ability to sanitary and microbiological Nor Gyugh village, analyze antibiotics, hormones, heavy monitoring of bottled, mineral, Kotayk marz, Armenia metals, dyes, toxins and other materials spring and tap water Phone: in meat and meat products, fish, eggs, (+374 60) 460076 dairy products, diet and baby food, FDA Lab is unique in that it has four E-mail: alcoholic and non-alcoholic beverages, different laboratories under one roof, the [email protected] and natural honey. only such facility in the region. FDA Lab Website: is already accredited within its 32 fields www.fdalab.am The Drug Quality and Bioequivalence (Certificate ISO 17025 No. 001/T-001). Number of employees: Laboratory conducts in vivo/in vitro 11 analysis of bioequivalence, quality control In the future, a research center of medicines and pharmaceutical raw for bioequivalence study will be materials, and processing and validation established. All the analyses carried of analytical methods for quality control. out in FDA Lab are in accordance with In order to perform proper analysis of current reference standards, sanitary bioequivalence there is a 32-bed clinic rules and industry norms. ■

FDA LAB IS THE FIRST LABORATORY COMPLYING WITH ISO/IEC 17025 REQUIREMENTS AND IS ACCREDITED WITHIN ITS 32 FIELDS INVESTMENT ENVIRONMENT 77-82 INVESTMENT ENVIRONMENT 76

INVESTMENT The promotion of investment is one of 8. No tax and custom restrictions in ENVIRONMENT the key focuses of Armenian economic Free Economic Zones; policy. Armenia has declared an “open 9. Free exchange of foreign door” policy, which is defined in the currencies; law “On Foreign Investments” and 10. No restrictions on remittances; has one of the most open investment 11. No restrictions on repatriation of regimes among emerging market profit, capital, dividends, interest, countries. According to this law, foreign royalties, management or technical investors can benefit from the following service fees; incentives: 12. No restrictions on staff recruitment; 1. 100% Ownership; and, 2. No screening and no specific 13. No sector-specific or geographic authorization required to make an restrictions on investments. investment; 3. Land ownership: Companies In addition to the specific investment registered by a foreigner in incentives described above, the Armenia have the right to buy land. following factors make Armenia Foreign citizens may have only attractive for foreign direct investment: long-term lease contracts; a. Stable macroeconomic situation; 4. VAT is deferred for three years on b. Sustainable banking system in line the import of goods destined for with international standards; use in investment projects that c. Highly experienced, creative, exceed the value of AMD 200 cost efficient, and well-educated million; workforce; 5. No export restrictions and duties; d. Strong Armenian diaspora; and, 6. Zero rating for goods and services e. High levels of hospitality and safety. exported under “Free Turnover” and “Re-exportation” customs Armenia is a signatory to the 1958 regimes; Convention on the Recognition and 7. Five-year grandfather clause, Enforcement of Foreign Arbitral national treatment and non- Awards, and is also a signatory to the discrimination for foreign investors International Convention on Investment are guaranteed; Disputes. ■

As mentioned above, the Armenian Several pharmaceutical manufacturing FOREIGN pharmaceutical industry has companies have managed to attract experienced sustained growth in recent foreign direct investment from both INVESTMENTS years, driven by the increase of sales private and institutional investors. to the domestic market and exports, together with a significant increase in Foreign investors are also interested investments. in conducting Bioequivalence and Analytical Studies in Armenia. An A number of multinational corporations example is Darmantest Laboratories (Astellas Pharma Europe B.V., Eli Lilly, founded and managed by American- Gedeon Richter, GlaxoSmithKline, Armenian partners. The first of its kind Hoffmann-La Roche, Les Laboratoires in Armenia and the CIS region, it is a Servier, Novartis, Pfizer, Sanofi and state-of-the-art Bio-Equivalence and Takeda Pharmaceutical Company Analytical laboratory that maintains Limited) have representation in Armenia the highest standards required to handle imports and/or to conduct by U.S. and European regulatory brand marketing and monitoring. agencies. ■ INVESTMENT Armenia, which largely depends on In order to seize expansion foreign trade, is making significant opportunities, many of Armenia's main OPPORTUNITIES efforts to attract foreign direct pharmaceutical producers are open to investment. The Government of Armenia investment. Investment opportunities AND COMPETITIVE has adopted an “open door” policy, range from a few hundred thousand with Most Favored Nation and National USD, to several million USD for the ADVANTAGES Treatment regimes in place, and legal construction of new facilities. Some key protection to promote foreign investment. players that can serve as local partners, both for new ventures and for investing Foreign investors are entitled to into existing businesses, are discussed implement investments through: on pages 20-27 of this guide. • Establishing a fully foreign-owned company (including representatives, Investment opportunities exist in affiliates and branches), or pharmaceutical product packaging, purchasing an existing company; either through establishing a stand- • Establishing a new joint venture alone pharmaceutical packaging facility company with the participation of or partnering with existing companies. Armenian companies or citizens, or Armenia has a developed printing purchasing of shares in an existing industry that provides packaging, company; and the Government of Armenia has • Purchasing different types of established a favorable business securities; environment for development of the • Procuring permits to use the land, industry. The FEZ in the territory of “RAO or creating a concession agreement MARS” CJSC and the Yerevan Scientific for the use of Armenian natural Research Institute of Mathematical resources with the participation of Machines provides a number of Armenian companies or citizens; incentives for companies interested in and/or pharmaceutical packaging: • Procuring other property rights. • No VAT for delivering services and supplying goods to the territory; The areas that are attractive for • Tax-free profit to legal entities and no investment in Armenia’s pharmaceutical income tax for sole proprietors; sector are discussed below. • No property taxes on public and industrial buildings and structures PHARMACEUTICAL PRODUCTION AND CONTRACT owned or leased within the FEZ; MANUFACTURING ORGANIZATIONS • No customs charges and non-tariff Armenia already has a strong base regulation measures applied to the of pharmaceutical producers, some export of goods; and, GMP-certified and some in the • Freely convertible currency allowed process of attaining GMP certification. as a medium of exchange while Pharmaceutical production has been trading within FEZ. growing at a fast pace, averaging at 20% annually for the past five years, HERBAL MEDICINE PRODUCTION with production totaling USD 15.1 The global demand for medicinal herbs million in 2015. Exports have also and plants is currently growing at been increasing, accounting for 52% approximately 11% annually (according of Armenia's pharmaceutical output. to International Trade Centre, ITC), and ARMENIA HAS A With rising incomes, still relatively low Armenia offers a number of competitive expenditures on pharmaceuticals advantages in this sub-sector. Armenia FAVORABLE BUSINESS in Armenia, a favorable business has over 2,500 varieties of medicinal environment and effective support herbs and berries growing wild in its ENVIRONMENT AND institutions, it is believed that the growth mountains, and Armenia's knowledge of in Armenia’s pharmaceutical sector is herbal medicines has been developed EFFECTIVE SUPPORT just beginning. over 3,000 years. Today, some of the larger Armenian pharmaceutical ► INSTITUTIONS INVESTMENT ENVIRONMENT 78

producers are manufacturing herb- objectives of the pharmaceutical/ based pharmaceuticals and dietary biotechnology sector is to promote the supplements, and a number of attraction of foreign direct investment smaller players are involved in the in intensive knowledge through the cultivation and production of teas, development and promotion of research extracts, lotions, gels, topical creams centers established in Armenia. For and oils made from medicinal its part, the Government of Armenia spices and aromatic herbs. These is ready to provide the necessary companies, mainly SME's, use solar assistance for R&D promotion. dryers and sell their production not only in the domestic market, but Investors and pharmaceutical also export them all over the world. companies can establish their own There is opportunity to increase the CRO's in Armenia, or can invest in export volume of herbal medicines or collaborate with existing CRO's, and to penetrate new markets and research institutions or pharmaceutical achieve greater value added within producers with CRO capabilities. There Armenia. There is ample opportunity to are already CRO's established by invest in the manufacturing of herb- Armenian and/or foreign professionals based pharmaceuticals and dietary that are in full compliance with supplements, as well as in cultivation, standards of the U.S. Food and Drug packaging, and expanding export Administration, European Medicines through start-up ventures, establishing Agency, International Conference on partnerships with existing Armenian Harmonization Good Clinical Practice, players, or consolidating some of the Good Laboratory Practice and Good many players of the herbal medicine Distribution Practice. There are also a segment of the pharmaceutical number of hospitals that conduct clinical industry. trials. Armenia is a unique region for clinical trials due to a number of factors: • Armenia has highly professional R&D AND CONTRACT RESEARCH ORGANIZATIONS (CRO’S) doctors with extensive medical R&D is one of the core sectors of practices in various areas; Armenia's economy. Due to its rich • Doctors are highly motivated, both history in research, educational professionally and financially, to be traditions and skilled human resources, actively involved in clinical studies; Armenia has attracted numerous global and, technology firms over the past few • Patients are motivated to volunteer years who have established branches for clinical trials in order to receive and R&D centers in Armenia. high quality treatment, which they THE GOVERNMENT cannot otherwise afford. The Armenian pharmaceutical industry OF ARMENIA HAS has strong scientific and R&D potential, In addition to clinical trial capabilities, which can be developed through there are a number of research ESTABLISHED A the improvement of inter-cluster institutes and local production relations among R&D, production, and companies with the skills to handle FAVORABLE BUSINESS education. There are eight scientific contract work. research institutes undertaking research ENVIRONMENT in pharmaceutical and biotechnology related areas. COMPETITIVE ADVANTAGES FOR DEVELOPMENT Pharmaceuticals is one of the fastest However, R&D levels in Armenia are still growing sectors of Armenia’s economy. OF THE lower than in most developing countries In addition to a favorable business such as India, China, Brazil and environment, Armenia offers certain PHARMACEUTICAL others. Furthermore, more than 80% of competitive advantages that make investment in R&D is by public entities investment in the pharmaceutical sector INDUSTRY or public financing. One of the primary attractive: PRODUCTION OF OINTMENTS ACCORDING TO EU GMP STANDARDS; ARPIMED PHARMACEUTICAL COMPANY INVESTMENT ENVIRONMENT 80

Favorable business environment with State-of-the-art testing and laboratory no pharmaceutical price control facilities Armenia is a relatively easy country These facilities have cutting-edge for doing business. According to the equipment and highly skilled staffs World Bank study, Doing Business conducting all types of laboratory 2016, Armenia is the 35th easiest testing and research. Moreover there country in which to do business out of are several private-owned laboratories 189 countries, the best ranking among which provide Bioequivalence, CIS countries. There are absolutely Bioavailability and Biosimilar studies for no price controls on pharmaceuticals the pharmaceutical industry. in Armenia, and Armenia is updating its pharmaceutical-related legislation Open and collaborative cluster with to enhance free competition and enthusiastic entrepreneurs competitiveness. Open and willing to adopt international standards, these industry leaders are R&D institutions involved in ready to invest and be certified by the development of medicines, local and international accreditation chemistry, genetics, and availability bodies. Armenia announced the of professional, highly educated adoption of EU GMP standards in research staff 2010, and all Armenian pharmaceutical Armenia historically had strong scientific companies are currently working on the research institutions that still operate implementation of the GMP standards, a today. There are 72 research institutions process contemplated to be completed in Armenia, ten of which are involved in 2019. Three producers (Liqvor, in pharmaceutical and biotechnology Arpimed and Pharmatech) are already related research activities. GMP certified and the others plan to be by the end of 2019. Highly educated workforce, complemented every year by The Government of Armenia has already new graduates from Armenia’s established the GMP certification body internationally recognized universities within the SCDMTE, which applied for There are 12 state and private the pre-accession for the membership universities and institutions in Armenia to the Pharmaceutical Inspection that offer education in pharmaceuticals. Convention and Pharmaceutical Some of them offer master and doctoral Inspection Co-operation in 2012. It is level degrees in pharmacy. expected that Armenia will apply for the membership in 2016. Low labor and energy costs The average wage in Armenia is less Competitive advantage in herbal than that in Western and Eastern Europe medicines and medicinal herbs and the South Caucasus region, and The mountainous nature and in China and nearby Turkey. Human tremendously diverse climate of Armenia capital is regarded as the most valuable creates favorable conditions for herbal resource of the country; the literacy rate plants. There are over 2,500 varieties ARMENIA'S is 99.6%. of medicinal herbs and berries growing in the high mountains of Armenia. A KNOWLEDGE OF Energy tariffs are competitive throughout number of manufacturers specialize the region. Armenia has significant in the production of natural and herbal HERBAL MEDICINES domestic electricity generating medicines and dietary substances from resources: a nuclear power plant, medicinal spices and aromatic herbs, HAS BEEN gas-fired thermal power stations, with growing exports to CIS and other hydroelectric, cogeneration and wind countries. ■ DEVELOPED OVER power stations. 3,000 YEARS REGULATORY ENVIRONMENT AND QUALITY CONTROL 83-94 REGULATORY ENVIRONMENT AND QUALITY CONTROL 82

PHARMACEUTICAL The pharmaceutical sector of the registration, quality control, export, POLICY AND Republic of Armenia has undergone import and sale of pharmaceutical fundamental changes in recent products. LEGISLATION years, aimed at providing high quality pharmaceuticals and related services. Other major legal acts regulating Armenia’s pharmaceutical sector are: Development of the pharmaceutical sector is a priority of the Government of • Decree No. 581 of the Government the Republic of Armenia, as reflected of RA on “The Approval of Rules in the “Export-Led Industrial Policy of on Import and Export of Medicines the RA” strategy adopted in 2011. The and Pharmaceutical Substances strategy is principally focused on 11 in the RA,” adopted on September sectors and the corresponding action 20, 2000. plan for the pharmaceutical sector, Ensures that medicines can only be which has already been developed and imported to Armenia with a certificate is being implemented now. issued by the Ministry of Health. Only medicines registered The main strategic directions of the in Armenia can be imported. action plan are: Imported medicines should have a 1. Set-up of the quality control manufacturer’s quality certificate. system; The Decree has separate sections 2. Establishment of the base for local on rules for the import and export raw materials; of medicines (e.g. application for 3. Capacity building; getting the certificate, terms of the 4. Financial support; expertise, types of laboratory and 5. Involvement of Trans National documental expertise, legal and Corporations; and, technical bases for rejection of 6. Sales promotion. imports or exports, etc.).

Results of the policy are already being • Decree No. 347 of the Government seen. GMP standards have been legally of RA on “The Approval of Rules introduced in Armenia. Companies on State Registration of Medicines have developed schedules for meeting and Fees for Expertise of State GMP standards. Legislation for other Registration of Medicines,” GxP standards is being devised. adopted on April 25, 2001. Local pharmaceutical producers are This decree is based on the receiving support by several donor requirements of the Law “On organizations (particularly by the USAID Medicines” and has two sections. EDMC project) for entering international Section 1 establishes the registration markets and expanding exports. procedure, the basis for rejecting a registration, and the rules for As a result, exports of pharmaceutical withdrawing a registration. production reached 52% in 2015. Section 2 is devoted to the types of registration and relevant fees (see Table 5). (A detailed description of LEGISLATION the registration procedure is provided The Pharmaceutical sector in Armenia in section 10.3 of this guide.) is regulated by a number of legal acts intended to ensure safe, quality and • Decree No. 867 of the Government of effective medicines. RA of June 29, 2002 on “The Approval of Rules on Licensing Medicine The fundamental legal act regulating Production, Pharmacy Practice, Armenia’s pharmaceutical sector is Health Service, Implementation the Law “On Medicines”, adopted in of Medical Professional 1998. It regulates the manufacture, Education Curricula, and on ► Approval of Licensing Forms for these Advertisements”, adopted on Implementation of Mentioned November 2, 2006; Activities” • 8. Decree No. 63 of the Government Establishes general requirements of RA “On the Approval of Rules for licensing, specifying detailed for Implementation of Clinical Trials procedures for licensing several types of New Medicines”, adopted on of activities, including pharmaceutical January 24, 2002; production. (A detailed description of • Decree No. 281-N of the the licensing procedure for medicine Government of RA “On the Approval production is provided in section 10.4 of the Licensing Procedures during of this guide). Production, Export or Import and Wholesale Trade of Narcotic Drugs, Other important regulations affecting Psychotropic Substances and their the pharmaceutical sector include: Precursors, Defined by the RA Government”, adopted on March • Law “On Narcotics and 18, 2011; Psychotropic Substances”, adopted • Decree No. 1129-N of the on December 26, 2002; Government of RA “On the Approval • Law “On Licensing”, adopted on of the List of Narcotic Drugs, May 30, 2001; Psychotropic Substances and their • Law “On Advertising”, adopted on Precursors, Subject to Control in the April 30, 1996; RA”, adopted on August 23, 2003; • Law “On State Duty”, adopted on • Decree No. 1603-N of the December 27, 1997; Government of RA “On the Approval • Law “On Value-added Tax”, of the Rules of Good Manufacturing adopted on May 14 1997; Practice”, adopted on November • Law “On Medical Aid and 25, 2010; and, Population Services”, adopted on • Decree No. 1089-N of the March 4, 1996; Government of RA “On the Approval • Decree No. 1608-N of the of Rules for Implementation of GMP Government of RA “On the Compliance Inspection and Issuing Approval of Rules of Granting GMP Certification for Medicines Permission to Advertise Medicines, and Pharmaceutical Substances Medical Equipment and Methods Produced in the RA”, adopted on of Treatment and Requirements for September 26, 2013. ■

ARMENIA ADOPTED EU GMP STANDARDS IN 2010 REGULATORY ENVIRONMENT AND QUALITY CONTROL 84

STATE The Ministry of Health of the Republic • Implementation of the concept ADMINISTRATION of Armenia (MoH, www.moh.am) is the main of rational use of medicines − regulatory body of the pharmaceutical Reviews and updates the National sector. The MoH is responsible Essential Medicines List, develops for initiating laws, supervising and optimal pharmacotherapy schemes, regulating, developing public policy studies medicine prescription for the healthcare sector, develop practice, carries out pharmaco- and monitor the implementation of epidemiological research; health education programs, among • Control of clinical trials − Expert other responsibilities. The MoH is assessment of protocols and other solely authorized to license certain required documents for granting activities, including the production of permission of clinical trials in RA, medicines, pharmacy practice, and and monitoring of current clinical health services. The MoH also issues trials; and, and rejects medicine registrations and • Research activity − Conducts medicine import certificates. studies in the medical and pharmacy fields, conducts surveys The medicine regulatory authority in of the pharmaceutical market, and Armenia is the Scientific Center of Drug conducts pharmaco-economic and Medical Technology Expertise analysis. (SCDMTE, www.pharm.am), which was established in 1992. The Center is Based on recommendations by involved with numerous aspects of the World Health Organization and pharmaceutical regulation: with substantial support by donor • Registration − Expert assessment organizations, the Center has of medicines (including veterinary created modern laboratory facilities medicines), herbal medicines, (Laboratory of Quality Control of medical cosmetics, for the purpose of Medicines). The Laboratory received state registration; quality management ISO 9001-2008 in • Import and export expertise − December 2010. Expert assessment of medicines for the purpose of certification for import The main functions of the Laboratory and export; are: • Specialized expertise of • Providing expertise in medicine pharmaceutical organizations − quality and meeting specifications, Assuring the quality of medicines for the purposes of state registration; and other pharmaceutical products • Quality analysis of imported and available in Armenia, as well as exported medicines; detecting counterfeit medicines; • Quality control of medicines and “DOING BUSINESS • Control over Narcotics and other pharmaceutical products Psychotropics − Calculating sampled during inspections of 2016” RANKED an annual demand for narcotics pharmacies and wholesalers; and psychotropics in Armenia, • Laboratory analysis of medicines ARMENIA AS THE certification for import and export of and substances by the request of narcotics and psychotropics, and the state bodies; 35TH EASIEST submission of reports to the U.N. • Examination of quality and safety of International Narcotics Control Board; food; and, COUNTRY TO DO • Monitoring adverse effects of • Bioequivalence studies. medicines − Registration of adverse BUSINESS OUT OF drug reactions in Armenia and State control and supervision over the provision of relevant information implementation of pharmaceutical related 189 COUNTRIES to the World Health Organization legislation and other normative legal acts International Program on Monitoring and imposition of disciplinary sanctions SURVEYED Adverse Drug Reactions; are carried out by the State Health ► Inspectorate of the Ministry of Health. To achieve its aims, the MPI Union’s One of main tasks of the inspectorate is activities include: conducting inspections of pharmacies, • Continuous monitoring of legislation pharmaceutical export and import related to pharmaceutical, companies. economic and other areas; • Presenting legislative proposals to RA Government; SUPPORTING INSTITUTIONS • Protecting interests of the The Medicine Producers and Importers pharmaceutical industry in the Union of Armenia (MPI Union, Parliament of RA; A PPP BETWEEN THE www.pharmunion.am) was founded in 2003 • Implementing programs to and unites 23 leading pharmaceutical introduce international GOVERNMENT OF RA companies. Along with Armenia's standards and advanced leading pharmaceutical manufacturing, technologies in pharmaceutical AND MPI UNION WAS wholesale, and retail companies, the companies; MPI Union also has representatives • Assisting in the technological CREATED TO FURTHER from well-known foreign companies. modernization of domestic The aims of the MPI Union are to medicine-producing companies, DEVELOP THE SECTOR, integrate Armenian companies into the including involvement in RA international pharmaceutical market, Government supportive measures; ENHANCE PRODUCT implement constant improvements, and • Presenting projects and realizing provide fair and equal competition in their goals; QUALITY AND BOOST the industry. • Implementing and conducting educational and international ► EXPORTS REGULATORY ENVIRONMENT AND QUALITY CONTROL 86

exchange training programs magazine covers the development for pharmacy sector of the pharmaceutical industry and specialists; and, publicizes the industry and the • Raising awareness of Armenian medicine market. While its goals are pharmaceutical products within to reflect the priorities of the Armenian domestic and international pharmaceutical industry and to markets via campaigns, represent Armenian pharmacists and exhibitions, establishment of pharmacologists to medical society, business relations, business forums “Pharma” also focuses on global and conferences. pharmaceutical and pharmacological trends. In 2009, the MPI Union founded the “GXP Centre of Excellence” (www.gxp.am) Every year the MPI Union organizes the with the mission to develop professional annual “International Pharmaceutical “PHARMA” IS knowledge and ensure reliable Competitiveness Conference” information in the RA pharmaceutical (www.pharma-armenia.am) with the support A SCIENTIFIC and biotechnological sectors. Unique of the RA Ministries of Health and in the region, the GXP Centre of Economy. It unites all representatives PHARMACEUTICAL Excellence organizes professional and of pharmaceutics: legislative and internationally standardized training executive authorities, heads of MAGAZINE THAT courses on GxP standards, inviting domestic and international medicine- professionals from EU member states producing and importing companies, COVERS THE and other developed countries. doctors, pharmacists and other specialists. In conjunction with the DEVELOPMENT OF The MPI Union and GXP Centre attach conference, the Union holds an importance to the development of annual “Pharma-EXPO”, a specialized THE ARMENIAN pharma-biotechnology science in exhibition of pharmaceutics Armenia. In furtherance of this goal, (www.pharma-expo.am). Local and foreign PHARMACEUTICAL they created “Pharma”, a scientific pharmaceutical companies and/or their and business pharmaceutical representatives in Armenia take part in INDUSTRY magazine (www.pharma-mag.am). The this exhibition. ■ STATE Medicinal products can be produced, documentation and samples within imported, stored, distributed, sold and 10 days, after which the applicant REGISTRATION used in Armenia only after being state is notified in writing and charged an registered. Registration, registration advance fee for expert analysis of OF MEDICINAL renewal and withdrawal of registration the product. The expert analysis is are controlled by the Ministry of begun after payment of the fee. The PRODUCTS Health. The registration of medicinal maximum duration of the assessment products is based on scientific criteria is 180 days. and analysis of safety, efficacy and quality conducted by the SCDMTE. 3. For renewal of previously registered medicinal products, there is a The following are subject to simplified procedure that is completed registration: in a maximum of 23 working days • New original and generic after submission of all required medicinal products (including documents: (a) the application; (b) immunological, veterinary and a letter confirming the desire for homeopathic); renewal of the previously registered • Additional dosage strengths, product and the absence of pharmaceutical forms and new changes or additions in the previous indication of registered medicinal registration documents; (c) Periodic products; and, Safety Update Report (PSUR); and (d) • New combinations of medicinal documentation of payment of the state products. duty.

Registration of medicinal products in 4. Registration applications for Armenia expires after five years, after medicinal products should be which they can be renewed (please submitted to the SCDMTE in CTD visit http://pharm.cals.am/pharm/drug_images (Common Technical Document) for the list of registered medicines in format. Armenia). The procedures for registration and analysis of medicinal products are detailed by the Decree of the MEDICINE REGISTRATION PROCEDURE Government of the RA No. 347 1. Medicines registered in EU adopted on April 25, 2001, “On countries, the US or Japan are Adopting the Rule of Registration of subjected to a simple recognition Medicinal Products and Expertise procedure. Assessments of products Fees for Registration of Medicinal registered in these countries are Products in the Republic of Armenia”; completed within 30 days, without any and Order No. 123-N of the Ministry laboratory examination. The decision of Health of the RA, dated February to grant a registration certificate is 7, 2006, entitled “On Approval of the made by the Ministry of Health within Procedure of Expertise for Registration 10 days on the basis of the analysis, of Medicinal Products in the Republic after payment of the state duty. of Armenia, Form and Description of MEDICINES the Registration Certificate and the 2. For medicines not eligible for the List of Variations of Medicinal Products REGISTERED IN THE simple recognition procedure noted Registered in the Republic of Armenia above, the importer or manufacturer that Do Not Require New Registration.” EU, USA OR JAPAN (the applicant) must submit a set of registration documents, During the process of registration of ARE SUBJECTED TO A samples of medicinal products, medicines packages and labels, the and the standards followed to the SCDMTE is guided not only by the RA SIMPLE RECOGNITION SCDMTE. The SCDMTE conducts a law “On Medicines,” but also by the preliminary examination of submitted EU Directive 2001/83/EC. ► PROCEDURE REGULATORY ENVIRONMENT AND QUALITY CONTROL 88

TABLE 5. FEES FOR MEDICINAL PRODUCT REGISTRATION ANALYSIS Expertise Fee No. Type of application for registration (including VAT) (AMD) 1. The first dosage form and dosage strength of generic 900,000 (USD 2,197) medicinal products • for each additional pharmaceutical form 450,000 (USD 1,099)

• for each additional dosage strength 240,000 (USD 586)

• for each new indication 450,000 (USD 1,099) 2. New combination of known medicinal products 1,200,000 (USD 2,930) 3. The first pharmaceutical form and dosage strength 2,250,000 (USD 5,493) of medicinal products containing new active substances • for each additional pharmaceutical form and dosage 1,200,000 (USD 2,930) strength 4 The first pharmaceutical form and dosage strength of 240,000 (USD 586) homeopathic medicinal products • for each additional pharmaceutical form, dosage 60,000 (USD 147) strength and new indication 5. Herbal preparations and other preparations of natural 240,000 (USD 586) substances and dietary supplements 6. Re-formulating of the registration certificates, in cases of changes of product name and/or manufacturing company, changes of packaging, and other minor 24,000 (USD 59) changes which do not affect the approved quality, safety and efficacy of the product

STATE DUTIES FOR THE REGISTRATION OF MEDICINAL PRODUCTS IN ARMENIA Rate of the State Duty No. Type of application for registration (AMD) For the first dosage form or dosage strength of medicines A SIMPLIFIED 1 with new active substances, new dosage form or dosage 70,000 (USD 171) strength of a new medicines PROCEDURE IS 2 New combination of known medicinal products 40,000 (USD 98) For the first dosage form or dosage strength of generic APPLIED FOR 3 medicines and for each following dosage form or dosage 40,000 (USD 98) RENEWING strength 4 New indications 10,000 (USD 24)

PREVIOUSLY 5 For state registration of pharmaceutical substances 30,000 (USD 73) Herbal preparations and other preparations of natural REGISTERED 6 10,000 (USD 24) substances MEDICINAL 7 Homeopathic medicinal products 2,000 (USD 5) PRODUCTS 8 Dietary supplements 20,000 (USD 49) For updates in the registration certificate related to pharmaceutical production, the name of the producing (MAXIMUM 23 9 5,000 (USD 12) company, packaging and product safety, efficacy and WORKING DAYS) other alterations and changes that do not affect quality PHARMACEUTICAL LICENSING the Government of RA No. 1089-N, “On The law “On Medicines” requires the Approval of Rules for Implementation of MANUFACTURING businesses that manufacture GMP Compliance Inspection and Issuing pharmaceutical products in Armenia to GMP Certification for Medicines and be licensed. The licensing procedure Pharmaceutical Substances Produced in is detailed in Decree No. 867 of the the RA,” adopted on September 26, 2013. Government of the RA, “The Approval of Rules on Licensing Medicine A GMP certificate is initially issued for Production, Pharmacy Practice, Health three one-year periods. After three years of Service, Implementation of Medical continuous GMP conformity, the certificate Professional Education Curricula, as well is issued on a two-year period basis. as on Approval of Licensing Forms for Implementation of Mentioned Activities”, QUALITY CONTROL & ASSURANCE adopted on June 29, 2002. Quality control is crucial in the pharmaceutical sector, to ensure that Licenses for medicine production are pharmaceutical substances and other raw issued by the Ministry of Health. In order to materials are suitable for use in medicine obtain a license the applicant must include and that manufactured medicinal products in the application the expert opinion meet the highest quality standards. given by the SCDMTE on the availability of material and technical resources Product quality is a high priority for necessary for medicinal production. Armenian medicine producers. Therefore, most raw materials and chemical Applicants for the pharmaceutical compounds used in production are manufacturing license submit required purchased from EU and US suppliers. As documents by either visiting the Ministry stated above, Armenia officially introduced of Health, or through the online licensing GMP requirements for medicine system (www.e-gov.am/licenses). manufacturing in 2010. Three Armenian medicine producers have already Assuming there is no reason to reject an achieved GMP certification; others are application for a license, the Ministry of working towards certification. Health issues the medicine production license within 23 working days of receipt According to the legislation, the quality of the application. The license is for an of medicinal products registered in the unlimited term. State duty for obtaining RA shall comply with the requirements the license is 200,000 AMD (488 USD) of currently used Pharmacopoeias per year. Payments can be made in Armenia: former Soviet Union electronically through the e-payment State Pharmacopea XI, European system of the Government of RA Pharmacopea (Ph. Eur.), International APPLICATIONS FOR (www.e-payments.am/en). Pharmacopea (Ph. Int.), United State Pharmacopea, British Pharmacopea, A PHARMACEUTICAL GMP CERTIFICATION German Pharmacopea (DAB), German In 2013 Armenia introduced a process Homeopathic Pharmacopea (HAB), MANUFACTURING of certification of medicine production French Pharmacopea (PhF). compliance with GMP. Certification is LICENSE CAN currently voluntary, however all Armenian The Quality Control Laboratory of SCDMTE pharmaceutical companies are realigning is responsible for: BE SUBMITTED their production processes, readjusting • Testing medicines at the process of infrastructure, and training their workers registration; THROUGH THE in preparation for applying for GMP • Testing the quality of imported medicines; certification. • Testing the quality of pharmaceuticals ONLINE LICENSING produced in Armenia; and, GMP certification is issued by the Ministry • Testing the quality of products sampled SYSTEM (WWW.E-GOV. of Health. The procedure for GMP during inspection of pharmacies and certification is detailed by the Decree of wholesalers. ■ AM/LICENSES) REGULATORY ENVIRONMENT AND QUALITY CONTROL 90

PHARMACEUTICAL IMPORT OF MEDICINE RETAIL (PHARMACIES AND PHARMACY KIOSKS) SALES The procedures for importing medicinal Retail sale of medicinal products in products into Armenia are set forth in Armenia is permitted only through the Decree of the Government of the pharmacies and pharmacy kiosks, RA No. 581 “On the Approval of Rules which are subject to requirements as on Import and Export of Medicines and to type, area, sanitary conditions and pharmaceutical substances in the RA,” other standards. Pursuant to the law adopted on September 20, 2000. of RA “On Medicinal product” and “On Licensing,” medicinal products Only entities registered in Armenia can can be sold at retail by legal entities import medicine. Importing medicinal and sole proprietors having a relevant products and/or pharmaceutical license. The procedure and conditions substances into Armenia requires an for obtaining a retail medicine license import certificate, which is provided by are detailed in Decree No. 867 of the the Ministry of Health of the RA based on Government of RA “On the Approval documentation and laboratory expertise. of Rules on Licensing Medicine Production, Pharmacy Practice, Health Only medicines registered in Armenia Service, Implementation of Medical can be imported. Importers must submit Professional Education Curricula, a manufacturer quality certificate and/ and on Approval of Licensing Forms or batch certificate or their verified for Implementation of Mentioned copies. According to legislation, parallel Activities,” adopted on June 29, 2002. imports are also allowed. Unregistered Retailers must have the necessary medicines can be imported for: personnel that meet specific qualifications and must adhere to • Pre-clinical and clinical trials; medicine storage requirements. • Registration of medicinal products in Armenia; According to the Law “On • Exhibits at exhibitions, conferences Licensing,” the license for selling etc. without the right to sell; pharmaceuticals is issued by the • Humanitarian aid or during Ministry of Health. Applicants should disasters, epidemics and other submit required documents either by emergencies; and, visiting the Ministry of Health, or via • Packaging purposes (if the the online licensing system medicines underwent all stages of (www.e-gov.am/licenses). production, except packaging and marking). If there are no grounds for denial of a license application, the Ministry The import certificate for medicinal of Health issues a license within products and/or pharmaceutical 23 working days of receipt of the substances is issued by the Ministry application. The license is given for an of Health based on the expertise of unlimited term. State duty for obtaining THERE ARE 25 the SCDMTE. The Ministry issues the the license is 50 thousand AMD (USD import certificate within ten working 122) per year. Payment of the duty can PHARMACEUTICAL days of receiving the application and be made electronically through the all necessary documents. The import e-payment system of the Government IMPORTERS AND of medicines and pharmaceutical of Armenia (www.e-payments.am/en). substances with a remaining expiry date MORE THAN 1,700 less than one year (or 2/3 if the shelf life Medicines prepared in pharmacies are is less than one year) is not allowed. not subject to state registration and RETAIL OUTLETS AND their sale to other medicinal product All medicinal products imported to the sellers is prohibited. Pharmacies PHARMACIES IN territory of Armenia are subject to state making medicinal products are quality control, which is performed by required to have the necessary ARMENIA the SCDMTE. equipment. ► “Good Pharmacy Practice” is a set of maintenance conditions, and drug standards promoted by the Minister of Health containers. Pharmaceutical products and are to be introduced in pharmacies. and materials should be stored in accordance with GSP standards. STORAGE AND TRANSPORTATION The storage and transportation of Medicinal products should be medicinal products is governed by transported according to storage the Order of the Minister of Health conditions indicated on the No. 17-N “On the Approval of Rules packaging. on Transportation, Storage and Maintenance of Medicinal Products”, It is the responsibility of the distributor adopted on September 9, 2010. to ensure that vehicles and equipment used to distribute, store or handle At each storage site (manufacturer, medicinal products are suitable. distributor, wholesaler, pharmacy) This includes ensuring appropriate there should be an adequate number equipment to prevent exposure of of qualified personnel who receive the products to conditions that could proper training on GSP, regulations, affect their quality and packaging procedures and safety. integrity, and to prevent contamination of any kind. Delivery drivers (including There are also detailed requirements contract drivers) should be trained in for storage areas, cleaning procedures, the relevant areas of GDP. ■ REGULATORY ENVIRONMENT AND QUALITY CONTROL 92

INTELLECTUAL Armenian legislation protects international treaties or after their state PROPERTY intellectual property rights, patents, registration. Armenia is a signatory know-how, trade secrets, trademarks, to such international treaties as the and service marks, which is in Madrid Agreement for the Repression compliance with the WTO Agreement of False or Deceptive Indications on Trade-Related Aspects of Intellectual of Source on Goods; the Madrid Property Rights. Agreement Concerning the International Registration of Marks; the Vienna The “Law on Copyright and Related Agreement Establishing an International Rights” provides for the legal Classification of the Figurative protection of literary works, musical Elements of Marks; and, the Nice works, paintings, films, software, and Agreement Concerning the International other intellectual property rights, as Classification of Goods and Services well as the legal protection of the for the Purposes of the Registration of rights of performers, producers of Marks. sound recordings and broadcasting organizations. Armenia has ratified a The rules for registration and legal number of international conventions protection of inventions, industrial for the protection of copyright and designs and utility models are set by related rights: the Berne Convention for the law “On Inventions, Utility Models the Protection of Literary and Artistic and Industrial Designs,” which provides Works; the Rome Convention for the patent protection for inventions (20 Protection of Performers, Producers years), industrial designs (5 years with of Phonograms and Broadcasting extension possibility) and utility models Organizations; the WIPO Copyright (10 years). Armenia has also ratified Treaty; WIPO Performances and several international conventions Phonograms Treaty; and others. in this area, such as the: Patent Cooperation Treaty; Paris Convention The registration and protection of for the Protection of Industrial Property; trademarks, service marks and Strasbourg Agreement Concerning geographical indications is governed the International Patent Classification; by the laws “On Trademarks” and Geneva Act of the Hague Agreement “On Geographical Indications”. A Concerning the International trademark or service mark is subject Registration of Industrial Designs, and, ARMENIA IS A to legal protection in the Republic others. of Armenia by virtue of international MEMBER OF THE treaties, acknowledgement of its The Intellectual Property Agency of renown, or after its state registration. the Ministry of Economy (www.aipa.am) is WORLD INTELLECTUAL Designations of origin are also responsible for granting patents and for subject to legal protection by virtue of overseeing other IPR related matters. PROPERTY ■ ORGANIZATION AND HAS SIGNED A NUMBER OF INTERNATIONAL AGREEMENTS ON INTELLECTUAL PROPERTY RIGHTS USEFUL CONTACTS 95-99 USEFUL CONTACTS 94

MINISTRY OF SCIENTIFIC The Ministry of Health of the The Scientific Center of Drug and HEALTH Republic of Armenia is an CENTER OF Medical Technology Expertise was executive body that elaborates established in 1992 to implement the and implements the policies of DRUG AND national drug policy in order to ensure the Government of Armenia in the the safety, efficacy and quality of CONTACTS healthcare sector. The Ministry's MEDICAL medicinal products in Armenia. Drug Policy mission is: the development and TECHNOLOGY and Medical implementation of healthcare policy; The main tasks of the Center are: Technology ensuring RA population's sanitary EXPERTISE • Expert assessment of medicines Department and epidemic safety; organizing for the purpose of state registration, the provision of first and specialized (SCDMTE) including veterinary drugs, herbal Head of medical care and services to drugs, medical cosmetics, dietary Department: RA's population; implementation supplements and medical devices; Varduhi Grigoryan of maternal and child health • Expert assessment of medicines Address: policy; state control of locally CONTACTS for the purpose of certification for Government produced and imported medicines; Scientific Center of import and export; Building 3, Republic registration of pharmaceutical Drug and Medical • Assuring the quality of medicines Square, Yerevan, products among others. Technology and other pharmaceutical products 0010, Armenia Expertise available in Armenia, including Phone: The Drug Policy and Medical detecting counterfeit drugs; (+374 10) 522721 Technology Department is a Director: • Calculating an annual demand E-mail: subdivision of the Ministry of Health Hakob Topchyan for narcotics and psychotropics [email protected] and is responsible for elaborating, Address: in Armenia, certification for import Website: introducing and monitoring the 49/4 Komitas and export of narcotics and www.moh.am implementation of Armenia's drug Avenue, Yerevan, psychotropics, and submission of policy. 0051, Armenia reports to the U.N. International Phone: Narcotics Control Board; (+374 10) 231682 • Registration of adverse drug (+374 10) 230896 reactions in Armenia and provision MINISTRY OF The Ministry of Economy of the RA (+374 10) 232091 of relevant information to the World is an executive body that elaborates E-mail: Health Organization International ECONOMY the economic development policies [email protected] Program on Monitoring Adverse of the Government of RA. The main Website: Drug Reactions; goals of the Ministry are to increase www.pharm.am • Reviews and updates the National competitiveness and promote Essential Medicines List, develops CONTACTS sustainable economic development, optimal pharmacotherapy schemes, Investment Policy as well as ensure security of the RA's studies drug prescription practice, Department economy through the development, and carries out pharmaco- implementation, coordination and epidemiological research; Head of evaluation of economic policies. To • Expert assessment of protocols Department: achieve these goals, the Ministry; and other required documents for Vahagn Lalayan develops economic policy and granting permission for clinical trials Address: strategy; ensures balanced regional in RA, and monitoring of current 5 Mher Mkrtchyan economic development; promotes clinical trials; and, Street, Yerevan, investments, a knowledge-based • Conducts studies in the medical 0010, Armenia economy, entrepreneurship and and pharmacy fields, surveys of Phone: innovation; ensures access to efficient the pharmaceutical market, and (+374 11) 597125 markets; and, improves the business pharmaco-economic analysis. E-mail: environment of the country. [email protected] [email protected] The Investment Policy Department, Website: is a subdivision of the Ministry of www.mineconomy.am Economy and is responsible for developing investment policy and regulating investment activities. SMALL AND SME DNC provides state support to DEVELOP- The Development Foundation of small and medium entrepreneurship Armenia (DFA) is Armenia’s National MEDIUM in the country. SME DNC carries out MENT FOUN- Authority for Investment, Export and its activities through a network of Tourism promotion. ENTREPRE- regional branches and representative DATION OF offices covering all marzes (regions) of The DFA provides in depth services NEURSHIP Armenia. SME DNC’s duties are to: ARMENIA to foreign investors including the DEVEL- • Ensure effective dialogue provision of requisite information on between SMEs and the (DFA) Armenia’s business climate, investment OPMENT government opportunities and relevant legislation, • Increase efficiency and ground support in organizing site visits NATIONAL competitiveness of SMEs CONTACTS for investors, management of post-visit • Ensure availability of business Development support, assistance with investment CENTER OF development services for SMEs Foundation of project implementation, business • Expand access to finance for Armenia introductions, as well as liaison with ARMENIA SMEs governmental institutions. The DFA also (SME DNC) • Promote innovations and R&D General Director: provides after-care investment services activities of SMEs Karen Mkrtichyan to investors already established in • Assist establishment of new SMEs Address: Armenia. • Support internationalization of 5 Mher Mkrtchyan SME activities. Street, Yerevan, The DFA assists Armenia based SME DNC is also a member of 0010, Armenia businesses in expanding export volumes CONTACTS the Enterprise Europe Network. Phone: and diversifying export markets through “Small and The Enterprise Europe network (+374 11) 597808 promotion of Armenia made products Medium serves as a “one-stop shop” for E-mail: at international trade fairs, assisting Entrepreneurship SMEs, providing free information [email protected] companies in increasing the level of Development and practical advice on market Website: export readiness, providing them with National Center” opportunities and on EU-relevant www.dfa.am financial assistance within the scope of Fund of Armenia legislative and regulatory requirements specific governmental programs and for export purposes. The Enterprise organizing trade fairs showcasing export Executive Director: Europe Network helps SMEs to find products to international buyers and Levon Mnatsakanyan suitable business partners using its distributors. Address: business and technology cooperation 5a Mher Mkrtchyan database, provides information on The DFA is Armenia’s tourism agency Street, Yerevan, tender opportunities and supports and assists the development of the 0010, Armenia international networking. tourism sector through promotional Phone: SME DNC is governed by a Board campaigns aimed at increased (+374 12) 541648 of Trustees headed by the Minister international awareness of Armenia as (+374 12) 563714 of Economy. Members of the Board a prime tourism destination, assisting (+374 12) 583261 of Trustees include the Deputy Armenia based tour operators in Fax: Ministers of Economy , Finance and participating at key international tourism (+374 12) 541642 Agriculture, President of Union of shows, and organizing familiarization E-mail: Entrepreneurs of Armenia, the Head trips to Armenia for international media [email protected] of Expertise and Analysis Department and tour operators. The DFA also works Website: of the Government, the Head of the with various governmental and private www.smednc.am “Armenian Entrepreneurship Small sector organizations to develop tourism and Medium Entrepreneurship products and achieve capacity building Association”, the Executive Director within the tourism sector in Armenia. of the Union of Business Support Organizations, the Deputy President of Union of Manufactures and Businessmen (Employers) of Armenia, the Executive Director of the Union of Banks, and the Executive Director of the Union of Information Technology. ABBREVIATIONS 96

ADB GDP LLC SOP Asian Development Good Distribution Limited Liability Company Standard Operating Bank Practice Procedures LTD AMD GMP Limited Company TNC Armenian Dram Good Manufacturinarg Transnational Practice MPI UNION Corporation BP Medicine Producers British Pharmacopoeia GLP and Importers Union of UHPLC Good Laboratory Armenia Ultra High Performance CAPA Practice Liquid Chromatography Corrective and MOH Preventive Action GCP Ministry of Health of the UK Good Clinical Republic of Armenia United Kingdom CDB Practice Culture of Dry Biomass NAS U.N. GPP National Academy of United Nations CIS Good Pharmacy Science of the Republic Commonwealth of Practice of Armenia U.S. (USA) Independent States United States (United GSP NSS States of America) CJSC Good Storage Practice National Statistical Close Joint Stock Company Service of the Republic USD GXP of Armenia United States Dollar CRO Good (Varies, ie Contract Research Manufacturing, OJSC U.S. FDA Organization Distribution, Storage, Open Joint Stock U.S. Food and Drug etc.) Practice Company Administration CTD Common Technical HPLC PPP USP Document High Performance Liquid Public-private United States Chromatography Partnership Pharmacopoeia DFA Development Foundation ICH RA USSR of Armenia International Conference Republic of Armenia Union of Soviet Socialist on Harmonization Republics DTL RAU Darmantest Laboratories IMB Russian-Armenian VAT Institute of Molecular University Value Added Tax EAEU Biology of Armenia Eurasia Economic Union RF WIPO IPR Russian Federation World Intellectual EBRD Intellectual Property Property Organization European Bank for Rights R&D Reconstruction and Research and WTO Development ISO Development World Trade International Organization Organization EMA for Standardization SCDMTE European Medicines Agency Scientific Center of Drug YSMU JICA and Medical Technology Yerevan State Medical EU Japan International Expertise University after European Union Cooperation Agency M. Heratsi NPUA FEZ JV National Polytechnic YSU Free Economic Zone Joint Venture University of Armenia Yerevan State University Developed and Designed by: