ROMANIA Newsletter Year 14, no. 4 (56), 4th quarter of 2012 National Agency for Medicines and Medical Devices Emergency Ordinance no. 91 of 12.12.2012 amending certain healthcare regulations Report of the activities performed by the National Agency for Medicines and Medical Devices in 2010 Medicinal product batches recalled during the 4th quarter of 2012 Applications for marketing authorisation/marketing authorisation renewal submitted to the NAMMD during the 3rd quarter of 2012 Medicinal products authorised for marketing by the NAMMD during the 3rd quarter of 2012 EMA centrally authorised medicinal products for which a marketing price was established in Romania during the 3rd quarter of 2012 1 All data herein represent official information and are under direct authority of the National Agency for Medicines and Medical Devices. The entire content of the present publication lies under complete legislative protection of the National Agency for Medicines and Medical Devices. Any use of present publication content for revenue purposes or its marketing without express consent of the National Agency for Medicines and Medical Devices is forbidden and punishable by law. The National Agency for Medicines and Medical Devices reserves exclusive publishing rights. ISSN 1583-347X 2 TABLE OF CONTENTS Emergency Ordinance no. 91/2012 of 12/12/2012 amending certain healthcare regulations, published in the Official Gazette of Romania, Part I, no. 886 of 27.12.2012 .................................................................... 4 Report of activities performed by the National Agency for Medicines and Medical Devices in 2010, published in the Official Gazette of Romania, Part III, no. 19 of 21 January 2013 ........................................ 36 Medicinal product batches recalled during the 4th quarter of 2012 ..… 90 Applications for marketing authorisation/marketing authorisation renewal submitted to the NAMMD during the 3rd quarter of 2012….. 93 Applications for marketing authorisation/marketing authorisation renewal submitted to the NAMMD during the 3rd quarter of 2012… 95 EMA centrally authorised medicinal products for which a marketing price was established in Romania during the 3 rd quarter of 2012………………………………………………………………........ 111 3 THE GOVERNMENT OF ROMANIA EMERGENCY ORDINANCE amending certain healthcare regulations Having regard to Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use as regards the prevention of the entry into the legal supply chain of falsified medicinal products, Taking into account Romania's obligation to observe deadlines for transposition of Directive 2011/62/EU into national law, namely by 31 December 2012, To reduce the risk of action for failure to fulfil Member State obligations, according to art. 258 of the Treaty on the Functioning of the European Union, Taking into account that transposition of the directives in question provide the necessary and obligatory conditions for achievement of quality medical intervention for citizens of Romania, Having in mind that failure to meet these provisions entails the risk of decisions by the European Court of Justice imposing payment by Romania of financial penalties, according to art. 260(3) of the Treaty on the Functioning of the European Union, with major negative impact on the state budget, Taking into account the Communication 2011/C 12/01 of the European Commission on Implementation of Article 260 (3) of the Treaty on the Functioning of the European Union, in particular the obligation of Member States to transpose directives within the deadlines laid down by the legislator and hence to ensure that Union legislation is genuinely effective, Taking into account that failure to adopt emergency measures contained in this regulatory act may affect the rights of individuals, who may refer to national courts under the principle of the direct effect of directives, where harm has been done in result of non-compliance with European Union legislation on the prevention of the entry into the legal supply chain of falsified medicinal products, Taking into account that the activities included in national health programs involve a combination of interventions intended for the therapeutic structure for patients with chronic diseases, such as rare diseases, transplants of organs, tissues or cells, cancer, diabetes mellitus and others, which require high costs for a certain number of affected persons, also intended for the public health structure, and for medical services whose costs are not covered by the DRG system financed from the budget of the Single National Social Health Insurance Fund, Taking into account the undertaking of the Romanian Government concerning implementation before 31 December 2012 of the measures meant for reorientation of national healthcare programs towards primary public health field in accordance with the “Health Action Plan“, 4 For consistent regulation and adoption of immediate measures to ensure compliance with commitments of the Romanian Government in negotiations for loan agreements with financial institutions, Taking into account that failure to adopt such immediate measures and their implementing regulations, by emergency ordinance, would cause major disruptions adversely affecting the health of the population, as well as for efficient use of healthcare human and financial resources, Considering that these factors of major impact on public health concern the general public interest and represent emergency and extraordinary situations whose regulation may not be delayed, Pursuant to Article 115(4) of the Romanian Constitution, republished, The Government of Romania hereby adopts this Emergency Ordinance. Art. I. - Law 95/2006 on healthcare reform, published in the Official Gazette of Romania, Part I, no. 372 of 28 April 2006, as amended, is hereby amended as follows: 1. Under Article 6 h), two new points, 9 and 10, are added after (8), as follows: “9. Healthcare services for children; 10. Transfusion security services.“ 2. Under Article 6, a new point, i), is added after h), reading as follows: “i) Medical and specific treatment of diseases with a major impact on public health (TB, HIV / AIDS, diseases, cancer, diabetes) and transplantation of organs, tissues or cells.“ 3. Under Article 8, c) is amended as follows: “c) Activities within national health programs;“ 4. Article 9 (3) and (5) are amended as follows: “(3) National healthcare programs cover the main areas of intervention of public health and respond to national priorities identified by national health strategy. ................................................................................................ (5) National healthcare programs are developed by the Ministry of Health, with the participation of the National Health Insurance House; their development is carried out by the Ministry of Health and / or the National Health Insurance House as appropriate. “ 5. Under Article 16 (1), points a) and c) are amended as follows: “a) Establish national public health priorities, develop national healthcare programs and achieve coordination, monitoring, evaluation and control of the Ministry of Healthcare programs funded from the state budget and own revenues; .................................................................................................. c) Periodically assess population health indicators;“ 5 6. Under Article 17 (2), o) is amended as follows: “o) Ensure the implementation of national healthcare programs run by their own structures, coordination, monitoring and implementation of national public healthcare programs carried out under contracts with public institutions, healthcare providers network of local authorities, ministries and private health network institutions as well as private healthcare providers, as provided in the rules for performance of national public healthcare programs;“. 7. Under Article 17, (21) is repealed. 8. Article 45 is amended as follows: “Art. 45. - (1) For the purposes of this title, the terms and expressions below have the following meaning: a) National healthcare programs - overall annual action directed towards the main areas of public healthcare intervention; b) Development of national healthcare programs - the implementation, coordination, monitoring, evaluation and control of national healthcare programs; c) Implementation of national healthcare programs, organisation of human, material and financial resources at the level of special units in order to ensure the goods, services or changes of behaviours and of living and working environment for the beneficiaries of these programs in response to certain health needs identified in objective data; d) Specialised unit - structure of the public health system assigned to the implementation of national healthcare programs; e) National/regional unit for national healthcare programs technical assistance and management units – the non-legal organisational structure of public institutions subordinated to the Ministry of Health, established by Order of the Minister of Health, responsible for providing national healthcare programs technical assistance and management units; f) Technical assistance - all activities related to the training and information of special units responsible for the implementation of national healthcare programs and other activities undertaken to improve implementation of national healthcare programs; g) Eligible expenditure - expenditure