1. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 20 – Enterprise and Industrial policy Bilateral screening: Chapter 20 PRESENTATION OF MONTENEGRO Brussels, 28 November 2012

2. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 20 – Enterprise and Industrial policy- Bilateral screening: Chapter 20 Presentation of Montenegro Brussels, 28 November 2012 Chapter 20: Enterprise and Industrial policy

3. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Pharmaceuticals Željka Bešović Agency for medicines and medical devices Marketing Authorisation department zeljka.besovic@calims.me Chapter 20: Enterprise and Industrial policy

4. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Outline Pharmaceutical sector – key data Legal framework Institutional framework Harmonization with the acquis Planned activities Chapter 20: Enterprise and Industrial policy

5. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Relevant acquis Celex: 52008DC0666 Chapter 20: Enterprise and Industrial policy

6. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Montenegro pharmaceutical sector – key data 2 manufacturers – Generic medicines/human use – No manufacturing of innovative or biologic medicines Total market of human medicines (both public and private) in 2011 around 56, 5 milion euros* – 3% (financial) of total market – domestic manufacturers – 97% (financial) import (60% from EEA, 30% countries of the region) – ~65% generics – No approved biosimilars yet *data from the report on consumption by CALIMS, available on http://calims.me /http://calims.me / Chapter 20: Enterprise and Industrial policy

7. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Legal framework Master plan for development of health sector in Montenegro 2010-2013 Law on medicines (“Off. Gazette of Montenegro” No. 56/11) – Both human and veterinary medicinal products Rulebooks Rulebook on criteria fo setting the maximum prices of medicines („Off.gazzete“ No 50/2007 and 62/2010) Rulebook on conditions for issuing marketing authorization („Off.gazzete“ No 30/2009) Rulebook on pharmaceutical documentation („Off.gazzete“ No 38/2009) Rulebook on pharmacological and toxicological documentation („Off.gazzete“ No 68/2009) Rulebook on quality control of medicines („Off.gazzete“ No 4/2010) Chapter 20: Enterprise and Industrial policy

8. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Institutional framework Goverment of Montenegro Criteria for the maximum prices of medicines Ministry of health Licences for health institutions (pharmacies) Agency for medicines and medical devices Issuing MA for medicines (H+V), Clinical trials, PhV, licences for manufacturing and wholesale, issuing of GMP, GDP, GCP certificates, register of medical devices, narcotic substances, reports on consumption of medicines, maximum prices of medicines Administration for inspection affairs Supervision over Law implementation Chapter 20: Enterprise and Industrial policy

9. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Institutional framework Public Fund for health insurance – Positive list of medicines (100% reimbursed) – List structured by generic names (INN) - no brand names Montefarm – wholesale and 45 pharmacies/state owned – Performing annaul tender for procurement of medicines from positive list of the Fund – Medicines with MA can apply for the tender – Tender provides medicines for public health institutions – primary health centers (13), hospitals (10) and public pharmacies (45) – Private pharmacies and health institutions – not in the Fund system – patients paying out of pocket for medicines Chapter 20: Enterprise and Industrial policy

10. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization Law on medicines and Rulebooks have been harmonised with the following Celex: 32001L0083 32001L0020 32003L0063 32004L0024 32004L0027 31989L0105 Chapter 20: Enterprise and Industrial policy

11. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization Placing the MP on the market/Marketing authoriazation – National procedure – requirements and timeline harmonised with the 32001L0083 (210 days, /Q/S/E – evaluated in line with the EMA guidelines) – Fast track procedure introduced for the medicines that have MA in the EU via CP/MRP/DC procedure – Data and market exclusivity for innovative medicines – harmonised with the 32001L0083 (8y+2y+1y) – Medicines that have orphan designation in EMA - from 2013 no fees for MA – Variations – Rulebook currently harmonised 1084/2003/EC Chapter 20: Enterprise and Industrial policy

12. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization Biotechnological medicinal products Definition of biological i biosimilar MP harmonised with 32003L0063 i 32004L0027 Definition of MP for advanced therapies harmonised with 32007R1394 No biosimilars with MA yet (several in procedure – having MA in EU from CP) – Interchangeability with reference biological MP – no defined guidelines Chapter 20: Enterprise and Industrial policy

13. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization Prices of medicines Law foresees setting of maximum prices only for medicines that are reimbursed by the Public Fund – harmonisation with 31989L0105 – system of reference countries – new competence for the Agency/beginning of the implementation is planned for 2013 Labeling/Availability Packages that are marketed in the region are accepted in Montenegro (from Croatia, Bosnia and Hercegovina and Serbia) – increasing interest of industry Chapter 20: Enterprise and Industrial policy

14. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization Pharmacovigilance – Definition of ADR harmonised with 32010L0084 – System established for national reporting from health professionals and MAH – Member of WHO UMC from 2009 Providing information on medicines – Advertisement to patients - allowed for OTC MP only – Rulebook an advertisement of MP expected in 2013 – No codex on relation between industry and healthcare professionals (initiative and workshop with HCP Chambers) Chapter 20: Enterprise and Industrial policy

15. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization Falsified medicinal products – Defined in Law according to WHO – Agency has a project for establishing a laboratory for detection of substandard/falsified medicines – Laboratory will be using specific techniques/not represented in the National laboratories of the region/possibility for closer regional cooperation and customs and police Chapter 20: Enterprise and Industrial policy

16. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Projects From February 2010 Agency participating in IPA project with EMA – observers to some of the WP Two projects for development of internal capacity in the Agency in 2011 i 2012 - realised with the Agency of Serbia and Croatia/funded by the World Bank Donation of the hardware equipment for the Agency from EU delegation in Montenegro Chapter 20: Enterprise and Industrial policy

17. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Planned activities Further harmonisation with the acquis trough set of Rulebooks foreseen in the period of 2013-2015 – Variations on MA – Advertisement of MP – Clinical trials and GCP guidelines – Pharmacovigilance – Traditional herbal MP and homeopathic MP Begging of implementation of maximum process of medicines in 2013 Increasing the amount and quality of information for HCP and patients - portal with the approved SPC and PIL / end of 2012 Falsified medicines – realisation of the project for laboratory/better cooperation with the customs, police and Agencies in the region Chapter 20: Enterprise and Industrial policy

18. Chapter 20: Enterprise and Industrial policy M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Biotechnology in Medicine Ružica Milović Ministry of Health ruzica.milovic@mzd.gov.me Chapter 20: Enterprise and Industrial policy

19. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: Enterprise and Industrial policy EU legislation Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells adopted by the European Parliament and the Council of 31 March, 2004; Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells; Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. Chapter 20: Enterprise and Industrial policy

20. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: Enterprise and Industrial policy National legislation LAW ON INFERTILITY TREATMENT THROUGH ASSISTED REPRODUCTIVE TECHNOLOGIES ("OFFICIAL GAZETTE OF MONTENEGRO", NO. 74/2009) 1.Rulebook on the form, content and manner of granting approval for transplantation of human body parts for the purpose of medical treatment ("Official Gazette of Montenegro", No. 76/09), 2. Rulebook on the procedure for granting approval, and content of the approval for removal of human body parts from deceased donors and identification mode for the donor ("Official Gazette of Montenegro", No. 76/09), 3. Rulebook on the procedure of granting approvals, and content of the approval for removal of human body parts from living donors ("Official Gazette of Montenegro", No. 76/09); 4. Rulebook on the manner, procedure and medical criteria for determining death of a person whose body parts may be taken for the transplantation for the purpose of treatment ("Official Gazette of Montenegro", No. 67/09). 5.Regulations on the collection, storage and use of stem cells Chapter 20: Enterprise and Industrial policy

21. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: Enterprise and Industrial policy National legislation THE LAW ON REMOVAL AND TRANSPLANTATION OF HUMAN BODY PARTS FOR THE PURPOSES OF MEDICAL TREATMENT ("OFFICIAL GAZETTE OF MONTENEGRO", NO. 76/2009) LAW ON THE INTAKE AND USE OF BIOLOGICAL SAMPLES ("OFFICIAL GAZETTE OF MONTENEGRO", NO. 14/2010) THE LAW ON THE GENETIC DATA PROTECTION ("OFFICIAL GAZETTE OF MONTENEGRO", NO. 25/2010) Chapter 20: Enterprise and Industrial policy

22. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: Enterprise and Industrial policy Institutional Framework Ministry of Health Agency for medicines and medical devices Health Institutions Pharmacists’ Association of Montenegro Doctors ’ association of Montenegro Health Insurance Fund of Montenegro Chapter 20: Enterprise and Industrial policy

23. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: Enterprise and Industrial policy Description of administrative capacities There is existing need to strengthen Administrative capacity trough recruitment of the appropriate professional staff - both in the Ministry of Health as well as in health care facilities within the network Creating of new obligations will require strengthening existing administrative capacity will provide consistent implementation of commitments During the next period it is necessary to transpose EU directives into national legislation in line with the EU legislation Chapter 20: Enterprise and Industrial policy

24. Thank you for your attention! QUESTIONS