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 1 – Free movement of goods Bilateral screening: Chapter 1 PRESENTATION OF MONTENEGRO Brussels, 06 March 2013

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 1 – Free movement of goods – Bilateral screening: Chapter 1 Presentation of Montenegro Brussels, 06 March 2013 Chapter 1: Free movement of goods

3. Chapter 1: FREE MOVEMENT OF GOODS 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 1: Free movement of goods

4. Chapter 1: FREE MOVEMENT OF GOODS 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 1: Free movement of goods

5. Chapter 1: FREE MOVEMENT OF GOODS 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 domestic manufacturers – Generic medicines/human use (one is EU GMP certified) – No manufacturing of innovative or biologic medicines – No manufacturing of veterinary medicines or vet premixes 27 wholesalers for human medicines/ 7 wholesalers for vet medicines Total market of human medicines (both public and private) in 2011 56, 4 milion euros* ~ 65% generics / ~ 35% innovative (issued MA) *data from the Agency report on consumption, available on www.calims.me /www.calims.me / Chapter 1: Free movement of goods

6. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Human medicines 20102011 Total value of market for human MP* (in mill €.) 56, 956,4 % (financial)61,9% EEA 27,2% ex Yu 2,3% domestic 61,9% EEA 28,7% ex Yu 2.4% domestic Value of market for HMP covered by form the Public Health Insurance Fund * (in mill €.) 2829,5 Montenegro pharmaceutical sector – key data Chapter 1: Free movement of goods Veterinary medicines 20102011 Total value of market for VMP (100% import) 654 600 €461 104 €

7. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Structure of physical volume in manufacturing industry Chapter 1: FREE MOVEMENT OF GOODS Chapter 1: Free movement of goods

8. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Legal framework Law on medicines (“Off. Gazette of Montenegro” No. 56/11) Both human and veterinary medicinal products Rulebooks Decree on criteria for 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 detailed content of pharmaceutical testing of medicines („Off. Gazzete“ No 38/2009) Rulebook on detailed content of pharmacological-toxicological studies of medicines („Off. Gazzete“ No 68/2009) Rulebook on quality control of medicines („Off. Gazzete“ No 4/2010) Rulebook on form, content and period for submitting reports on sales of medicines ((„Off. Gazzete“ No 2/2013) Guidelines on Good Distribution Practice (published on Ministry of Health web site 14.11.2012) Chapter 1: Free movement of goods

9. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Institutional framework Implementation Chapter 1: Free movement of goods Goverment of Montenegro Criteria for the maximum prices of medicines Ministry of Health / Ministry for agriculture Propose Laws Adopts Rulebooks and Guidelines Licencing pharmacies /Licencing vet clinics National Assembly Adopting Laws Legislation Agency for medicines and medical devices MA (H+V), CT, PhV, GMP, GDP, GCP, narcotic substances… Veterinary Administration Licencing distributors for VMP Supervision Administration for inspection affairs

10. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Institutional framework Administrative capacities Ministry of health 11 people (4 full time) working on national legislation and harmonisation with the EU acquis Agency for medicines and medical devices 26 employees performing competences set in the Law Veterinary Administration 8 employees performing competences set in the Law Administration for inspection affairs 9 health inspectors performing supervision over human medicines in the market 21 veterinary inspectors performing supervision over veterinary medicines in the market Chapter 1: Free movement of goods

11. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization/Relevant acquis – Dir. 2001/20/EC – Dir. 2001/83/EC – Dir. 2002/98/EC – Dir. 2003/63/EC – Dir. 2003/94/EC – Dir. 2004/23/EC – Dir. 2004/24/EC – Dir. 2004/27/EC – Dir. 2005/28/EC – Dir. 2009/53/EC – Dir. 2010/84/EC – Dir. 2011/62/EC – Dir. 2012/26/EC – Dir. 91/412/EC – Dir. 2001/82/EC – Dir. 2004/28/EC – Dir. 2006/130/EC – Dir. 2009/9/EC – Dir. 2009/53/EC – Reg. 726/2004 – Reg. 1950/2006 – Reg. 1234/2008 – Reg. 470/2009 Chapter 1: Free movement of goodsv – Reg. 141/2000 – Reg. 726/2004 – Reg. 1901/2006 – Reg. 1394/2007 – Reg. 1234/2008 – Reg. 1027/2012 HumanVeterinary

12. Chapter 1: FREE MOVEMENT OF GOODS 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 partially harmonised with the following Celex: Dir. 2001/20/ECReg. 2007/1394 Dir. 2001/82/ECReg. 2004/726 Dir. 2001/83/EC Dir. 2003/63/EC Dir. 2004/24/EC Dir. 2004/27/EC Dir. 2010/84/EC Chapter 1: Free movement of goods

13. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization - marketing authorisation- Placing the MP on the market/Marketing authoriazation – National procedure –timeline harmonised with the Dir. 2001/83/EC and Dir. 2001/82/EC (210 days) – Fast track procedure introduced for the medicines that have obtained MA in the EU trough CP/MRP/DC procedure (150 days) – Q/S/E – no national guidelines, evaluation in line with the EMA guidelines – Data and market exclusivity for innovative medicines HMP 8y+2y + 1y (2001/83/EC) VMP 8y+2y + max 3y (1. for fish and bees, 2. for another food producing animal species) (2001/82/EC) Chapter 1: Free movement of goods

14. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization - marketing authorisation- Documentation on Q/S/E required: – CTD format (human) – EU file (veterinary and exceptional cases human) MA issued for period of 5 years – Conditional authorisation – Exceptional circumstances authorisation Register of medicines with MA together with the approved SPC and PIL can be searched on the Agency web site www.calims.mewww.calims.me Chapter 1: Free movement of goods

15. 15 30 days for answers on Deficiency letters Аssessment of validity of application Evaluation of Q/S/E 30 days Deficiency letters Applicant Submission of application Confirmation on submission Valid application e xperts/ Committee 180 days for answer on Deficiency letters Confirmation of a valid application Agency MA (SmPC, PIL, labeling) Chapter 1: FREE MOVEMENT OF GOODS Marketing Authorisation procedure M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods 210 or 150 days Deficiency letters Negative decision Appeal to the Ministry of Health

16. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization - marketing authorisation- List of variations to MA – Currently harmonised with 1084/2003/EC Renewal - risk / benefit reassessment – Based on pharmacovigilance data – possibility of renewal for indefinite period MA can be revoked if medicine was not marketed for three years upon issuing Chapter 1: Free movement of goods

17. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization Definition of biological i biosimilar MP introduced – harmonised with 32003L0063 i 32004L0027 – Interchangeability with reference biological MP – no defined guidelines Definition of MP for advanced therapies introduced – harmonised with 32007R1394 Medicines that have orphan designation in EU – submitted after 05/12/2011 no fees for MA Chapter 1: Free movement of goods

18. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization - manufacture- Agency is issuing licences for manufacturing – for specific manufacturing site, pharmaceutical forms and finished medicinal products – for all or part of the production processes Issued for indefinite period Manufacturer must have – Qualified person for manufacturing – Qualified person for batch release Manufactures must comply with the GMP (issued by the Agency) * Rulebook on manufacturing and GMP guidelines not yet adopted Chapter 1: Free movement of goods

19. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization - wholesale- Agency is issuing licences for wholesale of HMP / Veterinary administration for wholesale of VMP – Wholesale licence includes import / export / procurement / storage and distribution – the licences can include/exclude specific categories of medicines Issued for indefinite period Wholesalers must have qualified person for storage and distribution Distributer must comply with the GDP (issued by the Agency) Wholesalers must ensure a continuous supply of medicines * GDP guidelines published / Rulebook on wholesale not yet adopted Chapter 1: Free movement of goods

20. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization - labeling/availability- Labeling in accordance with the MA Summary of product characteristics/ Patient information leaflet/labeling – integral part of the MA Packages that are marketed in the region are accepted in Montenegro (from Croatia, Bosnia and Hercegovina and Serbia) – increasing interest of industry * Rulebook on labeling not yet adopted Chapter 1: Free movement of goods

21. Chapter 1: FREE MOVEMENT OF GOODS 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 The Agency and the MAH organize the pharmacovigilance system Based on the PhV Agency may change the conditions from the MA or revoke the MA National reporting from health professionals and MAH established Member of WHO UMC from 2009 *Rulebook on pharmacovigilance not yet adopted Chapter 1: Free movement of goods

22. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Harmonization - advertisement - Prescription only medicines - promotion to health care professionals; OTC - advertisement to patients allowed – In line with the MA and approved SPC No codex on relation between industry and healthcare professionals (initiative and workshop with HCP Chambers) * Rulebook an advertisement of medicines not yet adopted Chapter 1: Free movement of goods

23. Chapter 1: FREE MOVEMENT OF GOODS 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- Definition according to WHO HCP and all companies and persons coming into contact with medicines are obliged to report any doubt of the substandard or falsified medicines 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 1: Free movement of goods

24. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Web portal Legislation (national and english) Register of approved medicines Safety information Chapter 1: Free movement of goods

25. Chapter 1: FREE MOVEMENT OF GOODS 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 1: Free movement of goods

26. Chapter 1: FREE MOVEMENT OF GOODS 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 National project IPA 2011 - Development of Quality Infrastructure and Metrology – Montenegro, one of the components is dedicated to drafting necessary legislation in area of pharmaceuticals. – Representatives of Ministry of Health and Agency for medicines and medical devices will establish working party that will work with EU experts. Strengthen Administrative capacities – Improve the compliance with the timelines set in the legislation – Improve the standard in assessing Q/S/E in line with the EU requirements Falsified medicines – realisation of the project for laboratory/better cooperation with the customs, police and Agencies in the region New object for the Agency – finished by April 2013 Chapter 1: Free movement of goods

27. Chapter 1: FREE MOVEMENT OF GOODS M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Planned activities Rulebook on variations to MA Rulebook on pharmacovigilance Rulebook on clinical trials of medicines Rulebook on labeling of medicinal products Rulebook on advertisement of medicinal products Rulebook on import of medicinal products Rulebook on manufacturing of medicinal products Rulebook on distribution of medicinal products Rulebook on the criteria for the classification and dispensing of medicinal products Rulebook on the traditional herbal medicines Rulebook on homeopathic medicines Guidelines on Good Manufacturing Practise Guidelines on Good Clinical Practise Guidelines on Good Laboratory Practise Chapter 1: Free movement of goods

28. Thank you for your attention! QUESTIONS