MONTENEGRO Negotiating Team for the Accession of Montenegro

MONTENEGRO 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, 05 March 2013

MONTENEGRO 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, 05 March 2013 Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Good Laboratory Practice medicinal products for human and veterinary use Željka Bešović Agency for medicines and medical devices Marketing Authorisation department zeljka. besovic@calims. me MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Relevant acquis • • Celex: 32004 L 0009 Celex: 32004 L 0010 MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Legal framework Medicinal products for human and veterinary use • Law on medicines (“Off. Gazette of Montenegro” No. 56/11) – Both human and veterinary medicinal products • The Law gives grounds for adopting national GLP guidelines, but they have not been adopted yet MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Institutional framework • National Assembly Adopts the Law on medicines • Ministry of health Proposes Laws and Decrees and adopts the Rulebooks and Guidelines Licences for health institutions (pharmacies) Agency for medicines and medical devices Issuing MA for medicines (H+V), CT, Ph. V, licences for manufacturing and wholesale, register of medical devices, narcotic substances, reports on consumption of medicines, establishing maximum prices of medicines • Administration for inspection affairs Supervision over Law implementation MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Harmonization • The Law on medicines: – Good Laboratory Practice is a quality assurance system related to the organization and conditions for conducting pre-clinical testing related to the safety of the people and the environment, their control, the manner of reporting and documentation (Art 4. 19) – The data on pharmacological-toxicological testing are presented within the dossier for obtaining Marketing Authorisation which is submitted to the Agency (Art 60, 63) MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Current situation • There are no laboratories in Montenegro performing the pharmacological-toxicological testing of medicines. • There are no indications that such a laboratory is to be established. • GLP compliance monitoring authority have not been named • There is no national GLP Monitoring Programme adopted and such a programme have not been conducted so far MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Planned activities • Further harmonisation with the directives trough the national Guidelines on Good Laboratory Practice – Expected during 2014 • There is existing need to strengthen administrative capacity trough recruitment of the appropriate professional staff - both in the Ministry of Health, Agency and Administration for inspection affairs. MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Good Laboratory Practice industrial chemicals Dragana Raonić, adviser Ministry of Sustainable Development and Tourism dragana. raonic@mrt. gov. me MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Legal framework • Law on Chemicals Montenegro” 18/12) - (“Off. Gazette of industrial chemikals • The Law gives grounds for adopting national GLP guidelines, but they have not been adopted yet MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Institutional framework • National Assembly - Adopts the Law on medicines • Ministry of Sustainable Development and Tourism - Proposes Laws and Decrees and adopts the Rulebooks and Guidelines - Authority to laboratories may perform non-clinical tests • Agency for Environmental Protection - compliance with GLP requirements - issues GLP certificates. • Administration for inspection affairs - Supervision over Law implementation MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Harmonization • The Law on Chemicals: - Good Laboratory Practice (GLP) is a quality system that applies to the organizations, processes, and the conditions under which non-clinical tests are performed in relation to risk assessment of dangers to life and human health and the environment, in accordance with international standards (Art. 3) - Non-clinical chemical tests are performed to evaluate the chemicals and assess the risk of their potential danger to life and human health and the environment. Non-clinical testing of chemicals shall be performed by laboratories whose work is compliant with the GLP guidelines (Art. 50) - Compliance with GLP requirements shall be determined by the Agency that issues GLP certificates. GLP certificate is issued on the basis of application submitted by the laboratory (Art. 51) MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Current situation - There are no laboratories in Montenegro performing the non-clinical testing chemicals - There are no indications that such a laboratory is to be established. - GLP compliance monitoring authority have not been named MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

Chapter 1: FREE MOVEMENT OF GOODS Planned activities • Further harmonisation with the directives trough the national Guidelines on Good Laboratory Practice - expected during 2013 • There is existing need to strengthen administrative capacity trough recruitment of the appropriate professional staff - both in the Ministry of Sustainable Development and Tourism, Agency for Environmental Protection and Administration for inspection affairs MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free movement of goods

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