MONTENEGRO Negotiating Team for the Accession of Montenegro

MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Working Group on Chapter 1 – Free movement of goods Bilateral screening: Chapter 1 Brussels, 5 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, 5 Match 2013 Chapter 1: Free movement of goods

Chapter 1: Free movement of goods Drug precursors Nina Milović Ministry of Health nina. milovic@mzd. gov. me MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter Poglavlje 1: 20: 25 Free movement Nauka xxxxxxx i istraživanje of goods

Chapter 1: Free movement of goods Content • • • Legal framework Institutional framework Harmonization MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: 20: Free movement xxxxxxx of goods

Chapter 1: Free movement of goods EU legislation • REGULATION (EC) NO. 273/2004 OF 11 TH FEBRUARY, 2004 MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: xxxxxxx

Chapter 1: Free movement of goods National legislation • The Law on Control of production and trade of substances that can be used in the manufacture of narcotic drugs and psychotropic substances ("Off. Gazette of Montenegro", no. 83/09) • Rulebook on the list of substances that can be used in the production of narcotic drugs and psychotropic substances ("Official Gazette of Montenegro", no. 58/10) MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: 20: Free movement xxxxxxx of goods

Chapter 1: Free movement of goods National legislation • The adoption of this Law shall provide the implementation of the following United Nations Conventions: - Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988; - The Convention on Psychotropic Substances of 1971; - The Single Convention on Narcotic Drugs of 1961. MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: 20: Free movement xxxxxxx of goods

Chapter 25: Science and Research INSTITUTIONAL FRAMEWORK • • • Ministry of Health Agency for medicines and medical devices Ministry of Interior Affairs Police Directorate Inspection Directorate Customs Directorate MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: xxxxxxx

• The law governs the monitoring and control of the production and trade of substances that can be misused for the production of narcotic drugs and psychotropic substances, in order to protect human life and health. • By regulating the production and trade of precursors and the determination of the competent authority, a complete control system and timely actions to prevent abuse of precursors and their use for illegal purposes has been provided MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: xxxxxxx

• Precursors are divided into first, second and third category. • The first category consists of precursors which are used as the basic and most important raw material in the production of narcotic drugs and psychotropic substances. • The second category consists of precursors that are used as secondary raw material in the production of narcotic drugs and psychotropic substances. • The third category consists of precursors that are used as secondary raw material in the production of narcotic drugs and psychotropic substances, which, in the process, can be replaced by other suitable raw materials. • The list of precursors divided into categories shall be adopted by the Ministry of Health as proposed by the Agency for Medicines and Medical Devices and the Police. • Ordinance on the list of substances that may be used in the production of narcotic drugs and psychotropic substances ("Official Gazette of Montenegro", no. 58/10) identified a list of 23 controlled substances. MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: xxxxxxx

PRODUCTION OF PRECURSORS • Law stipulates that the production of precursors can be performed by a legal entity which obtained a license for the production of precursors from the Ministry or the Agency. • Manufacturer of precursor of the first category that are pharmacologically active substances used for the manufacture of medicines, must meet requirements in terms of space, staff and equipment in line with the regulations governing the manufacture of medicines. MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: xxxxxxx

Chapter 1: Free movement of goods PRODUCTION OF PRECURSORS • The license for the production of precursors which are toxic, shall be issued by the Ministry within 60 days of receipt of the complete documentation required by the Law and regulations for the implementation of this Law. • The license for the production of precursors that are pharmacologically active substances shall be issued by the Agency within 60 days of the receipt of complete documentation that is required by the Law and regulations to implement the Law. MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: xxxxxxx

Chapter 1: Free movement of goods TRADE IN PRECURSORS • Trade in precursors shall perform a legal entity which obtained a permit for the trade in precursors by the Ministry or the Agency. • Permit for the trade in precursors shall be issued by the Ministry or the Agency, within 60 days of the receipt of the complete documentation required by the Law and regulations to implement this Law • Permit for the trade in precursors shall be issued on the written request of a legal person, for the trade in exactly specified precursor of the first and second category for a period of three years, and for the trade in precursors of the third category for a period of five years • Contents of the permit to trade in precursors, as well as the contents of the application for a license shall be specified by the Ministry • The Ministry keeps records of legal entities engaged in the production and /or sale of precursors, which includes legal name, type and quantity of precursors. MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: 20: Free movement xxxxxxx of goods

Chapter 1: Free movement of goods • The Ministry or the Agency shall keep a register of legal entities involved in the production, marketing, import, export, transit and transport of precursors, as well as a special register of the permits. • The Ministry or the Agency, prior to issuing a license for the export of precursors, shall submit the following information to the competent authority of the state on whose territory precursor is to be exported: The name and address of the exporter, importer and other entities involved in the export business and transportation, as well as enduser, if known, The name and category of precursors; The quantity and weight of precursors, or if it is a mixture, the quantity and weight of the precursor mixture; Information on transport (estimated time of the implementation of customs procedures and the route, if known) MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: xxxxxxx

Chapter 1: Free movement of goods • Transit of precursors Ministry of Health and the Agency issue permits for the transit of precursors. • The Ministry or the Agency provide one copy of the permission for the transit of precursors to the applicant, as well as a government agency responsible for customs duties/ Costume Directorate • The authority responsible for customs duties /Costume Directorate verifies the permission for the transit of precursors for each transit of precursors, and enter the date and the place of customs clearance and return the verified permission to the Ministry and the Agency within 15 days upon the transit. MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: xxxxxxx

Chapter 1: Free movement of goods • Legal entity that has the license to manufacture and transport precursors is required to submit an annual report on production and trade of precursor to the Ministry and the Agency, by 31 January of the current year for the previous year, or earlier upon request • Legal entities that manufacture, transport, or use precursors shall submit Reports on import and export of precursors for the previous year to the Ministry or the Agency by 31 January of the current year. MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: xxxxxxx

Chapter 1: Free movement of goods • Law stipulates that the legal entity who performs manufacture, i. e. trade of precursors shall be obliged to immediately inform the Ministry, i. e. the Agency and the Police Directorate of all facts that indicate suspicion of abuse of precursors in manufacture i. e. trade, as well as unusual orders, theft of precursors or other illicit activities relating to the manufacture, i. e. trade of precursors. • Ministry of Health, Agency for Medicines and Medical Devices, Customs Administration, Ministry of Interior, Directorate for Inspection Affairs - Health and Sanitary Inspection are Authorities responsible for managing the drug precursor control. MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: xxxxxxx

• Law stipulates that the legal entity who performs manufacture, i. e. trade of precursors shall be obliged to immediately inform the Ministry, i. e. the Agency and the Police Directorate of all facts that indicate suspicion of abuse of precursors in manufacture i. e. trade, as well as unusual orders, theft of precursors or other illicit activities relating to the manufacture, i. e. trade of precursors. • Ministry of Health, Agency for Medicines and Medical Devices, Customs Administration, Ministry of Interior, Directorate for Inspection Affairs - Health and Sanitary Inspection are Authorities responsible for managing the drug precursor control. MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 20: xxxxxxx

Chapter 1: Free movement of goods HARMONIZATION • In the aim of the full harmonization with EU legislation revision of the Law on Control of production and trade of substances that can be used in the manufacture of narcotic drugs and psychotropic substances is planned, as well as adoption of Rulebooks which will enable implementation of the Law MONTENEGRO Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: 20: Free movement xxxxxxx of goods

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