In line with the Law on medicines, the Institute for medicines and medical devices shall issue authorisations for medicines containing drugs and precursors in accordance with Law about Preventing Drug Abuse and Law on control of manufacture and trade of substances that can be used in the manufacture of narcotic drugs and psychotropic substances that regulate this area.

List of drugs and psychotropic substances is defined by the Rulebook on the list of drugs, while List of precursors is defined by the Rulebook on the list of substances that can be used in manufacture of narcotic drugs.

Regarding import/export/transit of drugs and psychotropic substances, registered legal person shall submit to the Institute an Application for import, export or transit of drugs, accompanied by appropriate documentation. In the same manner an Application for import, export and transit of precursors may be submitted, along with appropriate documentation.

Institute is also involved in following activities: drafting of laws and other legislation regulating the field of drugs and precursors; implementation and fulfillment of obligations from ratified international UN conventions – 1961 Single Convention on Narcotic Drugs, 1971 Convention on Psychotropic Substances, 1988 United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances; preparing drafts of List of drugs and List of Precursors in accordance with UN conventions that regulate this field; maintaining the database of legal persons that perform manufacture, marketing, import, export and transit of drugs and precursors; monitoring and analyzing of market supply with medicines that contain drugs and precursors; preparing quarterly and annual reports for the Ministry of Health which are then forwarded to the International Narcotic Control Board (INCB).

Institute cooperates with other authorities responsible for drugs and precursors.

Additionally, international cooperation is also achieved by fulfillment of obligations towards other states’ authorities responsible for narcotic drugs and precursors.

Instructions

Documentation required for issuance authorisation for import, export, transit of drugs and instruction for completing the application form (updated 6.6.2023.)

Documentation required for issuance authorisation for import, export, transit of precursors and medicines containing precursors and instruction for completing the application form (updated 6.6.2023.)

Forms

Application form for issuance of the authorisation for import, export and transit of precursors and medicines containing precursors (updated 23.11.2020.) –   document in Montenegrin

Application form for issuance of the authorisation for import, export and transit of drugs (updated 23.11.2020.) –  document in Montenegrin

Table for consumption of controlled substances (updated 10.1.2023.) –  document in Montenegrin