Medicines
Medicinal Products
- Law on Medicinal Products (“Official Gazette of Montenegro”, No. 14/26)
- Law on Administrative Procedure (“Official Gazette of Montenegro” No 56/14, 20/15, 40/16 and 037/17) – document in Montenegrin; Note: this act is applied to all procedures initiated upon 1 July 2017
Previously applicable legislation
- Law on medicines (“Official Gazette of Montenegro”, No. 80/20 , 84/20 and 35/25); Note: applied to all procedures initiated up to 17 February 2026
- Law on medicines („Official Gazette of Montenegro“, No. 56/2011) Note: applied to all procedures initiated up to 12 August 2020
- Law on general administrative procedure (“Official Gazette of Montenegro”, No 60/03, No 73/10 and No 32/11) – document in Montenegrin; Note: this act is applied to all procedures initiated up to 1 July 2017
Human Medicinal Products
Rulebook on conditions for granting marketing authorisation for medicinal products with Annex („Official Gazette of Montenegro“ No 22/26 and 24/26)
- Rulebook on the registration of homeopathic and traditional herbal medicines („Official Gazette of Montenegro“ No 22/26)
- Rulebook on detailed content of pharmaceutical testing of medicines („Official Gazette of Montenegro“ No 38/09)
- Rulebook on content and manner of conducting pharmaceutical testing of medicines with the Aim of Quality Control („Official Gazette of Montenegro“ No 4/10)
- Rulebook on detailed content of pharmacological-toxicological study of medicines („Official Gazette of Montenegro“ No 68/09)
- Rulebook on manner and conditions of advertising of medicines („Official Gazette of Montenegro“ No. 2/14)
- Rulebook on the form and content of a prescription, criteria for classification of medicines, as well as the manner of prescribing and dispensing medicines („Official Gazette of Montenegro“ No. 34/15, 36/16 and 59/17)
- Rulebook on more detailed conditions for the issuance of import authorization for a medicine that does not have marketing authorisation (“Official Gazette of Montenegro” No 19/24 and 34/24)
Veterinary Medicinal Products
Rulebook on conditions for granting marketing authorisation for veterinary medicinal product (“Official Gazette of Montenegro” No 22/26 and 24/26)
- Rulebook on conditions for manufacturing of veterinary medicinal products (“Official Gazette of Montenegro” No 22/26)
- Rulebook on pharmacovigilance system of veterinary medicinal products (“Official Gazette of Montenegro” No 23/26)
- Guidelines of good distribution practice for active substances used as starting materials in veterinary medicinal products (“Official Gazette of Montenegro” No 22/26)
- Rulebook on more detailed conditions for the issuance of import authorization for a medicine that does not have marketing authorisation (“Official Gazette of Montenegro” No 19/24 and 34/24)
- Order to prohibit treating animals with certain substances and veterinary medicines – document in Montenegrin (“Official Gazette of Montenegro” No 17/24)
Manufacture and Wholesale of Medicinal Prroducts
- Rulebook on conditions for manufacturing of medicinal products for humane use (“Official Gazette of Montenegro” No 22/26)
- Rulebook on conditions for manufacturing of active supstances for medicinal products for human use (“Official Gazette of Montenegro” No 22/26)
- Rulebook on conditions for manufacturing of veterinary medicinal products (“Official Gazette of Montenegro” No 22/26)
- Guidelines of good distribution practice for active substances used as starting materials in veterinary medicinal products (“Official Gazette of Montenegro” No 22/26)
- Rulebook on detailed conditions and manner of determining the fulfillment of conditions for performing wholesale of medicines for human use (“Official Gazette of Montenegro” No 45/21)
Pharmacovigilance
- Rulebook on the manner of collecting of data and reporting and monitoring adverse reactions to medicines for use in human medicine („Official Gazette of Montenegro” No 46/14)
Clinical Trials
- Rulebook on more detailed conditions and documentation required for approval and conduct of clinical trials of medicines for human use („Official Gazette of Montenegro“ No. 2/14)
Medicinal Products maximum prices
- Decree on the criteria of setting maximum prices of medicines (“Official Gazette of Montenegro” br. 130/21 and 9/22, 20/24 and 113/25)
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