• 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

• Rulebook on more detailed conditions for issuance of marketing authorisation for a medicine („Official Gazette of Montenegro“ No 30/2009)

• 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 more detailed conditions and manner of entering a medicine into the Register of Traditional Herbal Medicines („Official Gazette of Montenegro” No 04/15)
• Rulebook on more detailed conditions and manner of entering a medicine into the Register of Homeopathic Medicines  („Official Gazette of Montenegro” No 06/15)
• 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 issuance of marketing authorisation for a medicinal product (“Official Gazette of Montenegro” No 21/16 and 55/19)
• Rulebook on the contents and method of labelling the outer and immediate packaging of a medicine and contents of the package leaflet (“Official Gazette of Montenegro” No 21/16 and 67/18)
• 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)

Rulebooks

• Rulebook on the contents and manner of labelling packaging of a veterinary medicine (“Official Gazette of Montenegro” No 82/23)
• Rulebook on more detailed conditions and manner of determining fulfillment of conditions for performing wholesale of veterinary medicinal products (“Official Gazette of Montenegro”, No 44/16)
• Rulebook maximum residue levels of pharmacologically active substances of medicines for veterinary use in products of animal origin (“Official Gazette of Montenegro”, No 74/24) – document in Montenegrin
  
  
• Rulebook on the form, content, manner and period of reporting on sale of medicines („Official Gazette of Montenegro“ No 2/13)
• Rulebook on more detailed conditions for issuance of marketing authorisation for a medicinal product (“Official Gazette of Montenegro” No 21/16 and 55/19)
• 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

• Order to prohibit treating animals with certain substances and veterinary medicines – document in Montenegrin (“Official Gazette of Montenegro” No 17/24)

European Union legislation

• Consolidated text: Commission Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, last amended with Commission Implementing Regulation (EU) 2024/860 of 18 March 2024  (updated on 06.08.2024.)
• Consolidated text: Commission Regulation (EC) No 1950/2006 on a list of substances essential for the treatment of equidae and of substances bringing added clinical benefit (published on 13.04.2022.)
• Consolidated text: Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC (published on 13.04.2022.)

Note: These Regulations are published in the Montenegrin language

• Rulebook on more detailed conditions and manner of determining fulfillment of conditions for manufacture of medicines (“Official Gazette of Montenegro” No 72/15)
• 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)

• 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)

• 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)

• Decree on the criteria of setting maximum prices of medicines  (“Official Gazette of Montenegro” br.130/21 i and 09/22 abnd 20/24)

• Rulebook on the form, content, manner and period of reporting on sale of medicines („Official Gazette of Montenegro“ No 2/13)