In accordance with the Law on medicines, the Institute for medicines and medical devices shall:

• issue a consent for import of unauthorised medicines in accordance with the Article 5 of this Law,
• issue approval for import and export of immunological medicines and medicines from blood and plasma.

In accordance with Article 133 of the Law on medicines, the import and export of medicine falls within the wholesale of medicines. Wholesale of medicines may be performed by wholesalers which have the wholesale authorization for veterinary medicines issued by the  Directorate for Food Safety, Veterinary and Phytosanitary Affairs.

Required documentation for import/export of veterinary medicines is provided in the Instruction – Required documentation for import of veterinary medicinal products that do not have marketing authorization and export of immunological veterinary medicinal products  (updated 5.12.2023.). 

Excel table that is an integral part of the application shall be completed in line with the document – Instruction for completing excel table for import of veterinary medicinal products that do not have marketing authorisation (updated 31.3.2022.) and sent to: [email protected].

Processing of the application for the approval of procurement, i.e. import/export of veterinary medicines is paid for. More detailed information on the payment method and amount of fees for the exercise of competences of the Institute is available in the section Price list.

Information on veterinary medicines for which import authorization has been issued in current year is available here.  (updated  4.4. 2024.)

Veterinary medicines that obtained the approval for import into Montenegro in previous years are listed below:

• 2023.
• 2022.
• 2021.
• 2020.

• 2019.

• 2018.

• 2017.

• 2016.

• 2015.

• 2014.

• 2013.

• 2012.

• 2011.

• 2010.

In line with the Law on Medicines, the Institute for medicines and medical devices, shall issue authorizations for medicines containing drugs and precursors in accordance with the Law about Preventing Drug Abuse and  Law on Control of manufacture and marketing of substances that may be used in the manufacture of narcotic drugs and psychotropic substances that regulate these areas.  

Wholesale authorisations for human and veterinary medicines that contain drugs shall be issued by the Institute.

More detailed information on how to submit an application and required documentation for obtaining wholesale authorization for veterinary medicines that contain drugs is available in the section Wholesale of medicines/Good Distribution Practice.

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

When import/export/transit of drugs and psychotropic substances is in question, registered legal person shall submit to the Institute Application for import, export or transit of drugs, accompanied by appropriate documentation. In the same manner Application for import, export and transit of precursors may be submitted, also accompanied by appropriate documentation.

More detailed information on how to submit an application and required documentation for import/export/transit of drugs and precursors and medicines that contain prcursors is available in the section Controlled substances .