In accordance with the Law on Medicinal Products, wholesalers are legal persons seated in Montenegro that have a wholesale authorisation for medicines.

Wholesale shall include all activities consisting of procuring, holding, supplying or exporting medicines apart from supplying medicines to the public.

Wholesale distribution is subject to the possession of an authorisation to engage in activity as a wholesaler in medicinal products, stating the premises located on their territory for which it is valid, and it may be performed by:

• legal or natural persons established in Montenegro who hold a wholesale distribution authorisation (wholesalers);
• manufacturers established and authorised in Montenegro, for medicinal products covered by the manufacturing 

Wholesale is carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public.

Only medicinal products that have been granted a marketing authorisation or registered in accordance with this Law, as well as medicinal products referred to in Article 30 of this Law, may be included in wholesale distribution in Montenegro.

The wholesale distribution of donated or humanitarian aid medicinal products is also considered wholesale distribution.

Retail distribution includes dispensing and sale of medicinal products directly to public.

Retail distribution shall be conducted in accordance with special legislation.

Wholesale authorisation for medicines for human use is issued by the Institute, while wholesale authorisation for veterinary medicines is issued by the Directorate for Foodsafety, Veterinary and Phytosanitary Affairs.

Wholesale authorisation is issued for an indefinite period, except for medicines containing drugs.

Wholesale authorisation for medicines containing drugs is in accordance with the Law about preventing drugs abuse issued for 5 years. 

Legal or physical person performing wholesale of medicines shall act in accordance with Guidelines of Good Distribution Practice for medicines for human use (published 12.10.2020.).

Institute shall issue a certificate on the application of Guidelines of Good Distribution Practice (GDP certificate) based on verification of the fulfillment of conditions in accordance with this Law and secondary legislation before commencing wholesale for a period of up to 5 years from the control of fulfillment of conditions and at the request of the wholesaler.

Register of wholesalers is available here. The register is updated in accordance with amendments of its content (last update 27.3.2026).