Wholesale/Good Distribution Practice
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 of medicines includes also import and export.
Wholesale may be performed by:
- wholesalers which have the wholesale authorisation issued by the Institute for medicines for human use, or the competent authority for veterinary affairs for medicines for veterinary use; and
- manufacturers of medicines seated in Montenegro for a medicine they manufacture.
Wholesale may only be performed with medicines having marketing authorisation and medicines referred to in the Article 5 of the Law on medicines.
Wholesale of medicines from humanitarian aid shall also be considered the wholesale.
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 for medicines for human and veterinary use that contain drugs is issued by the Institute.
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 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 26.2.2024).
Legal persons seated in Montenegro performing the activities of manufacture, import and distribution of active substances shall enrole in the Register of manufacturers, importers, or wholesalers of active substances.
Register of manufacturers, importers, or wholesalers of active substances is available here. The register is updated in accordance with amendments of its content (last update 26.10.2023).
Instructions and forms
- Instruction for applicants for Registration/amendment to Registration/removal from the Register of manufacturer, importer or distributor of active substances (published on 28.6.2023.)
Registration of manufacturer, importer or distributor of active substances (published on 28.6.2023.)
Application form for Registration/amendment to Registration/removal from the Register of manufacturer, importer or distributor of active substances – pdf (published on 28.06.2023.)
Application form for Registration/amendment to Registration/removal from the Register of manufacturer, importer or distributor of active substances – word (published on 28.06.2023.)
- Instruction for applicants for obtaining/amending/cessation of validity of wholesale authorisation for medicines (updated 1.6.2023.)
- Instruction for applicants for obtaining/amending/extension/cessation of validity of wholesale authorisation for narcotic drugs (updated 1.6.2023.)
- Instruction for applicants for obtaining/amending/extension/cessation of validity of wholesale authorisation for veterinary narcotic drugs (updated 1.6.2023)
- Application form for obtaining/amending/cessation of validity of wholesale authorisation for medicines (updated 29.5.2023.)
- Application form for obtaining/amending/extension/cessation of validity of wholesale authorisation for narcotic drugs (updated 29.5.2023.)
- Application form for obtaining/amending/extension/cessation of validity of wholesale authorisation for veterinary narcotic drugs (updated 29.5.2023.)
- Wholesale authorisation for medicines for human use (published 12.10.2020.)
- GDP inspection report format (published 12.10.2020.)
- GDP certificate – medicines for human use (12.10.2020.)
- GDP certificate – active substances (published 12.10.2020.)
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Here you can search for medicines in our register
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