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 25.3.2025).

Instructions and forms for aplication

Instruction for applicants for Registration/amendment to Registration/removal from the Register of manufacturer, importer or distributor of active substances (update on 04.9.2025.)

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.)

Standardized form

Registration of manufacturer, importer or distributor of active substances (published on 28.6.2023.)

Search register

Here you can search for medicines in our register

Sign up for

Newsletter