World Trade Organization

Import Licensing Procedures

Human and veterinary medicines, and medical devices

Decision on the manner of payment and amount of fees for issuance of authorisations, certificates and approvals for manufacture and marketing of medicines (OG MNE No.22/13
17/05/2013
In force to 09/11/2023
Law on Administrative Procedure (OG MNE No.56/14)
Law on Administrative Procedure (OG MNE No.20/15)
Law on Administrative Procedure (OG MNE No.40/16)
Law on Administrative Procedure (OG MNE No.37/17)
Law on Medicines (OG MNE No.080/20)
Decision on the mode of payment and amount of fees for entering and removing medical devices, manufacturers and legal persons that market and import medical devices into and from the Register, as well as keeping the Register (OG MNE No.78/09)
Law on Medical Devices (OG MNE No.24/19)
Rulebook on more detailed conditions for import of medical devices that are not registered ("Official Gazette of Montenegro", No. 073/22)
Rulebook on more detailed conditions for import of medical devices that are not registered ("Official Gazette of Montenegro", No. 126/22).
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)
In force to 12/06/2024
Decision on the amount and payment method of the fees incurred by the performance of expert tasks in the area of medical devices "Official Gazette of Montenegro" No.35/23