The Institute for Medicines and Medical Devices of Montenegro (hereinafter: the Institute) announces that the updated instructions and form for submitting application for the transfer of marketing authorisation have been published on the Institute’s website, aligned with the new Law on Medicines (“Official Gazette of Montenegro”, No. 14/26).

According to the updated instructions, it is necessary to submit the Power of Attorney for representation in Montenegro, which replaces the previous practice of submitting a representation agreement. The form for preparing the Power of Attorney for representation in Montenegro (in Montenegrin and English), can be found in the section Instructions and forms.

All applicants are kindly requested to follow the published guidelines when preparing and submitting documentation and to use the prescribed templates.