The Institute for Medicines and Medical Devices of Montenegro (hereinafter: the Institute) informs that updated instructions for submitting the application and documentation for the renewal 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).

The instructions contain detailed information on the preparation and content of the documentation, with the aim of ensuring a more efficient application submission procedure, in accordance with the obligations arising from the new Law on Medicines.

The Institute invites its users to familiarise themselves with the changes in a timely manner and to comply with the updated instructions when preparing and submitting documentation.