The Institute for Medicines and Medical Devices of Montenegro (hereinafter: the Institute) informs applicants for the granting of a marketing authorisation for medicines for human use and veterinary medicinal products that updated instructions on the submission of applications and documentation have been published on the Institute’s website, aligned with the new Law on Medicines (“Official Gazette of Montenegro”, No. 14/26) and the accompanying bylaws.

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 and secondary legislation.

At the same time, the Institute has published on its website a template for preparing the Power of Attorney for representation in the marketing authorisation procedure in Montenegro (in Montenegrin and English), which replaces the previous practice of submitting representation agreements.

All applicants are kindly requested to follow the published guidelines when preparing and submitting documentation and to use the prescribed template for Power of Attorney.

For additional information or inquiries, interested parties may contact the Institute using the contact details available on the Institute’s website.