The Institute for Medicines and Medical Devices of Montenegro (hereinafter: the Institute) hereby informs all marketing authorisation holders for medicinal products for human use of the following:

The application form for the submission of variations has been updated on the Institute’s portal. A new section, E.7 – Administrative changes that cannot be classified under other categories in this Annex, has been added to the form.

Applicants are kindly requested to use the updated version of the APF form when submitting applications for variations.

All details regarding the submission of applications, required documentation, and applicable timelines are available on the official portal of the Institute or may be obtained directly via the contact information provided on the portal.