The Institute for Medicines and Medical Devices of Montenegro (hereinafter: the Institute) informs all marketing authorisation holders for medicinal products for human use that an updated application form for the notification/approval of variations has been published on the Institute’s website, under Human Medicines / Marketing Authorisation / Guidelines and Forms. The updated form includes an additional variation type: z) other variations.

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

Full details regarding application submission, required documentation and deadlines are available on the Institute’s official website or may be obtained directly using the contact details provided on the website.