The Institute for Medicines and Medical Devices of Montenegro (hereinafter: the Institute) hereby informs all applicants, i.e. marketing authorisation holders for veterinary medicinal products (VMP), that following the adoption of the new Law on Medicines, changes have been introduced to the classification of variations for VMPs. Accordingly, a new application form, as well as the guidance document Manner of submitting application and documentation for variations, have been published on the Institute’s portal.

The above-mentioned documents are available on the Institute’s website under the section Veterinary Medicinal Products / Marketing Authorisation / Guidelines and Forms.

The Institute invites its stakeholders to familiarise themselves with these changes and to align their procedures with the new regulatory requirements. All details regarding the submission of applications, required documentation, and applicable timelines can be found on the official portal of the Institute or obtained directly through the contact details available on the portal.