The Institute for medicines and medical devices of Montenegro (hereinafter: the Institute) hereby informs all applicants and marketing authorisation holders for medicinal products for human use that a new Regulation and a new Guideline in the field of variations have been adopted in the European Union.

In accordance with the new Guideline, which will apply as of 15 January 2026, changes have been introduced to the classification of variations. Accordingly, a new application form and updated Guidance on the submission of applications and documentation for variations have been published on the Institute’s website. These documents are available on the Institute’s website under: Human medicines / Placing a medicine on the market / Amendments to marketing authorisation (variations).

The deadline for the submission of variations in accordance with the previous classification (using the previously applicable application form) is three months from the date of entry into force of the new regulatory framework, i.e. until 15 April 2026. After this period, all variations may be submitted exclusively in accordance with the new classification, using the valid application form and in line with the updated guidance.

The Institute recommends that marketing authorisation holders, wherever possible, start submitting variations in accordance with the new classification and guideline as early as possible, in order to facilitate the transition period, avoid potential procedural uncertainties and ensure efficient and timely processing of applications.

The Institute invites its users to familiarise themselves in a timely manner with the introduced changes and to adjust their procedures to the new regulatory requirements. All details regarding application submission, required documentation and timelines are available on the Institute’s official website or may be obtained directly via the contact details provided on the website.