Article 5 classification requests for variation applications

The European Commission has published a guideline on the classification of variation applications. The Commission guideline is updated regularly, and the classifications might be changed pursuant to Article 5 of the Commission Regulation No. 1234/2008, if the marketing authorisation holder cannot classify the variation application using the existing guideline. For more information and instruction on the Article 5 classifications, visit the CMDh website.

To submit an Article 5 classification request for a national marketing authorisation or an MRP or DCP marketing authorisation where Finland is a Reference Member State, fill in the CMDh Request form for a recommendation - Article 5. Submit the form by email to mrp(a)fimea.fi. On the subject line, please write Art. 5 variation classification request.