Article 5 classification requests for variation applications

The European Commission has published an online guideline on the classification of variation applications (PDF). 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 CMD(h) 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 CMD(h) form Request for a recommendation on the classification of an unforeseen variation under Article 5 of commission regulation (EC) no 1234/2008. Submit the form by email to mrp(a)fimea.fi. On the subject line, please write Art. 5 variation classification request.