Classification of changes: questions and answers

This page is intended to provide advice to Marketing Authorisation Holders of centrally authorised medicinal products about classification of changes to the Marketing Authorisation post-authorisation and certain variation classification categories. Revised topics are marked 'New' or 'Rev.' upon publication.

A PDF version of the entire post-authorisation guidance is available:

It should be read in conjunction with the European Commission 'Variations Guidelines' 2013/C 223/01 and the CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008.

MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

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