Article 5 procedure: Regulatory and procedural guidance

Marketing authorisation holders (MAHs) can request a recommendation on the classification of an unforeseen variation, in line with Article 5 of the Commission Regulation (EC) No 1234/2008. This refers to a marketing authorisation variation that is not detailed in the European Commission guideline that highlights the various categories of variations, and that does not have a recommendation under Article 5.

For centrally authorised medicines, MAHs have to address requests for a recommendation on the classification of an unforeseen variation to the European Medicines Agency (EMA).

For nationally authorised medicines, MAHs have to submit such requests to a relevant national competent authority (NCA). 

EMA provides guidance for MAHs on how to request such a recommendation for a human medicine authorised through the centralised procedure:

European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008

AdoptedReference Number: EMA/588416/2008 Rev. 3

Request to CMDh / European Medicines Agency for a recommendation on the classification of an unforeseen variation under Article 5 of Commission Regulation (EC) No 1234/2008