Article 3 paragraph 1 of Commission Regulation (EC) No 1234/2008 (Variation Regulation) refers to Annex II where a classification of minor variations, type IA and major variations, type II, is laid down. The classification of extensions of a marketing authorisation is laid down in a list in Annex I.
Article 4 of the Variation Regulation confers on the Commission the obligation to establish guidelines on the details of the various categories of variations. These guidelines shall be regularly updated, taking into account the annual report sent by the EMA in cooperation with the CMDh that includes the recommendations for unforeseen variations referred to in Article 5.
Article 5 of the Variation Regulation provides the basis for a marketing authorisation holder (MAH) to request to the EMA (in case of centralised marketing authorisations), the Reference Member State (RMS) (in case of Mutual Recognition or Decentralised marketing authorisations), or a national competent authority of a Member State (NCA) (in case of purely national marketing authorisations) to deliver a recommendation on classification of an unforeseen variation before the submission of the variation…
