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 inter alia the recommendations of the EMA as well as CMDh in the case of nationally authorised products through the mutual recognition/decentralised procedure. Article 5 of the Variation Regulation provides the basis for a marketing authorisation holder (MAH) or a
competent authority of a Member State (NCA) to request CMDh for nationally authorised products or EMA for centrally authorised products to deliver a recommendation on classification of an unforeseen variation. This recommendation shall be consistent with the Commission guideline and be delivered within 45 days following the receipt of the request. Cooperation between the CMDh and the EMA is envisaged by the legislation. The 45 days may be extended by an additional 25 days where the EMA deems it necessary to consult with the CMDh. The recommendations shall be published once adopted…
