Grouping of variations
Article 7
1. Where several variations are notified or applied for, a separate notification or application as laid down in Chapters II, III and IV shall be submitted in respect of each variation sought. 2. By way of derogation from paragraph 1, the following shall apply: (a) where the same minor variations of type IA to the terms of one or several marketing authorisations owned by the same holder are notified at the same time to the same relevant authority, a single notification as referred to in Articles 8 and 14 may cover all such variations; (b) where several variations to the terms of the same marketing authorisation are submitted at the same time, a single submission may cover all such variations provided that the variations concerned fall within one of the cases listed in Annex III or, if they do not fall within one of those cases, provided that the competent authority of the reference Member State in consultation with the other Member States concerned or, in the case of a centralised marketing authorisation, the Agency agrees to subject those variations to the same procedure. The submission referred to in point (b) of the first subparagraph shall be made by means of the following: — a single notification as referred to in Articles 9 and 15 where at least one of the variations is a minor variation of type IB and all variations are minor variations; — a single application as referred to in Articles 10 and 16 where at least one of the variations is a major variation of type II and none of the variations is an extension; — a single application as referred to in Article 19 where at least one of the variations is an extension.