Article 7: Grouping of variations

Location:

Chapter I

Source:

1. Where several variations are notified or applied for, a separate notification or application in accordance with Chapters II, III, or Article 19 as appropriate shall be submitted in respect of each variation sought.

2. By way of derogation from paragraph 1, the following shall apply:

(a) where minor variations of type IA to the terms of the same marketing authorisation are notified at the same time, a single notification as referred to in Article 8 or 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;

(c) where several variations to the terms of the same marketing authorisation are submitted at the same time and the variations do not fall within one of the cases listed in Annex III, a single submission may cover all such variations provided that the competent authority of the reference Member State in consultation with the competent authorities of the Member States concerned or, in the case of a centralised marketing authorisation, the Agency agrees to such single submission.

The submission referred to in subparagraphs (b) and (c) shall be made simultaneously to all relevant authorities by means of the following:

(i) a single notification in accordance with Article 9 or 15 where at least one of the variations is a minor variation of type IB and the remaining variations are minor variations;

(ii) a single application in accordance with Article 10 or 16 where at least one of the variations is a major variation of type II and none of the variations is an extension;

(iii) a single application in accordance with Article 19 where at least one of the variations is an extension.