Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance) (c. 1234)

[F1 CHAPTER IIa U.K. VARIATIONS TO PURELY NATIONAL MARKETING AUTHORISATIONS

Article 13d U.K. Grouping of variations to purely national marketing authorisations

1. Where several variations are notified or applied for, a separate notification or application in accordance with Articles 13a, 13b, 13c, or 19 as appropriate shall be submitted to the competent authority in respect of each variation sought.

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

(a) where the same minor variation(s) of type IA to the terms of one or more marketing authorisations owned by the same holder are notified at the same time to the same competent authority, a single notification as referred to in Article 13a may cover all such variations;

(b) where several variations to the terms of the same marketing authorisation are submitted at the same time to the same competent authority, 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 the same variation(s) to the terms of one or more marketing authorisations owned by the same holder are submitted at the same time to the same competent authority and they are not covered under subparagraph (a) or (b), a single submission may cover all such variations provided that the competent authority agrees to such single submission.

The submission referred to in points (b) and (c) shall be made by means of the following:

(i)

a single notification in accordance with Article 13b 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 13c 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.]

Textual Amendments

F1 Inserted by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance).