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)

CHAPTER III U.K. VARIATIONS TO CENTRALISED MARKETING AUTHORISATIONS

Article 14 U.K. Notification procedure for minor variations of type IA

1. Where a minor variation of type IA is made, the holder shall submit to the Agency a notification containing the elements listed in Annex IV. This notification shall be submitted within 12 months following implementation of the variation.

However, the notification shall be submitted immediately after the implementation of the variation in the case of minor variations requiring immediate notification for the continuous supervision of the medicinal product concerned.

2. Within 30 days following receipt of the notification, the measures provided for in Article 17 shall be taken.