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Commission Regulation (EC) No 1234/2008Show full title
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)
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Article 15U.K.Notification procedure for minor variations of type IB
1.The holder shall submit to the Agency a notification containing the elements listed in Annex IV.
If the notification fulfils the requirement laid down in the first subparagraph, the Agency shall acknowledge receipt of a valid notification.
2.If within 30 days following the acknowledgement of receipt of a valid notification the Agency has not sent the holder an unfavourable opinion, its opinion shall be deemed favourable.
Where the opinion of the Agency on the notification is favourable, the measures provided for in Article 17 shall be taken.
3.Where the Agency is of the opinion that the notification cannot be accepted, it shall inform the holder, stating the grounds on which its unfavourable opinion is based.
Within 30 days of receipt of the unfavourable opinion, the holder may submit to the Agency an amended notification in order to take due account of the grounds laid down in that opinion.
[F1If the holder does not amend the notification in accordance with the second subparagraph, the notification shall be deemed rejected.]
4.Where an amended notification has been submitted, the Agency shall assess it within 30 days following its receipt and the measures provided for in Article 17 shall be taken.
[F25. This Article shall not apply where a type IB variation request is submitted in a grouping that includes a variation type II and does not contain an extension. In such case, the prior approval procedure in Article 16 shall apply.
This Article shall not apply where a type IB variation request is submitted in a grouping that includes an extension. In such case, the procedure in Article 19 shall apply.]
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