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Commission Regulation (EC) No 1234/2008Dangos y teitl llawn
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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Changes over time for: Article 9
Version Superseded: 17/05/2024
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Article 9U.K.Notification procedure for minor variations of type IB
1.The holder shall submit simultaneously to all relevant authorities a notification containing the elements listed in Annex IV.
If the notification fulfils the requirement laid down in the first subparagraph, the competent authority of the reference Member State shall, after consulting the other Member States concerned, acknowledge receipt of a valid notification.
2.If within 30 days following the acknowledgement of receipt of a valid notification, the competent authority of the reference Member State has not sent the holder an unfavourable opinion, the notification shall be deemed accepted by all relevant authorities.
Where the notification is accepted by the competent authority of the reference Member State, the measures provided for in Article 11 shall be taken.
3.Where the competent authority of the reference Member State is of the opinion that the notification cannot be accepted, it shall inform the holder and the other relevant authorities, stating the grounds on which its unfavourable opinion is based.
Within 30 days following the receipt of the unfavourable opinion, the holder may submit to all relevant authorities an amended notification in order to take due account of the grounds laid down in that opinion.
If the holder does not amend the notification in accordance with the second subparagraph, the notification shall be deemed rejected by all relevant authorities and the measures provided for in Article 11 shall be taken.
4.Where an amended notification has been submitted, the competent authority of the reference Member State shall assess it within 30 days following its receipt and the measures provided for in Article 11 shall be taken.
[F15. 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 10 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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