1. The holder shall submit to the competent authority a notification containing the elements listed in
Annex IV.
If the notification fulfils the requirement laid down in the first subparagraph, the competent authority shall acknowledge receipt of a valid notification.
2. If within 30 days following the acknowledgement of receipt of a valid notification, the competent authority has not sent the holder an unfavourable opinion, the notification shall be deemed accepted by the competent authority.
Where the notification is accepted by the competent authority, the measures provided for in Article 13e shall be taken.
3. Where the competent authority 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 following the receipt of the unfavourable opinion, the holder may submit to the competent authority 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.
4. Where an amended notification has been submitted, the competent authority shall assess it within 30 days following its receipt and the measures provided for in
Article 13e shall be taken.
5. 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 13c 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.