CHAPTER IICHANGES OF AUTHORISED PRODUCTS
Article 6Notification procedure for administrative changes of products
1.
2.
Without prejudice to the second subparagraph, the notification shall be submitted within 12 months following the implementation of the change.
In case of a change referred to in Section 1 of Title 1 of the Annex to this Regulation, the notification shall be submitted before the implementation of the change.
3.
Within 30 days following receipt of the notification, where F5the competent authority disagrees with the change or the relevant fee has not been paid, F6the competent authority shall inform the authorisation holder, or its representative, F7... that the change is rejected and the grounds for the rejection.
If, within 30 days following receipt of the notification, F8the competent authority has not expressed its disagreement, F9it shall be deemed to have agreed with the change.