Article 14 Administrative changes of products

Administrative changes referred to in Section 2 of Title 1 of the Annex may be implemented any time before completion of the procedures laid down in F1Article 6.

Administrative changes referred to in Section 1 of Title 1 of the Annex may be implemented at the earliest on the date when the F2competent authority explicitly agrees with the change, or 45 days following receipt of the notification submitted in accordance with Article 6, whichever is earliest.

Where one of the changes referred to in paragraph 1 is rejected, the authorisation holder shall cease to apply the concerned change within 30 days following notification of the decision of the F3competent authority.