The Veterinary Medicines Regulations 2005

Application in another member State

42.—(1) When the Secretary of State has granted a marketing authorisation for a veterinary medicinal product and she is notified by the marketing authorisation holder that he has applied to have that veterinary medicinal product authorised in another member State, she shall prepare an assessment report for the product within 90 days of the notification and send it to the member State or States concerned.

(2) If the other member State (or, if there is more than one, all of them) agrees with the assessment report, the summary of product characteristics, the labelling and the package leaflet she need take no further action.

(3) If not all the other member States concerned agree with the assessment report, the summary of product characteristics, the labelling and the package leaflet within a further 90 days she shall send a detailed statement setting out why they have disagreed to the other member States, the applicant and the coordination group for action in accordance with Article 33(3) of Directive 2001/82/EC.

(4) The Secretary of State shall comply with the decision of the coordination group or, if the coordination group refers the matter to the Agency, the decision of the Commission within 30 days.