Paragraph 37 Compulsory variation

If the Secretary of State decides, for any of the reasons for which he may or must suspend a marketing authorisation specified in paragraph 38, or because the classification of a veterinary medicinal product should be changed, that a variation to a marketing authorisation is necessary, he must notify the marketing authorisation holder in writing of the required variation, together with his reasons.

In the notification he may specify a time limit within which the marketing authorisation holder must apply for the variation.

If the variation is on the grounds of safety, quality or efficacy, the applicant may, within 28 days of the notification, appeal to the Veterinary Products Committee.

If the marketing authorisation holder fails to apply for the variation within that time limit the Secretary of State may suspend or revoke the marketing authorisation.