Paragraph 37 Compulsory variation

If the Secretary of State decides, for any of the reasons for suspending 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, the Secretary of State must by a notification in writing to the holder of the marketing authorisation require that person to apply for a variation of the marketing authorisation, giving reasons for requiring the application to be made.

The notification 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.