The Veterinary Medicines Regulations 2008

Suspension of a marketing authorisation: procedure

39.—(1) If a marketing authorisation is suspended the Secretary of State must notify the holder immediately, and, unless the Secretary of State directs otherwise, the suspension has immediate effect, and continues in effect unless the marketing authorisation is reinstated.

(2) If the suspension is on the grounds of safety, quality or efficacy, the holder may, within 28 days of the notification, appeal to the Veterinary Products Committee.

(3) If the veterinary medicinal product is authorised in more than one member State, the Secretary of State—

(a) must immediately refer the matter to the Agency, and must comply with a decision of the Commission within 30 days of the decision; and

(b) may suspend the marketing and the use of the veterinary medicinal product in the United Kingdom pending a decision of the Agency, but must inform the Commission and the other member States no later than the following working day of the reasons for the action.

(4) When a marketing authorisation is suspended, the Secretary of State may in addition prohibit the supply of the veterinary medicinal product, and if necessary require the marketing authorisation holder to recall the product; and failure to comply with a requirement or prohibition under this sub-paragraph is an offence.