The Veterinary Medicines Regulations 2009

PART 5 Suspension, etc. of a marketing authorisation

Suspension of a marketing authorisation: grounds

38.—(1) The Secretary of State may suspend a marketing authorisation at any time on being satisfied that —

(a) this is necessary for the protection of animal or public health or the environment;

(b) the terms of the marketing authorisation have not been complied with; or

(c) the veterinary medicinal product has insufficient therapeutic effect.

(2) The Secretary of State may also suspend a marketing authorisation on being satisfied that a marketing authorisation holder has failed to make an application for a variation to take account of scientific and technical progress in manufacturing and control methods to enable the veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.

(3) The Secretary of State must suspend a marketing authorisation on being satisfied that—

(a) the risk-benefit balance is unfavourable;

(b) the withdrawal period does not ensure that residues in foodstuffs obtained from the treated animal comply with Council Regulation (EEC) No 2377/90;

(c) information given in the application documents is incorrect;

(d) any control tests required have not been carried out;

(e) changes have been made to the manufacturing process without the authority of the Secretary of State; or

(f) any information required to be supplied to the Secretary of State has not been so supplied.

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.

Revocation

40.  The Secretary of State may revoke any marketing authorisation that has been suspended for more than 28 days unless there is a current appeal to the Veterinary Products Committee, and may publicise a revocation in such manner as the Secretary of State sees fit.

Prohibiting the supply of veterinary medicinal products

41.—(1) In addition to the powers to suspend a marketing authorisation, the Secretary of State, on being satisfied that a product has not been manufactured in accordance with the marketing authorisation, may prohibit the supply of a veterinary medicinal product, and if necessary require the marketing authorisation holder to recall it, and failure to comply with a requirement or prohibition under this sub-paragraph is an offence.

(2) The prohibition on supply and the requirement for recall may be confined to specific production batches.

(3) In the case of an immunological veterinary medicinal product manufactured outside the United Kingdom, if a batch has had all the tests that were originally carried out by the manufacturer repeated by the competent authority of another member State, the Secretary of State may not prohibit the release of that batch if all the results have been submitted to the Secretary of State and the results demonstrate that the product is within the terms of the authorisation.