The Veterinary Medicines Regulations 2005

PART 5 Suspension and revocation of a marketing authorisation

Suspension, etc., of a marketing authorisation

38.—(1) The Secretary of State may suspend, vary or revoke a marketing authorisation at any time if she is 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;

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

(2) She must suspend, vary or revoke a marketing authorisation if she is 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;

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

(3) She may also suspend, vary or revoke a marketing authorisation if she is 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 a veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.

(4) When she suspends, varies or revokes a marketing authorisation, the Secretary of State may additionally prohibit the supply of a 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.

(5) She shall publicise a revocation in such manner as she sees fit.

Suspension, etc., of a marketing authorisation of a product authorised in more than one member State

39.—(1) In the case of a veterinary medicinal product that is authorised in more than one member State, where the Secretary of State considers that a variation or its suspension or withdrawal is necessary for the protection of human or animal health or the environment, she shall immediately refer the matter to the Agency, and shall comply with a decision of the Agency within 30 days of the decision.

(2) Where the Secretary of State considers that immediate suspension is necessary to protect human or animal health or the environment, she may suspend the marketing and the use of the veterinary medicinal product concerned in the United Kingdom pending a decision of the Agency, and in this case she shall inform the Commission and the other member States no later than the following working day of the reasons for her action.

Prohibiting the supply of veterinary medicinal products

40.—(1) In addition to her powers to suspend a marketing authorisation, if she is satisfied that a product has not been manufactured in accordance with the marketing authorisation the Secretary of State 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) She may confine the prohibition on supply and the requirement for recall 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 her and the results demonstrate that the product is within the terms of the authorisation.