The Veterinary Medicines Regulations 2006

Suspension, etc. of a marketing authorisation U.K.

38.—(1) The Secretary of State may suspend, vary or revoke a marketing authorisation at any time if he 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) He must suspend, vary or revoke a marketing authorisation if he 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 him.

(3) He may also suspend, vary or revoke a marketing authorisation if he 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 he 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) He shall publicise a revocation in such manner as he sees fit.

Commencement Information

I1 Sch. 1 para. 38 in force at 1.10.2006, see reg. 1