# The Veterinary Medicines Regulations 2005, Paragraph 38: Suspension, etc., of a marketing authorisation


(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.

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Source: https://www.legislation.gov.uk/uksi/2005/2745/schedule/1/paragraph/38 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2005/schedule-1/paragraph-38
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.