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The Veterinary Medicines Regulations 2006
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Changes over time for: Paragraph 38
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- 01/10/2006- Amendment
- 01/10/2006
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There are currently no known outstanding effects for the The Veterinary Medicines Regulations 2006, Paragraph 38.
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Suspension, etc. of a marketing authorisationU.K.
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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
I1Sch. 1 para. 38 in force at 1.10.2006, see reg. 1
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