Paragraph 38 Suspension, etc. of a marketing authorisationI1
United Kingdom
The Secretary of State may suspend, vary or revoke a marketing authorisation at any time if he is satisfied that—
this is necessary for the protection of animal or public health or the environment;
the terms of the marketing authorisation have not been complied with;
the veterinary medicinal product has insufficient therapeutic effect.
He must suspend, vary or revoke a marketing authorisation if he is satisfied that—
the risk-benefit balance is unfavourable;
the withdrawal period does not ensure that residues in foodstuffs obtained from the treated animal comply with Council Regulation (EEC) No. 2377/90;
information given in the application documents is incorrect;
any control tests required have not been carried out;
changes have been made to the manufacturing process without the authority of the Secretary of State;
any information required to be supplied to the Secretary of State has not been communicated to him.
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.
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.
He shall publicise a revocation in such manner as he sees fit.
Annotations
Commencement
- I1
Sch. 1 para. 38 in force at 1.10.2006, see reg. 1