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.