The Veterinary Medicines Regulations 2008

Suspension of a marketing authorisation: grounds

38.—(1) The Secretary of State may suspend a marketing authorisation at any time on being 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; or

(c) the veterinary medicinal product has insufficient therapeutic effect.

(2) The Secretary of State may also suspend a marketing authorisation on being 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 the veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.

(3) The Secretary of State must suspend a marketing authorisation on being 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; or

(f) any information required to be supplied to the Secretary of State has not been so supplied.