S.L. 437.47 Art. 76Regulations dealing with the prohibition or withdrawal of the supply of a veterinary medicinal product.

(1) Without prejudice to regulation 75, in the Director, shall take the necessary measures to ensure that the supply of a veterinary medicinal product is prohibited and the medicinal product concerned is withdrawn from the market where -

(a) it is clear that the risk-benefit assessment of the veterinary medicinal product is, under the authorized conditions of use, unfavourable, particular regard being had to the benefits for animal health and welfare and to the safety and health benefits for the consumer, when the authorisation concerns a veterinary medicinal product for zootechnical use;

(b) the veterinary medicinal product has no therapeutic effect on the species of animal for which the treatment was intended;

(c) the qualitative and quantitative composition of the veterinary medicinal product is not as stated;

(d) the recommended withdrawal period is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer;

(e) the control tests referred to in regulation 73(1) have not been carried out, or any other requirement or obligation relating to the grant of the manufacturing authorisation referred to in regulation 38(1) has not been complied with.

(2) The Veterinary Services may confine the prohibition on supply and withdrawal from the market solely to the contested production batches.