The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994

Application of the Medicines Act 1968, the Trade Descriptions Act 1968 and the Consumer Protection Act 1987 to marketing authorisations

18.—(1) Section 7 of the Medicines Act 1968 (which requires, inter alia, the products to which these Regulations apply to be the subject of product licences) shall not apply to the placing on the market of a veterinary medicinal product to which these Regulations apply except for those products which are to retain product licences by virtue of the provisions of regulation 19(1) below.

(2) The following provisions of the Medicines Act 1968 and instruments made under those provisions shall apply in relation to marketing authorisations as they apply in relation to product licences granted under that Act:

• section 23 (special provisions as to effect of manufacturer’s licence);

• section 40 (medicated animal feeding stuffs);

• sections 51 to 54 (provisions as to sale or supply of medicinal products);

• sections 55 to 57 (exemptions from sections 52 and 53);

• sections 58 to 63 (additional provisions);

• sections 67 and 68 (offences and provision for disqualification);

• sections 85 and 86 (labelling and marking);

• sections 92 to 97 (promotion of sales of medicinal products);

• sections 108 to 110 (enforcement);

• section 111 (rights of entry);

• section 112 (powers to inspect, take samples and seize goods and documents);

• section 113 (application of sampling procedures);

• section 114 (supplementary provisions);

• section 115 (analysis of samples);

• section 119 (protection of officers of enforcement authorities);

• section 121 (contravention due to default of another person);

• section 122 (warranty as defence);

• section 123 (offences in relation to warranties);

• section 124 (offences by bodies corporate);

• section 125 (prosecutions);

• section 126 (presumptions);

• section 127 (service of documents);

• section 132 (interpretation);

• section 133(2) (general provisions as to operation of the Act);

• section 134(3), (4) and (5) (special provisions as to Northern Ireland).

(3) In sections 3 and 4 of the Medicines Act 1968, which relate to the commission and committees, any function of the commission or a committee relating to product licences shall apply to marketing authorisations in the same way as they apply to licences.

(4) In sections 32 to 39 of the Medicines Act 1968, which relate to animal tests, a marketing authorisation granted under these Regulations shall be sufficient for any requirement in those sections that any person must be in possession of a product licence.

(5) The provisions of the Trade Descriptions Act 1968(1) shall apply to the application of a trade description to goods subject to a marketing authorisation in the same way as, by virtue of section 2(5)(b) of that Act, they apply to the application of a trade description to goods subject to any provision made under Part V of the Medicines Act 1968.

(6) The provisions of the Consumer Protection Act 1987(2) shall apply to a product for which a marketing authorisation has been granted in the same way as they apply to a licensed medicinal product as defined in section 19 of that Act.

(7) It shall be the duty of—

(a) the Minister of Agriculture, Fisheries and Food in relation to England,

(b) the Secretary of State in relation to Scotland and Wales, and

(c) the Department of Health and Social Services for Northern Ireland in relation to Northern Ireland,

to enforce the provisions of these Regulations, and such duty shall be deemed to be a duty imposed by sections 108 to 110 of the Medicines Act 1968 as appropriate.

(1)

1968 c. 29; the relevant amendment to section 2(5) is in the Medicines Act 1968, Schedule 5, paragraph 16.

(2)

1987 c. 43.