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The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994

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Duties on persons responsible for placing products on the market

6.—(1) After a marketing authorisation has been issued, the person responsible for placing a veterinary medicinal product on the market shall comply with:

(a)articles 5.2.13, 14, 15, 42.2, 42c, 42d and 43 to 48 of Council Directive 81/851/ EEC;

(b)the third paragraph of the introduction to the Annex to Council Directive 81/ 852/EEC and, if appropriate, the final paragraph of Title I, Part 4, Chapter II.1 and the final paragraph of Title I, Part 4, Chapter III, 2.1 of Council Directive 81/852/EEC;

(c)if appropriate, articles 2 and 3 of Council Directive 90/677/EEC;

(d)any direction given by the Ministers in accordance with article 37 of Council Directive 81/851/EEC; and

(e)the requirement in article 35 of Council Directive 81/851/EEC to provide the data specified in that article.

(2) In addition to the requirements in the provisions referred to in the preceding paragraph relating to information to be provided on labels and package inserts, the holder of a marketing authorisation shall ensure that labels and package inserts—

(a)include the words “store out of reach of children”;

(b)include the following initials in a box within which there is no other written material:

(i)in the case of a product categorised under the Medicines Act 1968 as a medicinal product on prescription only (that is, a prescription only medicine), the capital letters “POM”;

(ii)in the case of a product categorised under that Act as a Pharmacy and Merchants' List product, the capital letters “PML”;

(iii)in the case of a product categorised under that Act as a medicinal product on a general sale list, the capital letters “GSL”;

(iv)in any other case the capital letter “P”;

(c)do not include any reference to the Medicines Act 1968, the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994, any committee established under section 4 of the Medicines Act 1968, the Medicines Commission or the Committee for Veterinary Medicinal Products;

(d)do not refer to any other product except in accordance with the marketing authorisation; and

(e)do not falsely describe the product, or mislead as to its nature, quality, uses or effects.

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