The Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 1988

Explanatory Note

(This note is not part of the Regulations)

These Regulations consolidate with amendments the Medicines (Labelling of Medicated Animal Feeding Stuffs) Regulations 1973 and that part of the Medicines (Labelling) Regulations 1976, as amended, (“the 1976 Regulations”) which dealt with medicinal products for incorporation in animal feeding stuffs and medicated animal feeding stuffs in respect of which a product licence or an animal test certificate had been granted under the Medicines Act 1968. The 1976 Regulations implemented in part Council Directive 81/851/EEC (OJ No. L317, 6.11.81, p.1) on the approximation of the laws of the Member States relating to veterinary medicinal products.

These Regulations impose detailed requirements relating to the labelling of containers and packages of such medicinal products and medicated feeding stuffs which are sold or supplied in the United Kingdom in the course of a business or are in the possession of any person for the purpose of sale or supply in the United Kingdom (regulation 3). The Regulations—

(a) prescribe standard labelling requirements in respect of medicinal products and excepted medicated feeding stuffs (regulation 4 and Schedule 2) and other medicated feeding stuffs (regulation 5 and Schedule 3);

(b) prescribe special labelling requirements in respect of—

(i) medicinal products and medicated feeding stuffs for administration in medicinal tests on animals (regulation 6 and Schedule 4);

(ii) certain medicinal products exempt from product licences and medicated feeding stuffs in which such products have been incorporated (regulation 7);

(c) make provision for the sale or supply of medicinal products and medicated feeding stuffs not enclosed in a container, if specified particulars are set out in an accompanying leaflet (regulation 8);

(d) impose general requirements relating to such matters as the manner of labelling (regulation 9), prohibit the removal of labels in certain circumstances (regulation 10), provide exemptions (regulation 11) and transitional provisions (regulation 12) and create offences (regulation 13).

The principal changes of substance effected by these Regulations are—

(a) the requirement to specify in certain cases a withdrawal period or standard withdrawal period before an animal treated with a medicated feeding stuff is slaughtered for human consumption and before products derived from such an animal are taken for human consumption (regulations 2(1) and 7(2), Schedule 1, Schedule 2, paragraph 11 and Schedule 3, paragraph 7);

(b) the increase of the maximum fine which may be imposed on summary conviction for an offence against the Regulations or against certain provisions of the Medicines Act 1968 relating to labelling from £400 to £2,000 (regulation 13(a)).