The Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Regulations 1994

Explanatory Note

(This note is not part of the Regulations)

These Regulations implement Article 4.1 (part), 4.3 (part), 4.4 and 4.5 (part) of 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 (“the Directive”) as amended by Council Directive 90/676/EEC (OJ No. L373, 31.12.90, p.15), and Article 2.1 (part) of Council Directive 92/74/EEC (OJ No. L297, 13.10.92, p.12) widening the scope of Directive 81/851/EEC and laying down additional provisions on homeopathic veterinary medicinal products.

The Regulations prohibit the administration of unlicensed veterinary medicinal products to animals except for specified purposes such as medicinal tests or where the Medicines (Veterinary Medicinal Products) (Veterinary Surgeons from Other EEA States) Regulations 1994 apply (regulation 4) or in specified circumstances to avoid causing unacceptable suffering to an animal (regulation 5). Additional rules apply where unlicensed products are administered to food-producing animals (regulation 5(2)), but less restrictions are applied in the case of treatment of minor or exotic species which are non-food-producing (regulation 5(3)).

The Regulations are to be enforced by the Ministers having a duty to enforce the provisions of the Medicines Act 1968 and each of those Ministers is then an “enforcement authority” under the Act (regulation 6(1)). Certain enforcement provisions of the Act are applied and offences and penalties are prescribed (regulations 6(2) and 7 to 9).

The Regulations make consequential amendments to sections 9 and 10 of the Medicines Act 1968 so as to provide that the exemptions from licensing granted to veterinary surgeons, veterinary practitioners and pharmacists do not extend to anything done in relation to ready-made veterinary medicinal products, which the Directive requires to be licensed. The only unlicensed products permitted to be administered to animals are as provided by the Directive and reflected in these Regulations, which include in certain circumstances products prepared extemporaneously, known as “veterinary specials” (regulations 10 and 11). The Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 is amended accordingly (regulation 12). The Animals, Meat and Meat Products (Examination for Residues and Maximum Residue Limits) Regulations 1991 are also amended so as to allow an unlicensed substance within the meaning of those Regulations to be administered in accordance with the exemptions in these Regulations, and a further consequential amendment is made to the definition of “veterinary medicinal product” (regulation 13).

The Medicines (Restriction on the Administration of Veterinary Medicinal Products) Regulations 1983 are revoked (regulation 14).

A Compliance Cost Assessment has been prepared and a copy has been placed in the library of each House of Parliament.