Title and commencement

1. These Regulations may be cited as the Medicines (Veterinary Medicinal Products) (Veterinary Surgeons from Other EEA States) Regulations 1994 and shall come into force on 31st December 1994.

Interpretation

2. In these Regulations-

• "EEA State" means a State which is a contracting party to the EEA Agreement other than the United Kingdom, but until the EEA Agreement comes into force in relation to Liechtenstein does not include the State of Liechtenstein, and"ready-made veterinary medicinal product" has the meaning given by Article 1.2 of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products(3), as amended by Council Directive 90/676/EEC(4).

Exemption from licences for certain veterinary medicinal products

3.-(1) Subject to the conditions in paragraph (2) below, the provisions of section 7 of the Medicines Act 1968(5) (General provisions as to dealing with medicinal products) shall not apply to the importation of a ready-made veterinary medicinal product from another EEA State, or to its subsequent sale or supply.

(2) The conditions referred to in paragraph (1) above are that the product is carried into the United Kingdom by a veterinary surgeon who practises both in that other EEA State and in the United Kingdom, and that veterinary surgeon complies with the requirements of Article 4.5 of Council Directive 81/851/EEC as amended by Council Directive 90/676/EEC.

Explanatory Note

(This note is not part of the Regulations)

These Regulations implement Article 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 as amended by Council Directive 90/676/EEC (OJ No. L373, 31.12.90, p.15).

The Regulations exempt from the provisions of section 7 of the Medicines Act 1968 (which requires that certain dealings in medicinal products must be in accordance with a product licence) the importation and subsequent sale or supply of ready-made veterinary medicinal products brought into the United Kingdom by veterinary surgeons practising in other EEA States who also practise in the United Kingdom, subject to the requirements of Article 4.5 of Council Directive 81/851 EEC as amended. The veterinary surgeon must be familiar with the principles of good veterinary practice in the United Kingdom, and may only bring with him products other than immunological products, which are authorised to be placed on the market in his own member State, in their original packaging and in small quantities sufficient for daily needs, for treatment of animals under his care. Particular requirements are imposed in relation to the amount of products which may be supplied to the owner of the animals, and in relation to products intended for food-producing animals, as to their active ingredients and the applicable withdrawal period, and in relation to the keeping of records.