The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

Explanatory Note

(This note is not part of the Regulations)

These Regulations, which come into force on 31st March 1997, implement the provisions of Council Directive 92/74/EEC widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products (OJ No. L297, 13.10.92, p. 12) insofar as they relate to homoeopathic veterinary medicinal products that satisfy all of the conditions specified in Article 7.1 of that Directive (“products”).

The Regulations apply to products other than those that were marketed in the United Kingdom for the first time before 31st March 1997 (regulation 3).

The principal provisions of the Regulations—

(a) include provisions relating to applications for the registration of products to which the Regulations apply (“relevant products”) (regulation 4), the renewal of such registrations (regulation 7), the alteration of dossiers on which registrations are based (regulation 8) , the suspension and revocation of registrations (regulation 9) and the service of prohibition and withdrawal notices relating to registered products (regulation 10);

(b) include provisions relating to applications for the grant of authorisations (“Article 24 authorisations”) authorising the manufacture of registered products and the import of such products from third countries (regulation 13) and the suspension and revocation of such authorisations (regulation 16);

(c) prohibit the marketing of a relevant product on or after 1st September 1997 unless it is registered and complies with the dossier on which its registration is based (regulation 18);

(d) lay down requirements relating to the labelling of registered products and their package inserts (regulation 21);

(e) prohibit the manufacture of a relevant product, or the import of such a product from a third country, on or after 1st September 1997 unless the product is registered, an Article 24 authorisation has been obtained authorising its manufacture or import and its manufacture or import is in accordance with that authorisation (regulations 22 and 23);

(f) lay down requirements relating to the export of specified registered products to other EEA States (regulation 24);

(g) provide for the enforcement of the Regulations (regulation 31);

(h) make the contravention, or failure to comply with, provisions of specified regulations a criminal offence (regulation 32);

(i) apply specified provisions of the Medicines Act 1968 (c. 67) to relevant products (regulation 34); and

(j) disapply certain provisions of the Trade Descriptions Act 1968 (c. 29) and Part II of the Consumer Protection Act 1987 (c. 43) in relation to registered products (regulation 35).

A Compliance Cost Assessment has been prepared and a copy has been placed in the library of each House of Parliament. Copies can be obtained from the Veterinary Medicines Directorate, Woodham Lane, Addlestone, Surrey, KT15 3NB.