UK Offence Report

The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993

UK Statutory Instrument 1993 No. 2398 — creates 1 criminal offence.

1offences created
0recorded in force
0revoked
Made
30 September 1993
In force from
29 October 1993
Extent
Not stated
Subject
Drugs and medicines
Made under
European Communities Act 1972, Medicines Act 1968

Explanatory note

(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.

These Regulations implement Articles 5 and 5a of Council Directive 81/851EEC (OJ No. L317, 6.11.81, p.1) (“Directive 81/851”) as amended by Council Directive 90/676/EEC (OJ No. L373, 31.12.90, p.15) on the approximation of the laws of the Member States relating to veterinary medicinal products, Council Directive 81/852/EEC (OJ No. L317, 6.11.81, p.16) (“Directive 81/852”) as amended by Council Directive 87/20/EEC (OJ No. L15, 17.1.87, p.34) and Commission Directive 92/18/EEC (OJ No. L97, 10.4.92, p.1) on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products, and Article 2 of Council Directive 90/677/EEC (OJ No. L373, 31.12.90, p.26) (“Directive 90/677”) extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products. The Regulations apply to applications for product licences in relation to veterinary medicinal products to which Directive 81/851 applies (see Article 2 of the Directive). Such products are to be treated as medicinal products within the meaning of section 130 of the Medicines Act 1968 for the purposes of the Regulations (see the definitions of “product licence” and “veterinary medicinal product” in regulation 2(1)). The Regulations prescribe the form and manner of an application (regulation 3), require the applicant to submit to the licensing authority the particulars and documents set out in Articles 5 and 5a of Directive 81/851, to comply with the provisions of Article 2 of Directive 90/677 in relation to immunological products and to comply with the requirements set out in the Annex to Directive 81/852 (regulation 4 and Schedules 1 and 2, which apply to veterinary medicinal products other than immunological products and veterinary medicinal products which are immunological products respectively). An applicant is required to confirm to the licensing authority that he has taken account of certain guidance published by the European Commission referred to in the Introduction to the Annex to Directive 81/852 (regulation 5(1)(a)). This guidance is at present contained in a publication entitled “The Rules Governing Medicinal Products in the European Community”, Volume V/B, “Notice to applicants for marketing authorisation for veterinary medicinal products in the European Community”, Revised Edition, January 1993 (ISBN 92-826-5780-9), which may be obtained from Her Majesty’s Stationery Office or from the Office for Official Publications of the European Communities, L/2985, Luxembourg. The Regulations revoke the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971, as amended, in so far as they relate to applications for product licences for veterinary medicinal products (regulation 6 and Schedule 3).

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