The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994

UK Statutory Instrument 1994 No. 3142 — creates 1 criminal offence.

1offences created

0recorded in force

1revoked

Made: 5 December 1994
In force from: 1 January 1995
Extent: Not stated
Subject: Drugs and medicines
Made under: European Communities Act 1972

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 Council Directive 93/40/EEC, which is the latest in a series of amendments to Council Directive 81/851/EEC. They provide for veterinary medicinal products to be placed on the market subject to marketing authorisations rather than the previous system of product licences. These authorisations may be granted either by the Ministers or, in accordance with Council Regulation 2309/93/EEC, by the European Agency for the Evaluation of Medicinal Products (regulation 3). They provide for the form and manner of an application, and the terms on which the Ministers may grant an authorisation (regulations 4 and 5 and Schedules 1 and 2). They place duties on persons responsible for placing products on the market (regulation 6), on person where a product is manufactured outside the EEA (regulation 7) and on an importer who holds a marketing authorisation (regulation 8). There are provisions for the variation, renewal, suspension and refusal of an authorisation (regulations 9 to 13 and Schedule 3), provisions as to confidentiality (regulation 14) and fees (regulation 15). Breach of the regulations is an offence under regulation 16, with a defence in regulation 17. Provisions of the Medicines Act 1968, under which the system was previously enforced, and provisions of the Trade Descriptions Act 1968 and the Consumer Protection Act 1987, are applied to marketing authorisations in the same way as they previously applied to product licences (regulation 19). Regulation 20 contains transitional provisions. Schedule 4 revokes the Medicines (Leaflets for Veterinary Drugs) Regulations 1983, S.I. 1983/1727, the Medicines (Veterinary Medicinal Products) (Applications for Product Licences Regulations) 1993, S.I. 1993/2398 and the Medicines (Veterinary Medicinal Products) (Applications for Product Licences) (Amendment) Regulations 1994, S.I. 1994/2157. Schedule 5 makes amendments to statutory instruments consequential on changing from product licences to marketing authorisations. A Compliance Cost Assessment has been prepared and placed in the library of each House of Parliament.

Offences created by this instrument

Any person contravening any provision of regulation 3, 6, 7, 8, or 14 of these Regulations shall be guilty of an… regulation 16(1) · Revoked · Strict liability

What Parliament said about it

Contributions, debates and written statements mentioning this instrument by name. Parliamentary material is reused under the Open Parliament Licence v3.0.

Reserved Matters Commons · Commons Chamber · 31 March 1998
Amendments made: No. 555, in page 75, line 17, after '1968', insert ', the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994'.
Government of Wales Bill Commons · Commons Chamber · 23 January 2006 · The Chairman of Ways and Means (Sir Alan Haselhurst)
With this it will be convenient to discuss the following: New schedule 1— 'RESERVED MATTERS— PART 1 GENERAL RESERVATIONS The Constitution 1 The following aspects of the constitution are reserved matters, that is— (a) the Crown, including succession to the Crown and a regency, (b) the Parliament of the United Kingdom, (c) the continued existence of the High Court of Justiciary as a criminal court of first instance and of appeal, (d) the continued existence of the Court of Session as a civil court of first instance and of appeal. 2 (1) Paragraph 1 does not reserve— (a) Her Majesty's…

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