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Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (S.I. No. 3142 of 1994).

Country/Territory
United Kingdom
Document type
Regulation
Date
1994
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal by-products Inspection Quarantine Pests/diseases Transport/storage Hygiene/sanitary procedures Animal health Drugs
Geographical area
Atlantic Ocean Islands, Europe, Europe and Central Asia, North Atlantic, North Sea, North-East Atlantic, Northern Europe
Abstract

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 authorizations rather than the previous system of product licences. These authorizations 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 (reg. 3). They provide for the form and manner of an application, and the terms on which the Ministers may grant an authorization (regs. 4 and 5 and Schedules 1 and 2). They place duties on persons responsible for placing products on the market (reg. 6), on person where a product is manufactured outside the EEA (reg. 7) and on an importer who holds a marketing authorization (reg. 8). There are provisions for the variation, renewal, suspension and refusal of an authorization (regs. 9 to 13 and Schedule 3), provisions as to confidentiality (reg. 14) and fees (reg. 15). Breach of the regulations is an offence under regulation 16, with a defence in regulation 17.

Full text
English
Website
www.opsi.gov.uk

References - Legislation

Implements

Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products.

Legislation | European Union | 1981

Keyword: Animal health, Drugs, Authorization/permit, Internal trade, Animal feed/feedstuffs

Source: FAO, FAOLEX

Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products.

Legislation | European Union | 1981

Keyword: Drugs, Authorization/permit, Registration, Internal trade, International trade, Animal health, Institution

Source: FAO, FAOLEX

Council Directive 93/40/EEC amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products.

Legislation | European Union | 1993

Keyword: Drugs, Authorization/permit, Registration, Internal trade, International trade, Animal health

Source: FAO, FAOLEX

Amended by

Marketing Authorisations for Veterinary Medicinal Products Amendment Regulations 2000 (S.I. No. 776 of 2000).

Legislation | United Kingdom | 2000

Keyword: Animal by-products, Inspection, Quarantine, Pests/diseases, Transport/storage, Hygiene/sanitary procedures, Animal health

Source: FAO, FAOLEX

Repealed by

Veterinary Medicines Regulations 2005 (S.I. No. 2745 of 2005).

Legislation | United Kingdom | 2005

Keyword: Animal health, Drugs, Classification/declassification, Inspection, Animal feed/feedstuffs

Source: FAO, FAOLEX