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.

Subject

Livestock

Keyword

Animal health Drugs Authorization/permit Internal trade Animal feed/feedstuffs

Geographical area

European Union Countries

Abstract

Member States shall take all appropriate measures to ensure that the particulars and documents which shall accompany applications for authorization to place a veterinary medicinal product on the market, pursuant article 5 of Directive 81/851/EC, are submitted by the persons concerned in accordance with the Annex to this Directive. The Annex is divided in 3 parts: analytical (physico-chemical, biological or microbiological) tests of veterinary medicinal products (I), toxicological and pharmacological tests (II), clinical trials (III). (4 articles and 1 Annex).

Full text

English

Website

europa.eu

References - Legislation

Implemented by

Legislative Decree No. 119 implementing Directives Nos. 81/851/CEE, No. 81/852/CEE, No. 87/20/CEE and No. 90/676/CEE on veterinary drugs.

Legislation | Italy | 1992 (1997)

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

Source: FAO, FAOLEX

Veterinary medicinal products (Presentation and content of license applications forms) Regulations 2002 (P.I. 200/2002).

Legislation | Cyprus | 2002

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

Source: FAO, FAOLEX

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

Animal Remedies Regulations, 1996.

Legislation | Ireland | 1996

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

Source: FAO, FAOLEX

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

Legislation | United Kingdom | 1994

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

Source: FAO, FAOLEX

Amended by

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

Commission Directive 99/104/EC amending the Annex to Council Directive 81/852/EEC 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.

Legislation | European Union | 1999

Keyword: Animal health, Drugs

Source: FAO, FAOLEX

Repealed by

Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products.

Legislation | European Union | 2001

Keyword: Basic legislation, Animal health, Drugs, Authorization/permit, Data collection/reporting, Access-to-information, Inspection, Internal trade, International trade, Offences/penalties

Source: FAO, FAOLEX