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Directive UE

Scris de ICBMV.

Directive U.E.

Directive şi reglementări Comunitare transpuse în domeniul produselor medicinale de uz veterinar.

Directive 90/167/EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community;

Directive 96/22/EC concerning the interdiction of the marketing and administration of some thyreostatic substances and of beta agonists in farm animals, repealing Directives 81/602/EEC, 88/846/EEC and 88/2999/EEC;

Directive 87/18/EEC on the harmonization of the laws, regulations and administrative provisions relating to the application of the principles of GLP and the verification of their application for tests on chemical substances;
 
Directive 88/320/EEC on the inspection and verification of Good Laboratory Practice (GLP);

Directive 78/25/EEC on the approximation of the laws of the Member States relating to the colouring matters which can be added to medicinal products, as amended by the Directive 81/464/EEC;
 
Council Regulation 1768/92/EC concerning the creation of a supplementary protection certificate for medicinal products

Directive 84/539/EEC on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine

Council Regulation 2309/93/EEC laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing an European Agency for the Evaluation of Medicinal Products (EMEA);

Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products;
 
Commission Regulation 1234/2008/EC concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products

Council Regulation 1084/2003/EC concerning the examination of variations to the terms of a marketing authorization by the competent authority of a Member State;
 
Commission Regulation 540/95/EC laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious whether arising in the Community or in a third country, to medicinal products for human and veterinary use authorized in accordance with the provisions of the Council Regulation 2309/93
 
Directive 2001/82/EC on the Community code relating to veterinary medicinal products

Directive 2004/28/EC amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products
 
Regulation 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, with the subsequent amendments

Regulation 1831/2003/EC on additives for use in animal nutrition