Directive 1992/18 - Modification of the Annex to Council Directive 81/852/EEC on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the texting of veterinary medicinal products - Main contents

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Commission Directive 92/18/EEC of 20 March 1992 modifying the Annex to Council Directive 81/852/EEC on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the texting of veterinary medicinal products

Official Journal L 097 , 10/04/1992 P. 0001 - 0023

Finnish special edition: Chapter 13 Volume 22 P. 0008

Swedish special edition: Chapter 13 Volume 22 P. 0008

COMMISSION DIRECTIVE 92/18/EEC of 20 March 1992 modifying the Annex to Council Directive 81/852/EEC on the approximation of theilaws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (1), as amended by Council Directive 87/20/EEC (2),

Having regard to Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of laws of the Member States relating to veterinary medicinal products, and laying down additional provisions for immunological veterinary medicinal products (3), and in particular Article 5 thereof,

Whereas following the adoption of Directive 90/677/EEC, it is necessary to amend the Annex to Directive 81/852/EEC in order to lay down special requirements for the testing of immunological veterinary medicinal products;

Whereas it is further necessary to adapt to technical progress the existing requirements laid down in the Annex to Directive 81/852/EEC;

Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector established under Article 2b of Directive 81/852/EEC,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The text of the Annex to Directive 81/852/EEC is hereby replaced by the text of the Annex to this Directive.

Article 2

• 1. 

  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 April 1993. They shall forthwith inform the Commission thereof.

• 2. 

  When the Member States adopt these provisions, the provisions shall contain a reference to this Directive or shall be accompanied by such a reference when they are published in official form. The arrangements for this reference shall be decided by Member States.

Article 3

This Directive is addressed to Member States.

Done at Brussels, 20 March 1992.

For the Commission

Martin BANGEMANN

Vice-President

• (1) 

  OJ N° L 317, 6. 11. 1981, p. 16.

• (2) 

  OJ N° L 15, 17. 1. 1987, p. 34.

• (3) 

  OJ N° L 373, 31. 12. 1990, p. 26.

ANNEX

INTRODUCTION

The particulars and documents accompanying an application for marketing authorization pursuant to Article 5 of Council Directive 81/851/EEC (¹) shall be presented in accordance with the requirements set out in this Annex and taking account of the guidance contained in the 'Notice to applicants for marketing authorizations for veterinary medicinal products in the Member States of the European Community`, published by the Commission in The rules governing medicinal products in the European Community, volume V: Veterinary Medicinal Products.

In assembling the dossier for application for marketing authorization, applicants shall take into account the Community guidelines relating to the quality, safety and efficacy of veterinary medicinal products published by the...

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