EC code relating to veterinary medicinal products - EU monitor

EU monitor
Wednesday, May 22, 2019
calendar

Please note

This page contains a limited version of this dossier in the EU Monitor.

1.

Current status

The directive is in effect from Decemberá18,á2001 until Januaryá27,á2022.

2.

Key information

Official title Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
Original proposal COM(1999)213 EN
EURlex-codeái 32001L0082
Legal instrument Directive
Addressee Member States of the European Union
Date of decision 06-11-2001
Entry into forceái 18-12-2001; Entry into force Date pub. + 20 See Art 97
Date of end of validity 27-01-2022; Repealed by 32019R0006

3.

Legislative text

Directive 2001/82/EC of the European Parliament and of the Council

of 6 November 2001

on the Community code relating to veterinary medicinal products

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social Committee(1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),

Whereas:

(1) Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products(3), Council Directive 81/852/EEC of 28 September 1981 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(4), Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products(5), and Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products(6) have been frequently and substantially amended; in the interests of clarity and rationality, the said Directives should therefore be codified by assembling them in a single text.

(2) The primary purpose of any rules for the production and distribution of veterinary medicinal products must be the safeguarding of public health.

(3) However, this objective must be achieved by means which will not hinder the development of industry and trade in medicinal products within the Community.

(4) In so far as the Member States already have certain provisions laid down by law, regulation or administrative action governing veterinary medicinal products, such provisions differ in essential principles. This results in the hindering of trade in medicinal products within the Community, thereby directly affecting the functioning of the internal market.

(5) Such hindrances must, accordingly, be removed; whereas this entails approximation of the relevant provisions.

(6) It is necessary from the point of view of public health and the free movement of veterinary medicinal products for the competent authorities to have at their disposal all useful information on authorized veterinary medicinal products in the form of approved summaries of the characteristics of products.


More
This text has been adopted from EUR-Lex.

4.

Original proposal

 

5.

Sources and disclaimer

For further information you may want to consult the following sources that have been used to compile this dossier:

This dossier is compiled each night drawing from aforementioned sources through automated processes. We have invested a great deal in optimising the programming underlying these processes. However, we cannot guarantee the sources we draw our information from nor the resulting dossier are without fault.

 

6.

Full version

This page is also available in a full version containing the summary of legislation, the legal context, de Europese rechtsgrond, other dossiers related to the dossier at hand, the related cases of the European Court of Justice and finally consultations relevant to the dossier at hand.

The full version is available for registered users of the EU Monitor by ANP and PDC Informatie Architectuur.

7.

EU Monitor

The EU Monitor enables its users to keep track of the European process of lawmaking, focusing on the relevant dossiers. It automatically signals the newly added documents and subsequent meetings in which these are scheduled for discussion or vote. The latest state of affairs is conveniently presented in such a way that a single glance is sufficient to keep informed. By way of alerts through e-mail or digital newsletters users and their clients are kept in the loop 24/7.

If you are interested in the EU Monitor, please contact us at info@eumonitor.eu.