Federation of Veterinarians of Europe
Veterinary EU Legislation
Medicines


Veterinary Medicinal Products

In the following you will find an overview of the most important European pharmaceutical legislation on medicinal products for veterinary use. For a more complete list: DG Enterprise

European Legislation

Directives

Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products.

Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use.

Directive 2006/130/EC implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescription.

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.

Directive 2004/28/EC of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.

Consolidated 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 as amended by Directive 2004/28/EC.

Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC.

Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC.


Regulations

COMMISSION REGULATION (EU) No 122/2013 of 12 February 2013 amending Regulation (EC) No 1950/2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae.

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council.

(Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.)

Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Consolided version : 20/04/2009).


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Maximum Residue Limits

European Legislation:

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council.

(Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.)


Equine Medicines

European Legislation:

For equidae the following Legislation is important in addition to the above mentioned veterinary medicines legislation.

Commission Decision 93/623/EEC establishing the identification document (passport) accompanying registered equidae.

Commission Decision 2000/68/EC amending Commission Decision 93/623/EEC and establishing the identification of equidae for breeding and production.

Commission Regulation (EC) No 1950/2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae.


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Minor uses and Minor species

EMA Position Paper:

Position Paper regarding availability of products for minor uses and minor species (MUMS)

Available VMPs for bees in Europe:

FVE table with available veterinary medicinal products for honey-bees and hive in Europe. This information has been updated in November 2013. In case that you notice any omissions or mistakes please notify FVE office.


Use of veterinary medicinal products under the cascade


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European Medicines Agency (EMA)

The European Medicines Agency (EMA) is a decentralised body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The EMA is also responsible for the evaluation of applications for European marketing authorisation for medicinal products (centralised procedure).

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Committee for Medicinal Products for Veterinary use

The Committee for Medicinal Products for Veterinary Use (CVMP) of the EMA is responsible for preparing the Agency's opinions on all questions concerning veterinary medicinal products, in accordance with Regulation (EC) No 726/2004.

In the ‘centralised’ procedure, the CVMP is responsible for conducting the initial assessment of veterinary medicinal products (for a Community-wide marketing authorisation). The CVMP is also responsible for several post-authorisation and maintenance activities, including the assessment of any modifications or extensions to the existing marketing authorisation, and it arbitrates in cases where there is a disagreement between Member States concerning the marketing authorisation of a particular veterinary medicinal product. A core activity of the CVMP is the establishment of the 'maximum residue limits' (MRLs) of veterinary medicinal products permissible in food produced by or from animals for human consumption.


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Pharmacovigilance

Pharmacovigilance is the constant monitoring of the safety of medicines after authorisation. It mainly concerns adverse reactions in animals and humans related to the use of veterinary medicinal products.

EudraVigilance Veterinary is the European data-processing network and database management system for the exchange, processing and evaluation of Suspected Adverse Reaction Reports (SARs) related to veterinary medicinal products authorised in the European Economic Area (EEA: EU, Norway, Iceland and Liechtenstein). See also EudraVigilance Veterinary website.

Pharmacovigilance is also an important part of the work of the national competent authorities and EMA. The EMA receives safety reports from within the EU and outside concerning centrally authorised medicinal and coordinates action relating to the safety and quality of medicinal products.

 


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European &National Soft Law

FVE leaflets on responsible use of antimicrobials

FVE advice to the general public

 

FVE advice to veterinarians

 

FVE advice to the owners of companion animals

FVE advice to the owners of horses

EN: How to use antibiotics responsibly: Advice for the owners of horses and other equidae

LV: Kā atbildīgi lietot antibiotikas : ieteikumi zirgu īpašniekiem

 

FVE and Copa-Cogeca advice to the farmers

FVE, CPME and CED advice to the public

FVE, CPME and CED advice to the heath professionals

 

 

 

National guidelines

Denmark

Finland

France

Germany

Italy

Sweden

The Netherlands

UK