Veterinary Medicinal Products

European Legislation:

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.

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.

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.

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.

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.

European Legislation:

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.

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.

Emea Position Paper:

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

The Committee for Medicinal Products for Veterinary Use (CVMP) of the EMEA 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.

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).

Pharmacovigilance is also an important part of the work of the national competent authorities and EMEA. The EMEA 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.