EU Directive 2001/82/EC relating to veterinary medicinal products
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 will apply to all veterinary medicinal products, with the exception of:
- Medicated feedingstuffs;
- Inactivated immunological medicinal products which are manufactured from pathogens obtained from an animal from the same holding;
- Medicinal products prepared in a pharmacy in accordance with a “magistral” or “official” formula;
- Medicinal products based on radioactive isotopes;
- Certain additives incorporated into animal feeding stuffs.
To take better account of the emergence of new therapies, such as cell therapies, the definition of veterinary medicinal product was amended in 2004. Further amendments were made in the year 2009.
Manufacture and import
The Member States must make subject to the holding of an authorisation:
- Total or partial manufacture of the veterinary medicinal products and the various processes of dividing up, packaging or presentation (unless these processes are carried out by pharmacists for retail supply);
- Importing of veterinary medicinal products.
Applicants for manufacturing or import authorisations must have suitable premises and equipment and at least one qualified person (as defined in the Directive).
No veterinary medicinal product (with the exception, under certain conditions, of those for aquarium fish, cage birds, homing pigeons, terrarium animals and small rodents) may be placed on the European Union (EU) market without a marketing authorisation. In exceptional cases, where required by the health situation or in the event of a serious disease epidemic, derogation from this principle may be permitted.
Medicinal products intended for food producing species may only be granted a marketing authorisation if the active substances they contain are listed in Regulation (EEC) No 2377/90 on residue limits of veterinary medicinal products in foodstuffs of animal origin.
No veterinary medicinal product may be administered to animals unless a marketing authorisation has been issued, except for the purpose of product testing.
The authorisation is issued by the competent authority of the Member State concerned or, where the centralised procedure established by Regulation (EEC) No 726/2004 applies, by the European Agency for the Evaluation of Medicinal Products (“the Agency”). A marketing authorisation may only be granted to an applicant established in the EU.
Various particulars must be appended to the application for a marketing authorisation
- composition and characteristics of the medicinal product,
- manufacturing method,
- therapeutic indications,
- contra-indications and adverse reactions,
- indication of the withdrawal period in order to limit the level of product residues in foodstuffs,
- control methods,
- results of toxicological and pharmacological tests and clinical trials,
- copy of any marketing authorisation or refusal of marketing authorisation issued in another Member State, etc..
The documents and particulars supplied to the competent authorities must be drafted by experts with the requisite qualifications and analyses must be carried out in accordance with the guidelines in Annex 1.