General Provisions

EU Legislation

Council Regulation (EEC) 2377/90 (OJ L224, p1, 18/08/90 ) of 26 June 1990 establishing Community procedures for fixing maximum limits for veterinary drug residues in foodstuffs of animal origin

(Note: This Regulation has been amended on numerous occasions - the link above is to a consolidated version published on the 16th August 2008)


 Commission Regulation (EC) 1662/95  (OJ L158, p4, 08/07/1985) of 7 July 1995 laying down certain arrangements for implementing the Community decision-making procedures in respect of marketing authorisations for products for human or veterinary use


Directive 2001/82/EC (OJ L311, p1, 28/11/2001 ) of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal product

Amended by

  • Directive 2004/28/EC (OJ L136, p34, 30/04/2004 ) of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use

Regulation (EC) 726/2004 (OJ L136, p1, 30/04/2004) of 31 March 2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

Amended by


National Legislation

Regulation (EEC) No 726/2004 lays down a European Community procedure for the authorisation and supervision of medicinal products for human and veterinary use while the basic rules governing the marketing of veterinary medicinal products within the European Union is contained in Directive 2001/82/EC. The evaluation procedure laid out in Council Regulation (EC) 2377/90 requires that the toxicity of potential residues is evaluated before the use of a medicinal substance in food producing animals is authorised. Regulation (EEC) No 2377/90 also lays down a Community procedure for the establishment of maximum residue limits (MRLs) for veterinary medicinal products in foodstuffs of animal origin so that foodstuffs obtained from animals treated with veterinary medicinal products do contain residues of that medicine or its metabolites which might constitute a health hazard for the consumer.

The Animal Remedies Act, 1993 defines an animal remedy as “any substance or combination of substances administered to animals for the purpose of treating, preventing or modifying disease, making a medical or surgical diagnosis in animals or correcting or modifying physiological functions in animals”. More detailed provisions for animal remedies are contained in the secondary legislation made under this Act.

For the control of illegal substances, the Animal Remedies Act, 1993, sets out a full range of enforcement powers to authorised officers of the Department of Agriculture, Food and Marine (DAFM), to the Garda and customs services, including powers to enter and search premises/lands, examine and take samples, detain/seize animals, records, substances etc. Where evidence of the use of hormones or other prohibited substances is found in an animal or its carcass, the carcass will be condemned and live animals found to be illegally treated will be permanently excluded from the food chain. Included in the possible penalties in the 1993 Act is the provision for the possibility of a person, who is convicted on indictment, being disqualified from keeping animals or animal remedies.

The European Communities (Animal Remedies)(No.2) Regulations 2007 (S.I. No.786 of 2007) sets out detailed rules regarding the authorisation of animal remedies and the manufacture, import , wholesale and retail sale of animal remedies. The Regulations include rules for the administration of animal remedies and certain matters relating to veterinary practice in relation to animal remedies.

The competent authority for approval of medicines covered by Directive 2001/82/EC on the Community code relating to veterinary medicinal products is the Health Products Regulatory Authority (HPRA) (except for vaccines where the Minister for Agriculture, Food and the Marine is the competent authority). All animal remedies are required to be authorised by either the HPRA or by the Minister for Agriculture, Food and the Marine as appropriate. Animal remedies may only be used in accordance with the conditions attached to the product authorisation. It is an offence not to observe the proper dose rate and withdrawal period stated on the product label.

S.I. No.786 of 2007 requires that all premises involved in the wholesale or retail sale of animal remedies are required to be licensed by the Minister for Agriculture, Food and the Marine (with the exception of pharmacies and veterinary surgeons' professional practices).

Animals or foods which have been treated, either with a prohibited substance or illegally treated with an authorised product are deemed to be unfit for human consumption and the Regulations provide for the destruction of animals in such cases.

Last reviewed: 22/7/2015

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