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Veterinary Medicines, Remedies, Illegal Substances

Here you can find the legislation and guidance for veterinary medicines.

EU legislation

Commission Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products.

Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 (OJ L 131, 17/05/2019, p. 51-100).

Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established noncompliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances. (OJ L 317, 09/12/2019, p. 28-37).

Commission 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.

Implementing Measures:

  • Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L 4, 7.1.2017, page 1)
  • Commission Regulation (EU) 2017/880 of 23 May 2017 laying down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species, in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L 135, 24.5.2017, page 1)
  • Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (OJ L 132, 30.5.2018, page 5)

Commission Regulation (EC) 1662/95 laying down certain arrangements for implementing the Community decision-making procedures in respect of marketing authorisations for products for human or veterinary use.

Regulation (EU) 2019/6, as amended on the Community code relating to veterinary medicinal products.

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 Regulation (EU) 2019/6. The evaluation procedure laid out in Regulation (EEC) No 726/2004 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 726/2004 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.

Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, page 1)

Important Note: This Regulation has been amended over 85 times. It can be accessed from Regulation 37/2010 Consolidated Text (April, 2022).

National legislation

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 An Garda Síochána 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 animal product, 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 Health Products Regulatory Authority (HPRA) is the competent authority for approval of medicines covered by Directive 2001/82/EC on the Community code relating to veterinary medicinal products (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.