The Department of Agriculture, Food and the Marine oversees and implements a number of controls in relation to veterinary medicines and residues, in order to safeguard public health and also animal health and welfare. The applicable national legislation is as follows;
• The European Communities (Animal Remedies) (No. 2) Regulations 2007 (S.I. No. 786/2007)
• The European Communities (Control of Animal Remedies and their Residues) Regulations 2009 (S. I. No. 183/2009);
• The European Communities (Animal Remedies and Medicated Feedingstuﬀs) Regulations 1994 (S. I. No. 176/1994);
• Control on Animal Vaccines Regulations 2014 (S. I. No. 193/2014)
Licensing of Veterinary Medicines
Only veterinary medicines (i.e. animal remedies, including vaccines) which have been licensed for the Irish market may be imported, sold or used on animals; this requirement applies both to ‘food-producing’ animals and pets or leisure animals. Licenses valid for the Irish market may be issued by:
• The Health Products Regulatory Authority (HPRA) – the bulk of veterinary medicines authorised for the Irish market have been licensed by the Authority
• The European Commission/European Medicines Agency – such licenses are valid in all EU States; for further information, see www.ema.europa.eu;
• The Department of Agriculture, Food and the Marine – the Department is enabled by EU legislation to issue exceptional licenses in limited circumstances, in particular to address speciﬁc health or suﬀering problems in animals.
In addition, in order to protect the national herd from certain diseases, the import and use of certain vaccines is subject to speciﬁc licensing.
Commercial Distribution of Veterinary Medicines
Commercial distribution of veterinary medicines is limited to licensed outlets (i.e. licensed wholesalers and retailers – Licensed Merchants), as well as veterinary practices supplying their own clients and pharmacies approved by the Pharmaceutical Society of Ireland.
In addition, certain medicines for pet animals may be sold by registered outlets (Companion Animal Medicine sellers). The category of medicine each outlet may supply is determined by the restriction placed on the product at time of licensing (route of supply); such designated routes of supply appear on the product packaging. Veterinary medicines may only be sourced from authorised outlets.
Manufacture, distribution and sale of medicated feedingstuﬀs and intermediate products is subject to licensing by the Minister for Agriculture, Food and the Marine under the European Communities (Animal Remedies and Medicated Feedingstuﬀs) Regulations, 1994.
The use of medicated feedingstuﬀs is prohibited except under and in accordance with the terms of a veterinary written direction issued by a registered veterinary practitioner. Medicated pre-mixes must be authorised by the Health Products Regulatory Authority (HPRA) or the European Commission, European Medicines Agency.
In order to verify that farmers and processors (i.e. Food Business Operators) comply with their obligations under EU Food Law and the Hygiene Legislation to protect consumers from residues, the Department implements a comprehensive National Residue Plan. Under the Plan, samples are tested for residues of banned products (such as growth promoting hormones) licensed medicines (these usually arise where animals enter the food chain before expiry of the prescribed withdrawal period for the medicine concerned), or environmental contaminants.
The Residue Plan covers eleven food-producing species (including aquaculture). Annually, approximately 18,000 samples were taken and tested at oﬃcially approved laboratories for 18 residue groupings. All positive results are followed up by an investigation on the farm of origin with a view to taking the necessary enforcement measures which can include prosecution in the Courts (see penalties below).
Oﬃcial testing is complemented by a statutorily based regime under which primary processors are obliged to implement residue-monitoring measures. This regime, which involves annual submission to the Department for approval of individual residue plans, makes it mandatory for processors to subject suppliers, whose animals or animal products test positive, to signiﬁcantly intensiﬁed monitoring. This regime of self-monitoring is subject to Department scrutiny.
Severe penalties may be imposed by the Courts for breaches of the legislation imposed for the sale, possession and use of unauthorised animal remedies; a person found guilty of an oﬀence may be prohibited from keeping animals or animal remedies. Penalties range from a Class A ﬁne and/or 6 months imprisonment for a person convicted on summary prosecution to a maximum of €500,000 ﬁne and/or 3 years imprisonment for a conviction on indictment. In addition to judicial action, farmers who breach the legislation are liable to have penalties applied to their Basic Farm Payment under EU Cross-Compliance Rules.