Accessing Unauthorised Veterinary Medicines

Every veterinary medicine supplied in Ireland must be authorised. Stringent rules exist governing the use by veterinary practitioners of medicines imported from abroad or of human medicines for the treatment of animals where no suitable authorised veterinary medicine exists. HRPA continues to work to improve the range of authorised veterinary medicine through a range of initiatives.

Under European and Irish legislation, all veterinary medicines (animal remedies) must be authorised (licensed) before being marketed in a Member State. Indeed, under national legislation (European Communities (Animal Remedies)(No2) Regulations, 2007 (S.I. No. 786 of 2007)) it is illegal for a person to have in his possession or to supply a veterinary medicine that is not authorised.

Stringent rules apply to the importation of veterinary medicines from abroad. The importation/internet sales of veterinary medicines is under the jurisdiction of the Veterinary Medicines section of the Department of Agriculture, Food and the Marine and not the HPRA. Veterinary practitioners may apply to the Department of Agriculture Food and the Marine for a licence to import a veterinary medicine under the ‘cascade’ provisions of the legislation (a system for exceptional use where no authorised veterinary medicine is available in Ireland). Veterinary practitioners are also entitled to use human medicines under the terms of Article 10 of the Directive 2001/82/EC (the cascade principle) and under Regulation 18 (2) of the European Communities (Animal Remedies)(No2) Regulations, 2007 (S.I. No. 786 of 2007).

As the HPRA understands the position, the supply of human medicines from a wholesaler is covered by the Medicinal Products (Control of Wholesale Distribution) Regulations, 2007 (S.I. No. 538 of 2007) as subsequently amended. These regulations define the ‘sale by wholesaler’ as meaning ‘the sale or supply for the purposes of sale in the course of a business or for the administration to patients in the course of a professional practice’. The agency interprets ‘professional practice’ as including professional practice by a registered veterinary practitioner; it is understood that veterinary practitioners have an ethical, professional obligation to relieve and prevent animal suffering. The HPRA understands that human medicines which might include poison antidotes, large volume parenterals, antiā€cancer drugs as well as certain medicines used as supportive or adjunct therapy for cardiovascular and other disease in animals can be supplied to veterinary practitioners in situations where there is no authorised veterinary medicine available.

The HPRA further understands that veterinary practitioners ordering human medicines from a human medicines wholesaler should not write a prescription (which should only be filled by a pharmacy currently) but that the records should be kept e.g. in the veterinary practitioner’s order book. It is suggested that veterinary practitioners making such orders could confirm in his/her order that the medicines sought were for use in animals under their care in accordance with the cascade and that the use was in accordance with his/her professional practice.