Veterinary Medicines - Introduction
The Department of Agriculture, Food and the Marine implements a number of controls in relation to veterinary medicines in order to safeguard public health and also animal health and welfare. The European Communities (Animal Remedies) (No 2) Regulations 2007 (SI 786/2007) provide a comprehensive legislative basis for licensing of veterinary medicines and controls on their distribution. Under this regime, the Health Products Regulatory Authority (HPRA) acts as the main national licensing authority for veterinary medicines (animal remedies), while the Department licenses premises engaged in the commercial distribution of veterinary medicines. All animal remedies intended for use are required to be authorised in the State and may only be used in accordance with the conditions attached to the product authorisation.
Irish legislation on veterinary medicines has been amended in recent years in light of the revised EU legislative code governing the approval and distribution of veterinary medicines. Following the successful outcome of negotiations on criteria (Commission Directive 2006/130/EC) to exempt certain veterinary medicines from a mandatory prescription requirement, the Department has reflected this in the national legislation. Other amendments include an extension in the maximum period of validity of veterinary prescriptions to 12 months to facilitate farmers and vets in reviewing and managing projected annual routine medicine needs and a refinement of the rules governing written prescriptions in the case of companion animals. The Regulations also make provision for an alternative prescribing regime for intramammary animal remedies, which are available only with a veterinary prescription, where a programme designed to reduce both the incidence of mastitis and recourse to such antibiotic treatments is in place. The Regulations also embody an additional EU measure (Commission Regulation (EC) No. 1950/2006) which provides for exceptional use of certain essential substances in horses under the responsibility of a vet, subject to appropriate consumer protection safeguards.
Currently, over 1300 individual products are licensed in accordance with the detailed requirements of EU legislation. In addition, in the region of 86 wholesale and 760 retail premises are regulated and licensed in accordance with relevant legislation having been inspected by the Department to ensure that they reach the required standard. The manufacture, distribution and sale of medicated feedingstuffs and intermediate products is also subject to licensing by the Minister under the European Communities (Animal Remedies and Medicated Feedingstuffs) Regulations, 1994 as amended by the European Communities (Animal Remedies and Medicated Feedingstuffs) (Amendment) Regulations, 2003. 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. There are currently in the region of 20 licensed medicated feed manufacturers and 62 home mixers licensed to manufacture medicated feed.