Regulation of the Market in Veterinary Medicines
The Department has overall national responsibility in relation to regulation of the veterinary medicines market in Ireland. Its activities in this regard are underpinned by an up to date legislative code which reflects current scientific principles and also gives effect to an extensive range of EU law governing this area, viz:
- The European Communities (Animal Remedies) (No. 2) Regulations 2007 (SI No. 786/2007)
- The European Communities (Animal Remedies and Medicated Feedingstuffs) Regulations 1994 (SI No. 176/1994).
In terms of product licensing, the role of the Health Products Regulatory Authority (HPRA) formally Irish Medicines Board ( IMB) as competent authority for all veterinary medicines is defined in the legislation, which also includes provisions governing the approval of products to ensure that they meet current requirements as regards quality safety and efficacy. The legislation also lays down objective criteria to enable appropriate sales designations ('routes of supply') to be applied to individual products to reflect the degree of control which it is necessary to apply in order to safeguard public health (including user safety) and also animal health and welfare.
Under the legislation, the Department applies appropriate controls to commercial outlets selling veterinary medicines, including those operated by veterinarians. All such outlets, at both wholesale and retail levels, must meet specified standards in order to be licensed, and the holding of a current licence is a perquisite for trading in this area. All premises are also subject to inspection by the Department. In March 2003, the Department was awarded with ISO 9000 registration for its administration of the licensing system for animal medicines. The Department also implements an exceptional licensing regime for the importation of animal remedies authorised in another Member State in `Certain Health Situations' and under the `Cascade Provision'. Furthermore, the Department operates a licensing control regime over the manufacturers and distributors of medicated feedingstuffs.
Further information on the above can be obtained from Veterinary Medicines Section, Department of Agriculture, Food and the Marine, Floor 1, Block B, Administration Building, Backweston, Youngs Cross, Celbridge, Co. Kildare (01) 5058662 /5058659