The Veterinary Medicines Regulations 2005

means a reaction to a veterinary medicinal product that is harmful and unintended and that occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function;

means all animals other than man and includes birds, reptiles, fish, molluscs, crustacea and bees;

includes any member of the equidae family.

means a reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicine;

means a veterinary medicinal product administered to animals in order to produce active or passive immunity or to diagnose the state of immunity;

includes any part of the manufacture of a veterinary medicinal product and any ingredient of the product until the finished product is packaged, labelled and ready for sale in its final form but does not include the manufacture of starting materials intended for use as an active substance in a veterinary medicinal product.

means a pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying and investigating a safety hazard relating to an authorised veterinary medicinal product.

includes any place, any vehicle or trailer, any container, any stall or moveable structure, and any ship or aircraft.

means a mixture of a veterinary medicinal product or a specified feed additive with feed materials, intended for further mixing with feedingstuffs before being fed to animals;

means a person employed on the premises and systems inspected.

means any supply other than to or from the holder of a wholesale dealer’s authorisation, and whether or not for payment;

means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to — (a) any risk relating to the quality, safety and efficacy of the veterinary medicinal product as regards animal or human health;

means an adverse reaction that results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or that results in permanent or prolonged signs in the animals treated.

means the amount of active substances in a dosage unit or unit of volume or weight.

means the European Medicines Agency established by Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;

has the meaning assigned in paragraph 2 of Schedule 4;

means the gross value at manufacturer’s prices of all authorised veterinary medicinal products sold or supplied in the United Kingdom. • “manufacturers' prices” means the prices charged for authorised products by manufacturers to wholesalers, except to the extent that— (a) the products are supplied by manufacturers direct to retailers, in which case it means the prices charged for the products by the manufacturers to the retailers reduced by such sum as, in the opinion of the Secretary of State, represents the difference between the prices paid by the retailers and those which could be expected to be charged by the manufacturers to wholesalers according to the practice prevailing during the period in question with regard to such products;

means—

means any additive used to maintain animals in good health or favourably affect their performance.