The Veterinary Medicines Regulations 2008

Definition of “veterinary medicinal product”, interpretation and scope U.K.

2.—(1) In these Regulations “veterinary medicinal product” means—

(a) any substance or combination of substances presented as having properties for treating or preventing disease in animals; or

(b) any substance or combination of substances that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

(2) In addition—

“adverse reaction” 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;

“the Agency” 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(1);

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

“the cascade” has the meaning given in paragraph 1 of Schedule 4;

“horse passport” means a passport issued in accordance with the provisions of—

(a)

the Horse Passports (England) Regulations 2004(2);

(b)

the Horse Passports Regulations (Northern Ireland) 2004(3);

(c)

the Horse Passports (Scotland) Regulations 2005(4); or

(d)

the Horse Passports (Wales) Regulations 2005(5),

and “horse” includes all species of equidae;

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

“risk-benefit balance” means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to—

(e)

any risk to human or animal health relating to the quality, safety or efficacy of the veterinary medicinal product; or

(f)

any risk of undesirable effects on the environment;

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

(3) In these Regulations any reference to a member State is a reference to a member State of the European Union and Norway, Iceland and Liechtenstein.

(4) For the avoidance of doubt, these Regulations apply to veterinary medicinal products irrespective of whether or not there is other legislation controlling a product.

(1)

OJ No. L136, 30.4.2004, p. 1.

(2)

S.I. 2004/1397.

(3)

S.R. (NI) 2004 No. 497.

(4)

S.S.I. 2005/223 as amended by S. S. I. 2007/217.

(5)

S.I. 2005/231 (W. 21).