The Veterinary Medicines Regulations 2005
| Jurisdiction | UK Non-devolved |
| Citation | SI 2005/2745 |
2005 No. 2745
MEDICINES
The Veterinary Medicines Regulations 2005
Made 6th October 2005
Laid before Parliament 7th October 2005
The Secretary of State is a Minister designated1for the purposes of making Regulations under section 2(2) of the European Communities Act 19722in relation to measures in the veterinary and phytosanitary fields for the protection of public health;
She has carried out the consultation required by Article 9 of Regulation (EC) No. 178/2002of the European Parliament and of the Council laying down the general principles of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety3;
In accordance with section 56(1) of the Finance Act 19734, the Treasury consents to the making of these Regulations;
The Secretary of State makes these Regulations in exercise of the powers conferred on her by section 2(2) of the European Communities Act 1972 and by section 56(1) of the Finance Act 1973:
PART 1
Introduction
Title and commencement
1. These Regulations may be cited as the Veterinary Medicines Regulations 2005 and come into force—
(a) except for regulation 14 and Schedule 5, on 30th October 2005;
(b) in the case of regulation 14 and Schedule 5, on 1st January 2006.
Definition of “veterinary medicinal product”, interpretation and scope
2.—(1) In these Regulations “veterinary medicinal product” means—
(a)
(a) any substance or combination of substances presented as having properties for treating or preventing disease in animals; or
(b)
(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. 726/2004of 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 Agency5;
“animal” means all animals other than man and includes birds, reptiles, fish, molluscs, crustacea and bees;
“the cascade” has the meaning assigned in paragraph 2 of Schedule 4;
“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 —
(a) any risk relating to the quality, safety and efficacy of the veterinary medicinal product as regards animal or human health; or
(b) 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 all veterinary medicinal products irrespective of whether or not there is other legislation controlling a product.
Products to which these Regulations do not apply
3.—(1) These Regulations do not apply to a veterinary medicinal product based on radio-active isotopes.
(2) They do not apply to a veterinary medicinal product that is the subject of a licence granted under the Animals (Scientific Procedure) Act 19866, except that, if the animals used under that licence are to be put into the human food chain, the veterinary medicinal product must be administered in accordance with an animal test certificate granted under regulation 8(3).
PART 2
Authorised veterinary medicinal products
Placing a veterinary medicinal product on the market
4.—(1) It is an offence to place a veterinary medicinal product on the market unless that product has been granted a marketing authorisation by the Secretary of State or the Agency.
(2) Any person who certifies data in relation to an application for a marketing authorisation or in relation to an existing marketing authorisation and who knows that those data are false, or does not believe that they are accurate, is guilty of an offence.
(3) Schedule 1 (provisions relating to marketing authorisations) has effect.
Manufacture of veterinary medicinal products
5.—(1) The holder of a marketing authorisation must ensure that every stage in the manufacture of the veterinary medicinal product is carried out by the manufacturer specified in the marketing authorisation (who must, if the manufacture is carried out in the United Kingdom, hold a manufacturing authorisation for that type of product granted by the Secretary of State) and failure to do so is an offence.
(2) Schedule 2 (provisions relating to the manufacture of veterinary medicinal products) has effect.
(3) “Manufacture” 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.
(4) Notwithstanding the above—
(a)
(a) the holder of a wholesale dealer’s authorisation (in accordance with regulation 13) or a suitably qualified person (in accordance with paragraph 9 of Schedule 3) may break open packages (other than the immediate packaging of the veterinary medicinal product);
(b)
(b) a pharmacist may break open any package other than the immediate packaging of injectable products; and
(c)
(c) a veterinary surgeon may break open any package.
The finished product
6. The holder of a marketing authorisation for a veterinary medicinal product is guilty of an offence if the finished product supplied by him or the manufacturer is not completely in accordance with the marketing authorisation.
Classification, supply and possession of the product
7.—(1) Part I of Schedule 3 (Classification and supply of authorised veterinary medicinal products) has effect.
(2) Any person who supplies a veterinary medicinal product that has passed its expiry date is guilty of an offence.
(3) Any person who supplies a medicinal product authorised for human use for administration to an animal (other than in accordance with a prescription from a veterinary surgeon for administration under the cascade) is guilty of an offence.
(4) Any person in possession of a veterinary medicinal product that was supplied to him other than in accordance with Schedule 3 is guilty of an offence.
Administration of the product
8.—(1) It is an offence to administer a veterinary medicinal product to an animal unless—
(a)
(a) the product has a marketing authorisation authorising its administration in the United Kingdom, and the administration is in accordance with that marketing authorisation; or
(b)
(b) it is administered in accordance with Schedule 4 (Administration of a veterinary medicinal product outside the terms a marketing authorisation).
(2) It is an offence to administer a veterinary medicinal product to a food-producing animal unless it was prescribed in accordance with Schedule 3 or is administered in accordance with Schedule 4.
(3) This regulation does not apply in the case of a product administered for research purposes in accordance with a certificate (“an animal test certificate”) granted for the purpose by the Secretary of State.
Importation of authorised veterinary medicinal products
9.—(1) It is an offence to import a veterinary medicinal product authorised for use in the United Kingdom except in accordance with this regulation.
(2) A holder of a marketing authorisation may import a veterinary medicinal product for which he holds the marketing authorisation.
(3) A holder of a manufacturing authorisation may import a veterinary medicinal product to which his authorisation relates.
(4) An authorised wholesale dealer may import a veterinary medicinal product if—
(a)
(a) his authorisation covers the product;
(b)
(b) the importation is in accordance with a certificate issued for the purpose by the Secretary of State; and
(c)
(c) he has notified the holder of the marketing authorisation in writing before he imports it.
(5) A veterinary surgeon or a pharmacist may import any authorised veterinary medicinal product.
(6) A suitably qualified person (in accordance with paragraph 9 of Schedule 3) may import any authorised veterinary medicinal product that he is permitted to supply.
(7) There are no restrictions on the importation of an authorised veterinary medicinal product in category AVM-GSL.
Advertising the product
10.—(1) It is an offence to advertise a veterinary medicinal product if the advertisement is misleading or contains any medicinal claim that is not in the summary of product characteristics.
(2) It is an offence to advertise a human medicine for administration to animals (including sending a price list of or including human medicines to a veterinary surgeon or veterinary practice).
(3) Paragraph (2) does not apply to the holder of a wholesale dealer’s...
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