The Veterinary Medicines Regulations 2011
| Jurisdiction | UK Non-devolved |
2011 No. 2159
Medicines
The Veterinary Medicines Regulations 2011
Made 25th August 2011
Laid before Parliament 7th September 2011
Coming into force 1st October 2011
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.
The Secretary of State 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 and requirements 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 consent to the making of these Regulations.
The Secretary of State makes these Regulations in exercise of the powers conferred 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 2011 and come into force on 1st October 2011.
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 given in paragraph 1 of Schedule 4;
“ Commission Regulation (EC) No 1234/2008” means Commission Regulation (EC) No 1234/2008concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products6;
“Commission Regulation (EU) No 37/2010” means Commission Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin7;
“extension variation” has the same meaning as “Extension of a marketing authorisation” in Article 2 of Commission Regulation EC No 1234/2008;
“horse passport” means a passport issued in accordance with the provisions of Commission Regulation (EC) No 504/2008implementing Council Directives 90/426/EECand 90/427/EECas regards methods for the identification of equidae8;
“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;
“Regulation (EC) No 470/2009of the European Parliament and of the Council” means Regulation (EC) No 470/2009of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin9;
“Regulation (EC) No 767/2009of the European Parliament and of the Council” means Regulation (EC) No 767/2009of the European Parliament and of the Council on the placing on the market and use of feed in relation to feedingstuffs containing specified feed additives10;
“risk-benefit balance” means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to—
(a) any risk to human or animal health relating to the quality, safety or efficacy of the veterinary medicinal product; 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 references to Types of variation are to those specified in Commission Regulation (EC) No 1234/2008;
(4) 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.
(5) For the avoidance of doubt, these Regulations apply to 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 in relation to a product intended for administration in the course of a procedure licensed under the Animals (Scientific Procedure) Act 198611, except that, if the animals are to be put into the human food chain, the only products that may be administered to the animals are—
(a)
(a) authorised veterinary medicinal products administered in accordance with their marketing authorisation, or
(b)
(b) products administered in accordance with an animal test certificate granted under paragraph 9 of Schedule 4.
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 (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 (the manufacture of veterinary medicinal products) has effect.
(3) “Manufacture” includes any part of the manufacture of a veterinary medicinal product until the finished product is ready for sale in its final form as specified in the marketing authorisation but does not include the manufacture of an ingredient or breaking open the package of a veterinary medicinal product12.
The finished product
6. The holder of a marketing authorisation for a veterinary medicinal product is guilty of an offence if either the holder or the manufacturer supplies a product that is not completely in accordance with the marketing authorisation.
Classification, supply and possession of the product
7.—(1) Schedule 3 (classification and supply, wholesale dealers and sheep dip) 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 opens the package (including the outer package) of a veterinary medicinal product before it has been supplied to the final user, other than as permitted under Schedule 3, is guilty of an offence.
(4) Any person who supplies an authorised human medicinal product for administration to an animal (other than a product supplied by a veterinary surgeon or in accordance with a written prescription from a veterinary surgeon that includes all the information specified in paragraph 6 of Schedule 3) is guilty of an offence.
(5) Any person in possession of a veterinary medicinal product that was supplied to that person other than in accordance with Schedule 3 is guilty of an offence.
Administration of the product
8. It is an offence to administer a veterinary medicinal product to an animal unless—
(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) it is administered in accordance with Schedule 4 (administration of a veterinary medicinal product outside the terms of a marketing authorisation) or Schedule 6 (exemptions for small pet animals).
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 for a veterinary medicinal product may import that veterinary medicinal product.
(3) A holder of a manufacturing authorisation may import a veterinary medicinal product to which that authorisation relates.
(4) An authorised wholesale dealer may import a veterinary medicinal product if—
(a)
(a) the authorisation covers the product; and
(b)
(b) the dealer has notified the holder of the marketing authorisation in writing before importation.
(5) A veterinary...
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