The Veterinary Medicines Regulations 2009

PART 4 Unauthorised veterinary medicinal products

Importation of an unauthorised veterinary medicinal product

25.—(1) It is an offence to import an unauthorised veterinary medicinal product except in accordance with this regulation.

(2) A holder of a marketing authorisation may import an unauthorised veterinary medicinal product if it is for the purpose of the manufacture of a veterinary medicinal product for which the importer holds the marketing authorisation.

(3) A holder of a manufacturing authorisation may import an unauthorised veterinary medicinal product if it is for the manufacture of a veterinary medicinal product that the importer is permitted to manufacture.

(4) A holder of a wholesale dealer’s authorisation may import an unauthorised veterinary medicinal product for the purposes of re-export.

(5) A veterinary surgeon may import an unauthorised veterinary medicinal product that is authorised in another member State if it is for the purpose of administration by that veterinary surgeon or under that veterinary surgeon’s responsibility under the cascade or administration in exceptional circumstances in accordance with Schedule 4; the import must be in accordance with the appropriate certificate granted by the Secretary of State, and the product may be imported by the veterinary surgeon personally or by using a wholesale dealer or pharmacist as an agent.

(6) A wholesale dealer or a pharmacist may import an unauthorised veterinary medicinal product for the purpose of storing it pending administration by a veterinary surgeon under the cascade or administration in exceptional circumstances in accordance with Schedule 4 if—

(a) the veterinary medicinal product is authorised in another member State or a third country;

(b) the Secretary of State has issued a certificate certifying that—

(i) the disease or condition is such that the veterinary medicinal product is likely to be needed as a matter of urgency for the treatment of an animal;

(ii) delay in administering the product will seriously affect the health or welfare of the animal; and

(iii) there is no suitable veterinary medicinal product authorised in the United Kingdom; and

(c) in the case of a wholesale dealer, the product is within the terms of the authorisation.

(7) The holder of an animal test certificate granted under paragraph 9 of Schedule 4 may import anything specified in the animal test certificate in accordance with the conditions in that certificate.

(8) The Secretary of State may authorise in writing the importation of any product or substance for use under a licence granted under the Animals (Scientific Procedures) Act 1986.

Possession of an unauthorised veterinary medicinal product

26.—(1) It is an offence to be in possession of an unauthorised veterinary medicinal product.

(2) This regulation does not apply to—

(a) a veterinary medicinal product imported in accordance with a certificate granted by the Secretary of State under these Regulations;

(b) a product prescribed by a veterinary surgeon under the cascade;

(c) a holder of a manufacturing authorisation if the possession is for export;

(d) a holder of a wholesale dealer’s authorisation if the possession is for export or re-export; or

(e) a holder of a manufacturer’s authorisation or marketing authorisation if the intention is to manufacture a veterinary medicinal product.

(3) A veterinary surgeon who practises in both the United Kingdom and another member State may hold veterinary medicinal products authorised in the other member State provided that the amount held does not exceed the amount expected to be used in that member State.

(4) It is a defence for a person charged under paragraph (1) to prove that the product was for the purposes of research or development of a veterinary medicinal product.

(5) A veterinary surgeon may have possession of an authorised human medicinal product intended for administration to animals under the cascade, but commits an offence if the amount possessed exceeds the amount expected to be used under the cascade.

Supply of an unauthorised veterinary medicinal product

27.—(1) It is an offence to supply an unauthorised veterinary medicinal product.

(2) This regulation does not apply to—

(a) a veterinary medicinal product prescribed by a veterinary surgeon under the cascade; or

(b) a product supplied in accordance with a certificate granted by the Secretary of State under these Regulations.

(3) It is a defence for a person charged under paragraph (1) to prove that the supply was for the purposes of research or development of a veterinary medicinal product.