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The Veterinary Medicines Regulations 2005

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PART 4Unauthorised 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 marketing authorisation holder may import an unauthorised veterinary medicinal product if it is for the purpose of the manufacture of a veterinary medicinal product for which he 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 he is permitted to manufacture.

(4) A wholesale dealer 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 him or under his supervision 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 himself or by using a wholesale dealer or pharmacist as his 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 his authorisation.

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 veterinary medicinal product prescribed by a veterinary surgeon under the cascade;

(c)wholesale dealers if the possession is for re-export;

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

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

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.

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