The Veterinary Medicines Regulations 2013

PART 4 U.K. Unauthorised veterinary medicinal products

Importation of an unauthorised veterinary medicinal product E+W+S

25.—(1) No person may import or be concerned in the importation of 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 [F1 country] 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 F2 ... 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 [F3 Great Britain]; 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.

[F4 (9) For the purposes of this regulation, references to the import or importation of an unauthorised veterinary medical product include the movement of such a product into Great Britain from Northern Ireland.]

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1 Word in reg. 25(5) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(4)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 25(6)(a) omitted (E.W.S.) (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(4)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 25(6)(b)(iii) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(4)(a)

F4 Reg. 25(9) inserted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(4)(b)

Importation of an unauthorised veterinary medicinal product N.I.

25.—(1) No person may import or be concerned in the importation of 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 [F7 a] 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 [F8 a] 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 [F9 Northern Ireland]; 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.

[F10 (9) For the purpose of this regulation, references to import or importation of an unauthorised veterinary medicinal product include the movement of such a product from Great Britain to Northern Ireland.]

Extent Information

E3 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F7 Word in reg. 25(5) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(5)(a)

F8 Word in reg. 25(6)(a) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(5)(a)

F9 Words in reg. 25(6)(b)(iii) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(5)(b)

F10 Reg. 25(9) inserted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(5)(c)

Possession of an unauthorised veterinary medicinal product E+W+S

26.—(1) No person may be in possession of an unauthorised veterinary medicinal product.

(2) No person may be in possession of an unauthorised veterinary medicinal product with the intention of supplying that product to another person.

(3) 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.

(4) A veterinary surgeon who practises in both [F5 Great Britain] and another [F6 country] may hold veterinary medicinal products authorised in the other [F6 country] provided that the amount held does not exceed the amount expected to be used in that [F6 country].

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

(6) A veterinary surgeon may have possession of an authorised human medicinal product intended for administration to animals under the cascade, provided that the amount held does not exceed the amount expected to be used under the cascade.

Extent Information

E2 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F5 Words in reg. 26(4) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(5)

F6 Word in reg. 26(4) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(5) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Possession of an unauthorised veterinary medicinal product N.I.

26.—(1) No person may be in possession of an unauthorised veterinary medicinal product.

(2) No person may be in possession of an unauthorised veterinary medicinal product with the intention of supplying that product to another person.

(3) 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.

[F11 (4) A veterinary surgeon who practices in Northern Ireland and a member State may hold veterinary medicinal products authorised in the member State provided that the amount held does not exceed the amount expected to be used in that member State.]

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

(6) A veterinary surgeon may have possession of an authorised human medicinal product intended for administration to animals under the cascade, provided that the amount held does not exceed the amount expected to be used under the cascade.

Extent Information

E4 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F11 Reg. 26(4) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(6)

Supply of an unauthorised veterinary medicinal product U.K.

27.—(1) No person may 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 with failing to comply with paragraph (1) to prove that the supply was for the purposes of research or development of a veterinary medicinal product.