31.—(1) No person may export a veterinary medicinal product for use in another [F1country] unless the veterinary medicinal product may be lawfully supplied or administered in that [F1country].
(2) If a veterinary medicinal product has been manufactured in accordance with a marketing authorisation, or if a product without a marketing authorisation has been manufactured under a manufacturing authorisation, and the product is intended for export F2..., the Secretary of State must, at the request of the exporter or the competent authorities of the country to which it is being exported, provide a certificate [F3that (as the case may be)—
(a)the manufacturer holds a manufacturing authorisation;
(b)the manufacturer holds a certificate of good manufacturing practice; or
(c)the product has been marketed under a marketing authorisation].
(3) When issuing the certificate the Secretary of State must take account of [F4any relevant administrative arrangements in relation to the form and content of such certificates which are in existence between the United Kingdom and the country to which the product is to be exported].
(4) If the veterinary medicinal product is authorised in the United Kingdom the Secretary of State must ensure that the exporter or the competent authorities of the [F5importing] country has access to the summary of product characteristics.
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Word in reg. 31(1) 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(6)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F2Word in reg. 31(2) omitted (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(6)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in reg. 31(2) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 18(a)
F4Words in reg. 31(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 18(b)
F5Word in reg. 31(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(6)(c) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
31.—(1) No person may export a veterinary medicinal product for use in another [F6country] unless the veterinary medicinal product may be lawfully supplied or administered in that [F6country].
(2) If a veterinary medicinal product has been manufactured in accordance with a marketing authorisation, or if a product without a marketing authorisation has been manufactured under a manufacturing authorisation, and the product is intended for export outside the European Union, the Secretary of State must, at the request of the exporter or the competent authorities of the country to which it is being exported, provide a certificate to that effect.
(3) When issuing the certificate the Secretary of State must take account of the model certificates issued by the World Health Organization(1).
(4) If the veterinary medicinal product is authorised in the United Kingdom the Secretary of State must ensure that the exporter or the competent authorities of the third country has access to the summary of product characteristics.
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F6Word in reg. 31(1) 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(7)
Published by the World Health Organization at: www.who.int/medicines/en.