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The Veterinary Medicines Regulations 2013
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[F1Good manufacturing practice certificates and inspection of sites]E+W+S
This section has no associated Explanatory Memorandum
6.—(1) The Secretary of State must, from time to time, inspect [F2sites] [F3authorised] under paragraph 3, basing the frequency of the inspection on the risks associated with each [F4site’s history] and the nature of the products handled at the [F2sites].
[F5(2) Within 90 days after an inspection, the Secretary of State must issue a certificate of good manufacturing practice to the manufacturer if the inspection establishes that the manufacturer has complied with the requirements of these Regulations in respect of the site to which the inspection relates.
(2A) Where the Secretary of State does not consider that compliance is established after inspection in accordance with sub-paragraph (2), the Secretary of State must enter that fact in the register mentioned in paragraph 12(a).
(2B) The Secretary of State may carry out an inspection on a site occupied by a manufacturer established in a country other than the United Kingdom notwithstanding any arrangements that may have been entered into between the United Kingdom and that country.
(2C) The importer of a veterinary medicinal product must ensure before importation that the manufacturer of that product has—
(a)a valid certificate of good manufacturing practice issued by the Secretary of State; or
(b)an equivalent certificate issued by a regulatory authority—
(i)with which the Secretary of State has an agreement or arrangement for such purposes; or
(ii)which the Secretary of State considers to have demonstrated equivalent standards to those in the United Kingdom.]
F6(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F6(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F6(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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
F1Sch. 2 para. 6 heading substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 86(c)
F2Word in Sch. 2 para. 6(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 86(a)(i)
F3Word in Sch. 2 para. 6(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 86(a)(ii)
F4Words in Sch. 2 para. 6(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 86(a)(iii)
F5Sch. 2 para. 6(2)-(2C) substituted for Sch. 2 para. 6(2) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 86(b)
F6Sch. 2 para. 6(3)-(5) 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(33)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
Inspection of premisesN.I.
6.—(1) The Secretary of State must, from time to time, inspect premises registered under paragraph 3, basing the frequency of the inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.
(2) Within 90 days after an inspection, the Secretary of State must issue a certificate of good manufacturing practice to the manufacturer if the inspection established compliance with the principles and guidelines on good manufacturing practice in accordance with Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products(1).
(3) If an inspection is carried out at the request of the European Pharmacopoeia to establish compliance with a monograph, the Secretary of State must issue a certificate of compliance with the monograph, if appropriate.
(4) The Secretary of State must provide details of each certificate of good manufacturing practice issued to the Agency for entry into a database.
(5) If the outcome of the inspection is that the manufacturer does not comply with the principles and guidelines of good manufacturing practice, the Secretary of State must provide details to the Agency for entry into the database.
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
(1)
OJ No L 228, 17.8.91, p. 70.
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