3.—[F1(1)] The product must have been manufactured by—
(a)the holder of a manufacturing authorisation if manufactured in [F2Great Britain];
F3(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F4(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(d)in the case of any other country, a manufacturer whose premises have been inspected and approved by an officer of the Secretary of State.
[F5(2) Sub-paragraph (1) does not apply where the exporting country has demonstrated equivalent standards to the United Kingdom or where appropriate arrangements have been made with the exporting country to ensure that the manufacturer of the veterinary medicinal product applies standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/412/EEC.]
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. 6 para. 3 renumbered as Sch. 6 para. 3(1) (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(36)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Sch. 6 para. 3(1)(a) substittued (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(36)(b)(i) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)(3)(e)(i)); 2020 c. 1, Sch. 5 para. 1(1)
F3Sch. 6 para. 3(1)(b) 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(36)(b)(ii) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)(3)(e)(i)); 2020 c. 1, Sch. 5 para. 1(1)
F4Sch. 6 para. 3(1)(c) 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(36)(b)(ii) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)(3)(e)(i)); 2020 c. 1, Sch. 5 para. 1(1)
F5Sch. 6 para. 3(2) inserted (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(36)(c) (as amended S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)(3)(e)(ii))); 2020 c. 1, Sch. 5 para. 1(1)
3. The product must have been manufactured by—
(a)the holder of a manufacturing authorisation if manufactured in the United Kingdom;
(b)the holder of a manufacturing authorisation issued under Directive 2001/82/EC if manufactured in [F6a] member State;
(c)in the case of Australia, Canada, New Zealand, or Switzerland, the holder of an authorisation from the competent authority permitting the manufacture of medicinal products;
(d)in the case of any other country, a manufacturer whose premises have been inspected and approved by an officer of the Secretary of State.
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 Sch. 6 para. 3(b) 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(16)