The Veterinary Medicines Regulations 2013

Manufacture E+W+S

3.— [F1 (1)] The product must have been manufactured by—

(a) the holder of a manufacturing authorisation if manufactured in [F2 Great 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)(d) does not apply where the United Kingdom has a formal agreement with the exporting country that includes mutual recognition of good manufacturing practice or where the Secretary of State is satisfied that the exporting country requires manufacturers of veterinary medicinal products to apply standards of good manufacturing practice which are at least equivalent to those in Great Britain.]

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 Sch. 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)

F2 Words 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)

F3 Sch. 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)

F4 Sch. 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)

F5 Sch. 6 para. 3(2) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 156

Manufacture N.I.

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 [F6 a] 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

E2 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

F6 Word 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)