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The Human Medicines Regulations 2012
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Changes over time for: Paragraph 12
Alternative versions:
- 14/08/2012- Amendment
- 09/02/2019- Amendment
- 31/12/2020- Amendment
- 31/12/2020
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The Human Medicines Regulations 2012, Paragraph 12 is up to date with all changes known to be in force on or before 26 December 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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12.—[F1(1)] [F2In Great Britain, the qualified person] is responsible for securing—
(a)that each batch of medicinal products manufactured in [F3Great Britain] has been manufactured and checked in accordance with these Regulations and the requirements of the [F4UK marketing authorisation], certificate of registration or traditional herbal registration [F5, or an equivalent authorisation,] relating to those products; F6... [F7and]
(b)in the case of [F8medicinal products imported from a country other than approved country for import, irrespective of whether the products have been manufactured in the United Kingdom or an approved country for import], that each batch has undergone—
(i)a full qualitative analysis,
(ii)a quantitative analysis of all the active substances, and
(iii)all other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the [F9UK marketing authorisation], certificate of registration or traditional herbal registration [F10, or an equivalent authorisation,] relating to those products; [F11and]
F12(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F13(2) In this paragraph “equivalent authorisation” means, in respect of a medicinal product that does not have a UK marketing authorisation, certificate of registration or traditional herbal registration, such equivalent authorisation or registration granted by an appropriate authority for the licensing of medicinal products in an approved country for import.]
Textual Amendments
F1 Sch. 7 para. 12 renumbered as Sch. 7 para. 12(1) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Sch. 7 para. 12(1) substituted (31.12.2020) by S.I. 2019/775, reg. 32(3)(a)(ia) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(a))
F3Words in Sch. 7 para. 12(1)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 32(3)(a)(ii)(zaa) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 22(b))
F4Words in Sch. 7 para. 12(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in Sch. 7 para. 12(1)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F6Word in Sch. 7 para. 12(a) omitted (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 17(a) and word in Sch. 7 para. 12(a) omitted (N.I.) (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 17(a)
F7Word in Sch. 7 para. 12(1)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(ii)(cc); 2020 c. 1, Sch. 5 para. 1(1)
F8Words in Sch. 7 para. 12(1)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(iii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F9Words in Sch. 7 para. 12(1)(b)(iii) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(iii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F10Words in Sch. 7 para. 12(1)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(iii)(cc); 2020 c. 1, Sch. 5 para. 1(1)
F11Sch. 7 para. 12(c) and preceding word inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 17(b) and Sch. 7 para. 12(c) and preceding word inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 17(b)
F12Sch. 7 para. 12(1)(c) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(iv); 2020 c. 1, Sch. 5 para. 1(1)
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