Paragraph 12

United Kingdom

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.

Annotations

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)
F2: Words 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))
F3: Words 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))
F4: Words 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)
F5: Words 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)
F6: Word 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)
F7: Word 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)
F8: Words 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)
F9: Words 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)
F10: Words 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)
F11: Sch. 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)
F12: Sch. 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)
F13: Sch. 7 para. 12(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 32(3)(a)(v); 2020 c. 1, Sch. 5 para. 1(1)