OpenLegislation

Regulation 80 Urgent safety restrictions

The holder of a F1UK marketing authorisation is guilty of an offence if the holder —

F2(a)

fails—

(i)

in respect of a UKMA(GB) or UKMA(UK), to inform the licensing authority in accordance with paragraph 14(1) of Schedule 10A, or

(ii)

in respect of a UKMA(NI) F3or UKMA(UK)(Category 2), to inform the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008,

that the holder has taken urgent safety restrictions on the holder’s own initiative;

F4(b)

fails—

(i)

in respect of a UKMA(GB) F5or UKMA(UK)(Category 2), to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with paragraph 14(3) of Schedule 10A, or

(ii)

in respect of a UKMA(NI) F6or UKMA(UK)(Category 2), to implement an urgent safety restriction imposed on the holder by the European Commission under Article 22(2) of Regulation (EC) No 1234/2008; or

(c)

fails F7in respect of a UKMA(NI) to submit an application for variation of the marketing authorisation to the licensing authority or the European Commission in accordance with Article 22(3) of that Regulation before the end of a period of fifteen days beginning on the day after—

(i)

the taking under Article 22(1) or, as the case may be,

(ii)

the imposition under Article 22(2),

of that Regulation of an urgent safety restriction.

F8(d)

fails in respect of a UKMA(GB) F9or UKMA(UK)(Category 1) to submit an application for variation of the UK marketing authorisation to the licensing authority in accordance with paragraph 14(4) of Schedule 10A before the end of the period of fifteen days beginning with the day after—

(i)

the taking under paragraph 14(1) of Schedule 10A or, as the case may be,

(ii)

the imposition under paragraph 14(3) of that Schedule,

of an urgent safety restriction.

Annotations

Textual amendments

F1

Word in reg. 80 inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 89(2); 2020 c. 1, Sch. 5 para. 1(1)

F2

Reg. 80(a) substituted (31.12.2020) by S.I. 2019/775, reg. 89(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(a))

F3

Words in reg. 80(a)(ii) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 63(a)

F4

Reg. 80(b) substituted (31.12.2020) by S.I. 2019/775, reg. 89(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(b))

F5

Words in reg. 80(b)(i) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 63(b)

F6

Words in reg. 80(b)(ii) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 63(c)

F7

Words in reg. 80(c) inserted (31.12.2020) by S.I. 2019/775, reg. 89(4A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(c))

F8

Reg. 80(d) inserted (31.12.2020) by S.I. 2019/775, reg. 89(5) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 66(d)(ii)(iii)); 2020 c. 1, Sch. 5 para. 1(1)

F9

Words in reg. 80(d) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 63(d)