Regulation 189 Signal detection: licensing authority obligations

(1)

The licensing authority must in relation to each medicinal product—

(a)

monitor the data F1that it collects by virtue of operating its pharmacovigilance system under this Part to determine whether there are any relevant changes;

(b)

assess updates to the risk management system for the product;

(c)

monitor the outcome of risk minimisation measures contained in the risk management plan (if any); and

(d)

monitor the outcome of conditions imposed under F2regulations 59, 60 and 61 (conditions of UK marketing authorisations) (if any).

(2)

F3In relation to medicinal products subject to a UKMA(UK)(Category 2) F4, a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the licensing authority must collaborate with the EMA in carrying out its functions under paragraph (1).

(3)

F5In relation to medicinal products subject to a UKMA(UK)(Category 2) F6, a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the licensing authority must inform the bodies specified in paragraph (4) without delay if it detects any relevant changes in relation to a medicinal product.

(4)

The bodies specified in this paragraph are—

(a)

the EMA; and

(b)

the relevant competent authorities.

(5)

In this regulation “relevant changes” in relation to a medicinal product means—

(a)

new risks;

(b)

risks that have changed; or

(c)

changes to the risk-benefit balance.

Annotations

Textual amendments

F1: Words in reg. 189(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 149(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in reg. 189(1)(d) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 149(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
F3: Words in reg. 189(2) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 80(a)
F4: Words in reg. 189(2) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 149(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 116)
F5: Words in reg. 189(3) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 80(b)
F6: Words in reg. 189(3) substituted (31.12.2020) by virtue of S.I. 2019/775, reg. 149(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 116)