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The Human Medicines Regulations 2012, Section 189 is up to date with all changes known to be in force on or before 26 August 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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189.—(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), 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) [F4In relation to medicinal products subject to a UKMA(UK), 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.
Textual Amendments
F1Words 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)
F2Words 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)
F3Words 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)
F4Words 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)
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