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)