The Human Medicines Regulations 2012 No. 1916

PART 11 U.K. Pharmacovigilance

Signal detection U.K.

Signal detection: licensing authority obligations U.K.

189.—(1) The licensing authority must in relation to each medicinal product—

(a) monitor the data [F1 that 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 [F2 regulations 59, 60 and 61] (conditions of UK marketing authorisations) (if any).

(2) [F3 In 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) [F4 In 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

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 (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)

F4 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)

Signal detection: holder obligation U.K.

190.— [F5 (1) The holder must inform—

(a) the licensing authority, and

(b) in respect of a UKMA(UK), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the EMA,

without delay if it detects any relevant changes in relation to the product.]

(2) In this regulation, “relevant changes” has the meaning given in regulation 189(5).

Textual Amendments

F5 Reg. 190(1) substituted (31.12.2020) by S.I. 2019/775, reg. 150 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 117)