# The Human Medicines Regulations 2012, Regulation 189: Signal detection: licensing authority obligations


(1) The licensing authority must in relation to each medicinal product—
(a) monitor the data 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 regulations 59, 60 and 61 (conditions of UK marketing authorisations) (if any).
(2) In relation to medicinal products subject to a UKMA(UK)(Category 2) , 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) In relation to medicinal products subject to a UKMA(UK)(Category 2) , 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.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/189 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-189
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.