# The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, Paragraph 8: Amendment of regulation 139 (amendment of regulation 177 of the 2012 Regulations – application of Part 11 (pharmacovigilance) and interpretation)


For regulation 139(6), substitute—
“(6) In paragraph (5)—
(a) for “Schedule 33” substitute “Schedules 33 and 33A”;
(b) in paragraph (c) of the definition of “relevant post-authorisation safety study”, omit “and”;
(c) after that definition, insert—
““signal” means information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, which is judged to be of sufficient likelihood to justify verificatory action; and”; and
(d) omit the definitions of “co-ordination group”, “Eudravigilance database”, “Implementing Regulation” and “relevant competent authorities”.”.

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111189092/schedule/1/paragraph/8 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-1/paragraph-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.