- Draft legislation
This is a draft item of legislation. This draft has since been made as a UK Statutory Instrument: The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 No. 1385
8. 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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