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”.”.