The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

107.  In regulation 139 (amendment of regulation 177 (application of part and interpretation))—

(a) for paragraph (2) substitute—

“(2) After paragraph (1) insert—

“(1A) Schedule 12A applies in relation to medicinal products that are the subject of a UKMA(GB) ora THR(GB).”.”’

(b) in paragraph (3) omit sub-paragraphs (b) and (c);

(c) in paragraph (4) omit sub-paragraphs (b) and (c);

(d) omit paragraph (5);

(e) for paragraph (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”; and

(c) after that definition, insert—

““signal” means, in relation to a UKMA(GB) or THR(GB), 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”.”.