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139.—(1) Regulation 177 M1 is amended as follows.
[F1(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).”.]
(3) In paragraph (2)—
(a)after “this Part” insert “ and Schedule 12A ”;
F2(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F3(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(4) In paragraph (3)—
(a)for “Schedule 33” substitute “ Schedules 12A and 33 ”;
F4(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F5(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F6(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F7(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”.]
Textual Amendments
F1Reg. 139(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(a)
F2Reg. 139(3)(b) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(b)
F3Reg. 139(3)(c) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(b)
F4Reg. 139(4)(b) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(c)
F5Reg. 139(4)(c) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(c)
F6Reg. 139(5) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(d)
F7Reg. 139(6) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(e)
Commencement Information
I1Reg. 139 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Marginal Citations
M1Regulation 177 was amended by S.I. 2013/1855 and 2014/1878.