Regulation 139 Amendment of regulation 177 (application of Part and interpretation)I1

United Kingdom

(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”.

Annotations

Textual amendments

F1: Reg. 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)
F2: Reg. 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)
F3: Reg. 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)
F4: Reg. 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)
F5: Reg. 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)
F6: Reg. 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)
F7: Reg. 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)

Marginal citations

M1: Regulation 177 was amended by S.I. 2013/1855 and 2014/1878.

Commencement

I1: Reg. 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