Amendment of regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation)U.K.
175.—(1) Regulation 210A M1 is amended as follows.
(2) In the heading, [F1after] “the Implementing Regulation [F2insert “and Schedule 12A”].
(3) In paragraph (1)—
[F3(a)in sub-paragraph (a), at the beginning insert “in relation to a UKMA(NI), UKMA(UK), THR(NI) THR(UK) or Article 126a authorisation,”;
(b)after sub-paragraph (a) insert—
“(aa)in relation to a UKMA(GB) or THR(GB), fails to comply with any requirement or obligation contained in a provision of Schedule 12A listed in paragraph (2A); or”.]
(4) [F4After paragraph (2) insert]—
[F5“(2A)] The provisions of Schedule 12A mentioned in paragraph (1)(a) are—
(a)Part 1 (pharmacovigilance system master file);
(b)Parts 2 and 3 (minimum requirements for the quality systems in the performance of pharmacovigilance activities);
(c)Part 6 (transmission of reports of suspected adverse reactions);
(d)paragraph 24 (update of risk management plans);
(e)Part 8 (periodic safety update reports); and
(f)Part 9 (post-authorisation safety studies).
F6(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F6(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.
[F7(5) In paragraph (4), after “Implementing Regulation” insert “, or of paragraph 26(8) or 29(1) of Schedule 12A,”.]
Textual Amendments
F1Word in reg. 175(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. 137(a)(i)
F2Words in reg. 175(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. 137(a)(ii)
F3Reg. 175(3)(a)(b) 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. 137(b)
F4Words in reg. 175(4) 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. 137(c)(i)
F5Words in reg. 175(4) renumbered (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. 137(c)(ii)
F6Words in reg. 175(4) 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. 137(c)(iii)
F7Reg. 175(5) inserted (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. 137(d)
Commencement Information
I1Reg. 175 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 210A was inserted by S.I. 2013/1855.