The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 No. 775

PART 11 U.K. Amendment of Part 11 (Pharmacovigilance)

Amendment of regulation 195 (obligation on licensing authority to assess PSURs) U.K.

155.—(1) Regulation 195 M1 is amended as follows.

(2) In the heading, omit “where EU single assessment procedure does not apply”.

[F1 (2A) Before paragraph (1) insert—

“(A1) This regulation applies in the circumstances specified in paragraphs (1) and (1A).”.

(2B) In paragraph (1)—

(a) after “relating to a medicinal product” insert “authorised for sale or supply authorised under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation”; and

(b) in sub-paragraph (a)(i) omit “other than the United Kingdom”.]

(3) [F2 After] paragraph (1) [F3 insert]—

[F4 “( 1A)] This regulation applies where PSURs relating to a medicinal product [F5 authorised for sale or supply under a UKMA(GB) or THR(GB)] have been submitted to the licensing authority under regulations 191 to 192.”.

(4) After paragraph (3) insert—

“(3A) If the licensing authority considers under paragraph (3)(b) that an authorisation or registration needs to be varied, it may require the holder to submit to the licensing authority, within a time period that the licensing authority specifies, an application for a variation, including—

(a) an updated summary of the product characteristics; and

(b) an updated package leaflet.”.

F6 (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Reg. 155(2A)-(2B) 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. 122(a)

F2 Word in reg. 155(3) 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. 122(b)(i)

F3 Word in reg. 155(3) 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. 122(b)(ii)

F4 Words in reg. 155(3) 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. 122(b)(iii)

F5 Words in reg. 155(3) 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. 122(b)(iv)

F6 Reg. 155(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. 122(c)

Commencement Information

I1 Reg. 155 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

M1 Regulation 195 was amended by S.I. 2014/1878.