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

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

Amendment of regulation 200 (amendment to study protocols for required studies) U.K.

160.—(1) Regulation 200 is amended as follows.

[F1 (2) In paragraph (2) for “to the body specified in paragraph (3)” to the end substitute—

“to—

(a) the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation for the product is a UKMA(NI) or UKMA(UK);

(b) the licensing authority, where the authorisation for the product is a UKMA(GB),

before their implementation.”.]

[F2 (3) In paragraph (4)—

(a) after “protocol is submitted” insert “only”;

(b) after “paragraphs (2) and (3)(a)” insert “(and is not submitted to the Pharmacovigilance Risk Assessment Committee)”.]

F3 (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F4 (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Reg. 160(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. 128(a)

F2 Reg. 160(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. 128(b)

F3 Reg. 160(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. 128(c)

F4 Reg. 160(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. 128(c)

Commencement Information

I1 Reg. 160 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1