Amendment of regulation 199 (submission of draft study protocols for required studies)U.K.
159.—(1) Regulation 199 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 is a UKMA(NI) or UKMA(UK);
(b)the licensing authority, where the authorisation is a UKMA(GB),
before the study is commenced.”.]
[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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F3(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F3(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Reg. 159(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. 127(a)
F2Reg. 159(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. 127(b)
F3Reg. 159(4)-(6) 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. 127(c)
Commencement Information
I1Reg. 159 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1