161.—(1) Regulation 201 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),
a final study report and an abstract of the study results.”.]
F2(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(4) In paragraph (4), [F3omit “for reports falling under paragraph (3)(a)” and “for reports falling under paragraph (3)(b)]
Textual Amendments
F1Reg. 161(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. 129(a)
F2Reg. 161(3) 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. 129(b)
F3Words in reg. 161(4) substituted (31.12.2020 ) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 129(c)
Commencement Information
I1Reg. 161 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1