The Human Medicines Regulations 2012 No. 1916

SCHEDULES

SCHEDULE 11 U.K. Advice and representations

PART 3 U.K. Referral to the [F1 appropriate committee for traditional herbal registrations]

Textual Amendments

F1 Words in Sch. 11 Pt. 3 heading substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(8)(a); 2020 c. 1, Sch. 5 para. 1(1)

Decision of licensing authority following report U.K.

29.—(1) After receiving the appropriate committee's report under paragraph 26 or 27 or notification under paragraph 28 the licensing authority must decide whether to [F2 grant or refuse the application]. U.K.

(2) If the appropriate committee gives a report under paragraph 26 or 27, the licensing authority must take that into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a) its decision; and

(b) any advice given to it by the appropriate committee and the reasons for that advice.

Textual Amendments

F2 Words in Sch. 11 para. 29(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(8)(c); 2020 c. 1, Sch. 5 para. 1(1)