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)

Right to review after paragraph 29 notification U.K.

30.—(1) This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 29 to refer the applicant to the Committee on Herbal Medicinal Products as proposed. U.K.

(2) The applicant may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations.

(3) The applicant must give the notification within the period of 28 days beginning with the day on which the licensing authority's notification is given or such longer period as the licensing authority may allow.

(4) The review must be conducted in accordance with Schedule 5.

(5) This paragraph does not apply if the person has not made any representations in accordance with paragraph 26 or 27.