The Human Medicines Regulations 2012

[F1 Opportunity to make representations U.K.

13B.— (1) If the licensing authority proposes to make a decision to which this Part applies, the licensing authority must notify the person to whom the proposed decision would be addressed (“the applicant”).

(2) The applicant may, by notice in writing to the licensing authority, request the opportunity to make written or oral representations to the appropriate committee.

(3) The applicant must make the request before the end of the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.

(4) The licensing authority must inform the appropriate committee of the applicant's request.]

Textual Amendments

F1 Sch. 11 Pt. 1A inserted by S.I. 2019/775, reg. 63(3A) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(5)); 2020 c. 1, Sch. 5 para. 1(1)