Paragraph 13C Written representationsF1

(1)

If the applicant requests the opportunity to make written representations, the applicant must provide the appropriate committee with those representations and any documents on which the applicant wishes to rely in support of them—

(a)

before the end of the period of 28 days beginning with the date of the request; or

(b)

before the end of such shorter period as the licensing authority may specify in the notification under paragraph 13B.

(2)

The appropriate committee may at the request of the applicant extend the period mentioned in sub-paragraph (1) up to a maximum of 56 days beginning with the date of the request under paragraph 13B.

(3)

The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.

(4)

The appropriate committee must—

(a)

take the representations made under this paragraph into account; and

(b)

report its findings and advice to the licensing authority together with the reasons for that advice.

Annotations

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)