Paragraph 13F Decision of licensing authorityF1

(1)

The licensing authority must decide whether to proceed with its proposed decision—

(a)

if the applicant requested the opportunity to make written or oral representations, after receiving the appropriate committee's report under paragraph 13C or 13D or notification under paragraph 13E; or

(b)

if the applicant did not request the opportunity to make written or oral representations, after the expiry of the period of time for notifying a request for that opportunity.

(2)

If the appropriate committee gives a report under paragraph 13C or 13D, the licensing authority must take that into account in making its decision.

(3)

The licensing authority must notify the applicant of—

(a)

its decision; and

(b)

any advice given to it by the appropriate committee and 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)