The Human Medicines Regulations 2012

10.—(1) After receiving the appropriate committee's report under paragraph 7 or 8 or notification under paragraph 9 the licensing authority must— U.K.

(a) decide whether to grant or renew the UK marketing authorisation, certificate of registration or traditional herbal registration;

(b) decide whether to grant or renew the authorisation, certificate or registration in accordance with the application; F1 ...

(c) decide whether to proceed with its proposal to revoke, vary or suspend the authorisation, certificate or registration [F2 ; or

(d) decide whether to proceed with its proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation,]

as the case may be.

(2) If the appropriate committee has given a report under paragraph 7 or 8, the licensing authority must take the report 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

F1 Word in Sch. 11 para. 10(1)(b) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(2D)(a) (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(3); 2020 c. 1, Sch. 5 para. 1(1))

F2 Sch. 11 para. 10(1)(d) and word inserted (31.12.2020) by S.I. 2019/775, reg. 63(2D)(b) (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(3); 2020 c. 1, Sch. 5 para. 1(1))