Paragraph 10

(1)

After receiving the appropriate committee's report under paragraph 7 or 8 or notification under paragraph 9 the licensing authority must—

(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.

Annotations

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))