# The Human Medicines Regulations 2012, 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; ...
(c) decide whether to proceed with its proposal to revoke, vary or suspend the authorisation, certificate or registration ; 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.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/11/paragraph/10 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-11/paragraph-10
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

