# The Human Medicines Regulations 2012, Paragraph 1


(1) This Part of this Schedule applies to—
(a) an application for the grant of a UK marketing authorisation, certificate of registration or traditional herbal registration;
(b) an application to renew a UK marketing authorisation, certificate of registration or traditional herbal registration; ...
(c) a proposal to revoke, vary or suspend a UK marketing authorisation, certificate of registration or traditional herbal registration (including variation by the variation or removal of a condition to which a UK marketing authorisation or a certificate of registration is subject) other than a proposal to vary the authorisation, certificate or registration on the application of or by agreement with its holder ; and
(d) a 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.
(1A) Paragraphs 12 and 13 of this Part also apply to—
(a) an application for the grant of a parallel import licence;
(b) an application to renew a parallel import licence;
(c) a proposal to revoke, vary or suspend a parallel import licence (including variation by the variation or removal of a condition to which a parallel import licence is subject) other than a proposal to vary the licence on the application of or by agreement with its holder; and
(d) a refusal to vary a parallel import licence following an application for a variation by the holder.
(2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/11/paragraph/1 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-11/paragraph-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.