SCHEDULE 11Advice and representations
PART 1General procedures
Application of this Part
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; F1...
(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 F2; 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.
F3(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.
F4(2)
In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.