The Human Medicines Regulations 2012

This section has no associated Explanatory Memorandum

1.—(1) This Part of this Schedule applies to—U.K.

(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.]

Textual Amendments