The Human Medicines Regulations 2012

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

F1 Word in Sch. 11 para. 1(1)(b) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(2)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F2 Sch. 11 para. 1(1)(d) and word inserted (31.12.2020) by S.I. 2019/775, reg. 63(2)(a)(ii) (as substituted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(2); 2020 c. 1, Sch. 5 para. 1(1))

F3 Sch. 11 para. 1(1A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 63(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F4 Sch. 11 para. 1(2) substituted (31.12.2020) by S.I. 2019/775, reg. 63(2)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 46(a))