The Human Medicines Regulations 2012

Application of this Schedule U.K.

[F1 1.— (1) This Schedule applies if a person (“the applicant”) mentioned in sub-paragraph (2) notifies the licensing authority that the applicant wishes the licensing authority to submit the proposal or as the case may be the decision to review upon oral representations under— U.K.

(a) regulation 27(3)(b);

(b) regulation 45H(3)(b);

(c) regulation 45R(3)(b);

(d) regulation 256J(4)(b); or

(e) Part 1, 2 or 3 of Schedule 11.

(2) Those persons are—

(a) in respect of notification under regulation 27(3)(b) the licence holder;

(b) in respect of a notification under regulation 45H(3)(b) the person registered as a broker;

(c) in respect of a notification under regulation 45R(3)(b) the person with an active substance registration;

(d) in respect of a notification under regulation 256J(4)(b) the person on the list in accordance with Part 12A; and

(e) in respect of a notification under Part 1, 2 or 3 of Schedule 11—

(i) an applicant for a UK marketing authorisation, [F2 parallel import licence,] certificate of registration or traditional herbal registration,

(ii) an applicant for the renewal of an authorisation, [F3 licence,] certificate or registration, and

(iii) the holder of an authorisation, [F3 licence,] certificate or registration.]

Textual Amendments

F1 Sch. 5 para. 1 substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 32(a)

F2 Words in Sch. 5 para. 1(2)(e) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 22(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Sch. 5 para. 1(2)(e) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 22(2)(b); 2020 c. 1, Sch. 5 para. 1(1)