The Human Medicines Regulations 2012

Submission of draft study protocols for required studies U.K.

199.—(1) This regulation applies to a relevant post-authorisation safety study that is to be conducted pursuant to a condition of a UK marketing authorisation imposed under regulation 59 (conditions of a UK marketing authorisation: general) or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation).

(2) The holder for the product which is the intended subject of the study must submit a draft protocol for the study [F1 to—

(a) the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation is a UKMA(NI) or [F2 UKMA(UK)(Category 2)];

(b) the licensing authority, where the authorisation is a UKMA(GB) [F3 or UKMA(UK)(Category 1)],

before the study is commenced.]

(3) The body specified in this paragraph is—

(a) where the study is to be conducted in the United Kingdom only, the licensing authority; or

(b) in all other cases [F4 where the study is to be conducted in the EU or an EEA State], the Pharmacovigilance Risk Assessment Committee.

(4) Paragraph (5) applies where a draft protocol is submitted [F5 only] to the licensing authority under paragraphs (2) and (3)(a) [F6 (and is not submitted to the Pharmacovigilance Risk Assessment Committee)].

(5) Where this paragraph applies, the licensing authority, before the end of the period of 60 days beginning on the day after the day on which the draft protocol is submitted, must issue—

(a) a letter endorsing the draft protocol;

(b) a letter objecting to the draft protocol on the grounds that—

(i) it considers that the conduct of the study promotes the use of a medicinal product, or

(ii) it considers that the design of the study does not fulfil the study objectives; or

(c) a letter notifying the holder for the product which is the intended subject of the study that the study is a clinical trial within the meaning of the Clinical Trials Regulations.

(6) A study may not commence unless a letter endorsing the draft protocol has been issued by—

(a) the licensing authority under paragraph (5)(a); or

(b) the Pharmacovigilance Risk Assessment Committee under Article 107n(2) of the 2001 Directive.

(7) Paragraph (8) applies where a letter endorsing the draft protocol has been issued by the Pharmacovigilance Risk Assessment Committee under Article 107n(2) of the 2001 Directive.

(8) Where this paragraph applies, the holder for the product which is the intended subject of the study must forward the protocol to the competent authorities of the EEA States in which the study is to be conducted before commencing the study.

(9) In this regulation, “a letter” includes email correspondence.

(10) This regulation is subject to regulation 212 (transitional arrangements).

Textual Amendments

F1 Reg. 199(2)(a)(b) substituted for words in reg. 199(2) (31.12.2020) by S.I. 2019/775, reg. 159(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 127(a))

F2 Words in reg. 199(2)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 90(a)(i)

F3 Words in reg. 199(2)(b) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 90(a)(ii)

F4 Words in reg. 199(3)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 90(b)

F5 Word in reg. 199(4) inserted (31.12.2020) by S.I. 2019/775, reg. 159(3)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 127(b))

F6 Words in reg. 199(4) inserted (31.12.2020) by S.I. 2019/775, reg. 159(3)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 127(b))