The Medicines for Human Use (Clinical Trials) Regulations 2004

PART 9 U.K. MISCELLANEOUS PROVISIONS

Construction of references to specified publications U.K.

53.—(1) Where any authorisation granted under these Regulations refers to a specified publication, but not to any particular edition of that publication, then, for the purpose of determining whether anything done, at a time when the authorisation is in force, is done in accordance with the authorisation, the reference shall, unless the authorisation otherwise expressly provides, be construed as a reference to the current edition of that publication as in force at that time.

(2) In this regulation any reference to the current edition of a specified publication as in force at a particular time is a reference to the edition of that publication in force, under whatever title, at that time together with any amendments, additions and deletions made to it up to that time.

(3) In this regulation, “specified publication” has the meaning given by [F1 regulation 321(1) of the 2012 Regulations].

Textual Amendments

F1 Words in reg. 53(3) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 60 (with Sch. 32)

Consequential and other amendments to enactments U.K.

54.   [F2 The provisions of the enactments specified in Schedule 10 are amended as there specified.]

Textual Amendments

F2 Reg. 54 revoked in part (1.10.2010) by The Health and Social Care Act 2008 (Commencement No.16, Transitory and Transitional Provisions) Order 2010 (S.I. 2010/807), art. 1(1)(b), Sch. 2

Revocations U.K.

55.  The enactments specified in column (1) of Schedule 11 are revoked to the extent specified in column (3) of that Schedule.

Transitional provisions U.K.

56.  The transitional provisions set out in [F3 Schedules 12 and 13] shall have effect.

Textual Amendments

F3 Words in reg. 56 substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 22; 2020 c. 1, Sch. 5 para. 1(1)

[F4 Functions in relation to good clinical practice U.K.

57.— (1) Regulations may, in respect of Great Britain—

(a) amend the conditions and principles of good clinical practice to take account of technical and scientific progress;

(b) specify requirements for documentation relating to a clinical trial which constitute the master file on the trial at the time the file is archived;

(c) amend or revoke the requirements of regulation 31A relating to the content of the trial master file; and

(d) require guidance published under regulation 58 to be taken into account when interpreting any enactment or other requirement to which the guidance relates.

(2) Any power to make regulations under paragraph (1)—

(a) is exercisable by the Secretary of State by statutory instrument;

(b) includes power to make—

(i) different provision for different purposes or different areas;

(ii) consequential, supplementary, incidental, transitional, transitory or saving provisions, including consequential amendments to these Regulations.

( 3) Regulations under paragraph (1) are subject to annulment in pursuance of a resolution of either House of Parliament.

Textual Amendments

F4 Regs. 57, 58 inserted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 23 (as amended by by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 1 para. 7); 2020 c. 1, Sch. 5 para. 1(1)

Detailed guidance U.K.

58.   The licensing authority may publish guidance on—

(a) the application format and documentation to be submitted in an application for an ethics committee opinion, in particular regarding the information that is given to subjects, and on the appropriate safeguards for the protection of personal data;

(b) the format and contents of a request for authorisation of a clinical trial, as well as the documentation to be submitted to support that request, on the quality and manufacture of the investigational medicinal product, any toxicological and pharmacological tests, the protocol and clinical information on the investigational medicinal product including the investigator's brochure;

(c) the presentation and content of any proposed substantial amendment to the clinical trial authorisation insofar as it relates to the protocol;

(d) the declaration of the end of the clinical trial;

(e) the collection, verification and presentation of adverse event or adverse reaction reports, together with decoding procedures for unexpected serious adverse reactions;

(f) the content of essential documents forming part of the trial master file;

(g) the elements to be taken into account when evaluating investigational medicinal products for the purpose of regulation 43(2).]

Textual Amendments

F4 Regs. 57, 58 inserted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 23 (as amended by by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 1 para. 7); 2020 c. 1, Sch. 5 para. 1(1)