Part 12Amendment to the Schedules

Amendment to Schedule 1

regulation 37 + 37.—(1) Schedule 1 (conditions and principles of good clinical practice and for the protection of clinical trial subjects) is amended as follows.

(2) In the heading, for “subjects” substitute “participants”.

(3) In Part 1 (application and interpretation)—

regulation 37 3 a + (a)for “any subject”, in each place where it occurs, substitute “any participant”;

regulation 37 3 b + (b)for “that subject”, in each place where it occurs, substitute “that participant”;

regulation 37 3 c + (c)for “a subject”, in each place where it occurs, substitute “a participant”;

regulation 37 3 d + (d)in paragraph 1(7)(1)—

regulation 37 3 d i + (i)for “the subject” substitute “the participant”;

regulation 37 3 d ii + (ii)omit “or by an appeal panel appointed under Schedule 4”;

regulation 37 3 e + (e)in paragraph 2, in the definition of “Declaration of Helsinki” omit “, as amended by the General Assembly of the Association in October 1975, October 1983, September 1989 and October 1996”;

regulation 37 3 f + (f)in paragraph 3—

regulation 37 3 f i + (i)in sub-paragraph (1)—

regulation 37 3 f i aa + (aa)at the beginning, insert “Subject to sub-paragraph (3),”;

regulation 37 3 f i bb + (bb)in paragraph (b)(ii), for “given orally” substitute “communicated (whether by talking, using sign language or any other means);

regulation 37 3 f ii + (ii)after sub-paragraph (2), insert—

“(3) Where sub-paragraph (4) applies, the protocol for the clinical trial for which consent is given may make provision for simplified arrangements for obtaining and evidencing consent, which shall include—

(a)the reason for obtaining consent using simplified arrangements;

(b)the information to be provided to the participant, and the means of providing that information; and

(c)the means by which consent shall be evidenced.

(4) This sub-paragraph applies where—

(a)the investigational medicinal product or, if there is more than one, each of the investigational medicinal products, is authorised for use in the United Kingdom and is used in accordance with that authorisation;

(b)the investigational medicinal product or, if there is more than one, each of the investigational medicinal products, is given to the participant in the course of that participant’s routine health care; and

(c)the participant receives no additional medication and undergoes no additional intervention or diagnostic procedure, solely for the purposes of the clinical trial.

(5) For the purposes of sub-paragraph (4)—

“intervention” includes complementary or alternative therapies, the taking of tissue samples, and requirements in relation to imaging and radiotherapy; and

“medication” includes nutritional products and alternative remedies.”.

(4) For Part 2 (conditions and principles which apply to all clinical trials) substitute(2)—

“Part 2CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS

1.  Clinical trials must be conducted in accordance with the principles of good clinical practice set out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice, as amended from time to time(3).

2.  Except where it would be a contravention of these Regulations, clinical trials must be conducted in accordance with the principles of the Declaration of Helsinki.

3.  The investigator and sponsor must have regard to all relevant guidance with respect to commencing and conducting a clinical trial.

4.  Provision must be made for insurance or indemnity to cover all liabilities of the investigator and sponsor which may arise in relation to the clinical trial.”.

(5) In Part 3 (conditions which apply in relation to an adult able to consent or who has given consent prior to the onset of incapacity), for “the subject”, in each place where it occurs, substitute “the participant”.

(6) In Part 5 (conditions and principles which apply in relation to an incapacitated adult)—

regulation 37 6 a + (a)for “the subject”, in each place where it occurs, substitute “the participant”;

regulation 37 6 b + (b)in paragraph 1, for “the subject’s” substitute “the participant’s”;

regulation 37 6 c + (c)in paragraph 7, for “a subject” substitute “a participant”.

Omission of Schedule 2

regulation 38 + 38.  Omit Schedule 2 (additional provisions relating to ethics committees).

Amendment to Schedule 3

regulation 39 + 39.—(1) Schedule 3 (particulars and documents that must accompany an application for an ethics committee opinion, a request for authorisation, a notice of amendment and a notification of the conclusion of a trial) is amended as follows.

(2) In the heading, for “an application for an ethics committee opinion, a request for authorisation, a notice of amendment” substitute “a request for approval, a modification request”.

(3) At the beginning of the Schedule insert—

“Part A1REQUEST FOR APPROVAL

1.  A completed application.

2.  A statement or cover letter drawing attention to any features which are particular to the clinical trial, if required.

3.  The protocol for the proposed trial describing the objective, design, methodology, statistical considerations, purpose and organisation of the clinical trial.

4.  The investigator’s brochure or equivalent document.

5.  The following documents or, in each case, an explanation of why that document is not being provided—

(a)documentation relating to compliance with the principles and guidelines of good manufacturing practice, where applicable;

(b)a dossier providing the following information or cross-referring to the document in paragraph 4 if it contains such information—

(i)details of the quality of any investigational medicinal product or non-investigational medicinal product,

(ii)details of the manufacture and control of the investigational medicinal product, and

(iii)data from non-clinical studies and from clinical use of the product;

(c)a copy of the scientific advice of the licensing authority, or of any third country, with regard to the clinical trial;

(d)a description of the content of the labelling;

(e)all information given to the participants, or their legal representatives, before their decision to participate or abstain from participation in the clinical trial;

(f)proof of insurance, a guarantee, or any other similar arrangement, where applicable;

(g)responses to areas for discussion raised by the Commission on Human Medicines, where applicable.”.

(4) Omit Parts 1 (application for ethics committee opinion) and 2 (request for authorisation).

(5) In Part 3 (notice of amendment)—

regulation 39 5 a + (a)in the heading to Part 3, for “notice of amendment” substitute “modification request”;

regulation 39 5 b + (b)omit paragraph 1;

regulation 39 5 c + (c)in paragraph 2(b)(4), for “on the European database referred to in Article 11 of the Directive” substitute “by the authorities”;

regulation 39 5 d + (d)in paragraph 3, for “amendment” substitute “modification”;

regulation 39 5 e + (e)in paragraph 4, for “amendment” substitute “modification, and if more than one modification, a statement for each modification”;

regulation 39 5 f + (f)in paragraph 5(b), for “authorisation or the application for an ethics committee opinion” substitute “approval”;

regulation 39 5 g + (g)in paragraph 6—

regulation 39 5 g i + (i)in sub-paragraph (a), for “amendment” substitute “modification or modifications”;

regulation 39 5 g ii + (ii)in sub-paragraph (b), for “assessment referred to in paragraph 11(2) of Part 2” substitute “summary assessment of the potential risks and benefits of using the product in the proposed trial”.

(6) In Part 4 (notification of conclusion of a clinical trial)—

regulation 39 6 a + (a)omit paragraph 1;

regulation 39 6 b + (b)in paragraph 2(b)(5), for “on the European database referred to in Article 11 of the Directive” substitute “by the authorities”;

regulation 39 6 c + (c)in paragraph 4—

regulation 39 6 c i + (i)in sub-paragraph (2)—

regulation 39 6 c i aa + (aa)for “site” substitute “location”;

regulation 39 6 c i bb + (bb)for “sites” substitute “locations”;

regulation 39 6 c ii + (ii)for sub-paragraph (3), substitute—

“(3) If the trial was conducted at any trial locations outside the United Kingdom, a statement as to whether the trial has ended at any of those locations and—

(a)if ended, the date on which the trial ended; or

(b)if not ended, the anticipated end date of the trial.”.

Amendment to Schedule 4

regulation 40 + 40.—(1) Schedule 4 (appeal against unfavourable ethics committee opinion) is amended as follows.

(2) In paragraph 1—

regulation 40 2 a + (a)in sub-paragraph (1)(6)—

regulation 40 2 a i + (i)for “regulation 16(3), 4(b) or (7)” substitute “regulation 24(3)”;

regulation 40 2 a ii + (ii)for “chief investigator” substitute “sponsor”;

regulation 40 2 a iii + (iii)omit paragraph (b) and the “or” preceding it;

regulation 40 2 b + (b)in sub-paragraph (2) omit—

regulation 40 2 b i + (i)“Subject to sub-paragraph (4),”;

regulation 40 2 b ii + (ii)“or appoint a panel”;

regulation 40 2 c + (c)in sub-paragraph (3)—

regulation 40 2 c i + (i)omit “or appoint a panel”;

regulation 40 2 c ii + (ii)for “chief investigator” substitute “sponsor”;

regulation 40 2 d + (d)omit sub-paragraph (4).

(3) In paragraph 2—

regulation 40 3 a + (a)in sub-paragraph (a)—

regulation 40 3 a i + (i)for “ethics committee which gave the unfavourable opinion” substitute “Authority”;

regulation 40 3 a ii + (ii)for “chief investigator” substitute “sponsor”;

regulation 40 3 a iii + (iii)at the end, omit “and”;

regulation 40 3 b + (b)in sub-paragraph (b), for “regulation 15,” substitute “regulation 17; and”;

regulation 40 3 c + (c)after sub-paragraph (b), insert—

“(c)that committee shall within 30 days beginning with the day on which the application is sent to the committee under paragraph (a), or such extended period as the Authority may in any particular case allow, either confirm the opinion or give a favourable opinion.”.

(4) Omit paragraphs 3 to 6.

Amendment to Schedule 5

regulation 41 + 41.—(1) Schedule 5 (procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorisations and the suspension or termination of clinical trials) is amended as follows.

(2) In paragraph 1(7), for “regulation 26(1)” substitute “regulation 23(2)”.

(3) In paragraph 2—

regulation 41 3 a + (a)in sub-paragraph (1)—

regulation 41 3 a i + (i)in the opening words, for “an amendment to the clinical trial authorisation” substitute “a substantial modification”;

regulation 41 3 a ii + (ii)in paragraph (a), for “amendment” substitute “modification”;

regulation 41 3 a iii + (iii)in paragraph (b), for “amendment to the clinical trial authorisation” substitute “modification”;

regulation 41 3 b + (b)in sub-paragraph (2), for “notice of amendment to a clinical trial authorisation” substitute “valid modification request”.

Amendment to Schedule 7

regulation 42 + 42.—(1) Schedule 7 (standard provisions for manufacturing authorisations) is amended as follows.

(2) In Part 1 (interpretation)—

regulation 42 2 a + (a)before the definition of “Commission Directive 2003/94/EC” insert—

““Commission Delegated Regulation 2017/1569”, in relation to the holder of an authorisation in Northern Ireland, means Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and the guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections, as that Regulation has effect in EU law(8);”;

regulation 42 2 b + (b)in the definition of “Commission Directive 2003/94/EC”(9) omit paragraph (b).

(3) In Part 2 (provisions which may be incorporated in an authorisation relating to the manufacture or assembly of investigational medicinal products)—

regulation 42 3 a + (a)in paragraph 3, after “Commission Directive 2003/94/EC” insert “in respect of Great Britain, or Article 10(1) of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland,”;

regulation 42 3 b + (b)in paragraph 4, after “Commission Directive 2003/94/EC” insert “in respect of Great Britain, or Article 10(2) of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland,”;

regulation 42 3 c + (c)in paragraph 7(a), after “Commission Directive 2003/94/EC” insert “in respect of Great Britain or Article 8 of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland”;

regulation 42 3 d + (d)in paragraph 8, after “Commission Directive 2003/94/EC” insert “in respect of Great Britain or Article 11 of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland”.

(4) In Part 3 (provisions which may be incorporated in an authorisation relating to the importation of investigational medicinal products)—

regulation 42 4 a + (a)in paragraph 2, after “Commission Directive 2003/94/EC” insert “in respect of Great Britain, or Article 10(2) of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland,”;

regulation 42 4 b + (b)in paragraph 5(a), after “Commission Directive 2003/94/EC” insert “in respect of Great Britain or Article 8 of Commission Delegated Regulation 2017/1569 in respect of Northern Ireland”.