Part 12Amendment to the Schedules

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)(1), 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)(2), 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.”.