Paragraph 5 F1

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.

Annotations

Textual amendments

F1: Sch. 3 Pt. A1 inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 39(3)

Notes on Schedule 3

Textual amendments

F1: Words in Sch. 3 heading substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 39(2)