Paragraph 6
Summaries of—
any data submitted in support of the proposed F1modification or modifications; and
any change to the F2summary assessment of the potential risks and benefits of using the product in the proposed trial.
Annotations
Textual amendments
- F1
Words in Sch. 3 Pt. 3 para. 6(a) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 39(5)(g)(i)
- F2
Words in Sch. 3 Pt. 3 para. 6(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 39(5)(g)(ii)
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)
Notes on Part 3
Textual amendments
- F1
Sch. 3 Pt. 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(5)(a)