Paragraph 9
There are grounds for expecting that administering the medicinal product to be tested in the trial will produce a benefit to F1the participant outweighing the risks or produce no risk at all.
Annotations
Textual amendments
- F1
Words in Sch. 1 Pt. 5 substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 37(6)(a)
Notes on Schedule 1
Textual amendments
- F1
Word in Sch. 1 heading substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 37(2)