Paragraph 5
A copy of the proposed changes to—
(a)
the clinical trial protocol; or
(b)
any other particulars or documents accompanying the request for F1approval.
Annotations
Textual amendments
- F1
Word in Sch. 3 Pt. 3 para. 5(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)(f)
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)