Paragraph 6 Labelling of investigational medicinal products used in old rules clinical trialsF1
Part 7 of the old rules applies in respect of investigational medicinal products used in old rules clinical trials, if those products are manufactured before the relevant day, and in these circumstances investigational medicinal products—
(a)
manufactured before the relevant day; and
(b)
labelled in accordance with regulation 46 of the old rules,
may continue to be used in a clinical trial for which they are for use, subject to complying with Part 7 of the old rules.
Annotations
Textual amendments
- F1
Sch. 14 inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 45