Regulation 45A Non-investigational medicinal and non-medicinal productsF1
(1)
A non-investigational medicinal product shall be manufactured or assembled in accordance with the principles and guidelines for good manufacturing practice which apply under these Regulations or the 2012 Regulations.
(2)
A product which is not a medicinal product but which is used or to be used in a clinical trial, as described in the protocol, must—
(a)
comply with safety standards applicable to that product; and
(b)
be listed in the investigational medicinal product dossier with information about its properties, labelling, manufacture and safety controls, appropriate to the product.
Annotations
Textual amendments
- F1
Pt. 6A inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 31