The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
Write the words of this act the way you think they should read. Solon shows your change as a redline against the published text and pins it to that exact text, so it can never be applied to wording you did not see.
Change 1
31 Insertion of new Part 6A
After Part 6, insert— Part 6A NON-INVESTIGATIONAL MEDICINAL AND NON-MEDICINAL PRODUCTS Non-investigational medicinal and non-medicinal products 45A (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. .
31 Insertion of new Part 6A
After Part 6, insert— Part 6A NON-INVESTIGATIONAL MEDICINAL AND NON-MEDICINAL PRODUCTS Non-investigational medicinal and non-medicinal products 45A (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. .
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