The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 No. 87

PART 3 Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

Amendment of regulation 46

48.  After regulation 46(2) (labelling of investigational medicinal products)(1) insert—

“(3) Paragraph (1) does not apply to a POC investigational medicinal product that is to be administered in its entirety immediately after manufacture.”.

(1)

There are amendments but none is relevant.