The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
40 Amendment of regulation 13
(1) Regulation 13 (supply of investigational medicinal products for the purpose of clinical trials) is amended as follows. (2) In paragraph (2)(b)(i), after “United Kingdom” insert “except for an MM investigational medicinal product or a POC investigational medicinal product”. (3) After paragraph (2)(b)(i) insert— (ia) an MM investigational medicinal product manufactured or assembled in the United Kingdom, the product has been manufactured or assembled in accordance with the terms of a manufacturing authorisation (MM) or assembled under the exemption in regulation 37; (ib) a POC investigational medicinal product manufactured or assembled in the United Kingdom, the product has been manufactured or assembled in accordance with the terms of a manufacturing authorisation (POC) or assembled under the exemption in regulation 37; .
40 Amendment of regulation 13
(1) Regulation 13 (supply of investigational medicinal products for the purpose of clinical trials) is amended as follows. (2) In paragraph (2)(b)(i), after “United Kingdom” insert “except for an MM investigational medicinal product or a POC investigational medicinal product”. (3) After paragraph (2)(b)(i) insert— (ia) an MM investigational medicinal product manufactured or assembled in the United Kingdom, the product has been manufactured or assembled in accordance with the terms of a manufacturing authorisation (MM) or assembled under the exemption in regulation 37; (ib) a POC investigational medicinal product manufactured or assembled in the United Kingdom, the product has been manufactured or assembled in accordance with the terms of a manufacturing authorisation (POC) or assembled under the exemption in regulation 37; .
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