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The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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- UK Statutory Instruments
- 2025 No. 87
- PART 3
- Regulation 41
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Amendment of regulation 36
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41.—(1) Regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products)(1) is amended as follows.
(2) In paragraph (1), after “an authorisation” insert “of the appropriate type”.
(3) After paragraph (1) insert—
“(1A) For the purposes of paragraph (1), the appropriate type of authorisation is an authorisation that relates to whichever, or whichever combination, of the following that is appropriate—
(a)manufacture or assembly of investigational medicinal products, except for MM investigational medicinal products and POC investigational medicinal products;
(b)import of investigational medicinal products, except for MM investigational medicinal products and POC investigational medicinal products;
(c)manufacture or assembly of MM investigational medicinal products;
(d)manufacture or assembly of POC investigational medicinal products.”.
(4) After paragraph (2) insert—
“(3) Regulation 36A sets out additional requirements in relation to the manufacture and assembly of MM investigational medicinal products.
(4) Regulation 36B sets out additional requirements in relation to the manufacture and assembly of POC investigational medicinal products.”.
(1)
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