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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 2
- Regulation 8
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Amendment of regulation 22
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8. After regulation 22(1) (factors relevant to determination of application for manufacturer’s or wholesale dealer’s licence) insert—
“(1A) In dealing with an application for a manufacturer’s licence (MM) the licensing authority must, in addition to the matters specified in paragraph (1), take into consideration the arrangements made, or to be made, for—
(a)supervising and controlling operations at a modular unit specified in the application; and
(b)ensuring that manufacture or assembly is under appropriate control so that the MM medicinal product consistently meets the requirements in the MM master file when manufactured at that modular unit.
(1B) In dealing with an application for a manufacturer’s licence (POC) the licensing authority must, in addition to the matters specified in paragraph (1), take into consideration the arrangements made, or to be made, for—
(a)supervising and controlling operations at a POC site specified in the application; and
(b)ensuring that manufacture or assembly is under appropriate control so that the POC medicinal product consistently satisfies the requirements in the POC master file when manufactured at that POC site.”.
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