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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 6
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Insertion of new regulations 17A and 17B (manufacturing of MM and POC medicinal products)
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6. After regulation 17 (manufacturing of medicinal products) insert—
“Manufacturing of MM medicinal products
17A. A person may not manufacture or assemble an MM medicinal product unless—
(a)it is specified in a manufacturer’s licence (MM); and
(b)there is an MM master file relating to that product and it is manufactured or assembled in accordance with that master file.
Manufacturing of POC medicinal products
17B. A person may not manufacture or assemble a POC medicinal product unless—
(a)it is specified in a manufacturer’s licence (POC); and
(b)there is a POC master file relating to that product and it is manufactured or assembled in accordance with that master file.”.
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