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The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025

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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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