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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 18
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Insertion of new regulations 74A and 74B (obligations to provide information relating to methods of manufacture and control)
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18. After regulation 74 (obligation to take account of scientific and technical progress) insert—
“Obligation to provide information relating to methods of manufacture and control: MM medicinal products
74A. The holder of a UK marketing authorisation relating to an MM medicinal product must provide the holder of the manufacturer’s licence (MM) relating to that product with information in order to enable the licence holder to ensure that the manufacturer’s licence (MM) and MM master file relating to the product are consistent with the marketing authorisation at all times.
Obligation to provide information relating to methods of manufacture and control: POC medicinal products
74B. The holder of a UK marketing authorisation relating to a POC medicinal product must provide the holder of the manufacturer’s licence (POC) relating to that product with information in order to enable the licence holder to ensure that the manufacturer’s licence (POC) and POC master file relating to the product are consistent with the marketing authorisation at all times.”.
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