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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 43
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Amendment of regulation 39
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43. After regulation 39(4) (consideration of application for manufacturing authorisation) insert—
“(4A) If the application for a manufacturing authorisation relates (wholly or partially) to an MM investigational medicinal product, the licensing authority shall take into consideration the arrangements 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 investigational medicinal product consistently meets the requirements in the MM (IMP) master file when manufactured at that modular unit.
(4B) If the application for a manufacturing authorisation relates (wholly or partially) to a POC investigational medicinal product, the licensing authority shall take into consideration the arrangements for—
(a)supervising and controlling operations at any POC (IMP) site specified in the application; and
(b)ensuring that manufacture or assembly is under appropriate control so that the POC investigational medicinal product consistently meets the requirements in the POC (IMP) master file when manufactured at that site.”.
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