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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 36
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Amendment of Schedule 7
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36. In Schedule 7 (qualified persons)(1), after paragraph 12A insert—
“12B. In the case of an MM medicinal product or a POC medicinal product, the obligations in paragraphs 12(1)(a) and 12A(1)(a) may be satisfied by securing that each product has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation relating to the product.”.
(1)
Paragraph 12A was inserted by S.I. 2019/775. There are other amendments but none is relevant.
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