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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 19
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Amendment of regulation 167
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19.—(1) Regulation 167 (supply to fulfil special patient needs)(1) is amended as follows.
(2) In paragraph (6), at the beginning insert “Except in the case of an MM medicinal product or a POC medicinal product,”.
(3) After paragraph (6) insert—
“(6A) In the case of an MM medicinal product, condition E is that the product is manufactured or assembled by the holder of a manufacturer’s licence (MM) that relates specifically to the manufacture or assembly of special medicinal products and in accordance with the MM master file relating to the product.
(6B) In the case of a POC medicinal product, condition E is that the product is manufactured or assembled by the holder of a manufacturer’s licence (POC) that relates specifically to the manufacture or assembly of special medicinal products and in accordance with the POC master file relating to the product.”.
(4) In paragraph (7), delete “a country other than”.
(1)
Regulation 167 was amended by S.I. 2019/775. There are other amending instruments but none is relevant.
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