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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 47
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Amendment of regulation 45
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47.—(1) Regulation 45 (suspension and revocation of manufacturing authorisation)(1) is amended as follows.
(2) In paragraph (2)—
(a)at the end of sub-paragraph (a) delete “or”; and
(b)after sub-paragraph (b) insert—
“(c)in the case of a manufacturing authorisation (MM), limited to modular units specified in an MM (IMP) master file associated with the authorisation; or
(d)in the case of a manufacturing authorisation (POC), limited to POC (IMP) sites specified in a POC (IMP) master file associated with the authorisation.”.
(3) After paragraph (4) insert—
“(5) If the licensing authority suspends or revokes a manufacturing authorisation (MM) in accordance with paragraph (2)(c) so that manufacturing or assembly is suspended, or no longer authorised, at a modular unit, the holder of the authorisation may not approve that unit for the purpose of manufacturing or assembly of the MM investigational medicinal product other than by way of an application under regulation 44.
(6) If the licensing authority suspends or revokes a manufacturing authorisation (POC) in accordance with paragraph (2)(d) so that manufacturing or assembly is suspended, or no longer authorised, at a POC (IMP) site, the holder of the authorisation may not approve that site for the purpose of manufacturing or assembly of the POC investigational medicinal product other than by way of an application under regulation 44.”.
(1)
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