The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
10 Insertion of new regulation 27A (effect of suspension or variation relating to modular unit or POC site)
After regulation 27 (procedure where licensing authority proposes to suspend, revoke or vary licence) insert— Effect of suspension or variation relating to modular unit or POC site 27A. (1) If the licensing authority suspends or varies a manufacturer’s licence (MM) in accordance with regulation 26(2)(d) so that manufacturing or assembly is suspended, or no longer authorised, at a modular unit, the licence holder may not approve that unit for the purpose of manufacturing or assembly of the MM medicinal product other than by way of an application under regulation 29. (2) If the licensing authority suspends or varies a manufacturer’s licence (POC) in accordance with regulation 26(2)(e) so that manufacturing or assembly is suspended, or no longer authorised, at a POC site, the licence holder may not approve that site for the purpose of manufacturing or assembly of the POC medicinal product other than by way of an application under regulation 29. .
10 Insertion of new regulation 27A (effect of suspension or variation relating to modular unit or POC site)
After regulation 27 (procedure where licensing authority proposes to suspend, revoke or vary licence) insert— Effect of suspension or variation relating to modular unit or POC site 27A. (1) If the licensing authority suspends or varies a manufacturer’s licence (MM) in accordance with regulation 26(2)(d) so that manufacturing or assembly is suspended, or no longer authorised, at a modular unit, the licence holder may not approve that unit for the purpose of manufacturing or assembly of the MM medicinal product other than by way of an application under regulation 29. (2) If the licensing authority suspends or varies a manufacturer’s licence (POC) in accordance with regulation 26(2)(e) so that manufacturing or assembly is suspended, or no longer authorised, at a POC site, the licence holder may not approve that site for the purpose of manufacturing or assembly of the POC medicinal product other than by way of an application under regulation 29. .
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