The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
14 Insertion of new regulations 37A and 37B (manufacturing and assembly of MM and POC medicinal products: additional requirements)
After regulation 37 (manufacturing and assembly) insert— Manufacturing and assembly of MM medicinal products: additional requirements 37A. In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (MM) must ensure that— (a) the requirements in regulation 37(2) to (7), (9) and (11) are complied with in relation to manufacturing or assembly carried out at the modular units specified in the MM master file; and (b) only the MM medicinal products specified in the licence are manufactured or assembled at the modular units specified in the MM master file. Manufacturing and assembly of POC medicinal products: additional requirements 37B. In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (POC) must ensure that— (a) the requirements in regulation 37(2) to (7), (9) and (11) are complied with in relation to manufacturing or assembly carried out at the POC sites specified in the POC master file; (b) only the POC medicinal products specified in the licence are manufactured or assembled at the POC sites specified in the POC master file; and (c) a POC medicinal product specified in the licence is only manufactured at a POC site specified in the POC master file. .
14 Insertion of new regulations 37A and 37B (manufacturing and assembly of MM and POC medicinal products: additional requirements)
After regulation 37 (manufacturing and assembly) insert— Manufacturing and assembly of MM medicinal products: additional requirements 37A. In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (MM) must ensure that— (a) the requirements in regulation 37(2) to (7), (9) and (11) are complied with in relation to manufacturing or assembly carried out at the modular units specified in the MM master file; and (b) only the MM medicinal products specified in the licence are manufactured or assembled at the modular units specified in the MM master file. Manufacturing and assembly of POC medicinal products: additional requirements 37B. In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (POC) must ensure that— (a) the requirements in regulation 37(2) to (7), (9) and (11) are complied with in relation to manufacturing or assembly carried out at the POC sites specified in the POC master file; (b) only the POC medicinal products specified in the licence are manufactured or assembled at the POC sites specified in the POC master file; and (c) a POC medicinal product specified in the licence is only manufactured at a POC site specified in the POC master file. .
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