The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
45 Amendment of regulation 44
After regulation 44(8) (variation of manufacturing authorisation) insert— (9) In the case of an application of a type specified in paragraph (11), the information to be provided under sub-paragraph (d) in the definition of “valid application” in paragraph (8) shall include the information specified in paragraph 10 of Schedule 6. (10) In the case of an application of a type specified in paragraph (12), the information to be provided under sub-paragraph (d) in the definition of “valid application” in paragraph (8) shall include the information specified in paragraph 11 of Schedule 6. (11) The following types of application are specified for the purpose of paragraph (9)— (a) an application to vary the licence so that it relates to the manufacture or assembly of MM investigational medicinal products; (b) an application to vary a manufacturing authorisation (MM) to add a new MM investigational medicinal product. (12) The following types of application are specified for the purpose of paragraph (10)— (a) an application to vary the licence so that it relates to the manufacture or assembly of POC investigational medicinal products; (b) an application to vary a manufacturing authorisation (POC) to add a new POC investigational medicinal product. (13) In dealing with an application of a type specified in paragraph (11), the licensing authority shall take into consideration the arrangements made or to be made for— (a) supervising and controlling operations at a modular unit; and (b) ensuring that manufacturing or assembly is under appropriate control so that the MM investigational medicinal product consistently satisfies the requirements in the MM (IMP) master file when manufactured at a modular unit. (14) In dealing with an application of a type specified in paragraph (12), the licensing authority shall take into consideration the arrangements made or to be made for— (a) supervision and controlling operations at a POC (IMP) site specified in the application; and (b) ensuring that manufacturing or assembly is under appropriate control so that the POC investigational medicinal product consistently satisfies the requirements in the POC (IMP) master file when manufactured at that POC (IMP) site. .
45 Amendment of regulation 44
After regulation 44(8) (variation of manufacturing authorisation) insert— (9) In the case of an application of a type specified in paragraph (11), the information to be provided under sub-paragraph (d) in the definition of “valid application” in paragraph (8) shall include the information specified in paragraph 10 of Schedule 6. (10) In the case of an application of a type specified in paragraph (12), the information to be provided under sub-paragraph (d) in the definition of “valid application” in paragraph (8) shall include the information specified in paragraph 11 of Schedule 6. (11) The following types of application are specified for the purpose of paragraph (9)— (a) an application to vary the licence so that it relates to the manufacture or assembly of MM investigational medicinal products; (b) an application to vary a manufacturing authorisation (MM) to add a new MM investigational medicinal product. (12) The following types of application are specified for the purpose of paragraph (10)— (a) an application to vary the licence so that it relates to the manufacture or assembly of POC investigational medicinal products; (b) an application to vary a manufacturing authorisation (POC) to add a new POC investigational medicinal product. (13) In dealing with an application of a type specified in paragraph (11), the licensing authority shall take into consideration the arrangements made or to be made for— (a) supervising and controlling operations at a modular unit; and (b) ensuring that manufacturing or assembly is under appropriate control so that the MM investigational medicinal product consistently satisfies the requirements in the MM (IMP) master file when manufactured at a modular unit. (14) In dealing with an application of a type specified in paragraph (12), the licensing authority shall take into consideration the arrangements made or to be made for— (a) supervision and controlling operations at a POC (IMP) site specified in the application; and (b) ensuring that manufacturing or assembly is under appropriate control so that the POC investigational medicinal product consistently satisfies the requirements in the POC (IMP) master file when manufactured at that POC (IMP) site. .
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