The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
11 Amendment of regulation 29
After regulation 29(2) (variation of licence on the application of the holder) insert— (2A) In the case of an application of a type specified in paragraph (2C), the information to be provided under paragraph (2)(d) must include the information specified in paragraph 1A(2) of Schedule 3. (2B) In the case of an application of a type specified in paragraph (2D), the information to be provided under paragraph (2)(d) must include the information specified in paragraph 1B(2) of Schedule 3. (2C) The following types of application are specified for the purpose of paragraph (2A) and (2E)— (a) an application to vary the licence so that it relates to the manufacture or assembly of MM medicinal products; (b) an application to vary a manufacturer’s licence (MM) to add a new MM medicinal product. (2D) The following types of application are specified for the purpose of paragraphs (2B) and (2F)— (a) an application to vary the licence so that it relates to the manufacture or assembly of POC medicinal products; (b) an application to vary a manufacturer’s licence (POC) to add a new POC medicinal product. (2E) In dealing with an application of a type specified in paragraph (2C), the licensing authority must take into consideration the arrangements made or to be made for— (a) supervising and controlling operations at a modular unit specified in the application; and (b) ensuring that manufacture or assembly is under appropriate control so that the MM medicinal product consistently satisfies the requirements in the MM master file when manufactured at that modular unit. (2F) In dealing with an application of a type specified in paragraph (2D), the licensing authority must take into consideration the arrangements made or to be made for— (a) supervising and controlling operations at a POC site specified in the application; and (b) ensuring that manufacturing or assembly is under appropriate control so that the POC medicinal product consistently satisfies the requirements in the POC master file when manufactured at that POC site. .
11 Amendment of regulation 29
After regulation 29(2) (variation of licence on the application of the holder) insert— (2A) In the case of an application of a type specified in paragraph (2C), the information to be provided under paragraph (2)(d) must include the information specified in paragraph 1A(2) of Schedule 3. (2B) In the case of an application of a type specified in paragraph (2D), the information to be provided under paragraph (2)(d) must include the information specified in paragraph 1B(2) of Schedule 3. (2C) The following types of application are specified for the purpose of paragraph (2A) and (2E)— (a) an application to vary the licence so that it relates to the manufacture or assembly of MM medicinal products; (b) an application to vary a manufacturer’s licence (MM) to add a new MM medicinal product. (2D) The following types of application are specified for the purpose of paragraphs (2B) and (2F)— (a) an application to vary the licence so that it relates to the manufacture or assembly of POC medicinal products; (b) an application to vary a manufacturer’s licence (POC) to add a new POC medicinal product. (2E) In dealing with an application of a type specified in paragraph (2C), the licensing authority must take into consideration the arrangements made or to be made for— (a) supervising and controlling operations at a modular unit specified in the application; and (b) ensuring that manufacture or assembly is under appropriate control so that the MM medicinal product consistently satisfies the requirements in the MM master file when manufactured at that modular unit. (2F) In dealing with an application of a type specified in paragraph (2D), the licensing authority must take into consideration the arrangements made or to be made for— (a) supervising and controlling operations at a POC site specified in the application; and (b) ensuring that manufacturing or assembly is under appropriate control so that the POC medicinal product consistently satisfies the requirements in the POC master file when manufactured at that POC site. .
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