The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
35 Amendment of Schedule 4
In Schedule 4 (standard provisions of licences under Part 3), after paragraph 14B insert— Part 1A Manufacturer’s licence (MM) 14C. The provisions of paragraphs 14D to 14K are incorporated as additional standard provisions of a manufacturer’s licence (MM). 14D. The licence holder must maintain an MM master file for each MM medicinal product specified in the licence. 14E. An MM master file may relate to one MM medicinal product only. 14F. An MM master file must contain, as a minimum, the following information— (a) the information specified in paragraph 1A(2) of Schedule 3; and (b) the location and identification of any modular unit at which manufacturing or assembly of the MM medicinal product has commenced, has been suspended or has ceased, the date on which manufacturing or assembly commenced or ceased, and the dates on which it was suspended. 14G. The licence holder must ensure that the information contained in the MM master file is kept up to date, and consistent with any UK marketing authorisation for the product, at all times. 14H. The licence holder must make the MM master file available to the licensing authority at all times on request. 14I. The licence holder must submit to the licensing authority, at annual intervals, an update of any changes to the MM master file made in the previous 12 month period, the first update being required to be submitted no later than the date that is 12 months from the date on which the manufacturer’s licence (MM) was granted. 14J. The licence holder must keep under review the arrangements for supervision and control of the manufacture or assembly operations at each modular unit and, if the arrangements are found to be inadequate, ensure that appropriate remedial action is taken as soon as reasonably practicable. 14K. (1) The licence holder must record all suspected adverse reactions to the MM medicinal product which are brought to the licence holder’s attention. (2) The licence holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals. (3) The licence holder must report suspected adverse reactions identified under sub-paragraph (1) to the holder of the UK marketing authorisation, or the EAMS scientific opinion holder (as applicable), relating to the MM medicinal product as soon as reasonably practicable after the licence holder gains knowledge of the reaction. Part 1B Manufacturer’s Licence (POC) 14L. The provisions of paragraphs 14M to 14T are incorporated as additional standard provisions of a manufacturer’s licence (POC). 14M. The licence holder must maintain a POC master file for each POC medicinal product specified in the licence. 14N. A POC master file may relate to one POC medicinal product only. 14O. A POC master file must contain, as a minimum, the following information: (a) the information specified in paragraph 1B(2) of Schedule 3; and (b) the location of any POC sites at which manufacturing or assembly of the POC medicinal product has commenced, has been suspended or has ceased, the date on which manufacturing or assembly commenced or ceased, and the dates on which it was suspended. 14P. The licence holder must ensure that the information contained in the POC master file is kept up to date, and consistent with any UK marketing authorisation for the product, at all times. 14Q. The licence holder must make the POC master file available to the licensing authority at all times on request. 14R. The licence holder must submit to the licensing authority, at annual intervals, an update of any changes to the POC master file made in the previous 12 month period, the first update being required to be submitted no later than the date that is 12 months from the date on which the manufacturer’s licence (POC) was granted. 14S. The licence holder must keep under review the arrangements for supervision and control of the manufacture or assembly operations at each POC site and, if the arrangements are found to be inadequate, ensure that appropriate remedial action is taken as soon as reasonably practicable. 14T. (1) The licence holder must record all suspected adverse reactions to the POC medicinal product which are brought to the licence holder’s attention. (2) The licence holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals. (3) The licence holder must report suspected adverse reactions identified under sub-paragraph (1) to the holder of any UK marketing authorisation, or the EAMS scientific opinion holder (as applicable), relating to the POC medicinal product as soon as reasonably practicable after the licence holder gains knowledge of the reaction. .
35 Amendment of Schedule 4
In Schedule 4 (standard provisions of licences under Part 3), after paragraph 14B insert— Part 1A Manufacturer’s licence (MM) 14C. The provisions of paragraphs 14D to 14K are incorporated as additional standard provisions of a manufacturer’s licence (MM). 14D. The licence holder must maintain an MM master file for each MM medicinal product specified in the licence. 14E. An MM master file may relate to one MM medicinal product only. 14F. An MM master file must contain, as a minimum, the following information— (a) the information specified in paragraph 1A(2) of Schedule 3; and (b) the location and identification of any modular unit at which manufacturing or assembly of the MM medicinal product has commenced, has been suspended or has ceased, the date on which manufacturing or assembly commenced or ceased, and the dates on which it was suspended. 14G. The licence holder must ensure that the information contained in the MM master file is kept up to date, and consistent with any UK marketing authorisation for the product, at all times. 14H. The licence holder must make the MM master file available to the licensing authority at all times on request. 14I. The licence holder must submit to the licensing authority, at annual intervals, an update of any changes to the MM master file made in the previous 12 month period, the first update being required to be submitted no later than the date that is 12 months from the date on which the manufacturer’s licence (MM) was granted. 14J. The licence holder must keep under review the arrangements for supervision and control of the manufacture or assembly operations at each modular unit and, if the arrangements are found to be inadequate, ensure that appropriate remedial action is taken as soon as reasonably practicable. 14K. (1) The licence holder must record all suspected adverse reactions to the MM medicinal product which are brought to the licence holder’s attention. (2) The licence holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals. (3) The licence holder must report suspected adverse reactions identified under sub-paragraph (1) to the holder of the UK marketing authorisation, or the EAMS scientific opinion holder (as applicable), relating to the MM medicinal product as soon as reasonably practicable after the licence holder gains knowledge of the reaction. Part 1B Manufacturer’s Licence (POC) 14L. The provisions of paragraphs 14M to 14T are incorporated as additional standard provisions of a manufacturer’s licence (POC). 14M. The licence holder must maintain a POC master file for each POC medicinal product specified in the licence. 14N. A POC master file may relate to one POC medicinal product only. 14O. A POC master file must contain, as a minimum, the following information: (a) the information specified in paragraph 1B(2) of Schedule 3; and (b) the location of any POC sites at which manufacturing or assembly of the POC medicinal product has commenced, has been suspended or has ceased, the date on which manufacturing or assembly commenced or ceased, and the dates on which it was suspended. 14P. The licence holder must ensure that the information contained in the POC master file is kept up to date, and consistent with any UK marketing authorisation for the product, at all times. 14Q. The licence holder must make the POC master file available to the licensing authority at all times on request. 14R. The licence holder must submit to the licensing authority, at annual intervals, an update of any changes to the POC master file made in the previous 12 month period, the first update being required to be submitted no later than the date that is 12 months from the date on which the manufacturer’s licence (POC) was granted. 14S. The licence holder must keep under review the arrangements for supervision and control of the manufacture or assembly operations at each POC site and, if the arrangements are found to be inadequate, ensure that appropriate remedial action is taken as soon as reasonably practicable. 14T. (1) The licence holder must record all suspected adverse reactions to the POC medicinal product which are brought to the licence holder’s attention. (2) The licence holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals. (3) The licence holder must report suspected adverse reactions identified under sub-paragraph (1) to the holder of any UK marketing authorisation, or the EAMS scientific opinion holder (as applicable), relating to the POC medicinal product as soon as reasonably practicable after the licence holder gains knowledge of the reaction. .
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