Paragraph 10 F1

a description and means of identification of each modular unit at which manufacture or assembly of the MM investigational medicinal product is to take place;

the location of each unit at which manufacturing or assembly of the MM investigational medicinal product is to take place;

the location of each site at which operations related to the manufacture or assembly of the MM investigational medicinal product are to take place;

a description of the process by which the proposed holder of the authorisation will approve new modular units;

a description of the processes by which the proposed holder of the authorisation will initiate, suspend and cease manufacturing or assembly of the product at a modular unit;

a description of the manufacturing, assembly and product release processes to take place at each modular unit;

a description of the arrangements for supervision and control by the proposed holder of the authorisation of the manufacture or assembly operations at each modular unit;

a description of the arrangements for reporting of suspected adverse reactions from modular units to the MM (IMP) control site;

the name and contact details of the person at the MM (IMP) control site who is to be contacted in respect of manufacturing or assembly operations under the authorisation;

the name and contact details of the person to be contacted in respect of manufacturing or assembly operations at each modular unit;

the name and contact details of the person at the MM (IMP) control site who is to be contacted in respect of quality operations under the authorisation;

the name and contact details of the person to be contacted in respect of quality operations at each modular unit; and

a description of the processes by which the proposed holder of the authorisation will review and amend the MM (IMP) master file for the product.