# The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 10


Where the application relates to an MM investigational medicinal product, the application for each product must be accompanied by a dossier which includes, as a minimum, the following:
(a) 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;
(b) the location of each unit at which manufacturing or assembly of the MM investigational medicinal product is to take place;
(c) the location of each site at which operations related to the manufacture or assembly of the MM investigational medicinal product are to take place;
(d) a description of the process by which the proposed holder of the authorisation will approve new modular units;
(e) 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;
(f) a description of the manufacturing, assembly and product release processes to take place at each modular unit;
(g) 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;
(h) a description of the arrangements for reporting of suspected adverse reactions from modular units to the MM (IMP) control site;
(i) 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;
(j) the name and contact details of the person to be contacted in respect of manufacturing or assembly operations at each modular unit;
(k) 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;
(l) the name and contact details of the person to be contacted in respect of quality operations at each modular unit; and
(m) 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.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/schedule/6/paragraph/10 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-6/paragraph-10
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.