# The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 11


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

---
Source: https://www.legislation.gov.uk/uksi/2004/1031/schedule/6/paragraph/11 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-6/paragraph-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.