# The Human Medicines Regulations 2012, Paragraph 1A


(1) This paragraph applies to an application for a manufacturer’s licence relating to MM medicinal products.
(2) In addition to the requirements in paragraph 1, the application must be accompanied by a dossier for each MM medicinal product to which the application relates, 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 medicinal product is to take place;
(b) the location of each unit at which manufacturing or assembly of the MM medicinal product is to take place;
(c) the location of each site at which operations related to the manufacture or assembly of the MM medicinal product are to take place;
(d) a description of the process by which the licence holder will approve new modular units;
(e) a description of the processes by which the licence holder 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 licence holder 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 control site;
(i) the name and contact details of the person at the MM control site who is to be contacted in respect of manufacturing or assembly operations under the licence;
(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 control site who is to be contacted in respect of quality operations under the licence;
(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 licence holder will review and amend the MM master file for the product.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/3/paragraph/1A (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-3/paragraph-1A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.