Paragraph 1A F1

(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.

Annotations

Textual amendments

F1: Sch. 3 paras. 1A, 1B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 34(4)