The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025

Amendment of Schedule 6

51.—(1) Schedule 6 (particulars that must accompany an application for a manufacturing authorisation)(1) is amended as follows.

(2) In paragraph 2, after “forms” insert “and whether any of them is an MM investigational medicinal product or a POC investigational medicinal product”.

(3) In paragraph 3—

(a) in sub-paragraph (a), after “products” insert “, including specifically MM investigational medicinal products or POC investigational medicinal products”;

(b) in sub-paragraph (b), after “products” insert “, including specifically MM investigational medicinal products or POC investigational medicinal products”; and

(c) in sub-paragraph (c), after “products” insert “except for MM investigational medicinal products and POC investigational medicinal products”.

(4) In paragraph 4—

(a) in sub-paragraph (1), at the beginning insert “Except where the application relates to an MM investigational medicinal product or a POC investigational medicinal product,”;

(b) after sub-paragraph (1) insert—

“(1A) Where the application relates to an MM investigational medicinal product, the address of the MM (IMP) control site and the location of any testing associated with manufacture or assembly that is, or is to be, carried out.

(1B) Where the application relates to a POC investigational medicinal product, the address of the POC (IMP) control site and the location of any testing associated with manufacture or assembly that is, or is to be, carried out.”;

(c) after sub-paragraph (2) insert—

“(2A) Where the application relates to an MM investigational medicinal product, the address of each of the premises other than the MM (IMP) control site where the proposed holder of the manufacturing authorisation (MM) proposes to store components or equipment to be used in the manufacturing process.

(2B)  Where the application relates to a POC investigational medicinal product, the address of each of the premises other than the POC (IMP) control site where the proposed holder of the manufacturing authorisation (POC) proposes to store components or equipment to be used in the manufacturing process.”; and

(d) in sub-paragraphs (3), (4) and (5), for “(1) and (2)” substitute “(1) to (2B) (as applicable)”.

(5) After paragraph 9 insert—

“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.

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.”.

(1)

Paragraph 2 was substituted by S.I. 2006/1928. There are other amendments but none is relevant.