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

Amendment of Schedule 3

34.—(1) Schedule 3 (applications for licences under Part 3)(1) is amended as follows.

(2) In paragraph 1(2)—

(a) in sub-paragraph (c), at the beginning insert “except where the operations will relate to an MM medicinal product or a POC medicinal product,”;

(b) after sub-paragraph (c) insert—

“(ca) where the application relates to an MM medicinal product, the address of the MM control site;

(cb) where the application relates to a POC medicinal product, the address of the POC control site;”; and

(c) in sub-paragraph (d), after “paragraph (c)” insert “, (ca) or (cb)”.

(3) In paragraph 1(3), after sub-paragraph (b) insert—

“(ba) a statement of whether any of the medicinal products to be manufactured or assembled are MM medicinal products or POC medicinal products;”.

(4) After paragraph 1 insert—

“Manufacturer’s licences (MM)

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.

Manufacturer’s licence (POC)

1B.— (1) This paragraph applies to an application for a manufacturer’s licence relating to POC medicinal products.

(2) In addition to the requirements in paragraph 1, the application must be accompanied by a dossier for each POC medicinal product to which the application relates, which includes, as a minimum, the following—

(a) the location of each site at which manufacturing or assembly of the POC medicinal product is to take place;

(b) the location of each site at which operations related to the manufacture or assembly of the POC medicinal product are to take place;

(c) a description of the process by which the licence holder will approve new POC sites;

(d) a description of the processes by which the licence holder will suspend and cease manufacturing or assembly of the POC medicinal product at a POC site;

(e) a description of the manufacturing, assembly and product release processes to take place at each POC site;

(f) a description of the arrangements for supervision and control by the licence holder of the manufacture or assembly operations at each POC site;

(g) a description of the arrangements for reporting of suspected adverse reactions from POC sites to the POC control site;

(h) the name and contact details of the person at the POC control site who is to be contacted in respect of manufacturing or assembly operations under the licence;

(i) the name and contact details of the person to be contacted in respect of manufacturing or assembly operations at each POC site;

(j) the name and contact details of the person at the POC control site who is to be contacted in respect of quality operations under the licence;

(k) the name and contact details of the person who is to be contacted in respect of quality operations at each POC site; and

(l) a description of the processes by which the licence holder will review and amend the POC master file for the product.”.

(1)

There are amendments but none is relevant.