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

Amendment of Schedule 7

52.—(1) Part 2 of Schedule 7 (standard provisions for manufacturing authorisation)(1) is amended as follows.

(2) In paragraph 1—

(a) for sub-paragraph (a) substitute the following—

“(a) provide and maintain such staff, premises and plant (including technical equipment) as are necessary for the carrying out of such stages of the manufacture and assembly of the investigational medicinal products or EAMs medicinal products as are undertaken by the holder, in accordance with the following—

(i) the holder’s authorisation;

(ii) the product specification;

(iii) the MM (IMP) master file, in the case of an MM investigational medicinal product; and

(iv) the POC (IMP) master file, in the case of a POC investigational medicinal product; ” and

(b) in sub-paragraph (b), at the beginning insert “except in the case of an MM investigational medicinal product and a POC investigational medicinal product,”.

(3) In paragraph 2(b), after “authorisation” insert “or, in the case of an MM investigational medicinal product, the MM (IMP) master file and in the case of a POC investigational medicinal product, the POC (IMP) master file,”.

(4) After paragraph 2 insert—

“2A.   The holder of a manufacturing authorisation (MM) shall not use premises other than the MM (IMP) control site and the modular units specified in the MM (IMP) master file for the purposes specified in paragraph 2(a).

2B.   The holder of a manufacturing authorisation (POC) shall not use premises other than the POC (IMP) control site and the sites specified in the POC (IMP) master file for the purposes specified in paragraph 2(a).”.

(5) In paragraph 6(a), at the beginning insert “except in the case of an MM investigational medicinal product or a POC investigational medicinal product,”.

(6) After paragraph 6 insert—

“6A.   The holder of the authorisation shall inform the licensing authority before making a material alteration to the premises or plant used at the MM (IMP) control site or to any modular unit specified in the MM (IMP) master file, or to the operations for which they are used.

6B.   The holder of the authorisation shall inform the licensing authority before making a material alteration to the premises or plant used at the POC (IMP) control site, or to the operations for which they are used.”.

(7) After paragraph 14A insert—

“Part 2A Manufacturing authorisation (MM)

14B.   The provisions of paragraphs 14C to 14I are incorporated as additional standard provisions of a manufacturing authorisation (MM).

14C.   The holder of the authorisation shall maintain and make available on request of the licensing authority an MM (IMP) master file for each MM investigational medicinal product to which the authorisation relates.

14D.   Each master file may relate to one MM investigational medicinal product only.

14E.   An MM (IMP) master file shall contain, as a minimum, the following information:

(a) the information specified in paragraph 10 of Schedule 6; and

(b) the location of any modular units at which manufacturing or assembly of the MM investigational medicinal product has commenced, has been suspended or has ceased, and the date on which manufacturing or assembly commenced, the dates on which it is suspended, or the date from which it has ceased.

14F.   The holder of the authorisation shall ensure that the information in the MM (IMP) master file is kept up to date at all times.

14G.   The holder of the authorisation shall submit to the licensing authority at annual intervals an update of any changes to the MM (IMP) master file made in the previous 12 month period, the first update being required to be submitted no later than the date that is 12 months from the date on which the manufacturing authorisation (MM) was granted.

14H.   The holder of the authorisation shall conduct regular reviews of the arrangements for supervision and control of the manufacture or assembly operations at each modular unit and ensure that, where appropriate, remedial action is taken as soon as reasonably practicable.

14I.   The holder of a manufacturing authorisation (MM) shall ensure that—

(a) the requirements of paragraphs 1 to 14 and 14C to 14H are complied with in relation to manufacturing carried out at the modular units specified in the MM (IMP) master file;

(b) only the MM investigational medicinal products specified in the MM (IMP) master file are manufactured or assembled at those modular units; and

(c) an MM investigational medicinal product specified in the MM (IMP) master file is only manufactured on premises specified in the MM (IMP) master file.

Part 2B manufacturing authorisation (POC)

14J.   The provisions of paragraphs 14K to 14Q are incorporated as additional standard provisions of a manufacturing authorisation (POC).

14K.   The holder of the authorisation shall maintain and make available on request of the licensing authority a POC (IMP) master file for each POC investigational medicinal product to which the authorisation relates.

14L.   Each master file may relate to one POC investigational medicinal product only.

14M.   A POC (IMP) master file shall contain, as a minimum, the following information:

(a) the information specified in paragraph 11 of Schedule 6; and

(b) the location of any POC (IMP) sites at which manufacturing or assembly of the POC investigational medicinal product has commenced, has been suspended or has ceased, and the date on which manufacturing or assembly commenced, the dates on which it is suspended, or the date from which it has ceased.

14N.   The holder of the authorisation shall ensure that the information in the POC (IMP) master file is kept up to date at all times.

14O.   The holder of the authorisation shall submit to the licensing authority at annual intervals an update of any changes to the POC (IMP) master file made in the previous 12 month period, the first update being required to be submitted no later than the date that is 12 months from the date on which the manufacturing authorisation (POC) was granted.

14P.   The holder of the authorisation shall conduct regular reviews of the arrangements for supervision and control of the manufacture or assembly operations at each POC (IMP) site and ensure that, where appropriate, remedial action is taken as soon as reasonably practicable.

14Q.   The holder of a manufacturing authorisation (POC) shall ensure that—

(a) the requirements of paragraphs 1 to 14 and 14K to 14P are complied with in relation to manufacturing carried out at the POC (IMP) sites specified in the POC (IMP) master file;

(b) only the POC investigational medicinal products specified in the authorisation are manufactured or assembled at those sites; and

(c) a POC investigational medicinal product specified in the authorisation is only manufactured at a POC (IMP) site specified in the POC (IMP) master file.”.

(1)

Paragraphs 1 and 2 were amended by S.I. 2022/352. There are other amendments but none is relevant.