The Human Medicines Regulations 2012

1.—(1) This paragraph applies to an application for a manufacturer's licence relating to the manufacture or assembly of medicinal products. U.K.

(2) The application must contain—

(a) the name and address of the applicant;

(b) the name and address of the person (if any) making the application on the applicant's behalf;

(c) the address of each of the premises where any operations to which the licence relates are to be carried out;

(d) the address of any premises not mentioned by virtue of paragraph (c) where—

(i) the applicant proposes to keep any living animals, from which a substance used in the production of the medicinal product to which the application relates is to be derived, or

(ii) materials of animal origin, from which a substance is to be derived as mentioned in sub-paragraph (i), are to be kept;

(e) the address of each of the premises where medicinal products are to be stored, or from which medicinal products are to be distributed;

(f) the name, address, qualifications and experience of the person (“S”) whose duty it will be to supervise the manufacturing or assembling operations, and the name and job title of the person to whom S reports;

(g) the name, address, qualifications and experience of the person with responsibility for quality control in relation to the medicinal products to be manufactured or assembled under the licence (and, if that responsibility is to be carried out by the holder of the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to the products, a statement of that fact);

(h) the name, address and qualifications of the person to be responsible for any animals kept as mentioned in sub-paragraph (d)(i);

(i) the name, address and qualifications of the person to be responsible for the culture of any living tissue for use in the manufacture of medicinal products;

(j) the name, address and qualifications of the qualified person.

(3) The application must also contain—

(a) the pharmaceutical form of each medicinal product to be manufactured or assembled;

(b) details of the manufacturing or assembling operations to which the licence is to relate, including a statement of whether they include—

(i) the manufacture of medicinal products, or

(ii) the assembly of medicinal products;

(c) a statement of whether the medicinal products are to be manufactured or assembled for the purpose of—

(i) being administered to human beings in that form, or

(ii) as an ingredient in the preparation of another medicinal product;

(d) a statement of the facilities and equipment available at each of the premises where medicinal products are to be stored, or from which medicinal products are to be distributed;

(e) a separate statement, in respect of each of the premises mentioned in the application, of—

(i) the manufacturing or assembling operations capable of being carried out at those premises, and the class of medicinal products to which those operations relate, and

(ii) the equipment available at those premises for carrying out each stage of those operations;

(f) a statement of the authority conferred on the person mentioned in sub-paragraph (2)(g) to reject unsatisfactory medicinal products;

(g) a description of the arrangements for the identification and storage of materials and ingredients before and during manufacture or assembly and for the storage of medicinal products after manufacture or assembly;

(h) a description of the arrangements, at each of the premises where the applicant proposes to store medicinal products, for ensuring, so far as practicable, the turn-over of stocks of medicinal products;

(i) a description of the arrangements for maintaining—

(i) production records, and

(ii) records of analytical and other tests used in the course of manufacture or assembly for ensuring compliance of materials used in manufacture, or of medicinal products, with the specification for such materials or medicinal products;

(j) a description of the arrangements for keeping reference samples of—

(i) materials used in the manufacture of medicinal products, and

(ii) medicinal products;

(k) where the application relates to an exempt advanced therapy medicinal product, an outline of the arrangements for maintaining records to allow product traceability containing sufficient detail to enable the linking of a product to the patient who received it and vice versa; and

(l) details of—

(i) any manufacturing operations, other than those to which the licence is to relate, carried on by the proposed licence holder on or near the premises mentioned in sub-paragraph (2)(c), and

(ii) the substances or articles to which those operations relate.