The Human Medicines Regulations 2012

Regulation 21(1)

SCHEDULE 3 U.K. Applications for licences under Part 3

Manufacturer's licences U.K.

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;

[F1 (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—

(i) in the case of a product for sale or supply in Great Britain, the UK marketing authorisation, certificate of registration or traditional herbal registration relating to the products, or

(ii) in the case of a product for sale or supply in Northern Ireland, 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.

Textual Amendments

F1 Sch. 3 para. 1(2)(g) substituted (31.12.2020) by S.I. 2019/775, reg. 18(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(a))

Manufacturers' licence relating to import U.K.

2.— [F2 (1) This paragraph applies to an application for a manufacturer's licence relating to the import from— U.K.

(a) in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import, or

(b) in the case of an import into Northern Ireland, a country other than an EEA State,

of medicinal products.]

(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 name, pharmaceutical form, country of origin and marketing authorisation number of each imported medicinal product;

(d) the address of each set of premises where the importation operation is to take place;

(e) the address of each set of premises where any testing associated with the importation is to take place;

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

(g) the name, address and qualifications of the qualified person; and

(h) the name, address, qualifications and experience of the person in charge of quality control.

(3) The application must also contain—

(a) details of the importation operations to which the licence is to relate;

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

(c) details of—

(i) any manufacturing of medicinal products carried on by the applicant on or near the premises mentioned in sub-paragraph (2)(d) to (f), and

(ii) the substances or articles manufactured or used in the manufacturing;

(d) a description of the arrangements for storage of the medicinal products after importation;

(e) a description of the arrangements at each set of premises for ensuring, so far as practicable, the turn-over of stocks of medicinal products;

(f) a description of the arrangements for maintaining—

(i) records of importation, and

(ii) records of analytical and other procedures applied in the course of importation; and

(g) a description of the arrangements for keeping reference samples of the medicinal products.

Textual Amendments

F2 Sch. 3 para. 2(1) substituted (31.12.2020) by S.I. 2019/775, reg. 18(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(b))

Wholesale dealer's licences U.K.

3.—(1) This paragraph applies to an application for a wholesale dealer's licence. 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 medicinal products are to be stored, or from which they are to be distributed; and

(d) the name, address and qualifications of the responsible person [F3 or the responsible person (import)].

(3) The application must also contain—

(a) details of the distribution by way of wholesale dealing to which the licence is to relate;

(b) a statement of whether the medicinal products to which the distribution relates are the subject of—

[F4 (i) in the case of a product for sale or supply in Great Britain, a UK marketing authorisation,

(ia) in the case of a product for sale or supply in Northern Ireland, a marketing authorisation,]

(ii) a certificate of registration,

(iii) a traditional herbal registration, or

(iv) [F5 in the case of a product for sale or supply in Northern Ireland,] an Article 126a authorisation;

[F6 (v) an authorisation granted by an authority in a country other than the United Kingdom to sell or supply the medicinal product in that other country;]

(c) a statement of whether the medicinal products to which the distribution relates are—

(i) prescription only medicines,

(ii) pharmacy medicines, or

(iii) medicines subject to general sale;

(d) a statement of whether the medicinal products to which the distribution relates are—

(i) special medicinal products, F7 ...

[F8 (ia) EAMS medicinal products,]

(ii) sold or supplied pursuant to regulation 174 (supply in response to spread of pathogenic agents [F9 etc), or]

[F10 (iii) to be distributed by means of export from Great Britain to an approved country for import;]

(e) a statement of whether the medicinal products dealt in under the licence are to be used—

(i) for administration to human beings, or

(ii) as ingredients in the preparation of medicinal products for administration to human beings;

(f) an indication of the range of medicinal products to be stored at each of the premises mentioned in the application;

(g) a statement of the facilities and equipment available at those premises for storing and distributing medicinal products;

(h) a description of the arrangements at those premises for ensuring, so far as practicable, the turn-over of stocks of medicinal products (whether by the maintenance of records or by other means);

(i) details of an emergency plan which satisfies the requirements of regulation 43(7)(b), and

(j) a description of the arrangements for keeping records relating to products received or dispatched.

[F11 (4) In sub-paragraph (2)(d)—

“the responsible person” means the person who has the functions described in regulation 45(2);

“the responsible person (import)” means the person who has the functions described in regulation 45AA(4).]

Textual Amendments

F3 Words in Sch. 3 para. 3(2)(d) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 18(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F4 Sch. 3 para. 3(3)(b)(i)(ia) substituted for Sch. 3 para. 3(3)(b)(i) by S.I. 2019/775, regs. 1, 18(4)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(c)(i))

F5 Words in Sch. 3 para. 3(3)(b)(iv) inserted (31.12.2020) by S.I. 2019/775, reg. 18(4)(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 12(c)(ii))

F6 Sch. 3 para. 3(3)(b)(v) inserted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 18(4)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F7 Word in Sch. 3 para. 3(3)(d)(i) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 18(4)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F8 Sch. 3 para. 3(3)(d)(ia) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 13 (with reg. 19)

F9 Words in Sch. 3 para. 3(3)(d)(ii) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 18(4)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F10 Sch. 3 para. 3(3)(d)(iii) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 18(4)(c)(iii) (as amended by S.I. 2020/1488, reg. 1 Sch. 2 para. 12(d)); 2020 c. 1, Sch. 5 para. 1(1)

F11 Sch. 3 para. 3(4) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 18(4)(d); 2020 c. 1, Sch. 5 para. 1(1)

All licences U.K.

4.—(1) If an application does not include information or other matters required under this Schedule, the application must state— U.K.

(a) why that information is not applicable; or

(b) any other reason for not including them.

(2) An application for a licence must be in English.

(3) The pages of an application for a licence must be serially numbered.

(4) The applicant must sign the application.

(5) If the application is made by another person on behalf of the applicant, that person must also sign the application.