The Human Medicines Regulations 2012

Manufacturers' licence relating to import U.K.

2.— [F1 (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

F1 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))