The Human Medicines Regulations 2012

Wholesale dealer’s licences

3.—(1) This paragraph applies to an application for a wholesale dealer’s licence.

(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.

(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—

(i) a marketing authorisation,

(ii) a certificate of registration,

(iii) a traditional herbal registration, or

(iv) an Article 126a authorisation;

(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, or

(ii) sold or supplied pursuant to regulation 174 (supply in response to spread of pathogenic agents etc);

(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.

(4) In sub-paragraph (2)(d) “the responsible person” means the person who is to have responsibility, in relation to wholesale distribution activity carried out under the licence, for—

(a) ensuring that any conditions subject to which the licence is granted are complied with; and

(b) ensuring the quality of medicinal products being handled by the holder of the licence is being maintained in accordance with the requirements of the marketing authorisations, Article 126a authorisations, certificates of registration or traditional herbal registrations applicable to those products.