The Veterinary Medicines Regulations 2013

[F1Application for authorisationE+W+S

This section has no associated Explanatory Memorandum

17.—(1) An application for a wholesale dealer’s authorisation (which must be submitted to the Secretary of State electronically) must include the matters mentioned in sub-paragraph (2).

(2) For the purposes of sub-paragraph (1) the matters are—

(a)the name of the person who will hold the wholesale dealer’s authorisation and that person’s address or registered place of business;

(b)the names and addresses of the sites from which wholesale dealing of veterinary medicinal products is to take place;

(c)evidence that the sites mentioned in paragraph (b) are—

(i)weatherproof;

(ii)secure and lockable;

(iii)clean;

(iv)free from contaminants;

(v)designed with designated areas for the receipt of veterinary medicinal products; and

(vi)where the veterinary medicinal products for which the authorisation is sought are subject to specific storage requirements, capable of fulfilling those requirements;

(d)the name of the person nominated to act in accordance with good distribution practice (the “wholesale qualified person”);

(e)the qualifications and a description of the relevant experience of the wholesale qualified person;

(f)a description of the veterinary medicinal products proposed to be dealt in under the authorisation;

(g)evidence that the proposed holder of the authorisation has available to it the services of technically competent staff;

(h)evidence that the proposed holder of the authorisation has in place—

(i)an effective emergency recall plan; and

(ii)a quality system;

(i)a declaration that the applicant complies with good distribution practice and any relevant legislation;

(j)a declaration that any site mentioned in paragraph (b) is ready for inspection.]

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Time limitsN.I.

17.  The Secretary of State must process an application for a wholesale dealer’s authorisation within 90 days of receiving it.

Extent Information

E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only