Regulation 110 Amendment to paragraph 17

For paragraph 17 (time limits) substitute—

“Application for authorisation

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.”.