# The Veterinary Medicines (Amendment etc.) Regulations 2024, 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.”.

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Source: https://www.legislation.gov.uk/ukdsi/2024/9780348258523/regulation/110 (the official version)
Page: https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-110
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

