The Veterinary Medicines (Amendment etc.) Regulations 2024
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Change 1
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. .
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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