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The Veterinary Medicines (Amendment etc.) Regulations 2024

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Amendment to paragraph 18

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111.  For paragraph 18 (granting authorisation) substitute—

“Procedure and time limits for authorisations

18.—(1) The Secretary of State must inspect the sites mentioned in paragraph 17(2)(b) within 90 days of validating the application.

(2) Where the Secretary of State is satisfied, following the inspection mentioned in sub-paragraph (1) that—

(a)the sites are suitable for the intended purposes; and

(b)the applicant has—

(i)suitable and sufficient staff and facilities for the storage of veterinary medicinal products; and

(ii)a documented quality system in place,

the Secretary of State must grant the wholesale dealer’s authorisation.

(3) Where the Secretary of State is not satisfied in relation to one or more of the matters mentioned in sub-paragraph (2), the Secretary of State may—

(a)reject the application; or

(b)grant a conditional wholesale dealer’s authorisation for a period specified by the Secretary of State until the deficiency has been addressed.

(4) The Secretary of State may extend the period for which a conditional wholesale dealer’s authorisation is granted under sub-paragraph (3)(b).

(5) Where a conditional wholesale dealer’s authorisation is granted under sub-paragraph (3)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect without those conditions.”.

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