- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
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There are currently no known outstanding effects for the The Veterinary Medicines Regulations 2013, Paragraph 18.
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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.]
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
F1Sch. 3 para. 18 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 111
18.—(1) The Secretary of State must grant a wholesale dealer’s authorisation on being satisfied that this paragraph is complied with.
(2) The authorised site must be—
(a)weatherproof;
(b)secure and lockable;
(c)clean; and
(d)free from contaminants.
(3) If the veterinary medicinal products covered by the authorisation are subject to specific storage conditions, the site must be capable of fulfilling those requirements.
(4) The authorisation holder must—
(a)have the services of technically competent staff; and
(b)have an effective emergency recall plan.
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
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