Procedure and time limits for authorisations18

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.