PART 5Amendments to Schedule 3 to the 2013 Regulations
Amendment to paragraph 18111
For paragraph 18 (granting authorisation) substitute—
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.