The Medicines (Products for Human Use) (Fees) Regulations 2016

Wholesale dealer’s licences: inspection of short duration

7.—(1) Sub-paragraph (3) applies if the time taken to make the inspection is not more than 3 hours and 30 minutes, and

(a) the site is that of a wholesale dealer whose licence is limited to dealing only in medicinal products classified as subject to general sale under regulation 5(1) of the Human Medicines Regulations;

(b) the site relates to a registered pharmacy as referred to in paragraph 31(3) of Part 2 of Schedule 2; or

(c) the total turnover in respect of sales by way of wholesale dealing in authorised medicinal products of the wholesale dealer does not exceed £35,000.

(2) If paragraph (c) of sub-paragraph (1) applies because the applicant has not held a wholesale dealer’s licence during the 12 month period preceding the date of the application, sub–paragraph (1) does not apply unless at the time of making the application—

(a) it is reasonable for the applicant to believe that the gross amount of total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence will not exceed £35,000; and

(b) the applicant so informs the licensing authority.

(3) If this sub-paragraph applies, the fee payable in respect of an inspection of a site made in connection with the grant, variation or renewal of a wholesale dealer’s licence is £968.