The Medicines (Products for Human Use-Fees) Regulations 2008

Wholesale dealer’s licences: inspection of short duration

7.—(1) 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 £896.

(2) Sub-paragraph (1) 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 falling within a description or class specified in an Order made under section 51(1) (general sale lists) of the Act;

(b) the site relates to a registered pharmacy as referred to in paragraph 9(3) of Part 2 of Schedule 1; 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.

(3) In paragraph (c) of sub–paragraph (2), “turnover” means the gross amount of the total sales made during the period of 12 months preceding the date of the application.

(4) But if the reason paragraph (c) of sub-paragraph (2) applies is 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—

(a) at the time of making the application 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) he so informs the licensing authority when he makes his application.