The Medicines (Products for Human Use) (Fees) Regulations 2012

Wholesale dealer’s licences

31.—(1) Unless sub-paragraph (2) or (5) applies, the fee payable under regulation 12(1)(a) in connection with an application for a wholesale dealer’s licence is £1,754.

(2) Where this sub-paragraph applies, the fee payable under regulation 12(1)(a) is £751.

(3) Subject to sub-paragraph (4), sub–paragraph (2) applies where an application for a wholesale dealer’s licence—

(a) relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than 15% of the total turnover of the sale of authorised medicinal products carried on at that pharmacy;

(b) does not relate to anything done in a registered pharmacy but where the total turnover of the sale by way of wholesale dealing of authorised medicinal products does not exceed £35,000; or

(c) relates only to medicinal products falling within a description or class specified in an Order which is for the time being in force made under section 51(1) (general sale lists) of the Act(1).

(4) Sub-paragraph (2) does not apply where the applicant has not held a wholesale dealer’s licence during the 12 month period preceding the date of the application unless at the time of making the application it is reasonable for the applicant to believe—

(a) in the case of an application for a wholesale dealer’s licence which relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and which amounts to wholesale dealing, that such dealing will constitute no more than 15% of the gross amount of the total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence, or

(b) in the case of an application for a wholesale dealer’s licence which does not relate to anything done in a registered pharmacy, 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 that applicant so informs the licensing authority when the application is made.

(5) The fee payable under regulation 12(1)(a) in connection with a change of ownership application is £388.

(1)

Section 51(1) has been amended by S.I. 2006/2407.