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

PART 2 U.K. Value of the Product Sold or Supplied

Determining the total value of the product U.K.

2.  For the purposes of this Schedule, the “ total value of the product” means, the gross value at manufacturer's prices of all medicinal products to which the authorisation relates that are sold or supplied in the United Kingdom by the holder of that authorisation during a period of 12 months preceding the commencement of the relevant fee period.

Manufacturer's prices U.K.

3.  For the purposes of paragraph 2 manufacturer's prices means—

(a) for products manufactured or obtained, sold or supplied by the authorisation holder to wholesalers or to distributors or assemblers named in the marketing authorisation, which that holder has manufactured or obtained from the manufacturer, the prices charged for the supply;

(b) for products sold or supplied by the authorisation holder to retailers, which that holder has manufactured or obtained from the manufacturer, the prices which, in the opinion of the licensing authority, the authorisation holder would have charged, in accordance with the practice prevailing during the relevant year, to a wholesaler of the product; or

(c) for products sold or supplied by the authorisation holder which that holder has neither manufactured nor obtained from the manufacturer, the price which the authorisation holder paid for the supply.

Information requirements U.K.

4.—(1) The authorisation holder shall determine the total value of product sold or supplied in accordance with paragraphs 2 and 3 and provide such information to the licensing authority if required to do so.

(2) The licensing authority may additionally require an auditor's certificate verifying the authorisation holder's determination of the value of products sold or supplied.

(3) If an auditor's certificate has not been provided to the licensing authority within one month of it being required, or such longer period that the authority may allow, the periodic fee shall be calculated in accordance with sub-paragraph (4).

(4) The periodic fees for the relevant fee period in question shall be equal to the fee provided for in paragraphs 10 and 13 of Part 3 of this Schedule or, such lesser sum as the licensing authority may specify in a written notice served on the authorisation holder.