The Medicines (Products for Animal Use — Fees) Regulations 1995

PART I

Calculation of turnover

1.  In relation to the calculation of turnover in any calendar year in accordance with the provisions of the succeeding paragraphs of this Part of this Schedule, “manufacturer’s prices” shall mean, subject to the provisions of paragraph 2, the prices charged by manufacturers to wholesalers, except where products are supplied by manufacturers direct to retailers, in which case the prices charged by the marketing authorisation or licence holder may be reduced by such sum as, in the opinion of the relevant authority, represents the difference between the prices paid by wholesalers and those normally charged by them to retailers according to the practice prevailing during the period in question with regard to such products.

2.  Where a market authorisation or licence holder sells or supplies products which he has neither manufactured nor obtained from the manufacturer, in relation to the calculation of turnover in any calendar year in accordance with the provisions of the succeeding paragraphs of this Part of this Schedule “manufacturers' prices” shall mean the prices paid by, or on behalf of, the marketing authorisation or licence holder for those products.

3.—(1) For the purpose of calculating annual fees for marketing authorisations and product licences for intermediate feed in relation to the calculation of turnover in any calendar year in accordance with the provisions of the succeeding paragraphs of this Part of this Schedule, the value of the feedingstuff shall be included in the value of the intermediate feed.

(2) For the purposes of this Part of this Schedule, “intermediate feed” means a medicated feedingstuff sold, supplied or imported for use wholly or mainly as an ingredient in the preparation of a substance which is to be fed to one or more animals for a medicinal purpose or for purposes that include that purpose, with or without further processing.

4.  For the purpose of calculating annual fees for marketing authorisations and product licences, “turnover” means the gross value at manufacturers' prices of all authorised or licensed products sold or supplied in the United Kingdom during the previous calendar year and in relation to which the person from whom the fee is due holds the marketing authorisation or licence.

5.  Where the marketing authorisation or licence holder fails to furnish evidence of the amount of annual turnover to the satisfaction of the relevant authority, the relevant authority may require the marketing authorisation or licence holder to furnish an auditor’s certificate containing such evidence. If within one month of the date by which such certificate is required to be furnished, or such longer period as the relevant authority may allow, the marketing authorisation or licence holder has failed to furnish such certificate the sum payable by way of fees for the period in question shall be calculated as provided for in paragraph 5 of Part II of this Schedule or shall be such lesser sum as the relevant authority shall specify in a notice served on the marketing authorisation or licence holder.

6.  Where the holder of a marketing authorisation or product licence (in this paragraph referred to as “the new authorisation or licence holder”) was not dealing in authorised or licensed products during the previous calendar year, but has taken over an existing business or concern which was dealing in such products, whether by purchase or merger or otherwise, the gross value of sales made by that existing business or concern of such authorised or licensed products during the previous calendar year may be treated as the gross value of sales of such products for that year of the new authorisation or licence holder for the purpose of calculating the first annual fee payable by that person.