The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1991

Regulation 11

SCHEDULE 4 ANNUAL FEES FOR PRODUCT LICENCES

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, “manufacturers' prices” shall mean, subject to the provisions of paragraph 2, the prices charged by manufacturers to wholesalers, except where medicinal products are supplied by manufacturers direct to retailers, in which case the prices charged by the licence holder may be reduced by such sum as, in the opinion of the licensing 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 licence year in question with regard to such products.

2.  Where a licence holder sells or supplies medicinal 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 licence holder for those medicinal products.

3.—(1) For the purpose of calculating annual fees for 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 product licences of a particular kind, “turnover” means the gross value at manufacturers' prices of all medicinal products sold or supplied by the applicant in the United Kingdom during the calendar year which ends 3 months before the beginning of the licence year. For the purposes of this paragraph medicinal products sold or supplied by the licence holder shall comprise only those products in respect of which a licence is held during that calendar year.

5.  Where the licence holder fails to furnish evidence of the amount of annual turnover to the satisfaction of the licensing authority the licensing authority may require the 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 licensing authority may allow, the licence holder has failed to furnish such certificate the sum payable by way of fees for the licence year 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 licensing authority shall specify in a notice serviced on the licence holder.

6.  Where an applicant for a licence was not dealing in medicinal products during the calendar year which ends 3 months before the beginning of the licence year in which the application is made, but has taken over an existing business or concern, whether by purchase or merger or otherwise, the gross value of sales of that business or concern during the calendar year which ends 3 months before the beginning of the licence year in which the application is made may be treated as the gross value of sales for the purpose of calculating the turnover of that business or concern.

PART II CALCULATION OF ANNUAL FEES

1.  Subject to the provisions of these Regulations annual fees shall be payable at the basic rate of £250 or 0.637percnt; of turnover, whichever is the greater.

2.  For the purpose of calculating annual turnover the provisions of Part I of this Schedule shall apply.

3.  The amount payable by way of annual fees in accordance with this Schedule shall, when calculated on the basis of turnover, be rounded up to the nearest £10.

4.  Where in any licence year the licence holder does not submit evidence of turnover in relation to the relevant calendar year to the satisfaction of the licensing authority the annual fee payable by him in respect of that licence year shall be the sum of £10,000 together with an additional £2,000 for each description of medicinal product in respect of which a licence is held by the licence holder.

5.  Where the holder of, or an applicant for a product licence is liable to pay an annual fee and his turnover for the purpose of calculating such a fee exceeds £30 million, one half of such turnover which is the excess of the said amount of £30 million shall be deducted from such turnover for the purpose of calculating the said annual fee.

PART III LESSER AMOUNTS OF FEES

Where the holder of a product licence sells or supplies emergency vaccines, the annual fee payable shall be 0.63% of turnover, calculated in accordance with paragraph 2 of Part I rounded up to the nearest £1, except that the minimum sum payable under this provision shall not be less than £10.