The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1989

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 0.4% 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 an application is made by an applicant who was not dealing in medicinal products during the calendar year which begins 15 months before the end of the licence year in which the application was made, he shall be liable to pay in respect of the year in which the licence is granted the sum of £250 until such time as the fee calculated in accordance with paragraph (1) is greater than that sum.

5.  Where a licence holder has duly paid an annual fee of the appropriate kind at the rate applicable for any licence year, no additional annual fee shall be payable by that person for that year in respect of any application made earlier in that licence year.

6.  Where applications are made on more than one occasion in the same licence year for product licences of the same kind, one annual fee only shall be payable which shall be regarded as having been paid in respect of all such applications made in that licence year.

7.  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.

8.  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.