Regulation 15
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. 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 15 months before the end of a licence year. For the purposes of this paragraph medicinal products sold or supplied by the licence holder or applicant shall comprise only those products in respect of which a licence is held or for which application for a licence has been made.
4.—(a) For the purpose of satisfying the Licensing Authority for the purposes of Part II of this Schedule, an applicant shall state the amount of the turnover, calculated in accordance with the preceding paragraphs of this Part in respect of the calendar year which ends 15 months before the end of the licence year during which the application is made and in respect of each subsequent calendar year which ends 15 months before the end of any subsequent licence year during any part of which licences are held;
(b)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 7 of Part II of this Schedule or shall be such lesser sum as the Licensing Authority shall specify in a notice served on the licence holder.
5. Where an applicant for a licence was not dealing in medicinal products during the calendar year which ends 15 months before the end 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 15 months before the end 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.
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.
1. Where the holder of a product licence sells or supplies emergency vaccines for use in poultry or other animals, the annual fee payable shall, instead of the amount otherwise payable under this Schedule, be 0.4% 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.
2. For the purposes of paragraph 1, “emergency vaccines” means (a) no other suitable licensed vaccines are readily available for such use and (b) the vaccines are manufactured or assembled only from material obtained from the particular animal, flock or herd intended to be vaccinated.