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

3.—(1) Subject to sub-paragraphs (2) to (5), where the licensing authority—

(a) is satisfied that the annual turnover (as calculated in accordance with Part I of Schedule 4) of a medicinal product during any calendar year of the first five years of the currency of the product licence, has not exceeded, or is unlikely to exceed, £30,000; and

(b) is of the opinion that the interests of human or animal health require a product licence to be granted

any capital fee otherwise payable under these Regulations in connection with an application for a product licence or an inspection during the currency of that licence, may be reduced or, if such a fee has already been paid, be refunded in part in proportion to the difference between the maximum turnover of the product in any calendar year (during any of the first five years of the currency of the licence) and the sum of £30,000.

(2) Before a licence holder pays any reduced fee or receives any refund pursuant to sub-paragraph (1), he shall furnish evidence to the satisfaction of the licensing authority of the amount of annual turnover, in respect of the particular medicinal product, in each calendar year of the first five years of the currency of the licence.

(3) Where a reduced fee is determined in accordance with sub-paragraph (1) at the time of application on the basis of the estimated likely maximum turnover of the medicinal product during the first five years of the currency of the licence, any fee so determined shall be regarded as a provisional payment on account.

(4) Where a provisional payment on account is made in accordance with sub-paragraph (3) and subsequently the turnover in any calendar year in the first five years of the currency of the licence exceeds £30,000, the licence holder shall be liable to pay the balance of the full fee otherwise payable under these Regulations within 28 days of notification by the licensing authority.

(5) Where any provisional payment on account is made in accordance with sub-paragraph (3), the reduced fee shall be recalculated in accordance with the provisions of sub-paragraph (1) at the end of five years from the date of the grant of the licence and any difference between the fee so calculated and the provisional payment on account shall be payable by the applicant or, as the case may be, refunded to the applicant by the licensing authority within 28 days of a request for such a refund.