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

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

(a) is satisfied that the annual turnover (as calculated in accordance with Schedule 3) of a product during any calendar year of the first five years of the currency of the marketing authorisation or product licence, has not exceeded, or is unlikely to exceed, £40,000; and

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

any fee otherwise payable under these Regulations in connection with an application for a marketing authorisation, product licence or an inspection during the currency of that authorisation or 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 authorisation or licence) and the sum of £40,000.

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

(3) Where a reduced fee is determined in accordance with sub-paragraph (1) above at the time of the application on the basis of the estimated likely maximum turnover of the product during the first five years of the currency of the authorisation or 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) above and subsequently the turnover in any calendar year in the first five years of the currency of the marketing authorisation or licence exceeds £40,000, the authorisation or 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 relevant authority.

(5) Where any provisional payment on account is made in accordance with sub-paragraph (3) above, the reduced fee shall be recalculated in accordance with the provisions of sub-paragraph (1) above at the end of five years from the date of the grant of the marketing authorisation or 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 relevant authority within 28 days of a request for such a refund.