# The Medicines (Products for Animal Use—Fees) Regulations 1998, Paragraph 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) relating to a particular product during any calendar year of the first five years of the currency of its actual or prospective 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 for the products in question to be granted, varied or renewed (as the case may be),
a fee otherwise payable under these Regulations in connection with an application made during that five year period for a marketing authorisation or product licence or application for a variation or first application for a renewal of such authorisation or product licence in relation to the product or in connection with an inspection in relation to the product 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 product licence) as established or as anticipated by the relevant authority and the sum of £40,000.
(2) Before a marketing authorisation or product 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 actual or anticipated 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 product 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 product 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 actual turnover relating to the product in question in any calendar year in the first five years of the currency of the marketing authorisation or product licence exceeds £40,000, the authorisation or product licence holder shall be liable to pay the balance of the full fee otherwise payable under these Regulations within 30 days from and including the date of written notice sent by the relevant authority in accordance with regulation 17(2).
(5) Where any provisional payment on account is made in accordance with sub-paragraph (3) above, the reduced fee shall be recalculated on the basis of actual turnover 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 product licence and any difference between the fee so calculated and the provisional payment on account shall be payable by the applicant within 30 days from and including the date of written notice sent by the relevant authority in accordance with regulation 17 or, as the case may be, refunded to the applicant by the relevant authority.

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Source: https://www.legislation.gov.uk/uksi/1998/2428/schedule/7/paragraph/3 (the official version)
Page: https://openlegislation.uk/medicines-products-for-animal-usefees-regulations-1998/schedule-7/paragraph-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.