The Medicines (Products for Animal Use—Fees) Regulations 1998

Marketing authorisations and product licences: annual fees

11.—(1) The holder of any marketing authorisation or product licence shall, following each calendar year during which or part of which any product to which the marketing authorisation or product licence relates has been sold, supplied or manufactured, pay an annual fee calculated in accordance with Schedules 3 and 4 in respect of that year.

(2) Where, during the course of the calendar year in question, a new marketing authorisation or product licence has been granted as part of an arrangement involving the termination of a previous marketing authorisation or product licence in respect of a product the characteristics of which are identical to that of the product covered by the new authorisation or licence, any sale, supply or manufacture of a product covered by the previous authorisation or licence shall for the purposes of paragraph (1) be treated as covered by the new authorisation or licence.