# The Medicines (Products for Animal Use—Fees) Regulations 1998, Regulation 17: Time for payment of fees


(1) Subject to regulation 15 and paragraphs (2) and (3)(b), any fee payable under these Regulations in connection with any application shall be payable at the time of that application.
(2) A fee payable under regulation 11, 12 or 13 or any fee for an inspection made either in connection with an application or during the currency of a marketing authorisation or licence shall be payable within 30 days from and including the date of written notice requiring payment of the fee being sent by post by the relevant authority to the person by whom the fee is payable.
(3) If, for the purposes of processing or provision of assistance in connection with an application or carrying out an inspection, a particular fee has been paid and, following the determination of the application, completion of the provision of assistance or the inspection, it becomes apparent that–
(a) a lesser fee was properly payable, the excess shall be refunded to that person; or
(b) a higher fee was properly payable, the balance due shall be payable within 30 days from and including the date of the written notice requiring payment of the balance being sent by post by the relevant authority to that person.
(4) The relevant authority need not and to the extent required by Regulation (EC) No. 541/95 shall not process an application in connection with–
(a) a marketing authorisation, or
(b) a manufacturer’s or wholesale dealer’s licence relating to products to which Directive 81/851/EEC applies,
until receipt of the appropriate fee, unless the application is a relevant variation application.
(5) In the case of any relevant variation application relating to such an authorisation or licence, the relevant authority–
(a) may by notice sent to the applicant specify the difference between the appropriate fee payable and the fee paid by the applicant, explain the reason for the difference and stipulate that, if the difference in question is not paid to the relevant authority by such a date as is specified in the notice (being at least 14 days after the date that the notice is sent), the application may not be further processed, and
(b) if that difference is not paid, need not continue to process the application once the time specified for payment of that difference in the notice has expired, until receipt of that payment.
(6) In relation to any application to which regulation 14 applies, paragraph (4) shall apply as if the application were an application (not being a relevant variation application) relating to a marketing authorisation and the Ministers (as defined in regulation 14) were the relevant authority.
(7) For the purposes of paragraph (4), “relevant variation application” means any application falling within paragraph (b) of the definition of “individual variation” in Part I of Schedule 1 in relation to which a fee has been paid which is based on the applicant’s assessment of the fee payable but is less than the appropriate fee for the application.

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Source: https://www.legislation.gov.uk/uksi/1998/2428/regulation/17 (the official version)
Page: https://openlegislation.uk/medicines-products-for-animal-usefees-regulations-1998/regulation-17
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.