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The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1989

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PART VIIANNUAL FEES

Product Licences—annual fee

15.—(1) Subject to paragraph (3) and regulation 24 in connection with any application for the grant or renewal of any product licence there shall be payable by the applicant an annual fee in respect of each licence year during any part of which a product licence, granted or renewed in pursuance of the application is in force, or a product licence already held by the applicant, is in force, save that no annual fee shall be payable in respect of the licence year during which the last to expire of such product licences expires if that licence expires on a date earlier than the anniversary of that date on which that licence was granted which falls in that licence year.

(2) The annual fee shall be calculated in accordance with Schedule 4.

(3) The annual fee may be adjusted or refunded in any of the circumstances set out in Schedule 5. PART VIII ADMINISTRATION

Payment of fees to Ministers

16.  Any sums which under the provisions of these Regulations become payable by way of, or on account of, fees shall be paid to one of the Agriculture Ministers specified in section 1(1)(b) of the Act as appropriate.

Time for payment of capital fees in connection with applications or inspections and refunds of such fees

17.—(1) Subject to paragraphs (2) and (3), all sums payable by way of capital fees under these Regulations in connection with any application shall be payable at the time of the application.

(2) If, following either the determination of an application or an inspection, it becomes apparent that–

(a)a lesser fee was properly payable, the excess shall be refunded to the applicant, or as the case may be, the holder of the licence or certificate concerned; or

(b)a higher fee was properly payable, the balance due shall be payable within 14 days following written notice from the Licensing Authority to the applicant or, as the case may be, the holder of the licence or certificate concerned.

(3) All sums payable by way of fees in respect of inspections made either in connection with an application or during the currency of a licence or certificate or in respect of samples submitted for testing shall become payable within 14 days following written notice from the Licensing Authority.

Time for payment of annual fees

18.—(1) Subject to paragraphs (2) and (3), all annual fees shall be payable on 1st April of the licence year to which they relate: Provided that the annual fee payable under these Regulations for the licence year beginning 1st April 1989 shall not become payable until 1st September 1989.

(2) Subject to the proviso to paragraph (1), where an applicant first becomes liable to make any payment by way of annual fees of a particular kind during the course of a licence year, such fees shall be payable forthwith.

(3) Where an application is made by an applicant who has not previously held a product licence he shall be liable to pay a sum at the basic rate referred to in Part II of Schedule 4 at the time of the application in respect of the licence year in which the licence is granted.

Late payment of annual fees

19.—(1) Where an annual fee has not been paid by the holder or former holder of the licence by the end of the period of three months from the due date, a further fee, calculated in accordance with the provisions of the following paragraphs, shall be payable.

(2) The further fee referred to in the preceding paragraph shall be an amount equivalent to 1 per cent of the annual fee payable multiplied by the number of complete months contained in the period from the day after the end of the period of three months from the due date until the date when the annual fee is paid, rounded down to the nearest £10. Where the annual fee payable is less than £10, no such fee shall be payable.

(3) Where the holder or former holder of a licence has not furnished evidence of his annual turnover in accordance with the provisions of Part I of Schedule 4 so that the annual fee payable in respect of a licence year cannot be determined before the due date, he may make a payment of an amount on account of the annual fee payable by him (in this regulation referred to as a “payment on account”).

(4) Where the holder or former holder of a licence has made a payment on account in the circumstances mentioned in the preceding paragraph the further fee payable by him shall be calculated as if in paragraph (2) above the reference to the annual fee payable were to the difference between the payment on account and the amount of the annual fee as subsequently determined.

(5) In this regulation–

(a)“due date” means the date upon which an annual fee became payable in accordance with the provisions of these Regulations;

(b)references to a period calculated from a day are references to the period inclusive of that day.

Suspension of Licences

20.  Where any sum due by way of, or on account of, any fee or any part thereof payable under these Regulations remains unpaid by the holder of a licence or certificate, the Licensing Authority may serve a notice on him requiring payment of the sum unpaid and, if after a period of one month from the date of service of such notice, or such longer period as the Licensing Authority may allow, the said sum remains unpaid, the Licensing Authority may forthwith suspend the licence or certificate until such sum has been paid.

Civil proceedings to recover unpaid fees

21.  All unpaid sums due by way of, or on account of, any fees payable under these Regulations shall be recoverable as debts due to the Crown.

Waiver, Reduction or Refund of Fees

22.  The Licensing Authority may waive payment of, reduce any fee or part of a fee otherwise payable under these Regulations or refund the whole or part of any fee already so paid in exceptional circumstances or in any of the circumstances specified in Schedule 3.

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