The Medicines (Products for Human Use-Fees) Regulations 2008

PART 13 Administration

Payment of fees to Ministers

37.  Any sums which under the provisions of these Regulations become payable by way of, or on account of, fees must be paid to one of the Ministers.

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

38.—(1) Except where regulation 11, 17, 23 or 36 applies and subject to paragraph (2) and to regulations 39 and 44, all sums payable by way of capital fees under these Regulations in connection with any application must be paid at the time of the application.

(2) All sums payable by way of fees in respect of inspections made either in connection with an application for, or during the currency of, an authorization, licence or certificate must be paid within 14 days following receipt of written notice from the licensing authority requiring payment of those fees.

Time for payment of capital fees – applications made by small companies

39.—(1) Schedule 4 shall have effect with respect to the capital fee payable in connection with an application made by or on behalf of a small company.

(2) For the purpose of these Regulations, a company is a small company if, for the financial year before that in which the application is made, the amount of its turnover for the financial year is not more than the amount for the time being specified under the heading “Small company” in section 247(3) (qualification of company as small or medium-sized) of the Companies Act 1985(1); and

(a) its balance sheet total (as defined in section 247(5) of that Act) is not more than the amount for the time being specified under the heading “Small company” in section 247(3) of that Act; or

(b) the average number of persons employed by the company in the financial year before that in which the application is made (determined on a weekly basis) does not exceed the number for the time being specified under the heading “Small company” in section 247(3) of that Act.

Time for payment of periodic fees

40.  All periodic fees must be paid on the first day of the fee period to which they relate.

Penalty fees for late payment of periodic fees

41.—(1) Subject to paragraph (2), if a person has failed to pay a periodic fee at the time it should have been paid under regulation 40, a penalty fee is payable by that person.

(2) A penalty fee is payable only if after 60 days following written notice from the licensing authority requiring payment of that fee, the fee remains unpaid.

(3) Unless regulation 42 applies, the penalty fee is—

(a) £100 where the total periodic fee unpaid by a person after 60 days following the notice referred to in paragraph (2) exceeds £200; or

(b) £50 where the total periodic fee unpaid by a person after such period does not exceed £200.

(4) In paragraph (3), the “total periodic fee” means the aggregate of all the periodic fees payable by a person in connection with all the authorizations, registrations, authorisations or licences held by that person.

Daily penalty fees for late payment of periodic fees

42.  If the periodic fee and penalty fee under regulation 41 (“the outstanding amount”) have not been paid within 90 days following the written notice from the licensing authority, the amount of penalty fee payable shall be the amount specified in regulation 41(3) plus £5 for each day of the period which—

(a) begins with the day 90 days from the date of the written notice; and

(b) ends with the day before that on which payment of the outstanding amount is actually made.

Refund or waiver of fees under regulation 41 or 42

43.  The licensing authority may refund or waive payment of the penalty fee, or reduce the amount payable, where it is satisfied that the holder of the authorization, registration, authorisation or licence was not responsible for the failure to pay the periodic fee within the period specified in regulation 41(2) or 42.

Adjustment, waiver, reduction or refund of fees

44.—(1) If after a capital or periodic fee is paid it becomes apparent that—

(a) a lesser fee should have been paid, the excess shall be refunded to the applicant or, as the case may be, the holder of the authorization, registration, authorisation or licence concerned; or

(b) a higher fee should have been paid, 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 authorization, registration, authorisation or licence concerned requiring payment of that balance.

(2) The licensing authority shall, to the extent provided in Schedule 5 in relation to capital fees or in Schedule 6 in relation to periodic fees—

(a) adjust, waive payment of or reduce any fee or part of a fee otherwise payable under these Regulations; or

(b) refund the whole or part of any fee already paid.

Suspension of licences and certificates

45.  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 product licence or a product licence of right, a manufacturer’s licence or a wholesale dealer’s licence, the licensing authority may serve a written 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 until such sum has been paid.

Civil proceedings to recover unpaid fees

46.  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.

(1)

C.6. Relevant amendments have been made by section 13(1) of the Companies Act 1989 (c.40) and by S.I. 1992/2452, 1996/189, 2004/16 and 2004/2947. On 1^st February 2008 the figures specified in section 247(3) under the heading “small company” applying to turnover, balance sheet total and numbers of employees respectively were, £5.6 million, £2.8 million and 50.