Office of Public Sector Information
31.—(1) Unless paragraphs (2), (4), (5) or (6) or regulation 44 or 48 applies, the periodic fee must be paid for each fee period during which the authorization, registration, authorisation or licence is in force, even if it is in force for only part of that fee period.
(2) Marketing authorizations of a type referred to in Part 3 of Schedule 3 shall be treated for the purposes of paragraph (1) as if they were one marketing authorization and only one periodic fee in respect of each relevant fee period is payable in connection with the holding of such authorizations.
(3) The periodic fee is the appropriate fee prescribed in Part 3 of Schedule 3 and, for the purposes of that Part, Parts 1 and 2 of that Schedule have effect.
(4) No periodic fee is payable in respect of the fee period during which a marketing authorization or a traditional herbal registration is first granted unless the authorization or registration is granted pursuant to—
(a) a change of ownership application; or
(b) an application for a marketing authorization or traditional herbal registration which—
(i) is for a product for which an authorization or registration has expired,
(ii) will contain identical provisions to those contained in the expired authorization or registration,
(iii) is made by the person who held the expired authorization or registration, and
(iv) is made no later than three months after the expiry of the authorization or registration referred to in sub-paragraph (i),
and, in each case, a periodic fee has not been paid in respect of that fee period in connection with the expired marketing authorization or a traditional herbal registration.
(5) An authorization, registration, authorisation or licence which is in force is treated for the purposes of this regulation as not being in force during any part of a fee period if—
(a) at least three months before the commencement of that fee period, the holder of that authorization, registration, authorisation or licence has given written notice to the licensing authority indicating that he wishes it to cease to have effect before the commencement of that period; and
(b) no products are sold, supplied or manufactured pursuant to that authorization, registration authorisation or licence within that fee period.
(6) No periodic fee is payable in respect of the fee period during which a manufacturing authorisation, a manufacturer’s or wholesale dealer’s licence is first granted unless—
(a) that authorisation or licence is granted pursuant to a change of ownership application; and
(b) a periodic fee has not been paid in respect of that fee period in connection with the manufacturing authorisation or manufacturer’s or wholesale dealer’s licence which is mentioned in that application in the statement of intention to cease activities.
32.—(1) Unless paragraph (3) or regulation 44 applies, the holder of a clinical trial authorisation must pay the periodic fee for each fee period during which the authorisation is in force, even if the authorisation is in force for only part of that fee period.
(2) The periodic fee is the fee prescribed in paragraph 16 of Part 3 of Schedule 3.
(3) No periodic fee is payable in respect of the fee period during which the clinical trial to which the authorisation relates was authorised by the licensing authority in accordance with regulation 18 (authorisation procedure for clinical trials involving general medicinal products), 19 (authorisation procedure for clinical trials involving medicinal products for gene therapy etc.) or 20 (authorisation procedure for clinical trials involving medicinal products with special characteristics) of the Clinical Trials Regulations(33).
33. In this Part—
“good clinical practice accreditation scheme” means the non-statutory voluntary scheme of accreditation operated by the licensing authority in relation to Phase 1 trials which participants may join following satisfactory completion of a good clinical practice inspection; and
“Phase I trials” are clinical trials to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial.
34.—(1) The fee payable by an applicant for membership of the good clinical practice accreditation scheme is £120.
(2) The fee payable by an applicant for a certificate of membership of the good clinical practice accreditation scheme is £63.
35.—(1) The fee payable by an applicant or holder of an authorization who gives notice under paragraph 11 (right to be heard by a person appointed or to make further representations) or 16 (right to be heard by a person appointed) of Schedule 2 to the 1994 Regulations(34) of his wish to appear before or be heard by a person appointed by the licensing authority is £10,000.
(2) But the licensing authority will refund to that person—
(a) 60% of that fee if the person withdraws the notice two weeks before the commencement of the hearing before the person appointed;
(b) 100% of that fee if the decision notified by the licensing authority in accordance with sub-paragraph (10) of paragraph 17 (hearing before person appointed) of Schedule 2 to the 1994 Regulations is—
(i) not to revoke, vary or suspend the authorization, or
(ii) to grant or renew the authorization in accordance with the application submitted under regulation 4(1) (applications for the grant, renewal or variation of a UK marketing authorization) of the 1994 Regulations.
36. The fee in regulation 35 is payable at the time the notice is given.
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.
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.
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(35); 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.
40. All periodic fees must be paid on the first day of the fee period to which they relate.
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.
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.
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.
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.
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.
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.
Regulation 19 has been amended by S.I. 2005/2754. Back [33]
Schedule 2 was substituted by S.I. 2005/1094. Back [34]
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 1st 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. Back [35]
The Medicines (Products for Human Use-fees) Regulations 2008