MEDICINES PART I GENERAL Citation, commencement and scope 1 1 These Regulations may be cited as the Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989 and shall come into force on 1st April 1989. 2 Subject to paragraphs (3) and (4) below, these Regulations apply only to fees payable – a in connection with applications for the grant, variation or renewal of licences or certificates under Part II of the Medicines Act 1968 relating wholly or partly to medicinal products for human use; or b in respect of inspections made in connection with applications for the grant, renewal or variation of, or during the currency of any such licence or certificate. 3 No fee shall be payable under these Regulations in connection with any application for the grant, variation or renewal of a licence or certificate under Part II of the Medicines Act 1968 by an authority constituted under the National Health Service Act 1977 , the National Health Service (Scotland) Act 1978 or the Health and Personal Social Services (Northern Ireland) Order 1972 or in respect of any inspection made in connection with such an application or during the currency of a licence or certificate held by such an authority. 4 No fee shall be payable under these Regulations in connection with any application for the grant, variation or renewal of a licence or certificate under Part II of the Medicines Act 1968 where that application is made at the specific written invitation of the licensing authority. Interpretation 2 1 Except as provided in paragraph (2) below, expressions used in these Regulations have the same meaning as in the Medicines Act 1968. 2 In these Regulations, “medicinal product” includes any substance or article specified in any order made under section 104 or 105(1)(a) of the Medicines Act 1968 which directs that Part II of that Act shall have effect in relation to such substance or article. PART II FEES FOR APPLICATIONS FOR LICENCES OR CERTIFICATES AND FOR INSPECTIONS IN CONNECTION THEREWITH Applications for Licences 3 Subject to regulations 16 and 20 of these Regulations, in connection with an application for a product licence, a manufacturer’s licence or a wholesale dealer’s licence there shall be payable by the applicant – a the fee prescribed in Part II of Schedule 1 to these Regulations in connection with that application; and b in respect of any inspection of a description falling within paragraph 1 of Schedule 2 to these Regulations made in connection with that application the fee payable in accordance with paragraphs 2 to 5 of that Schedule. Applications for Clinical Trial Certificates 4 Subject to regulation 20 of these Regulations, in connection with an application for a clinical trial certificate, there shall be payable by the applicant a fee of £8,000. Applications for certificates for exports of medicinal products 5 1 In connection with an application for a certificate issued under section 50 of the Medicines Act 1968, there shall be payable by the applicant — a if the applicant requests that the certificate be issued within 24 hours of receipt of the application, a fee of £100; b in any other case, a fee of £50; and c in either case — i a fee of £10 for each certified copy of the original certificate requested by the applicant in excess of four, and ii a fee of £50 for each set of certificates requested by the applicant in addition to one. 2 In paragraph (1)(c)(ii) above, “set of certificates” means the original certificate plus up to four certified copies of that certificate. PART III FEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES Variations of Licences 6 Subject to regulations 9, 16 and 20 of these Regulations, in connection with an application under section 30 of the Medicines Act 1968 for the variation of a provision of a product licence, a manufacturer’s licence or a wholesale dealer’s licence, there shall be payable by the applicant – a the fee prescribed in Part III of Schedule 1 of these Regulations; and b in respect of any inspection of a description referred to in paragraph 1 of Schedule 2 to these Regulations made in connection with that application, the fee payable in accordance with paragraphs 2 to 5 of that Schedule. Variations of Clinical Trial Certificates 7 Subject to regulations 8, 9 and 20 of these Regulations, in connection with an application under section 39(4) of the Medicines Act 1968 for variation of a provision of a clinical trial certificate, there shall be payable by the applicant a fee of £175. Change of Name or Address in Clinical Trial Certificates 8 Where an application is made for a variation to a provision of the clinical trial certificate and the variation applied for consists of no more than a change of either or both the name and address of the holder of the certificate, there shall be payable by the applicant a fee of £50. Applications for Multiple Variations 9 A separate fee shall be payable in respect of each variation of each provision of a licence or certificate applied for in any one application except that no separate fee shall be payable in respect of any variation which is related to or is consequential upon another variation of a provision of the same licence or certificate which is applied for in the same application. PART IV FEES FOR APPLICATIONS FOR RENEWALS OF LICENCES OR CERTIFICATES Renewal of Licences 10 Subject to regulations 12, 16 and 20 of these Regulations, in connection with an application under section 24(2) of the Medicines Act 1968 for renewal of a product licence, a manufacturer’s licence or a wholesale dealer’s licence, there shall be payable by the applicant — a the appropriate fee prescribed in Part IV of Schedule 1 to these Regulations; and b in respect of any inspection of a description referred to in paragraph 1 of Schedule 2 to these Regulations made in connection with that application a fee payable in accordance with paragraphs 2 to 5 of that Schedule. Renewal of Certificates 11 Subject to regulations 12 and 20 of these Regulations, in connection with an application under section 38(2) of the Medicines Act 1968 for renewal of a clinical trial certificate there shall be payable by the applicant a fee of £2,000. Renewals in terms which are not identical to the existing licence or certificate 12 Where an applicant applies for renewal of a licence, or as the case may be, a clinical trial certificate so as to contain provisions which are not identical to that licence or certificate as in force at the date of that application, the fee payable under this Part of these Regulations shall be increased by an amount equal to the fee which would have been payable under Part III of these Regulations had he made a separate application for each variation of that licence or certificate. PART V FEES FOR INSPECTIONS MADE DURING THE CURRENCY OF A LICENCE 13 1 Subject to paragraph (4) below and to regulations 16 and 20 of these Regulations, a fee in accordance with paragraphs 2 to 5 of Schedule 2 to these Regulations shall be payable in respect of any inspection of a site made during the currency of a product licence, a manufacturer’s licence or a wholesale dealer’s licence (except for any inspection in respect of which a fee is otherwise payable under Parts III or IV of these Regulations). 2 The fee payable under paragraph (1) above in respect of an inspection of a site made during the currency of a manufacturer’s licence or a wholesale dealer’s licence shall be payable by the holder of the manufacturer’s or, as the case may be, the wholesale dealer’s licence. 3 Where a fee is payable under paragraph (1) above in respect of an inspection of a site located outside the United Kingdom, the fee shall be payable in equal proportions by each holder of a product licence in which that site is named as a possible site for manufacture of the medicinal product in respect of which the product licence is granted. 4 No fee shall be payable in respect of any inspection of a site carried out within 6 months of a previous inspection in order to ascertain whether alterations or improvements to the premises concerned which were required in writing by the licensing authority as the result of that previous inspection have been implemented. PART VI ADMINISTRATION Payment of fees to Ministers 14 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 Ministers specified in section 1(1)(a) of the Medicines Act 1968. Time for payment of fees in connection with applications or inspections and refunds of such fees 15 1 Subject to paragraphs (2) and (3) below, all sums payable by way of 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 shall become payable within 14 days following written notice from the licensing authority. Waiver, Reduction or Refund of Fees 16 The licensing authority shall 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 any of the circumstances specified in Schedule 3 to these Regulations. Suspension of Licences 17 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 18 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. PART VII REVOCATION, SAVINGS AND TRANSITIONAL PROVISIONS Revocation and Savings 19 1 Subject to paragraph (2) below, the Regulations specified in Schedule 4 to these Regulations are hereby revoked in so far as they apply in relation wholly or partly to medicinal products for human use. 2 Paragraph (1) above shall not affect any notice given or any suspension made under the Regulations referred to in Schedule 4 to these Regulations and any such notice or suspension shall have effect as if given or made under these Regulations. Transitional provisions 20 1 Subject to paragraphs (2) to (4) below, these Regulations shall not apply to any application made before 1st April 1989. 2 A fee shall be payable in respect of any inspection made on or after 1st April 1989 in connection with any application made before that date as if these Regulations applied to that application. 3 Where an application is made before 1st April 1989 to renew a licence or a certificate which is due to expire on or after 1st October 1989, a fee shall be payable in accordance with Part IV of these Regulations in connection with that application within 14 days following written notice from the licensing authority. 4 In the case of an article or substance to which Part II of the Medicines Act 1968 applies by virtue of the Medicines (Surgical Materials) Order 1971 , the fee payable under these Regulations in respect of an application for a product licence made on or before 31st March 1990 at the specific written invitation of the licensing authority shall be £250. Signed by authority of the Secretary of State for Health D. Mellor Minister of State, Department of Health 9th March 1989 Peter Walker Secretary of State for Wales 8th March 1989 Malcolm Rifkind Secretary of State for Scotland 8th March 1989 In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 8th March 1989. John MacGregor Minister of Agriculture, Fisheries and Food Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 9th March 1989. F.A. Elliott Permanent Secretary Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 9th March 1989. W.J. Hodges Permanent Secretary We consent, Stephen Dorrell Kenneth Carlisle Two of the Lords Commissioners of Her Majesty’s Treasury 7th March 1989