MEDICINES PART I GENERAL Citation, commencement and scope 1 1 These Regulations may be cited as the Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1990 and shall come into force on 2nd July 1990. 2 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 Act relating wholly or partly to medicinal products for animal 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; or c in respect of samples submitted for testing in connection with applications for the grant, renewal or variation of, or during the currency of a product licence; or d in respect of any reference to the Veterinary Products Committee or to the Medicines Commission in connection with an application for the grant of a product licence under Part II of the Act relating wholly or partly to medicinal products for animal use. Interpretation 2 1 In these Regulations, unless the context requires otherwise– “the Act” means the Medicines Act 1968 ; “annual fee” in relation to any product licence means the appropriate amount calculated in accordance with the provisions of Part II of Schedule 4; “biological medicinal product” includes an antigen, toxin, antitoxin, toxoid, serum, antiserum or vaccine or a fraction of any such product; “capital fee” means any fee (other than an annual fee) payable under the provisions of these Regulations; “emergency vaccines” means (a) no other suitable licensed vaccines are readily available for such use and (b) the vaccines are manufactured or assembled only from material obtained from the particular animal, flock or herd intended to be vaccinated; “licence year” means the period beginning with the first day of April and ending with the last day of March of the year next ensuing; “medicinal product” includes any substance or article specified in any Order made under (a) section 104 or 105(1)(a) of the Act which directs that Part II of the Act shall have effect in relation to such substance or article; or (b) section 130(3A) of the Act which provides that such substance or article shall be treated as a medicinal product. 2 In these Regulations any reference to a regulation or a Schedule shall be construed as a reference to a regulation contained in these Regulations, or as the case may be, to a Schedule thereto, and any reference in a regulation or a Schedule to a paragraph shall be construed as a reference to a paragraph of the regulation or, as the case may be, Schedule. PART II CAPITAL FEES FOR APPLICATIONS FOR LICENCES OR CERTIFICATES AND FOR INSPECTIONS IN CONNECTION THERE WITH Applications for Licences and Certificates 3 Subject to regulations 20 and 22, in connection with an application for a product licence, a manufacturer’s licence, a wholesale dealer’s licence, an animal test certificate or any certificate of exemption issued under the Act, there shall be payable by the applicant– a the fee prescribed in Part II of Schedule 1 in connection with that application; b in respect of any inspection of a description falling within paragraph 1 of Schedule 2 made in connection with that application the fee payable in accordance with paragraphs 2 to 5 of that Schedule. Applications for certificates for exports of medicinal products 4 1 In connection with an application for a certificate issued under section 50 of the Act, 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; or 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) “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 AND FOR INSPECTIONS IN CONNECTION THERE WITH Variations of Licences and Certificates 5 Subject to regulations 6, 7, 20 and 22, in connection with an application under section 30 of the Act for the variation of a provision of a product licence, a manufacturer’s licence or a wholesale dealer’s licence, and under section 39(4) in respect of an animal test certificate, there shall be payable by the applicant– a the fee prescribed in Part III of Schedule 1; and b in respect of any inspection of a description referred to in paragraph 1 of Schedule 2 made in connection with that application, the fee payable in accordance with paragraphs 2 to 5 of that Schedule. Applications for Multiple Variations 6 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. Variations at the Invitation of the licensing authority 7 Where an application for a variation is made at the express written invitation of the licensing authority, no fee shall be payable under this Part of these Regulations. PART IV FEES FOR APPLICATIONS FOR RENEWALS OF LICENCES OR CERTIFICATES AND FOR INSPECTIONS IN CONNECTION THERE WITH Renewal of Licences and Certificates 8 Subject to regulations 9, 20 and 22, in connection with an application under section 24(2) of the Act for renewal of a product licence, a manufacturer’s licence or a wholesale dealer’s licence, and under section 38(2) for an animal test certificate, there shall be payable by the applicant– a the appropriate fee prescribed in Part IV of Schedule 1; and b in respect of any inspection of a description referred to in paragraph 1 of Schedule 2 made in connection with that application a fee payable in accordance with paragraphs 2 to 5 of that Schedule. Renewals in terms which are not identical to the existing licence or certificate 9 Where an applicant applies for renewal of a licence, or as the case may be, an animal test 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 OF A SITE MADE DURING THE CURRENCY OF A LICENCE 10 1 Subject to paragraph (4) and to regulations 20 and 22, a fee in accordance with paragraphs 2 to 5 of Schedule 2 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) 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 licence or, as the case may be, the wholesale dealer’s licence. 3 Where a fee is payable under paragraph (1) 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 FEES FOR TESTING OF BIOLOGICAL MEDICINAL PRODUCTS ON APPLICATION FOR, OR DURING THE CURRENCY OF, A LICENCE OR CERTIFICATE 11 1 The fee payable for the testing of a biological medicinal product shall be determined by the category allocated to that product by the licensing authority in accordance with the provisions of this regulation. If, on consideration of the product, the licensing authority decides that it is necessary, the authority may re-allocate the product to a different category when the appropriate fee will become payable. 2 In connection with an application for the grant of a product licence or animal test certificate the fee payable shall be that specified in paragraph (4) below opposite the appropriate category– a for the testing of an emergency vaccine, category 5; b for the testing of any other biological medicinal product, category 2. 3 In respect of the batch control testing of a biological medicinal product (not being an emergency vaccine) in connection with the holding of a product licence (including a product licence of right) that product shall be allocated a category by the licensing authority according to one or more of the relevant following factors– a the actual cost of the test itself; b the number of batches of such a product actually submitted for testing in the previous year; c the number of times such a product was actually tested in the previous year and, subject to regulations 20 and 22, the annual fee payable on sending the first batch for testing after the date these Regulations come into force or in any subsequent licence year shall be that specified in paragraph (4) below opposite category, 1, 2, 3 or 4. (4) Category Testing Fee Category 1 £500 Category 2 £1,500 Category 3 £4,000 Category 4 £7,000 Category 5 £50 PART VII ANNUAL FEES Product Licences – annual fee 12 1 Subject to paragraph (3) and regulation 22 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 REFERENCES TO VETERINARY PRODUCTS COMMITTEE OR TO THE MEDICINES COMMISSION Product Licences – References 13 Subject to regulations 20 and 22, in respect of any reference to the Veterinary Products Committee or to the Medicines Commission under section 21 of the Act in connection with an application for the grant of a product licence, there shall be payable by the applicant a fee of £1,000. PART IX 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 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 15 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 28 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 28 days following written notice from the licensing authority. Time for payment of annual fees 16 1 Subject to paragraphs (2) and (3), all annual fees shall be payable on 1st September of the licence year to which they relate. 2 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 17 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 18 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 19 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 20 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. PART X REVOCATION, SAVINGS AND TRANSITIONAL PROVISIONS Revocation and Savings 21 1 Subject to paragraph (2), the Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1989 are hereby revoked. 2 Paragraph (1) shall not affect– a any annual fee or part of such a fee under the Regulations hereby revoked; b any notice given or any suspension made under the Regulations hereby revoked and any such notice or suspension shall have effect as if given or made under these Regulations; and c any proceedings constituted under the Regulations hereby revoked for the recovery of any fees due as debts due to the Crown. Transitional provisions 22 1 Subject to paragraphs (2) and (3), these Regulations shall not apply to any application made before the date these Regulations come into force. 2 A fee shall be payable in respect of any inspection made or any product testing required after the date these Regulations come into force in connection with any application made before that date as if these Regulations applied to that application. 3 Where an application is made before the date these Regulations come into force to renew a licence or certificate which is due to expire on or after 1st October 1990 a fee shall be payable in accordance with Part IV of these Regulations in connection with that application within 28 days following written notice from the licensing authority. Kenneth Clarke Secretary of State for Health 5th June 1990 David Hunt Secretary of State for Wales 5th June 1990 Sanderson of Bowden Minister of State, Scottish Office 5th June 1990 In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 4th June 1990. John Selwyn Gummer Minister of Agriculture, Fisheries and Food Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 4th June 1990. F. A. Elliott Permanent Secretary Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 8th June 1990. W. J. Hodges Permanent Secretary We consent, John Taylor Kenneth Carlisle Two of the Lords Commissioners of her Majesty’s Treasury 6th June 1990