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 1989 and shall come into force on 24th April 1989. 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. 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; “capital fee” means any fee (other than an annual fee) payable under the provisions of these Regulations; “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, or shall not, 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 THEREWITH Applications for Licences 3 Subject to regulations 22 and 24, 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 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; and c if appropriate, the fee prescribed in Part III of Schedule 1 in respect of samples submitted for testing at the request of the Licensing Authority in connection with that application. Applications for Animal Test Certificates 4 Subject to regulation 24, in connection with an application for an animal test certificate, there shall be payable by the applicant a fee of £2,500. Applications for certificates for exports of medicinal products 5 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 THEREWITH Variations of Licences 6 Subject to regulations 8, 9, 22 and 24, 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, there shall be payable by the applicant– a the 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, the fee payable in accordance with paragraphs 2 to 5 of that Schedule. Variations of Animal Test Certificates 7 1 Subject to paragraph (2) and regulations 8, 9, 22 and 24, in connection with an application under section 39(4) of the Act for the variation of a provision of an animal test certificate, there shall be payable by the applicant a fee of £200. 2 Where an application is made for a variation to a provision of the animal test 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 8 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 9 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 THEREWITH Renewal of Licences 10 Subject to regulations 12, 22 and 24, 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, there shall be payable by the applicant– a the appropriate fee prescribed in Part V 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. Renewal of Certificates 11 Subject to regulations 12 and 24, in connection with an application under section 38(2) of the Act for renewal of an animal test certificate there shall be payable by the applicant a fee of £500. 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, 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 MADE DURING THE CURRENCY OF A LICENCE 13 1 Subject to paragraph (4) and to regulations 22 and 24, 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 BATCH CONTROL TESTING DURING THE CURRENCY OF A LICENCE 14 1 A fee calculated in accordance with paragraph (2) shall be payable in respect of each product licence held, in which, as a condition of that licence there is a requirement that the licence holder shall submit for testing samples of each batch of the medicinal product which he has manufactured. 2 During any licence year the fees referred to in paragraph (1) shall be– a for the first sample and up to and including three samples, a fee of £600, payable by the licence holder at the time the first sample is submitted for testing; b for four samples and up to and including ten samples, an additional fee of £200, payable by the licence holder at the time the fourth sample is submitted for testing; c for ten samples or more, a further additional fee of £200 payable by the licence holder at the time the tenth sample is submitted for testing. PART VII ANNUAL 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. PART IX REVOCATION, SAVINGS AND TRANSITIONAL PROVISIONS Revocation and Savings 23 1 Subject to paragraph (2), the Regulations specified in Schedule 6 are hereby revoked in so far as they apply in relation wholly or partly to medicinal products for animal use. 2 Paragraph (1) shall not affect– a any annual fee or part of such a fee under any of the Regulations specified in Schedule 6; b any notice given or any suspension made under the Regulations specified in Schedule 6 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 specified in Schedule 6 for the recovery of any fees due as debts due to the Crown. Transitional provisions 24 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 sample 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 review a licence or 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. Kenneth Clarke Secretary of State for Health 23rd March 1989 Peter Walker Secretary of State for Wales 20th March 1989 Sanderson of Bowden Minister of State, Scottish Office 22nd March 1989 In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 19th 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 30th March 1989. Zelma I. Davies Under Secretary Sealed with the Official Seal of the Department of Agriculture for Northern Ireland 30th March 1989. J. C. Chalmers Under Secretary We consent, Kenneth Carlisle David Maclean Two of the Lords Commissioners of Her Majesty’s Treasury 20th March 1989