MEDICINES PART I GENERAL Citation and commencement 1 These Regulations may be cited as the Medicines (Products for Human Use — Fees) Regulations 1995 and shall come into force on 21st April 1995. Interpretation 2 1 In these Regulations, unless the context requires otherwise— “ the Act ” means the Medicines Act 1968 and, except as provided below, expressions used in these Regulations have the same meaning as in the Act; “the 1994 Regulations ” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 ; “authorised medicinal product” means a medicinal product in respect of which either a marketing authorization or marketing authorization (parallel import) has been granted; “blood product” means any medicinal product derived from human blood or human plasma and includes albumin, coagulating factor and immunoglobulin of human origin; “capital fee” means any fee, other than a periodic fee, payable under the provisions of these Regulations; “change of ownership application” means an application for a marketing authorization for a medicinal product in respect of which a person other than the applicant is the holder of a marketing authorization and which— includes a statement to the effect that that other person intends to cease selling or supplying that product pursuant to that authorization; is signed by or on behalf of that other person, as well as by or on behalf of the applicant; and except for the name and address of the applicant and particulars in relation to the labelling of the product and any leaflet relating to it, contains, or is accompanied by, particulars which are in all material respects identical to the particulars referred to in the marketing authorization already held by that other person; “Community marketing authorization” means a marketing authorization granted by the European Commission under Council Regulation ( EEC ) No. 2309/93 ; “fee period” means the period beginning with the first day of April in any year and ending with the last day of March in the following year; “immunological product” means any medicinal product which is a vaccine, toxin, serum or allergen product; “manufacturer’s licence” means a manufacturer’s licence which relates wholly or partly to medicinal products for human use; “marketing authorization” means— a United Kingdom marketing authorization granted by the licensing authority under the 1994 Regulations; a Community marketing authorization; or a product licence, including one which is a licence of right or one which has effect as a marketing authorization by virtue of paragraph 1 of Schedule 6 (transitional provisions) to the 1994 Regulations; which relates to a medicinal product for human use; “marketing authorization (parallel import)” means a marketing authorization granted by the licensing authority in respect of a medicinal product which is imported into the United Kingdom from another member State of the European Community, in respect of which there has been granted a marketing authorization by another member State of the Community and which has no differences having therapeutic effect from a medicinal product in respect of which a marketing authorization has previously been granted in the United Kingdom; “medicinal product” includes any medicinal product for human use to which Chapters II to V of Council Directive 65/65/EEC apply and any substance or article specified in any order for the time being in force made under section 104 (application of the Act to certain articles and substances) or 105(1)(a) (application of the Act to certain other substances which are not medicinal products) of the Act which directs that Part II of the Act shall have effect in relation to such substance or article; “periodic fee” means a fee payable under regulation 14; “product licence of right” means a product licence within the meaning of section 7 (general provisions as to dealing with medicinal products) of the Act which is a licence of right within the meaning of section 25(4) (entitlement to licence of right) of the Act; “relevant fee period” means any fee period during any part of which a marketing authorization or licence in respect of which a periodic fee is payable is in force; “variation” in relation to— a United Kingdom marketing authorization granted by the licensing authority under the 1994 Regulations; or a product licence which has effect as such a marketing authorization by virtue of paragraph 1 of Schedule 6 (transitional provisions) to those Regulations; means “variation to the terms of a marketing authorization” as defined in Article 2.1 of Commission Regulation ( EC ) No. 541/95 ; “wholesale dealer’s licence” means a wholesale dealer’s licence which relates wholly or partly to medicinal products for human use; and Part I of Schedule 1 shall have effect for the purpose of interpreting that Schedule. 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; any reference in a regulation or a Schedule to a paragraph shall be construed as a reference to a paragraph of that regulation or, as the case may be, Schedule, and any reference in a paragraph to a sub-paragraph shall be construed as a reference to a sub-paragraph of that paragraph. Fees payable in connection with applications and inspections 3 1 The amount of a capital fee payable in connection with an application is that payable in accordance with these Regulations as in force when the application is made. 2 The amount of a fee payable in respect of an inspection is that payable in accordance with these Regulations as in force when the inspection is made. PART II CAPITAL FEES F0R APPLICATIONS FOR AUTHORIZATIONS, LICENCES OR CERTIFICATES AND FOR ASSOCIATED INSPECTIONS Applications for authorizations, licences or certificates 4 Subject to regulations 5, 19 and 23, in connection with an application for a marketing authorization (other than a Community marketing authorization), a manufacturer’s licence, a wholesale dealer’s licence or a clinical trial certificate, there shall be payable by the applicant— a the fee prescribed in Part II of Schedule 1 in connection with that application; and b in respect of any inspection defined in paragraph 1 of Schedule 2 made in connection with that application the fee payable in accordance with paragraphs 2 to 6 of that Schedule. Inspections in connection with multiple applications for authorizations or licences 5 Where an inspection mentioned in regulation 4(b) is made at a site which has been named as a possible site for manufacture or assembly of a medicinal product, or for the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product, by more than one applicant for— a a marketing authorization and that site is located outside the United Kingdom; or b a manufacturer’s licence and that site is located in the United Kingdom, the fee in respect of that inspection shall be payable in equal proportions by each of those applicants. Applications for certificates by exporters of medicinal products 6 1 In connection with an application for a certificate issued under section 50 (export certificates) 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 £120: b in any other case, a fee of £60; and c in either case i a fee of £60 for each set of certificates requested by the applicant in addition to one: and ii a fee of £14 for each certified copy of the original certificate not forming part of a set of certificates, requested by the applicant. 2 In paragraph (1)(c), “set of certificates” means— a if it is the first set, the original certificate plus up to four certified copies of that certificate; and b in any other case, up to five copies of that certificate. PART III CAPITAL FEES FOR APPLICATIONS FOR VARIATIONS OF AUTHORIZATIONS, LICENCES OR CERTIFICATES AND FOR ASSOCIATED INSPECTIONS Variations of authorizations, licences and certificates 7 1 Subject to regulations 8, 9, 19 and 23, a person who makes an application— a under regulation 4 of the 1994 Regulations for the variation of a United Kingdom marketing authorization; b 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 c under section 39(4) of the Act for the variation of a provision of a clinical trial certificate, shall pay the fees mentioned in paragraph (2). 2 The fees referred to in paragraph (1) are— a the fee prescribed in Part III of Schedule 1 in connection with the application; and b in respect of any inspection of a description referred to in paragraph 1 of Schedule 2 made in connection with the application, the fee payable in accordance with paragraphs 2 to 6 of that Schedule. Inspections in connection with multiple applications for variations of authorizations and licences 8 Where an inspection is made at a site which has been named as a possible site for manufacture or assembly of a medicinal product, or for the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product, by more than one applicant for a variation to— a a marketing authorization and that site is located outside the United Kingdom; or b a manufacturer’s licence and that site is located in the United Kingdom, the fee in respect of that inspection shall be payable in equal proportions by each of those applicants. Applications for multiple variations 9 1 Subject to paragraph (2), a separate fee shall be payable in respect of each variation of each provision of a marketing authorization, licence or certificate applied for in any one application. 2 In respect of a variation which is wholly consequential upon another variation of a provision of a marketing authorization, licence or certificate which is applied for in the same application, no separate fee shall be payable. PART IV CAPITAL FEES FOR APPLICATIONS FOR RENEWALS OF CLINICAL TRIAL CERTIFICATES AND FOR CERTAIN MANUFACTURER'S LICENCES AND FOR ASSOCIATED INSPECTIONS Renewals of clinical trial certificates 10 Subject to regulations 19 and 23, in connection with an application under section 38(2) of the Act for renewal of a clinical trial certificate, there shall be payable by the applicant a fee of £2,405. Renewals of certain manufacturer’s licences 11 1 Subject to regulation 23, the fee payable in connection with an application for renewal of a manufacturer’s licence which is limited solely to the manufacture or assembly of medicinal products the sale or supply of which does not require a marketing authorization or a product licence and to which article 2(2)(i)(e) (exemptions for certain special manufactured products) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies, shall be £85. 2 In respect of any inspection made in connection with an application referred to in paragraph (1), the fee payable shall be that prescribed in paragraph 2(d) of Schedule 2. Renewals in terms which are not identical to the existing authorization, licence or certificate 12 Where an applicant applies for renewal of a marketing authorization (other than a Community marketing authorization), a manufacturer’s licence, a wholesale dealer’s licence or a clinical trial certificate so as to contain provisions which are not identical to the provisions of that authorization, 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 in addition made a separate application for variation of that authorization, licence or certificate in respect of each provision which is not identical. PART V FEES FOR INSPECTIONS MADE DURING THE CURRENCY OF A MARKETING AUTHORIZATION OR LICENCE Fees for inspections 13 1 Subject to paragraph (5) and to regulations 19 and 23, a fee in accordance with paragraphs 2 to 6 of Schedule 2 shall be payable in respect of any inspection of a site made during the currency of a marketing authorization, 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 Subject to paragraph (4), 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 that licence. 3 Where an inspection is made at a site located outside the United Kingdom and that site is named in more than one marketing authorization as a possible site for the manufacture of the medicinal product in respect of which the authorization is granted the fee payable under paragraph (1) shall be payable in equal proportions by each holder of a marketing authorization in which that site is named as a possible site for manufacture of the medicinal product in respect of which the marketing authorization is granted. 4 Where an inspection is made at a site located in the United Kingdom and that site is named in more than one manufacturer’s licence as a possible site for the manufacture of a medicinal product in respect of which the licence is granted the fee payable under paragraph (1) shall be payable in equal proportions by the holders of those licences. 5 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 carried out. PART VI PERIODIC FEES FOR MARKETING AUTHORIZATIONS AND LICENCES Periodic fees 14 1 Subject to paragraphs (2), (4) and (5) and to regulations 19 and 23, there shall be payable by the holder of a marketing authorization (other than a Community marketing authorization), a manufacturer’s licence or a wholesale dealer’s licence a fee in connection with the holding of the authorization or licence in respect of each fee period during any part of which the authorization or licence is in force. 2 Marketing authorizations of a type referred to in Part IV 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 shall be payable in connection with the holding of such authorizations. 3 The periodic fee shall be the appropriate fee prescribed in Part III of Schedule 3 and, for the purposes of that Part, Parts I and II of that Schedule shall have effect. 4 No periodic fee shall be payable in respect of the fee period during which a marketing authorization or licence is first granted except where a marketing authorization was granted pursuant to— a a change of ownership application; or b an application, made no later than three months after the expiry of a marketing authorization, which is for a marketing authorization containing identical provisions to those contained in the expired authorization and which is made by the person who held the expired authorization, and, in each case, a periodic fee has not been paid in respect of that fee period in connection with the holding of a marketing authorization for the medicinal product to which the authorization relates. 5 Notwithstanding that an authorization or licence has neither expired nor been revoked, it shall be treated for the purposes of this regulation as not being in force during any part of a fee period if— a not less than three months before the commencement of that fee period, the holder of that authorization or licence has given written notice to the licensing authority indicating that he wishes the authorization or licence to cease to have effect before the commencement of that period; and b no products are sold, supplied or manufactured pursuant to that authorization or licence within that fee period. PART VII ADMINISTRATION Payment of fees to Ministers 15 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) (Ministers responsible for the administration of the Act) of the Act. Time for payment of capital fees in connection with applications or inspections 16 1 Subject to paragraph (2) and to regulations 17 and 19, 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 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 shall become payable within 14 days following written notice from the licensing authority requiring payment of those fees. Time for payment of capital fees applications made by small companies 17 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 ; 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 18 All periodic fees shall be payable on the first day of the fee period to which they relate. Adjustment, waiver, reduction or refund of fees 19 1 If after a capital or periodic fee was paid 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 authorization, licence or certificate concerned: or b a higher fee was properly payable, the balance due shall be payable within l4 days following written notice from the licensing authority to the applicant or, as the case may be, the holder of the authorization, licence or certificate 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 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 product licence or a product licence of right, a manufacturer’s licence, a wholesale dealer’s licence or a clinical trial certificate, 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 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. PART VIII REVOCATION, SAVINGS AND TRANSITIONAL PROVISIONS Revocation and savings 22 1 Subject to paragraph (2), the following regulations (in this regulation called “the revoked Regulations”) are hereby revoked— a the Medicines (Products for Human Use Fees) Regulations 1991 ; b the Medicines (Products for Human Use Fees) Amendment Regulations 1992 ; c the Medicines (Products for Human Use Fees) Amendment Regulations 1994 . 2 Paragraph (1) shall not affect— a any written notice given or any suspension made under the revoked Regulations and any such notice or suspension shall have effect as if given or made under these Regulations; and b any proceedings constituted under the revoked Regulations for the recovery of any fees due as debts to the Crown. Transitional provisions 23 1 In relation to capital fees, these Regulations shad not apply to any application made before the date on which these Regulations come into force. 2 In connection with any periodic fee payable under these Regulations, these Regulations shall not apply— a to any marketing authorization or licence in respect of which the licensing authority has received written notice of surrender prior to the coming into force of these Regulations; or b so as to impose any liability to pay a periodic fee in respect of any period prior to the coming into force of these Regulations. Signed by authority of the Secretary of State for Health Tom Sackville Parliamentary Under Secretary of State, Department of Health 22nd March 1995 John Redwood Secretary of State for Wales 23rd March 1995 Fraser of Carmyllie Minister of State, The Scottish Office 24th March 1995 Angela Browning Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food 11th April 1995 Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on F. A. Elliott Permanent Secretary 13th April 1995. Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on J. Murray Permanent Secretary 19th April 1995. We consent, Tim Kirkhope Andrew Mitchell Two of the Lords Commissioners of Her Majesty’s Treasury 20th April 1995