The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1992

• Citation: S.I. 1992/694
• Sections: 59

Section 1 Citation, commencement and scope

(1) These Regulations may be cited as the Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1992 and shall come into force on 3rd April 1992.

(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;

(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 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.

Section 2 Interpretation

(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 vaccines manufactured or assembled only from material obtained from the particular animal, flock or herd intended to be vaccinated in circumstances in which no other suitable licensed vaccines are readily available for such use;

“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 (i) 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 (ii) section 130(3A) of the Act which provides that such substance or article shall be treated as a medicinal product.

(2) In these Regulations, unless the context otherwise requires, 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.

Section 3 Applications for licences and certificates

Subject to regulations 18 and 20, in connection with an application for a product licence, a manufacturer’s licence, a wholesale dealer’s licence, an animal test certificate, an animal test (confirmation of exemption) certificate or any other 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 specified in Schedule 2 made in connection with that application, the fee payable in accordance with paragraphs 2 to 6 of that Schedule.

Section 4 Variations of licences and certificates

Subject to regulations 5, 6, 18 and 20, 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, under section 39(4) in respect of an animal test certificate or an animal test (confirmation of exemption) 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 specified in Schedule 2 made in connection with that application, the fee payable in accordance with paragraphs 2 to 6 of that Schedule.

Section 5 Applications for multiple variations

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.

Section 6 Variations at the invitation of the licensing authority

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.

Section 7 Renewal of licences and certificates

Subject to regulations 8, 18 and 20, 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 or an animal test (confirmation of exemption) 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 specified in Schedule 2 made in connection with that application, the fee payable in accordance with paragraphs 2 to 6 of that Schedule.

Section 8 Renewals in terms which are not identical to the existing licence or certificate

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 payble 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.

Section 9 Inspections of a site

(1) Subject to paragraph (4) and to regulations 18 and 20, 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 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.

Section 10 Product licences — annual fee

(1) Subject to paragraph (3) and regulation 20, 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 calendar year—

(a) throughout which the product licence (having been granted or renewed) is in force; or

(b) during any part of which the product licence (already held by the applicant) is or was in force

and (in either case) the applicant has sold, supplied or manufactured any medicinal product to which the licence relates.

(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.

Section 11 Product licences and animal test certificates — references

Subject to regulation 18, in respect of any reference to the Veterinary Products Committee or to the Medicines Commission under section 21 of the Act in connection with a product licence or an animal test certificate, there shall be payable by the applicant at the time of the application the appropriate fee prescribed in Schedule 6.

Section 12 Payment of fees to Ministers

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.

Section 13 Time for payment of capital fees in connection with applications or inspections and refunds of such fees

(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 within 28 days of a request for a refund; 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 payble within 28 days following written notice from the licensing authority.

Section 14 Time for payment of annual fees

All annual fees shall be payable during September of the licence year following the calendar year to which they relate.

Section 15 Late payment of annual fees

(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 5 per cent of the annual fee payable, in respect of every full calendar month during which the annual fee is not paid, rounded up to the nearest £10. Where the annual fee payable is less than £10, no such further 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 becomes payable following written notice from the licensing authority;

(b) references to a period calculated from a day are references to the period inclusive of that day.

Section 16 Suspension of licences

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.

Section 17 Civil proceedings to recover unpaid fees

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.

Section 18 Waiver, reduction or refund of fees

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.

Section 19 Revocation and savings

(1) Subject to paragraph (2), the Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1991 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 instituted under the Regulations hereby revoked for the recovery of any fees due as debts due to the Crown.

Section 20 Transitional provisions

(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 July 1992 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.

Section 1 Product licences

Subject to paragraph 2, the fee payable under regulation 3(a) in connection with an application for a product licence of a kind described in column 1 of the following Table shall be the fee specified in the corresponding entry in column 2 of that Table:

Section 1 Product licences

The fee payable under regulation 4(a) in connection with an application for variation of a product licence—

(a) in the case of a complex application, shall be £1,100;

(b) in any other case—

(i) requiring veterinary, scientific or pharmaceutical assessment—

(aa) for a variation, shall be £320;

(bb) for any other consequential variation to other licences, in identical terms, shall be £110;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £110 in respect of each variation;

(iii) where the variation applied for involves the reissue of the product licence in the new name of the company, shall be £110;

(iv) where the product licence relates solely to an emergency vaccine, shall be £30.

Section 1 Product licences

The fee payable under regulation 7(a) in connection with an application for renewal of a product licence shall be £440, and, in the case of a licence relating solely to an emergency vaccine, £30.

Section 2 Product licences

Where—

(a) a major or a complex application is made by a person who is already the holder of an animal test certificate, in respect of a medicinal product containing the same active ingredient as the medicinal product in respect of which the product licence is applied for, or

(b) a major or a complex application is made by a person who is already the holder of a product licence (export only), relating to the same medicinal product as the product licence applied for,

the fee payable under regulation 3(a) in connection with that application shall be reduced by the amount of the fee paid in connection with the application for that certificate or licence.

Section 2 Manufacturers' licences

The fee payable under regulation 4(a) in connection with an application for variation of a manufacturer’s licence—

(a) in the case of a manufacturer’s licence referred to in paragraph 5(2) of Part II of this Schedule, shall be £90;

(b) in any other case—

(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £320;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £110.

Section 2 Manufacturers' licences

The fee payable under regulation 7(a) in connection with an application for renewal of a manufacturer’s licence—

(a) referred to in paragraph 5(2) of Part II of this Schedule, shall be £90;

(b) in any other case, shall be an annual fee of £195 payable on the annual renewal date of the licence.

Section 3 Product licences

(1) Subject to sub-paragraphs (2) and (3) below, where an application for a product licence consists of an application for more than one such licence each relating to a product containing the same active ingredient or combination of ingredients, the fee payable under regulation 3(a) shall be an amount equal to the aggregate of the amounts payable under paragraph 1 in respect of separate applications for each such licence.

(2) If the application is a major application, the amount payable shall be the amount payable in respect of a major application under paragraph 1 plus—

(a) in respect of each additional product licence applied for which relates to a medicinal product of a different dosage form, the amount payable in respect of a complex application under paragraph 1; and

(b) in respect of each additional product licence applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a standard application under paragraph 1.

(3) If the application is a complex application, the amount payable shall be the amount payable in respect of a complex application under paragraph 1 plus—

(a) in respect of each additional product licence applied for which relates to a medicinal product of a different dosage form, the amount payable in respect of a complex application under paragraph 1; and

(b) in respect of each additional product licence applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a standard application under paragraph 1.

Section 3 Wholesale dealers' licences

The fee payable under regulation 4(a) in connection with an application for variation of a wholesale dealer’s licence—

(a) requiring veterinary, scientific or pharmaceutical assessment, shall be £320;

(b) not requiring veterinary, scientific or pharmaceutical assessment, shall be £110.

Section 3 Wholesale dealers' licences

(1) Subject to paragraph (2) below, the fee payable under regulation 7(a) in connection with an application for renewal of a wholesale dealer’s licence shall be an annual fee of £125 payable on the annual renewal date of the licence.

(2) In the case of a wholesale dealer who has a turnover in veterinary medicinal products—

(a) of less than £30,000; or

(b) of less than 15% of his total turnover

the fee payable in connection with an application for renewal of a wholesale dealer’s licence, accompanied (in either case) by an auditor’s certificate certifying the low turnover, shall be £80.

(3) For the purposes of this paragraph, “turnover” means the gross value of all veterinary medicinal products sold by way of wholesale dealing by the applicant in the United Kingdom during the calendar year which ends three months before the beginning of the licence year. Medicinal products sold by way of wholesale dealing by the licence holder shall comprise only those products in respect of which a licence is held during the whole or part of that calendar year.

Section 4 Animal test certificates

The fee payable under regulation 3(a) in connection with an application for an animal test certificate shall be £4,200.

Section 4 Animal test certificates

The fee payable under regulation 4(a) in connection with an application for variation of an animal test certificate—

(a) in the case of a complex application, shall be £1,100;

(b) in any other case—

(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £320;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £110;

(iii) where the variation applied for involves the reissue of the animal test certificate in the new name of the company, shall be £110; or

(c) an animal test (confirmation of exemption) certificate—

(i) requiring veterinary, scientific or pharmaceutical assessment, shall be £320;

(ii) not requiring veterinary, scientific or pharmaceutical assessment, shall be £110;

(iii) where the variation applied for involves the reissue of the animal test (confirmation of exemption) certificate in the new name of the company, shall be £110.

Section 4 Animal test certificates

The fee payable under regulation 7(a) in connection with an application for renewal of—

(a) an animal test certificate, shall be £525;

(b) an animal test (confirmation of exemption) certificate, shall be £315.

Section 5 Manufacturers' licences

(1) The fee payable under regulation 3(a) in connection with an application for a manufacturer’s licence shall be—

(a) in a case to which sub-paragraph (2) below applies, £90; or

(b) in any other case, £1,900; and

(c) in either case, if appropriate, a fee calculated in accordance with Schedule 2 in respect of any inspection made in connection with that application.

(2) Sub-paragraph (1)(a) above applies to the case of an application for a manufacturer’s licence which is limited solely to the manufacture or assembly of—

(a) medicinal products the sale or supply of which do not require a product licence and to which article 2(2)(i)(e) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies; or

(b) emergency vaccines.

Section 6 Wholesale dealers' licences

(1) Subject to paragraph (2) below the fee payable under regulation 3(a) in connection with an application for a wholesale dealer’s licence shall be £1,260.

(2) In the case of a wholesale dealer who has a turnover in respect of veterinary medicinal products—

(a) of less than £30,000; or

(b) of less than 15% of his total turnover

the fee payable in connection with an application for a wholesale dealer’s licence, if accompanied (in either case) by an auditor’s certificate certifying the low turnover, shall be £425.

(3) For the purposes of this paragraph, “turnover” means the gross value of all veterinary medicinal products sold by way of wholesale dealing by the applicant in the United Kingdom during the calendar year which ends three months before the beginning of the licence year. Medicinal products sold by way of wholesale dealing by the licence holder shall comprise only those products in respect of which a licence is held during the whole or part of that calendar year.

Section 7 Animal test (confirmation of exemption) certificate

The fee payable under regulation 3(a) in connection with an application for an animal test (confirmation of exemption) certificate under the Medicines (Exemptions from Licences and Animal Test Certificates) Order 1986 shall be—

Section 1 Interpretation

(1) In this Schedule—

“dormant biological medicinal product” means a product which is not currently being manufactured or sold and in respect of which there is no current intention to recommence the manufacture or sale;

“major inspection” means an inspection at a site at which 60 or more, but fewer than 250, relevant persons are employed;

“minor inspection” means an inspection at a site at which fewer than 10 relevant persons are employed;

“relevant person” means any person directly or indirectly engaged in, or assisting in, the manufacture or assembly of medicinal products and also includes any person connected with such production who is involved in management, quality control, site maintenance, packing, storage or distribution;

“standard inspection” means an inspection at a site at which 10 or more, but fewer than 60, relevant persons are employed;

“supersite inspection” means an inspection at a site at which 250 or more relevant persons are employed.

(2) In calculating the number of relevant persons for the purposes of this Schedule, any person partly engaged or assisting in the manufacture or assembly of medicinal products (whether as a part-time employee or by virtue of being only partly employed in such work) shall be included in the calculation but only as a fraction calculated by reference to the amount of time spent by that person engaged or assisting in the manufacture or assembly of medicinal products or, where such a calculation is inappropriate, by reference to the percentage of his job which relates to the manufacture or assembly of such products and, in either case, by comparison with the average working week of a relevant person engaged in full-time employment at the same site.

Section 2 Fees

Subject to paragraphs 3 to 5, the fee payable in respect of an inspection under these Regulations shall be—

(a) except in the case of an inspection falling within sub-paragraphs (b) to (d) below—

(i) in respect of a minor inspection, £1,450;

(ii) in respect of a standard inspection, £2,900;

(iii) in respect of a major inspection, £5,800;

(iv) in respect of a supersite inspection, £10,915;

(b) where the site inspected is wholly or partly concerned with the manufacture of sterile products or the filling of the containers directly in contact with such products—

(i) in respect of a minor inspection, £2,415;

(ii) in respect of a standard inspection, £4,825;

(iii) in respect of a major inspection, £9,600;

(iv) in respect of a supersite inspection, £18,190;

(c) except in the case of an inspection falling within sub-paragraph (b) above or sub- paragraph (d) below, where the site inspected is concerned only with the assembly of medicinal products—

(i) in respect of a minor inspection, £975;

(ii) in respect of a standard inspection, £1,925;

(iii) in respect of a major inspection, £3,850;

(iv) in respect of a supersite inspection, £5,670;

(d) where the site inspected is limited solely to the manufacture or assembly of—

(i) medicinal products, the sale or supply of which do not require a product licence and to which article 2(2)(i)(e) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies, £90;

(ii) emergency vaccines, £90.

Section 3 Fees

(1) Subject to paragraph (2), unless the applicant or, as the case may be, the holder of the licence establishes that an inspection is a minor inspection or a standard inspection, the fee payable shall be the appropriate fee specified in paragraph 2 above for a major inspection.

(2) If, following an inspection, it becomes apparent that the inspection fell into a different category from that established by the applicant or the holder of the licence, the fee payable under these Regulations in respect of that inspection shall be the fee payable in respect of an inspection falling within the category into which the inspection should have fallen.

Section 4 Fees

(1) In the case of an inspection in connection with the grant, variation or renewal of a wholesale dealer’s licence or during the currency of such a licence, the fee payable under these Regulations—

(a) except in a case falling within sub-paragraph (b) or (c) shall be, £1,260;

(b) where the site is that of a wholesale dealer whose licence is limited to dealing only in medicinal products falling within a description or class of such products specified in an Order made under section 51(1) of the Act, shall be £480;

(c) where the site is that of a wholesale dealer who has a turnover in respect of veterinary medicinal products—

(i) of less than £30,000; or

(ii) of less than 15% of his total turnover

and if he produces (in either case), on request, an auditor’s certificate certifying the low turnover, shall be £480.

(2) For the purposes of this paragraph, “turnover” means the gross value of all veterinary medicinal products sold by way of wholesale dealing by the applicant in the United Kingdom during the calendar year which ends three months before the beginning of the licence year. Medicinal products sold by way of wholesale dealing by the licence holder shall comprise only those products in respect of which a licence is held during the whole or part of that calendar year.

Section 5 Fees

The fee payable in respect of any inspection of the premises and the procedures used or any inspection of the premises or the procedures used for the quality control of a biological medicinal product in respect of which a product licence has been granted or applied for, shall be £1,050 for each such product which is not a dormant biological medicinal product. Any such inspection in connection with such a licensed biological medicinal product (not being a dormant biological medicinal product) in respect of which a product licence was granted because it was identical to an existing product, shall be £55.

Section 6 Fees

The fee payable in respect of an inspection at a site outside the United Kingdom shall be increased by an amount equal to the travelling and subsistence costs of the inspector relating to the inspection and any additional costs reasonably incurred by him in respect of that inspection as a result of its being at a site outside the United Kingdom (such as interpreter’s fees). The fee payable in respect of an inspection pursuant to paragraph 5 above at a site, whether or not outside the United Kingdom, shall be increased by an amount equal to the travelling and subsistence costs of the inspector relating to the inspection and any additional costs reasonably incurred by him in respect of that inspection in the case of its being at a site outside the United Kingdom (such as interpreter’s fees).

Section 1

Where the manufacture, assembly, sale or supply of medicinal products of a particular class or description will be, or is likely to be, interrupted for a period, and in consequence thereof the health of animals will be, or is likely to be, put at risk, the licensing authority may decide that any fees otherwise payable under these Regulations—

(a) in connection with an application for the grant (variation or renewal) of a product licence relating to a medicinal product falling within that class or description; or

(b) in respect of any inspection made during the currency of such a licence

shall be waived during that particular period or, if the period will, or is likely to, exceed 3 months, during the first 3 months of that period.

Section 2

The licensing authority may waive or reduce the payment of any capital fee payable under these Regulations in circumstances where—

(a) in its opinion the interests of human or animal health require a licence or certificate to be granted or an inspection to be made; and

(b) the medicinal product in respect of which an application for a licence or certificate has been made—

(i) is not intended for sale; or

(ii) is intended only for use in the treatment of rare conditions or in the treatment of a minor species of animal or as an emergency vaccine.

Section 3

(1) Subject to sub-paragraphs (2) to (5) below, where the licensing authority—

(a) is satisfied that the annual turnover (as calculated in accordance with Part I of Schedule 4) of a medicinal product during any calendar year of the first five years of the currency of the product licence, has not exceeded, or is unlikely to exceed, £30,000; and

(b) is of the opinion that the interests of human or animal health require a product licence to be granted

any capital fee otherwise payable under these Regulations in connection with an application for a product licence or an inspection during the currency of that licence, may be reduced or, if such a fee has already been paid, be refunded in part in proportion to the difference between the maximum turnover of the product in any calendar year (during any of the first five years of the currency of the licence) and the sum of £30,000.

(2) Before a licence holder pays any reduced fee or receives any refund pursuant to sub-paragraph (1), he shall furnish evidence to the satisfaction of the licensing authority of the amount of annual turnover, in respect of the particular medicinal product, in each calendar year of the first five years of the currency of the licence.

(3) Where a reduced fee is determined in accordance with sub-paragraph (1) above at the time of application on the basis of the estimated likely maximum turnover of the medicinal product during the first five years of the currency of the licence, any fee so determined shall be regarded as a provisional payment on account.

(4) Where a provisional payment on account is made in accordance with sub-paragraph (3) above and subsequently the turnover in any calendar year in the first five years of the currency of the licence exceeds £30,000, the licence holder shall be liable to pay the balance of the full fee otherwise payable under these Regulations within 28 days of notification by the licensing authority.

(5) Where any provisional payment on account is made in accordance with sub-paragraph (3) above, the reduced fee shall be recalculated in accordance with the provisions of sub-paragraph (1) above at the end of five years from the date of the grant of the licence and any difference between the fee so calculated and the provisional payment on account shall be payable by the applicant or, as the case may be, refunded to the applicant by the licensing authority within 28 days of a request for such a refund.

Section 4

Where an application for the grant or renewal of a product licence is made at the specific written request of the licensing authority any fee otherwise payable under these Regulations in connection with that application shall be waived.

Section 5

(1) Subject to sub-paragraph (2) below, where an application for a product licence is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable (under regulation 3(a)) in connection with that application shall be refunded or, if it has not yet been paid, shall be waived—

(a) if the application has been received but no veterinary scientific or pharmaceutical assessment thereof has begun, 90%;

(b) except in a case to which sub-paragraph (c) below applies, veterinary, scientific or pharmaceutical assessment has begun but not been completed, 50%;

(c) if a request for further information in connection with the application has been made by the licensing authority under section 44(1) of the Act, 25%.

In the case of sub-paragraph (b) above, where an application has been withdrawn because it is deficient and a 50% refund of the fee has been made by the licensing authority, any subsequent reapplication in respect of the same product licence by the same applicant shall be charged at 50% of the fee otherwise payable under regulation 3(a).

(2) If an application for a product licence is withdrawn either after scientific or veterinary pharmaceutical assessment has been completed or following consideration of that application by a committee established under section 4 of the Act or by the Medicines Commission, no refund or waiver of the fee payable (under regulation 3(a) of these Regulations) in connection with that application shall be made under this paragraph.

(3) Where the same site is inspected at the same time in connection with applications for the grant, variation, or renewal of both a manufacturer’s licence and a wholesale dealer’s licence or during the currency of both such licences, the fee otherwise payable under these Regulations in respect of the inspection relating to the wholesale dealer’s licence shall be waived.

Section 1

In relation to the calculation of turnover in any calendar year in accordance with the provisions of the succeeding paragraphs of this Part of this Schedule, “manufacturers' prices” shall mean, subject to the provisions of paragraph 2, the prices charged by manufacturers to wholesalers, except where medicinal products are supplied by manufacturers direct to retailers, in which case the prices charged by the licence holder may be reduced by such sum as, in the opinion of the licensing authority represents the difference between the prices paid by wholesalers and those normally charged by them to retailers according to the practice prevailing during the licence year in question with regard to such products.

Section 1

Subject to the provisions of these Regulations annual fees shall be payable at the basic rate of £250 or 0.63% of turnover, whichever is the greater.

Section 2

Where a licence holder sells or supplies medicinal products which he has neither manufactured nor obtained from the manufacturer, in relation to the calculation of turnover in any calendar year in accordance with the provisions of the succeeding paragraphs of this Part of this Schedule “manufacturers' prices” shall mean the prices paid by, or on behalf of, the licence holder for those medicinal products.

Section 2

For the purpose of calculating annual turnover the provisions of Part I of this Schedule shall apply.