(1)    These Regulations may be cited as the Medicines (Products for Animal Use—Fees) Regulations 2004 and shall come into force on 17th November 2004.

(2)    These Regulations apply only to fees relating to products for animal use.

(1)    In these Regulations—

“the Act” means the Medicines Act 1968;

“assistance in connection with a mutual recognition application” means the preparation of an assessment report of the type required by virtue of the second paragraph of Article 32.1 of Directive 2001/82/EC in order for an application to be made to a Member State for mutual recognition of a marketing authorisation, or the updating of an existing assessment report for the purpose of enabling such an application to be made, and includes any assistance given of the type specified in Article 33 of that Directive in connection with the application for mutual recognition in relation to which the assessment report or updated assessment report has been prepared;

“Directive 2001/82/EC” means Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products;

“EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992, amended as at the date of making these Regulations);

“EEA State” means a State which is a Contracting Party to the EEA Agreement other than the United Kingdom;

“export certificate” means a certificate issued under section 50 of the Act;

“marketing authorisation” means an authorisation to place on the market in the United Kingdom a veterinary medicinal product but does not include a marketing authorisation granted by the Community in accordance with the provisions of Council Regulation (EEC) No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products;

“product” means a medicinal product as defined in the Act save that—

(a)    it includes—

(i)    any substance or article to be administered in a medicinal test on animals under section 32(6)(c) of the Act;

(ii)    any article or substance in relation to which provisions of Part II of the Act have effect by virtue of an order under section 104 or 105 of that Act; and

(iii)    any veterinary medicinal product which would not otherwise count as a medicinal product; and

(b)    it excludes medicated feedingstuffs;

“Regulation (EC) No 541/95” means Commission Regulation (EC) No 541/95 concerning the examination of variations to the terms of a marketing authorisation granted by the competent authority of a Member State, as it was immediately before repeal;

“Regulation (EC) No 1084/2003” means Commission Regulation (EC) No 1084/2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State;

“the 1994 Regulations” means the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994;

“the relevant authority” insofar as it is used in relation to a marketing authorisation or an application therefor, means the Secretary of State, and otherwise means the licensing authority as defined in section 6 of the Act;

“specific batch control” means consideration by the relevant authority of a marketing authorisation or animal test certificate holder's documentation relating to a specific batch of a veterinary medicinal product (other than an immunological product) where the quality characteristics of that product or of a material used during its manufacture or its packaging to produce the finished product for sale differ from those detailed in the marketing authorisation or animal test certificate, so that the relevant authority may decide whether action under Article 84 of Directive 2001/82/EC either to instigate a recall or to prohibit the placing on the market of the veterinary medicinal product would be required;

“variation with extras” means changes to a marketing authorisation falling within Annex II to Regulation (EC) No 541/95 except in the case of a mutually recognised marketing authorisation, where it means changes falling within Annex II to Regulation (EC) 1084/2003;

“veterinary medicinal product” has the same meaning as in Article 1.2 of Directive 2001/82/EC; and

“Veterinary Products Committee” means the committee established by the Medicines (Veterinary Products Committee) Order 1970.

(2)    Expressions used in relation to variations to marketing authorisations (other than mutually recognised marketing authorisations) have the same meaning as in Directive 851/81/EC on the approximation of the laws of the Member States relating to veterinary medicinal products, as it was immediately before repeal, and Regulation (EC) No 541/95.

(3)    Expressions used in relation to mutually recognised marketing authorisations have the same meaning as in Directive 2001/82/EC and Regulation (EC) No 1084/2003.

(4)    Part 1 of Schedule 1 shall have effect for the purposes of interpretation of Schedule 1.

(5)    Save as otherwise provided other expressions used in these Regulations have the same meaning as in the Act and the Medicines Act 1971.

(1)    Part 2 of Schedule 1 (application fees for a marketing authorisation, manufacturer's licence, product licence, wholesale dealer's licence, an animal test certificate or export certificate) shall have effect.

(2)    Paragraph (1) shall not be taken to impose any obligation on an applicant for a new marketing authorisation or product licence falling within regulation 9(2) or on an applicant for a variation with extras.

Where the holder of a marketing authorisation (other than a mutually recognised marketing authorisation) or an animal test certificate requests the relevant authority to undertake specific batch control he shall pay a fee of £500.

Part 3 of Schedule 1 (fees for assistance in connection with a mutual recognition application) shall have effect.

(1)    Part 4 of Schedule 1 (fees for an application to vary a marketing authorisation, product licence, manufacturer's licence, wholesale dealer's licence or an animal test certificate) shall have effect.

(2)    Paragraph (1) extends to applications for a variation with extras.

(3)    Paragraph (1) shall not apply to—

(a)    a variation of a marketing authorisation, licence or certificate consequential upon another variation of the same marketing authorisation, licence or certificate applied for in the same application;

(b)    a variation application made at the express written invitation of the relevant authority;

(c)    a TSE variation application,

for which no fee is payable.

(4)    For the purposes of paragraph (3), “TSE variation application” means an application (other than a complex application as defined in Schedule 1 or an application which seeks to demonstrate compliance by cross-referring to data held by the relevant authority) to vary—

(a)    a marketing authorisation to comply with regulation 6(1)(d) of the 1994 Regulations; or

(b)    a product licence to reduce the risk of revocation under section 28(3) of the Act by reason of the relevant authority not being satisfied that the product was manufactured in the manner carrying the least risk of transmitting animal spongiform encephalopathy agents.

(1)    The fee—

(a)    for the renewal of a marketing authorisation, a product licence, a manufacturer's licence or an animal test certificate;

(b)    to terminate a marketing authorisation or product licence and for it to be replaced with a new marketing authorisation or product licence in respect of the same product,

is that prescribed in Part 5 of Schedule 1.

(2)    Where a person applies for renewal of a marketing authorisation, a product licence, a manufacturer's licence or an animal test certificate so as to contain variations, he shall pay the fee payable pursuant to paragraph (1) plus the fee which would have been payable had the application been an application to vary the authorisation, licence or certificate in question.

(1)    Fees for inspections in connection with an application for the grant, variation or renewal of a manufacturer's licence or for any other inspection in connection with such a licence shall be paid by the applicant or holder of the licence in accordance with Schedule 2 except as provided below.

(2)    Where a manufacturing site in a non-EEA state is specified in a marketing authorisation or product licence or an application therefor and the site is inspected by the relevant authority, the marketing authorisation or product licence holder or applicant shall pay the relevant fee prescribed in Schedule 2; and if there is more than one marketing authorisation or product licence or application therefor in which the site in question is inspected, liability to pay the relevant fee prescribed in Schedule 2 shall be divided between the holders of or applicants for those marketing authorisations or product licences, as the case may be, in proportion to the number of marketing authorisations or product licences for products manufactured at that site held or applied for by each.

(3)    No fee is payable in respect of any inspection of a site carried out within 6 months of a previous inspection in order to ascertain whether an alteration or improvement to that site, which was required in writing by the relevant authority as the result of that previous inspection, has been implemented.

(1)    The holder of any marketing authorisation or product licence shall, following each anniversary of the grant of the authorisation or licence, provided that the product to which it relates has been sold, supplied or manufactured during the year ending on that date, pay an annual fee calculated in accordance with Schedule 3 in respect of that year.

(2)    Where, during the course of the year in question, a new marketing authorisation or product licence has been granted in accordance with regulation 7(1)(b), any sale, supply or manufacture of a product covered by the previous authorisation or licence shall for the purposes of paragraph (1) be treated as covered by the new authorisation or licence.

The holder of a manufacturer's licence, other than one specified in paragraph 4(2) of Part 2 of Schedule 1, shall pay an annual fee of £230 following each anniversary of the grant of the licence.

(1)    The annual fee for a wholesale dealer's licence is, where turnover is—

(a)    certified to be lower than £40,000, £230; and

(b)    otherwise £465.

(2)    The annual fee is payable by the licence holder following each anniversary of the grant of the licence.

(3)    For the purposes of this regulation, “turnover” means the gross value of all authorised or licensed products sold by way of wholesale dealing by the licence holder in the United Kingdom during the previous year, and it counts as certified to be lower than £40,000 when payment of the annual fee is accompanied by a declaration of that actual lower amount.

(1)    Schedule 4 (fees relating to applications for registration of homoeopathic veterinary medicinal products) shall have effect.

(2)    A person who applies to the Ministers to renew the registration of a product shall pay a fee of £90.

(3)    A person who applies to the Ministers for authorisation to alter an Article 8 dossier relating to a registered product shall pay a fee of £105.

(4)    No fee is payable for an application for the registration of a product, for the renewal of a registration of a product, or for an application to alter an Article 8 dossier of a registered product, which is made at the express written invitation of the Ministers.

(5)    For the purposes of this regulation and Schedule 4 the terms—

“Article 8 dossier”;

“the Board”;

“the Ministers”

“product”; and

“registered”,

shall have the meanings respectively given to them by regulation 2(1) of the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997, as read, in the case of the expression “the Ministers”, with regulation 2(5) of those Regulations.

In respect of any reference to the Veterinary Products Committee or to the Medicines Commission—

(a)    notified to an applicant under section 21 of the Act in connection with his application for the grant or renewal of a product licence or under that section as adapted by section 38 of the Act in connection with his application for the grant or renewal of an animal test certificate;

(b)    in relation to which notification is given to an applicant under the 1994 Regulations in connection with his application for the grant or renewal of a marketing authorisation; or

(c)    in relation to an application for a variation with extras insofar as it falls within regulation 9 of the 1994 Regulations,

the applicant shall pay, within 14 days following notice of the reference being sent to him, the relevant fee prescribed in Schedule 5.

(1)    Any fee due under these Regulations is payable to the Secretary of State.

(2)    Fees for an application or request shall be paid by its maker at the time it is made.

(3)    Paragraph (2) does not apply to fees due under regulation 9, 10 or 11 or for any inspection, which shall be paid no later than 30 days after the date of notice requiring payment being sent by the Secretary of State to the person by whom the fee is payable.

(4)    If, for the purposes of processing or provision of assistance in connection with an application or carrying out an inspection, a fee has been paid and, following the determination of the application, or completion of the provision of assistance or inspection, it becomes apparent that—

(a)    a lesser fee was due, the excess shall be refunded; or

(b)    a higher fee was due, the balance shall be payable within 30 days from and including the date of the notice requiring payment of the balance being sent by the relevant authority.

(5)    The relevant authority need not and to the extent required by Regulation (EC) 1084/2003 shall not process an application or request in connection with—

(a)    a marketing authorisation, animal test certificate, export certificate or specific batch control; or

(b)    a manufacturer's or wholesale dealer's licence relating to products to which Directive 2001/82/EC applies,

until receipt of the appropriate fee, unless the application is a relevant variation application.

(6)    In the case of any relevant variation application, the relevant authority—

(a)    may by notice sent to the applicant specify the difference between the appropriate fee payable and the fee paid, explaining the reason for it and stipulating that, if the difference in question is not paid by the date specified in the notice (being at least 14 days after the date that the notice is sent), the application may not be further processed; and

(b)    if that difference is not paid, need not continue to process the application once the time specified for payment has expired, until receipt of that payment.

(7)    Nothing in paragraph (6) shall be construed as preventing the relevant authority from fulfilling its obligations to observe the duties imposed on Member States under Articles 81 or 83 of Directive 2001/82/EC

(8)    For the purposes of paragraph (4), “relevant variation application” means any application falling within paragraph (b) of the definition of “individual variation” in Part 1 of Schedule 1 in relation to which a fee has been paid which is based on the applicant's assessment of the appropriate fee but is less than the fee payable for the application.

(1)    Where a person fails to pay the annual fee for a marketing authorisation or product licence within 30 days from and including the due date, he shall pay an additional fee equivalent—

(a)    where payment is received by the relevant authority after 30 but before 60 days have expired from and including the due date, to 1% of the annual fee;

(b)    where payment is received by the relevant authority after 60 but before 90 days have expired from and including the due date, to 2% of the annual fee; and

(c)    where payment has not been received by the relevant authority after the expiry of 90 days, to 5% of the annual fee.

(2)    In calculating the sum due under paragraph (1) the additional fee shall in all cases be rounded up to the nearest £10.

(3)    Where the person to whom regulation 9(1) applies has not furnished evidence of his annual turnover in accordance with the provisions of paragraph 2 of Schedule 3 so that the annual fee cannot be determined before the due date, he may make a payment of an amount on account of the annual fee.

(4)    Where paragraph (3) applies and a payment on account has been made, any additional fee payable under this regulation shall be calculated as if, in paragraph (1) above, the reference to the annual fee were a reference to the difference between the payment on account and the amount of the annual fee as subsequently determined.

(5)    In this regulation, “the due date” means the date of the written notice sent in accordance with regulation 14(3).

(1)    Where any sum payable under these Regulations remains unpaid by the holder of a licence or certificate, the relevant authority may send notice to him requiring payment and, if after a period of one month from the date of service of such notice, or such longer period as the relevant authority may allow, the sum remains unpaid, the relevant authority may forthwith suspend the licence or certificate until the sum has been paid.

(2)    In paragraph (1), “licence” does not include a manufacturer's or wholesale dealer's licence for products to which Directive 2001/82/EC applies.

(1)    The relevant authority—

(a)    may waive or reduce payment of any fee payable under these Regulations or refund the whole or part of any fee already so paid—

(i)    on an individual application to do so, if it concludes that exceptional circumstances justify it;

(ii)    in any of the circumstances specified in paragraphs 1 to 3 of Schedule 6; and

(b)    shall do so as required by paragraph 4 of Schedule 6.

(2)    Paragraph (1)(a)(ii) does not apply to products covered by regulation 12.

The following Regulations are hereby revoked:

(a)    The Medicines (Products for Animal Use—Fees) Regulations 1998;

(b)    The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 1999;

(c)    The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2000;

(d)    The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2001;

(e)    The Medicines (Products for Animal Use—Fees) (Amendment) (No 2) Regulations 2001;

(f)    The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2002; and

(g)    The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003.

(1)    These Regulations shall not apply in respect of any application made before the date these Regulations come into force.

(2)    Paragraph (1) does not apply where an—

(a)    inspection is made after the date these Regulations come into force in connection with an application made before that date, in which case the inspection fee payable is that due under these Regulations; or

(b)    application to renew a marketing authorisation, licence or certificate due to expire after these Regulations come into force is made before that date, in which case the fee payable is that due under these Regulations.

Ben Bradshaw

Parliamentary Under Secretary of State,

Department for Environment, Food and Rural Affairs

15th October 2004

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety

D C Gowdy

Permanent Secretary,

Department of Health, Social Services and Public Safety

14th October 2004

Sealed with the Official Seal of the Department of Agriculture and Rural Development

Gerald Lavery

Deputy Secretary,

Department of Agriculture and Rural Development

15th October 2004

We consent

Nick Ainger

Joan Ryan

Two of the Lords Commissioners of Her Majesty's Treasury

21st October 2004

Interpretation

1

(1)    In this Schedule—

“biological product” has the same meaning as set out in Part 1 of Schedule 1;

“dormant biological product” means a biological 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;

“immunological veterinary medicinal product” has the same meaning as in Directive 2001/82/EC;

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

“minor”, in relation to an inspection, describes an inspection at a site at which fewer than 10 relevant persons are employed;

“relevant person” means any person directly or indirectly engaged, or assisting in the activity of manufacturing or assembling products and includes any person whose work involves management, quality control, site maintenance, packing, storage or distribution;

“standard”, in relation to an inspection, describes an inspection at a site at which 10 or more, but fewer than 60, relevant persons are employed; and

“supersite”, in relation to an inspection, describes 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 operating partly as a relevant person (whether as a part-time employee or by virtue of being only partly employed in relevant work) shall be included in the calculation pro rata.

Fees

2

(1)    The fee for an inspection is that specified in the table below.

(2)    Sub-paragraph (1) does not apply 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 in which case the fee payable is that specified in the table below.

(3)    Sub-paragraph (1) does not apply where the site inspected is concerned only with the assembly of products, in which case the fee payable is that specified in the table below.

(4)    Sub-paragraph (1) does not apply where the site inspected is limited solely to the manufacture or assembly of—

(a)    products the sale or supply of which would require a product licence but for article 2(2)(i) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971, in which case the fee payable is £105;

(b)    emergency vaccines, in which case the fee payable is £115;

(c)    products covered by paragraph (a) above and vaccines covered by paragraph (b), in which case the fee payable is £200.

3

Paragraph 2 does not apply to a biological product (not being a dormant biological product), for which—

(a)    a marketing authorisation or product licence was granted because it was identical to an existing product, in which case the inspection fee is £65;

(b)    the fee for any inspection limited to either or both of the premises where it is manufactured or assembled and the procedures for its quality control is £1,480.

4

(1)    The fee payable for an inspection at a site outside the United Kingdom shall be increased by an amount equal to the travelling and subsistence costs of one or more inspectors and any additional costs reasonably incurred by them on account of it being outside the United Kingdom.

(2)    For the purposes of sub-paragraph (1), the fees of an interpreter shall be regarded as an additional cost capable of being reasonably incurred.

Calculation of turnover

1

For the purpose of calculating any annual fee payable in respect of marketing authorisations and product licences—

“turnover” means the gross value at manufacturers' prices of all authorised or licensed products sold or supplied in the United Kingdom during the previous calendar year and in relation to which the person from whom the fee is due holds the marketing authorisation or product licence;

“manufacturers' prices” means the prices charged for authorised or licensed products by manufacturers to wholesalers, except to the extent that—

(a)    the products are supplied by manufacturers direct to retailers, in which case it means the prices charged for the products by the manufacturers to the retailers reduced by such sum as, in the opinion of the relevant authority, represents the difference between the prices paid by the retailers and those which could be expected to be charged by the manufacturers to wholesalers according to the practice prevailing during the period in question with regard to such products;

(b)    a marketing authorisation or product licence holder sells or supplies products which he has neither manufactured nor obtained from the manufacturer, in which case it means the prices paid by him for those products.

2

(1)    The relevant authority may require a marketing authorisation or product licence holder to furnish an auditor's certificate evidencing his turnover.

(2)    If within one month of the date by which such certificate is required, or such longer period as the relevant authority may allow, the marketing authorisation or product licence holder has failed to furnish it, the annual fee payable shall be calculated as provided for in paragraph 4 or may be such lesser sum, based on the relevant authority's estimate of turnover, as the relevant authority shall specify in a notice served on the marketing authorisation or product licence holder.

Calculation of annual fees

3

(1)    The annual fee shall be—

(a)    in the case of emergency vaccines, 0.71% of turnover, rounded up to the nearest £1, except that the minimum sum payable shall be £10; and

(b)    in all other cases either 0.61% of turnover or £205 whichever is the greater, plus for each marketing authorisation or product licence held, where turnover is—

(i)    below £208,000, £26;

(ii)    £208,000 or more, £208.

(2)    Where application of sub-paragraph (1)(b) incorporates an amount charged on a percentage basis the annual fee shall be rounded up to the nearest £10.

4

Where this paragraph applies, the annual fee payable by the marketing authorisation or product licence holder shall be £10,000 together with an additional £2,000 for each product in respect of which a marketing authorisation or product licence is held.

5

Where an annual fee calculated in accordance with paragraph 4 has been paid and the relevant authority is subsequently satisfied as to the turnover for the relevant calendar year, the difference between the amount paid and the annual fee calculated in accordance with paragraph 3 (if less) may be refunded by the relevant authority.

6

Any sums payable to a person by way of refund under paragraph 5 may be treated as having been paid on account of any other fee which that person is liable to pay under these Regulations.

Interpretation

1

In this Schedule—

“formulation”, in relation to a product, does not include the formulation of a homoeopathic stock contained in the product;

“homoeopathic stock” has the same meaning as in article 1.8 of Directive 2001/82/EC

“identical” means in relation to—

(a)    the formulation of a product, identical as regards its qualitative composition, preparation and testing;

(b)    a homoeopathic stock, identical as regards its source, composition, preparation and testing;

“product” includes a series of products which are all dilutions prepared from an identical homoeopathic stock or stocks and each of which has the same pharmaceutical dosage form;

“repeat formulation”, in relation to an application, means—

(a)    the formulation of a product which is identical to the formulation of a registered product—

(i)    which the applicant markets; or

(ii)    to which the applicant has been authorised in writing to make reference to in his application by the person responsible for marketing that product;

(b)    the formulation of a product which is identical to another product in respect of which the applicant has made a simultaneous application;

“repeat stock”, in relation to an application, means a homoeopathic stock which is used in the preparation of a product (either on its own or in combination with another homoeopathic stock or stocks), and which is identical to another homoeopathic stock which is used (whether on its own or in combination with any other homoeopathic stock or stocks) in the preparation of a—

(a)    registered product—

(i)    which the applicant markets; or

(ii)    to which the applicant has been authorised in writing to make reference in his application by the person responsible for marketing that product; or

(b)    product in respect of which the applicant has made a simultaneous application; and

“simultaneous application” means the first of applications submitted at the same time by the same applicant to be considered by relevant authority.

Fees relating to applications for registration

2

The fee for a registration application is that specified in the table below.

Waiver or refund of fees

3

(1)    Where an application for registration is withdrawn before determination by the relevant authority, the following percentage of the fee otherwise payable in connection with that application shall be refunded or, if it has not yet been paid, shall be waived:

(a)    if no assessment (veterinary, scientific or pharmaceutical) has begun, 90%;

(b)    if such assessment has begun but has not been completed, 50%.

(2)    If an application for registration is withdrawn either after veterinary, scientific or pharmaceutical assessment has been completed, or following consideration of that application by the Veterinary Products Committee or by the Medicines Commission, no refund or waiver of the fee payable in connection with that application shall be made.

1

The fee for a reference to the Veterinary Products Committee or to the Medicines Commission in connection with an application for—

(a)    a marketing authorisation or licence is that specified in the table below;

(b)    an animal test certificate is £610; and

(c)    a variation with extras to which regulation 13(c) applies is £960.

2

For the purposes of this Schedule, the terms—

“complex”;

“major”;

“simple”; and

“standard”,

have the meanings given to them in Part 1 of Schedule 1.

1

Where the manufacture, assembly, sale or supply of 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 relevant authority may determine that any fees payable under these Regulations—

(a)    in connection with an application for the grant, variation or renewal of a marketing authorisation or product licence relating to such products; or

(b)    in respect of any inspection made during the currency of such a marketing authorisation or product licence,

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

2

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

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

(b)    the product in respect of which an application for, or for a variation of, a marketing authorisation, product 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.

3

(1)    Where the relevant authority—

(a)    is satisfied that the annual turnover (as calculated in accordance with Schedule 3) relating to a particular product during any calendar year of the first five years of the currency of its actual or prospective marketing authorisation or product licence, has not exceeded, or is unlikely to exceed, £40,000; and

(b)    is of the opinion that the interests of human or animal health require a marketing authorisation or product licence for the products in question to be granted, varied or renewed (as the case may be),

a fee payable under these Regulations for a marketing authorisation or product licence application or for a variation or first application for a renewal thereof or for an inspection in relation to the product during the currency of that authorisation or licence, made during that five year period application may be reduced or, if the fee has already been paid, 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 authorisation or product licence) as established or as estimated by the relevant authority and the sum of £40,000.

(2)    Before a marketing authorisation or product licence holder or applicant pays any reduced fee or receives any refund pursuant to sub-paragraph (1) he shall furnish evidence to the satisfaction of the relevant authority of the actual or estimated amount of annual turnover of the product for each calendar year of the first five years of the currency of the authorisation or product licence.

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

(4)    Where a provisional payment on account was made and evidence furnished to the relevant authority's satisfaction pursuant to sub-paragraph (2) shows that the maximum turnover in any of those years—

(a)    exceeded £40,000, the holder shall be liable to pay the balance of the full fee otherwise payable under these Regulations within 30 days from and including the date of written notice sent by the relevant authority in accordance with regulation 14(3);

(b)    was less than the estimated maximum turnover, the relevant authority may refund the balance between the amount so paid and that payable calculated in accordance with sub-paragraph (1).

4

(1)    Where an application for a marketing authorisation or product licence or manufacturer's or wholesale dealer's licence is withdrawn before determination by the relevant authority, the relevant authority shall refund, or where no payment has been made, waive the following percentage of the fee otherwise payable in connection with that application:

(a)    if no assessment (veterinary, scientific or pharmaceutical) has begun, 90%;

(b)    if such assessment has begun but not been completed, 50%, except where paragraph (c) applies;

(c)    if such assessment has begun but not been completed and a request for further information in connection with the application has been made by the relevant authority under section 44(1) of the Act, or under Article 23 of Directive 2001/82/EC as applied by regulation 5 of the 1994 Regulations, 25%.

(2)    In the case where an application has been withdrawn under sub-paragraph (1)(b), and a 50% refund of the fee has been made, any re-application in respect of the same product by the same applicant shall be charged at 50% of the fee otherwise payable under these Regulations.

(3)    If an application for a marketing authorisation or product licence is withdrawn either after scientific or veterinary pharmaceutical assessment has been completed or following consideration of that application by the Veterinary Products Committee or by the Medicines Commission, no refund or waiver of the fee payable shall be made under this paragraph.

These Regulations revoke and re-enact with modifications the Medicines (Products for Animal Use—Fees) Regulations 1998 ('the 1998 Regulations') (SI 1998/2428), together with the instruments which amend them. As in the case of the 1998 Regulations, they prescribe fees in connection with applications and inspections relating to—

(a)    marketing authorisations under the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (SI 1994/3142);

(b)    licences and certificates under the Medicines Act 1968 insofar as they apply to medicinal products for animal use; and

(c)    the registration of homoeopathic veterinary medicinal products under the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997 (SI 1997/322).

References to EC legislation have, where appropriate, been updated.

The only change to the fee structure in these Regulations is that in relation to annual fees for marketing authorisations and product licences, the differentiation between veterinary medicinal products with a turnover of under or over £2.8m is abolished. In addition there is an overall increase in fees of 8.7%,

The Regulations also provide for:

(a)    the method and time for payment of fees (regulations 14 and 15);

(b)    the suspension of licences and certificates where fees remain unpaid (regulation 16); and

(c)    the waiver, reduction or refund of fees (regulation 17).

Regulation 19 (transitional provisions) provides that the Regulations (save for the exception in paragraph (2) of that regulation) only apply to applications made after the Regulations come into force.

A Regulatory Impact Assessment has been prepared and a copy has been placed in the library of each House of Parliament. Copies may be obtained from the Veterinary Medicines Directorate, Woodham Lane, Addlestone, Surrey, KT15 3LS.