The Veterinary Medicines Regulations 2006

Regulation 16

SCHEDULE 7FEES

PART 1Introduction

Interpretation of Schedule 7

1.  In this Schedule—

“national application” means an application for a marketing authorisation that does not involve another member State;

“pharmaceutical product” means any veterinary medicinal product other than an immunological product;

“simultaneous application” is an application in which, at the time an authorisation for a product is applied for, one or more additional applications are submitted for products that are identical to the first product except that—

Payment of fees

2.  All fees under this Schedule are payable to the Secretary of State.

Time of payment

3.  All fees are payable on invoice unless otherwise specified.

Multiple inspections

4.  If a site is inspected for more than one type of authorisation at the same time, only one fee (the highest) is payable.

Translation

5.  All translation costs are charged additionally.

PART 2Fees relating to marketing authorisations

Fees for specified pharmaceutical applications

6.  The following table sets out the fees relating to a pharmaceutical veterinary medicinal product for—

(a)a national application for a marketing authorisation that is—

(i)a full application under Part 1 of Schedule 1;

(ii)a bibliographic application; or

(iii)an application based on pharmacological equivalence;

(b)an application for a marketing authorisation using the decentralised procedure where the United Kingdom is a concerned member State;

(c)an application for the mutual recognition of a product authorised in another member State.

Decentralised pharmaceutical application where the United Kingdom is the reference member State

7.—(1) The fee for a decentralised application for a pharmaceutical product where the United Kingdom is the reference member State is the same as for a national application as set out in the table in paragraph 6, with the addition of the fees in the following table.

(2) In the case of a simultaneous application, the fee for each additional product in the application is £6,400 for one concerned member State and £110 for each additional concerned member State.

Application for a marketing authorisation for an immunological product

8.—(1) The fee for a national application for a marketing authorisation relating to an immunological product, a decentralised application where the United Kingdom is the concerned member State or the mutual recognition of a product authorised in another member State is in accordance with the following table.

(2) The fee for an application for a marketing authorisation for an immunological product that is identical to a product already authorised in the United Kingdom but with a lesser number of antigens and which only contains antigens contained in the product already authorised is £10,020 (United Kingdom only) or £5,170 (decentralised application where the United Kingdom is a concerned member State).

Decentralised immunological application where the United Kingdom is the reference member State

9.—(1) The fee for a decentralised application for a marketing authorisation for an immunological product where the United Kingdom is the reference member State is the same as for a national application as set out in the table in paragraph 8(1), with the additions of £3,330 for one concerned member State and £510 for each additional concerned member State.

(2) In the case of a simultaneous application the fee for each additional product in the application is £6,400 for one concerned member State and £110 for each additional concerned member State.

Application for a marketing authorisation using identical data

10.  The fee for an application for a marketing authorisation using identical data is in accordance with the following table.

Application for a provisional marketing authorisation

11.  The fee for an application for a provisional marketing authorisation is the same as that for a full national marketing authorisation in paragraph 6 (in the case of a pharmaceutical product) or the fee for a national application in paragraph 8 (in the case of an immunological product), and the fee for its conversion into a full marketing authorisation is—

(a)if the application for the full marketing authorisation is received within two years of the grant of the provisional marketing authorisation—

(i)£8,130, or

(ii)if the application for the provisional marketing authorisation was made before 1st October 2006, £10,705; and

(b)in any other case the same fee as for the provisional marketing authorisation.

Application for a marketing authorisation relating to a parallel import

12.  The fee for a marketing authorisation for a parallel import is in accordance with the following table.

Application for a variation

13.—(1) An applicant must make a separate application for a variation for each change in the marketing authorisation (unless a change is a direct consequence of the first change) and the appropriate fee is payable for each application.

(2) As an exception from sub-paragraph (1), if an applicant applies for more than one variation to the quality data in a marketing authorisation on the same application form, he may elect to pay a total fee of £4,440; but this sub-paragraph does not apply—

(a)if one or more of the variations relates to a new source of an active substance and the applicant does not submit a Certificate of Suitability issued by the European Pharmacopeia relating to the new source, or

(b)if a significant formulation change is applied for that requires a new assessment of the safety or efficacy of the veterinary medicinal product.

(3) If the variation is one specified in Annex I to Commission Regulation (EC) No. 1084/2003, the fee is £440 for a variation specified as Type 1A in that Annex.

(4) If the variation is specified as Type 1B in that Annex, the fee is £835 except in accordance with the following table.

(5) The fee for a variation classified as Type II in Article 3 of Commission Regulation (EC) No.1084/2003 is £2,220 except in the following cases, where the fee is as specified.

Application for a variation to a marketing authorisation that has been issued in other member States

14.—(1) In this paragraph the types of variation are those specified in Commission Regulation (EC) 1084/2003.

(2) An applicant must make a separate application for a variation for each change in the marketing authorisation (unless a change is a direct consequence of the first change).

(3) The fee is in accordance with the following table.

Application for an extension to a marketing authorisation

15.  The fee for an application for an extension to a marketing authorisation is in accordance with the following table.

Decentralised application for an extension where the United Kingdom is the reference member State

16.—(1) The fee for a decentralised application for an extension where the United Kingdom is the reference member State is the same as for a national application as set out in the table in paragraph 15, with the additions of the fees in the following table.

(2) In the case of a simultaneous application, the fee for each additional product in the application is £6,400 for one concerned member State and £110 for each additional concerned member State.

Provision of information relating to the recognition of a United Kingdom marketing authorisation

17.—(1) Where an application is made for the Secretary of State to provide information to other member States to enable them to recognise a marketing authorisation already granted by the United Kingdom the following fees are payable.

(2) Where a valid application to provide information to another member State is received within six months of the original grant of the marketing authorisation, or where the Secretary of State has already provided the information to a member State, and a further valid application is made for him to provide the information to an additional member State within six months of the date he last provided the information the fees are—

(3) In any other case the fees are—

(4) In the case of simultaneous applications, the above fees are payable for each additional product in the application for one member State, with a fee of £110 for each additional product for each additional member State.

Application for the renewal of a national marketing authorisation

18.—(1) The fee for the renewal of a national marketing authorisation originally granted on or after 30th October 2005 is £1,305.

(2) In the case of a marketing authorisation originally granted before 30th October 2005—

(a)if it is the first time the marketing authorisation has been renewed, or if the renewal entails assessment of post authorisation commitments the fee is £1,305, and

(b)otherwise £295.

(3) The fee for the first reassessment of a provisional marketing authorisation is £295, and the fee for each subsequent reassessment is £1,305.

Application for the renewal of a marketing authorisation granted in more than one member State

19.  The fee for the renewal of a marketing authorisation granted in more than one member State is—

(a)£1,765 if the United Kingdom is the reference member State, and

(b)£1,175 where the United Kingdom is a concerned member State.

Registration of a homeopathic remedy

20.  The fee for an application for the registration of a homeopathic remedy is in accordance with the following table.

Annual fees for marketing authorisations

21.—(1) Within 30 days of receiving a written demand from the Secretary of State, a holder of a marketing authorisation shall provide him with a statement of his turnover for the previous calendar year; and, if specified in the demand, an audit certificate relating to the turnover.

(2) When he provides the statement of his turnover he shall pay an annual fee, rounded up to the next £10, of—

(3) In the case of an authorisation holder with a turnover relating to all marketing authorisations held of less than £220,000, the amount, rounded up to the next £10, is—

(4) In this paragraph—

“turnover” means the gross value at manufacturers' prices of all authorised veterinary medicinal products sold or supplied in the United Kingdom;

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

Auditor’s certificate

22.—(1) If the Secretary of State required an audit certificate when he sent out the demand for the statement of turnover, and the holder of the marketing authorisation has not provided it within 30 days, an additional fee is payable for that year of £10,765 plus an additional £2,155 in respect of each marketing authorisation held.

(2) If the Secretary of State is not satisfied that the audit certificate provides sufficient assurance that the figures fairly present the financial records of the company, he shall require the marketing authorisation holder to produce within 30 days a further certificate and specify what further assurances he needs; and if these are not provided within those 30 days the additional fee specified in sub-paragraph (1) is payable.

(3) Nothing in this paragraph limits the powers of an inspector to examine financial records.

Late payment of annual fees

23.—(1) Where a person fails to pay the annual fee for a marketing authorisation within 30 days from and including the date of the demand, he must pay an additional fee, rounded up to the nearest £10, of—

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

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

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

(2) Where a marketing authorisation holder has not provided the Secretary of State with a statement of his annual turnover 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, in which case the additional fee is calculated on the difference between the amount paid on account and the actual amount due.

PART 3Fees payable by manufacturers

Application for a manufacturing authorisation

24.  The fee for an application for a manufacturing authorisation for a veterinary medicinal product is £2,660.

Application for a variation of a manufacturing authorisation

25.  The fee for an application to vary a manufacturing authorisation is £475 where the variation requires scientific or pharmaceutical assessment, and £165 where it does not.

Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade

26.—(1) The fee for an application for a standard authorisation to manufacture an autogenous vaccine or a veterinary medicinal product for administration under the cascade is £3,035 for each manufacturing site, with the same fee for each subsequent inspection.

(2) In the case of an application for an individual authorisation to manufacture a single batch of autogenous vaccine, or a single batch of veterinary medicinal product for administration under the cascade the fee is £1,515.

(3) The fee to vary an authorisation is £285 if no further inspection is required, and otherwise is the full application fee.

Annual fees

27.—(1) An annual fee of £245 is payable in respect of each manufacturing authorisation held (other than a manufacturing authorisation in relation to an autogenous vaccine or a veterinary medicinal product for administration under the cascade).

(2) The annual fee for a manufacturing authorisation for an autogenous vaccine or a veterinary medicinal product for administration under the cascade is 0.67% of the turnover in the previous calendar year rounded up to the next £1, with a minimum fee of £10, and in this paragraph “turnover” has the meaning given in paragraph 21(4).

Site inspections—type of site

28.  For the purposes of deciding the fee for a site inspection—

• “super site” is a site at which 250 or more relevant persons are employed;

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

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

• “minor site” is a site at which fewer than 10 relevant persons are employed;

• “relevant person” means a person employed on the premises and systems inspected.

Inspection of a site where immunological veterinary medicinal products are manufactured

29.  The fees for the inspection of a site where immunological veterinary medicinal products are manufactured are in accordance with the following table.

Inspection of a site where sterile veterinary medicinal products are manufactured

30.  The following fees are payable for the inspection of a site where no immunological veterinary medicinal products are manufactured, but where sterile products are manufactured.

Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured

31.  The following fees are payable for the inspection of a site where only non-immunological and non-sterile veterinary medicinal products are manufactured—

Inspection of a site where veterinary medicinal products are assembled

32.  The following fees are payable for the inspection of a site where the only manufacturing process in relation to veterinary medicinal products is their assembly after the product has been put into its immediate container.

Test sites

33.  The fee for the inspection of a test site is £2,730.

Animal blood bank authorisations

34.—(1) The fee for an authorisation to operate a blood bank is £3,035, with the same fee for each subsequent inspection.

(2) The fee for a variation is £285.

Expenses

35.  In addition the travel and subsistence costs of the inspectors, and any additional costs reasonably incurred by them (including, in the case of an inspection outside the United Kingdom, interpreters' fees) are payable.

PART 4Fees relating to a wholesale dealer’s authorisation

Application for a wholesale dealer’s authorisation

36.—(1) The fee for an application for a wholesale dealer’s authorisation is—

(a)£1,550; or

(b)£635 if the application is accompanied by an estimate that the first year’s turnover will be less than £40,000.

(2) If the applicant paid a fee of £635, he shall send a declaration of his turnover for the first year of trading on the anniversary of the grant of the authorisation, and if the figure is more than £40,000 he shall pay the balance of £915 within 30 days.

(3) If the applicant paid £1,550 but his turnover for the first year of trading was lower than £40,000, if he sends a declaration certifying the turnover, the Secretary of State shall refund the excess.

(4) Nothing in this paragraph limits the powers of an inspector to examine financial records.

(5) For the purposes of this paragraph, “turnover” has the same meaning as in paragraph 38.

Variation of a wholesale dealer’s authorisation

37.  The fee for an application to vary a wholesale dealer’s authorisation is—

(a)£475 if the variation requires scientific or pharmaceutical assessment;

(b)otherwise £165.

Annual fee for a wholesale dealer’s authorisation

38.—(1) The annual fee for a wholesale dealer’s authorisation, payable on the anniversary of the grant of the authorisation, is—

(a)£495, or

(b)£245 if the holder certifies when making the payment that his turnover for that year was less than £40,000.

(2) For the purposes of this paragraph, “turnover” means the gross value of all veterinary medicinal products (whether or not authorised for use in the United Kingdom) sold by way of wholesale dealing by the holder in the United Kingdom during the previous year.

PART 5Fees relating to feedingstuffs

Fees relating to feedingstuffs

39.—(1) Fees relating to feedingstuffs are payable with the application, or on invoice for the subsequent annual fee.

(2) Where more than one activity is carried out at one premises, only one fee (the highest) is payable.

(3) Fees are in accordance with the following table.

Fees relating to distributors

40.  The fee for an application or subsequent annual fee to be a distributor of specified feed additives, premixtures or feedingstuffs containing specified feed additives, or premixtures or feedingstuffs containing veterinary medicinal products is £135 in Great Britain (or £160 if the annual fee is not paid within 60 days of the invoice) and £62 in Northern Ireland (or £74 if the annual fee is not paid within 60 days of the invoice).

PART 6General

Testing samples

41.  The fee for testing a sample required to be submitted by the Secretary of State is the full economic cost of the test.

Animal test certificates

42.—(1) The fee for an animal test certificate is £330 in the case of—

(a)an immunological veterinary medicinal product that has been authorised in another member State for the species on which the proposed test will be conducted;

(b)a pharmaceutical veterinary medicinal product which has been authorised in another member State for use with a food-producing species on which the proposed test will be conducted where the same or similar dosage regime and method of administration is to be used in the medicinal test as is authorised; or

(c)a pharmaceutical veterinary medicinal product authorised in another member State for human or animal use where the test is to be conducted on non-food-producing animals only.

(2) In any other case the fee is £785.

(3) The fee for an application for a variation of the certificate is £255 for each change.

(4) The fee for an application to renew a certificate is £125.

Treatment under the cascade

43.  The fee for a certificate to import (if necessary) and be in possession of and administer a veterinary medicinal product authorised in another member State for treatment under the cascade is £15.

Treatment in exceptional circumstances

44.—(1) The fee for a certificate to import (if necessary), be in possession of and administer a veterinary medicinal product authorised in a third country is £30 for the initial certificate and £30 for its renewal (£15 for a renewal if the certificate is renewed on-line using the website of the Veterinary Medicines Directorate) payable in respect of each animal treated.

(2) In the case of administration to and treatment of a discrete group of animals, the Secretary of State may notify the applicant in writing that a fee for only one animal is payable.

Specific batch control

45.  The fee for an authorisation to release a veterinary medicinal product under specific batch control is £535.

Submission of control tests of an immunological product

46.  The fee for the submission of the results of tests carried out on a batch of immunological products prior to release is £80.

Export certificates

47.  The fee for an application for an export certificate is £30, and £15 for each certified copy.

Fees relating to premises for supply by suitably qualified persons

48.—(1) The fee to approve premises for the retail supply of veterinary medicinal products by suitably qualified persons is—

(a)£245, or

(b)if the premises are only authorised to supply veterinary medicinal products for the treatment of horses and companion animals, £135.

(2) The subsequent annual fee is—

(a)£175, or £205 if the fee is not paid within 60 days of the invoice, or

(b)if the premises are only authorised to supply veterinary medicinal products for the treatment of horses and companion animals, £90, or £110 if the fee is not paid within 60 days of the invoice.

Application to the Veterinary Products Committee

49.—(1) If the Secretary of State refuses to grant a marketing authorisation or an animal test certificate, or grants one that is different from what was applied for, the fee for making representations to the Veterinary Products Committee is in accordance with the following table.

(2) If the holder of a marketing authorisation applies for a variation and the Secretary of State refuses it, the fee for making representations to the Veterinary Products Committee is in accordance with the following table—

Non-payment of fees

50.  Where fees (other than fees relating to a manufacturing authorisation or wholesale dealer’s authorisation) are not paid, the Secretary of State may, after giving one month’s written warning, suspend the authorisation to which the fee relates.

Waiver or reduction of fees

51.—(1) If the Secretary of State is satisfied that for reasons of human or animal health or the protection of the environment it is desirable that a product should be authorised for veterinary use or that an authorised product should remain on the market he may waive or reduce any fees payable under these Regulations.

(2) An applicant or the holder of a marketing authorisation must provide full written justification for any waiver or reduction.

Reduction of application fee

52.—(1) Where an application for a marketing authorisation is withdrawn before determination, or refused on the grounds that data requested by the Secretary of State have not been supplied within the time limit specified in the request, the applicant may request a refund of a proportion of the fee (or, if the fee has not yet been paid, a reduction of the fee) in accordance with this paragraph.

(2) The request for a reduced fee must be made in writing within two months of the withdrawal of the application, or of the date of notification of a refusal.

(3) No reduction is payable if the application is withdrawn after all the data have been fully assessed, or if the application has been referred to the Veterinary Products Committee.