— This paragraph applies in relation to an application for a variation to a marketing authorisation obtained under a national procedure.

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.

If the variation is one specified as Type 1A in Commission Regulation (EC) No 1084/200338, the fee is £455.

If the variation is specified as Type 1B in those Regulations, the fee is £885 except in accordance with the following table.

The fee for a variation classified as Type II in Commission Regulation (EC) No 1084/2003 is £2,310 except in the following cases, where the fee is as specified.

This paragraph applies until 1st January 2010.

It applies in relation to an application for a variation to a marketing authorisation obtained through mutual recognition or decentralised procedures.

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

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).

The fee is in accordance with the following table.

This paragraph applies from 1st January 2010.

It applies in relation to an application for a variation to a marketing authorisation obtained through mutual recognition or decentralised procedures.

In this paragraph the types of variation are those specified in Commission Regulation (EC) 1234/2008 (concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products40).

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) except where the variations are grouped in accordance with Article 7 of Commission Regulation (EC) No 1234/2008 (“grouped variations”).

In this paragraph “worksharing” means the procedure set out in Article 20 of Commission Regulation (EC) No 1234/2008.

The fee for any kind of variation where the Agency co-ordinates worksharing is £455 for each marketing authorisation.

In any other case the fee is in accordance with the following table.

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.

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 to provide the information to an additional member State within six months of the date the last information was provided, the fees are—

In any other case the fees are—

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 £115 for each additional product for each additional member State.

The fee for an application for the renewal of a marketing authorisation originally granted on or after 30th October 2005 is £1,360.

The fee for the first reassessment of an exceptional marketing authorisation is £305, and the fee for each subsequent reassessment is £1,360.

Within 30 days of receiving a written demand from the Secretary of State, a holder of a marketing authorisation must provide the Secretary of State with a statement of turnover for the previous calendar year; and, if specified in the demand, an audit certificate relating to the turnover.

When providing the statement of turnover the holder must pay an annual fee, rounded up to the next £10, of—

£0.67T100+£230n

In the case of an authorisation holder with a turnover relating to all marketing authorisations held of less than £230,000, the amount, rounded up to the next £10, is—

£0.67T100+£200n

In this paragraph—

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

• “manufacturers’ prices” means the prices charged (excluding value added tax) for authorised products by manufacturers to wholesalers, except to the extent that—

  1. 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 Secretary of State, 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;

  2. b

     a marketing authorisation holder sells or supplies products that the marketing authorisation holder has neither manufactured nor obtained from the manufacturer, in which case it means the prices paid by the marketing authorisation holder for those products.

If the Secretary of State required an audit certificate when the demand for the statement of turnover was sent out, and the holder of the marketing authorisation has not provided it within 30 days, an additional fee is payable for that year of £11,200 plus an additional £2,245 in respect of each marketing authorisation held.

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, the Secretary of State may require the marketing authorisation holder to produce within 30 days a further certificate and specify what further assurances are needed; and if these are not provided within those 30 days the additional fee specified in sub-paragraph (1) is payable.

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

Where a marketing authorisation holder has not provided the Secretary of State with a statement of annual turnover so that the annual fee cannot be determined before the due date, the holder 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.

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 £3,240 for each manufacturing site, with the same fee for each subsequent inspection.

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 £1,620.

The fee to vary an authorisation is £300 if no further inspection is required, and otherwise is the full application fee.

An annual fee of £490 is payable in respect of each manufacturing authorisation held (other than as specified in this paragraph).

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.

There is no annual fee for a manufacturing authorisation for a veterinary medicinal product manufactured in accordance with Schedule 6 for small pet animals.

In this paragraph “turnover” means the sales value at manufacturers’ prices net of value added tax of all authorised veterinary medicinal products sold or supplied in the United Kingdom.

The fee for an authorisation to operate a blood bank is £2,800, with the same fee for each subsequent inspection.

The fee for an authorisation to operate an equine stem cell centre is £3,240, with the same fee for each subsequent inspection.

The fee for a variation to an authorisation to operate a blood-bank or equine stem cell centre is £300.

An applicant who has paid a fee of £775 must send a declaration of turnover for the first year of trading on the anniversary of the grant of the authorisation, and if the figure is more than £35,000 must pay the balance of £980 within 30 days.

If the applicant paid £1,745 but the turnover for the first year of trading was lower than £35,000, if the applicant sends a declaration certifying the turnover, the Secretary of State must refund the excess.

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

In this paragraph “turnover” means the sales value net of value added tax 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.

In this paragraph “turnover” means the sales value net of value added tax 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.

Fees relating to feedingstuffs are payable with the application, or on invoice for the subsequent annual fee.

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

Fees are in accordance with the following table.

The fee for an animal test certificate to administer medicinal products in a small scale trial to test them for clinical safety or efficacy is £30.

In any other case the fee is £815.

The fee for an application for a variation of the certificate is £265 for each change.

The fee for an application to renew a certificate is £130.

The Secretary of State may waive the fee if satisfied that the application is in relation to developing a veterinary medicinal product for a limited market (for example, for a minor species, a minor use, or for a disease with restricted regional distribution).

The fee is payable in respect of each animal treated, but 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.

There is no fee if the application is made using the website of the Veterinary Medicines Directorate.

The fee for a certificate to import a product or substance for administration under a licence granted under the Animals (Scientific Procedure) Act 1986 is £15.

There is no fee if the application is made using the website of the Veterinary Medicines Directorate.

The fee payable by the holder of a wholesale dealer’s authorisation for a certificate to import and store a veterinary medicinal product not authorised in the United Kingdom to enable it to be supplied for administration under Schedule 4 is £750.

The fee is only payable if, in the twelve month period immediately before the application, the applicant has supplied the veterinary medicinal product to which the certificate relates in accordance with at least 100 certificates.

The fee for the inspection of a veterinary surgeon’s practice premises is £250.

The annual fee for the registration of veterinary practice premises with the Royal College of Veterinary Surgeons to supply veterinary medicinal products is £40.

Notwithstanding paragraph 2 of this Schedule, this is payable to the Royal College of Veterinary Surgeons.

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 the Secretary of State may waive or reduce any fees payable under these Regulations.

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

Where an application for a marketing authorisation, a Type II variation or a variation referred to in paragraph 16(2) is withdrawn before determination, the fee is reduced in accordance with this paragraph.

If no assessment (veterinary, scientific or pharmaceutical) has begun, the reduction is 90% .

If assessment has begun but the Secretary of State has not yet requested further data, the reduction is 50% .

If the Secretary of State has requested further information but it has not yet been provided, the reduction is 25% .

If the further information requested has been supplied but has not yet been fully assessed or the application has not been referred to the Veterinary Products Committee, the reduction is 10% .

Once the further information has been fully assessed, or the application has been referred to the Veterinary Products Committee, there is no reduction.