This paragraph applies in relation to an application for a variation to one or more marketing authorisations except where paragraph 18, 19 or 21 applies.

The fees for the variations to which this paragraph applies are set out in the following table.

Where applications are made at the same time seeking an identical change to the terms of more than one marketing authorisation, and those applications are based on identical data, fees are payable as for a grouped variation.

References in this paragraph to a grouped variation being “led” by a particular type of variation indicate that the principal variation in that group is a variation of that type.

This paragraph applies in relation to an application for a variation to a marketing authorisation dealt with in accordance with worksharing procedures as set out in Article 20 of Commission Regulation (EC) 1234/2008.

The fee for a worksharing application, involving marketing authorisations obtained by a national procedure in the United Kingdom only, is the fee specified in the following table in the column headed; “UK Only”.

The fee for a worksharing application, involving marketing authorisations obtained through a national procedure in the United Kingdom and any other Member State, is specified in the following table by reference to the United Kingdom’s role in the procedure, as “UK Reference Authority”, “UK Co-Reference Authority” or “Other”.

The fee for a worksharing application, involving at least one marketing authorisation obtained through the mutual recognition or decentralised procedure, is specified in the following table by reference to the United Kingdom’s role in the procedure, as “UK Reference Authority”, “UK Co-Reference Authority” or “UK Concerned member State”.

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

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.

Those fees also apply where a marketing authorisation has been granted in more than one Member State, the holder applies for an extension for that marketing authorisation and the United Kingdom acts as reference member State.

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 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.

The annual fee, rounded to the next £1, is —

$$\pounds \genfrac{}{}{0.1ex}{}{0.67T}{100}+\pounds 230n$$

where T is the annual turnover in the previous calendar year and n is the number of active marketing authorisations held at any time during the previous calendar year.

In the case of an authorisation holder with a turnover relating to all marketing authorisations held of less than £230,000, the annual fee, rounded to the next £1 is—

$$\pounds \genfrac{}{}{0.1ex}{}{0.67T}{100}+\pounds 200n$$

where T is the annual turnover in the previous calendar year and n is the number of active marketing authorisations held at any time during the previous calendar year.

The Secretary of State may at any time require an audit certificate in support of a statement of turnover.

If the holder of the marketing authorisation does not provide an audit certificate before the date stipulated in the demand, an additional fee is payable for that year of £11,300 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 a further certificate and specify what further assurances are needed; and if these are not provided by the required date, the additional fee specified in sub-paragraph (2) is payable.

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

The fee for each inspection after a standard authorisation has been granted is (in each case) the same as the fee specified in paragraph (1).

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 £1,635.

The fee to vary an authorisation is £305 if no further inspection is required, and otherwise is the full application fee.

An annual fee of £495 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 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 an equine stem cell centre is £3,270, and £3,435 for each subsequent inspection.

The fee for a variation to an authorisation to operate a blood-bank or equine stem cell centre is £305.

An applicant who has paid a fee of £785 on the grounds of turnover 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 £975 within 30 days.

If the applicant paid £1,760 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 £760.

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, or any variation referred to in paragraph 17 or 18 as a Type II variation, an extension, an extension-led grouped variation or a Type II led grouped variation 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.