Office of Public Sector Information
SCHEDULE 7 continued PART 2 continued
18. The fee for an application for an extension to a marketing authorisation is in accordance with the following table.
| Extension | Fee if the marketing authorisation is UK only (£) | Fee for a decentralised application where the United Kingdom is a concerned member State or the mutual recognition of an extension authorised in another member State (£) |
|---|---|---|
| Change of strength or potency or the addition of a new strength or potency | 6,570 | 3,250 |
| Change of pharmaceutical form or the addition of a new pharmaceutical form | 8,290 | 3,780 |
Change of route of administration, or the addition of a new one, of
|
5,310 | 7,030 |
| – a pharmaceutical product for a food-producing animal: | 2,850 | 3,380 |
| Change or addition of target species | 9,480 | 4,180 |
| Change of active substance | 8,290 | 3,780 |
| Other | 8,290 | 3,780 |
| Simultaneous application: fee for each additional product in the application | 2,850 | 1,660 |
19.—(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 18, with the additions of the fees in the following table.
| Application | Additional fee (£) |
|---|---|
| Pharmaceutical product for a food-producing animal—one member State: | 3,650 |
| Pharmaceutical product for a non-food-producing animal—one member State: | 3,170 |
| Immunological product—one member State: | 3,410 |
| Each additional member State: | 520 |
(2) In the case of a simultaneous application, the fee for each additional product in the application is £6,570 for one member State and £115 for each additional member State.
20.—(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—
| Type of application | Fee (£) |
|---|---|
| Pharmaceutical product for a food-producing animal—one member State: | 2,405 |
| Pharmaceutical product for a non-food-producing animal—one member State: | 1,865 |
| Immunological product—one member State: | 2,100 |
| Each additional member State: | 525 |
(3) In any other case the fees are—
| Type of application | Fee (£) |
|---|---|
| Pharmaceutical product for a food-producing animal—one member State: | 10,360 |
| Pharmaceutical product for a non-food-producing animal—one member State: | 7,255 |
| Immunological product—one member State: | 8,810 |
| Each additional member State: | 525 |
(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 £115 for each additional product for each additional member State.
21.—(1) The fee for an application for the renewal of a marketing authorisation originally granted on or after 30th October 2005 is £1,340.
(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 the fee is £1,340, and otherwise £300;
(b) if further assessment of post authorisation commitments is required the fee is £650.
(3) The fee for the first reassessment of a provisional marketing authorisation is £300, and the fee for each subsequent reassessment is £1,340.
22. The fee for an application for the renewal of a marketing authorisation granted in more than one member State is—
(a) £1,810 if the United Kingdom is the reference member State, and
(b) £1,205 where the United Kingdom is a concerned member State.
23. The fee for an application for the registration of a homeopathic remedy is in accordance with the following table.
| Type of application | Fee(£) |
|---|---|
If all stocks and the formulation have already been assessed by the Secretary of State—
|
|
If either all the stocks have already been assessed by the Secretary of State but there is a new formulation, or if the formulation has already been assessed by the Secretary of State but one or more of the stocks have not been already assessed—
|
|
If the formulation and at least one of the stocks has not already been assessed by the Secretary of State—
|
|
If the product is already authorised for human use in the United Kingdom, or for human or veterinary use in the United Kingdom or in another member State—
|
|
24.—(1) Within 30 days of receiving a written demand from the Secretary of State, a holder of a marketing authorisation must 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 must pay an annual fee, rounded up to the next £10, of—
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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.
(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—
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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.
(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—
(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;
(b) a marketing authorisation holder sells or supplies products that he has neither manufactured nor obtained from the manufacturer, in which case it means the prices paid by him for those products.
25.—(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 £11,035 plus an additional £2,210 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 may 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.
26.—(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.
The Veterinary Medicines Regulations 2007