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7. 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.
Menu | Full national application under Part 1 of Schedule 1 (£) | Bibliographic national application (£) | Pharmacologically equivalent national application | Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£) | |
---|---|---|---|---|---|
Reference product authorised in UK (£) | Reference product not authorised in UK (£) | ||||
Base Fee: | 930 | 1,860 | 1,860 | 2,380 | 460 |
The following fees are in addition to the base fee: | |||||
Quality assessment (if quality data are assessed): | 3,900 | 3,320 | 2,790 | 3,560 | 1,860 |
Safety assessment (if safety data are assessed): | 3,900 | 3,120 | 1,060 | 1,360 | 1,860 |
Efficacy assessment (if efficacy data are assessed): | 3,900 | 3,120 | 1,060 | 1,360 | 1,860 |
Ecotoxicology assessment: (if ecotoxicology data are assessed): | 660 | 530 | 330 | 420 | 400 |
Additional fee if any of the target species is a food-producing animal (not payable if neither safety data nor ecotoxicology data are assessed): | 3,850 | 3,520 | 2,120 | 2,710 | 1,390 |
Reduced by— | |||||
| 2,160 | 2,160 | 1,320 | 1,690 | 660 |
| 1,020 | 780 | 300 | 380 | 300 |
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom— | |||||
| 7,350 | 6,500 | 5,770 | 7,370 | 2,590 |
| 6,430 | 5,770 | 5,510 | 7,030 | 2,260 |
Additional fee for each additional pack type: | 730 | 730 | 600 | 760 | 330 |
Reduced by— | |||||
| 360 | 360 | 360 | 460 | 120 |
| 180 | 180 | 120 | 150 | 60 |
| 60 | 60 | 60 | 80 | 60 |
| 60 | 60 | - | - | 60 |
Additional fee for each additional active ingredient (food-producing animal): | 6,360 | 6,030 | 3,980 | 5,090 | 2,060 |
Reduced by— | |||||
| 1,440 | 1,440 | 1,440 | 1,840 | 480 |
| 2,690 | 2,690 | 1,620 | 2,070 | 840 |
| 900 | 720 | 540 | 690 | 300 |
| 720 | 600 | - | - | 240 |
Additional fee for each additional active ingredient (non-food-producing animal): | 4,250 | 4,050 | 3,180 | 4,070 | 1,460 |
Reduced by— | |||||
| 1,440 | 1,440 | 1,440 | 1,840 | 480 |
| 1,440 | 1,440 | 900 | 1,150 | 480 |
| 900 | 720 | 540 | 690 | 300 |
| 60 | 60 | - | - | 60 |
Additional fee if there is more than one target species, for each additional species (food-producing animal): | 3,910 | 3,520 | 2,390 | 3,050 | 1,260 |
Reduced by— | |||||
| 180 | 180 | 180 | 230 | 60 |
| 1,440 | 1,440 | 900 | 1,150 | 480 |
| 1,800 | 1,440 | 1,080 | 1,380 | 540 |
| 120 | 120 | - | - | 60 |
Additional fee if there is more than one target species, for each additional species (non- food-producing animal): | 2,460 | 2,060 | 1,530 | 1,950 | 800 |
Reduced by— | |||||
| 180 | 180 | 180 | 230 | 60 |
| 180 | 180 | 120 | 150 | 60 |
| 1,800 | 1,440 | 1,080 | 1,380 | 540 |
| 60 | 60 | - | - | 60 |
Additional fee for each additional recommended route of administration (food-producing animal): | 2,650 | 2,460 | 1,590 | 2,040 | 930 |
Reduced by— | |||||
| 1,440 | 1,440 | 900 | 1,150 | 480 |
| 900 | 720 | 540 | 690 | 300 |
| 60 | 60 | - | - | 60 |
Additional fee for each additional recommended route of administration (non- food-producing animal): | 1,190 | 1,000 | 730 | 930 | 400 |
Reduced by— | |||||
| 180 | 180 | 120 | 150 | 60 |
| 900 | 720 | 540 | 690 | 300 |
Simultaneous applications: fee for each additional product in the application: | 2,850 | 2,850 | 2,850 | 3,640 | 1,660 |
8. 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 7, with the addition of the fees in the following table.
Application | Additional fee for a pharmacologically equivalent product (£) | Additional fee otherwise (£) |
---|---|---|
Food-producing animal: one member State: | 5,150 | 3,650 |
Non-food-producing animal: one member State: | 3,920 | 3,170 |
Each additional member State: | 520 | 520 |
Simultaneous application: fee for each additional product in the application: | ||
| 6,570 | 6,570 |
| 120 | 120 |
9. 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.
Menu | National application for a marketing authorisation(£) | Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£) |
---|---|---|
1. Immunological product other than in paragraph 2: Base fee: | 11,600 | 5,700 |
The following fees are in addition to the base fee. | ||
| 7,290 | 2,450 |
| 1,330 | 660 |
| 1,330 | 400 |
| 5,300 | 1,590 |
| 5,300 | 1,590 |
| 2,850 | 1,660 |
2. Immunological product that is identical to a product already authorised in the United Kingdom but with a lesser number of antigens and that only contains antigens contained in that product | 10,270 | 5,300 |
10. 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 set out in the previous table, with the addition of the fees in the following table—
Application | Additional fee (£) |
---|---|
One member State | 3,420 |
Each additional member State | 520 |
Simultaneous applications: fee for each additional product in the application | |
| 6,570 |
| 120 |
11. The fee for an application for a marketing authorisation using identical data is in accordance with the following table.
Application | Fee (£) |
---|---|
Any application other than decentralised where the United Kingdom is the reference member State: | 930 |
Decentralised application where the United Kingdom is the reference member State— | |
| 4,105 |
| 520 |
12. The fee for an application for a provisional marketing authorisation for a pharmaceutical product is in accordance with the following table.
Menu | Fee (£) |
---|---|
Base Fee: | 930 |
The following fees are in addition to the base fee: | |
Quality assessment (if quality data are assessed): | 3,900 |
Safety assessment (if safety data are assessed): | 3,900 |
Efficacy assessment (if efficacy data are assessed): | 2,420 |
Ecotoxicology assessment (if ecotoxicology data are assessed): | 660 |
Additional fee if any of the target species is a food-producing animal (not payable if neither safety data nor ecotoxicology data are assessed): | 3,850 |
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom— | |
| 5,770 |
| 4,840 |
Additional fee for each additional pack type: | 700 |
Additional fee for each additional active ingredient (food-producing animal): | 5,860 |
Additional fee for each additional active ingredient (non-food-producing animal): | 3,750 |
Additional fee if there is more than one target species, for each additional species (food-producing animal): | 2,920 |
Additional fee if there is more than one target species, for each additional species (non- food-producing animal): | 1,460 |
Additional fee for each additional recommended route of administration (food-producing animal): | 2,160 |
Additional fee for each additional recommended route of administration (non- food-producing animal): | 700 |
Simultaneous applications— fee for each additional product in the application: | 2,850 |
13. The fee for an application for a provisional marketing authorisation for an immunological product is in accordance with the following table.
Menu | Fee (£) |
---|---|
Base fee: | 10,650 |
The following fees are in addition to the base fee. | |
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom, and for each new combination of active ingredients: | 5,560 |
Additional fee for each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the United Kingdom and for each new combination of adjuvants or preservatives: | 1,330 |
More than one antigenic component – fee for each additional component: | 1,170 |
More than one species – fee for each additional species: | 3,990 |
More than one route of administration – fee for each additional route of administration: | 3,990 |
Simultaneous application - fee for each additional product in the application | 2,850 |
14. The fee for the conversion of a provisional marketing authorisation to a full marketing authorisation is the same as the fee for an application for a full marketing authorisation except that, if the application for conversion is made within two years of the grant of the provisional marketing authorisation—
(a)if the application for the provisional marketing authorisation was made before 1st October 2006 the fee is £10,995; and
(b)if the application for the provisional marketing authorisation was made on or after 1st October 2006 the fee is £5,780.
15. The fee for a marketing authorisation for a parallel import is in accordance with the following table.
Application | Fee (£) |
---|---|
Application where the imported product has been authorised in accordance with the mutual recognition procedure or decentralised procedure, and the United Kingdom is included in these procedures— | |
| 1,730 |
| 350 |
Application to add an additional member State after the marketing authorisation has been granted—fee for each member State | 450 |
Any other application—fee for each member State from which the product is imported: | 2,100 |
16.—(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 £4,550; 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 £450 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 £870 except in accordance with the following table.
Variation | Conditions | Fee (£) | |
---|---|---|---|
Identical changes to a number of products | All the products are from the same marketing authorisation holder Supporting data are identical All applications are submitted at the same time | First product | 870 |
Each subsequent product | 450 |
(5) The fee for a variation classified as Type II in Article 3 of Commission Regulation (EC) No. 1084/2003 is £2,275 except in the following cases, where the fee is as specified.
Change | Conditions | Fee (£) | |
---|---|---|---|
a) Identical changes to a number of products | All the products are from the same marketing authorisation holder Supporting data are identical All applications are submitted at the same time | First product Each subsequent product | 2,275 450 |
b) Change of distributor | No other aspect of the dossier is changed and the marketing authorisation holder remains the same | 870 | |
c) Change of legal entity of marketing authorisation holder | No other aspect of the dossier is changed | 870 | |
d) Simple dosage instruction changes intended to remove ambiguity | The change is not as a result of safety concerns No new studies are required to support the change The dosage regime remains the same | 870 | |
e) Addition or change to safety warnings | No other aspects of the dossier are changed No safety warnings are removed No new studies are required to support the change and the proposed warnings serve to increase the protection of the user/ environment /target species as appropriate | 870 | |
f) Corrections or simple text layout changes to summary of product characteristics and/or product literature. Included in this is the introduction of multilingual labelling | The changes are not a result of safety concerns No new studies are required to support the change and no other aspect of the dossier is changed The legibility of the current English labelling is not compromised The indications and warnings are the same in all languages | 870 | |
g) Abbreviated resubmission of a previously refused Type II variation | At the time of refusal of a Type II variation, the Secretary of State has given written permission for resubmission under this category The application has been resubmitted within 3 months of the date the refusal advice was issued | 870 | |
h) Submission made following the formal advice of the Secretary of State | The Secretary of State has already assessed the relevant data and formed an opinion on these The change is not required as a result of the holder failing to keep the Part II (quality) data in accord with current practice or in line with current guidelines issued by the Committee for Medicinal Products for Veterinary Use(1) | 870 | |
i) Approval of a mock-up for an authorised pack size | The pack size is already authorised No new studies are required to support the change and no other aspect of the dossier is changed | 870 | |
j) Changes to the summary of product characteristics and product literature of a marketing authorisation for parallel import as a direct consequence of the approval of a variation to the summary of product characteristics and product literature for the United Kingdom authorised product | The only changes to the summary of product characteristics and product literature are those required to bring the marketing authorisation for parallel import back in direct line with those of the United Kingdom authorised product | 870 | |
k) Changes to details of the marketing authorisation holder’s pharmacovigilance system | No other changes to the dossier | 870 |
17.—(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.
Type of variation | UK is the reference member State (£) | UK is a concerned member State (£) |
---|---|---|
Type II variation: | 5,125 | 3,075 |
If a marketing authorisation holder applies for a Type II variation for a number of marketing authorisations, and— | ||
| ||
| ||
| ||
the fee payable is— | ||
| 5,125 | 3,075 |
| 675 | 450 |
If a marketing authorisation holder— | ||
| ||
| ||
| ||
| ||
the fee payable is: | 1,305 | 870 |
Changes to details of the marketing authorisation holder’s pharmacovigilance system (no other changes to the dossier) | 1,305 | 870 |
Type 1A variation: | 675 | 450 |
Type 1B variation: | 1,305 | 870 |
If a marketing authorisation holder applies for a Type 1B variation for a number of marketing authorisations, and— | ||
| ||
| ||
| ||
the fee payable is— | ||
| 1,305 | 870 |
| 675 | 450 |
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 | 2,850 |
| 7,030 | 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. 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 |
Simultaneous application: fee for each additional product in the application: | |
| 6,570 |
| 115 |
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 for a pharmacologically equivalent product (£)(a) | Fee (other products) (£) |
---|---|---|
(a) This fee is payable if the application for the marketing authorisation was on the basis that the product was pharmacologically equivalent to another veterinary medicinal product. | ||
Pharmaceutical product for a food-producing animal – one member State: | 3,905 | 2,405 |
Pharmaceutical product for a non-food-producing animal – one member State: | 2,615 | 1,865 |
Immunological product – one member State: | 2,100 | 2,100 |
Each additional member State: | 525 | 525 |
(3) In any other case the fees are—
Type of application | Fee for a pharmacologically equivalent product (£)(a) | Fee (other products) (£) |
---|---|---|
(a) See footnote for previous table. | ||
Pharmaceutical product for a food-producing animal – one member State: | 11,860 | 10,360 |
Pharmaceutical product for a non-food-producing animal – one member State: | 8,005 | 7,255 |
Immunological product – one member State: | 8,810 | 8,810 |
Each additional member State: | 525 | 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— | |
| 160 |
| 370 |
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— | |
| 450 |
| 655 |
If the formulation and at least one of the stocks has not already been assessed by the Secretary of State— | |
| 750 |
| 970 |
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— | |
| 160 |
| 370 |
24.—(1) 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 his turnover for the previous calendar year; and, if specified in the demand, an audit certificate relating to the turnover.
(2) When providing the statement of his turnover the holder must pay an annual fee, rounded up to the next £10, of—
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—
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—
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;
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 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 £11,035 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, 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.
(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, 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 Committee was established by Article 30 of Regulation (EC) No. 762/2004 of the European Parliament `and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ No. L136, 30.4.2004, p. 1.
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