Office of Public Sector Information
SCHEDULE 7 continued PART 1
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—
in the case of an immunological product, they have a lesser number of antigens than the first product, but only contain antigens contained in the first product; and
in the case of a pharmaceutical product, they have different strengths of the active substance,
and, in the case of an application involving more than one member State, the additional applications do not include a member State that was not included in the first application.
2. All fees under this Schedule are payable to the Secretary of State.
3. All fees are payable on invoice unless otherwise specified.
4. If a site is inspected for more than one type of authorisation at the same time, only one fee (the highest) is payable.
5. Whenever premises are inspected, the travel and subsistence costs of the inspectors and, in the case of an inspection outside the United Kingdom, interpreters' fees are payable in addition to the inspection fee specified.
6. All translation costs are charged additionally.
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.
| Pharmacologically Equivalent national application | |||||
|---|---|---|---|---|---|
| Menu | Full national application under Part 1 of Schedule 1 (£) | Bibliographic national application (£) | Reference product authorised in UK (£) | Reference product not authorised in UK (£) | Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£) |
| 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— if no safety data are assessed: | 2,160 | 2,160 | 1,320 | 1,690 | 660 |
| if no ecotoxicology data are assessed: | 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— | |||||
| food-producing animal: | 7,350 | 6,500 | 5,770 | 7,370 | 2,590 |
| non-food-producing animal: | 6,430 | 5,770 | 5,510 | 7,030 | 2,260 |
| Additional fee for each additional pack type: | 730 | 730 | 600 | 760 | 330 |
| Reduced by— if no quality data are assessed: | 360 | 360 | 360 | 460 | 120 |
| if no safety data are assessed: | 180 | 180 | 120 | 150 | 60 |
| if no efficacy data are assessed: | 60 | 60 | 60 | 80 | 60 |
| if no ecotoxicity data are assessed: | 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— if no quality data are assessed: | 1,440 | 1,440 | 1,440 | 1,840 | 480 |
| if no safety data are assessed: | 2,690 | 2,690 | 1,620 | 2,070 | 840 |
| if no efficacy data are assessed: | 900 | 720 | 540 | 690 | 300 |
| if no ecotoxicity data are assessed: | 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— if no quality data are assessed: | 1,440 | 1,440 | 1,440 | 1,840 | 480 |
| if no safety data are assessed: | 1,440 | 1,440 | 900 | 1,150 | 480 |
| if no efficacy data are assessed: | 900 | 720 | 540 | 690 | 300 |
| if no ecotoxicity data are assessed: | 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— if no quality data are assessed: | 180 | 180 | 180 | 230 | 60 |
| if no safety data are assessed: | 1,440 | 1,440 | 900 | 1,150 | 480 |
| if no efficacy data are assessed: | 1,800 | 1,440 | 1,080 | 1,380 | 540 |
| if no ecotoxicity data are assessed: | 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— if no quality data are assessed: | 180 | 180 | 180 | 230 | 60 |
| if no safety data are assessed: | 180 | 180 | 120 | 150 | 60 |
| if no efficacy data are assessed: | 1,800 | 1,440 | 1,080 | 1,380 | 540 |
| if no ecotoxicity data are assessed: | 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— if no safety data are assessed: | 1,440 | 1,440 | 900 | 1,150 | 480 |
| if no efficacy data are assessed: | 900 | 720 | 540 | 690 | 300 |
| if no ecotoxicity data are assessed: | 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— if no safety data are assessed: | 180 | 180 | 120 | 150 | 60 |
| if no efficacy data are assessed: | 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—(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 7, with the addition of the fees in the following table.
| Application | Additional fee (£) |
|---|---|
| Food-producing animal: one member State: | 3,650 |
| Non-food-producing animal: one member State: | 3,170 |
| 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 £120 for each additional member State.
9.—(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.
| 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 (£) |
|---|---|---|
| Base fee: | 11,600 | 5,700 |
| 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: | 7,290 | 2,450 |
| 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 | 660 |
| More than one antigenic component—fee for each additional component: | 1,330 | 400 |
| More than one species—fee for each additional species: | 5,300 | 1,590 |
| More than one route of administration—fee for each additional route of administration: | 5,300 | 1,590 |
| Simultaneous application—feefor each additional product in the application: | 2,850 | 1,660 |
(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 £10,270 (United Kingdom only) or £5,300 (decentralised application where the United Kingdom is the concerned member State).
10.—(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, with the additions of £3,420 for the first member State involved in the application and £520 for each additional member State.
(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 £120 for each additional member State.
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 isthe reference member State— | |
| one member State: | 4,105 |
| each additional member State: | 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— | |
| food-producing animal: | 5,770 |
| non-food-producing animal: | 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— | |
| import from one member State: | 1,730 |
| each additional member State: | 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 Each subsequent product |
870 450 |
(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 2,275 Each subsequent product 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 inline with current guidelines issued by the Committee for Medicinal Products for Veterinary Use(37) |
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— |
||
| – for the first variation: | 5,125 | 3,075 |
| – for each subsequent variation: | 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— |
||
| – for the first variation | 1,305 | 675 |
| – for each subsequent variation | 870 | 450 |
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. Back [37]
The Veterinary Medicines Regulations 2007