xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"
7. The following table sets out the fees relating to a pharmaceutical veterinary medicinal product for—
(a)[F2an 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;
F3(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(c)F4...
Application | Full F5...application under Part 1 of Schedule 1 (£) | Bibliographic F6...application (£) | F7... | |||
---|---|---|---|---|---|---|
[F8Pharmacologically equivalent application] | F7... | |||||
Base Fee: | 13,530 | 12,115 | 7,195 | F7 | F7 | |
Additional fee if any of the target species is a food-producing animal: | 3,905 | 3,585 | 2,155 | F7 | F7 | |
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom— | ||||||
food-producing animal: | 7,465 | 6,595 | 5,885 | F7 | F7 | |
non-food-producing animal: | 6,525 | 5,855 | 5,590 | F7 | F7 | |
Additional fee for each additional pack type: | 740 | 740 | 605 | F7 | F7 | |
Additional fee for each additional active ingredient (food-producing animal): | 6,465 | 6,125 | 4,040 | F7 | F7 | |
Additional fee for each additional active ingredient (non-food-producing animal): | 4,310 | 4,105 | 3,235 | F7 | F7 | |
Additional fee if there is more than one target species, for each additional species (food-producing animal): | 3,970 | 3,565 | 2,425 | F7 | F7 | |
Additional fee if there is more than one target species, for each additional species (non- food-producing animal): | 2,495 | 2,090 | 1,550 | F7 | F7 | |
Additional fee for each additional recommended route of administration (food-producing animal): | 2,695 | 2,490 | 1,620 | F7 | F7 | |
Additional fee for each additional recommended route of administration (non- food-producing animal): | 1,215 | 1,010 | 740 | F7 | F7 | |
Simultaneous applications: fee for each additional product in the application: | 2,895 | 2,895 | 2,895 | F7 | F7 | |
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Sch. 7 para. 7 heading substituted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Sch. 7 para. 7(a) substituted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F3Sch. 7 para. 7(b) omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
F4Sch. 7 para. 7(c) omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
F5Word in Sch. 7 para. 7 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(b)(iv)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F6Word in Sch. 7 para. 7 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(b)(iv)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F7Words in Sch. 7 para. 7 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(b)(iv)(dd); 2020 c. 1, Sch. 5 para. 1(1)
F8Words in Sch. 7 para. 7 Table substituted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(b)(iv)(cc); 2020 c. 1, Sch. 5 para. 1(1)
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.
Application | 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: | 13,530 | 12,115 | 7,195 | 9,220 | 6,515 | |
Additional fee if any of the target species is a food-producing animal: | 3,905 | 3,585 | 2,155 | 2,760 | 1,415 | |
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom— | ||||||
food-producing animal: | 7,465 | 6,595 | 5,885 | 7,495 | 2,630 | |
non-food-producing animal: | 6,525 | 5,855 | 5,590 | 7,155 | 2,295 | |
Additional fee for each additional pack type: | 740 | 740 | 605 | 775 | 330 | |
Additional fee for each additional active ingredient (food-producing animal): | 6,465 | 6,125 | 4,040 | 5,165 | 2,085 | |
Additional fee for each additional active ingredient (non-food-producing animal): | 4,310 | 4,105 | 3,235 | 4,135 | 1,475 | |
Additional fee if there is more than one target species, for each additional species (food-producing animal): | 3,970 | 3,565 | 2,425 | 3,100 | 1,280 Applies for a maximum of 2 additional species | |
Additional fee if there is more than one target species, for each additional species (non- food-producing animal): | 2,495 | 2,090 | 1,550 | 1,980 | 805 Applies for a maximum of 2 additional species | |
Additional fee for each additional recommended route of administration (food-producing animal): | 2,695 | 2,490 | 1,620 | 2,070 | 940 | |
Additional fee for each additional recommended route of administration (non- food-producing animal): | 1,215 | 1,010 | 740 | 945 | 405 | |
Simultaneous applications: fee for each additional product in the application: | 2,895 | 2,895 | 2,895 | 3,705 | 1,685 | |
Extent Information
E15This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
F98. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F9Sch. 7 para. 8 omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(c); 2020 c. 1, Sch. 5 para. 1(1)
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: | 5,230 | 3,705 | |
Non-food-producing animal: one member State: | 3,985 | 3,220 | |
Each additional member State: | 530 | 530 | |
Simultaneous application: fee for each additional product in the application: | |||
one member State: | 6,670 | 6,670 | |
each additional member State: | 120 | 120 |
Extent Information
E16This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
9.—(1) The fee for [F10an application] for a marketing authorisation relating to an immunological or biosimilar product,F11... is in accordance with the following table.
(2) In this paragraph a biosimilar application means an application made in accordance with Article 13(4) of Directive 2001/82/EC and a biosimilar product means a product which is the subject of such an application.
Application | F12... application for a marketing authorisation(£) | F13... | |
---|---|---|---|
1. Immunological or biosimilar product other than in paragraph 2 below: Base fee: | 11,775 | F13... | |
The following fees are in addition to the base fee— | F13... | ||
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: | 7,405 | F13... | |
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: | 1,345 | F13... | |
More than one antigenic component – fee for each additional component: | 1,350 | F13... | |
More than one species – fee for each additional species: | 5,380 | F13... | |
More than one route of administration – fee for each additional route of administration: | 5,380 | F13... | |
Simultaneous application - fee for each additional product in the application: | 2,895 | F13... | |
2. Immunological or 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: | 10,430 | F13... |
Extent Information
E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F10Words in Sch. 7 para. 9(1) substituted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(d)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F11Words in Sch. 7 para. 9(1) omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(d)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F12Word in Sch. 7 para. 9 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(d)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F13Words in Sch. 7 para. 9 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(d)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
9.—(1) The fee for a national application for a marketing authorisation relating to an immunological or biosimilar 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.
(2) In this paragraph a biosimilar application means an application made in accordance with Article 13(4) of Directive 2001/82/EC and a biosimilar product means a product which is the subject of such an application.
Application | 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 or biosimilar product other than in paragraph 2 below: Base fee: | 11,775 | 5,785 | |
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: | 7,405 | 2,490 | |
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: | 1,345 | 675 | |
More than one antigenic component – fee for each additional component: | 1,350 | 405 | |
More than one species – fee for each additional species: | 5,380 | 1,615 Applies for a maximum of 2 additional species | |
More than one route of administration – fee for each additional route of administration: | 5,380 | 1,615 | |
Simultaneous application - fee for each additional product in the application: | 2,895 | 1,685 | |
2. Immunological or 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: | 10,430 | 5,380 |
Extent Information
E17This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
F1410. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F14Sch. 7 para. 10 omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(e); 2020 c. 1, Sch. 5 para. 1(1)
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: | 3,470 | |
Each additional member State: | 530 | |
Simultaneous applications: fee for each additional product in the application: | ||
one member State: | 6,670 | |
each additional member State: | 120 |
Extent Information
E18This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
11. The [F16fee ] for applications for marketing authorisations using identical data submitted simultaneously or on the basis of information provided under Article 13(c) of Directive 2001/82/EC [F17is £945 per application.]
Extent Information
E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F15Sch. 7 para. 11 heading substituted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(f)(i); 2020 c. 1, Sch. 5 para. 1(1)
F16Word in Sch. 7 para. 11 substituted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(f)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F17Words in Sch. 7 para. 11 substituted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(f)(iii); 2020 c. 1, Sch. 5 para. 1(1)
11. The fees for applications for marketing authorisations using identical data submitted simultaneously or on the basis of information provided under Article 13(c) of Directive 2001/82/EC are in accordance with the following table.
Application | Fee (£)per authorisation | |
---|---|---|
Decentralised application where the United Kingdom is the reference member State— | ||
one member State: | 4,165 | |
each additional member State: | 530 | |
Any other application: | 945 |
Extent Information
E19This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
12. The fee for an application for an exceptional marketing authorisation for a pharmaceutical product is in accordance with the following table.
Application | Provisional (£) | Limited (£) | |
---|---|---|---|
Base Fee: | 12,015 | 6,765 | |
The following fees are in addition to the base fee— | |||
Additional fee if any of the target species is a food-producing animal: | 3,905 | 1,952 | |
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom— | |||
food-producing animal: | 5,850 | 3,732 | |
non-food-producing animal: | 4,910 | 3,262 | |
Additional fee for each additional pack type: | 710 | 370 | |
Additional fee for each additional active ingredient (food-producing animal): | 5,955 | 3,232 | |
Additional fee for each additional active ingredient (non-food-producing animal): | 3,800 | 2,155 | |
Additional fee if there is more than one target species, for each additional species (food-producing animal): | 2,965 | 1,985 | |
Additional fee if there is more than one target species, for each additional species (non-food-producing animal): | 1,485 | 1,247 | |
Additional fee for each additional recommended route of administration (food-producing animal): | 2,185 | 1,347 | |
Additional fee for each additional recommended route of administration (non-food-producing animal): | 710 | 608 | |
Simultaneous applications— fee for each additional product in the application: | 2,895 | 1,447 |
13. The fee for an application for an exceptional marketing authorisation for an immunological product is in accordance with the following table.
Application | Provisional (£) | Limited (£) |
---|---|---|
Base fee: | 10,810 | 5,887 |
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: | 5,650 | 3,702 |
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: | 1,350 | 672 |
More than one antigenic component – fee for each additional component: | 1,190 | 675 |
More than one species – fee for each additional species: | 4,060 | 2,690 |
More than one route of administration – fee for each additional route of administration: | 4,060 | 2,690 |
Simultaneous application - fee for each additional product in the application: | 2,895 | 1,447 |
14. The fee for the conversion of an exceptional marketing authorisation to a full marketing authorisation is £3,000.
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 is identical to a product which is authorised for sale in the United Kingdom | 2,130 |
Application where the imported product is therapeutically similar to a product which is authorised for sale in the United Kingdom (can only be applied to imported products for non-food producing species) | 4,710] |
Extent Information
E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F18Sch. 7 para. 15 Table substituted (E.W.S) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), Sch. 8 Pt. 2 ( as amended by S.I. 2020/1461, regs. 1(2)(a), 2(4)); 2020 c. 1, Sch. 5 para. 1(1)
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 or more member States: | 1,755 | |
Application to add an additional member State after the marketing authorisation has been granted – fee for each member State: | 455 | |
Application where the imported product has not been authorised in accordance with the mutual recognition procedure or the decentralised procedure but where the imported product originates from the same manufacturing site as the product authorised in the United Kingdom to which the imported product is considered to be essentially similar: | 2,130 | |
Any other application – fee for each member State from which the product is imported: | 4,710 |
Extent Information
E20This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
F1916. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E7This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F19Sch. 7 para. 16 omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(h); 2020 c. 1, Sch. 5 para. 1(1)
16. The fee to change the distribution category of a product authorised through the centralised procedure is £3,135.
Extent Information
E21This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
17.—(1) 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.
(2) The fees for the variations to which this paragraph applies are set out in the following table.
(3) 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.
(4) 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.
Type of variation | F21... | F22... | F22... | ||||||
---|---|---|---|---|---|---|---|---|---|
Single variations; one change for each product | |||||||||
Extension: | |||||||||
Change of strength or potency or the addition of a new strength or potency: | 6,670 | F22... | F22... | ||||||
Change of pharmaceutical form or the addition of a new pharmaceutical form: | 8,415 | F22... | F22... | ||||||
Change of route of administration, or the addition of a new one, of— | |||||||||
(i) an immunological product, or a pharmaceutical product for a [F23non-food-producing] animal: | 5,390 | F22... | F22... | ||||||
(ii) a pharmaceutical product for a food-producing animal: | 7,135 | F22... | F22... | ||||||
Change or addition of a food producing target species: | 9,620 | F22... | F22... | ||||||
Change of active substance, including: | 8,415 | F22... | F22... | ||||||
use of a different salt, ester, complex or derivative of the same therapeutic moiety: | |||||||||
use of a different biologically active substance with a slightly different molecular structure: | |||||||||
modification of the vector used to produce the antigen or the source material, including a new master cell bank from a different source: | |||||||||
use of a new ligand or coupling mechanism for a radiopharmaceutical: | |||||||||
change of the extraction solvent or change of the ratio of herbal drug to herbal drug preparation: | |||||||||
Change of bioavailability: | 8,415 | F22... | F22... | ||||||
Change of pharmacokinetics: | 8,415 | ...F22... | F22... | ||||||
Simultaneous application: fee for each additional product in the application: | 2,895 | F22... | F22... | ||||||
Type II: | 2,895 | F22... | F22... | ||||||
Type IB: | 885 | F22... | F22... | ||||||
Type IA: | 455 | F22... | F22... | ||||||
Grouped variations | |||||||||
Extension-led: | |||||||||
The fee for an application for an extension-led grouped variation is the fee for that extension as specified above plus — | |||||||||
(a) if there is one variation in addition to the extension, the fee for that variation as specified above; or | |||||||||
(b) if there is more than one variation in addition to the extension, the fee that would be payable for a grouped variation of that type as specified below. | |||||||||
Type II led: | |||||||||
For the first nine changes: | 6,280 | F22... | F22... | ||||||
For each subsequent group of up to ten changes: | 4,500 | F22... | F22... | ||||||
Type IB led: | |||||||||
For the first nine changes: | 1,770 | F22... | F22... | ||||||
For each subsequent group of up to ten changes: | 4,500 | F22... | F22... | ||||||
Type IA led: | |||||||||
For the first nine changes: | 885 | F22... | F22... | ||||||
For each subsequent group of up to ten changes: | 4,500 | F22... | F22... |
Extent Information
E8This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F20Words in Sch. 7 para. 17 heading omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(i); 2020 c. 1, Sch. 5 para. 1(1)
F21Words in Sch. 7 para. 17 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(i)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F22Words in Sch. 7 para. 17 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(i)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F23Words in Sch. 7 para. 17 substituted (14.4.2014) by The Veterinary Medicines (Amendment) Regulations 2014 (S.I. 2014/599), regs. 1, 4(2)
17.—(1) 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.
(2) The fees for the variations to which this paragraph applies are set out in the following table.
(3) 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.
(4) 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.
Type of variation | National | UK is the reference member State | UK is a concerned member State | ||||||
---|---|---|---|---|---|---|---|---|---|
Single variations; one change for each product | |||||||||
Extension: | |||||||||
Change of strength or potency or the addition of a new strength or potency: | 6,670 | - | 1,998 | ||||||
Change of pharmaceutical form or the addition of a new pharmaceutical form: | 8,415 | - | 2,301 | ||||||
Change of route of administration, or the addition of a new one, of— | - | ||||||||
(i) an immunological product, or a pharmaceutical product for a [F34non-food-producing] animal: | 5,390 | - | 1,737 | ||||||
(ii) a pharmaceutical product for a food-producing animal: | 7,135 | - | 2,058 | ||||||
Change or addition of a food producing target species: | 9,620 | - | 2,547 | ||||||
Change of active substance, including: | 8,415 | - | 2,301 | ||||||
use of a different salt, ester, complex or derivative of the same therapeutic moiety: | |||||||||
use of a different biologically active substance with a slightly different molecular structure: | |||||||||
modification of the vector used to produce the antigen or the source material, including a new master cell bank from a different source: | |||||||||
use of a new ligand or coupling mechanism for a radiopharmaceutical: | |||||||||
change of the extraction solvent or change of the ratio of herbal drug to herbal drug preparation: | |||||||||
Change of bioavailability: | 8,415 | - | 2,301 | ||||||
Change of pharmacokinetics: | 8,415 | - | 2,301 | ||||||
Simultaneous application: fee for each additional product in the application: | 2,895 | - | 1,011 | ||||||
Type II: | 2,895 | 6,030 | 1,872 | ||||||
Type IB: | 885 | 1,325 | 531 | ||||||
Type IA: | 455 | 685 | 273 | ||||||
Grouped variations | |||||||||
Extension-led: | |||||||||
The fee for an application for an extension-led grouped variation is the fee for that extension as specified above plus — | |||||||||
(a) if there is one variation in addition to the extension, the fee for that variation as specified above; or | |||||||||
(b) if there is more than one variation in addition to the extension, the fee that would be payable for a grouped variation of that type as specified below. | |||||||||
Type II led: | |||||||||
For the first nine changes: | 6,280 | 12,060 | 3,768 | ||||||
For each subsequent group of up to ten changes: | 4,500 | 4,500 | 2,700 | ||||||
Type IB led: | |||||||||
For the first nine changes: | 1,770 | 2,650 | 1,062 | ||||||
For each subsequent group of up to ten changes: | 4,500 | 4,500 | 2,700 | ||||||
Type IA led: | |||||||||
For the first nine changes: | 885 | 1,325 | 531 | ||||||
For each subsequent group of up to ten changes: | 4,500 | 4,500 | 2,700 |
Extent Information
E22This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F34Words in Sch. 7 para. 17 substituted (14.4.2014) by The Veterinary Medicines (Amendment) Regulations 2014 (S.I. 2014/599), regs. 1, 4(2)
18.—(1) 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) No 1234/.
[F24(2) The fees for a worksharing application are specified in the following table.]
F25(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F25(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F25(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Type of application | F26... | F27... | F27... | ||||||
---|---|---|---|---|---|---|---|---|---|
F27... | F27... | F27... | F27... | F27... | F27... | ||||
Worksharing applications The following fees apply for each change to each product: | |||||||||
Type II | |||||||||
For the first nine changes: | 6,240 | F27... | F27... | F27... | F27... | F27... | F27... | ||
For each subsequent group of up to ten changes: | 4,500 | F27... | F27... | F27... | F27... | F27... | F27... | ||
Type IB | ... | ||||||||
For the first nine changes: | 1,770 | F27... | F27... | F27... | F27... | F27... | F27... | ||
For each subsequent group of up to ten changes: | 4,500 | F27... | F27... | F27... | F27... | F27... | F27... |
Textual Amendments
F24Sch. 7 para. 18(2) substituted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(j)(i); 2020 c. 1, Sch. 5 para. 1(1)
F25Sch. 7 para. 18(3)-(5) omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(j)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F26Words in Sch. 7 para. 18 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(j)(iii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F27Words in Sch. 7 para. 18 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(j)(iii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
18.—(1) 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) No 1234/.
(2) 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”.
(3) 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”.
(4) 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”.
(5) The fee for any kind of variation where the Agency co-ordinates worksharing is £455 for each marketing authorisation.
Type of application | UK Only | Where the application involves nationally authorised products in more than one member State | Application involves mutually recognised products | ||||||
---|---|---|---|---|---|---|---|---|---|
UK Only | UK Reference Authority | UK Co-Reference Authority | Other | UK Reference Authority | UK Co-Reference Authority | UK Concerned member State | |||
Worksharing applications The following fees apply for each change to each product: | |||||||||
Type II | |||||||||
For the first nine changes: | 6,240 | 12,060 | 7,485 | 12,060 | 13,265 | 6,745 | 3,372 | ||
For each subsequent group of up to ten changes: | 4,500 | 4,500 | 4,500 | 4,500 | 4,500 | 4,500 | 2,700 | ||
Type IB | |||||||||
For the first nine changes: | 1,770 | 2,650 | 2,120 | 2,650 | 2,915 | 1,905 | 954 | ||
For each subsequent group of up to ten changes: | 4,500 | 4,500 | 4,500 | 4,500 | 4,500 | 4,500 | 2,700 |
Extent Information
E23This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
F2819. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E9This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F28Sch. 7 para. 19 omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(k); 2020 c. 1, Sch. 5 para. 1(1)
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 17, with the addition of the supplementary fees in the following table (save that, where the application is for the addition of more than one species, only one supplementary fee applies).
Application | Supplementary fee (£) | |
---|---|---|
Pharmaceutical product for a food-producing animal – one member State: | 3,705 | |
Pharmaceutical product for a non-food-producing animal – one member State: | 3,220 | |
Immunological product – one member State: | 3,460 | |
Each additional member State: | 530 | |
Simultaneous application: fee for each additional product in the application: | ||
one member State: | 6,670 | |
each additional member State: | 120 |
Extent Information
E24This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
F2920. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E10This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F29Sch. 7 para. 20 omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(k); 2020 c. 1, Sch. 5 para. 1(1)
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) 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.
(3) 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—
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: | 3,940 | 2,440 | ||
Pharmaceutical product for a non-food-producing animal ‑ one member State: | 2,645 | 1,895 | ||
Immunological product – one member State: | 2,130 | 2,130 | ||
Each additional member State: | 535 | 535 |
(4) Where the information to be provided relates to a product granted a marketing authorisation using identical data submitted simultaneously or on the basis of information provided under Article 13(c) of Directive 2001/82/EC the fees are—
Application | Fee (£) | |
---|---|---|
Provision of information to— | ||
one member State: | 4,165 | |
each additional member State: | 530 | |
(5) In any other case 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: | 12,015 | 10,515 | |
Pharmaceutical product for a non-food-producing animal – one member State: | 8,115 | 7,365 | |
Immunological product – one member State: | 8,940 | 8,940 | |
Each additional member State: | 535 | 535 |
(6) 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.
Extent Information
E25This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
21. If the only purpose of a variation is to remove animal testing or to reduce the numbers of animals used in testing, no fee is payable for the variation F30....
Extent Information
E11This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F30Words in Sch. 7 para. 21 omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(l); 2020 c. 1, Sch. 5 para. 1(1)
21. If the only purpose of a variation is to remove animal testing or to reduce the numbers of animals used in testing, no fee is payable for the variation in the case of a national authorisation, and the United Kingdom element of the fee for the variation is not payable for an authorisation obtained through the mutual recognition procedure or the decentralised procedure.
Extent Information
E26This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
22.—(1) The fee for an application for the renewal of a marketing authorisation is £1,360.
(2) The fee for the first reassessment of an exceptional marketing authorisation is £305, and the fee for each subsequent reassessment is £1,360.
Extent Information
E12This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F31Word in Sch. 7 para. 22 heading omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(m); 2020 c. 1, Sch. 5 para. 1(1)
22.—(1) The fee for an application for the renewal of a marketing authorisation is £1,360.
(2) The fee for the first reassessment of an exceptional marketing authorisation is £305, and the fee for each subsequent reassessment is £1,360.
Extent Information
E27This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
F3223. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E13This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F32Sch. 7 para. 23 omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(n); 2020 c. 1, Sch. 5 para. 1(1)
23. The fee for an application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure is —
(a)£1,835 if the United Kingdom is the reference member State; and
(b)£1,225 if the United Kingdom is a concerned member State.
Extent Information
E28This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
24. The fee for an application for the registration of a homeopathic remedy is in accordance with the following table.
Type of application | Fees(£) | ||
---|---|---|---|
If all stocks and the formulation have already been assessed by the Secretary of State— | |||
not more than five stocks: | 160 | ||
more than five stocks: | 375 | ||
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— | |||
not more than five stocks: | 455 | ||
more than five stocks: | 665 | ||
If the formulation and at least one of the stocks has not already been assessed by the Secretary of State— | |||
not more than five stocks: | 760 | ||
more than five stocks: | 985 | ||
If the product is already authorised for human use in the United Kingdom, or for human or veterinary use in the United Kingdom F33...— | |||
not more than five stocks: | 160 | ||
more than five stocks: | 375 |
Extent Information
E14This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F33Words in Sch. 7 para. 24 Table omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(o); 2020 c. 1, Sch. 5 para. 1(1)
24. The fee for an application for the registration of a homeopathic remedy is in accordance with the following table.
Type of application | Fees(£) | ||
---|---|---|---|
If all stocks and the formulation have already been assessed by the Secretary of State— | |||
not more than five stocks: | 160 | ||
more than five stocks: | 375 | ||
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— | |||
not more than five stocks: | 455 | ||
more than five stocks: | 665 | ||
If the formulation and at least one of the stocks has not already been assessed by the Secretary of State— | |||
not more than five stocks: | 760 | ||
more than five stocks: | 985 | ||
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— | |||
not more than five stocks: | 160 | ||
more than five stocks: | 375 |
Extent Information
E29This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
25. The fee for the renewal of a homeopathic remedy is £320.
26.—(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 turnover for the previous calendar year.
(2) The annual fee, rounded to the next £1, 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.
(3) 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—
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 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—
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 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.
27.—(1) The Secretary of State may at any time require an audit certificate in support of a statement of turnover.
(2) 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.
(3) 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.
(4) Nothing in this paragraph limits the powers of an inspector to examine financial records.