- Latest available (Revised)
- Original (As made)
The Veterinary Medicines Regulations 2013
You are here:
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
More Resources
Status:
There are multiple versions of this provision on screen. These apply to different geographical extents.
Status
The term provision is used to describe a definable element in a piece of legislation that has legislative effect – such as a Part, Chapter or section.
Sometimes the text of a provision is changed, but the change(s) only apply to a particular geographical area. In some limited cases where this happens, the editorial team create a version for each different geographical area. Multiple versions are only created in this way where the change in question is a substitution so that there are different versions of the text for the different extents. Insertions and repeals of text do not give rise to such multiple versions.
Changes to legislation:
There are currently no known outstanding effects for the The Veterinary Medicines Regulations 2013, Paragraph 9.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
Application for a marketing authorisation for an immunological or biosimilar productE+W+S
This section has no associated Explanatory Memorandum
9.—(1) The fee for [F1an application] for a marketing authorisation relating to an immunological or biosimilar product,F2... 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.
Fees for specified immunological and biosimilar applications
| Application | F3... application for a marketing authorisation(£) | F4... | |
|---|---|---|---|
| 1. Immunological or biosimilar product other than in paragraph 2 below: Base fee: | 11,775 | F4... | |
| The following fees are in addition to the base fee— | F4... | ||
| 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 | F4... | |
| 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 | F4... | |
| More than one antigenic component – fee for each additional component: | 1,350 | F4... | |
| More than one species – fee for each additional species: | 5,380 | F4... | |
| More than one route of administration – fee for each additional route of administration: | 5,380 | F4... | |
| Simultaneous application - fee for each additional product in the application: | 2,895 | F4... | |
| 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 | F4... | |
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
F1Words 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)
F2Words 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)
F3Word 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)
F4Words 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)
Application for a marketing authorisation for an immunological or biosimilar productN.I.
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.
Fees for specified immunological and biosimilar applications
| 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
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Options/Help
Print Options
PrintThe Whole Instrument
PrintThe Whole Schedule
PrintThe Whole Part
PrintThis Section only
You have chosen to open The Whole Instrument
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
You have chosen to open The Whole Instrument as a PDF
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
You have chosen to open the Whole Instrument
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
You have chosen to open Schedules only
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
See additional information alongside the content
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Opening Options
Different options to open legislation in order to view more content on screen at once
Explanatory Memorandum
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as enacted version that was used for the print copy
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
Impact Assessments
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
- Why the government is proposing to intervene;
- The main options the government is considering, and which one is preferred;
- How and to what extent new policies may impact on them; and,
- The estimated costs and benefits of proposed measures.
Timeline of Changes
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as made version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.