- Latest available (Revised)
- Point in Time (01/10/2009)
- Original (As made)
Version Superseded: 01/10/2011
Point in time view as at 01/10/2009.
There are currently no known outstanding effects for the The Veterinary Medicines Regulations 2009 (revoked), PART 6.
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.
46. The fee for testing a sample required to be submitted by the Secretary of State is the full economic cost of the test.
47.—(1) The fee for an animal test certificate is £345 in the case of—
(a)an immunological veterinary medicinal product that has been authorised in another member State for the species on which the proposed test will be conducted;
(b)a pharmaceutical veterinary medicinal product that has been authorised in another member State for use with a food-producing species on which the proposed test will be conducted where the same or similar dosage regime and method of administration is to be used in the medicinal test as is authorised; or
(c)a pharmaceutical veterinary medicinal product authorised in another member State for human or animal use where the test is to be conducted on companion animals only.
(2) The fee for an animal test certificate to administer medicinal products in a small scale trial to test them for clinical safety or efficacy is £30.
(3) In any other case the fee is £815.
(4) The fee for an application for a variation of the certificate is £265 for each change.
(5) The fee for an application to renew a certificate is £130.
(6) The Secretary of State may waive the fee if satisfied that the application is in relation to developing a veterinary medicinal product for a limited market (for example, for a minor species, a minor use, or for a disease with restricted regional distribution).
48.—(1) The fee for a certificate to import (if necessary) and be in possession of and administer a veterinary medicinal product under the cascade is—
(a)£15 if the veterinary medicinal product is authorised in another member State;
(b)£30 if the veterinary medicinal product is authorised in a third country.
(2) The fee is payable in respect of each animal treated, but in the case of administration to and treatment of a discrete group of animals, the Secretary of State may notify the applicant in writing that a fee for only one animal is payable.
(3) There is no fee if the application is made using the website of the Veterinary Medicines Directorate.
49.—(1) The fee for a certificate to import a product or substance for administration under a licence granted under the Animals (Scientific Procedure) Act 1986 is £15.
(2) There is no fee if the application is made using the website of the Veterinary Medicines Directorate.
50.—(1) The fee payable by the holder of a wholesale dealer’s authorisation for a certificate to import and store a veterinary medicinal product not authorised in the United Kingdom to enable it to be supplied for administration under Schedule 4 is £750.
(2) The fee is only payable if, in the twelve month period immediately before the application, the applicant has supplied the veterinary medicinal product to which the certificate relates in accordance with at least 100 certificates.
51. The fee for an authorisation to release a veterinary medicinal product under specific batch control is—
(a)£560; or
(b)£455 for each batch if a number of specific batch control applications are made at the same time and all the batches are affected by the same issue.
52. The fee for the submission of the results of tests carried out on a batch of immunological products prior to release is £80.
53. The fee for an application for an export certificate is £30, and £15 for each certified copy.
54. If the Secretary of State refuses to grant a marketing authorisation or an animal test certificate, or grants one that is different from what was applied for, the fee for an appeal to the Veterinary Products Committee is in accordance with the following table.
Type of application | Fee(£) |
---|---|
Application involving a new active substance | 1,940 |
Standard application | 515 |
Application for a pharmacologically equivalent product | 515 |
Application using identical data | 205 |
Application for an animal test certificate | 675 |
55. If the holder of a marketing authorisation applies for a variation and the Secretary of State refuses it, the fee for an appeal to the Veterinary Products Committee is in accordance with the following table.
Type of application | Fee(£) |
---|---|
Type 1A variation | 205 |
Type 1B variation | 205 |
Type II variation | 270 |
56. The fee for an appeal to the Veterinary Products Committee following the suspension of a marketing authorisation or animal test certificate is £675.
57. The fee for an appeal to the Veterinary Products Committee against the refusal or suspension of an approval of an active substance under Schedule 6 is £675.
58. The appellant is liable for the full economic cost of a referral to an appointed person subject to a maximum of £5,000.
59.—(1) The fee for the inspection of a veterinary surgeon’s practice premises is £250.
(2) The annual fee for the registration of veterinary practice premises with the Royal College of Veterinary Surgeons to supply veterinary medicinal products is £40.
(3) Notwithstanding paragraph 2 of this Schedule, this is payable to the Royal College of Veterinary Surgeons.
60. The Secretary of State must refund the fee payable in relation to an appeal to the Veterinary Products Committee or to an appointed person if, as a result of the appeal, the Secretary of State changes the decision that was the subject of the appeal.
61. If an improvement notice is served under these Regulations, the fee for any subsequent inspection necessary as a result of the notice is the full economic cost of the inspection, payable by the person on whom the notice was served.
62. Where fees (other than fees relating to a manufacturing authorisation or wholesale dealer’s authorisation) are not paid, the Secretary of State may, after giving one month’s written warning, suspend the authorisation to which the fee relates.
63.—(1) If the Secretary of State is satisfied that for reasons of human or animal health or the protection of the environment it is desirable that a product should be authorised for veterinary use or that an authorised product should remain on the market the Secretary of State may waive or reduce any fees payable under these Regulations.
(2) An applicant or the holder of a marketing authorisation must provide full written justification for any waiver or reduction.
64.—(1) Where an application for a marketing authorisation, a Type II variation or a variation referred to in paragraph 16(2) is withdrawn before determination, the fee is reduced in accordance with this paragraph.
(2) If no assessment (veterinary, scientific or pharmaceutical) has begun, the reduction is 90% .
(3) If assessment has begun but the Secretary of State has not yet requested further data, the reduction is 50% .
(4) If the Secretary of State has requested further information but it has not yet been provided, the reduction is 25% .
(5) If the further information requested has been supplied but has not yet been fully assessed or the application has not been referred to the Veterinary Products Committee, the reduction is 10% .
(6) Once the further information has been fully assessed, or the application has been referred to the Veterinary Products Committee, there is no reduction.
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?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
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?
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?
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.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
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.
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.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
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.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: