Appeal against a regulatory decision made by the VMD
You can appeal against certain decisions made by the Veterinary Medicines Directorate (VMD) that affect you.
Can I appeal
You can appeal against a decision, or the intention to make a decision, by the VMD acting on behalf of the Secretary of State, on any matter covered by the Veterinary Medicines Regulations (VMR) 2013 Great Britain if you:
- receive a notification from the Secretary of State informing you of a right to an appeal to the Veterinary Products Committee (VPC)
- feel aggrieved by a provisional decision of the Secretary of State under the Veterinary Products Committee appeals procedure
- are a body aggrieved by a decision to suspend or revoke its recognition under paragraph 14(1) of Schedule 3 to the VMR
- are served an Improvement Notice or Seizure Notice under the VMR
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are an applicant for:
- a variation of a marketing authorisation
- a manufacturing authorisation
- a variation to a manufacturing authorisation
- an appointment as a Qualified Person for the purpose of a manufacturing authorisation
- an authorisation for a person or premises to manufacture autogenous vaccines
- an authorisation for a non-food animal blood bank
- an authorisation for a person and premises to manufacture an unauthorised veterinary medicine for administration under the cascade
- an authorisation of a stem cell centre
- a registration in relation to active substances
- a wholesale dealer’s authorisation
- the authorisation of premises for the supply of POM-VPS (Prescription Only Medicine – Veterinarian, Pharmacist, SQP) or NFA-VPS (Non-Food Animal – Veterinarian, Pharmacist, SQP) veterinary medicines by a suitably qualified person
In Northern Ireland, you can appeal if you:
- receive a notification from the Secretary of State informing you of a right to an appeal to the Veterinary Products Committee (VPC)
- feel aggrieved by a provisional decision of the Secretary of State under the Veterinary Products Committee appeals procedure
- are served an Improvement Notice or Seizure Notice under the VMR
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are an applicant for:
- a variation of a national marketing authorisation i.e. not submitted as part of Decentralised Procedure (DCP) or Mutual Recognition Procedure (MRP)
- a manufacturing authorisation
- an appointment as a Qualified Person for the purpose of a manufacturing authorisation
- an authorisation for a person or premises to manufacture autogenous vaccines
- an authorisation for a non-food animal blood bank
- an authorisation for a person and premises to manufacture an unauthorised veterinary medicine for administration under the cascade
- an authorisation of an equine stem cell centre
- a wholesale dealer’s authorisation
- the approval of premises for the supply of POM-VPS (Prescription Only Medicine – Veterinarian, Pharmacist, SQP) or NFA-VPS (Non-Food Animal – Veterinarian, Pharmacist, SQP) veterinary medicines by a suitably qualified person
Note: If the MA is submitted under EU procedures e.g. MRP/DCP, appeals will follow Regulation EU 2019/6 and appeals to the VPC are not possible.
Types of appeal
Appeals to the VPC
You can appeal to the VPC against the VMD’s decision on the following applications:
- new marketing authorisation (MA)
- registered veterinary homeopathic remedy (VHR)
- variations requiring an assessment (standard) or compulsory variations of an MA
- approvals for active substances (refer to schedule 6 VMR)
- suspensions of an MA
You have up to 28 days to decide whether to appeal. Your appeal may be written or oral, or both. Details about how to appeal will be provided in a letter from the VMD notifying you of the outcome of your application.
How to appeal to the VPC
On receipt of notification of your intention to appeal the VMD will make the necessary arrangements. The VPC Secretariat will inform you of the date of the VPC meeting at which your appeal will be considered. Other than in exceptional circumstances, it will not be possible to postpone the date of the appeal.
The grounds for appeal must be based on refusal conditions attached to the original application made to VMD; or concern the elements of the approved Summary of Product Characteristics (SPC) that were applied for but ultimately not approved; or on the reasons given for suspension of the MA.
New data, specifically data not available to the VMD when it made its decision, may not be submitted for the appeal.
Your appeal will involve the presentation of data relating to the points of refusal or suspension, or a reasoned case why data that has already been presented and considered should be regarded as sufficient to indicate compliance with the legislative requirements, or both.
You will be asked to provide an electronic version of your appeal data for distribution to the VPC and necessary officials at least 28 days before the date of the meeting at which it is to be considered, so that it can be assessed by the VMD and distributed to the VPC for consideration.
If the VPC does not receive your documentation by the appropriate date, it will consider your appeal on the basis of the information before it and will advise the VMD accordingly.
Types of Appeals to the VPC
There are two types of appeal to the VPC:
- Written appeal
- Oral appeal
The VPC Secretariat will inform you of the procedure for dealing with your appeal once you have made a request to appeal.
Outcome of appeal to the VPC
The VMD will advise you of the outcome of the appeal to the VPC within 4 weeks of the appeal hearing taking place and will provide you with a copy of VPC’s report.
In the case that your appeal is denied and the original decision is upheld, VMD will offer you a further opportunity to make an appeal to an appointed person.
An appointed person is an independent person appointed to review and consider appeals against specific regulatory decisions made by the VMD.
You have 28 days to notify the VPC Secretariat in writing of your intent to appeal to an appointed person.
Appeal direct to an appointed person
In Great Britain you can appeal directly to an appointed person for the following applications:
- manufacturing authorisation
- variation to a manufacturing authorisation
- wholesale dealer’s authorisation
- appointment as a Qualified Person for the purposes of a manufacturing authorisation
- authorisation for a person or premises to manufacture autogenous vaccines
- authorisation of a blood bank
- authorisation for a person and premises to manufacture an unauthorised veterinary medicine for administration under the cascade
- authorisation of a stem cell centre
- registration in relation to active substances
- the authorisation of premises for the supply of POM-VPS or NFA-VPS veterinary medicines by a suitably qualified person (SQP)
If you already hold one of the above authorisations or appointments, you may appeal to an appointed person if it is:
- suspended
- revoked
- compulsory varied
In Northern Ireland you can appeal directly to an appointed person for the following applications:
- manufacturing authorisation
- wholesale dealer’s authorisation
- appointment as a Qualified Person for the purposes of a manufacturing authorisation
- authorisation for a person or premises to manufacture autogenous vaccines
- authorisation of a blood bank
- authorisation for a person and premises to manufacture an unauthorised veterinary medicine for administration under the cascade
- authorisation of an equine stem cell centre
- the approval of premises for the supply of POM-VPS or NFA-VPS veterinary medicines by a suitably qualified person (SQP)
If you already hold one of the above authorisations or appointments, you may appeal to an appointed person if it is:
- suspended
- revoked
- compulsory varied
An SQP body aggrieved by a decision to suspend or revoke its recognition under paragraph 14(1) of Schedule 3 of the Veterinary Medicines regulations 2013 may appeal against the decision in the same way.
How to appeal to an appointed person
If you wish to appeal a decision, you must notify the VMD of your intention to appeal within 28 days of being informed of the decision. Details about how to appeal will be provided in a letter from the VMD notifying you of the outcome of your application. Appeals must be submitted in writing.
The VMD will:
- confirm the name of the appointed person, and
- notify you of the date on which the appeal will be considered
The VMD will propose an appointed person based on their knowledge of the regulatory framework and expertise. They will be independent of UK government, VPC and the VMD. This will be confirmed by ministers.
Your appeal will involve the presentation of data relating to the points raised or of a reasoned case why data already presented and considered should be regarded as sufficient to indicate compliance with the legislative requirements, or both.
New data that was not available at the time of the original decision may not be submitted for the appeal.
The appointed person will consider the appeal and submit a written report to the VMD with a recommended course of action. The VMD will make a final decision, and you will be notified of the outcome, including the reasons for it.
Improvement Notices
An inspector appointed under the VMR or the Animal Health Act 1981 may serve an Improvement Notice on you for failure to comply with the VMR.
The notice will set out the inspector’s view on how you are failing to comply, the measures you need to take to comply and how quickly you should take them.
If you feel you have been unjustly served with an Improvement Notice you can appeal to a magistrates’ court (England, Northern Ireland and Wales) or the sheriff (Scotland).
Your appeal must be lodged within 28 days of the issue of the Improvement Notice or by the end of the time set in the improvement notice, whichever is sooner.
The court will decide whether to uphold, adjust or overturn the Improvement Notice.
Seizure Notices
An inspector appointed under the VMR or the Animal Health Act 1981 may seize items, including equipment and documentation, if the inspector reasonably believes that an offence under the VMR is being or has been committed in relation to, or by means of, that item.
If you feel the item should not have been seized, you may make a claim to the VMD’s Chief Executive against the notice you have been served with for the return of the property or compensation for its loss.
You must submit the claim within 28 days of the seizure and set out the grounds in full.
Fees
In most cases you will have to pay a fee for your appeal to cover the cost of any assessment work related to the appeal. The fee is refundable if, as a result of the appeal, the VMD changes the decision you appealed against.
Details on the relevant fees can be found in Schedule 7 of the Veterinary Medicines Regulations 2013.
Updates to this page
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Process review and update.
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Updated to reflect changes to the VMR .
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First published.