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.
The VMD will tell you about the procedures for dealing with your appeal once you have made a request to appeal.
A fee may apply for your appeal.
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) 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
- are served an Improvement Notice or Seizure Notice under the VMR
- are an applicant for:
- a variation or renewal of a marketing authorisation
- an animal test certificate
- 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 blood bank
- an authorisation for a person and premises to manufacture an unauthorised veterinary medicinal product for administration under the cascade
- an authorisation of an equine stem cell centre
- a wholesale dealer’s licence
- 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) medicines by a suitably qualified person
Types of appeal
Appeals to the VPC
You can appeal to the VPC against the VMD’s decision on the following applications:
- marketing authorisation (MA)
- registered veterinary homeopathic remedy (VHR)
- Type II or compulsory variations or renewal of an MA
- animal test certificate (ATC) - Type B
- approvals for active substances and suspensions of an MA made under a national procedure
You have up to 28 days to decide whether to appeal. You can either present your appeal in writing or in person.
If, following the VPC’s advice, the VMD upholds its original decision, you will be given a further opportunity to appeal to a person appointed by the VMD.
For an MA application made under the centralised procedure and the mutual recognition or decentralised procedures, appeals must be made to the Committee on Veterinary Medicinal Products (CVMP) via the European Medicines Agency (EMA) as set out in the Directive 2001/82/EC (as amended by Directive 2004/28/EC).
Appeal to an appointed person
You can appeal against the VMD’s decision under the 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 non-food animal blood bank
- authorisation to manufacture an unauthorised veterinary medicinal product (also known as a Special) 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 medicines by a suitably qualified person
You will be notified how to do this when you receive the VMD’s decision letter.
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.
An inspector appointed under the VMR or the Animal Health Act 1981 may seize products, equipment and documentation. If you feel the product should not have been seized, you may make a claim to the VMD’s Director of Operations 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.
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.
The relevant fees are set out in the Veterinary Medicines Regulations.