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 appealappeal 

You can appeal against a decision, or the intention toto make make a decision, by the  VMD acting acting on behalf of the Secretary of State, on any matter covered by the Veterinary Medicines Regulations (VMR))  if2013 you: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

• are an applicant for:

  • a variation of a marketing authorisation
  • an animal test certificate
  • 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

• 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 registrationnon-food inanimal relationblood bank
  • an authorisation for a person and premises to activemanufacture substancesan unauthorised veterinary medicine for administration under the cascade
  • an authorisation of an equine stem cell centre
  • a wholesale dealer’s authorisation
  • the authorisation 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 appealappeal  

Appeals to the  VPC   

You can appeal to thethe  VPC against against the  VMD’s decision on the following applications:applications:  

• marketingnew marketing authorisation authorisation (MA)
• registered veterinary homeopathic remedy (VHR)
• variations requiring an assessmentassessment (standard) or or compulsory variations of an MA
• animal test certificate (ATC)
• approvals for active substancessubstances (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.  

VPC Appeals process map

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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 writingexceptional  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 inconcern person.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.   

If,New followingdata, 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’s advice,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 upholdsand itsdistributed originalto decision,the youVPC for consideration.   

If the VPC does not receive your documentation by the  appropriate date,  it will beconsider givenyour aappeal  furtheron opportunitythe 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 personrequest appointedto byappeal.   

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.   

Appeal

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

person.   

YouAn canappointed appealperson is an independent person appointed to review and consider appeals against specific regulatory decisions made by the VMD’s.   

You decisionhave 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: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 non-food animal blood bank
• authorisation for a person and premises to manufacture an unauthorised veterinary medicine (also known as a Special) 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)

YouIf willyou 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.

Appointed Person Appeals process map

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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 doappeal thiswill whenbe provided in a letter from the VMD notifying you receiveof the outcome of your application. Appeals must be submitted in writing.

The VMD’s 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 letter.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

Notices  

An inspector appointed under thethe  VMR  or the Animal Health Act 1981 may serve an Improvement Notice on you for failure to comply with the the  VMR..  

The notice will set out the inspector’s view on how you are failing failing to comply, the measures you need to take to comply and how quickly you should take them.them.  

If you feel you have been unjustly served with an Improvement Notice you can appeal to a magistrates’ court (England, NorthernNorthern  Ireland and and Wales) or the sheriff (Scotland).(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.sooner.  

The court will decide whether to uphold, adjust or overturn the Improvement Notice.Notice.  

Seizure Notices

Notices  

An inspector appointed under thethe  VMR  or the Animal Health Act 1981 may seize items, including equipment and documentation.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.loss.  

You mustmust submit the submit the claim within 28 days of the seizure and set out the grounds in full.full.  

FeesFees   

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,if,  as a result of the the appeal, the VMD changes the decision you appealed against.against.   

TheDetails on the relevant fees arecan setbe outfound inin Schedule 7 of Feesthe applied to veterinary medicine authorisation applications in GB)Veterinary Medicines Regulations 2013..