Guidance

Apply for a new Animal Test Certificate (including Type-S) or to renew or change an existing certificate

Guidance on the application process for an ATC or ATC-S to carry out veterinary field trials of a medicinal product.

You need to apply for an Animal Test Certificate (ATC or ATC-S) to carry out the veterinary field trial of a medicinal product. This guidance provides information on the application process. It is essential that this guidance is read together with detailed guidance notes on Animal Test Certificates.

How to apply

Prior to submission

You must consider whether you need to apply for an ATC or ATC-S. Please refer to guidance notes on the Types of Animal Test Certificate.

You are also welcome to contact the VMD to discuss your proposed application; please email: postmaster@vmd.defra.gsi.gov.uk

If you wish to arrange a meeting, please email the above address and include ‘Request to arrange a company meeting’ in the subject line.

Contact with the VMD prior to submission is recommended for all applications which concern the use of a biological or immunological product.

You must contact the VMD for advice prior to submission for applications involving veterinary medicines containing or consisting of genetically modified (GM) organisms. A clinical trial in animals involving the deliberate release of genetically modified organisms into the environment requires both an Animal Test Certificate and consent granted by the Secretary of State for the Environment; a Part B experimental release under Directive 2001/18/EC. The GM Team of Defra is the UK Competent Authority implementing that Directive.

Consent for the Part B release is required before a trial may start. This may take up to 90 calendar days with the addition of any clock stops if information is needed from the applicant so you will need to apply well ahead of the ATC application.

Submission

You can submit your application electronically, or in hard-copy. More details can be found on the Submission of an application for an animal medicine licence page.

Application Forms

Supporting Data

The data and documents required in support of an application are listed in their respective application forms. Do not submit any data or information that has not been asked for; doing so will delay the application process.

Evidence of an ethics committee approval should be provided, if available.

If you require an ATC you will need to consider whether you require an ATC Type A or Type B application. The type of ATC application will influence the data requirements. Please refer to guidance notes on the Types of Animal Test Certificate.

Target species safety and efficacy

Data to support the safety of the test product after administration to the target species are required for all all applications with the following exception . Target species safety data may not be required for ATC applications (Type A procedure) and ATC S applications if all of the following criteria are met:

  • The application concerns the trial of a veterinary medicine that has an existing UK, EU or EEA marketing authorisation,

  • The medicine will be administered to a target species named on this existing authorisation. and, The medicine will be administered using the authorised route of administration and the authorised dose (or lower).

For all applications, you need to provide evidence that supports a reasonable expectation of efficacy (i.e. that the test product will produce the desired effect when used in accordance with the trial protocol). For example, reference to laboratory efficacy or challenge studies and/or pilot field studies may be necessary. Applicants may cross refer to relevant studies in the dossier of an authorised veterinary medicine, provided the applicant has a right of access.

Manufacturing information

Trials to be conducted under an ATC obtained via a Type B application procedure must comply with the current revision of the Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01). You must provide appropriate information to confirm that this is the case.

Protocol

For an ATC application (Type A or B procedure) the trial protocol must be submitted with the application form. While the VMD will not approve trial protocols, the protocol will be reviewed to ensure that safety issues are adequately addressed. The applicant must ensure that the results of trials carried out under an ATC will be appropriate for any subsequent applications for a marketing authorisation.

For an ATC-S application, the senior investigator and two veterinary surgeons independent of the trial must view the protocol. They must sign a declaration (section 6 of the application form) to confirm that, in their opinion, the study is ethical and is to be conducted in accordance with the RCVS Guide to Professional Conduct and ‘recognized veterinary practice’.

A blank example owner consent form must be submitted as part of an ATC application (Type A or B procedure).

Informed consent is a documented process by which an owner, or owner’s agent, voluntarily confirms the owner’s willingness to allow their animal(s) to participate in a particular study, after having been informed of all aspects of the study that are relevant to the decision to participate. The consent form should be in easily understandable language (i.e. minimising and explaining medical jargon) for the owner and include at least the following:

  • the owner’s consent to the inclusion of their animals into the clinical trial
  • explanation that the owner understands:
    • the nature of the trial and the purpose of the treatment
    • that their animals are participating in a clinical trial using a medicine that has not been authorised or is being used ‘off-label’
    • if a negative control or placebo is being included that their animal may not receive treatment as part of the trial
    • they may withdraw their animal from the trial at any time without any prejudice for the future veterinary care of the animal
  • statement from the vet concerned confirming that if the animal is not responding to treatment that they may treat the animal at any time to maintain appropriate level of veterinary care
  • confirmation that the owner has fully understood the consent form

Labelling

Products administered in accordance with an Animal Test Certificate are subject to the normal labelling requirements. There are also additional labelling requirements depending on the type of product.

The requirements for product literature are set out in the Product Literature Standard.

A package leaflet will be required if there is insufficient space on the label to include all required text.

For already authorised veterinary medicines, you should use the approved labelling, but a small over label should indicate any amended directions or warnings, the ATC number, and the words, ‘Veterinary clinical trial use only’ to ensure accountability in line with GCP requirements.

As a general rule, the VMD will expect labels to contain the following minimum information in English:

  • the words “For veterinary clinical trial use only”
  • name or other designation of the product
  • quantity of product
  • any restrictions on use
  • expiry date and, if appropriate, in-use expiry date
  • directions for use specific to the trial including dosage, frequency, duration, method and route of administration
  • contra-indications, warnings and precautions, and special instructions for handling and storing the product
  • instructions for disposal (in most cases, these should state that any unused product and containers should be returned to the trial sponsor)
  • if to be used in species used to produce food (including horses, rabbits and pigeons) either the specified withdrawal period or the words “Not to be used in animals for human consumption”
  • name and address of ATC holder and ATC number
  • the manufacturer’s batch number
  • a unique code/number identifying the individual container, where appropriate (e.g. where the identity of the products used in the trial are blinded)

For an ATC application (Type A or B procedure), you should provide a draft label and package leaflet text with the application form.

For an ATC-S application you must submit a statement of user and target species safety warnings that will appear on the label/leaflet (section 3 of the ATC S application form). It is your responsibility to ensure that the labelling/leaflets conform to requirements. Additional guidance on the warnings can be found in annex 1 of the application form.

A suggested pro-forma for labelling can be found on the Apply to run a clinical trial using an animal medicine page.

Validation

All applications are checked (validated) upon receipt.

It is up to you to identify and submit all the necessary information in support of your application. If the application is incomplete, it is likely to fail validation.

Assessment phase

Once the application has passed validation it will proceed into the assessment phase.

On approval of the application you will be sent a certificate verifying that the trial has been approved and this may be subject to a number of conditions that will be specified on the certificate.

Timescales

The timescales for dealing with an application are as follows:

  • new ATC applications (Type A procedure) and ATC-S applications: within 30 calendar days of receipt
  • new ATC applications (Type B procedure) within 50 clock days of receipt
  • variations and renewals within 30 calendar days of receipt

ATC (Type-A procedure), ATC-S, variation and renewal applications

Validation Validated within 5 days of receipt.
Initial assessment Approved, refused or questions asked within 15 days of receipt.
Company response If questions asked, you should provide a full company response within 10 days.The timescales will not be suspended during this time.
Sign-off Approved or refused by Day 30.
Issue Following approval, authorisation documentation will be issued within 5 days.

ATC (Type B procedure) applications

Validation Validated within 5 days of receipt.
Initial assessment Approved, refused or questions asked within 35 days of receipt.
Company response If questions asked, you should provide a full company response by the deadline set. The timescales are suspended during this time.
Sign-off Approved or refused by Day 50. The timescales may be suspended during this time if further information is required from you.
Issue Following approval, authorisation documentation will be issued within 5 days.

Renewal

Certificates are valid for two years. If the trial is not finished within this period you may apply to renew your certificate. If an certificate is not renewed by the renewal date it will cease to be valid.

There is no formal application form for a renewal.

You should submit a letter via email requesting the renewal of your certificate. The letter should include a justification of why it needs to be renewed, any variations made to the ATC, the certificate, the ATC/ATC-S number, particulars of the progress of the trial, and a summary account of any adverse events noted.

Email your letter to: s.response@vmd.defra.gsi.gov.uk.

Variation

If you wish to make any changes to your certificate, you will need to submit a variation application to the VMD. The respective application forms are available on the Apply to change an animal test certificate page.

Only certain changes may be made by way of a variation (permitted changes are listed in the application form). All other changes will require submission of a new application; Where a new application is necessary to vary an ATC issued following a Type B procedure, the timescales used for a new ATC (Type A procedure) will apply as long as the product formula, species and purpose of the trial remain the same.

It is recognised that some tests cannot be set up until an outbreak of a particular disease occurs. In these cases, the certificate may be issued for a maximum number of sites and animals, on the condition that you notify us of the test sites for the exact number of animals included at each site, as soon as they are known. There will be no charge for this.

Fees

Once an application has passed validation, you will be sent an invoice for the fee.

For further information regarding fees, see the Fees charged for an application for animal test certificate page.

The fee for a new ATC-S, or to vary or renew an existing ATC-S, is £30.

Contact us

Email: postmaster@vmd.defra.gsi.gov.uk

Published 31 March 2016
Last updated 26 March 2018 + show all updates
  1. Guidance reviewed and updated
  2. First published.