You need to apply for an Animal Test Certificate to undertake a veterinary (clinical) field trial using a veterinary medicinal product.
When you need an Animal Test Certificate
You need an Animal Test Certificate (ATC) to carry out a veterinary field trial with a Veterinary Medicinal Product (VMP) under development or a VMP used outside of the terms of its marketing authorisation.
EU Directive 2001/82 defines a veterinary medicinal product as: (a) any substance or combination of substances presented as having properties for treating or preventing disease in animals; or (b) any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
You must submit an application for an ATC to the VMD.
An ATC permits:
- the use of a veterinary medicine outside of the terms of its marketing authorisation (MA) during a veterinary field trial (‘off label’ VMP use) or the administration of an unauthorised VMP, e.g. in a clinical trial for a potential MA application
- the procurement and supply of that VMP
- the import of any VMP specified in the certificate in accordance with the conditions
- produce from treated animals to enter the food chain if appropriate
Before an ATC can be granted a benefit: risk assessment for administration of the medicine will be conducted based on submitted data. Adequate safeguards must be provided to ensure the safety of participating animals, users, consumers and the environment (where applicable). In addition, field trial protocols will be reviewed for compliance with Good Clinical Practice (GCP). All trials must be carried out in compliance with UK animal welfare legislation.
A veterinary field trial will assess the safety and/or efficacy of a VMP under conditions of field use and will usually be conducted in client-owned animals. Assessment of the field safety and/or efficacy of a product may include, for example, taking a blood sample prior to the administration of a veterinary medicine to establish a baseline for parameters. Also, subsequent sampling at key points following administration of the veterinary medicine to monitor these parameters where justified. It is also anticipated that the test product will be compared with a control, so a field trial may include a group of animals designated as positive controls and treated with either an existing medicine or an established procedure, or a group of animals designated as negative controls and treated with a placebo.
An ATC may not be required in the following cases:
- field trials involving food-supplements (‘nutraceuticals’) that are not VMPs or other non-medicinal therapies such as surgical interventions
- field trials carried out by a veterinary surgeon where the veterinary medicine under investigation will be administered in accordance with the Summary of Product Characteristics (SPC) or the product will be administered in accordance with the provisions of “the cascade”. For further information, refer to The Cascade: Prescribing unauthorised medicines.
An ATC is not required for a Home Office licensed study including laboratory studies of a VMP conducted in animals that have been declared as not to enter the food chain where that study is authorised in full under the appropriate Home Office licence. However, should you intend for the produce from animals treated during a Home Office licensed study to enter the food chain an ATC will be required, whether treated with an unauthorised VMP or a VMP used ‘off label’.
Further information on how investigations are regulated under Home Office licences is available from the Home Office Animal (Scientific Procedures) Inspectorate.
Number of trials and products per ATC
Each trial requires a separate ATC as it should normally only investigate one therapeutic indication in a single species. Exceptions to this include trials of ectoparasiticides, endectocides, or multivalent vaccines.
A trial may involve more than one product if:
- the second product is a placebo, or a positive control which is authorised for that species and indication in at least one EU or European Economic Area (EEA) Member State. A human product may be used as a control product where its use is well supported by literature references and there is no suitable authorised veterinary medicine
- the products are of the same pharmaceutical form and contain the same ingredients, but differ in strength or dosage of the active or inactive ingredients
- for vaccines the products differ only in the inclusion or exclusion of particular antigens under investigation
- the products are of two or more dilutions of either the same allergen extract or mixture of allergen extracts used for desensitisation therapy; or the products used for in-vivo diagnosis of an allergy are manufactured by the same method from closely related substances, e.g. pollen
- more than one product is expected to be required to produce therapeutic efficacy such as sedative or analgesic combinations or allergens
Types of ATC
To get an ATC, you can apply using the Type A or B procedure.
To get an ATC-S, you must apply using the Type S procedure.
For further information on which type you may need refer to the following tables.
|Q.1||Is the product authorised as a human or veterinary medicine in the EU or EEA?||Go to Q.2||Type B|
|Q.2||Is the product: an immunological / biological product?||Go to Q.3|
|A pharmaceutical product?||Go to Q.4|
|Q.3||Is the trial to be conducted in the species included in the existing MA?||Type A||Type B|
|Q.4||Is the trial to be conducted in companion animals only?||Type A||Go to Q.5|
|Q.5||Is the trial to be conducted in the authorised food species at the same or lower dose rate and using the same method of administration?||Type A||Type B|
Pharmaceutical products to be tested in:
- companion animals
- horses declared never to enter the food chain
- other animals declared to never enter the food chain
|Is the product:||Yes||No|
|Q.1||A human or veterinary medicine authorised in the EU (incl. UK) or EEA?||Go to Q.3||Type B|
|Q.2||A veterinary or human medicine authorised in the United States, Canada, Japan, New Zealand or Australia||Go to Q. 6||Type B|
|Q.3||A veterinary medicine to be used in the authorised species?||Go to Q.4||Go to Q.5|
|Q.4||To be used at the authorised (or lower) dosage regimen, which is supported by the published literature of the efficacy of the active substance in this species for the proposed indications?||Type S||Go to Q.5|
|Q.5||Is there published literature supporting the target species safety and efficacy of the active substance in this species, for the proposed indications and at the proposed dose regimen?||Type S||Type A|
|Q.6||Authorised for the same species and indications using the same dosage regimen?||Type S||Go to Q.7|
|Q.7||Is there published literature supporting the target species safety and efficacy of the active substance in this species, for the proposed indications and at the proposed dose regimen?||Type S||Type B|
Pharmaceutical products to be tested in food species
|Is the product:||Yes||No|
|Q.1||A human or veterinary medicine authorised in the EU (incl. UK) or EEA?||Go to Q.2||Type B|
|Q.2||A veterinary medicine to be used in the authorised species at the same or lower dose rate, observing the withdrawal period in the SPC?||Go to Q.5||Go to Q.3|
|Q.3||Are the pharmacologically active substances in the product listed in Table 1 of the Annex of Commission regulations 37/2010, and statutory withdrawal periods are to be applied?||Go to Q.6||Go to Q.4|
|Q.4||To be used for the treatment of horses and the active substances are listed as ‘essential for the treatment of equidae’ according to regulation (EC) 122/2013 and a 6 month withdrawal period is to be applied?||Go to Q.6||Type B|
|Q.5||Is there published literature to support the efficacy of the active substances in this species for the proposed indications?||Type S||Type A|
|Q.6||Is there published literature supporting the target species safety and efficacy of the active substance in this species, for the proposed indications and at the proposed dose regimen?||Type S||Type B|
The Type A or B procedures are appropriate for pharmaceutical companies wishing to generate data to support an application for an MA for a veterinary medicine. You will be required to confirm that the trial will be carried out in accordance with the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) Topic 9: Guideline on Good Clinical Practices.
Trials conducted under a Type S ATC should, where possible, be conducted in accordance with GCP. As these trials are specifically intended for small scale non-commercial research trials conducted by vets this may not be possible in all situations. To ensure robust study design and appropriate consideration of how to reduce, refine and replace the use of animals, the work should be subjected to an ethical review and conducted to recognised quality standards for published research, such as the Defra Joint Code of Practice for Research (JCoPR) March 2012. On completion it is expected that the work will be reported in compliance with the principles set out in the “Animal Research: Reporting In Vivo Experiments (ARRIVE)” Guideline (Kilkenny et al (2010))”.
This procedure is used where the product is already authorised as a human or veterinary medicine in the EU or EEA and is either:
- an immunological product and the field trial is to be conducted in species included in the existing marketing authorisation, or
- a pharmaceutical product and
- the trial is to be conducted in companion animals, or
- the trial is to be conducted in food-producing species and the existing MA is for the same species and the same or similar dosing regimen and method of administration
This procedure is used if the product does not meet the criteria set out for Type A.
This procedure is used for small-scale non-commercial trials involving no more than 50 animals. More than 50 animals may be used where justified for meaningful statistical analyses as part of the trial design in the product treatment group. These are carried out by researchers or practicing vets investigating the safety and/or efficacy of human or veterinary pharmaceutical products that are authorised in the EU, EEA, USA, Canada, Japan, New Zealand or Australia.
If you wish to use an immunological product that is not subject of a valid MA in the EU or EEA, contact the VMD before submitting an application under the Type S procedure.
You should contact the MA holder of the product before undertaking any trials using that product.
Post authorisation steps
Validity of an ATC
During the validity of the ATC, if evidence becomes available which casts doubt on the safety, quality or efficacy of the product(s) involved, or which alters the benefit:risk assessment the VMD may revoke, suspend or compulsorily vary the certificate.
If the VMD becomes aware that an ATC holder has changed any of the approved specifications of the ATC without the prior approval of the VMD, the ATC will be suspended immediately. The suspension will remain in force until the changes have been approved, or the product is brought into line with the terms and conditions of the certificate.
You are responsible for reporting adverse events to the VMD and must name a person responsible for pharmacovigilance in your application. This person, usually a vet, must have overall responsibility for investigating any suspected adverse events, monitoring them and, when necessary, reporting them to the VMD. You should ensure that they are notified promptly by the investigators of serious adverse events. Appropriate arrangements should be put in place to ensure that ‘blinding’ of products does not interfere with pharmacovigilance responsibilities.
Any serious adverse events, i.e. any reaction involving a human or which has caused increased mortality or serious ill health in treated animals or birth defects in the offspring of treated animals, to any substance used under an ATC must be reported to the VMD within 15 days. For further information on reporting adverse events, see the Veterinary Pharmacovigilance: your responsibilities page.
You should keep appropriate records of adverse events that may occur following administration of the test article, control or placebo including those which are not serious. A summary of all adverse events that occur during the trial will be required if the ATC is to be renewed. For studies conducted under GCP the study protocol should include procedures for observing, recording and reporting adverse events.