Animal Test Certificates

Question

Accepted Answer

Clinical trials in animals

A clinical trial is a study usually conducted in client-owned animals, that aims to confirm under field conditions the safety and/or efficacy of a veterinary medicine under normal conditions of animal husbandry or as part of routine veterinary practice.

You need an Animal Test Certificate (ATC) to carry out a clinical trial of a veterinary medicine in animals in GB and/or NI. You must submit your application for an ATC to the VMD.

Veterinary medicines investigated in clinical trials

Definition of a veterinary medicine

The Veterinary Medicines Regulations 2013 (VMR), as amended, define a veterinary medicine as:

any substance or combination of substances presented as having properties for treating or preventing disease in animals;
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; or
any substance or combination of substances that may be used for the purpose of euthanising an animal.

Products investigated in a clinical trial can be prescription or non-prescription, authorised or unauthorised, veterinary or human products. They may also be veterinary or human medicines under development.

Importantly, products investigated in a clinical trial may fall under the definition of a veterinary medicine based solely on the reason why they might be prescribed by a veterinary surgeon in relation to the clinical condition being investigated.

ATCs in the UK

An ATC is normally required if the design of a clinical trial in any way prevents participating vets from using their full professional judgement during clinical decision‑making concerning the prescription of veterinary medicines. This may occur if animals are randomised, or vets are blinded, to treatment groups or when the medicines used during a clinical trial will not be labelled in accordance with the VMR, as might be necessary to facilitate ‘blinding’ of study participants.

In this context, even if the same veterinary medicine is used in each study group, but aspects of its administration during a clinical trial are randomised between groups and/or blinded, an ATC is normally required. For example, the study protocol may dictate randomisation/blinding of the route of administration, the administration technique, and/or the dosage regimen; dose, frequency of administration, and duration of treatment course.

An ATC permits:

the use of a medicine during a clinical trial, including the use of a medicine outside the terms of its marketing authorisation
the procurement and supply of that medicine
the import of any medicine specified in the certificate in accordance with the conditions of that certificate
the produce from treated animals to enter the food chain, if appropriate
the use of randomisation and/or blinding within the study protocol
the administration of a placebo product, where specified

There are three different types of application that can be used to obtain an ATC; type‑A, type‑B, and type‑S. The type of ATC application required is dependent on several factors as set out below.

When an ATC is not required

In certain situations, an ATC is not required.

A clinical trial involving a non‑medicinal therapy, that does not meet the definition of a veterinary medicine, does not require an ATC. For example, an ATC is not required for a clinical trial of a purely surgical intervention, where no aspect of the administration of a veterinary medicine is under investigation. Additionally, an ATC is not required for a clinical trial investigating an animal feed additive, such as a nutritional supplement, provided the feed additive(s) to be tested does not fall within the definition of a veterinary medicine, when used in accordance with the study protocol.

The retrospective analysis of clinical observations is not a clinical trial, and therefore does not require an ATC.

Depending on the study design, a clinical trial carried out by a vet who will administer a veterinary medicine in accordance with the provisions of the prescribing ‘cascade’, or a clinical trial involving a veterinary medicine used fully in accordance with its Summary of Product Characteristics (SPC) may not require an ATC.

You can find more information on The Cascade: Prescribing unauthorised medicines.

Studies licensed in full by the Home Office under the Animals (Scientific Procedures) Act 1986 (ASPA), including laboratory studies, do not require an ATC if they are conducted in non-food animals or animals, including their products, declared never to enter the food chain.

Furthermore, for those studies in food‑producing animals that have been licensed in full under the ASPA, an ATC is not required provided the veterinary medicine to be used has a marketing authorisation (MA) in GB, NI, or the EEA and is to be administered in accordance with this MA.

Additionally, the authorised dosing regimen for the species and route of administration must be used, or a lower dose, and the withdrawal periods set out in the SPC must be observed.

For Home Office licensed studies conducted in food-producing animals where these criteria are not met, then a type-B ATC application should be submitted to determine or justify an appropriate withdrawal period.

Further information on how the Home Office regulates the use of animals in research can be obtained from the Home Office Animals (Scientific Procedures) Inspectorate and associated online guidance.

Contact us at postmaster@vmd.gov.uk if you are still unsure whether your proposed study design requires an ATC.

Types of ATC application

Commercial clinical trials

Commercial clinical trials are usually conducted by the pharmaceutical industry to generate the confirmatory data required to support a marketing authorisation (MA) application. This may be a new MA application for a veterinary medicinal product under development, or a change to an existing MA for an authorised product. To obtain an ATC for a commercial clinical trial you will need to submit a type‑A or type‑B ATC application.

Non-commercial clinical trials

Practising vets or researchers may wish to carry out a non-commercial and typically small-scale clinical trial of a medicine. Such a study may be conducted to inform clinical practice or be undertaken for academic purposes. To obtain an ATC for these types of non‑commercial clinical trial you will need to submit a type‑S ATC application. However, where the criteria for a type‑S ATC application cannot be met, a type‑B ATC application is usually required.

Further details regarding the types of ATC application are provided below.

Type-A

You should submit a type‑A ATC application if you wish to conduct a commercial clinical trial of a medicinal product that is already authorised (has an existing MA) for veterinary or human use in the UK/GB/NI or an EEA member country, and one of the following applies:

The product is a biological veterinary medicine, inclusive of immunological products and exclusive of human medicines, and the clinical trial is to be conducted in animals of the target species included in the existing MA, using a dosing regimen authorised for that species (or a lower dose) and the authorised route of administration.
The product is a non‑biological veterinary medicine, the clinical trial is to be conducted in animals from a food-producing species, and the dosing regimen to be tested; dose, frequency of administration, and duration of a treatment course, is the same as/lower than, the dosing regimen authorised for use in that species via the same route of administration.
The product is a non‑biological veterinary medicine or human medicine and the clinical trial is to be conducted in a companion animal species.

Where the criteria for a type‑A ATC application cannot be met, a type‑B ATC application is usually required.

Type‑S

You should submit a type‑S ATC application if you are a practising vet or researcher wishing to carry out a small-scale non-commercial clinical trial of a veterinary medicine or a human medicine and one of the following applies:

Biological veterinary medicine: The medicinal product is a biological veterinary medicine, inclusive of immunological products and exclusive of human medicines, with an existing MA granted in GB, NI, or an EEA member country and the clinical trial is to be conducted in animals of the target species included in the existing MA, using a dosing regimen authorised for that species (or lower) and the authorised route of administration.
Non-biological product studied in non‑food animals: The medicinal product is a non‑biological veterinary medicine or a human medicine and has an existing MA granted in the UK/GB/NI, Australia, Canada, an EEA member country, Japan, New Zealand, and/or the USA and the clinical trial is to be conducted in non‑food animals. These are companion animals or other animals, including their products, declared to never enter the food chain.
Non-biological product studied in food‑producing animals: The medicinal product is a non‑biological veterinary medicine or a human medicine with an existing MA granted in the UK/GB/NI and/or an EEA member country and the trial is to be conducted in food-producing animals, and one of the following applies:

a) The clinical trial is to be conducted in a species included in the existing MA, the dosing regimen to be tested; dose, frequency of administration, and duration of treatment course, is the same as (or lower than) the dosing regimen authorised for use in that species via the same route of administration, and the associated withdrawal periods set out in the SPC will be observed.

b) The medicinal product contains only substances that are listed in Table 1 of the Annex to Commission Regulation 37/2010 (for NI) or the GB MRL list (for GB) and an appropriate withdrawal period has been set. For a type‑S ATC application withdrawal periods may be determined by reference to the principles set out in VMD guidance concerning the setting of withdrawal periods under the prescribing cascade.

c) The clinical trial is to be conducted in Horses, the active substance(s) tested are listed as ‘essential for the treatment of equidae or are substances bringing added clinical benefit’ according to regulation (EC) 122/2013, and a 6 month withdrawal period will be applied.

Where the criteria for a type‑S ATC application cannot be met, a type‑B ATC application is usually required. Should the criteria set out above not apply, it is recommended that you contact us at postmaster@vmd.gov.uk before submitting an ATC application.

Sample size

Small-scale non-commercial clinical trials will usually involve no more than 25 animals in the group treated with the test product. However, where it is necessary to permit meaningful statistical analyses, larger sample sizes may be accepted. In these cases, you should provide an adequate statistical justification as part of the application.

Design

To ensure robust study design and appropriate consideration of how to reduce, refine and replace the use of animals, the work should be conducted to recognised quality standards for published research, such as the Defra Joint Code of Practice for Research (JCoPR). In addition, the VMD expects that the work will be subject to ethical review. If an ethical review has been carried out prior to an application for an ATC, this should be submitted as part of the application.

Before initiating your trial, you should inform the MA holder of the authorised product(s) under investigation. Upon completion of the trial we expect that the results will be reported in compliance with the principles set out in the Animal Research: Reporting In Vivo Experiments (ARRIVE) Guidelines.

Type‑B

You should submit a type‑B ATC application where the nature of a clinical trial or the medicinal product(s) under investigation do not meet the criteria set out above for either a type‑A, commercial clinical trial or a type‑S, small‑scale non‑commercial clinical trial, ATC application.

Type-B ATC applications require the submission of considerable data in relation to the Quality, Safety and Efficacy of the medicinal (and where relevant, placebo) products under investigation. Therefore, if not the manufacturer(s) themselves, applicants are encouraged seek input from the relevant pharmaceutical company before submitting an application for a type-B ATC. It is possible for companies to send such data directly and confidentially to the VMD, if preferred.

How to determine type of ATC application required

Contact us at postmaster@vmd.gov.uk if after using these tables you are still unsure which type of application to apply for.

Commercial clinical trials

Reference	Question	If Yes	If No
Q1.	Is the product authorised as a veterinary medicine or human medicine in the UK/GB/NI or an EEA member country?	Yes, go to Q.2	No = type‑B
Q2.	Is the product a biological (including immunological and excluding human medicine) veterinary medicine?	Yes, go to Q.3	No, go to Q.4
Q3.	Is the trial to be conducted in the species included in the existing MA, using a dosing regimen authorised for that species (or lower), via the authorised route of administration?	Yes = type‑A	No = type‑B
Q4.	Is the trial to be conducted exclusively in non‑food animals?	Yes = type‑A	No, go to Q.5
Q5.	Is the clinical trial to be conducted in a species of food producing animal included in the existing marketing authorisation for the medicinal product, using the dosing regimen authorised for that species (or lower), via the authorised route of administration, and observing the withdrawal periods in the SPC?	Yes = type‑A	No = type‑B

Small-scale non-commercial clinical trials in non-food animals

companion animals
horses declared never to enter the food chain
other animals. including their products, declared to never enter the food chain

Reference	Question	If Yes	If No
Q1.	Is the product a biological (including immunological and exclusive of human medicine) veterinary medicine?	Yes, go to Q.2	No, go to Q.4
Q2.	Is the product authorised as a veterinary medicine in the UK/GB/NI or an EEA member country?	Yes, go to Q.3	No = type‑B
Q3.	Is the trial to be conducted in the species included in the existing MA, using a dosing regimen authorised for that species (or lower), via the authorised route of administration?	Yes = type‑S	No = type‑B
Q4.	Is the product authorised as a veterinary medicine or human medicine in the UK/GB/NI, Australia, Canada, an EEA member country, Japan, New Zealand, or the USA?	Yes = type‑S	No = type‑B

Small-scale non-commercial clinical trials in food producing animals

Reference	Question	If Yes	If No
Q1.	Is the product a veterinary medicine or a human medicine authorised in the UK/GB/NI or an EEA member country?	Yes, go to Q.2	No = type‑B
Q2.	Is the product a biological (including immunological and excluding human medicines) veterinary medicine?	Yes, go to Q.3	No, go to Q.4
Q3.	Is the clinical trial to be conducted in the species included in the existing MA, using a dosing regimen authorised for that species (or lower), via the authorised route of administration?	Yes = type‑S	No = type‑B
Q4.	Is the veterinary medicine to be used in a species included in the existing MA, using a dosing regimen authorised for that species (or lower), via the authorised route of administration, and observing the withdrawal periods in the SPC?	Yes = type‑S	No, go to Q.5
Q5.	Are the pharmacologically active substances in the medicinal product listed in Table 1 of the Annex to Commission Regulation 37/2010 or on the GB MRL list?	Yes, go to Q.6	No, go to Q.7
Q6.	Will an appropriate withdrawal period be applied? An appropriate withdrawal period should be at least as long as the label withdrawal period and may be longer in accordance with the principles set out under schedule 4 (paragraph 2) of the Veterinary Medicines Regulations 2013.	Yes = type‑S	No = type‑B
Q7.	If the medicine is to be used for the treatment of horses, are the active substances listed as ‘essential for the treatment of equidae’ according to regulation (EC) 122/2013, and will a 6 month withdrawal period be applied?	Yes = type‑S	No = type‑B

Number of clinical trials and products per ATC

Each clinical trial requires a separate ATC and should normally only study one therapeutic indication in a single species. Exceptions include clinical trials of ectoparasiticides, endectocides, or multivalent vaccines.

A clinical trial may involve more than one product if:

the second product is a placebo control product
the second product is a positive control that is authorised in the UK/GB/NI or at least one EEA member country for administration to the same species for the same indication
the second product is a human medicine, its use is well supported by literature references, and there is no suitable authorised veterinary medicine
the medicinal products are of the same pharmaceutical form and contain the same ingredients, but they differ in the strength or dosage of the active or inactive ingredients
the medicinal products are vaccines and differ only in the inclusion or exclusion of particular antigens under study
the medicinal 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, for example, pollen
more than one product is expected to be required to produce therapeutic efficacy, for example, the administration of sedative or analgesic combinations or allergens.

Assessment of the application

When you submit an ATC application, we will conduct a benefit:risk assessment based on the data you provide. This assessment focuses on the risks associated with the proposed clinical trial and whether adequate safeguards are in place to ensure the safety of:

the animals participating in the clinical trial
those people using the medicines or handling treated animals
the consumers of produce derived from treated animals, where applicable
the environment, where applicable

For commercial clinical trials, applicants must confirm that the clinical trial will be carried out in accordance with the VICH guideline on Good Clinical Practices (GCP). Small-scale non-commercial clinical trials should also be conducted in compliance with GCP guidance where possible; however, it is recognised that this may not be possible in all situations.

If the benefit:risk assessment concludes positively and any other concerns have been addressed, the ATC application will be approved. We will send your certificate, verifying that the trial has been approved, although this may be subject to a number of conditions that will be specified on the certificate.

How to apply

Prior to submission

Before submitting your ATC application, you should first contact our Regulatory Affairs Section for more information and advice at postmaster@vmd.gov.uk.

If you require a meeting to discuss the ATC application, you should include ‘Request a company meeting’ in the subject line. A meeting is particularly important for those applications that concern the use of a biological or immunological product.

You must contact us before submitting applications involving veterinary medicines containing genetically modified (GM) organisms. A clinical trial in animals involving the deliberate release of GM organisms into the environment requires both an ATC and consent granted by the Secretary of State for the Environment before the trial can start.

This can take up to 90 calendar days, or longer if further information is needed from you, so you will need to apply for this well ahead of the ATC application.

Submission

You should submit your ATC application electronically using the VMDS Secure Messaging Service.

Validation

All applications are validated upon receipt to check that everything has been provided before we begin our assessment. It is up to you to identify and submit all the necessary information in support of your application. If the submission is incomplete, we may not be able to progress your application.

Supporting Data

An ATC is primarily intended to regulate the clinical trial of a veterinary medicine used in the context of routine veterinary practice (RVP) and to confirm the safety and efficacy of the medicine in the target population under field conditions. Importantly, there should be enough evidence already available to support a positive benefit risk balance for the proposed use of the medicine during the clinical trial, consistent with RVP.

Studies conducted earlier in the development of a veterinary medicine to investigate its margin of safety in a target population, or those performed in the target species for dose finding purposes, are normally conducted under Home Office licences.

ATC applications require a degree of prior evidence to be provided to support the target animal safety of the proposed dose of the veterinary medicine, alongside an expectation of efficacy when it is used according to the proposed study protocol. This evidence may include pre-clinical trials, clinical case reports/series, or other types of evidence that support the safe and efficacious administration of the proposed dose. It may also be necessary to similarly support the use of a control product, depending on the type of product selected, and the nature of its marketing authorisation.

Therefore, particularly for type-S ATCs, applicants should first consider whether there is sufficient data already available to demonstrate the safety and efficacy of the product(s) under investigation, and specifically in relation to their proposed use, or whether an ATC application might be premature, until such time as sufficient data becomes available.

The types of data and the documents required in support of an ATC application will differ depending on the type of ATC application (type A, B, or S) and the nature of the products used. Data requirements are listed in the respective application forms.

All references cited as evidence to support an ATC application should be submitted as PDF documents in the same single zipped folder as the application form, submitted via VMDS. Failing to submit full copies of all references used, including any cited scientific literature, may delay the application process. Do not submit any data or information that has not been explicitly cited in the application form; doing so will delay the application process.

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

Target species safety and efficacy

Data to support the safety of veterinary medicines after administration to the target species are required for all applications.

For ATC applications that concern a non‑biological veterinary medicine, data supporting the safety of the proposed medicinal product(s) in the target species must be provided in relation to the specific dose, dosing regimen, and route of administration proposed for the clinical trial. Further details of the evidence required can be found in the application forms.

As an exception to these requirements, for type‑A or type‑S ATC applications that concern a clinical trial of a veterinary medicine authorised in the UK/GB/NI or EEA and where the medicinal product(s) will be used in the authorised target species, it may not be necessary to submit target species safety data.

However, for a non‑biological veterinary medicine to be eligible for such an exemption, the medicinal product should be used via the authorised route of administration and according to the authorised dosage regimen; dose, frequency of administration, and duration of treatment course, or lower.

Furthermore, consideration should be given to any special characteristics of the target population for a clinical trial and whether, under the proposed conditions of use, any additional safety concerns exist. Applicants should ensure that any contraindications and special precautions for use of a veterinary medicine are appropriately considered, possibly by means of suitable exclusion criteria.

All type‑B ATC applications for a biological veterinary medicine should be accompanied by a GLP compliant target animal safety study.

For all ATC applications you need to provide evidence to support a reasonable expectation of efficacy when the test product is used in accordance with the trial protocol. For example, reference to laboratory efficacy studies, challenge studies, or pilot clinical trials under field conditions may be necessary.

ATC applicants may cross refer to relevant studies in the dossier of an authorised veterinary medicine provided they have a right of access.

During a clinical trial, the evaluation of field safety and/or efficacy may include the collection of a clinicopathological sample, such as a blood sample/tissue biopsy, prior to the administration of a medicinal product, to establish a baseline for the relevant parameters. It may also include additional sampling at key points after administration of the medicinal product, to monitor these parameters. However, any such samples must be clinically justified as being collected for the direct benefit of the animal, and an explicit rationale provided in the application form.

All procedures involved in a clinical trial regulated only under an ATC, must be primarily conducted for the direct clinical benefit of the individual animal. The study may require regulation by the Home Office under the Animals (Scientific Procedures) Act 1986 (ASPA) if additional samples are collected primarily for the generation of experimental data, for example, pharmacokinetic analyses. Applicants who wish to discuss this aspect of their proposed clinical trial are encouraged to contact postmaster@vmd.gov.uk before submission.

It is anticipated that animals treated during a clinical trial with the medicinal product under investigation will be compared with a control group. Therefore, the veterinary field trial may include either:

a group of animals designated as positive controls and treated with an existing veterinary medicine, an established procedure, or a human medicine, provided that it is outlined in the application form that its use is well supported, and there is no suitable authorised veterinary medicine; or
a group of animals designated as negative controls and treated with a placebo product or another type of negative control, provided this is adequately justified in the application form. In such cases, the study protocol must include adequate safeguards for animal welfare and align with the principles of the 3Rs

Manufacturing information

Clinical trials to be conducted under an ATC obtained via a type‑B ATC application 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.

The medicinal product(s) under investigation in a clinical trial are not legally required to be manufactured according to Good Manufacturing Practice (GMP). However, if applicants wish to use data generated in their clinical trial(s) to support a subsequent application for a marketing authorisation, the application of appropriate manufacturing standards, including those for documentation, may provide greater assurance that the medicinal product(s) under investigation is representative of the final formulation of the product(s) to be marketed.

Protocol

For all applications, a clinical trial protocol must be submitted, detailing how the aims will be achieved, and how the clinical endpoints will be evaluated. The VMD does not approve trial protocols but will review them thoroughly to ensure that any safety issues are adequately addressed. Failure to provide sufficient detail on the study protocol is likely to delay assessment of your application. For type-A or type-B ATC applications, you must ensure that the results of your clinical trial, carried out in accordance with the submitted protocol and under the ATC issued, will be appropriate for any subsequent MA applications.

For a type‑S ATC application, the senior investigator and two veterinary surgeons independent of the trial must review the protocol. They must sign a declaration in the application form to confirm that, in their opinion, the study is ethical and is to be conducted in accordance with the RCVS Code of Professional Conduct and ‘routine veterinary practice’.

For all applications a blank example owner consent form must be submitted. 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 written in plain English and include at least the following:

a) Confirmation that the owner understands:

the nature of the trial and the purpose of the treatment
that animals are participating in a clinical trial using a medicinal product that has not been authorised or is being used ‘off-label’
that their animal(s) may not receive active treatment as part of the clinical trial if a negative control or placebo control group are being included
that they can withdraw their animal from the trial at any time without prejudice to the future veterinary care of the animal

b) A 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 an appropriate level of veterinary care

c) Confirmation that the owner has fully understood the consent form

d) The owner’s consent to the inclusion of their animal(s) in the clinical trial

Labelling

Test and control products administered in accordance with an ATC are subject to the normal labelling requirements set out in the Product Literature Standard.

For authorised veterinary medicines you should use the approved labelling but with a small additional label to 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.

Example labels are available on the ATC application forms page.

We expect labels to contain the following minimum information in English:

the words “For veterinary clinical trial use only”
name or other designation of the medicinal 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 medicinal 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 a food‑producing species, 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 the identity of the medicinal products, including placebo products, used in the trial are blinded

You can use a package leaflet if there is insufficient space on the label to include all required text.

For type‑S ATC applications, you must submit a statement of the user and target species safety warnings that will appear on the product label and/or leaflet. It is your responsibility to ensure that the product label and/or leaflet conform to VMD requirements.

However, a statement of the warnings is not required for GB, NI, EEA, or EU authorised veterinary medicinal products for which the labels and product literature are in English, or if the medicinal product is to be administered directly by the investigator and there is no subsequent risk to other persons, and adverse effects are not likely to occur after the animal has left the investigator’s direct supervision.

Additional guidance on the warnings can be found in annex 1 of the type-S ATC application form.

Application Forms

Application forms and example labels can be found on the ATC application forms page.

There is no application form to renew an ATC

Post authorisation surveillance

Safety, quality and efficacy

During a clinical trial, if evidence becomes available which casts doubt on the safety, quality, or efficacy of the veterinary medicine(s) involved or alters the benefit:risk assessment we may revoke, suspend, or compulsorily vary the ATC.

If we become aware that an ATC holder has changed the approved test product formula or the clinical trial protocol, for example, dosing regimen, critical design elements relating to safety monitoring, or named personnel, without our prior approval, the ATC will be suspended immediately. The suspension will remain in force until the changes have been approved, or the medicinal product is brought into line with the terms and conditions of the certificate.

Pharmacovigilance

You are responsible for reporting all serious and non-serious adverse events (AEs) to us and a person responsible for pharmacovigilance, usually a vet, must be named in your application. They will have overall responsibility for investigating and monitoring any suspected AEs and, when necessary, reporting them to us.

You must put in place appropriate arrangements to ensure that ‘blinding’ of products does not interfere with pharmacovigilance responsibilities and that study personnel notify the responsible person if AEs occur. According to Schedule 4, paragraph 9(4) of the VMR, it is a legal requirement for all AEs that occur following the administration of a product under an ATC to be reported to the VMD within 30 days of learning of the event.

AEs as a result of a substance used under an ATC could include, but are not limited to:

death or increased rates of death in a species for which there is an accepted death rate
life-threatening clinical signs
persistent or significant disability/incapacity
congenital anomalies or birth defects
permanent or prolonged signs in the animal(s) treated
a reaction involving a human

Suspected lack of efficacy must also be reported. Refer to Pharmacovigilance of Veterinary Medicines in Great Britain for further information on reporting adverse events.

You should keep appropriate records of AEs that may occur following administration of the medicine, control or placebo, including those which are not serious. A summary of all the AEs that occur during a clinical trial must be submitted for review if the associated ATC is to be renewed.

For studies conducted under GCP, the clinical trial protocol should include the procedures for observing animals and should ensure observations are sufficient to allow the detection of AEs. The protocol should include the appropriate action to take when AEs are observed, how these AEs should be recorded in study documentation, and the procedures to follow when reporting AEs to the sponsor.

Variations to ATCs

If you wish to make any changes to your certificate, you must submit an ATC variation application. Only certain changes may be made by way of a variation, and these permitted changes are listed in the ATC variation application forms. Applicants are responsible for ensuring that none of these changes are required between the point an ATC is granted by the VMD, and the point at which the clinical trial commences.

All other changes will require submission of a new ATC application. In any such new ATC applications, applicants must describe the nature of the proposed change(s) to the previous ATC. Additionally, applicants should provide a copy of the previous ATC itself, any relevant information concerning the progress of the clinical trial (if already underway), and a summary account of any adverse events observed.

We recognise that some test sites cannot be set up until an outbreak of a particular disease occurs and in such cases an ATC may be issued for a maximum number of sites and animals, on the condition that you notify us of the test sites’ details as soon as they are known.

These details should include the name and address of the test site, the exact number of animals included at the site, and the name of the site investigator. There will be no charge for this.

ATC variation applications should be submitted via VMDS.

Renewal of an ATC

An ATC is valid for 2 years. If the trial is not finished within this period, you can apply to renew your certificate. There is no application form for the renewal of an ATC, but you must email a letter to s.response@vmd.gov.uk requesting the renewal at least one month before your ATC expires.

The ATC renewal letter should include a justification for why the ATC needs to be renewed, any variations made to the ATC, a copy of the certificate itself, any relevant information concerning the progress of the clinical trial, and a summary account of any adverse events observed.

If a certificate is not renewed by the expiry date it will cease to be valid and, to continue the clinical trial, you would need to submit a new ATC application. Without renewal, continuation of a clinical trial beyond the expiry date of an ATC is in breach of the VMR.

Application timescales

Further information about ATC application timescales can be found on the Timetables for national applications page.

Fees

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

Detailed fees are listed in:

Contact us

For all other enquiries that concern ATCs please email: postmaster@vmd.gov.uk

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Animal Test Certificates

Clinical trials in animals

Veterinary medicines investigated in clinical trials

Definition of a veterinary medicine

ATCs in the UK

When an ATC is not required

Types of ATC application

Commercial clinical trials

Non-commercial clinical trials

Type-A

Type‑S

Sample size

Design

Type‑B

How to determine type of ATC application required

Commercial clinical trials

Small-scale non-commercial clinical trials in non-food animals

Small-scale non-commercial clinical trials in food producing animals

Number of clinical trials and products per ATC

Assessment of the application

How to apply

Prior to submission

Submission

Validation

Supporting Data

Target species safety and efficacy

Manufacturing information

Protocol

Consent form

Labelling

Application Forms

Post authorisation surveillance

Safety, quality and efficacy

Pharmacovigilance

Variations to ATCs

Renewal of an ATC

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