Veterinary Pharmacovigilance: your responsibilities

What you must do to tell VMD about Adverse Events linked to the use of animal medicines – the law, regulations.

Pharmacovigilance is defined by the World Health Organisation as

the science and activities associated with the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

Veterinary pharmacovigilance is the on-going monitoring of the safety and efficacy of medicines used for the prevention, diagnosis and treatment of disease in animals.

You should read this guidance if you are a:

  • Marketing Authorisation Holder (MAH) of any authorised veterinary medicine, including Parallel Imports (MAPIs) and homeopathic remedies
  • distributor of authorised veterinary medicines
  • manufacturer or distributor of extemporaneous veterinary medicines (specials) or medicines for small pet animals that are exempt from the requirement for an MA
  • Autogenous Vaccine Authorisation (AVA)) holder
  • Animal Test Certificate holder
  • Special Import Certificate (SIC) or Special Treatment Certificate (STC) holder

as there are specific actions you must take to record and report any problems, known as Adverse Events (AEs) in:

  • animals (including problems with the withdrawal period)
  • humans
  • the environment

during or following the use or misuse of veterinary medicines.

UK legal requirements for pharmacovigilance are described in the Veterinary Medicines Regulations.

You are committing an offence if you fail to comply with the requirements of UK legislation.


Adverse event (AE)

Any observation in animals, whether or not considered to be product-related, that is unfavourable and unintended and that occurs after any use of a VMP (off-label and on-label uses). Included are events related to a suspected lack of expected efficacy according to approved labelling or noxious reactions in humans after being exposed to a veterinary medicine. (VICH definition)

Adverse reaction

A reaction to a veterinary medicine which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function.

Classification of AEs

For authorised products, the Summary of Product Characteristics (SPC) describes:

  • what a product is indicated for
  • how a product should be used
  • what AEs may occur following treatment with a product

If the product has not been used according to the SPC, this is off-label use.

If during the use of the product the intended beneficial effects have not been observed this is suspected lack of expected efficacy (SLEE).

If the nature, severity or outcome of an observed AE is not described in the SPC, that event is unexpected.

Serious AEs

Any AE, in a treated animal or any other animals exposed to a treated animal following use of a veterinary medicine, which results in:

  • death or increased rates of death in a species for which there is an accepted death rate
  • life-threatening clinical signs
  • significant disability or incapacity
  • congenital anomalies or birth defects
  • permanent or prolonged signs

is a serious AE.

The European Medicines Agency (EMA) has produced additional guidance on identifying non-fatal serious animal AEs.

If you are unsure if an animal AE is serious, you should ask us for advice, or submit it as a serious AE.

All adverse events occurring in humans are classified as serious.

Non- serious AEs

All other adverse reactions or lack of efficacy following treatment with a veterinary medicine are non-serious.

Other Sources of Information

The European Commission provides guidance on pharmacovigilance in Eudralex Volume 9b, Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use.

VICH pharmacovigilance guidelines

  • VICH GL 24 Management of adverse event reports (AERs)
  • VICH GL 29 Management of Periodic Summary Update Reports
  • VICH GL 30 Controlled list of terms
  • VICH GL 35 Electronic standards for transfer of data
  • VICH GL 42 Data elements for submission of adverse events reports

Marketing Authorisation Holder (MAH) responsibilities

You must

  • have the permanent and continuous services of an appropriately qualified person who lives within the European Economic Area
  • ensure that this person, known as the Qualified Person for Pharmacovigilance (QPPV), carries out the required pharmacovigilance duties
  • be able to receive and investigate AEs that have happened in the UK
  • have a telephone number that customers can use to report problems or ask for advice about your products

At any time we may inspect the premises, databases and other documents you use to perform your pharmacovigilance duties.


You must

  • live within the European Economic Area
  • maintain a suitable pharmacovigilance information system, accessible from within the European Union, for recording and collating adverse events reported to your company and sending them to the appropriate NCA
  • provide any additional product information requested, including volume of sales per calendar year, within the timeframe specified
  • provide any information relating to post-marketing surveillance studies carried out to identify and investigate a safety hazard involving a particular product

Any additional information that we ask for, will help with the evaluation of the benefits and risks associated with a product.

You may delegate some of your pharmacovigilance duties to other suitably qualified people. But you are responsible for making sure that those duties are done correctly.

Reporting responsibilities

NB If you think the AE might indicate a defect in the product or batch, you must report this to the VMD immediately.

Adverse events occurring in the UK:

If, following administration of an authorised medicine in the UK, you become aware of any suspected:

  • serious AE involving an animal
  • AE involving a human
  • unintended transmission of an infectious agent through a veterinary product

you must:

  • record what happened in as much detail as possible
  • report the event electronically to the VMD within 15 calendar days

If you become aware of any other suspected AE involving an animal, you must record it and report it within the next chronological Periodic Safety Update Report (PSUR) for the product involved.

Adverse events occurring elsewhere in the EU:

If any suspected adverse event following use of a UK authorised product occurs in another Member State (eg travelling pets), you should report it to the National Competent Authority (NCA) for veterinary medicines in that country according to their local requirements.

Adverse events occurring elsewhere in the world (third countries):

If you become aware of any suspected:

  • serious, unexpected adverse event involving an animal
  • adverse event involving a human
  • unintended transmission of an infectious agent through a veterinary product

that occurred in a third country (ie outside the EEA), following administration of a product authorised in the UK, you must:

You can also report any serious, expected or non-serious adverse events involving animals directly to the EMA. However, all adverse events must still be described in the next chronological PSUR.

Electronic adverse event reporting

As an MAH, you must submit serious adverse event reports to the appropriate NCA (VMD in UK) or the EMA electronically using EudraVigilance Veterinary (EVVet). EVVet is a European network and database for the exchange, processing, and evaluation of suspected AEs related to veterinary medicines authorised in the EEA.

The first organisation to send an AE report electronically via EVVet assigns a unique Worldwide Case Number. This Case Number consists of

  • the 2-character country code of the primary source country
  • the ID of the sender
  • the sender organisation’s case number.

You must not change this number for any future transmissions, even if you were not the original sender. This avoids the creation of duplicate reports.

Content of AE reports

You must include all the relevant information that is available to you at the time of sending each report and send any additional information relating to an event as soon as possible after you receive it.

Animal Reports

You should include:

  • a full description of the event
  • details of the animal(s) affected
  • the product(s) involved
  • the method and route of administration
  • duration of exposure to the product
  • the time to onset of clinical signs
  • whether the product has been stored, handled and used as instructed
  • a causality assessment, using the ABON system
  • a list of symptoms, using internationally recognised veterinary (VeDDRA) terminology.

For lack of efficacy reports, do not VeDDRA code all the signs, unless there are other signs eg anaphylaxis, that may be related to a safety issue. If lack of efficacy is the only problem, just code lack of efficacy and death, as required.

In your report you should also consider:

  • the accuracy of the diagnosis
  • what the product claims to do
  • any other factors that may have influenced the product’s effectiveness.

Human Reports

You should include:

  • a full description of the event
  • details of the person affected
  • the product(s) involved
  • the method of administration to the species of animal being treated
  • the nature and duration of exposure to the product
  • the time from product application or start of exposure to onset of symptoms
  • a list of symptoms, using internationally recognised veterinary (VeDDRA) terminology.

Food Safety Reports

Reports of residues of veterinary medicines above the Maximum Residue Limit being detected in food products (meat, milk, eggs, honey) derived from treated animals after the appropriate withdrawal period has been observed may originate from:

  • farmers or vets following bulk milk tank screening tests
  • surveillance programmes
  • routine analysis of food stuffs
  • doctors or hospitals investigating ill health in humans suspected of being caused by residues in food

Normally you can just include these reports in the next PSUR for a product but if an incident occurs that could compromise food safety or human health, you must report it immediately. Contact us for advice, if you are unsure whether to report.

Environmental Reports

Many veterinary medicines are used in food-producing species, and there is an increased risk of these unintentionally affecting other animals in the environment.

Areas at risk are:

  • water courses from spillage (vertebrates and invertebrates)
  • pasture land from
    • dung of treated animals (invertebrates)
    • treated animal carcases (vertebrates and invertebrates)

You must report immediately any incident that:

  • results in the death of vertebrates or invertebrates
  • has the potential to cause further environmental damage.

Contact us for advice, if you are unsure whether to report.

Periodic Safety Update Reports (PSURs)

You must submit a PSUR for each authorised product at required intervals, or on request.

A document published by the EMA provides guidance on the preparation, management and assessment of PSURs.

The PSUR checklist template (MS Word Document, 52.3KB) is an optional template to help with PSUR formation. It provides a simple framework for the report, detailing all the information you should include in a PSUR. You can adapt the structure and format as you wish, but your PSUR must include all the required information.

Release of information

You must inform the VMD before releasing pharmacovigilance-related information to the public. However, this does not prevent you from discussing individual adverse events with those involved or responding to individual enquiries. You must also inform the VMD of any planned communications about safety concerns due to quality issues, including:

  • notifications or advice to vets in the event of a product or batch defect
  • withdrawal of a product from the market for safety reasons.

Change of MAH or distributor

If you sell the MA for a veterinary medicine to another MAH, you should ensure that the new MAH is also given all available pharmacovigilance information relating to the medicine.

If someone other than the MAH becomes responsible for the distribution of a veterinary medicine, you must inform us by means of a suitable variation. You must have suitable pharmacovigilance contracts in place to make sure you are informed of any AEs reported to the distributor. If this change of responsibility affects the content of your pharmacovigilance system description, you must submit a variation to update that too.

Animal Test Certificate (ATC) holder responsibilities

You must:

  • name a person responsible for pharmacovigilance on the ATC application form
  • record all AEs in treated animals
  • report electronically all serious AEs in treated animals to the VMD within 15 days (include the ATC number in your report)

You must do this whether an animal was treated with the test product or control product (even if just a placebo, such as saline).

If you hold an ATC and are also an MAH, you must report using EVVET.

Refer to Animal Test Certificates for further information.

Medicines for small animals, exempt from authorisation

Manufacturers, importers or wholesalers of medicines exempt from authorisation because they are intended for use in minor pet species, must keep records of all AEs. You must:

  • keep all records for 3 years
  • provide us with copies of AE records, if we ask for them
  • report all serious AEs to us within 15 days of you becoming aware of them using our online reporting form

EVVET registration is not required to market these products, but if you are also an MAH, you must report using EVVET.

Autogenous Vaccine Authorisation (AVA) holder responsibilities

You must report any adverse event, including lack of efficacy, within 15 days of becoming aware of the incident.

The report should include:

  • a description of the adverse event
  • the number and species of animal involved
  • the date(s) of administration of the product
  • the date(s) that the event occurred
  • the clinical signs observed
  • the AVA number
  • the batch release request number, if available.

If the AVA number and/or batch release number are not available

  • a precise description of the vaccine constituents
  • the date the vaccine was produced
  • the expiry date should be provided

so that the exact product and batch can be identified. This information should be taken from the vaccine container label.

Reports should be submitted using the on-line reporting form.

Contact us

If you require any further information please email

Published 1 June 2015
Last updated 28 April 2016 + show all updates
  1. Added a template to help with PSUR formation.
  2. First published.