Guidance for Marketing Authorisation Holders and holders of other types of authorisations on their responsibilities for veterinary pharmacovigilance and how to report suspected Adverse Events.
This guidance applies to:
- Marketing Authorisation Holders (MAH) of any authorised veterinary medicine, including Parallel Imports (MAPIs) and veterinary homeopathic remedies
- distributors of authorised veterinary medicines
- manufacturers or distributors of extemporaneous veterinary medicines (specials) or medicines for small pet animals that are exempt from the requirement for an MA
- Autogenous Vaccine Authorisation (AVA)) holders
- Animal Test Certificate holders
- Special Import Certificate (SIC) holders
As a holder of an authorisation you must record and report adverse events that occur in animals, humans and the environment during or following the use or misuse of a veterinary medicine.
GB legal requirements for pharmacovigilance are described in the Veterinary Medicines Regulations. It is an offence to fail to comply.
|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 veterinary medicine (off-label and on-label uses). Included are events related to a suspected lack of expected efficacy or noxious reactions in humans after being exposed to a veterinary medicine.|
|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.|
|Off-label use||For authorised products, the Summary of Product Characteristics (SPC) describes what a product is indicated for, how a product should be used, and what AEs may occur following treatment with a product. If the product has not been used according to the SPC, including the misuse and serious abuse of the product, this is off-label use.|
|Lack of expected efficacy||The apparent inability of an authorised product to have the expected efficacy in an animal, according to the claims of the SPC and following use of the product in accordance with the SPC.|
|Unexpected AE||If the nature, severity or outcome of an observed AE is not described in the SPC, that event is unexpected.|
|Serious AEs||An AE is considered serious for a treated animal or any other animals exposed to a treated animal following use of a veterinary medicine, if it results in: death; is life-threatening; results in persistent or significant disability or incapacity; or a congenital anomaly or birth defect. For animals managed and treated as a group, only an increased incidence of serious adverse events as defined above exceeding the rates normally expected in that particular group is considered a serious adverse event. 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.|
For GB Marketing Authorisations, the guidance for Pharmacovigilance of Veterinary Medicines in Great Britain provides further guidance for Marketing Authorisation Holders and includes advice for identifying non-fatal serious animal AEs.
For Marketing Authorisations valid in NI, the European Commission provides guidance on pharmacovigilance in Eudralex Volume 9b, Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use. This guidance applies to products authorised in Northern Ireland.
- VICH GL 24 Management of adverse event reports
- 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
- have the permanent and continuous services of an appropriately Qualified Person for Pharmacovigilance (QPPV)
- ensure that the 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
- follow the guidance for Pharmacovigilance of Veterinary Medicines in Great Britain and the EU Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use
If you think the AE might indicate a defect in the product or batch, you must report this to the VMD immediately.
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
- record what happened in as much detail as possible
- report the event electronically to the VMD within 15 calendar days
There is no requirement to submit all other UK adverse events to the VMD, but these must be recorded and can be submitted within 30 days if MAHs wish to follow the same processes as they would do for submission to the EU.
From 1 January 2022 MAHs are no longer required to submit non-UK cases to the VMD on an expedited or routine basis. This applies to both serious and non-serious adverse events. Data from third country adverse events must be kept by MAHs in their systems. We reserve the right to request these data when needed to assess the benefit:risk balance of a product.
Electronic adverse event reporting
As an MAH, you must submit serious adverse event reports to the VMD electronically using the Veterinary Medicines Directorate Digital services (VMDS).
The first organisation to send an AE report electronically assigns a unique Adverse Event Report Identification Number (AERID). This number consists of:
- country of occurrence code (3 characters)
- your MAHORGID (8 characters)
- remaining free text (up to 47 characters, which can include your routing ID)
For example: GBR-VMDDEFRA-ITCHFIX2022001
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.
Please contact us if you suspect you have duplicate reports so that we can agree which report should be nullified.
Periodic Safety Update Reports (PSURs)
You must submit a PSUR for each authorised product at the required intervals or on request. For the first 2 years after a product is placed on the market, a PSUR is expected to be submitted every 6 months. However, MAHs can apply to the VMD to change this frequency to annual submissions, and this will be considered.
For products that have been on the market for a few years and that are already on a 3- year reporting cycle for PSURs, the MAH may voluntarily submit PSURs more frequently, for example, on an annual basis.
Your PSUR reporting period must follow on from the last PSUR without gaps or overlaps. The cut-off date for information to be included in a PSUR is called the Data Lock Point (DLP) and is the end date of the reporting period.
PSURs must be submitted directly to the VMD for all products using VMDS or via email to PSUR.email@example.com.
In each PSUR you should summarise the following for the period of the report:
- the amount of product you have sold
- all adverse event reports you have received
- information about your product from other sources (for example published literature, new studies)
Theis 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. You can also follow the format for PSURs specified in VICH GL29.
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
- name a person responsible for pharmacovigilance on the ATC application form
- record all AEs in treated animals
- report online 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 VMDS.
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
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 online reporting form.
If you require any further information please email firstname.lastname@example.org.