Implementation explainer: Pharmacovigilance
Source: gov.uk (2025-12-05)

Explainer for the pharmaceutical industry on the implementation of Pharmacovigilance requirements during the transition time from the date the revised VMR have effect in GB  to 17 May 2027.

Veterinary Medicines Regulations implementation from 17 May 2024

The Veterinary Medicines Regulations (VMR), as amended, took effect from 17 May 2024.

We recognise that industry will need time to plan and implement the final text of the law for pharmacovigilance activities. Industry has estimated that 3 years are needed to achieve full compliance.

IMPORTANT: Explainer must be read with the Pharmacovigilance Guidance Pharmacovigilance of Veterinary Medicinal Products in Great Britain - GOV.UK (www.gov.uk) (https://www.gov.uk/government/publications/pharmacovigilance-of-veterinary-medicines-in-great-britain)

There are significant changes to pharmacovigilance requirements in the Veterinary Medicines Regulation, as amended, for GB. Most notably the move from Periodic Safety Update Reports (PSURs) to Annual Benefit Risk Reports (BRR), alongside Signal notifications throughout the year, sending of all adverse events within 30 days, and the move from submitting the Detailed Description of the Pharmacovigilance System (DDPS) with each Marketing Authorisation to the Pharmacovigilance System Master File (PSMF).

Adverse event reporting

From 17 May 2024 Marketing Authorisation Holders (MAHs) are required to submit all UK serious and non-serious, human, transmission of infectious agents, suspected lack of expected efficacy and environmental adverse events within 30 days of becoming aware.

VMD is seeking advice from Defra lawyers to review the legislation regarding reporting of adverse events originating from clinical studies and post-marketing surveillance studies related to VMPs, to change the requirement to ‘MAHs must report adverse events without delay and no later than within 30 days from the date of the closure of the final study report’. This will align GB guidance with EMA VGVP: Module: Collection and recording of suspected adverse events for veterinary medicinal products.

Northern Ireland reports

Adverse event reports occurring in Northern Ireland should continue to be reported to the VMD and should follow the adverse reaction reporting guidance Pharmacovigilance of Veterinary Medicines in Great Britain (https://www.gov.uk/government/publications/pharmacovigilance-of-veterinary-medicines-in-great-britain).

Third country reports

We will not require and will not accept third country adverse event submissions prior to 1st January 2027. We continue to reserve the right to request these data at any time to assess the benefit-risk balance of a product. Product Group Codes (PGCs) will be utilised for submission of this data. Where XML files are submitted, the PGC must be included within field B.2.1.1. Further details will be released at a later date.

Third country reports will need to be submitted for third country products which are equivalent to UK-authorised products. Equivalent products are defined in section 4.3 of Guideline IV Signal management, including benefit-risk reports - GOV.UK (https://www.gov.uk/government/publications/pharmacovigilance-of-veterinary-medicines-in-great-britain/periodic-safety-update-reports). We will not expect third country adverse event reports that are identified by an MAH on EVVet, where the MAH is not the originator of the case, to be submitted​.

Third country reports received by MAHs between 17th May 2024 and 31st December 2026 inclusive should not be submitted until MAHs are notified to do so, to allow time for the new systems and processes to be embedded.

Format of the reports

MAHs must submit adverse event reports using the VICH HL7 format at all times when using the VMD Gateway.

MAHs who do not submit adverse event reports using the VMD Gateway should use VMDS AER (VMD Adverse Event Reporting system) where possible to submit reports. MAHs will not be able to upload .XML files with the VICH HL7 format through VMDS AER but can submit these via VMDS secure messaging. This includes EVVet .XML files. AER cannot accommodate human reports so these should also be submitted by VMDS secure messaging.

We are undertaking an R&D project to identify a system for non-Gateway MAHs to submit all adverse event reports (including UK, third country and human reports). We aim to enable MAHs to either submit VICH HL7 XML submissions (with minor edits required for third country reports) or submit manually via a web form.

Adverse event report reference number

These reference numbers are known as the ‘Unique Adverse Event Report Identification Number’ (AERID), otherwise known as the Worldwide Case Number (WWCN). They are made up of:
- country of occurrence code (3 characters)
- the MAH’s MAHORGID (8 characters)
- remaining free text (up to 47 characters, which can include your routing ID)
For example: GBR-VMDDEFRA-ITCHFIX2022001

The 3-character country code and the 8-character MAHORGID should be used for all AERs. The remaining free text (up to 47 digits) can include the MAHs’ routing ID as required by the EMA for EU reporting.

Reports from Northern Ireland should use the XXI country of occurrence code.

If you do not have a MAHORGID, or are unsure if you have one or not, email xxx@xxx.xx (mailto:xxx@xxx.xx) for help before submitting your report.

Note that where an alternative to the MAHORGID is used within a PGC, the MAHORGID should still be used for adverse event report submission.

Signal Management and Annual Benefit Risk Reporting

MAHs must follow the guidance within Guideline IV Signal management, including benefit-risk reports (https://www.gov.uk/government/publications/pharmacovigilance-of-veterinary-medicines-in-great-britain/periodic-safety-update-reports).

BRR and signal notification submissions must be made using the Benefit-Risk Submission Report template (BRSR) and Pharmacovigilance Sales Submission template (PSS) which can be found on the Benefit-risk report (BRR) and signal notification submissions (https://www.gov.uk/government/publications/benefit-risk-report-brr-and-signal-notification-submissions) page, alongside technical guidance documents for the completion of these templates. PSURs must no longer be submitted. Signal notifications must be submitted using the current BRSR template following the guidance within the Technical guidance for completion of Standard and Urgent Signal Notifications.

Any non-serious UK reports not previously submitted to the VMD i.e. since the last PSUR DLP, can either be submitted electronically or should be included in a line listing in the relevant sheet ‘Backlog line listings’ of the first BRSR submitted. There should be no overlap of data. Line listings should not be submitted both electronically and within the BRSR. Following the first BRSR submission, no line listings should be included, and all reports must be submitted electronically.

During the transition period, requests for exceptions to BRSR, PSS or signal notification submission processes should be e-mailed to xxx@xxx.xx (mailto:xxx@xxx.xx) at the earliest opportunity. Include a detailed proposal including a proposed timeline to reach full compliance and the reasons for your request.

For any other exception requests (PSS or BRSR), e-mail xxx@xxx.xx (mailto:xxx@xxx.xx) at the earliest opportunity with your proposal and reasons for your request.

The first BRSR may cover a reporting period that started prior to the amended VMRs coming into effect. This means that there may be information that occurred prior to 17th May 2024 that would have previously been highlighted within a PSUR, and which under the new guidelines would be reported as a signal notification. This includes terms requiring close monitoring or a post-marketing surveillance study.

Where the BRSR reporting period starts prior to 17th May 2024:

The BRSR should contain all signals determined by the MAH to require no further action at least since 17th May 2024 (provision of this information from the start of the reporting period until 17th May 2024 is optional).
- Historical signals/equivalent information identified from the start of the reporting period to 17th May 2024 which required actions (including close monitoring/post-marketing surveillance study) should be sent via a signal notification by the time of or alongside the first BRSR submission. The 30-day timeline does not apply to this historical information
- Signals requiring actions identified from 17th May 2024 onwards should be sent as per the requirements stated in sections 2 and 3 of Guideline IV of Pharmacovigilance of Veterinary Medicinal Products in Great Britain).
Where the BRSR reporting period starts after 17th May 2024:
- The BRSR should contain all signals determined by the MAH to require no further action.
- Signals requiring actions identified from 17th May 2024 onwards should be sent as per the requirements stated in sections 2 and 3 of Guideline IV of Pharmacovigilance of Veterinary Medicinal Products in Great Britain).
If you have already submitted your first BRSR and not yet submitted historical signals (requiring actions), please submit signal notifications for these as soon as possible and include any outstanding no further action signals within the next BRSR submission, highlighting them as historical. We may accept proposals for alternatives to this process. If you wish to make a proposal, please email xxx@xxx.xx.

Until 30 April 2026, we will accept UK sales data alone (without EEA sales data) to alleviate implementation pressures. MAHs are required to provide EEA data on request within an agreed timeline during this period if only UK data has been submitted. We can accept EEA submissions during this time if submission of both UK and EEA data is preferred by an MAH.

From 1 May 2026, EEA sales data per country will be required to be submitted in addition to UK sales data. To ensure no missing data, any EEA data that has not been previously submitted since 01 June 2024 would require submission at this point.

Product Group Codes (PGCs) must have been proposed/requested by 31st September 2026 for those products authorised in GB/NI/UK as of December 2025. A list of (at least) EEA equivalent product details must have been provided by this date. Non-EEA equivalent product details can also be provided. Further details can be found in section 4.3 of Guideline IV Signal management, including benefit-risk reports (https://www.gov.uk/government/publications/pharmacovigilance-of-veterinary-medicines-in-great-britain/periodic-safety-update-reports).

PSMF

MAHs should have made the transition from DDPS to PSMF and submitted their PSMF Summary to the VMD. This includes any re-submissions to ensure the PSMF Summary contains a signed statement from the MAH and the QPPV that the QPPV has the necessary means to fulfil the tasks and responsibilities required by the applicable GB legislation. Any outstanding submissions need to be made using the VNRA category C.6.

The full PSMF will need to be available for inspection. Specific information can be found in the Requirements for PSMF and the PSMF summary in the GB pharmacovigilance guidance (https://www.gov.uk/government/publications/pharmacovigilance-of-veterinary-medicines-in-great-britain).