Implementation explainer: Pharmacovigilance
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, take 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)
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 events cases 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.
Third country reports
We will not require third country adverse event submissions prior to 2026. We continue to reserve the right to request these data at any time to assess the benefit-risk balance of a product. Further technical details regarding third country report submission will be released at a later date.
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 cases using the VMD Gateway should use VMDS AER (VMD Adverse Event Reporting system) where possible to submit cases. 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 and will be continued until 2026 at the earliest. AER cannot accommodate human cases so these should also be submitted by VMDS secure messaging.
Adverse event report reference number
These reference numbers are known as the ‘Unique Adverse Event Report Identification Number’ (AERID) and made up 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
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.
Cases 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 [email protected] for help before submitting your report.
Moving to Signal Management and Annual Benefit Risk Report System
For products with a DLP after 17 May 2024, MAHs must move on to the new Signal Management and Annual Benefit-Risk Report System and should follow the recommendations of the GB pharmacovigilance guidance.
Note that BRR and signal notification submissions after 31 August 2024 must be made using the new 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 page.
For products with a PSUR DLP after 17 May 2024 (where the DLP was set prior to the amended legislation taking effect), the Closing (final) PSUR’s DLP may require amendment. All final PSUR DLPs must fall prior to or on 30 Apr 2025 and must be submitted within 2 months of this date (by 30 June 2025).
Closing PSURs must be submitted with a covering note stating the next cover period and the submission date (within 2 months of the DLP and aligning with the EMA annual statement submission date) for the first BRR.
If you wish to make adjustments to the DLP of a Closing PSUR to align with the next EMA annual statement submission date or would prefer to move directly onto the new benefit-risk templates, and not submit a Closing PSUR, they are requested to email [email protected] in advance, clearly detailing the proposed cover period including the submission date for the first BRSR, and requesting that the last PSUR submitted be classed as the Closing PSUR if applicable.
In exceptional circumstances, we may consider BRR submissions outside of these requirements. MAHs should email [email protected] at the earliest opportunity with their proposal and reasons for their request.
Any non-serious UK cases not previously submitted to the VMD i.e. since 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 BRSR.
PSS submissions that are not compliant with the current PSS templates will be accepted until 30 June 2025, although submissions via the PSS are preferred. Sales data may alternatively be submitted in the previously used PSUR format until this date. All sales data submitted from 01 July 2025 must be submitted within a PSS.
For any other exception requests (PSS or BRSR), e-mail [email protected] at the earliest opportunity with your proposal and reasons for your request.
Signal notifications must be submitted using the current BRSR/Signal notification template from 17 May 2024.
For those who have transitioned already to the BRR process, the first BRSR may cover a reporting period that started prior to the amended VMRs coming into effect.
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:
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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 [email protected].
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 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.
Supporting guidelines on how to complete the templates can be found within Technical guidance for completion of the Benefit-Risk Submission Report (BRSR), Technical guidance for completion of the Pharmacovigilance Sales Submission (PSS) and Technical guidance for completion of Standard and Urgent Signal Notifications at Benefit-risk report (BRR) and signal notification submissions - GOV.UK.
PSMF
MAHs should make the transition from DDPS to PSMF by 17/05/2025. MAHs can switch from their DDPS to the PSMF without the need to submit variations. MAHs should inform the VMD at [email protected] and submit their PSMF summary. 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.
Any submissions after 17/05/2025 will need to be made using the VNRA category C.6.
IMPORTANT: MAHs who have already submitted a PSMF Summary should resubmit their current PSMF Summary, including a signed statement from the marketing authorisation holder and the QPPV that the QPPV has the necessary means to fulfil the tasks and responsibilities required by the applicable GB legislation, via the notification procedure described above. Submissions of this type after 17/05/2025 will need to be made using the VNRA category C.6.
Updates to this page
Published 29 May 2024Last updated 16 December 2024 + show all updates
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Update to adverse event reporting, PSUR to BRR transition and sales data submission requirements and timelines.
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Update to section for Format of reports and Moving to Signal Management and Annual Benefit Risk Report System.
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First published.