Veterinary Medicines Regulations implementation from 17 May 2024

The Veterinary Medicines Regulations (VMR), as amended, tooktake 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.

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 eventevents reportscases 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 and will not accept third country adverse event submissions prior to 1st2026. January 2027. We continue to reserve the right to request these data at any time to assess the benefit-risk balance of a product. ProductFurther Grouptechnical Codesdetails (PGCs)regarding willthird becountry utilisedreport 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. 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 reportscases using the VMD Gateway should use VMDS AER (VMD Adverse Event Reporting system) where possible to submit reports.cases. MAHs will not be able to upload .XML.xml files with the VICH HL7 format through VMDS AERAER, but can submit these via VMDS secure messaging. This includes EVVet .XML.xml files.files and will be continued until 2026 at the earliest. AER cannot accommodate human reportscases 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(AERID) knownand as the Worldwide Case Number (WWCN). They are made up of:

• country of occurrence code (3 characters)
• theyour 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.

ReportsCases 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 adverse.events@vmd.gov.uk for help before submitting your report.

Note

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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,page. alongside 

For technicalproducts guidancewith documentsa forPSUR DLP after 17 May 2024 (where the completionDLP ofwas theseset templates.prior PSURsto the amended legislation taking effect), the Closing (final) PSUR’s DLP may require amendment. All final PSUR DLPs must nofall longerprior beto submitted. Signalor notificationson 30 Apr 2025 and must be submitted usingwithin the2 currentmonths BRSRof templatethis followingdate (by 30 June 2025).

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In exceptional circumstances, we may consider BRR submissions outside of data.these Linerequirements. listingsMAHs should notemail bepsur.queries@vmd.gov.uk submittedat boththe electronicallyearliest opportunity with their proposal and withinreasons thefor BRSR.their Followingrequest.

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DuringPSS submissions that are not compliant with the transitioncurrent  period,PSS requeststemplates will forbe exceptionsaccepted tountil BRSR,30 June 2025, although submissions via the PSS orare signalpreferred. notificationSales submissiondata processesmay shouldalternatively be e-mailedsubmitted to psur.queries@vmd.gov.uk atin the earliestpreviously opportunity.used IncludePSUR aformat detaileduntil proposalthis includingdate. aAll proposedsales timelinedata tosubmitted reachfrom full01 complianceJuly and2025 themust reasonsbe forsubmitted yourwithin request.a PSS.

For any other exception requests (PSS or BRSR), e-mail psur.queries@vmd.gov.uk at the earliest opportunity with your proposal and reasons for your request.

TheSignal 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 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 psur.queries@vmd.gov.uk.

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.

ProductSupporting Groupguidelines Codeson (PGCs)how mustto havecomplete beenthe proposed/requestedtemplates bycan 31st September 2026 forbe thosefound productswithin authorisedTechnical inguidance GB/NI/UKfor ascompletion of Decemberthe 2025. ABenefit-Risk listSubmission ofReport (at(BRSR), least)Technical EEAguidance equivalentfor productcompletion detailsof mustthe have beenPharmacovigilance providedSales bySubmission this(PSS) date. Non-EEAand equivalentTechnical productguidance detailsfor cancompletion alsoof beStandard provided. Furtherand detailsUrgent canSignal beNotifications foundat inBenefit-risk section 4.3report of Guideline(BRR) IVand Signalsignal management,notification includingsubmissions benefit-risk- reportsGOV.UK.

PSMF

MAHs should havemake made the transition from DDPS to PSMF and submitted theirby PSMF17/05/2025.  SummaryMAHs tocan theswitch VMD. Thisfrom includestheir anyDDPS re-submissions toto ensure the PSMF Summary contains awithout signedthe statementneed fromto submit variations. MAHs should inform the MAHVMD at adverse.events@vmd.gov.uk and thesubmit QPPV that thetheir QPPVPSMF hassummary. theThe necessaryfull meansPSMF will need to fulfilbe theavailable tasksfor andinspection. responsibilitiesSpecific requiredinformation bycan be found in the Requirements for PSMF and the applicablePSMF summary in the GB legislation.pharmacovigilance guidance.

Any outstanding submissions after 17/05/2025 will need to be made using the VNRA category C.6.C.6.