Implementation explainer: Pharmacovigilance

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.

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

SubmissionWe ofwill third country reports should not berequire submittedthird electronically until the UK/third country productadverse mappingevent hassubmissions beenprior finalisedto and2026. MAHs confirm system readiness (emailing adverse.events@vmd.gov.uk). 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 andshould currently use VMDS AER (VMD Adverse Event Reporting system),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 messagingmessaging. until 17 May 2025. 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 adverse.events@vmd.gov.uk 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.  Submissions 

For usingproducts with a PSUR DLP after 17 May 2024 (where the previousDLP Excelwas templatesset willprior notto 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 accepted. submitted within 2 months of this date (by 30 June 2025).

SignalClosing notificationsPSURs must be submitted usingwith a covering note stating the currentnext BRSRcover templateperiod fromand the submission date (within 2 months of publication.the DLP and aligning with the EMA annual statement submission date) for the first BRR.

SalesIf 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 psur.queries@vmd.gov.uk 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 psur.queries@vmd.gov.uk 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 templatetemplates will will be accepted until 30 June 2025, although submissionsubmissions usingvia the PSS isare preferred. If the PSS is not used, Sales data may alternatively be submitted in the previously used PSUR format until this date. All sales data submitted from 101 July 2025 must be submitted within a PSS.

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Signal datanotifications tomust be submitted untilusing afterthe thiscurrent date,BRSR/Signal howevernotification wetemplate willfrom accept17 EEAMay submissions.2024.

For MAHsthose willwho behave requiredtransitioned already to providethe thirdBRR countryprocess,  datathe onfirst requestBRSR withinmay ancover agreeda timelinereporting duringperiod thisthat period.started prior to the amended VMRs coming into effect.

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ForWhere productsthe withBRSR areporting PSURperiod DLPstarts afterprior 17to 17th May 20242024:

• The (whereBRSR theshould DLPcontain wasall setsignals priordetermined toby the amendedMAH legislationto takingrequire effect),no thefurther Closingaction (final)at PSUR’sleast DLPsince may17th requireMay amendment.2024 All(provision finalof PSURthis DLPsinformation mustfrom fallthe priorstart toof orthe onreporting 30period Apruntil 202517th andMay must2024 beis submittedoptional).

• Historical withinsignals/equivalent 2information monthsidentified from the start of thisthe datereporting (byperiod 30to June17th 2025).

  ClosingMay PSURs2024 mustwhich required actions (including close monitoring/post-marketing surveillance study) should be submittedsent withvia a coveringsignal notenotification statingby the nexttime coverof periodor andalongside the submissionfirst dateBRSR (withinsubmission. 2The months30-day oftimeline does not apply to this historical information

• Signals requiring actions identified from 17th May 2024 onwards should be sent as per the DLPrequirements stated in sections 2 and aligning3 withof theGuideline EMAIV annualof statementPharmacovigilance submissionof date)Veterinary forMedicinal theProducts firstin BRR.
  Great Britain).

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• Signals orrequiring wouldactions preferidentified tofrom move17th directlyMay onto2024 onwards should be sent as per the newrequirements benefit-riskstated templates,in andsections not2 submitand a3 Closingof PSUR,Guideline theyIV areof requestedPharmacovigilance toof emailVeterinary psur.queries@vmd.gov.ukMedicinal Products in advance,Great clearlyBritain).

If detailingyou thehave proposedalready coversubmitted periodyour includingfirst theBRSR submissionand datenot yet submitted historical signals (requiring actions), please submit signal notifications for thethese firstas BRSR,soon as possible and requestinginclude thatany outstanding no further action signals within the lastnext PSURBRSR submittedsubmission, behighlighting classedthem as thehistorical. ClosingWe PSURmay ifaccept applicable.proposals for alternatives to this process. If you wish to make a proposal, please email psur.queries@vmd.gov.uk.

AnyUntil non-serious30 April 2026, we will accept UK casessales notdata previouslyalone submitted(without EEA sales data) to thealleviate VMDimplementation i.e.pressures. sinceMAHs lastare PSURrequired DLP,to canprovide eitherEEA bedata submittedon electronicallyrequest orwithin shouldan beagreed includedtimeline induring athis lineperiod listingif inonly theUK relevantdata sheethas ‘Backlogbeen linesubmitted. listings’We can accept EEA submissions during this time if submission of theboth BRSR.UK and EEA data is preferred by an MAH.

InFrom exceptional1 circumstances,May we2026, mayEEA considerdata BRRper submissionscountry outsidewill ofbe theserequired requirements.to MAHsbe shouldsubmitted emailin psur.queries@vmd.gov.ukaddition atto theUK earliestsales opportunitydata. withTo theirensure proposalno andmissing reasonsdata, forany theirEEA request.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 onat the Benefit-risk report (BRR) and signal notification submissions page.- 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 adverse.events@vmd.gov.uk 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.