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.

Northern Ireland reports

Adverse events cases occurring in Northern Ireland should continue to be reported to the VMD and should follow the recommendationsadverse ofreaction the reporting guidance Pharmacovigilance of Veterinary Medicines in Great Britain.

Third country reports

Submission of third country reports should not be submitted electronically until the UK/third country product mapping has been finalised and 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 AERsadverse event reports using the VICH HL7 format.format at all times when using the VMD Gateway.

MAHs who currentlydo not submit adverse event cases using the VMD Gateway and currently use VMDS AER (VMD Adverse Event Reporting system), will not be able to upload xml.xml files with the VICH HL7 format through the VMDS AERAER, system, but you can submit these via VMDS secure messaging until 17 May 2025. This includes EVVet .xml files

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  routingrouting 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.

IfNote that BRR and signal notification submissions after 31 August 2024 must be made using the DLPnew ofBenefit-Risk Submission Report template (BRSR) and Pharmacovigilance Sales Submission template (PSS) which can be found on the previousBenefit-risk reportingreport period(BRR) wasand priorsignal tonotification 17submissions Maypage. 2024, Submissions using the firstprevious BRR’sExcel reportingtemplates periodwill shouldnot coverbe accepted. 

Signal notifications must be submitted using the periodcurrent BRSR template from thisthe DLP.date Thereof shouldpublication.

Sales submissions that are not compliant with the PSS template will be noaccepted gapsuntil in,30 orJune overlapping2025, of,although data.submission Anyusing signalsthe (whetherPSS theyis affectpreferred. If the benefit-riskPSS balanceis ornot not)used, shouldSales data may be includedsubmitted withinin the previously used PSUR format until this BRR.date. AdverseAll eventsales casesdata receivedsubmitted byfrom the1 MAHJuly 2025 must be submitted within a PSS.

Only UK sales data is required to be submitted until 30 April 2026 to alleviate implementation pressures. We do not require EEA  data to be submitted until after this reportingdate, periodhowever shouldwe will accept EEA submissions. MAHs will be sentrequired electronically,to orprovide ifthird country  data on request within an agreed timeline during this isperiod.

From 30 April 2026, EEA sales data, per country, will be required to be submitted alongside UK sales data. To ensure no missing data, any EEA  data that has not possible,been addedpreviously submitted since 01 June 2024 would require submission at this point.

For products with a PSUR DLP after 17 May 2024 (where the DLP was set prior to the Backlogamended linelegislation listingstaking sheeteffect), 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.

PSUR/BRRIf submissionsMAHs thatwish areto notmake fullyadjustments compliantto the DLP of a Closing PSUR to align with the currentnext BRREMA templateannual 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 willin advance, clearly detailing the proposed cover period including the submission date for the first BRSR, and requesting that the last PSUR submitted be acceptedclassed untilas 30the AprilClosing 2025.PSUR if applicable.

SignalAny notificationsnon-serious mustUK cases not previously submitted to the VMD i.e. since last PSUR DLP, can either be submitted usingelectronically or should be included in a line listing in the currentrelevant BRR/Signalsheet template‘Backlog fromline 17listings’ Mayof 2024.the BRSR.

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.

Supporting guidelines on how to complete the templatetemplates can be found within sectionsTechnical 3.1.4guidance for completion of the Benefit-Risk Submission Report (BRSR), Technical guidance for completion of the Pharmacovigilance Sales Submission (PSS) and 4.3-4.7Technical guidance for completion of GuidelineStandard IVand Urgent Signal managementNotifications ofon the GBBenefit-risk Pharmacovigilancereport guidance.(BRR) and signal notification submissions page.

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.  SpecificSpecific 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.