GovWire

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 adverse reaction reporting guidancePharmacovigilance 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 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 and currently use VMDS AER (VMD Adverse Event Reporting system), will not be able to upload .xml files with the VICH HL7 format through VMDS AER, but 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 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, emailadverse.events@vmd.gov.ukfor 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 theGB 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 using the previous Excel templates will not be accepted.

Signal notifications must be submitted using the current BRSR template from the date of publication.

Sales submissions that are not compliant with the PSS template will be accepted until 30 June 2025, although submission using the PSS is preferred. If the PSS is not used, Sales data may be submitted in the previously used PSUR format until this date. All sales data submitted from 1 July 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 date, however we will accept EEA submissions. MAHs will be required to provide third country data on request within an agreed timeline during this period.

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 been previously 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 amended legislation taking effect), the Closing (final) PSURs 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 MAHs 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.

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.

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 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 on the Benefit-risk report (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. Specific information can be found in theRequirements 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.