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.

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 guidancePharmacovigilance 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, 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.

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 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 templateswill 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 psur.queries@vmd.gov.uk 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:

• 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 wit

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