Implementation explainer: Pharmacovigilance
Explainer for the pharmaceutical industry on the implementation of Pharmacovigilance requirements during the transition time from the date the revised VMR have effect in GB to 17 May 2027.
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.
IMPORTANT: Explainer must be read with the Pharmacovigilance Guidance Pharmacovigilance of Veterinary Medicinal Products in Great Britain - GOV.UK (www.gov.uk)
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 recommendations of the 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 AERs using the VICH HL7 format.
MAHs who currently submit using the VMD Gateway will not be able to upload xml files with the VICH HL7 format through the VMDS AER system, but you can submit these via secure messaging until 17 May 2025.
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.
If the DLP of the previous reporting period was prior to 17 May 2024, the first BRR’s reporting period should cover the period from this DLP. There should be no gaps in, or overlapping of, data. Any signals (whether they affect the benefit-risk balance or not) should be included within this BRR. Adverse event cases received by the MAH within this reporting period should be sent electronically, or if this is not possible, added to the Backlog line listings sheet of the first BRR.
PSUR/BRR submissions that are not fully compliant with the current BRR template will be accepted until 30 April 2025.
Signal notifications must be submitted using the current BRR/Signal template from 17 May 2024.
Supporting guidelines on how to complete the template can be found within sections 3.1.4 and 4.3-4.7 of Guideline IV Signal management of the GB Pharmacovigilance guidance.
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.
IMPORTANT: MAHs who have already submitted a PSMF Summary should resubmit their current PSMF Summary, including a signed statement from the marketing authorisation holder and the QPPV that the QPPV has the necessary means to fulfil the tasks and responsibilities required by the applicable GB legislation, via the notification procedure described above. Submissions of this type after 17/05/2025 will need to be made using the VNRA category C.6.