Primary source: EMA - What's new RSS
Revision 2 of Module III on pharmacovigilance inspections has been published, providing updated guidelines that replace previous versions effective 9 September 2026.
These updated guidelines will influence how pharmacovigilance inspections are conducted across the EU, affecting compliance and inspection readiness for all medicinal products authorized in the region.
Ensure that all inspection readiness protocols are updated to align with the new guidelines from revision 2 of Module III and incorporate implementation regulations effective from 12 February 2026.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Ensure that all inspection readiness protocols are updated to align with the new guidelines from revision 2 of Module III and incorporate implementation regulations effective from 12 February 2026.
The latest revision of Module III on pharmacovigilance inspections includes critical updates to the guidelines on pharmacovigilance practices within the EU, published on 9 September 2026, and following the implementation of new regulations.
What changed: Revision 2 of Module III on pharmacovigilance inspections has been published, providing updated guidelines that replace previous versions effective 9 September 2026.
Why it matters: These updated guidelines will influence how pharmacovigilance inspections are conducted across the EU, affecting compliance and inspection readiness for all medicinal products authorized in the region.
Practical implication: Ensure that all inspection readiness protocols are updated to align with the new guidelines from revision 2 of Module III and incorporate implementation regulations effective from 12 February 2026.
Published from the regulator source ingestion pipeline after PV impact triage.
Ensure that only the current national adverse event reporting details for HR and CZ are displayed on veterinary product packaging, as per the updated guidelines.
Review the updated guidance to incorporate the new compliance procedures starting from 1 January 2026, specifically regarding the electronic submission process.
Marketing authorization holders must implement processes to ensure timely submissions of required data within the defined 15 and 30 calendar day timelines, including details of the Qualified Person responsible for Pharmacovigilance and the submission of Pharmacovigilance System Master File information.
Update labeling materials for Gardasil 9 to incorporate new safety and efficacy data as per the revised EPAR.
