Insights

On 25 July 2025, the Guideline on Good Pharmacovigilance Practices (GVP) Module VI Addendum II, addressing the masking of personal data in individual case safety reports (ICSRs) submitted to EudraVigilance, came into effect. This update replies to recommendations from the European Data Protection Supervisor and seeks to strengthen pseudonymization practices in line with EU data protection requirements.

Key highlights of the guideline:

• 13 specific data (e.g. reporter names, addresses, and patient medical record numbers) must always be masked when submitting ICSRs.
• 11 sender-related data (e.g. sender’s name, address, and telephone) must always be left blank.
• Other data must remain unmasked when critical for pharmacovigilance functions such as signal management or duplicate detection.

The guideline reaffirms that there is no change to the EudraVigilance electronic submission process or the EU ICSR Implementation Guide.

This initiative aims to balance data protection and regulatory obligations by defining clearly which data must be masked, omitted or retained to ensure safety monitoring continuity.

RPN will provide any further update and is available to provide full support for Pharmacovigilance activities.