Masking of personal data in individual case safety reports: New rules from August 2026

Swissmedic adopts EMA's GVP Module VI Addendum II standard for the protection of personal data in ICSRs

In Addendum II of Module VI of Good Pharmacovigilance Practice (GVP) "Masking of per-sonal data in individual case safety reports submitted to EudraVigilance", the European Medicines Agency specifies how data fields that may contain sensitive data should be processed in individual case safety reports (ICSRs) submitted to the EudraVigilance database¹.

A distinction is made between three types of data fields: fields to be left blank; fields to be masked; and fields that may contain sensitive data, but are required for pharmacovig-ilance processes and therefore should not be masked or left blank.Swissmedic has reviewed the EMA's requirements in respect of their compatibility with Swiss legislation and concluded that the Swiss provisions can be interpreted as con-sistent and in accordance with the masking rules specified by the EMA.

Since there is an overriding public interest in adopting these rules for Switzerland as well, GVP Module VI Addendum II will also apply to Switzerland from 1 August 2026. With effect from this date, marketing authorisation holders will be required to submit ICSRs to Swissmedic in accordance with these rules.

Swissmedic will also comply with these rules when sub-mitting ICSRs. The information sheet "Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway" will be revised accordingly.

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Guideline on good pharmacovigilance practices (GVP) Module VI Addendum II – Masking of personal data in individual case safety reports submitted to EudraVigilance, (2025).
Good pharmacovigilance practices (GVP) | European Medicines Agency (EMA)}