GVP Module VI Addendum II: how to comply with the new EMA Rules on ICSR data

GVP Module VI Addendum II issued by the EMA introduces new rules on the processing of personal data in ICSRs (Individual Case Safety Reports) submitted to EudraVigilance. In this article, we explain which ICH E2B(R3) fields are subject to masking, which must be left blank, and how to comply.

GVP Module VI Addendum II is a technical and operational update published by the EMA and entered into force in July 2024 to supplement the European pharmacovigilance guidelines with new guidance on the protection of personal data in ICSRs (Individual Case Safety Reports) submitted to EudraVigilance.

The addendum was published following an audit by the EDPS (European Data Protection Supervisor), which recommended that EMA introduce a common policy on masking personal data. The goal is to strengthen privacy protection by ensuring that no information that could identify patients, reporters, or senders appears.

This update does not change the technical framework of ICSRs or the EudraVigilance business rules, but directly impacts their content. It is therefore essential for the QPPV and pharmacovigilance team to know precisely which fields should be masked, which should be left blank, and how to manage them.

The first category concerns 13 ICH fields. The data contained in these fields is not required for signal management, duplicate detection, or ICSR processing, but contains data that can be directly linked to an individual.

These fields, if filled in, must be masked with the nullFlavor code “MSK”.
If they are not filled in, you can use the nullFlavor codes ASKU, NASK, UNK or leave the field blank.

The ICH fields in question are:

• C.2.r.1.1 Reporter’s Title
• C.2.r.1.2 Reporter’s Given Name
• C.2.r.1.3 Reporter’s Middle Name
• C.2.r.1.4 Reporter’s Family Name
• C.2.r.2.1 Reporter’s Organization
• C.2.r.2.2 Reporter’s Department
• C.2.r.2.3 Reporter’s Street
• C.2.r.2.6 Reporter’s Postcode
• C.2.r.2.7 Reporter’s Telephone
• D.1.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (GP
• Medical Record Number)
• D.1.1.2 Patient Medical Record Number(s) and Source(s) of the Record Number
• (Specialist Record Number)
• D.1.1.3 Patient Medical Record Number(s) and Source(s) of the Record Number
• (Hospital Record Number)
• D.10.1 Parent Identification

The second category includes 11 ICH fields whose data is not required for signal management, duplicate detection, or ICSR processing, but contains personal data.

If filled in, these fields must be submitted to EudraVigilance blank, as the use of nullFlavors is not supported by the ICH-E2B(R3) guidelines.

The fields in question are:

• C.3.3.2 Sender’s Title
• C.3.3.3 Sender’s Given Name
• C.3.3.4 Sender’s Middle Name
• C.3.3.5 Sender’s Family Name
• C.3.4.1 Sender’s Street Address
• C.3.4.2 Sender’s City
• C.3.4.3 Sender’s State or Province
• C.3.4.4 Sender’s Postcode
• C.3.4.5 Sender’s Country Code
• C.3.4.6 Sender’s Telephone
• C.3.4.7 Sender’s Fax

This category includes approximately 185 ICH and EU fields that, while they may in some cases include personal data, must not be masked or left blank as they are essential to ensure quality and the effectiveness of pharmacovigilance processes.

For the relevant fields, please refer to the official document.

This category includes 73 ICH and EU fields that do not contain personal information and are required for signal management, duplicate detection, and ICSR processing. ICSR submitters to EudraVigilance must not mask or leave blank the data for these data elements.

For the relevant fields, please refer to the official document.

The addendum does not change the EV Business Rules or the ICSR XML schema. The electronic submission processes and technical guidelines remain unchanged.

The ICSR XML files already submitted will remain archived in their original form for regulatory and audit purposes. Access to this information remains limited to a small number of authorized members who can make the XML files available to Member State competent authorities for inspections of clinical trial sponsors, marketing authorization applicants, and marketing authorization holders.

EMA, however, requires that measures to comply with the Addendum be implemented as soon as possible and in any case within a reasonable timeframe.

Addendum II Module VI GVP requires ICSR submitters to mask or leave blank specific ICH-E2B(R3) fields. Without a properly configured system, this would mean having to manually edit the XML files, risking errors and delays in submitting to EudraVigilance.

SafetyDrugs, the pharmacovigilance database developed by Max Application, features a GDPR module that, in addition to its data masking functions for submitting ICSRs outside the EU, automatically ensures compliance with the Addendum. During submission to EudraVigilance, it allows:
• masking of the 13 ICH fields relating to the reporter, patient medical record number(s), and source(s) of the record number and parent identification;
• deletion of the contents of the 11 ICH fields relating to the sender.

If you would like more information on the SafetyDrugs GDPR module or to request its activation or update, please do not hesitate to contact us.

You may also be interested in: Transferring ICSRs outside the EU: how to comply with the GDPR with SafetyDrugs