✅ GVP Module VIII – Addendum I: Requirements and Recommendations for the Submission of Information on Non-Interventional Post-Authorization Safety Studies (PASS)

📘 Purpose

This Addendum supplements GVP Module VIII by providing detailed procedural and operational guidance for Marketing Authorization Holders (MAHs) regarding the submission of information on non-interventional PASS, especially those imposed as obligations by regulatory authorities.

🔹 Scope

Covers non-interventional PASS, including those that are:

• Imposed as obligations by EU regulators (e.g., under Article 107n-q of Directive 2001/83/EC).

• Conducted voluntarily by MAHs.

🔹 Key Requirements

1. Study Registration

• All non-interventional PASS should be registered in the EU PAS Register.

• Include protocol, summary, milestones, and study status.

2. Submission of Protocols

• If the study is an obligation, the MAH must:

  • Submit the protocol to PRAC or the relevant NCA for endorsement.

  • Include a cover letter, study protocol, and summary.

• The protocol must be submitted before study start.

3. Amendments to Protocol

• Any substantial changes must be:

  • Justified

  • Submitted as protocol amendments

  • Approved or endorsed by authorities (for imposed PASS)

4. Study Reports

• Final study reports must be:

  • Submitted within 12 months of study completion.

  • Accompanied by a summary and cover letter.

• Progress reports may also be requested.

5. Submission Channels

• Use the Common European Submission Portal (CESP) or CTIS (if applicable).

• Centralized procedure products: Submit to EMA and PRAC.

• National products: Submit to the relevant NCA.

6. Timelines

• Adherence to agreed milestones is expected.

• Delays must be justified and reported to authorities.

🔹 Recommendations

• Maintain transparency by updating the EU PAS Register.

• Ensure scientific rigor and quality in study conduct and reporting.

• Follow Good Pharmacoepidemiology Practices (GPP).

• Keep stakeholders (e.g., HCPs, ethics committees) informed.

🔹 Oversight and Review

• PRAC is the main body for scientific review of imposed non-interventional PASS.

• Recommendations may impact the product’s risk management plan (RMP) or labelling.

📌 Conclusion

This Addendum ensures harmonised and transparent submission procedures for non-interventional PASS across the EU. It promotes high standards in the real-world monitoring of medicinal product safety and supports informed regulatory decisions.

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