The European Medicines Agency has recently announced significant updates affecting pharmaceutical companies, especially concerning the management of Periodic Safety Update Reports (#PSURs) and referral procedures. These modifications are particularly crucial for Qualified Person for Pharmacovigilance (QPPV) roles, as they directly influence compliance and communication protocols.
Key Highlights:
- IRIS Industry Manager Role: All Marketing Authorisation Holder (#MAH) product contacts must be kept current with the IRIS Industry Manager role. This ensures your company is updated and aligned with EMA regulations.
- Centrally Authorised Products (#CAPs): For CAPs, only those authorized as a CAP Person should handle communications with the Medicines Agency. This ensures that interactions are streamlined and efficiently managed.
- Non-CAP Procedures:
- For PSURs: It is essential to use the MAH contact provided in the PSUR submission form. This step is critical to maintaining the accuracy and timeliness of communications.
- For Referrals: Depending on the procedure, use one of the following contacts:
- A QPPV from the Art 57 database
- Responsible Contact Person (RCP) from #Eudravigilance
- National MAH contact
These updates from the EMA are fundamental for maintaining compliance and ensuring that communications are both timely and accurate. It’s crucial for all involved stakeholders to review and adjust their procedures to align with these recent changes.
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