As an On-Boarded Partner (OBP) involved in the European Medicines Verification System (EMVS), it is crucial to understand the process of investigating and handling alerts generated by the EU Hub. Alerts indicate potential issues with the verification and decommissioning of medicinal packs, and prompt investigation is essential to ensure compliance and patient safety. This article provides a step-by-step guide on how OBPs can effectively investigate and manage these alerts.
1. Understanding Alert Types
Alerts are categorized based on the type of issue detected. Common alerts include:
A2 (Batch Not Found): Triggered when no exact match is found between ‘the scanned/manually input Batch ID’ and ‘the Batch Ids stored in the repository associated with the Product Code of the pack’.
A3 (Pack Not Found): Triggered when no match is found between ‘the scanned/manually input Serial Number’ and ‘the Serial Number stored in the repository associated with the Product Code of the pack’.
A7 (Pack Already in Requested Status):
Triggered when an attempt is made to change the state of a pack when the pack is already in that state (the same as the requested one).
A24 (Attempt to Decommission an Already Decommissioned Pack):
Triggered when an attempt is made to change the state of a pack when the pack is in already in a decommissioned state (different state than the requested one).
A52 (Expiry Date Mismatch): Triggered when there is a mismatch between ‘the scanned/manually input Expiry Date’ and ‘the Expiry Date stored in the repository associated with the Batch of the pack’ (no check on Day Date).
A68 (Batch Number Mismatch): Triggered when no exact match is found between ‘the scanned/manually input Batch ID’ and ‘the Batch Id stored in the repository associated with the Product Code and with the Serial Number of the pack’.
2. Initial Investigation Steps
Determine the Source of the Alert:
Check the Event Message to determine if the alert was generated by an MAH transaction via the EU Hub or by another source, such as a parallel distributor.
Verify the Client ID to ascertain responsibility.
3. Root Cause Analysis
Once the alert's source is identified, the next step involves determining the root cause. This includes:
Technical Issues: Investigate if the alert was due to a technical problem within the EU Hub or the OBP's system.
Procedural Errors: Check for any procedural lapses, such as incorrect manual entries or improper handling of packs.
Software or Scanner Issues: In cases where alerts suggest problems with end-user software or scanners, work with NMVOs to diagnose and resolve these issues.
4. Corrective Actions
Based on the root cause analysis, take the following actions:
Technical Corrections: Implement necessary changes to correct the technical issues identified. This may include software updates or configuration adjustments.
Training and Communication: If procedural errors are found, ensure relevant staff are trained to prevent recurrence. Communicate with NMVOs and other stakeholders as needed.
Follow-up and Monitoring: Continuously monitor the system for similar alerts and ensure that corrective actions have resolved the issue.
5. Communicating with Stakeholders
OBPs must maintain open lines of communication with relevant stakeholders, including NMVOs and NCAs. Notify them of the findings, actions taken, and any further steps required. This is especially important if a potential falsification is suspected.
6. Documenting and Reporting
Finally, thoroughly document the entire investigation and resolution process. This documentation serves as a record for future reference and helps in compliance audits. Report the outcomes to the relevant authorities and ensure that all regulatory requirements are met.
Conclusion
Proper handling of EU Hub alerts is vital for maintaining the integrity of the pharmaceutical supply chain and ensuring patient safety. By following these best practices, OBPs can effectively manage alerts, mitigate risks, and comply with regulatory requirements. For more detailed guidance, always refer to the latest NMVO and NCA communications and documentation.
By adhering to these protocols, OBPs can contribute to the smooth operation of the EMVS and the safety of the European pharmaceutical market.