Associate blog post from Grant Courtney, Principle Consultant
It’s been 15 months since EU FMD came into force and after initial problems bedding in the new systems, false alerts remain a problem preventing the realisation of the full benefits of the directive. With many grace periods now coming to an end, where are manufacturers on the EU FMD journey and what are the real consequences of unresolved alerts moving forward? In part two of the FMD Alerts in 2020 series, Grant Courtney Principle Consultant at Be4ward, looks at the process that happens when an alert is triggered, what manufacturers should be doing and what’s coming next in the EU FMD journey.
With false alerts still in play, if an alert is triggered it is necessary to establish if it is due to a technical or procedural error or if in fact it is due to a suspected falsified product. The need to investigate and resolve alerts is stated as a requirement within the Delegated Regulation and the organisation operating the National Medicines Verification System should provide for the immediate investigation of all potential incidents of falsification (Art 37(d)). Moreover, the EU Q&A document makes specific reference that the National Medicines Verification Organisations should ensure the National Competent Authorities (NCA) are informed as soon as it is clear that the alert cannot be explained by a technical or procedural issue.
The MAH has a role to play in this and must check if they have caused the alert by not uploading the serialisation data or if the data has errors. The expectation is that this resolution should happen quickly, within just a few days, and the relevant NMVO is made aware of the outcome of this investigation. In addition, authorities are starting to introduce specific reporting requirements and systems which could vary from country to country.
The common goal remains that we must reach the point at which an alert prevents a pharmacist from dispensing the medicine to the patient, as dictated by the legislation, and with this in mind, ten member states have now ended their stabilisation period.
The resolution of alert errors heralds a new phase in the EU FMD journey, where the target is for investigation and resolution of alerts to happen quickly, with the results documented and shared with the NMVOs and authorities. If alerts are caused by technical or procedural issues within the MAH then Corrective and Preventative Actions (CAPAs) need to be executed in alignment with quality procedures and the data uploaded or corrected to resolve the issue before many more alerts are triggered for the same batch. The consequence of not addressing these false alerts is that the flow of goods will stop and product returns could increase.
So a year after the EU FMD compliance deadline, what should manufacturers be doing and what is coming next?
If manufacturers have not already started, processes and systems must now be put in place to receive, analyse and investigate alerts. The backlog of any alerts that have not been addressed should be cleared and any technical or procedural issues identified and resolved. The regulatory environment should be carefully monitored so that the emerging requirements on alert reporting are captured and built into internal procedures. Regulators are starting to include aspects of the EU FMD within audits and alert management will feature as a topic within these moving forward.
Companies also need to consider how they are going to manage this on an ongoing basis. Tools that have worked for tracking alerts up to now, such as spreadsheets, will reach their technical limit as over time the historical volume of alerts grows. Systems will also have to output to external alert reporting systems operated by the NMVOs and authorities requiring new functionality and potential interfaces.
It is perhaps not surprising that legislation as ambitious as the EU FMD will take some time to achieve its original goal of preventing falsified products from entering the pharmaceutical supply chain. A tremendous start has been made and it is now time to build on this significant foundation and ensure that necessary alert management steps are put in place to allow falsified packs to be correctly identified, only then will the benefits of EU FMD by fully realised.
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