The 2019 Falsified Medicines Directive (FMD) makes it clear: any suspicion of falsification must be addressed, and any falsification must be removed from distribution. In order to meet the strict requirements of the authorities, companies from the pharmaceutical industry must act GxP-compliant at all times. And that applies to every single FMD alert.
With Lean FMD and the Alert Guard, medAspis has developed an advanced service that prevents virtually all false alarms to the authorities and processes the remaining cases according to the rules.
Falsification alerts arise in many day-to-day situations: e.g. packs are deactivated twice by mistake or goods are delivered that have already been deactivated. Depending on the scan volume, this can be hundreds of alerts per day. These cases of suspected falsification must be separated and, if necessary, manually checked and documented. That means a lot of work.
In addition, the authorities are always in the loop; they are automatically informed about every mistake and can still make critical enquiries 5 years from now. Do you have the right answers then?
An FMD alert message indicates that a counterfeit medicine has been found or a possible counterfeit is present. Every single suspected case must be investigated. In terms of quality assurance and compliance, the following two cases are particularly important:
FMD scans are part of everyday work in pharmaceutical distribution. But so far, hardly any precautions are taken to reduce the numerous FMD alert messages. Truly critical cases often get lost in the mass and are consequently not handled correctly.
Every single case is automatically reported to the authorities and debits your compliance account. Sooner or later, audits will take place – and the authorities will demand accountability for individual scans.
medAspis has the entire FMD process perfectly under control. That’s why we enable not only extremely fast and efficient, but also virtually error-free processing.
The reason for the vast majority of false alarms is accidental multiple deactivations. medAspis Lean FMD identifies these and prevents almost all triggered false alarms. Our double scan filter reduces the number of alert messages to the NVMS that could trigger regulatory investigations to almost zero. Only the really critical cases remain.
You can rely 100% on medAspis if an alert does occur. We provide all participants with exactly the information they need in their position. Clear, well structured, quality-assuring and productivity-promoting.
Instant scan stop in case of critical alerts. Our poster with clear handling instructions shows your employees: Is the alert critical? And what to do now?
Despite all the training and well-intentioned advice, we know from experience that the scanning staff cannot always be relied upon and that suspected counterfeits are often lost in the day-to-day operations.
Our Alert Monitor ensures that no suspected counterfeiting case is being overseen. Automatically, the medAspis Alert Team will be informed immediately if you experience any critical cases. Then we take over and clarify the case. If necessary, we will involve your company or the manufacturer.
In principle, medicine packs suspected of being counterfeit must be quarantined and must not remain in circulation. Because the next scan definitely leads to the same alert. The pack comes back and causes even more trouble.
In order to systematically exclude more and more alert cases in the future, we are monitoring the findings of our alert team very closely. On this basis, we can help to optimise work processes and eliminate further sources of alerts in close consultation with you.
Support for all difficult cases: With our Alert Guard programme, the medAspis Alert Guard team is at your side with competence, experience and solution orientation.
With efficient scanning, a reduction of false alarms to almost zero and takeover of critical cases, medAspis is your 360° partner for FMD. With our service you reduce the amount of false alarms to the authorities to almost zero. We take care of all the rest. With Lean FMD, you can be sure that you are taking the best possible compliance and quality assurance measures at this moment.
Questions about FMD or Lean FMD? Just call or text us.