To avoid falsified medicines reaching the supply chain, European Medicines Verification Organization (EMVO) has designed a robust alerting functionality to track any potential falsified medicines that reach the supply chain.
The EU FMD framework was initially put into place on 9th February 2019. From that date onward, all products incorporated a data matrix barcode embedded with a serial number, and tamper proof features. The barcode is the key component that identifies the product and tracks its status. If any product contains a barcode that identifies it as being from outside the system or having an invalid status, it raises an alert that goes to the National Medical Verification Organization (NMVO) and the Market Authorization Holder (MAH).
It is mandatory to address every single alert that is raised. This framework was put in place to ensure patient safety.
Timely analysis of alerts is a challenge!
Initially, there were a lot of alerts generated by the quick implementation of the system and user error, gradually this reduced and stabilized at an error rate of about 1% of products being flagged. However, this is still very high, especially considering that there are some cases where automated systems are programmed to repeat authentication requests every 15-30 minutes.
While there are still alerts caused by user error, each alert requires the MAH to confirm the cause; whether there was a technical issue, or if there is an actual falsified product. The MAH’s job in this situation is to double-check whether there is a procedural error on their part, whether by a failure to upload all serial numbers or by incorrect data upload. This must happen within a limited window and the NMVO must be made aware of the details. And in case the MAH realise that the alert is not caused by an error, they are required to immediately notify the National Competent Authorities, or the NCAs.
Delays in responding to these alerts also has the risk of possibly incurring fines and penalties to the manufacturer in some countries. The longer an alert takes to address, the more the risk of returns, refunds, complaints from customers, and shortage of supply increases. There is also the problem of needing to ensure all the required authorities are updated on alert resolution in a timely manner.
How can CosmoTrace help?
To tackle the complexities of operating within the EU FMD regulations, Cosmotrace has created an Alert Management Service to help companies efficiently analyze, evaluate, and resolve alerts.
We perform the following activities as a part of our Alert Management service:
- Ensuring that all the alerts for a given day is captured correctly in our system
- Analysing each alert individually once it is in the system
- Providing detailed information regarding the root cause of each alert and the ways to fix it
- Providing detailed report to the clients on weekly, bi-weekly, or monthly basis.
- Ensuring the process is managed according to market-specific requirements, covering checklists for contacting NVMOs and NCAs
- Flagging recurring causes of the error and providing possible solutions
As Serialization Consulting Experts, our focus is on delivering the absolute best serialization support by offering long-term serialization and sustainability strategies and providing forward-thinking industry solutions. Contact us today to find out how we can help you manage your alerts.