What is EU FMD?
The EU FMD framework was initially put into place on 9th February 2019 to track any potential falsified medicines that reach the legal supply chain to ensure patient safety throughout the member countries. 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 Market Authorisation Holder (MAH) which is authorized to place a product on one or more national markets for sale.
How are the verifications performed in the EU FMD?
The verifications are done through two organizations – EMVO (European Medicine Verification Organization) which manages regulations at the Union level and NMVO (National Medicine Verification Organization) and both the EMVO and NMVO together is called the EMVS (European Medicine Verification Organization)
How does the system work?
Individual units are scanned at the dispensary to verify their legitimacy. In case of any verification failures, the National Medical Verification Organisation (NMVO) and the pharmaceutical manufacturer both receive an alert. The regulation makes it mandatory to address every single alert that is raised. Based on a set of characteristics, these alerts are communicated also to the EMVO and a falsified product alert in one national market has the potential to be flagged as such in the other national markets also.
What is the impact of not addressing these alerts?
Any packaging that triggers an alert cannot be sold. The longer an alert takes to address, the more the risk of returns, refunds, complaints from customers, and shortage of supply increases.
Delays in responding to these alerts also has the risk of possibly incurring fines and penalties to the manufacturer in some countries. There is also the problem of needing to ensure all the required authorities are updated on alert resolution in a timely manner.
Therefore, manufacturers need to find a streamlined method of analysis and evaluation of the alert.
How far have we come?
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. This would cause hundreds of alerts to be raised against the MAH, and each alert would require a response.
How are the alerts addressed?
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. 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 error, they are required to immediately notify the National Competent Authorities, or the NCAs.
Therefore, to deal with all these issues, pharmaceutical companies now need robust alert management services, which is a process put in place to analyse, evaluate, and resolve alerts. Manufacturers need to resolve any outstanding alerts from the implementation period and need to start cataloguing and flagging repeat alerts and work on solving the root cause. They must also keep an eye on any potential upcoming regulations and ensure that they ready internal processes and data for a smooth transition.
The challenges faced by the MAH in performing alert management.
- To build in house skills of experts who are well versed with alert management for the EU hub.
- In case these skilled employees leave, it is harder to find immediate replacements which makes it difficult to manage as the alerts pile up.
- Takes away significant time and resources of the current employees who are tasked with understanding and addressing the alerts while also managing their other duties in the supply chain.
- Since there could be sometimes long intervals with no alerts, it is entirely possible that some alerts might be overlooked by the current staff.
- The manufacturer always has to stay updated with the latest changes to the regulations in each country.
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.