The EU Falsified Medicines Directive (FMD) puts in a framework to track any potential falsified medicines that reach the legal supply chain.  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. This framework was put in place to ensure patient safety. It is mandatory to address every single alert that is raised.

Manufacturers need to find a streamlined method of analysis and evaluation of the alert, since 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. There is also the problem of needing to ensure all the required authorities are updated on alert resolution in a timely manner.

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 Market Authorisation Holder (MAH).

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 hundred of alerts to be raised against the MAH, and each alert would require a response.

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.

Upcoming Challenges to companies operating under EU FMD:

  1. Aggregation
    Currently, the EU FMD does not call for Aggregation. Under the EU FMD, each unit of medicine needs to have its own serialization number, but since the manufacturing and distribution system operates in batches, consignments, and shipping boxes, companies should ensure that the larger units also have unique identifying serial numbers. This helps clearer traceability throughout the supply chain, even when dealing with third-party logistic companies involved in transportation and shipping. The reason for integrating this level of accountability is for conducting business with end-users like hospitals. Hospitals do not normally scan each unit as it is dispensed; why this happens is a larger question, but for now but it’s just how the system operates.
    It is a good idea for companies to build aggregation capabilities into their systems, because while there are no formal regulations requiring this currently, it is surely on the horizon and with a little preparation, manufacturers can avoid scrambling to create it on short notice when the regulation is passed.
  2. New and evolving treatments
    Medicine is quickly moving beyond capsules and bottles into markets like biologics, cell therapy and gene therapy. These differ not only in the way they are manufactured and distributed but also in the way they are administered to patients. Companies must begin in find ways to ensure the traceability in how these are sourced, manufactured, shipped and tracked.The idea is to move beyond taking a reactive stance and trying to find a broad perspective that enables companies to plan ahead to find a completely transparent supply chain, regardless of the type of product.

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. Our alert management service has the following advantages:

  1. Each alert is specially handled by a Cosmotrace executive
  2. We ensure the process is managed according to market-specific requirements, covering checklists for contacting NVMOs and NCAs
  3. We provide detailed tracking of the root cause of the alert
  4. The client receives a report that clearly documents the analysis process
  5. Recurring causes of error are flagged and possible solutions provided
  6. We have an experienced team that is used to dealing with multiple error variants, and are thus able to deal with them effectively.

Cosmotrace’s team of experienced professionals have spent years working with every part of the pharmaceutical supply chain. Contact us today to find out how we can help you manage your alerts:

Tel: +44 203 097 1597


About CosmoTrace

CosmoTrace was formed by an expert, experienced team that has since worked extensively with every part of the pharmaceutical supply chain from manufacturing through to final distribution. 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.

We offer premium support and services that can help your business with serialization implementation. Our team of experts ensure that you are up to date with all global traceability regulations and will help in creating a successful long-term serialization strategy.

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