The EU-FMD deadline is fast approaching, Prepare for it. Today. Now.

The go-live date of the EU-FMD regulations is creeping up quickly. We are working with a wide variety of pharma to develop their serialization strategies and how to implement them. There must be a big focus on getting trading partners on-board the EMVO, including CMOs, brand-owners, 3PLs and wholesalers.

Christoph Krähenbühl, Senior Director at Excellis Europe and long-time member of the EMVO and EFPIA taskforces took part in an interactive webinar where he answered your questions and clarified some of the complexities of implementing the EU-FMD. As an international business, Excellis Europe has a global perspective by operating on both sides of the Atlantic. Noting the similarities and differences between the continents and comparing best practices in the supply chain of pharmaceutical products.

Current state of readiness: Are we stuck at the Red light?

With less than 200 days from the go-live date of the EU-FMD, there are still a lot of questions we are being asked. The biggest question on everyone’s mind within this industry and those affected externally is; are we going to be ready?

In this webinar there were several polling questions with the audience. Given the self-selecting nature of the audience, the overall strong position shown for manufacturer readiness is not unexpected.

However, the wider industry readiness must remain a grave concern as 3C Excellis’ experience shows when working with customers to prepare a trading partner risk assessment: These assessments, in the form of a traffic-light reports, typically show a high level of Red rather than Green, which is a major concern for all partners in the extended supply chain. There are 3 levels of concern regarding the state of readiness of their supply chain partners:

• Technical readiness for data exchange and correct systems.
• Process readiness for all concerned, being aware of overlapping and agreements.
• State of commercial agreements that will need to be upgraded.

The main concern in the pharma supply chain to compliance is still the basic awareness of members obligation, predominantly the smaller players and the communication needed to create a fully compliant supply chain. This is shown in the webinar there was a clear worry when implementing EU-FMD is the reporting, data exchange and integration with partners.

US and Europe: Compare and Contrast

Across the Atlantic, the general state of readiness – especially in the extended supply chain – is more advanced, Despite the obvious differences, there is much that Europe could, and should, learn from. Similarities on a global scale including size of markets, sophistication of healthcare and the same perceived need of serialization to tackle counterfeit products infiltrating the legitimate supply chain.

Europe however is made up of 32 countries with their own law, distinct health care systems and languages, which has in turn shaped the law that focuses on the end-points and the item, opposed to the end-to-end traceability and therefore the integration between logical and physical asset.

There is also still uncertainty about how the European legislation will affect the various stakeholders and the complex realities of the European medicines supply chain.

In the absence of clarity, customers must manage their risks by hoping for the best but preparing for the worst. They need to seek best advice and help to reach an understanding on how current processes should be adapted for managing serialised products.

In conclusion: what is the next step?

In conclusion, collaboration is essential and the drive for efficiency will push for aggregation and data exchange and those who implement this sooner rather than later will be in a good position for February 2019.

There are three things that are worth highlighting that need to be considered if you are part of the pharmaceutical serialization chain:

• Change needs to happen throughout the supply chain. The end-point authentication approach has seen a lack of understanding and involvement for partners in the middle, leading them to think they can get away with the minimum change.
• Data must be maintained. There needs to be a new understanding about importance of managing the integrity of data.
• Strategic benefits can be gained from serialization. We must extend collaboration and broaden it, leading to tightening integration that will allow for more strategic use of the data.

It is vital to gain more clarity and understand with clear and practical guidance for every partner in the extended medicinal supply chain. We need to move beyond what is needed for compliancy short-term and look at the bigger picture and understand the best way forward that will allow everyone to work together to reach the next level of collaborative supply chain efficiency.

The EU-FMD deadline is fast approaching, Prepare for it. Today. Now.

Listen to the webinar for more understanding of:

• How to integrate with your CMOs and 3PLs.
• The safety features and product coding in serialization.
• What are the obligations for marketing authorization holders.
• An overview of the industry’s readiness for the EU-FMD regulations.

https://www.tracelink.com/insights/30-weeks-to-eu-fmd-your-questions-answered