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May 25, 2021
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January 13, 2022
Managing EMVS EU-FMD alerts in a timely and GMP-compliant way is a legal obligation for every pharma manufacturer selling to the European market.
Over two years after go-live, it’s clear that this remains a challenge, and the volume of alerts – despite being reduced overall – will remain significant over the long-term.
Across the broad range of customers for whom Excellis operates the Alerts Management Service, we observe an alert rate of 3 alerts per 1,000 packs – making EU-FMD alerts a daily occurrence.
Every MAH therefore needs a solid, reliable, quality-compliant process, operating during EU pharmacy working hours to achieve the mandated response times – regardless of whether the alert’s source is caused by the MAH or more common supply chain factors beyond their control.
Join our Webinar to learn:
- What are your obligations?
- How can you manage your EU alerts in a compliant but lean way?
- How may the future EMVO AMS integrate with your process?
Share your thoughts ahead of our webinar: take our survey today
In this survey, in partnership with GIRP, the European Healthcare Distribution Association, we seek to understand more about the different experience our clients and peers are having with processing and managing alerts.
We would be most grateful for a few short minutes of your time in completing this. Your answers will be entirely anonymous, but will help us to build a better picture of the key challenges facing our industry.