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?
To view a copy of this webinar, please click here.