The EU-FMD process currently generates over 2.5 million system alerts every month that pharma manufacturers need to deal with.
The Excellis Health Service Bureau Alert Management will help you manage your alerts.
The EU FMD regulation requires investigation efforts to focus on “potential and/or confirmed falsified medicines” that reach the legal supply chain, putting patient safety at risk. For this reason the EMVS has been designed with a robust alerting capability.
While all stakeholders have obligations in this process, there is a specific duty on Pharma Manufacturers (OBPs) to receive and process alerts in a timely manner.
The ramp up of the EU-FMD system and processes is progressing at a fast pace, with routine scans at the point of dispense now running at over 30 million transactions per week. However, for a number of reasons, between 1% and 3% of these scans are generating alerts. These 2.5 million alerts per month need to be managed by pharma manufacturers.
Root causes for false alerts are found right along the supply chain:
- MAH data upload failure
- Master data issues
- Data errors (expiry date issue)
- End-user system misconfiguration (scanners)
- Process errors
Even though most of these alerts are false alerts, it your duty as a Marketing Authorisation Holder to deal with these in a timely and GXP-compliant manner. Addressing the causes of alerts and managing them in the MAH’s organisation, in the MAH EPCIS and/or the European System creates a significant workload.
At present, a number of NCAs in various EU markets still operate a grace period but time is running out and new users are coming online that will generate more alerts.
Currently, most markets operate a stability period that allows pharmacists to dispense despite an unresolved alert. But markets are beginning to close out their respective stability periods. At the same time, more users, such as hospitals, are coming online and are expected to drive up the rate of alerts.
Pharma manufactures will therefore need a reliable GxP-compliant process, resources to manage the process and expert support in preparation for enforcement, which is likely to start from Q3 2019.
Excellis are pleased to announce our new Excellis Service Bureau Alert Management Service:
The Excellis Service Bureau Alert Management provides a robust and reliable managed service that scales and configures to your needs and helps you discharge your duty, in conjunction with your internal teams and pre-existing processes.