EU-FMD system alerts – a challenge that every pharma manufacturer needs to deal with in a timely and GMP-compliant manner.
The Excellis Health Service Bureau Alert Management helps you stay on top of your EU 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.
For Pharma Manufacturers (OBPs), this means they have a legal duty to receive and process EMVO alerts in a timely and GMP-compliant manner.
The highest level of alert indicates a suspect falsified pack has been scanned.
The pack cannot be dispensed to the patient until the alert has been fully investigated and medicines falsification has been ruled out.
Alerts are automatically escalated to the OBP and the National Competent Authority and require prompt action and a formal response by the OBP.
This means that every Pharma Manufacturer has to establish a new, robust and GMP-compliant process to receive, record, investigate and resolve every alert within the prescribed timeline.
Excellis have established the Excellis Service Bureau Alert Management extension that provides reliable support to customers to manage their EU alerts and discharge their legal obligation in all EU member states where they are marketing their products.
Dealing with EU-FMD Alerts Management is mandatory, not optional.
While the number of alerts is gradually declining due to hard work by manufacturers, National Medicines Verification Organisations, software providers and the other supply chain participants, the gradual phasing out of the grace periods offered by the National Competent Authorities in various EU markets means that the focus remains on getting this process right:
- Every Alert means that there are packs of medicines that cannot be sold; potential returns, refunds, customer complaints, supply shortages
- Handling the EU-FMD Alerts is a legal obligation and now part of the typical GMP audit scope
- Resolution / response timelines are being tightened up with a number of markets now requiring feedback by the end of the next working day (EU time)
Even though most of the EU alerts are not falsified medicines, it is 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 for your team.
The rate at which alerts are received very often varies significantly from day to day. Paradoxically, with lower level of alerts, and sometimes days without alerts. This raises the risk that alerts and/or response deadlines may be missed.
The Alert Management Service to fit your needs exactly:
The Excellis Service Bureau Alert Management offers a robust and reliable managed service that ensures our customers are resolving every alert within the mandated timeline.
The Excellis Alert Management service provides a standard process that leverages the Excellis Alert Management Platform. It is tailored to every customer’s requirements as part of the on-boarding process to ensure that our service dovetails with the customer’s internal team and pre-existing processes.
Our Alert Engineers are based in Europe and the US time zones and are therefore offering support during extended working day with timely alert resolution and response times for every EU market.
As we are supporting a growing number of customers; this means that we have seen every possible type of alerts and what may be novel for you will be a familiar alert scenario for us.
Our customers range from one of the top three global pharmaceutical companies with hundreds of alerts per day to virtual biopharma companies with single-digit alerts per quarter: Our service scales to the customers’ needs and requirements at either end of the scale.
The service we provide for each customer is based on a separate instance of the Excellis Alert Management Platform, with fully segregated secure data.
Your EU Alerts – Managed and Secured:
Through the Excellis Service Bureau we offer the best in class Alert Management Service:
- A full service, not just a tool
- A team of experts using the right technology
- Robust, scalable and flexible
- Leveraging a fully validated platform
- Built on the established and proven Service Bureau foundations
- Real time visibility for the customer and comprehensive reporting capability
- EPCIS Vendor independent
- Data retention as per EU-FMD requirements
- Optional customer sign-off for each alert using Adobe electronic signatures