The EMVO Alert Management Portal (EAMS) has been in place since the beginning of 2023. The new portal has changed a lot for everyone involved. Previously, the processing of alerts was not prioritized by either the NMVOs or the pharmaceutical companies. There was simply a lack of options for analyzing large volumes of alerts and reporting them to the relevant authorities. With the introduction of the EAMS, all functions required to meet the legal obligations of the EU-FMD have now been available for almost a year. As a result, the NMVOs are also taking their task of making pharmaceutical companies responsible for alert management more seriously, and some are already exerting significantly more pressure on the MAHs.
Alert management with the help of EAMS is becoming increasingly important. We can also see this in the click rate of our website texts on alert management. To give you a better understanding of this topic, we have compiled a list of the three most frequently read articles.
EMVS overview: Alert management portal of the EMVO
– The EAMS has been available to MAHs for their alert management since February 2023, both as a test and productive system.
– Use of the portal by the pharmaceutical companies is free of charge.
– The national systems are required to connect to the portal.
– As of March 2023, Poland, Germany, Switzerland, France, Slovakia, and Cyprus are already connected. Belgium and Ireland are to follow soon.
The AMS portal enables comprehensive alert management for all MAHs. Alerts for all target markets in the EU are fully listed in the EAMS and can be analyzed, processed, and documented. Communication with the NMVOs is also taking place via the portal, at least for the NMVSs that are already connected.
Step by step to EAMS
Pharmaceutical companies can easily register in the EMVO Alert Management System.
Step 1: Open a ticket and send an e-mail with your first and last name, e-mail address, and company ID
Step 2: EMVO creates the user in EAMS and informs the MAH
Step 3: MAH sets up his account
Step 4: Ready to start the alert management via
Advantages of EAMS
Using EAMS has numerous advantages over other channels and systems, such as the Melior Solutions EMVO Gateway or email notifications.
– Clarity: Alerts and corresponding information are visible at a glance.
– User management: Different roles can be assigned. This is important for documentation and the topic of Business Process Outsourcing (BPO).
– Communication: The exchange (between pharmaceutical companies and authorities/NMVOs) is simplified as all information can be stored in one place (single point of truth).
– Filter options: Numerous filter options facilitate alert processing.
– Organization: All alerts of an MAH can be found in the EAMS.
Further information can be found in the article “The EMVO AMS portal: Alert processing becomes easier.”
Alert types and handling
The different alert types play a decisive role in the analysis and processing of alerts, as the EMVO has a corresponding recommendation for action for each alert type. You can find more information on the individual alert types in this article.
Business process outsourcing using the example of “EAMS”
A lack of expertise within the company or a lack of capacities are two common arguments for outsourcing alert management. Experts such as tracekey can take over alert management for you.
At tracekey, we have developed a process that takes into account the needs of our alert management customers and is in line with the official guidelines and recommendations of the EMVO. If desired, our customers can operate parts of their alert management in-house or outsource up to 99% of standard cases to us. We offer our customers a cost-effective and efficient solution that complies with official legislation and guidelines. In this way, they can finally get their alert management up and running.
You can find more information about business process outsourcing in alert management in our BPO example. Here we have also provided an example of the costs for your internal alert management.