As of February 2023, EMVO’s AMS portal has been available to pharmaceutical companies for processing their alerts. With many functions, a clear presentation, and active user management, it makes the processing of error messages much easier.
Since the EU-FMD came into force, alerts have also been a concern for pharmaceutical manufacturers. Recently, there have been various ways to process them: individual national solutions and the Melior Solutions portal. Overall, alert processing has presented companies with significant time challenges. Thanks to the AMS portal, this can now be improved.
What are the benefits of using the AMS?
As of now, pharmaceutical manufacturers are not required to use EMVO’s AMS Hub to process their alerts. However, EMVO recommends the use of the portal from the perspective of efficient alert processing. What are the advantages of the AMS portal?
Clarity The setup of the portal is clear and easy to use. The home page already contains information such as alert ID, date of alert, product code, expiration date, serial number, classification code of the alert, status, and hours remaining for processing. In addition, it is possible to process several alerts at once (bulk processing) and to download them in an Excel spreadsheet.
User Management In the User Management section, different groups and persons can be assigned the corresponding access rights. Individual users, groups, and organizations can be created. Rights can then be assigned to the groups and users, for example, one group can only process specific country alerts. Active user management simplifies collaboration between employees or, if necessary, service providers. They can edit the alerts jointly and comprehensibly or divide them among themselves.
Communication The comment function allows information and files on an alert to be exchanged with all authorized users. Communication with pharmacies is also possible.
Filter options Various filter functions are available to simplify the processing and assessment of alerts. Among other things, it is possible to display which and how many alerts there are with the same/similar product code, make a country selection, filter alerts within a specific time, and sort by “uses AMS” and “not yet connected”.
Organization The AMS portal displays all alerts coming in via the EMVO gateway. That means even if a national system is not yet connected, all information is displayed in the AMS portal. Only the escalation/closure of the alerts must then be done via the process of the respective national authority as long as they are not yet connected. It is envisaged that all national systems will connect to the AMS.
In addition to the AMS, there are still national systems for alert processing. The AMS portal of the EMVO will not replace these but enables all systems or their data to be accessed and processed via a single point of access. Currently, only a few of the national systems are connected to the AMS. These include Cyprus, Slovenia, Germany (hybrid model), and Poland. Switzerland and France are also expected to be connected soon. Liechtenstein is currently in the qualification phase. (Status: September 2023)
Melior Solutions and AMS in comparison
| Melior Solutions | AMS |
| Download all alerts individually | All alerts at a glance |
| Display as XML file | Clear presentation, all info, categories, filter functions, comments |
| All alerts are closed/escalated via different processes of the national systems | Investigation results for all alerts from connected markets can be submitted to NMVOs directly from the AMS portal |
| No additional info, functions, etc. | Filter options, bulk processing, comment function, all information at a glance |
| – | All user actions are traceable, increasing transparency and enhancing collaboration between stakeholders |
| – | Active user management |
How quickly must manufacturers respond to alerts?
Depending on country-specific requirements, manufacturers have different amounts of time to process alerts and respond accordingly. Timeframes range from “as soon as possible” (Denmark and Finland) to 14 days processing time for the Czech Republic and Northern Ireland. However, some countries, such as Portugal or the Netherlands, have not yet defined a specific timeframe.
- ASAP: Denmark and Finland
- 1 day: Slovenia and Spain (Spain at the end of the stabilization period).
- 1-3 days: Estonia
- 2 days: Iceland, Latvia, Luxembourg, and Poland
- 3 days: Austria, Croatia, Cyprus, Malta, Norway, and Sweden
- 7 days: Germany and Romania
- 10 days: Slovakia
- 14 days: Czech Republic and Northern Ireland
- Not defined: Belgium, Bulgaria, Hungary, Ireland, Lithuania, Liechtenstein, Netherlands and Portugal
How to register as an MAH
Pharmaceutical companies can register for the AMS portal/ hub free of charge. There are no costs associated with using the system. The companies can choose between a test and a productive environment. However, no data is stored in the test environment, but dummy data can be uploaded. (As of September 2023) Registration is done via the EMVO helpdesk by e-mail. This must contain the following data: First and last name, email address, and identification number of the organization. The full process, including the different scenarios depending on the role and responsibilities of the person to be registered, can be found in the following document: EAMS-How-to-join-the-EMS-Guide-to-OBPs.
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