EAMS comprises AMS Hub, connected NAMS and connected OBPs. The OBPs can access EAMS via ‘AMS Portal’ and/or via API connection.
National alert management systems (NAMS) can operate without being connected to AMS Hub, but being connected facilitates OBPs/MAHs who want to manage alerts across multiple via one access point (AMS Hub) instead of having to connect to each NAMS individually. EAMS went live on 9th Feb this year and Cyprus was first NAMS connected.
1- How to access the EAMS ?
Few steps to take into account before accessing the EAMS :
*For security purposes, EMVO will not provide any passwords, the user will be required to reset their password through the log-in page of the AMS Portal before being able to connect to the AMS Portal.
First connection :
Testing : https://ams-uat.emvo-medicines.eu
Production : https://ams.emvo-medicines.eu
After accessing the AMS Portal, the OBP will log in for the first time. To do so, the OBP will have to reset the password to the Portal. This will have to be done for each environment.
After the initial successful log in to the AMS Portal, a dialog with the Terms and Conditions will be displayed.
The OBP Users must check the acknowledge box for the accept button to become active.
2- EAMS Numbers from 01/05/2023 to 31/05/2023 :
Alerts in the AMS Hub vs EU Hub : 99.7% (09/02/2023 till 30/04/2023)
In general :
21.33% of all alerts were modified by using the EAMS (↑ 5.6%)
9.97% of all alerts were closed by using the EAMS (1.64% in April)
0.77% of all alerts were closed in connected markets (0.08%)
0.01% of all alerts were closed in productive markets
10.93% of alerts were modified by OBPs in all markets (2.4% in April)
9.34% of all alerts were closed by OBPs in all markets (1% in April)
Countries connections :
Fully productive using the EAMS: CY and SI
Plan to use the EAMS productively in 2023
· June/July – PL
· Q3 – DE (Hybrid until January 2024)
· Q4 – BE
· Awaiting green light from NCA – FR
· Awaiting for confirmation – AT, LI
No plan to connect in 2023: TBC
0.13% alerts were raised in the connected (and productive) countries
26.26 % of alerts were raised in the connected Pilot countries (CY, DE, FR, PL & SI)
OBPs connections :
66 OBPs accepted the EAMS Terms and Conditions and are able to use the EAMS. This covers 36.6% of the total alerts in the EAMS.
3- Deployment of AMS Cybersecurity 1 :
EMVO announced that the release of AMS Cybersecurity 1 (Hub V3.0.0 – Portal V2.3.0) was done on PRD on June 27, 2023.
AMS Cybersecurity 1 includes a new feature for AMS Organisations connected to the AMS Hub via APIs: “Secret expiration management.
Implementation of new features :
Through the AMS Portal, AMS Organisations will be able to perform actions on secrets such as:
Create new secrets (limited to 2 secrets maximum)
Delete secrets
See the list of secrets available
See their expiration date
With these new features, the AMS Organisation will be able to automate their processes internally and via their own system.
Current Situation (before Cybersecurity 1) :
General explanation about secret’s expiration :
Secrets are the necessary keys which allow external systems to interact with the AMS Hub.
There are two types of secrets and the expiration of those secrets imply that the user will be completely blocked from using the AMS Hub.
The time set up before the expiration of those secrets is at most 2 years thus some secrets are bound to soon expire (IQE Sep 2023/PRD Oct 2023).
Risks involved :
For application secrets on Azure : The AMS components could potentially stop working.
For client secrets : AMS Organisation could become unauthorized to access the AMS Hub.
To mitigate both risks : The change (CR_24796: Secret expiration management) introduced with Release Cybersecurity 1 will include a notifications service via email to notify the clients. EMVO will also ensure that the information on the creation of the secret is part of the API Specifications document and Release Note.
What & who is impacted :
EMVO : AMS Hub & AMS Portal
NMVOs’ API
OBPs’ API
4- How to use the EAMS to manage alerts ?
Guidelines for Alert handling :
It proposes best practice for handling alerts generated in the EMVS. It sets out decision trees for investigation of alerts and the point at which the NCA must be notified. It also defines the role of end-users, MAHs, NMVOs and EMVO and describes communication channels between them, including alert management systems where they are in place.
EAMS Handbook :
This document at hand explains how the European Alert Management System (EAMS) can be used by MAHs to support alert handling as described in EMVO-00306 Best Practice on Alert Handling.
AMS public site :
Subscribe to AMS newletter in order to receive monthly updates
5- Acronyms :
EAMS : European Alert Management System
EMVO : European Medicines Verification Organisation
NMVO: National Medicines Verification Organisation
OBP : On-Boarding Partner
AMS : Alert Management System
NAMS: National Alert Management System
API : Application Programming Interface
NCA : National Competent Authority
ADN Team is expert in the serialization of drug. We are here to advise you, guide you and provide you with consultants for the management of alerts on AMS Hub and also the execution of validation system tests : NAMS / AMS.
Our team will support you throughout the serialization process to comply with the latest regulations and be informed of the latest updates and news regarding the alert processing process.
Article written by Siham OUTALEB : Head of Serialization pole & Consultant at ADN.
For more information : contact@adn.fr