The AMS Self-Qualification Process applies to National Alert Management Systems (NAMSs) and OBP AMSs connecting directly to the AMS Hub.
OBPs using only the AMS Portal to manage alerts do not need to complete the Self-Qualification Process.
Who must complete the Self-Qualification Process?
The Self-Qualification Process is required for:
An NMVO connecting its National Alert Management System (NAMS) directly to the AMS Hub.
An OBP connecting its own alert management system (OBP AMS) directly to the AMS Hub.
The process is not required for:
An OBP using only the AMS Portal.
When is a new Self-Qualification required?
A Self-Qualification may be required in the following cases:
The first connection of a NAMS or OBP AMS to the AMS Hub
A new NAMS or OBP AMS release that affects its interface or interoperability with the AMS Hub
A reconnection for which EMVO has requested a new Self-Qualification following interoperability or connection issues
Contractual requirements
The contractual requirements differ depending on the type of organization:
For an NMVO/NAMS, a Supplemental Agreement is required for the initial connection to the AMS Hub. The Supplemental Agreement is signed by the NMVO and EMVO only after the Self-Qualification documents have been completed, submitted, fully reviewed and approved.
For an OBP/OBP AMS, no Supplemental Agreement is required. The applicable EAMS OBP Terms and Conditions apply instead.
For an OBP using only the AMS Portal, the applicable EAMS OBP Terms and Conditions apply, but no Self-Qualification is required.
Detailed steps:
1. Request access to the qualification environment
The NMVO or OBP must first submit a ticket to the EMVO Helpdesk requesting the creation of its AMS organization and administrator user in the UAT environment.
The request must contain the following information:
New AMS Organization Request
Environment: UAT
Organization ID: ISO CODE of the NMVO or ORG ID of the OBP
Organization Name:
New AMS User Request
Environment: UAT
Organization ID: ISO CODE of the NMVO or ORG ID of the OBP
Admin: Yes
First Name:
Last Name:
Email Address:
The request must clearly state that the organization requires access for an AMS Hub connection and specify whether the candidate system is a NAMS or an OBP AMS.
The EMVO Helpdesk forwards the complete access request to the relevant support team for the creation of the organization and administrator user.
2. Retrieve the AMS Hub qualification credentials
Once the UAT organization and administrator user have been created, the administrator receives access to the AMS Portal in the qualification environment (AMS Portal).
The administrator must then log in to the AMS Portal and retrieve the AMS Hub credentials, including the applicable Secret ID and client ID, required to connect the candidate NAMS or OBP AMS to the AMS Hub qualification environment.
The organization can then prepare and test the connection of its system to the AMS Hub.
3. Request the start of the Self-Qualification Process
Once the candidate NAMS or OBP AMS is ready, the organization must submit a new ticket to the EMVO Helpdesk requesting the start of the AMS Self-Qualification Process.
The ticket should clearly identify:
The organization
The candidate system
Whether the system is a NAMS or an OBP AMS
The relevant system release or version
Confirmation that the qualification credentials have been retrieved
Confirmation that the organization is ready to begin the Self-Qualification Process.
EMVO Helpdesk then provides the applicable Self-Qualification documentation to the organization with the support of the EAMS Product Owner for the preparation of those documents.
4. Complete the Self-Qualification documentation
The NMVO or OBP performs the required Self-Qualification activities against the AMS Hub qualification environment.
The organization must complete the qualification documents provided by EMVO and record the results of the required tests.
The objective of the Self-Qualification Process is to demonstrate that the candidate NAMS or OBP AMS can connect to and interact with the AMS Hub in accordance with the applicable interface and interoperability requirements.
The organization remains responsible for the validation, qualification and correct operation of its own system.
Once completed, the Self-Qualification documentation must be returned for review through the related ticket to EMVO Helpdesk.
5. EMVO Helpdesk and EMVO QA review
EMVO Helpdesk forwards the Self-Qualification documentation submitted by the NMVO or OBP to the relevant EMVO QA representative for review.
If information is missing, unclear or requires correction, the documentation is returned to the organization for amendment.
The review continues until all required Self-Qualification documents have been completed and approved by the EMVO QA representative.
6. Sign the Supplemental Agreement for an NMVO/NAMS
For the initial qualification of an NMVO/NAMS, the Supplemental Agreement is processed only after the Self-Qualification documentation has been fully reviewed and approved.
The Supplemental Agreement must then be signed by both:
The NMVO authorized representative
EMVO General Manager
This step does not apply to an OBP/OBP AMS. OBPs do not sign a Supplemental Agreement for the AMS Hub connection.
7. Record the approved qualification documentation
After the following requirements have been completed:
The Self-Qualification documentation has been fully reviewed and approved; and
For an NMVO/NAMS, the Supplemental Agreement has been signed by both the NMVO and EMVO
EMVO QA records and finalizes the approved qualification documentation.
EMVO Helpdesk must await confirmation from the EMVO QA Representative that the Self-Qualification process for the relevant NMVO/OBP has been completed before proceeding.
Once confirmed, EMVO Helpdesk can notify the relevant NMVO/OBP that the self-qualification process has been successfully completed.
8. Request access to the Production environment
Once the Self-Qualification Process has been successfully completed, the NMVO or OBP can submit a new ticket to the EMVO Helpdesk requesting the creation of its AMS organization and administrator user in the Production environment.
The request must contain the following information:
New AMS Organization Request
Environment: PRD
Organization ID: ISO CODE of the NMVO or ORG ID of the OBP
Organization Name:
New AMS User Request
Environment: PRD
Organization ID: ISO CODE of the NMVO or ORG ID of the OBP
Admin: Yes
First Name:
Last Name:
Email Address:
The request must clearly state that it concerns the Production connection of the qualified NAMS or OBP AMS to the AMS Hub, including a reference to the ticket number where the self-qualification has been completed.
Before the request is forwarded for the creation of the Production access, EMVO Helpdesk must verify that:
The Self-Qualification process has been fully processed and approved for the relevant NMVO/OBP
Production credentials must not be provided before these requirements have been completed.
9. Retrieve the Production credentials and connect to the AMS Hub
Once the Production organization and administrator user have been created, the administrator can access the AMS Portal in PRD (AMS Portal).
The administrator must retrieve the Production AMS Hub credentials, including the applicable Secret ID and client ID, and use them to connect the qualified NAMS or OBP AMS to the AMS Hub Production environment.
10. Confirm the Production connection
Once the candidate system has successfully connected to the AMS Hub in Production, the NMVO or OBP must notify the EMVO Helpdesk.
For a new NMVO/NAMS connection, EMVO can then update the applicable internal documentation and communications to confirm that the country has joined the EAMS.
The on-boarding process is considered complete once the Production connection has been confirmed and the relevant post-connection activities have been performed.
All steps are described with more details in this document:
For further clarification to start the AMS Onboarding and Qualification process, please feel free to contact the EMVO Service Desk.
Email: helpdesk@emvo-medicines.eu