EAMS Onboarding for MAHs (Access, Teams, Workflows, and Day-to-Day Setup)

How is EAMS different from national alert systems?

EAMS functions as the European coordination layer for alert management, enabling communication between all actors in the alert investigation process, including MAHs, NMVOs, end-users, and EMVO and to support the alert-handling best practices and decision trees. 

National systems operate at the country level a National Alert System (NAMS) is a country-level system and supports investigations inside that country and may not always be fully connected to the AMS Hub, meaning MAHs may need other communication routes for investigation outcomes in those cases.

In other words, national systems are the local operational layer, while EAMS is the Europe-wide framework that helps standardize how alerts are coordinated and documented across stakeholders. Therefore, alert handling may require both centralized coordination and country-specific communication pathways.

Why is AMS OBP-based and what does that mean for MAHs?

As EMVO does not maintain a direct legal relationship with MAHs, OBPs are responsible for creating users and structuring access.

For MAHs, this means your onboarding success depends on access governance and segmentation: who your OBP is, how accounts and teams are structured, and whether market coverage and ownership are designed for daily execution.

How do teams and markets affect alert visibility?

In the AMS Portal, teams are how you control visibility. EMVO’s guidance shows that administrators create a team and then assign markets (countries) and members to that team. Market selection under “alerts raised in” determines which country alerts that team can see.

Practically, if a user is not in the right team, or the team does not include the right markets, alerts can become effectively invisible to the people who should act. That is why a scalable pharma supply chain digital transformation approach uses role-based teams (triage, investigation pods, IT diagnostics, packaging QA) rather than one global group.

When should MAHs escalate an alert?

Escalation is appropriate when standard investigation cannot progress, when patterns indicate potential systemic issues (same SKU, batch, market, or location), or when NMVO coordination is required to maintain end-user anonymity and move the case forward.

Operationally, EMVO explains that when a user escalates an alert, it is marked as “Escalated” and highlighted so all users concerned by the alert can see the status.

From a patient safety and compliance perspective, the handbook also emphasizes that national authorities should be informed about a suspected falsification as soon as technical reasons can be ruled out, so escalation should not be delayed when you are approaching that threshold.

What evidence should MAHs request first?

Initial evidence should focus on quickly narrowing down the likely root cause, whether the issue originates from data, system behavior, or packaging execution.

In practice, an effective first evidence set typically includes:

• A clear photo of the pack, capturing both the 2D Data Matrix and human-readable batch and expiry
• Confirmation of EU Hub upload and data availability, including timing and any retries
• Reference batch master data for the affected SKU (expected batch and expiry values)
• Relevant packaging documentation where applicable (e.g., packaging order or line clearance evidence)
  
  

The objective at this stage is not to complete the investigation, but to rapidly eliminate common technical and procedural causes and focus efforts where deeper analysis is required.

How do country-specific requirements affect workflows?

Country-specific requirements can modify or override the standard alert handling flow. In some markets, local procedures differ from the general guidelines, requiring additional steps or alternative communication paths.

In practice, this is best managed through a modular SOP structure: a single global workflow supported by country-specific appendices. This allows consistent execution while ensuring local requirements are fully addressed.