Keep EU-FMD operations connected, visible and ready to act.
Manage the data, partners and workflows behind EU-FMD compliance from one connected platform. Movilitas.Cloud helps pharmaceutical teams prepare serialization data, connect with the EU Hub and investigate alerts across European markets.
A connected framework for safer medicines.
The EU Falsified Medicines Directive and its delegated regulation introduce safety features and verification requirements for medicinal products placed on the European market. For medicines in scope, these features include a unique identifier in a 2D Data Matrix and an anti-tampering device. For MAHs and their partners, effective operations depend on accurate data, reliable connectivity and timely investigation of alerts.
Identify each pack
Prepare and maintain the product and serialization data required for unique identification.
Exchange through the EMVS
Move the required product and pack information through the European Hub and connected national systems.
Verify and investigate
Support verification, decommissioning and alert-related workflows across authorised supply-chain partners.
Built for the teams behind every compliant pack.
Marketing authorisation holders
Coordinate product data, outsourced production, market reporting and exception handling.
Contract manufacturers and 3PLs
Exchange commissioning, aggregation and serialization data with the organisations that need it.
Regulatory and quality teams
Review and investigate alerts and maintain the context behind follow-up actions.
Supply-chain operations
Keep manufacturing, packaging, distribution and market-release activities aligned.
Make EU-FMD work visible across your network.
Movilitas.Cloud connects the operational steps between product data, packaging, partners and market systems in one configurable environment.
Serial number management
Generate and manage serial number pools, identifiers and lifecycle histories.
EU Hub connectivity
Support configured exchanges of product data and serialization events with the European Hub.
Commissioning and aggregation
Maintain pack status and the relationships between items, cases and pallets.
Alert visibility
Identify failures, bring the relevant context together and support timely investigation.
Partner connectivity
Connect CMOs, 3PLs and external repositories within the required workflow.
Reporting and audit trail
Keep requests, responses and operational histories accessible to responsible teams.
Connect the systems. Clarify the next action.
Movilitas.Cloud connects the systems and organisations that create, move and verify serialized products.
Serial numbers
Create, source and allocate identifiers.
Commission and aggregate
Capture status and packaging relationships.
Exchange with the EU Hub
Send configured product and pack events.
Monitor responses
Keep outcomes and alerts visible.
Investigate and resolve
Use product, batch and partner context.
Built around European operating realities.
Support the workflows your teams need while keeping responsibilities, market requirements and regulatory connections clear.
Turn requirements into repeatable operations.
Build from the products, partners, systems and markets that define your European serialization landscape
Map your network
Identify the products, markets, partners, systems and responsibilities in scope
Connect the data
Bring together master data, serialization events and configured EU Hub processes.
Define the response model
Set visibility, ownership and follow-up paths for failed requests and alerts.
Extend across markets
Adapt the operating model as products, partners and national requirements evolve.
EU-FMD questions, answered.
Every setup depends on your role, products, partners and markets.
EU-FMD refers to the EU framework for preventing falsified medicines from entering the legal supply chain, including safety-feature and verification requirements.
Yes. Movilitas.Cloud supports MAH and CMO collaboration, including serial number allocation and the exchange of commissioning and aggregation data.
Yes. Movilitas.Cloud supports MAH and CMO collaboration, including serial number allocation and the exchange of commissioning and aggregation data.
Yes. Movilitas.Cloud supports MAH and CMO collaboration, including serial number allocation and the exchange of commissioning and aggregation data.
Yes. Movilitas.Cloud supports MAH and CMO collaboration, including serial number allocation and the exchange of commissioning and aggregation data.
Yes. Movilitas.Cloud supports MAH and CMO collaboration, including serial number allocation and the exchange of commissioning and aggregation data.
See how Movilitas.Cloud fits your lines, systems and partners.
Bring one real manufacturing workflow to the conversation. We will map the data, connections and capabilities it requires.
