The European Medicines Verification Organisation (EMVO) has published an important update for pharmaceutical companies and On-Boarding Partners (OBPs) connected to the European Medicines Verification System (EMVS).
EU Hub Release 1.20, currently planned for January 2027, will introduce the new Schema 2026.1, together with upcoming changes to EU Hub endpoints and certificates.
For Marketing Authorisation Holders (MAHs), serialization teams and IT providers, the key message is simple: 2027 preparation should not be treated as a single “EU Hub upgrade”.
Schema migration, endpoint migration, certificates, serialization platform compatibility and validation are separate — although interconnected — workstreams.
What is changing?
According to EMVO, EU Hub Release 1.20 is currently planned for January 2027 and will introduce Schema 2026.1.
Importantly, existing Schema versions 2018.1 and 2021.1 will remain available during a defined transition period.
EMVO nevertheless recommends that OBPs start preparing for migration to Schema 2026.1, which is positioned as the recommended long-term version.
This distinction is important.
The introduction of Schema 2026.1 in January 2027 does not automatically mean that every OBP must migrate its current Schema on the day Release 1.20 goes live.
Companies should therefore assess their current configuration and define a migration strategy based on their serialization platform, Gateway Provider, validation requirements and other ongoing projects.
New endpoints and certificates are also coming
Schema migration is only one part of the change.
EMVO has also announced that new EU Hub endpoints and certificates are expected towards the end of 2026.
OBPs migrating to Schema 2021.1 or Schema 2026.1 will need to complete the required endpoint migration before March 2027, when the current endpoints are planned to be discontinued.
For pharmaceutical companies, this means that at least four areas should be assessed independently:
- Schema compatibility and migration
- EU Hub endpoint migration
- Certificate management
- Serialization platform and Gateway compatibility
Treating all four activities as one generic “EU Hub upgrade” may create unnecessary complexity or, conversely, hide dependencies that could later affect connectivity.
What should pharmaceutical companies do now?
Companies connected to the EU Hub should already be discussing the change with their serialization or Gateway Provider.
At minimum, the following questions should be answered:
Which Schema version are we currently using?
Which version does our provider recommend as the target for 2027?
Which software release will support Schema 2026.1?
When will the new EU Hub endpoints be available?
Will new certificates require configuration changes?
What validation or regression testing will be required?
What is the proposed production cutover and rollback strategy?
These questions become particularly important for companies that are simultaneously preparing other major serialization projects, such as the Italian FMD transition in 2027.
Where possible, companies should avoid placing unrelated technical changes unnecessarily on the same critical path.
EMVO is also focusing on alert prevention
Release 1.20 is not the only relevant part of EMVO’s latest update.
EMVO has also published practical recommendations intended to reduce recurring alerts across the EMVS.
Many of these alerts are not caused by complex system failures. They originate from relatively simple data or process inconsistencies that can be prevented before packs enter the supply chain.
A2 alerts: Batch IDs are case-sensitive
Differences between uppercase and lowercase characters can result in an A2 alert.
Batch IDs should therefore be transferred consistently between ERP, serialization systems, packaging lines and the EMVS.
This is particularly relevant where Batch IDs are manually entered or transformed between systems.
A3 alerts: ensure serialization data is uploaded before batch release
An A3 alert may occur when a serial number being verified cannot be found in the EMVS.
EMVO recommends the following sequence:
- Generate serial numbers.
- Apply the Unique Identifier to the pack.
- Complete packaging and reconciliation.
- Remove packs intended for QC testing, retention/reference samples or destruction.
- Upload the relevant Unique Identifier data to the EMVS.
- Release the batch for sale or distribution.
This is not simply a good practice.
Under Article 33 of Commission Delegated Regulation (EU) 2016/161, Unique Identifier information must be uploaded to the repository system before the medicinal product is released for sale or distribution.
For companies working with Contract Manufacturing Organisations (CMOs), this raises an important operational question:
Who confirms that the EMVS upload has been successfully completed before batch release?
The answer should be clearly defined within procedures and, where appropriate, Quality Agreements.
Samples should also be considered carefully
Retention, reference and quality-control samples that are identified during packaging should generally not be uploaded to the EMVS.
If packs have already been uploaded and are later designated as samples, EMVO recommends decommissioning them using the appropriate SAMPLE status.
This is a small operational detail that can prevent unnecessary inconsistencies later in the product lifecycle.
A7/A24: check the pack status before performing another operation
EMVO also highlights alerts generated when an operation is attempted on a pack that has already been decommissioned or is in an incompatible state.
Before performing Product Status Updates, organisations should confirm the current pack status and, when investigating alerts, review the Pack Last Update Location (PLU).
Successful callbacks should also be confirmed before subsequent operations are performed.
One pack before thousands
One of the simplest recommendations may also be one of the most effective.
Before performing verification or decommissioning operations in bulk, EMVO recommends testing the intended operation on one pack first.
If the expected result is returned, bulk processing can proceed.
A configuration or status error affecting one pack is an incident.
The same error applied to several thousand packs can become a major investigation.
Alert prevention should become part of serialization governance
After several years of FMD operation, pharmaceutical serialization in Europe is increasingly moving beyond basic connectivity and compliance.
The question is no longer simply:
“Can we upload serialization data to the EU Hub?”
Companies should increasingly be asking:
“Are our processes preventing avoidable alerts before the product reaches wholesalers, pharmacies or hospitals?”
A practical EMVS alert-prevention assessment should therefore consider:
- Batch ID consistency across systems
- GTIN/Product Code governance
- Upload-before-release controls
- QC, retention and reference sample management
- Pack status checks
- Pack Last Update Location
- Callback handling
- Bulk operations
- Alert investigation and root-cause ownership
For companies working with multiple CMOs, these controls should also be reflected in responsibilities and Quality Agreements.
Preparing for 2027
The upcoming EU Hub changes do not require pharmaceutical companies to panic, but they do require planning.
The most effective approach is to separate the work into clear streams:
Schema migration
Endpoint migration
Certificate management
Serialization platform compatibility
Validation and regression testing
EMVS alert-prevention controls
Companies that assess these areas early will have significantly more flexibility to coordinate their 2027 serialization roadmap without unnecessarily combining multiple regulatory and technical projects into the same implementation window.
At PDG Consultant, we support pharmaceutical companies and CMOs with serialization readiness assessments, EU FMD/EMVS compliance, system migrations, validation, alert investigation and global Track & Trace implementations.
For organisations preparing for EU Hub Release 1.20 or reviewing their EMVS alert-management processes, now is the right time to understand the current configuration, identify potential gaps and define a controlled migration strategy.
Sources
European Medicines Verification Organisation (EMVO), Latest EMVS Updates & Alert Prevention Guidance, 28 August 2026.
European Medicines Verification Organisation (EMVO), Q&A EU Hub Schema Change, 12 August 2026.
Commission Delegated Regulation (EU) 2016/161, Article 33.
