EMA Implementation Timeline

2026 → 2028. The transition is now.

The EMA Management Board adopted a concrete implementation roadmap in March 2026. The rollout is phased by therapeutic area to ensure system stability.

① Vaccines

Q3 2026

English ePI via the PLM Portal. Centrally Authorised Products in ATC J07 go live — Marketing Authorisation Holders can begin submitting FHIR ePI bundles alongside the existing PDF QRD.

② Oncology

Q4 2026

Therapeutic expansion. Oncology products and biosimilars join the voluntary phase, broadening the range of ePI submitted through the PLM Portal.

③ Stabilisation

2027

Hypercare and multilingual ePI. Translation workflows, IRIS eSubmission integration and network-wide operations stabilise across all EU official languages.

④ Mandatory

2028

EU-wide mandatory ePI under the EU Pharmaceutical Legislation Reform. Existing products migrate on renewal; paper leaflet exceptions apply for hospital-only products and declared public-health emergencies.

Key Requirements

For Marketing Authorisation Holders

The 2026 regulatory landscape necessitates a transition toward digitised product information. These are the focus areas that matter.

PLM Portal Integration

Marketing Authorisation Holders are now required to use the PLM portal's ePI editor — the centralised interface for direct authoring or uploading of electronic product information.

Structured Data (HL7 FHIR)

Mandatory shift from Word/PDF document workflows to structured FHIR data formats, ensuring interoperability and consistency across the European regulatory network.

Physical-to-Digital Linking

Standardised 2D data matrix codes (QR) provide a verifiable link between physical packaging and the corresponding digital ePI.

Paperless Labeling Exceptions

Provisions for omission of physical leaflets in specific cases — hospital-only medications or declared public health emergencies — provided ePI is accessible.

2026 MAH readiness priorities

Digitize

Move from document-based product information to structured electronic product information.

Integrate

Adopt the EMA PLM Portal and HL7 FHIR standards across your regulatory operations.

Connect

Enable standardised QR / 2D Data Matrix access from the physical pack to the digital ePI.

Comply

Support evolving requirements, including eligible paperless labeling scenarios.

Production-ready today

Alnexia is ready for the EMA ePI transition — now.

We are not waiting for the mandatory date. Our authoring, conversion and submission pipeline is operating against the published EU ePI Common Standard today, benchmarked against the leading commercial platforms (ArisGlobal LifeSphere Regulatory, Docuvera READY! for ePI, myHealthbox eLeaflet).

EU ePI Common Standard (hl7.eu.fhir.epil v1.0.0) conformant output
PLM Portal API integration and IRIS eSubmission ready
SPOR / IDMP referential mapping in production
GS1 Data Matrix link between physical pack and digital ePI
HL7 validator_cli.jar evidence attached to every submission
Parallel-output benchmarking vs ArisGlobal LifeSphere, Docuvera READY! and myHealthbox eLeaflet

Start your migration See the workflow

Sources