The European Medicines Agency (EMA) is transitioning from static PDF and Word documents to structured, dynamic electronic Product Information (ePI). This digital shift changes how pharmaceutical companies, CROs, and medical device manufacturers manage regulatory filings. It also introduces technical requirements that can disrupt submission timelines if a localization workflow is unprepared.
The EMA released the ePI-Guide for Translators to establish technical and linguistic guidelines for translating SmPCs, package leaflets, and labelling under this new digital framework.
Regulatory affairs managers, CRO directors, and translation vendor managers can use these details to keep Greek translation workflows compliant.
What is ePI and the EU ePI common standard?
Historically, product information (PI) was submitted and updated in Word or PDF formats. This caused fragmented updates and required manual copy-pasting. The new ePI initiative structures this data into a format based on the FHIR (Fast Healthcare Interoperability Resources) XML standard.
This common standard makes product information:
- Interoperable: It is readable by electronic health records and databases across the EU.
- Easily updatable: It allows rapid safety label and dosage updates across all official EU languages.
- Searchable: It helps healthcare professionals and patients find safety data on any device.
Why ePI translations require technical code expertise
Translating ePI files requires editing structured code directly because the files are in FHIR XML format.
Working with generalist translators or post-edited machine translation (MTPE) workflows creates three regulatory risks:
- Broken XML tags and validation errors: A misplaced bracket, altered tag, or missing attribute in the FHIR XML file causes a validation failure in the EMA PLM Portal.
- Terminology inconsistencies: The EMA requires exact adherence to standardized medical terminology. This includes EDQM and MedDRA terms. Generalist translators do not have the specialized experience to map these terms correctly within the XML structure.
- Formatting corruption: Translators working without specialized computer-assisted translation (CAT) tools can accidentally translate system strings or metadata. This corrupts the entire file.
The business impact of the ePI standards on your workflow
Preventing delays in European submissions requires treating translation as both a linguistic and technical process. For upcoming regulatory submissions, verify that your Greek translator:
- Knows the EMA ePI Guide for Translators.
- Processes FHIR XML files directly within a CAT tool without damaging the underlying code.
- Validates translated XML structures and escapes special characters properly before delivery.
Partnering with an experienced freelance medical translator who understands both the regulatory requirements and the technical formats protects your submission timeline from technical rejections.
Specialized Greek ePI translation services
As a specialized freelance medical translator running Greek Medical Translator, I deliver high-precision medical translation and localization for the Greek market. I have analysed the EMA ePI standards and provide Greek translation files that comply with the FHIR XML format. This helps you secure validation in the EMA PLM Portal.
If you are a pharmaceutical company or a specialized life sciences translation agency, I can help you with your transition by offering pharmaceutical translation services.
Contact me today to discuss your next Greek ePI translation project.
