We transform your electronic product information according to EU standards
Reliable, future-proof, and compliant
Electronic product information (ePI) is ready for takeoff. In an increasingly digitized healthcare sector, electronic product information is expected to become the new standard for medication information within the EU in the coming years. For ePI, the product information of medications is converted from an unstructured document, such as a Word or PDF file, into FHIR XML or JSON format, with the goal of making prescribing information, labeling, and package leaflets more easily accessible, interoperable, and integratable.
In June 2025, the European Medicines Agency (EMA) conducted a user acceptance test for import functionality, and we were permitted to test the new Fast Healthcare Interoperability Resources (FHIR) format together with our customers at an early stage as part of our transformation service. With our comprehensive regulatory knowledge and technical expertise in converting and validating product information, mt-g is here to support you too as you make the move to ePI.
Why HL7 FHIR for ePI?
Advantages of structured medication information in FHIR format
For electronic product information (ePI), the EU and EMA rely on the Fast Healthcare Interoperability Resources (FHIR) structured file format to ensure harmonized, accessible, and interoperable delivery of medication information. The decision to opt for FHIR over other formats is based on several strategic and technical considerations:
FHIR is an internationally recognized standard for exchanging health data, and it allows for seamless integration of ePI into electronic health systems. This helps to ensure constant access to accurate, up-to-date product information for healthcare professionals and patients.
Using FHIR allows product information to be provided in a structured format, which can be read by both humans and machines. This improves searchability, allows information to be personalized, and facilitates integration into digital applications.
With FHIR, ePIs can be updated as soon as new information is available, ensuring that patients and medical professionals always have access to the latest information.
ePIs are searchable and are available on digital devices and in multiple languages, ensuring maximum reach and ease of use.
FHIR allows ePI to be linked with existing EMA databases, which are based on the ISO IDMP standards and/or SPOR. The structured format means that the data is interoperable and can also be reused by the author, which, in turn, promotes standardization and facilitates integration of ePI into existing regulatory and clinical processes.
Opting for structured data in line with the FHIR standard supports the long-term vision of globally harmonized electronic product information aimed at improving international collaboration and the use of medication information.
Compliance meets technology: Our ePI solution
From unstructured data to HL7 FHIR-compliant ePI
As medication information continues to assume digital form, it is becoming increasingly important to deliver structured, machine-readable product information.
We can help you to convert your existing documents to a format with a FHIR-compliant data structure in line with the EU-compliant ePI standard. The conversion process is efficient, compliant, and tailored to your product.
Would you like to find out more about our comprehensive service package for EU regulatory labelling?
Our service offer for your ePI transformation:
- Conversion of Word/PDF documents into structured HL7 FHIR-based ePIs
- Compliance with the EU ePI Common Standard
- Support with regulatory requirements and validation
- Time savings and minimization of sources of error thanks to transformation and validation service
- Integration into existing regulatory labelling processes
- Translation into all 24 EU languages
What does transformation into FHIR format involve?
An overview of our process
In addition to technical expertise, producing structured electronic product information (ePI) also requires a deep understanding of regulatory requirements. Our proven process ensures that the conversion of your documents into FHIR format is efficient and that the resulting ePI is of a high quality and complies with the relevant standards. The following overview details the individual steps – from analysis to delivery:
FAQs
The product information (PI) of a medication comprises three key components: the package leaflet (PL) for patients, the summary of product characteristics (SmPC) for medical professionals, and the labelling. These documents are compulsory for all medicinal products authorized in the European Union, and they provide detailed information on correct use and prescription.
The EU ePI Common Standard introduces a common format for electronic delivery of medication information. The objective is to improve the availability of structured, digital content in the EU so that both healthcare professionals and patients are able to access the information that will allow them to use medications safely.
No, electronic product information (ePI) is not currently compulsory in the European Union. It is being introduced gradually and on a voluntary basis, starting with centrally authorized medicinal products. Together with national authorities and the European Commission, the European Medicines Agency (EMA) has initiated pilot projects to test and refine the integration of ePI into regulatory processes. A broader implementation is planned in the long term, but a legal obligation to adopt the format has so far not been imposed.
Electronic product information (ePI) differs from conventional product information (PI) in several ways, including data format, structure, updates, availability or accessibility, and ease of use.
You can find out more about the differences in our glossary.
FHIR (Fast Healthcare Interoperability Resources) provides a structured, standardized basis for the digital exchange of medication information. The standard allows for seamless integration into electronic health systems and ensures high levels of interoperability across systems and borders. Its flexible, modular structure means that information can be updated and efficiently adapted in real time. FHIR supports modern web technologies, making it easier to implement and use for both developers and users.
There are clear requirements for electronic product information (ePI) in the EU in line with the EU ePI Common Standard, which was developed by the EU Network Data Board on behalf of the European Medicines Regulatory Network. The standard is based on the HL7 FHIR format and stipulates that the data must be structured, machine-readable, and interoperable. ePIs must be up-to-date, easily accessible, user-friendly, and able to be integrated into regulatory processes. The objective is to enable EU-wide harmonization and improved provision of reliable medication information.
The language requirements for electronic product information (ePI) in the EU are determined by the respective authorization procedure:
- Centrally authorized medicinal products: For products approved via the centralized EMA procedure, the ePI must be made available in all official EU languages.
- Nationally authorized medicinal products and/or medicinal products authorized via MRP/DCP: For national authorizations, the ePI must be provided in the official language of the respective member state.
In the long term, the intention is for ePIs to be provided in all EU languages to improve accessibility for patients and medical professionals.
You can find more information on our Regulatory Affairs page.
FHIR (Fast Healthcare Interoperability Resources) is already used in a variety of ways in the healthcare sector, such as, for example, in mobile health applications and for exchanging patient data between electronic health records (EHRs). It also supports research projects and clinical studies by standardizing data access. Public health surveillance and secure data exchange between various healthcare facilities are also facilitated by the use of FHIR. Overall, FHIR promotes interoperability and improves access to health information.
Structured data is organized in a defined format, for example, in tables, databases, or standardized file formats, such as HL7 FHIR. It consists of clearly defined fields (e.g., product name, dosage, active substance), which can be easily and automatically processed, searched, and analyzed.
By contrast, unstructured data is found in free text or documents. It can be easily read by people, but it is difficult for IT systems to analyze automatically, as it has no common structure or semantic markup.
