Implementation of ePI: Leveraging Article 63 of the New EU Pharmaceutical Directive
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27 Apr Implementation of ePI: Leveraging Article 63 of the New EU Pharmaceutical Directive

Posted at 11:31h in Legislation, Regulatory Affairs by

Electronic Product Information (ePI) refers to the authorised, statutory product information for a medicine (i.e., the Summary of Product Characteristics, Package Leaflet and Labelling) in a semi-structured format. Unlike a simple PDF, ePI uses the HL7 FHIR (Fast Healthcare Interoperability Resources) international standard. This technical structure allows the information to be easily shared across different platforms and viewed on various devices, such as smartphones or electronic health records.

The Legislative Framework

The transition to ePI is anchored in the Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use (hereafter “the Directive”), which is currently in the final stages of formal adoption.

Specifically, Article 63 of the Directive provides the legal basis for a digital-first approach:

  • Establishes that the package leaflet (PL) may be made available in paper format, electronically, or both.
  • Grants Member States (MS) the specific authority to mandate that the PL be made available only electronically for certain categories of medicinal products or for all products in their territory.

 

The Technical Architecture: FHIR and the Resolver. EMA’s draft reflection paper on linking to electronic product information from EU medicine packages sheds some light on the technical setup. The system does not rely on a new, separate QR code. Instead, it utilizes the existing 2D DataMatrix mandated by Commission Delegated Regulation (EU) 2016/161 for anti-counterfeiting.

Scanning. The healthcare professional (HCP) or patient scans the existing DataMatrix. This scanning function is expected to be available to smartphones and it will not require any specialised hardware. At this stage it is not clear if a dedicated application will be necessary. Even without a smartphone’s camera, by using the human readable data of the DataMatrix patients/HCPs will be able to retrieve ePI online.

Resolver. This web-based service matches the Global Trade Item Number (GTIN) or other data carrier identifiers from the scan to the corresponding product entry in the EMA-EMRN FHIR repository.

Data Standard. ePI is built on the FHIR (Fast Healthcare Interoperability Resources) standard, ensuring the data is structured, machine-readable, and can be integrated into electronic health records (EHR). Having EMA repository as a single trusted source of ePI enables the immediate dissemination of updated safety information and variations, ensuring healthcare professionals and patients always have access to the latest data. Moreover, digital formats allow for features like adjustable font sizes, text-to-speech, and advanced search functions, which is particularly important for patients/HCPs with visual impairments or those who need to quickly locate specific dosage instructions.

The Bulgarian Case: Overcoming the Cyrillic Barrier

As a small market and the only EU member using the Cyrillic script exclusively, Bulgaria faces barriers to Multi-country packs: the inventory intended for Bulgaria requires a physical Bulgarian PL.

By utilising the derogations provided in Article 63(3), the Bulgarian Drug Agency (BDA) could prioritise the exemption of printed leaflets for hospital-only products. Transitioning to ePI—and subsequently removing the requirement for a physical Bulgarian Package Leaflet (PL)—works in synergy with the existing local exemption procedure for placing foreign-language batches on the Bulgarian market. This combination could potentially allow for the rapid diversion of stock from other EU Member States during shortages, eliminating the need for time-consuming over-labelling or repackaging. Furthermore, MAHs can produce single, regional multi-country packs, hosting the required national language versions (including Bulgarian) on the FHIR-based ePI platform.

Under Article 63, the patient’s right to a printed copy must be guaranteed free of charge upon request—a requirement easily managed within a hospital infrastructure.