European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - final

Examples

ePI Samples

To support learning about the ePI FHIR resources described in this Implementation Guide, we provide a few samples containing validated examples of Summary of Product Characteristics (SmPC), Annex II, Labelling, and Package Leaflet documents.

Released Packages

In addition to validating Bundle and Composition resources, EU electronic Product Information (ePI) Composition resources are checked for their level of compliance with published Quality Review of Documents (QRD) templates.

ePI documents contain mandatory, non-mandatory, and additional sections:

  • Mandatory sections are required by legislation and defined in the QRD template. They cannot be moved or deleted.
  • Non-mandatory sections are optional; however, their headings and position are defined in the QRD template. They cannot be reordered, but can be renamed where necessary.

To check compliance with QRD templates, please download and use the structure definition files below. These files contain structure definitions for both Centrally Authorised Products (CAP) and Nationally Authorised Products (NAP).