The EPL System stores package information for medicinal products together with the associated metadata in FHIR format as a trusted source. The package information is uploaded and released by the respective marketing authorisation holders. Package information can be retrieved via the product name, the PZN or, in future, by scanning the DMC on the pack.

How do I provide my
package information?

Marketing authorisation holders, or their representatives, can upload and edit/update package information in the EPL System through various channels:

1. Via the ePIL entry in the EPL System web portal

In the basic variant, entry is done by inserting the individual chapters.
In the full-service variant, the entire ePIL document can be submitted in a single step.

2. Direct connection via the EPL API

If an in-house software solution is already used to create an ePIL FHIR-based document, this software can be connected directly to our system interface (eAAPI) to transfer the finished, released ePIL documents.

3. With a service provider

Alternatively, finished ePIL documents in FHIR format can be created by a service provider (e.g. Rote Liste Services GmbH). The service provider then handles the connection to our interface (eAAPI) for transferring the documents using their software.

  • Automatic import of package information from the EMA is also planned, as soon as this is offered by the EMA. Marketing authorisation holders can then adjust this package information in the EPL System afterwards (e.g. logo assignment or adding chapter 8).
  • Further input methods are currently under discussion and will be guided by the needs of the marketing authorisation holders.
  • An option to download your own package information in FHIR format is also planned.

Output channels

Health insurers and other parties with a legitimate interest can retrieve package information via the product name, the PZN or, in future, via the product code through the API (eCAPI) and display it in their own applications. Thanks to transmission in FHIR format, individual chapters can be displayed selectively.

If you are interested, feel free to contact us at epl-info@pharmaprotect.de.

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