Marketing authorisation holders, parallel distributors and parallel importers can connect to the EPL system to enter and provide digital package leaflets.

Feel free to send us an email at EPL-info@pharmaprotect.de. We will advise you individually and coordinate all further steps with you. To take part, a contract with PharmaProtect Solutions GmbH is required.

No, the EPL system is intended exclusively for marketing authorisation holders, parallel distributors and parallel importers.

After you get in touch, we usually provide advice and carry out a legitimation check. We then send you the contract. Once the contract has been signed, you receive your individual access credentials for the EPL system and can provide and maintain your package leaflets. The package leaflets are output once the contract has been concluded.

As a trusted source, the EPL system provides digital package leaflets centrally and is committed to high security standards.

Yes, you can. Taking part does not require any prior knowledge. You can make use of the support and training measures, familiarise yourself with the introduction of digital package leaflets and FHIR at an early stage, and acquire this knowledge before the upcoming legal obligation comes into force.

You only need a common operating system, an up-to-date browser, an email program and software for creating office or text documents (e.g. MS Word). You can enter your digital package leaflets either directly via the editor in the EPL system or, alternatively, via a service provider connected through an API.

• Benefits for electronic patient records
• Benefits for service apps
• Advertising-free

Private and statutory health insurance funds can connect.

Feel free to send us a no-obligation email at EPL-info@pharmaprotect.de. We will then advise you individually and coordinate all further steps with you.

Connecting is free of charge for statutory health insurance funds.

After you get in touch, we usually provide advice and carry out a legitimation check. We then send you an interface agreement and, where applicable, further documents. Once the contract has been signed, you receive access credentials for the EPL system's test environment as well as the interface information. After you have demonstrated that package leaflets can be retrieved correctly via your interface, you receive access credentials for the production environment.

To retrieve package leaflets based on product names or PZN (the German central pharmaceutical number), you need to develop an interface to the EPL system on your side. We will provide the information required for this on request.

The EPL system is aimed primarily at health insurance funds and other healthcare service providers. Feel free to get in touch if you are interested in using the EPL system.

For non-profit organisations, connecting is generally free of charge, apart from developing the interface yourself. Feel free to reach out to us about this.

The project offers a wide range of benefits and is primarily aimed at making digital package leaflets more easily available. You can find an overview of the benefits on the diGItal project page.

You can find detailed information and answers to the most important questions about the hospital pilot on the diGItal project page.

Fast Healthcare Interoperability Resources (FHIR, pronounced "Fire") is a modern international standard for exchanging electronic health data, developed by HL7. It uses web technologies such as JSON/XML and REST APIs to make health information accessible as modular "resources" (e.g. patient, diagnosis) and to enable interoperability between different IT systems. In doing so, PPS follows the EMA's specifications in order to ensure compatibility.

A package leaflet stored in FHIR format makes it possible to read out, process and display metadata or chapters in a targeted way. This enables, for example, a targeted check for interactions.

Yes. You can enter your package leaflets into the EPL system via the editor, where they are stored in FHIR format. Alternatively, there are also commercial providers that offer conversion of package leaflets into FHIR format and are already connected to our system.