Welcome to our FAQ page! Here you will find answers to frequently asked questions about joining our program and detailed information about our project. We hope you find this information useful. Should you have any further questions, please do not hesitate to contact us: Click here for the contact form.
The diGItal pilot project is aimed at marketing authorization holders, parallel distributors, and parallel importers.
The following requirements and steps apply for participation in the diGItal pilot project:
Registration for the pilot project includes access to the project components SHI integration, supply & delivery shortages, and hospital pilot.
Yes, to participate in the diGItal pilot project, you must register separately at Registration - diGItal Pilot Project (di-gi-pilot.de) and signing of a participation agreement is required.
If you are already a GI4.0 participant, you can easily incorporate your existing structured EPIL into the project.
Each marketing authorization holder, parallel distributor, or parallel importer must conclude their own participation agreement.
No, the diGItal pilot project is aimed exclusively at marketing authorization holders, parallel distributors, and parallel importers.
The uploaded instructions for use can be accessed by various user groups: from hospitals to insured persons and the general public. Therefore, incorrect or abusive uploads of instructions for use to the database must be prevented.
To ensure the highest possible data quality, ACS relies on the legitimation process already successfully established for access control within the framework of the FMD.
You can register for the pilot project at any time. Early participation will give you sufficient time to test and help shape the digitization of your product information. A signed participation agreement is required to participate in the diGItal pilot project.
Yes, you can participate even if you have not yet dealt with the topic internally. You can take advantage of the support and training measures, familiarize yourself with the introduction of elecronic product information at an early stage, and incorporate this knowledge into your project planning.
The pilot project is being carried out in collaboration with Rote Liste Service GmbH and is based on the same technologies (such as GI4.0). The goal remains to create a simple and widely accessible platform. Therefore, all you need is a common operating system, an up-to-date browser, an email program, software for reading and editing PDFs, and software for creating Office documents or text documents (e.g., MS Word).
The project offers a wide range of benefits and aims primarily to make digital user information more easily available. For the duration of the project, you can benefit from the following advantages:
We are seeking an exemption for medicinal products that
No. Integration into statutory health insurance apps is possible without special official approval and can therefore be implemented promptly.
In this case, regardless of the pilot project, approval from the BfArM (Federal Institute for Drugs and Medicia Devices) is required for marketing in a language other than German in accordance with Section 10 (1a) / Section 11 (1c) AMG. The diGItal pilot project will make German patient information significantly more accessible.
The exemption has been applied for and a response from the authorities is still pending. Regardless of this, the project components SHI app integration and delivery bottleneck mitigation are available.
No. Participation in the diGItal pilot project includes all pilot components: SHI app integration, delivery bottleneck mitigation, and hospital pilot.
A selection of project components can be made indirectly by specifying the EPIL contributed: If, for example, only pure hospital products were contributed, these would not be visible in SHI apps and would also not be available for delivery bottleneck mitigation.
We recommend using the project components as broadly as possible.
You can get individual advice on the individual pilot components from the PMO team to understand the extent to which all or only some components are useful and valuable for your company.
As soon as possible; products can be nominated until June 2026 (further extension possible). The longer products participate in the pilot project, the longer the evaluation period, so early involvement is recommended.
Once you have been verified and your login details have been sent to you, you will also receive an email containing a link to complete your registration on the diGItal server. You can create and save a password that only you can see directly on the diGItal server. This protects you against unauthorized third parties both inside and outside the system.
