Digital application dataset integration (DADI)
launch in October 2022

DADI is a Network project led by EMA which will support both centrally authorised product applications and nationally authorised product applications.

The main objectives are:

• replace current PDF-format application forms for marketing authorisation applications, variations, and renewals;
• provide a structured data format which can be imported into PMS services and reused in other submission related tasks;
• provide a readable PDF output;
• use an innovative solution for the interface.

The initial version of the form for variations for human medicinal products has been developed. This will be launched in October 2022 with the transition period up to April 2023, when the use of the variations web-form only will be required. For more information visit: eSubmission: Projects (europa.eu)