The European Medicines Regulatory Network’s Digital Application Dataset Integration (DADI) Project to replace electronic application forms is pleased to announce an update of information on the project. Within the next couple of weeks, we also aim to share an example of the variations form FHIR message based on the draft specification. Please keep an eye on updates for the latest news on DADI. The next update will be shared in September 2021. The Digital Application Dataset Integration Project (DADI) will replace current PDF-based electronic application forms with new web-forms. DADI will replace the form for variations for human medicinal products first in 2022, followed by other submissions forms in 2022-2023 for centrally and nationally authorised products. Introducing new technology for forms is a key step to optimising submissions handling processes and enabling the full use of product management services master data.
