On 23 May 2022 the EMA published the updated excel sheet listing all fields in the Variation and Medicinal Product on the DADI website. The excel sheet contains a hierarchy overview of the sections, section numbers and names, and business rules. It furthermore includes the Fast Healthcare Interoperability Resources (FHIR) mapping resources and the classification codes from the Variation Classification Guideline.
The Digital Application Dataset Integration (DADI) project will replace PDF electronic application forms (eAF) used for regulatory submissions with online forms, making the future form-filling and submission-handling process more efficient.
DADI is a European medicines regulatory network project that addresses eAFs for both centrally authorized products (CAPs) and nationally authorized products (NAPs). The new web-based forms will be aligned with EU Implementation Guides for human and veterinary medicinal product data description, using the FHIR data standard.
The Conceptual Data Models of the human variation FHIR message and the medicinal product in a variation FHIR message are now also available on the DADI website.