DADI project update is now available. This update includes a timeline for the first forms to be released, a list of features of the human variation form and an updated questions & answers document.

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 [...]

An updated release schedule for the electronic Application Forms (eAF) is now available. The version 1.25.0.0 of the electronic Application Forms (eAFs) is planned for release at the end of September 2021 with a short 1-month transitional period and mandatory use from 1st of November 2021. The release v1.25.0.0 will provide a major change into [...]

The version 1.25.0.0 of the electronic Application Forms (eAFs) is planned for release at the end of September 2021 with short 1-month transitional period and mandatory use from 1st of November 2021. The release v1.25.0.0 will provide a major change into the section 2.2.4 (Medical Device) of the human MAA form as well as adding [...]

An updated version (v3.0) of the draft guideline on the specifications for provision of an electronic submission (eSubmission) for veterinary medicinal products (Draft VNeeS guideline) and further information is now available.

An updated version (v3.0) of the draft guideline on the specifications for provision of an electronic submission (eSubmission) for veterinary medicinal products (Draft VNeeS guideline) is now available. The updates appearing in track-changes have been implemented mostly to align with the VMP-Regulation (EU) 2019/6. Please note that more updates will be envisaged towards October 2021 [...]

The EMA would like to inform applicants and Marketing Authorisation Holders (MAHs) that as part of the development of the Substance, Product, Organisation and Referential (SPOR) data management services, and in anticipation to the upcoming Digital Application Dataset Integration (DADI) project, the registration in Organisation Management Service (OMS) will become mandatory from the 1st of [...]

The EMA would like to inform applicants and Marketing Authorisation Holders (MAHs) that as part of the development of the Substance, Product, Organisation and Referential (SPOR) data management services, and in anticipation to the upcoming Digital Application Dataset Integration (DADI) project replacing the PDF format eAFs, the registration in Organisation Management Service (OMS) will become [...]

The European Medicines Regulatory Network's Digital Application Dataset Integration (DADI) project has released a Questions and Answers (Q&A) document with further details about the purpose and scope of the project. The project team aims to follow up in the coming month with further details, including key milestones, the full list of features and the first [...]

The European Medicines Regulatory Network has launched a new telematics project called the Digital Application Dataset Integration project (DADI) to modernise and improve use of the EU electronic Application Forms (eAFs). DADI has been established as the successor to the Common European Single Submission Portal (CESSP) phase 1 project.