DADI Project update now available
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.
DADI Project updated Questions and Answers document, Features List and project summary presentation now available
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 [...]
Call for volunteers for eAF v1.25.0.0 (reflecting the updated Medical Devices regulation)
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 [...]
Updated release schedule for eAF now available Call for volunteers for eAF v1.25.0.0 (reflecting the updated Medical Devices regulation) Updated technical documents for eAF v1.25.0.0 now available
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 [...]
Extended deadline for mandatory use of OMS for all CAP submissions
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.
Updated draft version of the VNeeS specification v3.0 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 [...]
Mandatory use of OMS in eAF for all CAP submissions
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 [...]
Mandatory use of OMS in eAF for all submissions to EMA
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 [...]
DADI Project Questions and Answers now available DADI Project Questions and Answers now available
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 [...]
Introduction
The Digital Application Dataset Integration (DADI) project will replace the current PDF-file based electronic application forms (eAFs), making the future form-filling and submission handling process more efficient. The new web-based system will be aligned with EU Implementation Guides for human and veterinary medicinal product data description, using the Fast Healthcare Interoperability Resources (FHIR) data standard, [...]