Últimas noticias
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 [...]
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.
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
Digital Application Dataset Integration (DADI) project
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 [...]
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 [...]
Updated eCTD EU M1 specification now available
The eCTD EU Module 1 specification has been updated. The updated EU M1 spec v3.0.4 and the related release notes are available here. There are no changes to the DTD and hence this version enters [...]
Updated EU M1 eCTD Specification
The EU eCTD Module 1 Specification has been updated to reflect clarifications and the updated version 3.0.4 is available for immediate use. Release notes with practical information on changes are provided below. There are no [...]
A new version of the eSubmission Gateway XML delivery file is now available A new version of the eSubmission Gateway XML delivery file is now available
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced changes to the delivery file (addition of ‘nitrosamine related’ radio button for initial variation submissions (human [...]
A new version of the eSubmission Gateway XML delivery file is now available
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced changes to the delivery file (addition of ‘nitrosamine related’ radio button for initial variation submissions (human [...]
A new version of the eSubmission Gateway XML delivery file for veterinary changes is now available
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is now available. This update has introduced changes to the delivery file (changes in the available submission [...]
A new version of the eSubmission Gateway XML delivery file for veterinary changes is planned for release in the evening of 8th March 2021
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is planned for release in the evening of 8th March 2021. This update will introduce changes to [...]
A new version of the eSubmission Gateway XML delivery file planned for release in the evening of 11th March 2021
An updated version of the eSubmission Gateway XML delivery file user interface is planned for release in the evening of 11th March 2021. This update will introduce changes to the delivery file (addition of ‘nitrosamine [...]
VHG reached a decision regarding mandatory use of the PDF/A format in VNeeS
Please be informed that the VHG reached a decision regarding mandatory use of the PDF/A format in VNeeS, starting after the transition period when the CESP dataset module becomes mandatory for all submission types. The [...]
Updated version of the VNeeS specification now available
The Guideline on eSubmissions for Veterinary products has been updated to version 2.7.1, applicable immediately. This minor change is Brexit related change in the list of country codes in table 4. This change has no [...]