06/2022 - DADI Project for Medicinal Products

The Digital Application Dataset Integration (DADI) Project aims to replace current PDF electronic application forms (eAF) with new web-based application forms, hosted on a dedicated portal.

The new web-forms will improve usability, reduce errors and facilitate data exchange (for example: automatic update of the article 57 database).

Timelines (see enclosed flowchart)

The first web-based application form - the variation form for human medicinal products - will be available for use from 10/2022 onwards. The use of this form is optional. A six month transition period is foreseen which means that from 04/2023 this form will become mandatory.

The aim is to switch all eAFs (initial marketing authorisations, variations for veterinary medicinal products and renewals) to web-based forms in the future.

DADI forms timeline
















In practice

Companies need to register with the EMA “IAM” portal to get access to the application forms (this is possible from June 2022 onwards). A level of access needs to be chosen per company user, and access rights need to be given to consultants.

The web based form will have a limited amount of free text fields and will use prepopulated standardized data from EMA databases/systems as source information. For example: only products which are registered in the article 57 database can be included in the web-based form.

Once the web-based form is completed, a human readable PDF document, in line with the Notice to Applicants, is  generated, together with an xml file.

The PDF document + xml file needs to be included in the eCTD folder for submission.

Further information can be found at: eSubmission: Projects (europa.eu)


Are you ready?

Do not hesitate to contact us if you need further information or help with these web-based application forms! We are ready to assist you!