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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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!