"Variaton submission" enables pharmaceutical companies both to create national and european variations using the data stored with the Competent Authorities (CAs) and also to submit these generated variations directly to the CAs.

The "Variation submission" application is a sub-project of the "Electronic submission" application. Once fully developed, "Electronic submission" will support the submission of applications to the competent authorities (pursuant to legal regulation) for all procedures including the submission of marketing authorisation documentation. Together with other PharmNet.Bund applications, "Electronic submission" will be part of the communication platform for competent authorities and applicants.

Please note that from 26.10.2023 it will no longer be possible to submit variations according to Regulation (EC) No 1234/2008 via the application "Electronic Variation Submission". The sending of notifications of changes according to § 29 AMG and other notifications remains unaffected and is still required via the PharmNet.Bund portal.

Information on notifications to change the marketing authorization holder can be found on the BfArM website Follow-up Procedures - Variations.