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Variation Submission

"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.

Access and user authorisation

There is a role-based, central authentication and registration for the access to applications. The roles differentiate between the administrator in the higher federal authorities and the main user(representative) in a company or an authority. Other users are created and administrated by the representative.

In addition to customer data a X.509-certificate is needed for a first registration. This ensures sufficient safety for authentication and authorization.

More information about the certificate, request access authorization and user administration can be found in the user manuals below.

Last modified: 2/16/21

Your position:  Homepage » For Companies » Variation Submission

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