Contact
E.1. Whom do I contact if I have questions regarding the sunset clause?
Questions not addressed in the FAQ or in the Explanatory Notes on Notification Procedures under the "Sunset Clause" can be sent to the e-mail address sunset-clause@bfarm.de .
For questions regarding registration or certificates please contact helpdesk-technik@bfarm.de .
Information on certificates, request access authorisation and user administration can be found in the PharmNet.Bund application Notifications for Sunset Clause.
E.2. How and when are applications for exemptions pursuant to Section 31 sub-section 1 sentence 2 AMG or applications for suspension of the 3-year period in accordance with Section 31 sub-section 1 number 1 AMG to be submitted?
An electronic application portal for exemptions and suspensions to the sunset clause was developed which should be used for submitting such applications. We expressly request to use this electronic procedure as opposed to conventional applications.
The PharmNet.Bund application “Sunset Clause - Exceptions”
It is recommended to submit these applications at least 3 months before, but in no event later than, the end of the 3-year period in accordance with Section 31 sub-section 1 number 1 AMG. Applications received after this deadline can no longer be considered, as the marketing authorisations have already expired by law at this point in time.