BfArM - Federal Institute for Drugs and Medical Devices

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Non-submission renewals

Marketing authorisation holders are able to notify the reasons for the non-submission of an application for renewal in accordance with Section 29 sub-section 1g AMG electronically by using this online procedure.

The notification obligations have been extended since 28 October 2013 as laid down in Section 29 sub-section 1g AMG.

Further information on the notification obligations is available on the BfArM website:
Written renouncement

Non-submission renewals

Online procedure to declare the reasons for the non-submission of an application for renewal

Non-submission renewals

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