Digital mailbox and digital notification consent
BfArM is continuously working on the development of digital communication structures. The digital mailbox opens up the possibility of delivering official notices and other documents digitally in a legally compliant manner. The digital delivery replaces paper delivery.
Pursuant to Section 41 Subsection 2a VwVfG, the party involved has to submit a declaration of consent for an electronic administrative act to be published by the party involved or their authorized representative via publicly accessible networks.
In the case of consent to use the digital mailbox BfArM will automatically place the documents in the digital electronic mailbox of the pharmaceutical company from the date of transmission of the declaration. Access to the mailbox can be activated by the company's main user via RuBen.
From August 5th, 2025, notices and other documents are uploaded by the BfArM to the company´s digital mailbox in several development stages. With the launch of the digital mailbox, national marketing authorization notices for duplicates and informed consent marketing authorization notices will be delivered electronically in a first step.
A document with a qualified electronic signature according to § 3a VwVfG is required to consent to the use of the digital mailbox, as this waives the written form requirement for the granting of a marketing authorization and the allocation of a marketing authorization number in accordance with Section 25 Subsection 1 AMG.