Digital notification consent
BfArM is continuously working on the development of digital communication structures. The digital mailbox opens up the possibility of delivering official notifications 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.
Notifications and other documents are uploaded to the digital mailbox by BfArM in several development stages. You will soon find information about the types of documents that will be placed in the digital mailbox on this page.
A document with a qualified electronic signature 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.