DE: BfArM publishes announcement regarding electronic-only submissions

!Updated 01-Mar-2010!

Today the German drug regulatory agency BfArM published an announcement detailing the plans for accepting electronic-only submissions for medicinal products for human use (see link below).

The current plan foresees to accept electronic-only submissions in eCTD and NeeS format from 31 March 2010 onwards. The following documents still need to be provided additionally in original paper format:

• Cover letter
• Application form
• Statement of the experts
• eCTD validation report

BfArM requests that the eCTD or NeeS submission should be subject to technical validaton before submission, a corresponding validation tool will be provided by BfArM. More detailed information and instructions for applicants will be published on the BfArM website around 26 March 2010.

[Source: BfArM website]

Please note that the announcement is currently available in German language only

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