Germany's BfArM moves to nearly paperless submissions (eCTD)

From 31.03.2010 onwards the German Federal Institute for Drugs and Medical Devices (BfArM) will accept to receive nearly paperless electronic-only submissions for new applications for authorisation or registration of medicinal product as well as for post authorisation procedures (e.g. variations, renewals, PSURs) of those medicinal products which have already been submitted under this new rules after 31.03.2010.

More information on technical aspects and requirements including validation: Open here