27.04.2015

National implementation of EU eSubmission roadmap - information from German BfArM and PEI

In line with the EU eSubmission roadmap that was adopted in November 2014, the German drug regulatory agencies BfArM and Paul Ehrlich Institute (PEI) have released corresponding information for Applicants concerning the electronic submission of dossiers for human medicinal products in Germany. The following important milestones apply in accordance with the EU roadmap:

  • 01 July 2015: New initial Marketing Authorisations in the Decentralized Procedure must be submitted in eCTD format only. This includes duplicate applications (German "Dubletten")
  • 01 January 2016: Usage of electronic Application forms will be mandatory

  • 01 January 2017: New initial Marketing Authorisations in the Mutual Recognition Procedure must be submitted in eCTD format only. This includes duplicate applications, Repeat-use procedures and Extension applications.

  • 01 January 2018: eCTD format will be mandatory for all applicable regulatory submissions for human medicinal product dossiers

The recent announcements from BfArM and PEI are in line with similar announcements earlier from the UK MHRA and Czech Republic SUKL (see related News Article below).

[Sources: BfArM, PEI, EU CMB]

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