BfArM - Federal Institute for Drugs and Medical Devices

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Further Regulatory Information on Submissions Date: 31. January 2017 Topics: Licensing Type: Article

Further Regulatory Information on Submissions

EudraCT Tutorials Date: 05. July 2016 Topics: Licensing Type: News

EudraCT has made multimedia tutorials for clinical trial results available on its website.

Inhaltsverzeichnis des Europäischen Arzneibuchs, 8. Ausgabe, 8. Nachtrag PDF, 52KB, File does not meet accessibility standards Date: 31. May 2016 Topics: Licensing Type: Download

Inhaltsverzeichnis des Europäisches Arzneibuches
Contents of Supplement 8.8 EUROPEAN PHARMACOPOEIA 8.8

National Variations Date: 31. March 2016 Topics: Licensing Type: Article

National Variations

Opinion No. 02/2016 of the Joint Expert Committee on Classification of Substances
PDF, 2MB, File is accessible
Date: 24. February 2016 Topics: Licensing Type: Download

Classification of red yeast rice products

see also press release on the topic

Update of the BfArM-websites in the section eSubmission including an update of the eValidator Date: 18. February 2016 Topics: Licensing Type: News

The BfArM updated its websites in the section eSubmission due to the use of electronic application forms (eAF) as of 1 January 2016.

In addition the BfArM offers an updated version of a tool which checks your dossier against …

Processing Statistics of the BfArM 2015 PDF, 221KB, File does not meet accessibility standards Date: 16. February 2016 Topics: Licensing Type: Download

State: February 2015

Electronic Common Technical Documents (eCTD) Date: 09. February 2016 Topics: Licensing Type: Article

eCTD

Step-by-step Guide on e-only Submission at BfArM Date: 09. February 2016 Topics: Licensing Type: Article

eSubmission