BfArM - Federal Institute for Drugs and Medical Devices

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Publication of the results of clinical trials in accordance with Section 42b AMG Date: 01. June 2012 Topics: Licensing Type: Article

BfArM has updated the procedural advice on the reqiurements regarding the publication of the results of clinical trials in accordance with Section 42b of the German Medicinal Products Act

Processing Statistics of the BfArM 2011 PDF, 324KB, File is accessible Date: 05. March 2012 Topics: Licensing Type: Download

State: March 2012

Processing Statistics of the BfArM 2010 PDF, 110KB, File is accessible Date: 28. February 2011 Topics: Licensing Type: Download

State: February 2011

Example 1 PDF, 25KB, File does not meet accessibility standards Date: 06. January 2011 Topics: Licensing Type: Form

German - English

Example 2 PDF, 24KB, File does not meet accessibility standards Date: 06. January 2011 Topics: Licensing Type: Form

German - English

Form for variation notification
new set of forms
doc, 48KB, File does not meet accessibility standards
Date: 04. January 2011 Topics: Licensing Type: Form

(available in German only)

B.6. When is the competent authority to be notified of the placing on the market? Date: 03. January 2011 Topics: Licensing Type: FAQ

In accordance with Section 29 sub-section 1b AMG, the marketing authorisation holder shall notify the competent federal higher authority immediately of the date on which the medicinal product is to be placed on the market, taking into consideration …

Tabelle doc, 45KB, File does not meet accessibility standards Date: 23. December 2010 Topics: Licensing Type: Download

Zoledonsäure Flying Team “FT