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

Prevention of drug-associated risks, Stage II
Medicinal products prepared using plants of Aristolochiaceae of the Asarum genus
PDF, 94KB, File is accessible
Date: 04. November 2010 Topics: Licensing Type: Download

Prevention of drug-associated risks, Stage II
Medicinal products prepared using plants of Aristolochiaceae of the Asarum genus

Are other electronic compilations accepted besides eCTD or NeeS? Date: 02. August 2010 Topics: Licensing Type: FAQ

Yes, but only if a full paper dossier is provided at the same time (all modules need to be printed). In case of electronic submissions not in accordance with the eCTD specifications or the NeeS guideline a paper dossier is required and the …

Do I still have to comply with the AMG-Submission Ordinance (AMG-EV)? Date: 02. August 2010 Topics: Licensing Type: FAQ

No, as long as you comply with the eCTD or NeeS requirements for electronic submissions and if you place all documents required by the eSubmission Ordinance (which were otherwise sent by e-mail) in the folder <sequence>workingdocuments.

The …

How will the confirmation of receipt be sent? Date: 02. August 2010 Topics: Licensing Type: FAQ

If you have provided information about your e-mail contact, BfArM will send the confirmation of receipt via e-mail, otherwise we will use conventional mail.

When is a history of sequences required? Date: 02. August 2010 Topics: Licensing Type: FAQ

Any time an electronic submission in eCTD or NeeS format is submitted, an updated “history of sequences“ named “tracking.pdf“ must be placed in the same folder as the cover letter and submitted in paper as well. This will support transparency and …

What should the Cover Letter contain? Date: 02. August 2010 Topics: Licensing Type: FAQ

The cover letter lists all medicinal products for which marketing authorisation is sought and to which the eCTD / NeeS submission applies, together with the corresponding procedure and processing numbers (ENR, "Eingangsnummern"). The electronic …

Can an ASMFs be submitted electronically? Date: 02. August 2010 Topics: Licensing Type: FAQ

Yes, the same requirements apply as for full dossiers for marketing authorisations. BfArM is willing to accept electronic submissions for ASMF according to the rules published on the EMA website. For details follow the link.

Is submission of a paper dossier still possible? Date: 02. August 2010 Topics: Licensing Type: FAQ

Basically, yes. However, it should be considered that the standard procedure cannot be followed in such cases and that delays cannot be excluded. In this case the eSubmission Ordinance (AMG-EV) also needs to be observed. Further advice can be found at

Advance payment (Vorschusserhebung) Date: 22. July 2010 Topics: Licensing Type: Article

Section 16 of the Administrative Cost Act (Verwaltungskostengesetz) provides that the performance of an official act on application may be made conditional on the payment of an appropriate advance up to the level of the estimated procedural …

Centralised Procedures Date: 12. April 2010 Topics: Licensing Type: Article

Centralised Procedures