BfArM - Federal Institute for Drugs and Medical Devices

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Cover letter BfArM doc, 38KB, File does not meet accessibility standards Date: 01. April 2010 Topics: Licensing Type: Download

If an electronic submission is made according the rules of "electronic only" you should mention this explicitly on the package and on the cover letter.

How do I report data regarding the Sunset Clause? Date: 26. March 2010 Topics: Licensing Type: FAQ

A dedicated application at PharmNet-bund-Portal can be used for electronic reports regarding the Sunset Clause. An additional paper version of the report is not required. For details follow the link.

Processing Statistics of the BfArM 2009 PDF, 257KB, File does not meet accessibility standards Date: 23. March 2010 Topics: Licensing Type: Download

State: March 2010

History of Sequences doc, 68KB, File does not meet accessibility standards Date: 26. February 2010 Topics: Licensing Type: Download

HiS

History of Sequences doc, 68KB, File does not meet accessibility standards Date: 26. February 2010 Topics: Licensing Type: Download

HiS

End User License Agreement PDF, 137KB, File does not meet accessibility standards Date: 26. February 2010 Topics: Licensing Type: Download

EULA

In what form should the national texts be submitted? Date: 01. February 2010 Topics: Licensing Type: FAQ

The national texts are to be inserted into the “Bescheidmaske”, which is made available on the BfArM homepage.

Submissions without a “Bescheidmaske” will be rejected unprocessed.

For each strength, a separate “Bescheidmaske” must be …

What has to be considered when preparing national translations? Date: 01. February 2010 Topics: Licensing Type: FAQ

If the final English product information is based upon a CHMP referral or a centralised procedure, the corresponding German translation has to be used.

If parallel procedures are concluded with identical final English product information, …

Paediatric Worksharing according to Article 45 and 46 Regulation (EG) No. 1901/2006 Date: 31. August 2009 Topics: Licensing Type: Article

The BfArM has implemented a specific procedure for variations (national, MRP and DCP) based on the assessment of paediatric clinical trials with authorised medicinal products (in accordance with Article 45 of Regulation (EC) No1901/2006, Paediatric …