Federal Institute for Drugs and Medical Devices
Encyclopedia
The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) is a medical regulatory body in Germany
Germany
Germany , officially the Federal Republic of Germany , is a federal parliamentary republic in Europe. The country consists of 16 states while the capital and largest city is Berlin. Germany covers an area of 357,021 km2 and has a largely temperate seasonal climate...

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It operates under the Federal Ministry of Health
Federal Ministry of Health (Germany)
The Federal Ministry of Health, is a ministry of the German federal government...

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It is headquartered in Bonn
Bonn
Bonn is the 19th largest city in Germany. Located in the Cologne/Bonn Region, about 25 kilometres south of Cologne on the river Rhine in the State of North Rhine-Westphalia, it was the capital of West Germany from 1949 to 1990 and the official seat of government of united Germany from 1990 to 1999....

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BfArM announced that it will accept pure electronic filings (eCTD
ECTD
The electronic Common Technical Document is an interface for the pharmaceutical industry to agency transfer of regulatory information.The content is based on the Common Technical Document format....

or NeeS) from mid-February 2010 (previously a full paper copy was required). Only those documents requiring signature will be required in paper.

External links

  • http://www.bfarm.de/EN/Home/homepage__node.html
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