Federal Institute for Pharmaceuticals and Medical Products

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Federal Institute for Drugs and Medical Devices
- BfArM -

Logo of the Federal Institute for Drugs and Medical Devices
State level Federation
position Higher federal authority
Supervisory authority Federal Ministry of Health
founding July 1, 1994
Headquarters Bonn
Authority management Karl Broich (President)
Servants 1050
Budget volume EUR 89.54 million (2019)
Web presence bfarm.de
Federal Institute for Drugs and Medical Devices (2012)
Building in Bonn, rear view
Federal Institute for Drugs u. Medical devices, aerial photo 2014

The Federal Institute for Drugs and Medical Devices ( BfArM ) is an independent federal authority with seat in the federal city Bonn . The Institute in division of the Federal Ministry of Health employs approximately 1,100 employees (physicians, pharmacists, chemists, biologists, lawyers and technical staff).

tasks

As the licensing authority, the main tasks of the BfArM are the approval of finished medicinal products (including the medicinal products of the special therapeutic directions phytotherapy , homeopathy and anthroposophic medicine ), the registration of homeopathic and traditional herbal medicinal products , the recording and evaluation as well as defense against drug risks ( pharmacovigilance ), the central recording and evaluation of risks in medical devices , the monitoring of the (legal) traffic of narcotics and raw materials , advising the federal government and research tasks . The legal framework for these tasks includes: a. the Medicines Act (AMG), the Medical Devices Act (MPG), the Narcotics Act (BtMG), the precursor control law (SOG), and this, in each case issued regulations .

The office of the Pharmacopoeia Commissions is based at the BfArM. The BfArM is a member of the working group of departmental research institutions . The Federal Opium Agency (BOPST) is part of the BfArM's business area.

According to a ruling by the Federal Administrative Court in March 2017, the BfArM should not deny the purchase of a drug for suicide in "extreme emergencies". The federal government refuses to implement the judgment.

history

The forerunner of the BfArM was the Institute for Drugs , which was founded on July 1, 1975 as part of what was then the Federal Health Office . The BfArM with effect on 1 July 1994 established . When the government moved from Bonn to Berlin , the Berlin / Bonn Act stipulated that the seat of the authority would be relocated from Berlin to Bonn as a compensatory measure for the federal city of Bonn. In March 2001, the move to a newly constructed building in Bonn- Hochkreuz was completed, which was expanded from 2010 to 2011. On July 1, 2005, a comprehensive restructuring process of the drug approval area was completed from a department organization based on medical fields (toxicology, clinical pharmacology, pharmaceutical quality, etc.) to an indication-related project structure.

The planned conversion of the BfArM from an independent higher federal authority into a federally direct legal entity under public law with the designation "German Medicines and Medical Devices Agency" (DAMA) was initially postponed due to the early federal elections in 2005 . The so-called DAMA Establishment Act should come into force on January 1, 2008. The law failed on October 25, 2007 because it was feared that the planned regulations would have endangered drug safety.

In May 2020, the previous German Institute for Medical Documentation and Information ( DIMDI ) was merged with the BfArM and integrated as the BfArM Cologne Office.

structure

The institute is divided into 9 departments, the administration, the EU area; international affairs, the press office and public relations as well as other areas. The president is Karl Broich , Julia Stingl has been the vice president since October 1, 2014 .

  • Department 1: Admission
  • Department 2: Admission
  • Department 3: Admission
  • Department 4: Admission
  • Department 5: Research
  • Department 6: Scientific Service
  • Department 7: Pharmacovigilance
  • Department 8: Federal Opium Agency
  • Department 9: Medical Devices
Previous leaders

Web links

Commons : Federal Institute for Drugs and Medical Devices  - collection of images

Individual evidence

  1. ↑ bfarm.de
  2. ↑ Bundeshaushalt.de: www.Bundeshaushalt.de. Retrieved August 30, 2019 .
  3. ↑ § 1 BGA successor law
  4. ↑ The state abandons the terminally ill . In: Der Spiegel . No. 20 , 2018, p. 27 ( online ).
  5. ↑ BGA successor law of June 24, 1994; promulgated in the Federal Law Gazette on June 30, 1994, coming into force on the day after promulgation.
  6. ^ Press release of the City of Bonn from June 14, 2011
  7. ↑ Government starts second attempt , Pharmazeutische Zeitung, edition 02/2007
  8. ^ Coalition project of a pharmaceutical agency failed , Deutsches Ärzteblatt of October 25, 2007
  9. ↑ Speech by the then chairman of the CSU health policy working group, Wolfgang Zöller, Member of the Bundestag, on March 1, 2007 ( Memento from January 3, 2013 in the Internet Archive )
  10. ^ Opinion on the DAMA Establishment Act for Transparency International Deutschland e. V. of March 14, 2007 ( Memento of September 12, 2010 in the Internet Archive )
  11. ↑ Döhler, M : From office to agency? In: Werner Jann , Marian Döhler (eds. :) Agencies in Westeuropa, Wiesbaden, 2007. pp. 12–47, ISBN 3-531-15422-2
  12. ↑ Joint statement of the German Medical Association and the Drugs Commission of the German Medical Association of March 15, 2007 on the DAMA Establishment Act (PDF; 43 kB).
  13. ↑ Federal Institute for Drugs and Medical Devices and essential functional units of DIMDI merged. In: About the BfArM. BfArM, accessed on June 5, 2020 .
  14. ↑ Prof. Dr. Julia Stingl is the new Vice President of the Federal Institute for Drugs and Medical Devices ( Memento from October 10, 2014 in the Internet Archive ) Press release of the BfArM, October 1, 2014; Retrieved October 4, 2014.

Coordinates: 50 ° 42 ′ 21.6 ″  N , 7 ° 8 ′ 12.1 ″  E