Inspections

The Austrian Inspectorate (Institute Surveillance)

Responsibilities:

  • Inspection of GLP according to the ordinance on GLP for substances legally relevant as provided in AMG (Medicinal Products Act),
  • Inspection of GMP and GDP at manufacturers, laboratories and distributers as provided in AMG and Blood Safety Act
  • Inspection as provided in the Tissue Safety Act
  • Issue of licenses, certificates, GLP- and GMP-certificates
  • Inspection of manufacturers, distributors, operators, assemblers, conditioners and appliers as provided in the Medical Devices Act
  • Issue of FSC free sales certificates for medical devices
  • Inspection of clinical trials as provided in AMG and Medical Devices Act
  • Inspection of ethics commissions and pharmacovigilance systems
  • Processing of quality deficiencies as provided in AMG
  • Processing of suspicions of illegal activities in the market of medicines and medical devices
  • Surveillance of the management of narcotic and psychotropic drugs
  • Processing of incidents with medical devices and in-vitro-diagnostics
  • Processing of applications for import licenses and notifications as provided in the Medicinal Products Importation Act

  

Created: 01.03.2009 | Page last modified: 22.08.2016

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