Activities

Tasks of BASG during the life cycle of a medicinal product

  1. Pursuant to GESG § 6a. (1) The Federal Office for Safety in Health Care is responsible for carrying out the following tasks:
  2. Implementation of the Austrian Medicines Act, Federal Law Gazette No 185/1983, to the extent the Federal Authority for Safety in Health Care is responsible for such implementation,
  3. Implementation of the Medicinal Products Import Act 2010, Federal Law Gazette No 79/2010, to the extent the Federal Authority for Safety in Health Care is responsible for such implementation,
  4. Implementation of the Blood Safety Act, Federal Law Gazette No 44/1999, to the extent the Federal Authority for Safety in Health Care is responsible for such implementation,
  5. Implementation of the Medical Devices Act, Federal Law Gazette No 657/1996, to the extent the Federal Authority for Safety in Health Care is responsible for such implementation,
  6. Implementation of the Compulsory Prescription Act, Federal Law Gazette No 413/1972, to the extent the Federal Authority for Safety in Health Care is responsible for such implementation,
  7. Implementation of the Austrian Tissue Safety Act, Federal Law Gazette No 49/2008, to the extent the Federal Authority for Safety in Health Care is responsible for such implementation,
  8. the inspection of companies which are allowed to own, to buy, to manufacture, to manipulate, to convert or to distribute addictive drugs according to § 6 para 1 subparas 1 and 2 of the Addictive Drug Act, Federal Law Gazette I No 112/1997, concerning their handling of these products,
  9. the inspection in accordance to the annual inspection plan of the Federal Ministry for Health of the release of addictive drugs through pharmacies according to  § 7 para 1 of the Addictive Drug Act,
  10. the inspection of the supply of human medicinal products by public pharmacies through sale at a distance according to § 59 a of the Austrian Medicines Act.
  11. GESG (1a) On Request, the Federal Office for Safety in Health Care gives scientific advice on the development of medicinal products.

Activities of BASG - during lifecyle of a medicinal product

  • Scientific Advice
  • Admission of Clinical Trials
  • Marketing Authorisation and Lifecycle Management of medicinal products
  • Pharmacovigilance
  • Quality of Medicinal Products (before and after Marketing Authorisation)
  • Inspections
  • Market Surveillance of Medicinal Products (legal and illegal market)
  • Market Surveillance und Vigilance of Medical Devices
  • Haemovigilance and Tissuevigilance
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