Tasks and Activities
Tasks of BASG according to GESG
Pursuant to Gesundheits- und Ernährungssicherheitsgesetz (GESG) § 6a. (1) The Federal Office for Safety in Health Care is responsible for carrying out the following tasks:
- 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,
- 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,
- 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,
- 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,
- 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,
- 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,
- 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,
- 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,
- 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.
- Implementation of the Veterinary Medicinal Products Act Federal Law Gazette I No. 186/2023, to the extent the Federal Authority for Safety in Health Care is responsible for such implementation.
- the inspection of the supply of veterinary medicinal products through sale at a distance according to § 50 of the Veterinary Medicinal Products Act.
- GESG §6a (1a) On Request, the Federal Office for Safety in Health Care gives scientific advice on the development of medicinal products.
Activities of BASG
- 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
- Form: Process BASG (L A120)| 154 KB20/03/2020
Further inquiry note
Page last modified:
23/05/2024