Legal basis of blood safety
For blood and blood products for transfusion:
- Austrian Medicines Act (AMG)
- Blood Safety Act (BSG)
- Haemovigilance Ordinance (HäVO)
- Blood Donor Regulation (BSV)
- Ordinance on the regulations for the operation and the quality system of blood establishments (QS-VO Blut)
- Good practice guidelines for implementing standards and specifications for the quality system in blood establishments (GPG)
With the amendment of § 2 Para. 4 QS-VO Blut, the Federal Office issues this guideline with the effective date 15 February 2018: Full reference is made to the provisions of the current Best Practice Guidelines jointly developed by the European Commission and the European Directorate for the Quality of Medicines and Health Care of the Council of Europe and published by the Council of Europe: the Blood Guide
Blood products other than products for transfusion:
If blood and blood components are processed into products other than products for transfusion (e.g. serum eye drops), the establishment must be authorized in accordance with § 63 AMG in conjunction with AMBO (Arzneimittelbetriebsordnung) 2009.
(see also: Good Manufacturing and Distribution Practices)
Plasma products see:
The role of the Federal Office for Safety in Health Care (BASG) in the context of tissue safety
- Contact person of the European Commission (Competent authority for tissue and cells)
- Implementation of the legal requirements in accordance with the Austrian Medicinals Product Act (AMG) and its associated ordinances and guidelines
- Authorisation/inspection of blood establishments and plasma centers
- Haemovigilance (notification of adverse reactions and events)
The role of the European Commission
The European Commission helps to address the risks of using blood and blood products (e.g. transmission of diseases) through its mandate to set high quality and safety standards for Substances of Human Origin (SoHO) in accordance with Article 4 (Article 168(4)(a) of the Treaty on the Functioning of the EU).
To this end, it undertakes a number of activities, including drafting legislation and developing guidelines, supporting national authorities with its implementation, accompanied by vigilance activities and project support. The overall objective is to protect citizens.
For further information see the homepage of the European Commission.