Tissue safety

The application of cells and tissues of human origin is an important type of therapy beside the use of drugs and medical devices. In order to ensure quality and safety, these products are subject to strict controls in Austria regulated by the Tissue Safety Act (GSG) and/or the Medicines Act (AMG).

Legal foundations for tissue safety

Legal basis for the areas of extraction, processing, storage and distribution of human tissues and cells:

New scientific advances in cell and molecular biotechnology have led to the development of novel therapies using tissues and cells as starting materials. The regulatory basis for these products (see ATMP) is set out in Regulation (EC) No 1394/2007 of the European Parliament and of the Council.

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)
  • Maintenance of the register of all certified procurement establishment and approved tissue banks in Austria (register § 29 GSG - EU Compendium)
  • Implementation of the legal requirements in accordance with the Tissue Safety Act (GSG) and its associated ordinances and guidelines
  • Authorisation/certification/inspection of tissue banks and tissue procurement establishments
  • Tissue vigilance (notification of adverse reactions or events)

The role of the European Commission

The European Commission helps address the risks of using cells and tissues (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

Definition of procurement establishment and tissue banks

  1. Procurement establishment: Facility, including mobile collection teams, where activities related to the procurement of human cells and tissues for human application are performed.
  2. Tissue bank: Establishment where activities related to the processing, storage or distribution of human cells and tissues for human application are carried out.

Register of certified collection establishments and authorised tissue banks

According to § 29 Abs 1 Gewebesicherheitsgesetz idgF (GSG) the Bundesamt für Sicherheit im Gesundheitswesen (Federal Office for Safety in Health Care) has to keep a register of all certified procurement establishments and approved tissue banks. This register also has to contain information on the activities for which certification or approval was granted. The register is maintained through the European Coding Platform.

EU Tissue Establishment compendium

It is an IT platform provided by the European Commission. The EU compendium of tissue establishments is a register of all tissue establishments authorised, licensed, designated or accredited by the competent authorities of the Member States, containing information on those tissue establishments in accordance with Annex VIII to Directive 2015/565/EU.

The list of all certified procurement establishments and approved tissue banks in Austria can be found by filtering by country under the Tab “Compendia”.

The “compendium” is updated immediately after changes in the certificate or authorisation of a tissue establishment.

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