Classification guide for cell and tissue products

More and more patients are taking advantage of treatments that use tissues and cells of human origin either directly or after (biotechnological) processing. The use of such cell or tissue preparations in medical care is no longer limited to transplantation. Tissues and cells of human origin are also used in the treatment of various diseases, such as cancer, diabetes and osteoarthritis.

Advances in biotechnology today allow the production of various tissue- or cell-based products, such as medicinal products and in particular the so-called "Advanced Therapies Medicines (ATMPs)". Just as the production and distribution of pharmaceuticals is regulated by the Medicines Act, the entire process of obtaining, processing and marketing products from human cells and tissues is regulated by law.

The Federal Office for Safety in Health Care is responsible for monitoring compliance with the legal framework. In terms of patient safety, this means not only the punishment of violations of the law that have already been committed, but also their suppression through preventive measures, such as (legal) assistance in the form of guidelines.

The present guideline offers an orientation aid regarding the legal framework conditions for products and methods in which human cells or tissues are used for medical purposes and is intended to help to facilitate the classification under the relevant legal regulations. It is intended to provide an overview of those sections of the various substantive laws that apply to the procurement, processing, storage and marketing of human cells and tissues for human use and to simplify the self-classification of whether and which authorization may be required.

Consequently, this guideline, which was prepared in coordination with the Federal Ministry of Social Affairs, Health, Care and Consumer Protection, does not make any statement about the safety or the risk of the listed therapies and does not represent a recommendation in this respect. This guideline is not legally binding. Binding information requires a separate request (to ATMP-leitfadenbasg.gvat) and can only be provided for specific cases after thorough examination of all information provided.

Further information regarding the applicable regulations regarding products made from human cells and tissues can be found at

www.basg.gv.at/gesundheitsberufe/gewebesicherheit, www.basg.gv.at/gesundheitsberufe/blutsicherheit und www.basg.gv.at/fuer-unternehmen/bewilligung-und-zertifizierung/gute-herstellungs-/-vertriebspraxis-gmp/gdp