More and more people are being treated with products made from human cells or tissue. These may be used directly or may have been technically processed beforehand. Today, such products are used not only in organ transplants, but also to treat diseases such as cancer, diabetes or joint problems (e.g. osteoarthritis).

Thanks to modern biotechnology, various products can be manufactured from human tissue or cells, including medicinal products for advanced therapies, known as ATMPs.

The manufacture and sale of medicinal products is regulated by law in Austria. This also applies to products made from human cells and tissues. The BASG is responsible for monitoring compliance with these rules.

This guide is intended to help classify such products correctly, i.e. to clarify:

• Which laws apply?
• Which authorisations are required?
• What steps must be taken into account during collection, processing, storage and sale?

It is primarily aimed at individuals or companies who wish to manufacture or distribute such products and offers initial guidance.

What can the guide not do?

• It does not assess whether a particular therapy is safe or risky.
• It does not recommend any treatment methods.
• It is not legally binding – this means that it cannot be invoked in legal matters.

If you need binding information, you must contact the BASG directly by email at: ATMP-leitfaden@basg.gv.at. However, such information is only available for specific individual cases after all the necessary information has been checked.

Further information

If you would like to learn more about the legal basis, you can find additional information on the following BASG pages:

• Tissue safety
• Blood safety
• Good manufacturing practice (GMP) and good distribution practice (GDP)