The use of human tissues and cells intended for therapeutic purposes increases the possibility of the development of new treatment modalities. Therefore, the European Parliament adopted Directive 2004/23/EC and the related directives 2006/17 and 2006/86, thereby laying down the quality and safety standards relating to the donation, procurement, testing, processing, preservation, storage and distribution of human cells and tissues. The provisions of the directives are transposed into Slovenian legislation by the Act Governing the Quality and Safety of Human Tissues and Cells Used in Medical Treatment (Official gazette of RS No 61/2007, hereinafter: ZKVČTC) and the associated implementing regulations.
The activity of the procurement of human tissues and cells for therapeutic purposes includes the acquisition, testing, processing, preservation, storage, distribution and allocation of tissues and cells, testing of donors as well as import and export of tissues and cells, or their entry and exit.
JAZMP is authorised to issue authorisation for the procurement of tissues and cells for therapeutic purposes, and to monitor the implementation of the provisions of ZKVČTC.
Register on the institutions with JAZMP’s licence for tissue and cell procurement can be found on the website of the Institute of the Republic of Slovenia for Organ and Tissue Transplantation (Slovenija – transplant), which is authorised to keep the register of tissue and cell institutions and their activities.