A tissue establishment (a provider whose activity consists in the processing, storage or distribution of tissues and cells, or the procurement or examination of tissues and cells; a tissue establishment is also a tissue bank), a procurement facility and a diagnostic laboratory may only carry out activities under the Human Tissues and Cells Act if the provider has been issued an activity permit, unless otherwise specified below. Such authorisation shall not be required for a procurement facility that procures tissues and cells for a tissue establishment.

Only a health service provider who is licensed as a diagnostic laboratory under the Human Tissues and Cells Act may carry out the activities of a diagnostic laboratory handling tissues and cells when carrying out laboratory testing of samples of biological materials taken from donors for the purpose of assessing medical fitness and selecting a donor. This authorisation is issued by the State Institute for Drug Control.

Tissue establishment (a provider whose activity consists of the processing, storage or distribution of tissues and cells, or the procurement or investigation of tissues and cells; a tissue establishment is also a tissue bank), in the case of tissues and cells released by it for distribution and use, or tissues and cells distributed by it from a Member State or imported from a third country, shall ensure that in the event of a serious adverse event, serious adverse reaction or suspected serious adverse reaction, the State Institute for Drug Control is notified without delay.

A tissue establishment, a procurement facility or an operator of a diagnostic laboratory shall be obliged to apply in advance to the State Institute for Drug Control for an amendment of the authorisation in case of intended changes from the conditions under which the authorisation was issued. The same shall apply in the event of a change of responsible person or a change of activity. The State Institute for Drug Control shall decide on the application within 30 days of receipt. If the holder of an operating authorisation does not carry out the activities specified in the authorisation for at least 3 years from the date of entry into force of the authorisation or discontinues carrying out those activities for 3 years, the operating authorisation shall lapse.

If the information contained in the database of tissue establishments of the European Union requires updating or correction, the tissue establishment shall inform the State Institute for Drug Control immediately, but not later than 10 working days from the date on which the fact in question was discovered.