Cells, tissues and organs can only be handled by special medical care providers who hold an activity licence for the handling of cells, tissues and organs.
In order to obtain an activity licence the applicant and the site of activity have to comply with the requirements set out in the Handling and Transplantation of Cells, Tissues and Organs Act and relevant Regulations of the Minister of Social Affairs.
The issue of an activity licence, the renewal of an activity licence or alteration of data contained in the activity licence are decided by the State Agency of Medicines.
Before issue or renewal of an activity licence the State Agency of Medicines inspect the conformity of the premises and practices in relation to the licensed activity. To ensure that compliance with these requirements is maintained, compliance is monitored through regular on-site inspections in the course of validity of an activity licence.
Upon application for an activity licence, an application and the documents and information related to the handling operations regarding cells, tissues and organs according to Regulation No. 80 have to be submitted to the State Agency of Medicines.
Payment of the applicable state fee is also required.