Licences to pursue the activities of procurement of human tissues and cells for therapeutic purposes
Legal entities and natural persons may operate in the field of tissues and cells in accordance with the relevant licence. JAZMP’s authorisation must be obtained for any activity relating to procurement, testing, processing, preservation, storage, allocation and distribution of tissues and cells for therapeutic use in humans, as well as for export and import and exit and entry of tissues and cells.
Pursuant to the Act Governing the Quality and Safety of Human Tissues and Cells Used in Medical Treatment (Official gazette of RS, No 61/07 and 56/15 – ZPPDČT), in the area of the procurement of human cells and tissues for therapeutic purposes, JAZMP is responsible for:
- Issuing authorisations for tissue and cell procurement activities within 60 days of receipt of a complete application;
- Managing the procedure for change of authorisation for tissue and cell procurement activities
- Implementing temporary or permanent revocation of authorisation for tissue and cell procurement activities.