1. KRATKI PREGLED EU I NACIONALNOG ZAKONODAVSTVA U PODRUČJU TKIVA I STANICA TAIEX workshop 30-31. siječnja 2013 Zagreb

3. EU ZAKONODAVSTVO TKIVA I STANICE

4. DIREKTIVE Predlaže stručno radno tijelo Usvaja skupina nadležnih tijela i odgovarajući DG (SANCO) i predlaže EK-i Donosi EK Obvezujuće su za članice EU

5. DIREKTIVE Propisuju tehničke i stručne standarde Samo izuzetno obra đ uju etička pitanja Zemlje članice imaju relativno veliku slobodu u implementaciji

6. POSTUPAK S DIREKTIVAMA Transpozicija Direktive se prenose u nacionalno zakonodavstvo u prikladnom obliku Implementacija OBVEZUJUĆE Propisuju MINIMALNE uvjete zemlje članice mogu propisati i strože uvjete

7. TKIVA I STANICE 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells 2006/17 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells 2006/86 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells

8. COMMISSION DECISION 2010/453 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council

9. CROATIAN LEGISLATION

10. CA for Blood, Tissues and Cells Ministry of Health Minister Directorate for Health Care Inspection Sector Service for Inspection of Blood, Tissues and Cells Institute for transplantation and Biomedicine

11. The process of authorising TE TE CA List of documentation needed for licencing Application and documentation prepared according to the list The Expert Committee CA Tissues/Cells inspector Expert representatives documentation sent reviewed TE on-the-site inspection

12. ACT ON TISSUES & CELLS OBSOLETE Zakon o uzimanju i presa đ ivanju dijelova ljudskog tijela u svrhu liječenja („Narodne novine“ 177/04, 45/09) Pravilnik o uvjetima u pogledu prostora, stručnih radnika i medicinsko-tehničke opreme, sustava kvalitete i drugih uvjeta za obavljanje djelatnosti uzimanja, pohranjivanja i presa đ ivanja tkiva („Narodne novine“ 74/09) Pravilnik o uvjetima u pogledu prostora, stručnih radnika i medicinsko-tehničke opreme za obavljanje djelatnosti uzimanja i pohranjivanja krvotvornih matičnih stanica iz pupkovine („Narodne novine“ 63/07) Pravilnik o uvjetima u pogledu prostora, stručnih radnika i medicinsko-tehničke opreme za obavljanje uzimanja, pohranjivanja i presa đ ivanja očnih tkivnih presadaka („Narodne novine“ 44/07) – van snage Pravilnik o postupku dodjele alogenih nesrodnih krvotvornih matičnih stanica i radu registra mogućih darivatelja koštane moždine („Narodne novine“ 151/05) Pravilnik o postupku obavještavanja o smrti osoba koje dolaze u obzir kao darivatelji dijelova ljudskog tijela zbog presa đ ivanja u svrhu liječenja („Narodne novine“ 152/05) Pravilnik o načinu izvješćivanja, načinu vo đ enja evidencije i rokovima izvješćivanja o ozbiljnim štetnim doga đ ajima i ozbiljnim štetnim reakcijama („Narodne novine“ 67/09) Pravilnik o kriterijima za dodjelu dijelova ljudskog tijela i vo đ enja nacionalne lista čekanja („Narodne novine“ 152/05, 84/07) 9. Pravilnik o načinu suradnje sa srodnim stranim i me đ unarodnim organizacijama u cilju razmjene organa, odnosno tkiva radi presa đ ivanja („Narodne novine“ 141/05, 44/07) …………………………………………………..

14. NEW Act on human tissues and cells aplication OG NN 144/12 Sub-lows dead-line: March 31st

15. NOVELTIES Hopefully improvement not a headache

16. Separation from organ transplantation legislation Designated hospital tissue coordinator, responsible for organsational aspects on tissue procurement Notification on tissue transplantation or donation of tissue to a recipient’s or living donor’s GP Better defined roll of inspection Less sublows, more order

17. Resulting good understanding of requirements better cooperation best end results

18. TAIEX 2009 - 2011 Study Visit on Tissue Bank and Competent Authority, Barcelona, June 2009 Study Visit on Quality Management System in Tissue Banking, Berlin, July 2009 Workshop on Tissue Banking Management for Regulators, Zagreb, December 2009 Expert Mission on National plan for Tissue and Cells Establishments, Zagreb, July 2009 Workshop on Procurement and Processing of Tissue and Cells, Zagreb, September 2010 Workshop on Quality Systems in Transfusion Medicine, December 2010

19. TAIEX 2009 - 2011 Expert Mission in Skin and Ocular Tissue Bank, Decembre 2010 Joint Inspection on Ocular Tissue Bank-Expert Mission, June 2011 Study visit on Skin Banking, Berlin, Decembre 2011 Joint Inspection on Skin and Ocular Tissue Bank - Expert Mission, February 2011 Study visit on Clinical Expansion and Application of Mesenchymal Stem Cells, Liverpool, June 2012

20. HVALA NA PAŽNJI