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KRATKI PREGLED EU I NACIONALNOG ZAKONODAVSTVA U PODRUČJU TKIVA I STANICA

KRATKI PREGLED EU I NACIONALNOG ZAKONODAVSTVA U PODRUČJU TKIVA I STANICA. TAIEX workshop 30 - 31 . siječnja 2013 Z agreb. EU ZAKONODAVSTVO. TKIVA I STANICE. DIREKTIVE. Predlaže stručno radno tijelo Usvaja skupina nadležnih tijela i odgovarajući DG (SANCO) i predlaže EK-i Donosi EK

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KRATKI PREGLED EU I NACIONALNOG ZAKONODAVSTVA U PODRUČJU TKIVA I STANICA

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  1. KRATKI PREGLED EU I NACIONALNOG ZAKONODAVSTVA U PODRUČJU TKIVA I STANICA TAIEXworkshop30-31. siječnja 2013Zagreb

  2. EU ZAKONODAVSTVO TKIVA I STANICE

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

  4. DIREKTIVE Propisuju tehničke i stručne standarde Samo izuzetno obrađuju etička pitanja Zemlje članice imaju relativno veliku slobodu u implementaciji

  5. 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

  6. TKIVA I STANICE • 2004/23/ECon setting standards of quality and safety for the donation, procurement, testing, processing,preservation, storage and distribution of human tissues and cells • 2006/17implementing Directive 2004/23/EC of the European Parliament and of the Council as regardscertain technical requirements for the donation, procurement and testing of human tissues and cells • 2006/86implementing Directive 2004/23/EC of the European Parliament and of the Council as regardstraceabilityrequirements, notification of serious adverse reactions and events and certaintechnical requirements for the coding, processing, preservation, storage and distribution ofhuman tissues and cells

  7. COMMISSION DECISION2010/453 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

  8. CROATIANLEGISLATION

  9. CA for Blood, TissuesandCells MinistryofHealth Minister Directorate for Health Care Institute for transplantation and Biomedicine InspectionSector Service for InspectionofBlood, TissuesandCells

  10. TheprocessofauthorisingTE List ofdocumentation needed for licencing CA TE Applicationanddocumentation preparedaccording to the list documentation sent reviewed TE on-the-site inspection TheExpertCommittee CATissues/Cellsinspector Expertrepresentatives

  11. ACT ON TISSUES & CELLSOBSOLETE • Zakon o uzimanju i presađivanju 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 presađivanja 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 presađivanja 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 presađivanja u svrhu liječenja („Narodne novine“ 152/05) • Pravilnik o načinu izvješćivanja, načinu vođenja evidencije i rokovima izvješćivanja o ozbiljnim štetnim događajima i ozbiljnim štetnim reakcijama („Narodne novine“ 67/09) • Pravilnik o kriterijima za dodjelu dijelova ljudskog tijela i vođenja nacionalne lista čekanja („Narodne novine“ 152/05, 84/07) • 9. Pravilnik o načinu suradnje sa srodnim stranim i međunarodnim organizacijama u cilju razmjene organa, odnosno tkiva radi presađivanja („Narodne novine“ 141/05, 44/07) • …………………………………………………..

  12. NEW Acton human tissuesandcellsaplication OG NN 144/12 Sub-lows dead-line: March31st

  13. NOVELTIES Hopefully improvementnot a headache

  14. 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

  15. Resulting good understanding of requirements better cooperationbest end results

  16. TAIEX 2009 - 2011 • Study Visit on Tissue Bank and Competent Authority, Barcelona, June 2009 • Study Visit on Quality Management System inTissue 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

  17. 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, February2011 • Study visit on Clinical Expansion and Application of Mesenchymal Stem Cells, Liverpool, June2012

  18. HVALA NA PAŽNJI

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