KRATKI PREGLED EU I NACIONALNOG ZAKONODAVSTVA U PODRUČJU TKIVA I

STANICA

TAIEX workshop 30-31. siječnja 2013 Zagreb

EU ZAKONODAVSTVO

TKIVA I STANICE

DIREKTIVE

• Predlaže stručno radno tijelo• Usvaja skupina nadležnih tijela i odgovarajući

DG (SANCO) i predlaže EK-i• Donosi EK• Obvezujuće su za članice EU

DIREKTIVE

Propisuju tehničke i stručne standarde

Samo izuzetno obrađuju etička pitanja

Zemlje članice imaju relativno veliku slobodu u implementaciji

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

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

COMMISSION DECISION 2010/453establishing 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

CROATIAN LEGISLATION

CA for Blood, Tissues and CellsMinistry of Health

Minister

Directorate for Health Care

Inspection Sector

Service for Inspection of Blood, Tissues and Cells

Institute for transplantation and Biomedicine

The process of authorising TE

TECA

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

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)

• …………………………………………………..

NEW

Act on human tissues and cells aplication OG NN 144/12

Sub-lows dead-line: March 31st

NOVELTIES

Hopefully improvement not a headache

• 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

Resulting

good understanding of requirements better cooperation

best end results

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

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

HVALA NA PAŽNJI