direct ec european parliament council march set standard qualiti safeti donat procur test process preserv storag distribut human tissu cell european parliament council european union regard treati establish european commun articl thereof regard propos commiss regard opinion european econom social committe consult committe region act accord procedur laid articl treati transplant human tissu cell strongli expand field medicin offer great opportun treatment incur diseas qualiti safeti substanc ensur order prevent transmiss diseas avail human tissu cell therapeut purpos depend commun citizen prepar donat order safeguard public health prevent transmiss infecti diseas tissu cell safeti measur donat procur test process preserv storag distribut promot inform awar campaign nation european level donat tissu cell organ base theme quot potenti donor quot aim campaign european citizen decid donor lifetim famili legal repres wish ensur avail tissu cell medic treatment member state promot donat tissu cell includ haematopoiet progenitor high qualiti safeti increas suffici commun urgent unifi framework order ensur high standard qualiti safeti respect procur test process storag distribut tissu cell commun facilit exchang thereof patient receiv type therapi year essenti commun provis ensur human tissu cell intend compar qualiti safeti establish standard reassur public human tissu cell procur member state nonetheless carri guarante countri tissu cell therapi field intens worldwid exchang take place desir worldwid standard commun endeavour promot highest level protect safeguard public health qualiti safeti tissu cell commiss includ report european parliament council inform progress made respect tissu cell intend industri manufactur product includ medic devic cover direct donat procur test concern process preserv storag distribut regul commun legisl manufactur step cover direct ec european parliament council novemb commun code relat medicin product human direct appli tissu cell includ haematopoiet peripher blood umbil cord blood bone marrow stem cell reproduct cell egg sperm foetal tissu cell adult embryon stem cell direct exclud blood blood product haematopoiet progenitor cell human organ organ tissu cell anim origin blood blood product regul direct ec ec recommend ec direct ec tissu cell autolog graft tissu remov transplant back individu surgic procedur subject bank process exclud direct qualiti safeti consider process complet organ extent rais issu tissu cell differ subject cover direct direct cover tissu cell intend human applic includ human tissu cell prepar cosmet product view risk transmiss communic diseas human cell tissu product cosmet product prohibit commiss direct ec juli adapt technic progress annex ii iii vi vii council direct eec approxim law member state relat cosmet product direct cover research human tissu cell purpos applic human bodi vitro research anim model cell tissu clinic trial appli human bodi compli qualiti safeti standard laid direct direct interfer decis made member state specif type human cell includ germ cell embryon stem cell cell authoris member state direct requir applic provis protect public health specif risk cell base scientif knowledg natur guarante respect fundament right direct interfer provis member state defin legal term quot person quot quot individu quot donat procur test process preserv storag distribut human tissu cell intend human applic compli high standard qualiti safeti order ensur high level health protect commun direct establish standard step human tissu cell applic process clinic tissu cell human origin human applic constrain limit avail desir criteria access tissu cell defin transpar manner basi object evalu medic increas confid member state qualiti safeti donat tissu cell health protect live donor respect deceas donor safeti applic process tissu cell allogen therapeut purpos procur live deceas donor order ensur health statu live donor affect donat prior medic examin requir digniti deceas donor respect notabl reconstruct donor bodi similar origin anatom shape tissu cell applic human bodi diseas unwant effect prevent care donor evalu test donat accord rule establish updat scientif advic matter principl tissu cell applic programm found philosophi voluntari unpaid donat anonym donor recipi altruism donor solidar donor recipi member state urg step encourag strong public profit sector involv provis tissu cell applic servic relat research develop voluntari unpaid tissu cell donat factor contribut high safeti standard tissu cell protect human health establish accredit tissu cell establish provid compli standard due regard principl transpar tissu establish accredit design authoris licens provis direct includ manufactur product human tissu cell subject commun legisl access relev tissu cell procur accord provis direct prejudic provis forc member state tissu cell direct respect fundament right observ principl reflect charter fundament right european union take account convent protect human right digniti human regard applic biologi medicin convent human right biomedicin charter convent make express provis harmonis prevent member state introduc stringent requir legisl measur order provid prospect donor tissu cell assur confidenti health relat inform provid authoris personnel result test donat futur traceabl donat direct ec european parliament council octob protect individu regard process person data free movement data appli person data process applic direct articl direct prohibit principl process data health limit exempt prohibit principl laid direct ec control implement technic organis measur protect person data accident unlaw destruct accident loss alter unauthoris disclosur access unlaw form process accredit system tissu establish system notif advers event reaction link procur test process preserv storag distribut human tissu cell establish member state member state organis inspect control measur carri offici repres compet author ensur tissu establish compli provis direct member state ensur offici involv inspect control measur appropri qualifi receiv adequ train personnel directli involv donat procur test process preserv storag distribut human tissu cell appropri qualifi provid time relev train provis laid direct train applic prejudic exist commun legisl recognit profession qualif adequ system ensur traceabl human tissu cell establish make verifi complianc qualiti safeti standard traceabl enforc accur substanc donor recipi tissu establish laboratori identif procedur record mainten label system gener principl ident recipi disclos donor famili vice versa prejudic legisl forc member state condit disclosur authoris except case notabl case gamet donat lift donor anonym order increas effect implement provis adopt accord direct provid penalti appli member state object direct set high standard qualiti safeti human tissu cell commun suffici achiev member state reason scale effect achiev commun level commun adopt measur accord principl subsidiar set articl treati accord principl proportion set articl direct order achiev object scientif advic commun relat safeti tissu cell order assist commiss adapt provis direct scientif technic progress light rapid advanc biotechnolog knowledg practic field human tissu cell opinion scientif committe medicin product medic devic european group ethic scienc technolog account intern experi field sought futur measur implement direct adopt accord council decis ec june lai procedur exercis implement power confer commiss adopt direct chapter gener provis articl object direct lai standard qualiti safeti human tissu cell intend human applic order ensur high level protect human health articl scope direct appli donat procur test process preserv storag distribut human tissu cell intend human applic manufactur product deriv human tissu cell intend human applic manufactur product cover direct direct appli donat procur test direct appli tissu cell autolog graft surgic procedur blood blood compon defin direct ec organ part organ function purpos entir organ human bodi articl definit purpos direct quot cell quot mean individu human cell collect human cell bound form connect tissu quot tissu quot mean constitu part human bodi form cell quot donor quot mean human sourc live deceas human cell tissu quot donat quot mean donat human tissu cell intend human applic quot organ quot mean differenti vital part human bodi form tissu maintain structur vascularis capac develop physiolog function import level autonomi quot procur quot mean process tissu cell made quot process quot mean oper involv prepar manipul preserv packag tissu cell intend human applic quot preserv quot mean chemic agent alter environment condit mean process prevent retard biolog physic deterior cell tissu quot quarantin quot mean statu retriev tissu cell tissu isol physic effect mean whilst await decis accept reject quot storag quot mean maintain product control condit distribut quot distribut quot mean transport deliveri tissu cell intend human applic quot human applic quot mean tissu cell human recipi extracorpor applic quot advers event quot mean untoward occurr procur test process storag distribut tissu cell lead transmiss communic diseas death life threaten disabl incapacit condit patient result prolong hospitalis morbid quot advers reaction quot mean unintend respons includ communic diseas donor recipi procur human applic tissu cell fatal life threaten disabl incapacit result prolong hospitalis morbid quot tissu establish quot mean tissu bank unit hospit bodi activ process preserv storag distribut human tissu cell undertaken respons procur test tissu cell quot allogen quot mean cell tissu remov person appli quot autolog quot mean cell tissu remov appli person articl implement member state design compet author author respons implement requir direct direct prevent member state maintain introduc stringent protect measur provid compli provis treati member state introduc requir voluntari unpaid donat includ prohibit restrict import human tissu cell ensur high level health protect provid condit treati met direct affect decis member state prohibit donat procur test process preserv storag distribut specif type human tissu cell cell sourc includ decis concern import type human tissu cell carri activ cover direct commiss recours technic administr assist mutual benefit commiss beneficiari relat identif prepar manag monitor audit control support expenditur chapter ii oblig member state author articl supervis human tissu cell procur member state ensur tissu cell procur test carri person train experi place condit accredit design authoris licens purpos compet author author compet author author measur ensur tissu cell procur compli requir refer articl test requir donor carri qualifi laboratori accredit design authoris licens compet author author articl accredit design authoris licens tissu establish tissu cell prepar process member state ensur tissu establish activ test process preserv storag distribut human tissu cell intend human applic undertaken accredit design authoris licens compet author purpos activ compet author author verifi tissu establish compli requir refer articl accredit design authoris licens tissu establish activ undertak condit appli authoris tissu cell prepar process tissu establish carri accord requir refer articl agreement tissu establish parti refer articl examin framework procedur tissu establish undertak substanti activ prior written approv compet author author compet author author suspend revok accredit design authoris licens tissu establish tissu cell prepar process inspect control measur demonstr establish process compli requir direct tissu cell determin accord requir refer articl agreement compet author author distribut directli transplant recipi long supplier provid accredit design authoris licenc activ articl inspect control measur member state ensur compet author author organis inspect tissu establish carri control measur order ensur complianc requir direct member state ensur control measur place procur human tissu cell inspect organis control measur carri compet author author regular basi interv inspect exce year inspect control measur carri offici repres compet author empow inspect tissu establish facil parti articl evalu verifi procedur activ carri tissu establish facil parti relev requir direct examin document record relat requir direct guidelin condit inspect control measur train qualif offici involv order reach consist level compet perform establish accord procedur refer articl compet author author organis inspect carri control measur advers reaction advers event addit inspect organis control measur carri duli justifi request compet author author member state case member state request member state commiss provid inform result inspect control measur carri relat requir direct articl traceabl member state ensur tissu cell procur process store distribut territori trace donor recipi vice versa traceabl appli relev data relat product materi come contact tissu cell member state ensur implement donor identif system assign uniqu code donat product tissu cell identifi label inform refer allow link inform refer articl tissu establish data ensur traceabl stage data requir full traceabl minimum year clinic data storag electron form traceabl requir tissu cell product materi come contact tissu cell effect qualiti safeti establish commiss accord procedur refer articl procedur ensur traceabl commun level establish commiss accord procedur refer articl articl import export human tissu cell member state measur ensur import tissu cell countri undertaken tissu establish accredit design authoris licens purpos activ import tissu cell trace donor recipi vice versa accord procedur refer articl member state tissu establish receiv import countri ensur meet standard qualiti safeti equival laid direct member state measur ensur export tissu cell countri undertaken tissu establish accredit design authoris licens purpos activ member state send export countri ensur export compli requir direct import export tissu cell refer articl authoris directli compet author author case emerg import export tissu cell authoris directli compet author author compet author author measur ensur import export tissu cell refer subparagraph meet qualiti safeti standard equival laid direct procedur verifi equival standard qualiti safeti accord paragraph establish commiss accord procedur refer articl articl regist tissu establish report oblig tissu establish record activ includ type quantiti tissu cell procur test preserv process store distribut dispos origin destin tissu cell intend human applic accord requir refer articl submit compet author author annual report activ report publicli access compet author author establish maintain publicli access regist tissu establish activ accredit design authoris licens member state commiss establish network link nation tissu establish regist articl notif advers event reaction member state ensur system place report investig regist transmit inform advers event reaction influenc qualiti safeti tissu cell attribut procur test process storag distribut tissu cell advers reaction observ clinic applic link qualiti safeti tissu cell person establish human tissu cell regul direct report relev inform establish engag donat procur test process storag distribut human tissu cell order facilit traceabl ensur qualiti safeti control respons person refer articl ensur compet author author notifi advers event reaction refer paragraph provid report analys ensu outcom procedur notifi advers event reaction establish commiss accord procedur refer articl tissu establish ensur accur rapid verifi procedur place enabl recal distribut product relat advers event reaction chapter iii donor select evalu articl principl govern tissu cell donat member state endeavour ensur voluntari unpaid donat tissu cell donor receiv compens strictli limit make good expens inconveni relat donat case member state defin condit compens grant member state report commiss measur april year basi report commiss inform european parliament council measur intend commun level member state measur ensur promot public activ support donat human tissu cell compli guidelin legisl provis laid member state guidelin legisl provis includ restrict prohibit advertis avail human tissu cell view offer seek financi gain compar advantag member state endeavour ensur procur tissu cell carri profit basi articl consent procur human tissu cell authoris mandatori consent authoris requir forc member state concern met member state keep nation legisl measur ensur donor rel person grant authoris behalf donor provid inform refer annex articl data protect confidenti member state measur ensur data includ genet inform collat scope direct parti access render anonym donor recipi remain identifi purpos ensur data secur measur place safeguard unauthoris data addit delet modif donor file deferr record transfer inform procedur place resolv data discrep unauthoris disclosur inform occur whilst guarante traceabl donat member state measur ensur ident recipi disclos donor famili vice versa prejudic legisl forc member state condit disclosur notabl case gamet donat articl select evalu procur activ relat tissu procur carri ensur donor evalu select carri accord requir refer articl tissu cell procur packag transport accord requir refer articl case autolog donat suitabl criteria establish accord requir refer articl result donor evalu test procedur document major anomali report accord requir refer annex compet author author ensur activ relat tissu procur carri accord requir refer articl chapter iv provis qualiti safeti tissu cell articl qualiti manag member state measur ensur tissu establish put place updat qualiti system base principl good practic commiss establish commun standard specif refer articl activ relat qualiti system tissu establish measur ensur qualiti system includ document standard oper procedur guidelin train refer manual report form donor record inform final destin tissu cell tissu establish measur ensur document inspect compet author author tissu establish data ensur traceabl accord articl articl respons person tissu establish design respons person fulfil condit qualif possess diploma certif evid formal qualif field medic biolog scienc award complet univers studi recognis equival member state concern year practic experi relev field person design paragraph respons ensur human tissu cell intend human applic establish person respons procur test process store distribut accord direct law forc member state provid inform compet author author requir articl implement requir articl tissu establish tissu establish inform compet author author respons person refer paragraph respons person perman temporarili replac tissu establish immedi inform compet author respons person date duti person commenc articl personnel personnel directli involv activ relat procur process preserv storag distribut tissu cell tissu establish qualifi perform task provid train refer articl articl tissu cell recept tissu establish ensur donat human tissu cell subject test accord requir refer articl select accept tissu cell compli requir refer articl tissu establish ensur human tissu cell document compli requir refer articl tissu establish verifi record fact packag human tissu cell receiv compli requir refer articl tissu cell compli provis discard accept reject receiv tissu cell document tissu establish ensur human tissu cell correctli identifi time deliveri batch tissu cell assign identifi code accord articl tissu cell held quarantin time requir relat donor test inform met accord articl articl tissu cell process tissu establish includ standard oper procedur process affect qualiti safeti ensur carri control condit tissu establish ensur equip work environ process design valid control condit complianc requir refer articl modif process prepar tissu cell meet criteria laid paragraph tissu establish includ standard oper procedur special provis handl tissu cell discard order prevent contamin tissu cell process environ personnel articl tissu cell storag condit tissu establish ensur procedur storag tissu cell document standard oper procedur storag condit compli requir refer articl tissu establish ensur storag process carri control condit tissu establish establish appli procedur control packag storag area order prevent situat aris advers affect function integr tissu cell process tissu cell distribut requir laid direct met member state ensur tissu establish agreement procedur place ensur event termin activ reason store tissu cell transfer tissu establish establish accredit design authoris licens accord articl prejudic member state legisl dispos donat tissu cell consent pertain articl label document packag tissu establish ensur label document packag conform requir refer articl articl distribut tissu establish ensur qualiti tissu cell distribut distribut condit compli requir refer articl articl relat tissu establish parti tissu establish establish written agreement parti time extern activ take place influenc qualiti safeti tissu cell process cooper parti circumst tissu establish entrust stage tissu cell process parti parti good servic affect tissu cell qualiti safeti assur includ distribut tissu establish servic tissu establish accredit tissu establish distribut tissu cell process parti tissu establish evalu select parti basi abil meet standard laid direct tissu establish complet list agreement refer paragraph establish parti agreement tissu establish parti respons parti detail procedur tissu establish provid copi agreement parti request compet author author chapter exchang inform report penalti articl code inform member state establish system identif human tissu cell order ensur traceabl human tissu cell pursuant articl commiss cooper member state design singl european code system provid inform main characterist properti tissu cell articl report member state send commiss april year report activ undertaken relat provis direct includ account measur relat inspect control commiss transmit european parliament council european econom social committe committe region report submit member state experi gain implement direct april year commiss transmit european parliament council european econom social committe committe region report implement requir direct inspect monitor articl penalti member state lai rule penalti applic infring nation provis adopt pursuant direct measur ensur implement penalti provid effect proportion dissuas member state notifi provis commiss april notifi delai subsequ amend affect chapter vi consult committe articl technic requir adapt scientif technic progress technic requir adapt scientif technic progress decid accord procedur refer articl requir accredit design authoris licens tissu establish requir procur human tissu cell qualiti system includ train select criteria donor tissu cell laboratori test requir donor cell tissu procur procedur recept tissu establish requir tissu cell prepar process tissu cell process storag distribut requir direct distribut recipi specif tissu cell articl committe commiss assist committe refer made paragraph articl decis ec appli regard provis articl thereof period refer articl decis ec set month committe adopt rule procedur articl consult scientif committe commiss consult relev scientif committe defin adapt technic requir refer articl scientif technic progress chapter vii final provis articl transposit member state bring forc law regul administr provis compli direct april forthwith inform commiss thereof member state adopt measur refer direct accompani refer occas offici public method make refer laid member state member state decid year date laid subparagraph paragraph appli requir direct tissu establish bound nation provis entri forc direct member state commun commiss text provis nation law adopt adopt field govern direct articl entri forc direct enter forc dai public offici journal european union articl addresse direct address member state strasbourg march european parliament presid cox council presid roch oj oj opinion european parliament april publish offici journal council common posit juli oj posit european parliament decemb publish offici journal decis council march oj direct amend commiss direct ec oj direct ec european parliament council novemb amend council direct eec medic devic incorpor stabl deriv human blood human plasma oj council recommend june suitabl blood plasma donor screen donat blood european commun oj direct ec european parliament council januari set standard qualiti safeti collect test process storag distribut human blood blood compon oj oj oj oj direct amend regul ec oj oj annex inform provid donat cell tissu live donor person charg donat process ensur donor properli inform aspect relat donat procur process outlin paragraph inform prior procur inform train person transmit clear manner term easili understood donor inform cover purpos natur procur consequ risk analyt test perform record protect donor data medic confidenti therapeut purpos potenti benefit inform applic safeguard intend protect donor donor inform receiv confirm result analyt test explain inform necess requir applic mandatori consent certif authoris order tissu cell procur carri deceas donor inform consent authoris obtain accord legisl forc member state confirm result donor evalu commun explain relev person accord legisl member state