direct ec european parliament council januari set standard qualiti safeti collect test process storag distribut human blood blood compon amend direct ec european parliament council european union regard treati establish european commun articl thereof regard propos commiss regard opinion econom social committe regard opinion committe region act accord procedur laid articl treati light joint text approv concili committe novemb extent human blood therapeut demand qualiti safeti blood blood compon ensur order prevent transmiss diseas avail blood blood compon therapeut purpos depend larg commun citizen prepar donat order safeguard public health prevent transmiss infecti diseas precautionari measur collect process distribut make scientif progress detect inactiv elimin transfus transmiss pathogen agent qualiti safeti efficaci requir proprietari industri prepar medicin product deriv human blood plasma ensur direct ec european parliament council novemb commun code relat medicin product human specif exclus blood plasma blood cell human origin direct led situat qualiti safeti intend transfus process subject bind commun legisl essenti intend purpos commun provis ensur blood compon compar qualiti safeti blood transfus chain member state bear mind freedom movement citizen commun territori establish high standard qualiti safeti reassur public human blood blood compon deriv donat member state nonetheless meet requir countri respect blood blood compon start materi manufactur proprietari medicin product direct ec refer measur member state prevent transmiss infecti diseas compris applic monograph european pharmacopoeia recommend council europ world health organis select test blood plasma donor member state measur promot commun suffici human blood blood compon encourag voluntari unpaid donat blood blood compon order ensur equival level safeti qualiti blood compon intend purpos technic requir collect test blood blood compon includ start materi medicin product establish direct direct ec amend commiss commun decemb blood safeti suffici european commun identifi blood strategi order reinforc confid safeti blood transfus chain promot commun suffici resolut june blood safeti suffici commun council invit commiss submit propos framework develop blood strategi resolut novemb strategi blood safeti suffici european commun council invit commiss submit propos matter urgenc view encourag develop coordin approach safeti blood blood product resolut septemb novemb juli april blood safeti suffici voluntari unpaid donat european commun european parliament stress import ensur highest level blood safeti reiter continu support object commun suffici elabor provis direct account opinion scientif committe medicin product medic devic intern experi field natur autolog transfus necessit specif consider respect appli provis direct hospit blood bank hospit unit perform limit number activ storag distribut compat test order ensur qualiti safeti blood blood compon preserv transfus chain take account specif natur function hospit blood bank provis relev activ appli hospit blood bank member state ensur mechan design authoris accredit licens exist ensur activ blood establish perform accord requir direct member state organis inspect control measur carri offici repres compet author ensur complianc blood establish provis direct personnel directli involv collect test process storag distribut blood blood compon appropri qualifi provid time relev train prejudic exist commun legisl recognit profession qualif protect worker blood establish establish maintain qualiti system involv activ determin qualiti polici object respons implement mean qualiti plan qualiti control qualiti assur qualiti improv qualiti system take account principl good manufactur practic ec conform assess system adequ system ensur traceabl blood blood compon establish traceabl enforc accur donor patient laboratori identif procedur record mainten identif label system desir system develop order enabl uniqu unmistak identif donat blood blood compon commun case blood blood compon import countri import equival level traceabl ensur blood establish stage preced import commun requir traceabl appli blood blood compon collect commun ensur stage import import introduc set organis surveil procedur collect evalu inform advers unexpect event reaction result collect blood blood compon order prevent similar equival event reaction occur improv secur transfus adequ measur end common system notif advers event reaction link collect process test storag distribut blood blood compon establish member state import abnorm find report donor relev counsel provid modern blood transfus practic found principl voluntari donor servic anonym donor recipi benevol donor absenc profit part establish involv blood transfus servic measur order provid prospect donor blood blood compon assur confidenti health relat inform provid authoris personnel result test donat futur traceabl donat articl treati provis direct affect nation provis donat blood articl treati state member state prevent maintain introduc stringent protect measur standard qualiti safeti blood blood compon voluntari unpaid blood donat factor contribut high safeti standard blood blood compon protect human health effort council europ area support measur encourag voluntari unpaid donat measur initi ensur donor gain greater public recognit increas suffici definit voluntari unpaid donat council europ account blood blood compon therapeut purpos medic devic obtain individu health statu detriment effect ensu result donat risk transmiss infecti diseas minimis blood donat test accord rule provid assur measur safeguard health individu recipi blood blood compon direct ec european parliament council octob protect individu regard process person data free movement data requir data relat health individu subject reinforc protect cover person data render anonym direct introduc addit safeguard prevent unauthoris donat registri process record unauthoris disclosur inform commiss empow establish technic requir adopt thereto annex order account scientif technic progress set technic requir adapt progress account council recommend june suitabl blood plasma donor screen donat blood ec relev recommend council europ indic relev european institut organis monograph european pharmacopoeia scientif advic commun relat safeti blood blood compon adapt provis direct scientif technic progress test carri conform latest scientif technic procedur reflect current practic defin regularli review updat expert consult process review process due account scientif advanc detect inactiv elimin pathogen transmit transfus measur implement direct adopt accord council decis ec june lai procedur exercis implement power confer commiss order increas effect implement provis adopt direct provid penalti appli member state object direct contribut gener confid qualiti donat blood blood compon health protect donor attain suffici commun level enhanc confid safeti transfus chain member state 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 respons organis health servic provis medic care remain respons member state adopt direct chapter gener provis articl object direct lai standard qualiti safeti human blood blood compon order ensur high level human health protect articl scope direct appli collect test human blood blood compon intend purpos process storag distribut intend transfus blood blood compon collect test sole purpos exclus autolog transfus identifi requir compli respect thereof accord refer articl direct appli prejudic direct eec ec ec direct appli blood stem cell articl definit purpos direct quot blood quot blood collect donor process transfus manufactur quot blood compon quot therapeut constitu blood red cell white cell platelet plasma prepar method quot blood product quot therapeut product deriv human blood plasma quot autolog transfus quot transfus donor recipi person pre deposit blood blood compon quot blood establish quot structur bodi respons aspect collect test human blood blood compon intend purpos process storag distribut intend transfus includ hospit blood bank quot hospit blood bank quot hospit unit store distribut perform compat test blood blood compon exclus hospit facil includ hospit base transfus activ quot advers event quot untoward occurr collect test process storag distribut blood blood compon lead death life threaten disabl incapacit condit patient result prolong hospitalis morbid quot advers reaction quot unintend respons donor patient collect transfus blood blood compon fatal life threaten disabl incapacit result prolong hospitalis morbid quot blood compon releas quot process enabl blood compon releas quarantin statu system procedur ensur finish product meet releas specif quot deferr quot suspens elig individu donat blood blood compon suspens perman temporari quot distribut quot act deliveri blood blood compon blood establish hospit blood bank manufactur blood plasma deriv product includ issu blood blood compon transfus quot haemovigil quot set organis surveil procedur relat advers unexpect event reaction donor recipi epidemiolog follow donor quot inspect quot formal object control adopt standard assess complianc direct relev legisl identifi problem articl implement member state design compet author author respons implement requir direct direct prevent member state maintain introduc territori stringent protect measur compli provis treati member state introduc requir voluntari unpaid donat includ prohibit restrict import blood blood compon ensur high level health protect achiev object set articl provid condit treati met 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 design authoris accredit licens blood establish member state ensur activ relat collect test human blood blood compon intend purpos prepar storag distribut intend transfus undertaken blood establish design authoris accredit licens compet author purpos purpos paragraph blood establish submit inform list annex compet author compet author verifi blood establish compli requir set direct blood establish activ undertak condit appli substanti chang activ undertaken blood establish prior written approv compet author compet author suspend revok design authoris accredit licenc blood establish inspect control measur demonstr blood establish compli requir direct articl hospit blood bank articl appli hospit blood bank articl provis exist establish member state decid maintain nation provis month date laid articl enabl blood establish oper legisl compli requir direct articl inspect control measur member state ensur compet author organis inspect control measur blood establish ensur requir direct compli inspect control measur organis compet author regular basi interv inspect control measur exce year inspect control measur carri offici repres compet author empow inspect blood establish facil parti territori entrust holder design authoris accredit licenc refer articl task carri evalu test procedur pursuant articl sampl examin analysi examin document relat object inspect subject provis forc member state time entri forc direct place restrict power regard descript method prepar compet author organis inspect control measur event advers event reaction suspicion thereof accord articl chapter iii provis blood establish articl respons person blood establish design person respons person respons ensur unit blood blood compon collect test intend purpos process store distribut intend transfus complianc law forc member state provid inform compet author design authoris accredit licens procedur requir articl implement requir articl blood establish respons person fulfil minimum condit qualif possess diploma certif evid formal qualif field medic biolog scienc award complet univers studi recognis equival member state concern practic post graduat experi relev area year establish authoris undertak activ relat collect test human blood blood compon prepar storag distribut task paragraph deleg person qualifi train experi perform task blood establish notifi compet author respons person refer paragraph person refer paragraph inform specif task respons respons person person refer paragraph perman temporarili replac blood establish provid immedi respons person date commenc compet author articl personnel personnel directli involv collect test process storag distribut human blood blood compon qualifi perform task provid time relev regularli updat train chapter iv qualiti manag articl qualiti system blood establish member state measur ensur blood establish establish maintain qualiti system blood establish base principl good practic commiss establish commun standard specif refer articl activ relat qualiti system carri blood establish articl document member state measur order ensur blood establish maintain document oper procedur guidelin train refer manual report form member state measur order ensur access provid document offici entrust inspect control measur refer articl articl record keep member state measur ensur blood establish maintain record inform requir annex ii iv articl record minimum year compet author record data receiv blood establish articl chapter haemovigil articl traceabl member state measur order ensur blood blood compon collect test process store releas distribut territori trace donor recipi vice versa end member state ensur blood establish implement system identif singl blood donat singl blood unit compon thereof enabl full traceabl donor transfus recipi thereof system unmistak identifi uniqu donat type blood compon system establish accord requir refer articl regard blood blood compon import countri member state ensur donor identif system implement blood establish permit equival level traceabl member state measur order ensur system label blood blood compon collect test process store releas distribut territori compli identif system refer paragraph label requir list annex iii data need full traceabl accord articl year articl notif advers event reaction member state ensur advers event accid error relat collect test process storag distribut blood blood compon influenc qualiti safeti advers reaction observ transfus attribut qualiti safeti blood blood compon notifi compet author blood establish place procedur accur effici verifi withdraw distribut blood blood compon notif refer advers event reaction notifi accord procedur notif format refer articl chapter vi provis qualiti safeti blood blood compon articl provis inform prospect donor member state ensur prospect donor blood blood compon commun provid inform refer articl articl inform requir donor member state measur ensur agreement willing commenc donat blood blood compon donor commun provid inform refer articl blood establish articl elig donor blood establish ensur evalu procedur place donor blood blood compon criteria donat refer articl met result donor evalu test procedur document relev abnorm find report donor articl examin donor examin donor includ interview carri donat blood blood compon qualifi health profession respons give gather donor inform assess elig donat basi thereof assess elig donor articl voluntari unpaid blood donat member state measur encourag voluntari unpaid blood donat view ensur blood blood compon provid donat member state submit report commiss measur year entri forc direct year basi report commiss inform european parliament council measur intend commun level articl test donat blood establish ensur donat blood blood compon test conform requir list annex iv member state ensur blood blood compon import commun test conform requir list annex iv articl storag transport distribut condit blood establish ensur storag transport distribut condit blood blood compon compli requir refer articl articl qualiti safeti requir blood blood compon blood establish ensur qualiti safeti requir blood blood compon meet high standard complianc requir refer articl chapter vii data protect articl data protect confidenti member state measur ensur data includ genet inform collat scope direct parti access render anonym donor longer 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 chapter viii exchang inform report penalti articl inform exchang commiss hold regular meet compet author design member state deleg expert blood establish relev parti exchang inform experi acquir regard implement direct articl report member state send commiss commenc decemb year report activ undertaken relat provis direct includ account measur relat inspect control commiss transmit european parliament council econom social committe committe region report submit member state experi gain implement direct commiss transmit european parliament council econom social committe committe region commenc juli year report implement requir direct relat inspect control 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 date articl latest notifi delai subsequ amend affect chapter ix committe articl regulatori procedur 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 technic requir adapt technic scientif progress adapt technic requir set annex iv technic scientif progress decid accord procedur refer articl technic requir adapt technic scientif progress decid accord procedur refer articl traceabl requir inform provid donor inform obtain donor includ identif health histori signatur donor requir suitabl blood plasma donor screen donat blood includ perman deferr criteria exempt thereto temporari deferr criteria storag transport distribut requir qualiti safeti requir blood blood compon requir applic autolog transfus commun standard specif relat qualiti system blood establish commun procedur notifi advers reaction event notif format articl consult scientif committe commiss consult relev scientif committe establish technic requir refer articl adapt technic requir set annex iv scientif technic progress view ensur equival level qualiti safeti blood blood compon transfus blood blood compon start materi manufactur medicin product chapter final provis articl amend direct ec articl direct ec replac quot articl collect test human blood human plasma direct ec european parliament council januari set standard qualiti safeti collect test process storag distribut human blood blood compon amend direct ec appli quot articl transposit member state bring forc law regul administr provis compli direct februari forthwith inform commiss thereof member state adopt provis refer direct accompani refer occas offici public member state determin refer made 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 brussel januari european parliament presid cox council presid dry oj oj oj oj opinion european parliament septemb oj council common posit februari oj decis european parliament june publish offici journal decis european parliament decemb decis council decemb oj oj oj oj oj oj oj oj oj oj council direct eec june medic devic oj direct amend direct ec european parliament council oj direct ec european parliament council octob vitro diagnost medic devic oj oj annex inform provid blood establish compet author purpos design authoris accredit licens accord articl part gener inform identif blood establish qualif contact detail respons person list hospit blood bank suppli part descript qualiti system includ document organis chart includ respons respons person report relationship document site master file qualiti manual describ qualiti system accord articl number qualif personnel hygien provis premis equip list standard oper procedur recruit retent assess donor process test distribut recal blood blood compon report record advers reaction event annex ii report blood establish preced year activ annual report includ total number donor give blood blood compon total number donat updat list hospit blood bank suppli total number donat number compon produc distribut incid preval transfus transmiss infecti marker donor blood blood compon number product recal number advers event reaction report annex iii label requir label compon inform offici compon volum weight number cell compon uniqu numer alphanumer donat identif produc blood establish abo group requir plasma intend fraction rh group rh posit rh neg requir plasma intend fraction date time expiri temperatur storag composit volum anticoagul addit solut annex iv basic test requir blood plasma donat test perform blood apheresi donat includ autolog predeposit donat abo group requir plasma intend fraction rh group requir plasma intend fraction test infect donor hepat hb ag hepat anti hcv hiv anti hiv addit test requir specif compon donor epidemiolog situat