commiss direct ec septemb implement direct ec european parliament council traceabl requir notif advers reaction event text eea relev commiss european commun regard treati establish european commun regard direct ec european parliament council januari set standard qualiti safeti collect test process storag distribut human blood blood compon amend direct ec point paragraph articl thereof direct ec lai standard qualiti safeti collect test human blood blood compon intend purpos process storag distribut intend transfus ensur high level human health protect order prevent transmiss diseas blood blood compon ensur equival level qualiti safeti direct ec call establish specif technic requir deal traceabl commun procedur notifi advers reaction event notif format notif suspect advers reaction advers event submit compet author direct establish notif format defin minimum data need prejudic faculti member state maintain introduc territori stringent protect measur compli provis treati provid articl direct ec direct lai technic requir account council recommend ec june suitabl blood plasma donor screen donat blood european commun direct ec european parliament council novemb commun code relat medicin product human commiss direct ec march implement direct ec european parliament council technic requir blood blood compon recommend council europ blood blood compon import countri includ start materi raw materi manufactur medicin product deriv human blood human plasma intend distribut commun meet equival commun standard specif relat traceabl advers reaction advers event notif requir set direct determin common definit technic terminolog order ensur consist implement direct ec measur provid direct accord opinion committe set direct ec adopt direct articl definit purpos direct definit appli quot traceabl quot mean abil trace individu unit blood blood compon deriv thereof donor final destin recipi manufactur medicin product dispos vice versa quot report establish quot mean blood establish hospit blood bank facil transfus take place report advers reaction advers event compet author quot recipi quot mean transfus blood blood compon quot issu quot mean provis blood blood compon blood establish hospit blood bank transfus recipi quot imput quot mean likelihood advers reaction recipi attribut blood blood compon transfus advers reaction donor attribut donat process quot facil quot mean hospit clinic manufactur bio medic research institut blood blood compon deliv articl traceabl member state ensur traceabl blood blood compon accur identif procedur record mainten label system member state ensur traceabl system place blood establish enabl trace blood compon locat process stage member state ensur blood establish system place uniqu identifi donor blood unit collect blood compon prepar intend purpos facil blood compon deliv member state ensur facil system place record blood unit blood compon receiv local process final destin receiv unit transfus discard return distribut blood establish member state ensur blood establish uniqu identifi enabl precis link unit blood collect blood compon prepar articl verif procedur issu blood blood compon member state ensur blood establish issu unit blood blood compon transfus hospit blood bank place procedur verifi unit issu transfus intend recipi transfus verifi subsequ disposit articl record data traceabl member state ensur blood establish hospit blood bank facil retain data set annex year readabl storag medium order ensur traceabl articl notif advers reaction member state ensur facil transfus occur procedur place retain record transfus notifi blood establish delai advers reaction observ recipi transfus attribut qualiti safeti blood blood compon member state ensur report establish procedur place commun compet author relev inform suspect advers reaction notif format set part part annex ii member state ensur report establish notifi compet author relev inform advers reaction imput level refer part annex ii attribut qualiti safeti blood blood compon notifi compet author case transmiss infecti agent blood blood compon describ action respect implic blood compon distribut transfus plasma fraction evalu suspect advers reaction imput level set part annex ii complet advers reaction notif conclus investig format set part annex ii submit complet report advers reaction compet author annual basi format set part annex ii articl notif advers event member state ensur blood establish hospit blood bank procedur place retain record advers event affect qualiti safeti blood blood compon member state ensur report establish procedur place commun compet author notif format set part annex iii relev inform advers event put danger donor recipi directli involv event concern member state ensur report establish evalu advers event identifi prevent process complet advers event notif conclus investig format set part annex iii submit complet report advers event compet author annual basi format set part annex iii articl requir import blood blood compon member state ensur import blood blood compon countri blood establish system traceabl place equival provid articl member state ensur import blood blood compon countri blood establish system notif place equival provid articl articl annual report member state submit commiss annual report june year notif advers reaction event receiv compet author format part annex ii part annex iii articl commun inform compet author member state ensur compet author commun inform regard advers reaction event order guarante blood blood compon suspect defect withdrawn discard articl transposit prejudic articl direct ec member state bring forc law regul administr provis compli direct august latest forthwith commun commiss text provis correl tabl provis direct member state adopt provis refer direct accompani refer occas offici public member state determin refer made member state commun commiss text main provis nation law adopt field cover direct articl entri forc direct enter forc dai public offici journal european union articl addresse direct address member state brussel septemb commiss marko kyprian member commiss oj oj oj direct amend direct ec oj oj annex record data traceabl provid articl blood establish blood establish identif blood donor identif blood unit identif individu blood compon identif date collect year month dai facil blood unit blood compon distribut subsequ disposit facil blood compon supplier identif issu blood compon identif transfus recipi identif blood unit transfus confirm subsequ disposit date transfus disposit year month dai lot number compon relev annex ii notif advers reaction part rapid notif format suspect advers reaction report establish report identif report date year month dai date transfus year month dai ag sex recipi date advers reaction year month dai advers reaction relat blood red blood cell platelet plasma type advers reaction immunolog haemolysi due abo incompat immunolog haemolysi due allo antibodi immunolog haemolysi transfus transmit bacteri infect anaphylaxi hypersensit transfus relat acut lung injuri transfus transmit viral infect hbv transfus transmit viral infect hcv transfus transmit viral infect hiv transfus transmit viral infect transfus transmit parasit infect malaria transfus transmit parasit infect post transfus purpura graft versu host diseas reaction imput level na part advers reaction imput level imput level assess advers reaction imput level explan na assess insuffici data imput assess exclud conclus evid reason doubt attribut advers reaction altern evid favour attribut advers reaction blood blood compon evid indetermin attribut advers reaction blood blood compon altern probabl evid favour attribut advers reaction blood blood compon conclus evid reason doubt attribut advers reaction blood blood compon part confirm format advers reaction report establish report identif confirm date year month dai date advers reaction year month dai confirm advers reaction imput level na chang type advers reaction clinic outcom complet recoveri minor sequela sequela death part annual notif format advers reaction report establish report period tabl refer blood red blood cell platelet plasma separ tabl compon number unit issu total number unit issu number blood compon number recipi transfus total number recipi transfus number blood compon number unit transfus total number blood compon unit transfus report period total number report number advers reaction imput level confirm annex iia number death assess level level level level immunolog haemolysi due abo incompat total death due allo antibodi total death immunolog haemolysi total death transfus transmit bacteri infect total death anaphylaxi hypersensit total death transfus relat acut lung injuri total death transfus transmit viral infect hbv total death hcv total death hiv total death total death transfus transmit parasit infect malaria total death total death post transfus purpura total death graft versu host diseas total death reaction total death annex iii notif advers event part rapid notif format advers event report establish report identif report date year month dai date advers event year month dai advers event affect qualiti safeti blood compon due deviat specif product defect equip failur human error blood collect apheresi collect test donat process storag distribut materi part confirm format advers event report establish report identif confirm date year month dai date advers event year month dai root analysi detail correct measur detail part annual notif format advers event report establish report period januari decemb year total number blood blood compon process advers event affect qualiti safeti blood compon due deviat total number specif product defect equip failur human error blood collect apheresi collect test donat process storag distribut materi