commiss decis juli nation provis notifi germani field pharmacovigil notifi document number german text authent text eea relev ec commiss european commun regard treati establish european commun articl thereof fact relev commun legisl current commun provis pharmacovigil supervis medicin product authoris contain chapter va articl council direct eec approxim provis laid law regul administr action relat proprietari medicin product amend direct ec chapter va ad direct eec direct eec provis report advers reaction relev notif contain primarili articl pursuant articl person respons place medicin product market requir recal report suspect advers reaction brought attent health care profession immedi compet author case dai latest pursuant articl record maintain suspect advers reaction sumit author regular interv articl commiss authoris updat provis chapter va accord procedur laid articl direct eec account scientif technic progress light knowledg field pharmacovigil continu effort achiev intern harmonis pharmacovigil data technolog develop electron data collect transmiss commiss made authoris contain articl amend point abovement provis direct ec commiss base high level protect pursuant articl ec treati account scientif base develop sake legal clariti irrespect scope amend individu provis redraft main object direct ec remodel pharmacovigil system date primarili paper base organis nation level commun wide electron data system pharmacovigil inform enter automat store data bank set european agenc evalu medicin product refer emea establish council regul eec juli lai commun procedur authoris supervis medicin product human veterinari establish european agenc evalu medicin product data retriev time member state commiss emea electron network base knowledg advanc field inform technolog make collect exchang data effici reliev market authoris holder unnecessari report oblig gener improv surveil medicin product commun central provis report advers reaction contain revis version articl year pursuant version articl market authoris holder requir record report suspect advers reaction brought attent health care profession immedi compet author member state territori incid occur case dai receipt inform pursuant version articl market authoris holder ensur suspect unexpect advers reaction occur territori member countri brought attent health care profession report immedi emea compet author member state medicin product authoris case dai receipt inform version articl emea requir collabor member state commiss set data process network facilit exchang pharmacovigil inform medicin product market commun order compet author share inform time pursuant paragraph articl make abovement network member state ensur report suspect advers reaction place territori immedi made agenc member state case dai notif nation provis provis notifi feder republ germani relat provis sentenc section law trade medicin product amg version notic decemb pursuant sentenc section amg applic notifi compet nation autor suspect case advers reaction case interact product case abus immedi case dai notif restrict text oblig exist irrespect suspect case occur insid feder republ germani advers effect confirm senctenc section amg provis relat document advers reaction present compet author comparison german provis commun legal provis oblig report advers reaction medicin product sentenc section amg differ oblig amend articl direct ec respect firstli sentenc section amg requir applic report suspect case advers reaction notifi word irrespect suspect case occur insid germani version articl market authoris holder requir report advers reaction compet author member state advers reaction place extent suspect advers reaction place member countri commun version articl establish oblig report suspect case advers reaction unexpect restrict contain sentenc section amg ii procedur letter januari receiv januari perman represent feder republ germani european union appli secretariat gener commiss allow maintain provis sentenc section amg oblig report advers reaction germani opinion justifi ground major mean articl ec treati protect health live human letter march commiss inform german author receiv notif pursuant articl ec treati period month provid articl ec treati examin notif begun run januari dai receiv letter april commiss inform member state notif feder republ germani gave opportun express opinion month notic notif publish offici journal european commun order inform interest parti provis notifi maintain germani iii assess consider admiss notif submit german govern aim maintain oblig report advers reaction contain section amg derog direct ec direct adopt basi articl direct eec turn base articl current articl ec treati direct ec repres harmonis measur adopt commiss mean articl ec treati accord requir articl ec treati germani notifi commiss text nation provis wish maintain ground germani opinion justifi applic commiss opinion notif germani request commiss approv mainten provis sentenc section amg derog direct ec admiss basi provis articl ec treati assess merit commiss approv notif pursuant articl ec treati condit list articl ec treati met maintain nation provis justifi ground major refer articl ec treati relat protect environ work environ articl ec treati addit nation provis mean arbitrari discrimin disguis restrict trade member state constitut obstacl function intern market articl ec treati major examin nation measur notifi articl justifi major commiss basi quot ground quot put forward member state justifi mainten nation provis mean provis treati respons prove measur justifi li request member state procedur framework establish articl ec treati principl commiss limit examin relev element submit request member state seek ground justif germani invok major protect health life human circums refer articl ec treati maintain oblig report provid current provis sentenc section amg attain highest level health protect popul medicin product high nation level protect endang direct ec firstli advers reaction futur report member state place advers reaction place member countri cover oblig report quot unexpect quot aa report advers reaction member state germani consid quot accept health ground quot report advers reaction member state suspect case occur justif germani point data network establish direct ec exist basi restrict notif requir guarante forese futur author member state receiv inform equival qualiti time major mean articl ec treati invok basi reason firstli statement feder republ germani data network refer direct ec exist establish forese futur decemb incorrect establish data network provid version articl requir preliminari work part emea commiss complet schedul decemb current timet emea make basic version central bank databank decemb date individu case report mean articl enter databank share author member state contrari germani statement technic procedur precondit establish data network exist end transposit period direct ec account fact establish databank task emea respons author member state pursuant version articl newli establish data network forward report advers reaction transmit emea member state inform enter member state subsequ transmit emea databank automat fed central databank retriev ensur report gener compar make intellig particip agre standard develop framework intern confer harmonis technic requir registr medicin product human collect enter data member state convert nation comput system uniform standard begin electron data transmiss emea standard member state made convers event suspect case member state basic inform product concern patient type advers reaction enter central databank emea electron retriev interfer dissemin pharmacovigil inform commun member state convert system due date decemb requir version articl transmit relev report form restrict oper capac data network advers consequ health protect legal posit member state counter germani argument major health protect requir maintain oblig report advers reaction member state current legal posit member state requir author inform suspect case advers reaction occur member state addit germani case austria portug unit kingdom member state requir commun nation author advers reaction occur nation territori regard inform advers reaction member state inform network exist commun part evid consid adequ true markedli improv data network establish basi direct ec altogeth major mean articl ec treati recognis justifi maintain oblig report advers reaction member state restrict contain version articl repres logic conclus establish data network make inform member state previous present improv maintain previou oblig report place unnecessari unjustifi burden respect market authoris holder bb report advers reaction member countri regard restrict oblig report advers reaction member countri unexpect contain version articl germani claim lead substanti increas risk transmit infecti pathogen medicin product biolog compon claim product inform mention risk viru transmiss medicin product obtain human bodi part event suspect case viru transmiss hiv hepat virus medicin product advers reaction classifi quot unexpect quot reason report occur member countri interfer batch recal effort identifi possibl infect patient follow measur diagnosi therapi extent germani remark relat specif transmiss hiv hepat virus base misconcept germani assum contamin medicin product hiv hepat viru classifi quot expect quot advers reaction exclud oblig report accord direct ec restrict quot unexpect quot advers reaction interpret correct blood product examin virus part manufactur authoris process principl understand medicin product infect infect exist unexpect advers reaction legal posit fulli cover notif requir irrespect viru infect medicin product classifi expect advers reaction reason germani argument ground major mean articl ec treati consider base fact expect advers reaction account test authoris product unexpect subsequ monitor medicin product framework pharmacovigil special signific attach unexpect oppos expect advers reaction reason gener report evalu advers reaction occur commun appear unexpect conclus base scientif evid acquir recent year relat medicin product approv part centralis commun procedur pursuant regul eec procedur obligatori product biotechnolog high technolog industri regard complex sensit subparagraph articl regul eec restrict oblig report advers reaction medicin product occur member countri unexpect analys evalu inform advers reaction gener central authoris medicin product confirm report evalu inform expect advers reaction member countri assess support fact feder republ germani member state restrict oblig report advers reaction occur member countri unexpect extend oblig advers reaction expect highlight fact member state consid order protect health life human includ report suspect expect advers reaction member countri pharmacovigil system maintain oblig report suspect expect advers reaction member countri germani invok major mean articl ec treati provis version articl appli scientif evid prejud high level health protect commun arbitrari discrimin disguis restrict trade obstacl function intern market pursuant articl ec treati commiss requir approv nation provis reject ensur constitut mean arbitrari discrimin disguis restrict trade member state obstacl function intern market light condit refer articl ec treati germani applic unfound commiss examin nation provis constitut mean arbitrari discrimin disguis restrict trade member state obstacl function intern market iv conclus opinion commiss germani applic admiss unfound commiss decid reject applic pursuant articl ec treati adopt decis articl nation provis oblig report advers reaction medicin product notifi commiss feder republ germani letter januari derog direct ec reject articl decis address feder republ germani brussel juli commiss erkki liikanen member commiss oj oj correct oj oj oj oj light corrigendum oj bgbl amend articl law juli bgbl oj