direct ec european parliament council march amend direct ec commun code relat medicin product human 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 direct ec european parliament council novemb commun code relat medicin product human codifi consolid singl text text commun legisl medicin product human interest clariti rationalis commun legisl adopt made major contribut achiev object free safe movement medicin product human elimin obstacl trade product light experi acquir clear measur elimin remain obstacl free movement align nation law regul administr provis differ regard basic principl order promot oper intern market realis high level human health protect main purpos regul manufactur distribut medicin product human safeguard public health object achiev mean hinder develop pharmaceut industri trade medicin product commun articl council regul eec juli lai commun procedur authoris supervis medicin product human veterinari establish european agenc evalu medicin product provid year entri forc commiss requir publish gener report experi acquir result oper market authoris procedur laid regul commun legal provis light commiss report experi acquir prove improv oper market authoris procedur medicin product commun result scientif technic progress definit scope direct ec clarifi order achiev high standard qualiti safeti efficaci medicin product human order account emerg therapi grow number call quot borderlin quot product medicin product sector sector definit quot medicin product quot modifi avoid doubt applic legisl product whilst fulli fall definit medicin product fall definit regul product definit type action medicin product exert physiolog function enumer action make cover medicin product gene therapi radiopharmaceut product medicin product topic view characterist pharmaceut legisl provis made legisl appli object clarifi situat product definit medicin product fall definit regul product case doubt order ensur legal certainti state explicitli provis compli product definit product categori food food supplement medic devic biocid cosmet direct appli improv consist terminolog pharmaceut legisl propos chang scope centralis procedur longer opt mutual recognit procedur decentralis procedur respect orphan medicin product medicin product activ substanc therapeut indic treatment acquir immun defici syndrom cancer neurodegen disord diabet year date entri forc regul ec longer opt mutual recognit procedur decentralis procedur respect medicin product activ substanc therapeut indic treatment auto immun diseas immun dysfunct viral diseas hand case gener medicin product refer medicin product grant market authoris centralis procedur applic seek market authoris choos procedur condit similarli mutual recognit decentralis procedur option medicin product repres therapeut innov benefit societi patient order increas avail medicin product smaller market case applic appli authoris medicin product context mutual recognit procedur member state member state justifi public health reason authoris place market medicin product evalu oper market authoris procedur reveal revis mutual recognit procedur order improv opportun cooper member state cooper process formalis set coordin group procedur defin oper settl disagr framework revis decentralis procedur regard referr experi acquir reveal procedur case referr relat entir therapeut class medicin product activ substanc provid ethic requir direct ec european parliament council april approxim law regul administr provis member state relat implement good clinic practic conduct clinic trial medicin product human appli medicin product authoris commun respect clinic trial conduct commun medicin product destin authoris commun verifi time evalu applic authoris trial conduct accord principl good clinic practic ethic requir equival provis direct gener medicin account major part market medicin product access commun market facilit light experi acquir period protect data relat pre clinic test clinic trial harmonis biolog medicin product similar refer medicin product meet condit consid gener medicin product due manufactur process characterist raw materi molecular characterist therapeut mode action biolog medicin product meet condit consid gener medicin product result test provid order fulfil requir relat safeti pre clinic test efficaci clinic test criteria qualiti safeti efficaci enabl risk benefit balanc medicin product assess market time compet author deem connect harmonis adapt criteria refus suspens revoc market authoris market authoris renew year grant market authoris market authoris unlimit valid authoris consecut year led place market medicin product member state concern period consid invalid order avoid administr burden maintain authoris exempt rule grant justifi public health ground environment impact assess case case basi specif arrang limit envisag event impact constitut criterion refus market authoris qualiti medicin product human manufactur commun guarante requir activ substanc composit compli principl good manufactur practic relat medicin product prove reinforc commun provis inspect compil commun regist result inspect pharmacovigil gener market surveil sanction event failur compli provis step field pharmacovigil account facil offer inform technolog improv exchang member state part proper medicin product rule packag adapt account experi acquir measur implement direct adopt accord council decis ec june lai procedur exercis implement power confer commiss direct ec amend adopt direct articl direct ec amend articl amend point delet point replac quot medicin product substanc combin substanc present properti treat prevent diseas human be substanc combin substanc administ human be view restor correct modifi physiolog function exert pharmacolog immunolog metabol action make medic diagnosi quot point replac quot homeopath medicin product medicin product prepar substanc call homeopath stock accord homeopath manufactur procedur european pharmacopoeia absenc thereof pharmacopoeia offici member state homeopath medicin product number principl quot titl point replac quot kit quot point insert quot repres market authoris holder person commonli local repres design market authoris holder repres member state concern quot point replac quot medicin product invent liabl confus common common scientif accompani trade mark market authoris holder quot head point replac concern portugues version point replac quot agenc european medicin agenc establish regul ec quot point replac point quot risk relat medicin product risk relat qualiti safeti efficaci medicin product patient health public health risk undesir effect environ risk benefit balanc evalu posit therapeut effect medicin product relat risk defin point indent quot articl replac quot articl direct appli medicin product human intend market member state prepar industri manufactur method involv industri process case doubt take account characterist product fall definit medicin product definit product cover commun legisl provis direct appli notwithstand paragraph articl titl iv direct appli medicin product intend export intermedi product quot articl amend point replac quot medicin product prepar pharmaci accord prescript pharmacopoeia intend suppli directli patient serv pharmaci question commonli officin formula quot point replac quot medicin product intend research develop trial prejudic provis direct ec european parliament council april approxim law regul administr provis member state relat implement good clinic practic conduct clinic trial medicin product human quot point replac quot blood plasma blood cell human origin plasma prepar method involv industri process quot articl replac quot articl member state accord legisl forc fulfil special exclud provis direct medicin product suppli respons bona fide unsolicit order formul accord specif authoris health care profession individu patient direct person respons member state temporarili authoris distribut unauthoris medicin product respons suspect confirm spread pathogen agent toxin chemic agent nuclear radiat harm prejudic paragraph member state lai provis order ensur market authoris holder manufactur health profession subject civil administr liabil consequ result medicin product authoris indic unauthoris medicin product recommend requir compet author respons suspect confirm spread pathogen agent toxin chemic agent nuclear radiat harm provis appli nation commun authoris grant liabil defect product provid council direct eec juli approxim law regul administr provis member state liabil defect product affect paragraph quot articl amend paragraph subparagraph ad quot medicin product grant initi market authoris accord subparagraph addit strength pharmaceut form administr rout present variat extens grant authoris accord subparagraph includ initi market authoris market authoris consid belong global market authoris purpos applic articl quot paragraph insert quot market authoris holder respons market medicin product design repres reliev market authoris holder legal respons quot paragraph quot radionuclid kit quot replac quot kit quot articl quot radionuclid kit quot replac quot kit quot articl amend point replac quot medicin product qualit quantit particular constitu medicin product includ refer intern proprietari inn recommend inn medicin product exist refer relev chemic quot point insert quot ca evalu potenti environment risk pose medicin product impact assess case case basi specif arrang limit envisag quot point replac point quot reason precautionari safeti measur storag medicin product administr patient dispos wast product indic potenti risk present medicin product environ descript control method emploi manufactur result pharmaceut physico chemic biolog microbiolog test pre clinic toxicolog pharmacolog test clinic trial ia detail descript pharmacovigil risk manag system applic introduc ib statement effect clinic trial carri european union meet ethic requir direct ec summari accord articl product characterist mock outer packag detail provid articl packag medicin product detail provid articl packag leaflet accord articl quot point ad quot copi design medicin product orphan medicin product regul ec european parliament council decemb orphan medicin product accompani copi relev agenc opinion proof applic servic qualifi person respons pharmacovigil mean notif advers reaction suspect occur commun countri quot subparagraph ad quot document inform result pharmaceut pre clinic test clinic trial refer point subparagraph accompani detail summari accord articl quot articl replac quot articl derog articl prejudic law relat protect industri commerci properti applic requir provid result pre clinic test clinic trial demonstr medicin product gener refer medicin product authoris articl year member state commun gener medicin product authoris pursuant provis market ten year elaps initi authoris refer product subparagraph appli refer medicin product authoris member state applic gener medicin product submit case applic applic form member state refer medicin product authoris request compet author member state applic submit compet author member state transmit period month confirm refer medicin product authoris full composit refer product relev document ten year period refer subparagraph extend maximum eleven year year ten year market authoris holder obtain authoris therapeut indic scientif evalu prior authoris held bring signific clinic benefit comparison exist therapi purpos articl refer medicin product medicin product authoris articl accord provis articl gener medicin product medicin product qualit quantit composit activ substanc pharmaceut form refer medicin product bioequival refer medicin product demonstr bioavail studi salt ester ether isom mixtur isom complex deriv activ substanc consid activ substanc differ significantli properti regard safeti efficaci case addit inform provid proof safeti efficaci salt ester deriv authoris activ substanc suppli applic releas oral pharmaceut form consid pharmaceut form bioavail studi requir applic demonstr gener medicin product meet relev criteria defin detail guidelin case medicin product fall definit gener medicin product provid paragraph bioequival demonstr bioavail studi case activ substanc therapeut indic strength pharmaceut form rout administr vi vi refer medicin product result pre clinic test clinic trial provid biolog medicin product similar refer biolog product meet condit definit gener medicin product ow differ relat raw materi differ manufactur process biolog medicin product refer biolog medicin product result pre clinic test clinic trial relat condit provid type quantiti supplementari data provid compli relev criteria state annex relat detail guidelin result test trial refer medicin product dossier provid addit provis laid paragraph applic made indic establish substanc cumul period year data exclus grant provid signific pre clinic clinic studi carri relat indic conduct studi trial view applic paragraph consequenti practic requir regard contrari patent right supplementari protect certif medicin product quot articl insert quot articl derog articl prejudic law relat protect industri commerci properti applic requir provid result pre clinic test clinic trial demonstr activ substanc medicin product establish medicin commun ten year recognis efficaci accept level safeti term condit set annex event test trial result replac scientif literatur articl case medicin product activ substanc composit authoris medicin product hitherto combin therapeut purpos result pre clinic test clinic trial relat combin provid accord articl provid scientif refer relat individu activ substanc articl grant market authoris authoris holder made pharmaceut pre clinic clinic document contain file medicin product view examin subsequ applic relat medicin product possess qualit quantit composit term activ substanc pharmaceut form quot articl replac quot articl summari product characterist order inform medicin product strength pharmaceut form qualit quantit composit term activ substanc constitu excipi knowledg essenti proper administr medicin product usual common chemic descript pharmaceut form clinic particular therapeut indic posolog method administr adult children contra indic special warn precaut case immunolog medicin product special precaut person handl product administ patient precaut patient interact medicin product form interact pregnanc lactat effect abil drive machin undesir effect overdos symptom emerg procedur antidot pharmacolog properti pharmacodynam properti pharmacokinet properti preclin safeti data pharmaceut particular list excipi major incompat shelf life reconstitut medicin product packag open time special precaut storag natur content contain special precaut dispos medicin product wast materi deriv medicin product market authoris holder market authoris number date authoris renew authoris date revis text radiopharmaceut full detail intern radiat dosimetri radiopharmaceut addit detail instruct extemporan prepar qualiti control prepar maximum storag time intermedi prepar eluat readi pharmaceut conform specif authoris articl part summari product characterist refer medicin product refer indic dosag form cover patent law time gener medicin market includ quot articl replac quot articl applic ensur detail summari refer subparagraph articl submit compet author drawn sign expert technic profession qualif set curriculum vita person technic profession qualif refer paragraph justifi made scientif literatur articl accord condit set annex detail summari form part file applic submit compet author quot articl replac quot articl member state ensur homeopath medicin product manufactur market commun regist authoris accord articl medicin product cover registr authoris grant accord nation legisl decemb case registr articl articl appli member state establish special simplifi registr procedur homeopath medicin product refer articl quot articl amend paragraph subparagraph insert quot scientif evid warrant commiss amend indent subparagraph procedur refer articl quot paragraph delet articl amend indent replac quot dossier describ homeopath stock stock obtain control justifi homeopath basi adequ bibliographi quot sixth indent replac quot mock up outer packag packag medicin product regist quot articl amend paragraph quot articl quot replac quot articl quot paragraph quot toxicolog pharmacolog test quot replac quot pre clinic test quot articl replac quot articl member state measur ensur procedur grant market authoris medicin product complet maximum dai submiss valid applic applic market authoris member state respect medicin product submit accord articl member state note market authoris applic medicin product examin member state member state concern declin assess applic advis applic articl appli articl member state inform accord articl member state authoris medicin product subject market authoris applic member state concern reject applic submit complianc articl quot articl amend introductori sentenc quot articl quot replac quot articl quot point quot articl quot replac quot articl quot point quot state laboratori laboratori design purpos quot replac quot offici medicin control laboratori laboratori member state design purpos quot point quot articl quot replac quot articl quot point articl quot except justifi case quot replac quot justifi case quot articl paragraph replac quot compet author make publicli delai market authoris summari product characterist medicin product authoris compet author draw assess report comment file result pharmaceut pre clinic test clinic trial medicin product concern assess report updat inform import evalu qualiti safeti efficaci medicin product concern compet author make publicli access delai assess report reason opinion delet inform commerci confidenti natur justif provid separ indic appli quot articl replac quot articl except circumst consult applic authoris grant subject requir applic meet condit safeti medicin product notif compet author incid relat action authoris grant object verifi reason base ground set annex continu authoris link annual reassess condit list condit made publicli access delai deadlin date fulfil quot articl paragraph ad quot authoris holder forthwith suppli compet author inform entail amend particular document refer articl annex forthwith inform compet author prohibit restrict impos compet author countri medicin product human market inform influenc evalu benefit risk medicin product human concern order risk benefit balanc continu assess compet author time holder market authoris forward data demonstr risk benefit balanc remain favour quot articl insert quot articl market authoris grant holder authoris inform compet author authoris member state date actual market medicin product human member state take account present authoris holder notifi compet author product ceas market member state temporarili perman notif except circumst made month interrupt place market product request compet author context pharmacovigil market authoris holder provid compet author data relat volum sale medicin product data possess relat volum prescript quot articl replac quot articl prejudic paragraph market authoris valid year market authoris renew year basi evalu risk benefit balanc compet author authoris member state end market authoris holder provid compet author consolid version file respect qualiti safeti efficaci includ variat introduc market authoris grant month market authoris ceas valid accord paragraph renew market authoris valid unlimit period compet author decid justifi ground relat pharmacovigil proce addit year renew accord paragraph authoris year grant actual place market authoris product authoris member state ceas valid authoris product previous market authoris member state longer present market period consecut year authoris product ceas valid compet author except circumst public health ground grant exempt paragraph exempt duli justifi quot articl replac quot articl market authoris refus verif particular document list articl clear risk benefit balanc consid favour therapeut efficaci insuffici substanti applic qualit quantit composit declar authoris likewis refus particular document submit support applic compli articl applic holder market authoris respons accuraci document data submit quot head chapter titl iii replac quot chapter mutual recognit procedur decentralis procedur quot articl replac quot articl coordin group set examin question relat market authoris medicin product member state accord procedur laid chapter agenc provid secretariat coordin group coordin group compos repres member state appoint renew period year member coordin group arrang accompani expert coordin group draw rule procedur enter forc favour opinion commiss rule procedur made public articl view grant market authoris medicin product member state applic submit applic base ident dossier member state dossier inform document refer articl document submit includ list member state concern applic applic request member state act refer member state prepar assess report medicin product accord paragraph medicin product receiv market authoris time applic concern member state recognis market authoris grant refer member state end market authoris holder request refer member state prepar assess report medicin product updat exist assess report refer member state prepar updat assess report dai receipt valid applic assess report approv summari product characterist label packag leaflet concern member state applic case medicin product receiv market authoris time applic applic request refer member state prepar draft assess report draft summari product characterist draft label packag leaflet refer member state prepar draft document dai receipt valid applic send concern member state applic dai receipt document refer paragraph member state concern approv assess report summari product characterist label packag leaflet inform refer member state refer member state record agreement parti close procedur inform applic member state applic submit accord paragraph adopt decis conform approv assess report summari product characterist label packag leaflet approv dai acknowledg agreement articl period laid articl member state approv assess report summari product characterist label packag leaflet ground potenti risk public health give detail exposit reason posit refer member state member state concern applic point disagr forthwith refer coordin group guidelin adopt commiss defin potenti risk public health coordin group member state refer paragraph endeavour reach agreement action applic opportun make point view oral write dai commun point disagr member state reach agreement refer member state record agreement close procedur inform applic articl appli member state fail reach agreement dai period laid paragraph agenc immedi inform view applic procedur articl agenc provid detail statement matter member state unabl reach agreement reason disagr copi forward applic applic inform matter refer agenc forthwith forward agenc copi inform document refer subparagraph articl circumst refer paragraph member state approv assess report draft summari product characterist label packag leaflet refer member state request applic authoris medicin product wait outcom procedur laid articl event authoris grant prejudic outcom procedur articl applic submit accord articl made market authoris medicin product member state adopt diverg decis authoris medicin product suspens revoc member state commiss applic market authoris holder refer matter committe medicin product human hereinaft refer committe applic procedur laid articl order promot harmonis authoris medicin product authoris commun member state year forward coordin group list medicin product harmonis summari product characterist drawn coordin group lai list take account propos member state forward list commiss commiss member state agreement agenc take account view interest parti refer product committe accord paragraph articl member state commiss applic market authoris holder specif case interest commun involv refer matter committe applic procedur laid articl decis reach request market authoris suspens revoc authoris variat term market authoris appear account inform collect accord titl ix member state concern commiss identifi question refer committe consider inform applic market authoris holder member state applic market authoris holder suppli committe inform relat matter question referr committe concern rang medicin product therapeut class agenc limit procedur specif part authoris event articl appli medicin product cover authoris procedur refer chapter articl refer made procedur laid articl committe matter concern issu reason opinion dai date matter refer case submit committe accord articl period extend committe period dai take account view applic market authoris holder concern emerg propos chairman committe agre shorter deadlin order matter committe appoint member act rapporteur committe appoint individu expert advis specif question appoint expert committe defin task time limit complet task issu opinion committe provid applic market authoris holder opportun present written oral explan time limit opinion committe accompani draft summari product characterist product draft text label packag leaflet committe call person provid inform relat matter committe suspend time limit refer paragraph order applic market authoris holder prepar explan agenc forthwith inform applic market authoris holder opinion committe applic satisfi criteria authoris summari product characterist propos applic market authoris holder accord articl amend authoris grant subject condit view condit consid essenti safe effect medicin product includ pharmacovigil market authoris suspend vari revok dai receipt opinion applic market authoris holder notifi agenc write intent request examin opinion case forward agenc detail ground request dai receipt opinion dai receipt ground request committe examin opinion accord fourth subparagraph articl regul ec reason conclus reach annex assess report refer paragraph articl dai adopt agenc forward final opinion committe member state commiss applic market authoris holder report describ assess medicin product state reason conclus event opinion favour grant maintain authoris place medicin product concern market document annex opinion draft summari product characterist refer articl condit affect authoris mean paragraph detail recommend condit restrict regard safe effect medicin product propos text label leaflet quot articl amend paragraph quot dai quot replac quot dai quot paragraph quot articl quot replac quot articl subparagraph quot fourth paragraph word quot market authoris holder quot ad word quot applic quot articl replac quot articl commiss final decis accord dai end procedur refer articl rule procedur stand committe establish articl adjust account task incumb chapter adjust entail provis case refer paragraph articl opinion stand committe write member state dai forward written observ draft decis commiss decis urgent shorter time limit set chairman degre urgenc involv time limit except circumst shorter dai member state option submit written request draft decis discuss plenari meet stand committe opinion commiss written observ member state rais import question scientif technic natur address opinion deliv agenc chairman suspend procedur refer applic back agenc consider provis implement paragraph adopt commiss accord procedur refer articl decis refer paragraph address member state report inform market authoris holder applic concern member state refer member state grant revok market authoris vari term compli decis dai notif refer inform commiss agenc quot subparagraph articl delet articl paragraph replac quot ten year commiss publish report experi acquir basi procedur chapter propos amend improv procedur commiss submit report european parliament council quot articl replac quot articl articl articl appli homeopath medicin product refer articl articl appli homeopath medicin product refer articl quot paragraph ad articl quot member state forward agenc copi authoris refer paragraph agenc enter inform commun databas refer articl quot articl point replac quot compli principl guidelin good manufactur practic medicin product start materi activ substanc manufactur accord detail guidelin good manufactur practic start materi point applic excipi list specif condit applic establish direct adopt commiss accord procedur refer articl quot articl insert quot articl purpos direct manufactur activ substanc start materi includ total partial manufactur import activ substanc start materi defin part point annex process divid packag present prior incorpor medicin product includ repackag label carri distributor start materi amend adapt paragraph scientif technic develop laid accord procedur refer articl quot articl paragraph ad quot principl good manufactur practic activ substanc start materi refer point articl adopt form detail guidelin commiss publish guidelin form content authoris refer articl report refer articl form content certif good manufactur practic refer articl quot articl quot minimum quot delet articl fourth subparagraph indent quot appli physic quot replac quot experiment physic quot articl quot state concern quot replac quot commun quot articl point replac quot case medicin product come countri irrespect product manufactur commun product batch undergon member state full qualit analysi quantit analysi activ substanc test check ensur qualiti medicin product accord requir market authoris quot articl amend point replac quot medicin product strength pharmaceut form intend babi children adult product activ substanc intern proprietari inn includ exist common quot point quot guidelin quot replac quot detail guidanc quot point replac quot method administr rout administr space provid prescrib dose quot point replac quot special warn medicin product store reach sight children quot point replac quot specif precaut relat dispos unus medicin product wast deriv medicin product refer collect system place quot point replac quot address market authoris holder applic repres appoint holder repres quot point replac quot case prescript medicin product instruct quot articl amend paragraph quot articl quot replac quot articl quot indent paragraph replac quot medicin product laid point articl quot indent paragraph replac quot medicin product laid point articl rout administr quot articl insert quot articl medicin product refer articl point express braill format packag market authoris holder ensur packag inform leaflet made request patient organis format blind partial sight quot articl paragraph ad quot medicin product authoris regul ec member state appli articl observ detail guidanc refer articl direct quot articl replac quot articl packag leaflet drawn accord summari product characterist includ order identif medicin product medicin product strength pharmaceut form intend babi children adult common includ product activ substanc invent ii pharmaco therapeut group type activ term easili comprehens patient therapeut indic list inform medicin product contra indic ii precaut iii form interact medicin product form interact alcohol tobacco foodstuff affect action medicin product iv special warn usual instruct proper dosag ii method rout administr iii frequenc administr time medicin product administ depend natur product iv durat treatment limit action case overdos symptom emerg procedur vi dose vii indic risk withdraw effect viii specif recommend consult doctor pharmacist clarif product descript advers reaction occur normal medicin product action case patient expressli ask commun advers reaction mention packag leaflet doctor pharmacist refer expiri date label warn product date ii special storag precaut iii warn visibl sign deterior iv full qualit composit activ substanc excipi quantit composit activ substanc common name present medicin product present product pharmaceut form content weight volum unit dosag vi address market authoris holder applic appoint repres member state vii address manufactur medicin product authoris accord articl name member state concern list name authoris member state date packag leaflet revis list set point paragraph account condit categori user children pregnant breastfeed women elderli person specif patholog condit mention effect abil drive vehicl oper machineri list excipi knowledg import safe effect medicin product includ detail guidanc publish pursuant articl packag leaflet reflect result consult target patient group ensur legibl clear easi quot articl replac quot mock up outer packag packag medicin product draft packag leaflet submit author compet authoris market market authoris request result assess carri cooper target patient group provid compet author quot articl quot quot replac quot quot articl quot health educ quot replac quot patient quot articl amend subparagraph ad paragraph quot case orphan medicin product particular list articl reason request offici languag commun quot paragraph replac quot packag leaflet written design clear understand enabl user act appropri health profession packag leaflet legibl offici languag languag member state medicin product market subparagraph prevent packag leaflet print languag provid inform languag product intend deliv directli patient compet author grant exempt oblig particular label packag leaflet leaflet offici languag languag member state product market quot articl replac quot articl consult member state parti concern commiss draw publish detail guidanc word special warn categori medicin product inform relat prescript medicin product legibl particular label packag leaflet method identif authent medicin product list excipi featur label medicin product excipi harmonis provis implement articl quot articl fourth indent replac quot address manufactur quot articl amend indent replac quot scientif stock stock degre dilut make symbol pharmacopoeia accord articl homeopath medicin product compos stock scientif name stock label supplement invent quot indent replac quot warn advis user consult doctor symptom persist quot articl amend point replac quot medicin product medic prescript renew renew deliveri quot point replac quot medicin product restrict medic prescript reserv specialis area quot articl replac quot articl fact brought attent compet author examin amend classif medicin product appli criteria list articl quot articl insert quot articl chang classif medicin product authoris basi signific pre clinic test clinic trial compet author refer result test trial examin applic applic holder market authoris chang classif substanc year initi chang authoris quot articl amend exist text paragraph paragraph ad quot case wholesal distribut storag medicin product cover market authoris grant pursuant regul ec compet author member state accord direct distributor market authoris holder import product member state notifi market authoris holder compet author member state product import intent import case product grant authoris pursuant regul ec notif compet author prejudic addit procedur provid legisl member state quot indent point articl replac quot medicin product quot articl replac quot articl regard suppli medicin product pharmacist person authoris entitl suppli medicin product public member state impos holder distribut authoris grant member state oblig public servic oblig stringent impos person authoris engag equival activ holder market authoris medicin product distributor medicin product market member state limit respons ensur continu suppli medicin product pharmaci person authoris suppli medicin product patient member state question cover arrang implement articl justifi ground public health protect proportion relat object protect complianc treati rule free movement good competit quot articl indent paragraph replac quot pharmaceut form medicin product quot articl replac quot articl commiss publish guidelin good distribut practic end consult committe medicin product human pharmaceut committe establish council decis eec quot articl replac quot articl titl appli homeopath medicin product quot fourth indent articl replac quot inform relat human health diseas provid refer indirect medicin product quot articl replac quot articl member state prohibit advertis gener public medicin product medic prescript accord titl vi substanc defin psychotrop narcot intern convent unit nation convent medicin product advertis gener public virtu composit purpos intend design intervent medic practition diagnost purpos prescript monitor treatment advic pharmacist member state entitl ban territori advertis gener public medicin product cost reimburs prohibit contain paragraph appli vaccin campaign carri industri approv compet author member state prohibit refer paragraph appli prejudic articl direct eec member state prohibit direct distribut medicin product public industri promot purpos quot text insert articl quot titl viiia inform advertis articl year entri forc direct ec commiss consult patient consum organis doctor pharmacist organis member state interest parti present european parliament council report current practic regard inform provis internet risk benefit patient analysi data commiss put forward propos set inform strategi ensur good qualiti object reliabl promot inform medicin product treatment address question inform sourc liabil quot articl amend indent point paragraph replac affect english version paragraph replac quot member state decid advertis medicin product gener public notwithstand paragraph includ medicin product intern proprietari exist trademark intend sole remind quot articl point delet articl paragraph replac quot member state decid advertis medicin product person qualifi prescrib suppli product notwithstand paragraph includ medicin product intern proprietari exist trademark intend sole remind quot articl replac quot hospit sale promot event strictli limit main purpos extend person health care profession quot articl replac quot articl provis articl prevent hospit offer directli indirectli event pure profession scientif purpos hospit strictli limit main scientif object event extend person health care profession quot point articl replac quot sampl larger smallest present market quot articl paragraph ad quot member state prohibit promot medicin product holder market authoris compani nomin quot articl replac quot articl advertis homeopath medicin product refer articl subject provis titl except articl inform articl advertis medicin product quot articl paragraph replac quot member state impos specif requir doctor health care profession respect report suspect unexpect advers reaction quot articl replac quot articl order ensur adopt harmonis regulatori decis medicin product authoris commun regard inform obtain advers reaction medicin product normal condit member state oper pharmacovigil system system collect inform surveil medicin product refer advers reaction human be evalu inform scientif member state ensur suitabl inform collect system commun member state agenc inform record databas refer point subparagraph articl regul ec perman access member state delai public system account inform misus abus medicin product impact evalu benefit risk quot articl insert quot articl manag fund intend activ connect pharmacovigil oper commun network market surveil perman control compet author order guarante independ quot articl introductori phrase paragraph replac quot qualifi person resid commun respons quot articl replac quot articl market authoris holder requir maintain detail record suspect advers reaction occur commun countri save except circumst reaction commun electron form report accord guidelin refer articl market authoris holder requir record suspect advers reaction brought attent health care profession report promptli compet author member state territori incid occur dai receipt inform market authoris holder requir record report suspect advers reaction meet notif criteria accord guidelin refer articl expect knowledg promptli compet author member state territori incid occur dai receipt inform market authoris holder ensur suspect unexpect advers reaction suspect transmiss medicin product infecti agent occur territori countri report promptli accord guidelin refer articl agenc compet author member state medicin product authoris inform dai receipt inform derog paragraph case medicin product cover direct eec qualifi procedur laid articl direct subject procedur articl direct market authoris holder ensur suspect advers reaction occur commun report access refer member state compet author act refer member state refer member state assum respons analys monitor advers reaction requir laid condit grant market authoris subsequ guidelin refer articl report advers reaction submit compet author form period safeti updat report immedi request month authoris place market period safeti updat report submit immedi request month year initi place market year year report submit yearli interv immedi request period safeti updat report includ scientif evalu risk benefit balanc medicin product commiss lai provis amend paragraph view experi gain oper commiss adopt provis accord procedur refer articl grant market authoris market authoris holder request amend period refer paragraph accord procedur laid commiss regul ec holder market authoris commun inform relat pharmacovigil concern gener public relat authoris medicin product give prior simultan notif compet author case market authoris holder ensur inform present object mislead member state measur ensur market authoris holder fail discharg oblig subject effect proportion dissuas penalti articl agenc collabor member state commiss set data process network facilit exchang pharmacovigil inform medicin product market commun order compet author share inform time make network refer paragraph member state ensur report suspect advers reaction place territori promptli made agenc member state case dai notif latest member state ensur report suspect advers reaction place territori promptli made market authoris holder case dai notif latest articl order facilit exchang inform pharmacovigil commun commiss consult agenc member state interest parti draw guidelin collect verif present advers reaction report includ technic requir electron exchang pharmacovigil inform accord internation agre format publish refer internation agre medic terminolog act accord guidelin market authoris holder internation agre medic terminolog report advers reaction guidelin publish volum rule govern medicin product european commun account intern harmonis work carri field pharmacovigil interpret definit refer point articl principl outlin titl market authoris holder compet author follow guidelin refer paragraph articl result evalu pharmacovigil data member state consid market authoris suspend revok vari accord guidelin refer articl forthwith inform agenc member state market authoris holder urgent action protect public health member state concern suspend market authoris medicin product provid agenc commiss member state inform work dai agenc inform accord paragraph relat suspens revoc subparagraph paragraph committe prepar opinion time frame determin depend urgenc matter relat variat committe request member state prepar opinion act basi opinion commiss request member state product market temporari measur immedi final measur adopt accord procedur refer articl quot articl amend paragraph replac quot compet author member state concern ensur mean repeat inspect unannounc inspect offici medicin control laboratori laboratori design purpos carri test sampl legal requir govern medicin product compli compet author carri unannounc inspect premis manufactur activ substanc start materi premis market authoris holder consid ground suspect complianc principl guidelin good manufactur practic refer articl inspect carri request member state commiss agenc order verifi data submit order obtain conform certif compli monograph european pharmacopoeia standardis bodi nomenclatur qualiti norm mean convent relat elabor european pharmacopoeia european director qualiti medicin product commiss agenc request inspect start materi concern subject european pharmacopoeia monograph compet author member state concern carri inspect start materi manufactur specif request manufactur inspect carri offici repres compet author empow inspect manufactur commerci establish manufactur medicin product activ substanc start materi laboratori emploi holder manufactur authoris carri check pursuant articl sampl includ view independ test carri offici medicin control laboratori laboratori design purpos member state examin document relat object inspect subject provis forc member state place restrict power regard descript manufactur method inspect premis record document market authoris holder firm emploi market authoris holder perform activ titl ix articl quot paragraph replac quot inspect refer paragraph offici repres compet author report manufactur compli principl guidelin good manufactur practic laid articl requir laid articl content report commun manufactur market authoris holder undergon inspect quot paragraph ad quot prejudic arrang conclud commun countri member state commiss agenc requir manufactur establish countri submit inspect refer paragraph dai inspect refer paragraph certif good manufactur practic issu manufactur outcom inspect show manufactur compli principl guidelin good manufactur practic provid commun legisl inspect perform part certif procedur monograph european pharmacopoeia certif drawn member state enter certif good manufactur practic issu commun databas manag agenc behalf commun outcom inspect refer paragraph manufactur compli principl guidelin good manufactur practic provid commun legisl inform enter commun databas refer paragraph quot articl term quot state laboratori laboratori design purpos quot replac term quot offici medicin control laboratori laboratori member state design purpos quot articl replac quot articl compet author suspend revok withdraw vari market authoris view product harm normal condit lack therapeut efficaci risk benefit balanc posit normal condit qualit quantit composit declar therapeut efficaci lack conclud therapeut result obtain medicin product authoris suspend revok withdrawn vari particular support applic provid articl articl incorrect amend accord articl control refer articl carri quot articl replac quot prejudic measur provid articl member state step ensur suppli medicin product prohibit medicin product withdrawn market view medicin product harm normal condit lack therapeut efficaci risk benefit balanc favour authoris condit qualit quantit composit declar control medicin product ingredi control intermedi stage manufactur process carri requir oblig relat grant manufactur authoris fulfil quot articl replac quot articl provis titl appli homeopath medicin product quot articl replac quot articl commiss assist stand committe medicin product human hereinaft call stand committe task adapt technic progress direct remov technic barrier trade medicin product sector refer made paragraph articl decis ec appli regard provis articl thereof period laid articl decis ec set month refer made paragraph articl decis ec appli regard provis articl thereof period laid articl decis ec set month stand committe adopt rule procedur made public articl member state measur ensur compet author concern commun inform guarante requir authoris refer articl certif refer articl market authoris fulfil reason request member state forthwith commun report refer articl compet author member state conclus reach accord articl valid commun except case member state unabl reason relat public health accept conclus reach inspect articl member state forthwith inform commiss agenc agenc inform member state concern commiss inform diverg opinion consult member state concern inspector perform origin inspect perform inspect inspector accompani inspector member state parti disagr quot articl subparagraph replac quot decis grant revok market authoris made publicli quot articl insert quot articl absenc market authoris pend applic medicin product authoris member state accord direct member state justifi public health reason authoris place market medicin product member state avail possibl adopt measur order ensur requir direct compli refer titl vi viii ix xi grant authoris member state notifi market authoris holder member state medicin product concern authoris propos grant authoris articl respect product concern request compet author state furnish copi assess report refer articl market authoris forc respect medicin product commiss set publicli access regist medicin product authoris paragraph member state notifi commiss medicin product authoris ceas authoris paragraph includ corpor perman address authoris holder commiss amend regist medicin product make regist websit april commiss present report european parliament council applic provis view propos amend quot articl insert quot articl order guarante independ transpar member state ensur member staff compet author respons grant authoris rapporteur expert concern authoris surveil medicin product financi interest pharmaceut industri affect imparti person make annual declar financi interest addit member state ensur compet author make publicli access rule procedur committe agenda meet record meet accompani decis detail vote explan vote includ minor opinion quot articl insert quot articl medicin product authoris accord regul ec scientif committe opinion refer recommend condit restrict regard safe effect medicin product provid articl regul decis address member state adopt accord procedur provid articl direct implement condit restrict quot articl insert quot articl member state ensur collect system place medicin product unus expir quot articl period protect provid articl point amend articl direct ec appli refer medicin product applic authoris submit date transposit refer articl paragraph articl member state bring forc law regul administr provis compli direct octob immedi inform commiss thereof member state adopt measur refer direct accompani refer occas offici public method make refer laid member state articl direct enter forc dai public offici journal european union articl direct address member state strasbourg march european parliament presid cox council presid roch oj oj publish offici journal oj opinion european parliament octob oj council common posit septemb oj posit european parliament decemb publish offici journal council decis march oj direct amend commiss direct ec oj oj regul repeal regul ec offici journal offici journal oj oj oj oj oj direct amend direct ec european parliament council oj oj oj oj oj