direct ec european parliament council march amend tradit herbal medicin product 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 act accord procedur laid articl treati direct ec requir applic authoris place medicin product market accompani dossier particular document relat result physico chemic biolog microbiolog test pharmacolog toxicolog test clinic trial carri product prove qualiti safeti efficaci applic demonstr detail refer publish scientif literatur constitu constitu medicin product establish medicin recognis efficaci accept level safeti mean direct ec requir provid result pre clinic test result clinic trial signific number medicin product long tradit fulfil requir establish medicin recognis efficaci accept level safeti elig market authoris maintain product market member state enact differ procedur provis differ exist provis laid member state hinder trade tradit medicin product commun lead discrimin distort competit manufactur product impact protect public health guarante qualiti safeti efficaci provid present regard characterist medicin product long tradit desir provid special simplifi registr procedur tradit medicin product simplifi procedur market authoris obtain pursuant direct ec lack suffici scientif literatur demonstr establish medicin recognis efficaci accept level safeti likewis appli homeopath medicin product elig market authoris registr direct ec long tradit medicin product make reduc clinic trial efficaci medicin product plausibl basi long stand experi pre clinic test medicin product basi inform tradit prove harm condit long tradit exclud possibl concern regard product safeti compet author entitl data assess safeti qualiti aspect medicin product independ tradit derog made regard physico chemic biolog microbiolog test product compli qualiti standard relev european pharmacopoeia monograph pharmacopoeia member state vast major medicin product suffici long coher tradit base herbal substanc limit scope simplifi registr step tradit herbal medicin product simplifi registr accept herbal medicin product reli suffici long medicin commun medicin commun account medicin product commun time limit evid commun assess carefulli valid relev commun object facilit registr tradit herbal medicin product enhanc harmonis possibl establish commun list herbal substanc fulfil criteria medicin suffici long time consid harm normal condit regard particular herbal medicin product committe herbal medicin product establish european agenc evalu medicin product hereinaft quot agenc quot set council regul eec committe carri task simplifi registr authoris medicin product provid direct task relat establish commun herbal monograph relev registr authoris herbal medicin product compos expert field herbal medicin product import ensur full consist committe committe human medicin product exist agenc order promot harmonis member state recognis registr tradit herbal medicin product grant member state base commun herbal monograph consist substanc prepar combin thereof contain list establish product member state due account registr direct medicin herbal product fulfil criteria food legisl regul food legisl commun commiss present report applic chapter tradit herbal medicin product european parliament council includ assess extens tradit registr categori medicin product amend direct ec adopt direct articl direct ec amend articl ad quot tradit herbal medicin product herbal medicin product fulfil condit laid articl herbal medicin product medicin product exclus activ ingredi herbal substanc herbal prepar herbal substanc combin herbal prepar herbal substanc fragment cut plant plant part alga fungi lichen unprocess dri form fresh exud subject specif treatment consid herbal substanc herbal substanc precis defin plant part botan binomi system genu speci varieti author herbal prepar prepar obtain subject herbal substanc treatment extract distil express fraction purif concentr ferment includ comminut powder herbal substanc tinctur extract essenti oil express juic process exud quot chapter insert titl iii quot chapter specif provis applic tradit herbal medicin product articl simplifi registr procedur hereinaft tradit registr establish herbal medicin product fulfil criteria indic exclus tradit herbal medicin product virtu composit purpos intend design supervis medic practition diagnost purpos prescript monitor treatment exclus administr accord strength posolog oral extern inhal prepar period tradit laid articl elaps data tradit medicin product suffici product prove harm condit pharmacolog effect efficaci medicin product plausibl basi long stand experi notwithstand articl presenc herbal medicin product vitamin miner safeti document evid prevent product elig registr accord paragraph provid action vitamin miner ancillari herbal activ ingredi claim indic case compet author judg tradit herbal medicin product fulfil criteria authoris accord articl registr pursuant articl provis chapter appli articl applic registr holder establish commun order obtain tradit registr applic submit applic compet author member state concern articl applic accompani particular document refer articl ii result pharmaceut test refer indent articl iii summari product characterist data articl iv case combin refer articl articl inform refer articl relat combin individu activ ingredi suffici data relat individu activ ingredi authoris registr obtain applic member state countri place medicin product market detail decis refus grant authoris registr commun countri reason decis bibliograph expert evid effect medicin product question product medicin period year preced date applic includ year commun request member state applic tradit registr submit committe herbal medicin product draw opinion adequaci evid long stand product product member state submit relev document support referr bibliograph review safeti data expert report requir compet author addit request data assess safeti medicin product annex appli analog particular document point product refer paragraph characteris activ ingredi irrespect excipi similar intend purpos equival strength posolog similar rout administr medicin product appli requir show medicin period year refer paragraph satisfi market product base specif authoris likewis satisfi number quantiti ingredi medicin product reduc period product commun year elig simplifi registr member state applic tradit registr submit refer product committe herbal medicin product member state submit relev document support referr committe criteria simplifi registr refer articl fulli compli committe consid establish commun herbal monograph refer articl account member state take final decis articl prejudic articl chapter titl iii appli analog registr grant accord articl provid commun herbal monograph establish accord articl herbal medicin product consist herbal substanc prepar combin thereof contain list refer articl herbal medicin product refer articl member state evalu applic tradit registr due account registr grant member state accord chapter articl tradit registr refus applic compli articl condit fulfil qualit quantit composit declar indic compli condit laid articl product harm normal condit data tradit insuffici pharmacolog effect efficaci plausibl basi long stand experi pharmaceut qualiti satisfactorili demonstr compet author member state notifi applic commiss compet author request decis refus tradit registr reason refus articl list herbal substanc prepar combin thereof tradit herbal medicin product establish accord procedur refer articl list regard herbal substanc indic strength posolog rout administr inform safe herbal substanc tradit medicin product applic tradit registr relat herbal substanc prepar combin thereof contain list refer paragraph data articl provid articl appli herbal substanc prepar combin thereof ceas includ list refer paragraph registr pursuant paragraph herbal medicin product substanc revok particular document refer articl submit month articl articl subparagraph direct commiss direct eec appli analog tradit registr grant chapter addit requir articl label user packag leaflet statement effect product tradit herbal medicin product indic exclus base long stand user consult doctor qualifi health care practition symptom persist medicin product advers effect mention packag leaflet occur member state requir label user packag leaflet state natur tradit question addit requir articl advertis medicin product regist chapter statement tradit herbal medicin product indic exclus base long stand articl committe herbal medicin product establish committe part agenc compet simplifi registr perform task aris articl perform task aris articl prepar draft list herbal substanc prepar combin thereof refer articl establish commun monograph tradit herbal medicin product refer paragraph articl authoris herbal medicin product establish commun herbal monograph herbal medicin product refer paragraph articl referr agenc chapter titl iii relat herbal medicin product refer articl perform task set articl medicin product herbal substanc refer agenc chapter titl iii give opinion herbal substanc final committe herbal medicin product perform task confer commun law coordin committe human medicin product ensur procedur determin execut director agenc accord articl regul eec member state appoint year term renew member altern committe herbal medicin product altern repres vote member absenc member altern chosen role experi evalu herbal medicin product repres compet nation author committe coopt maximum addit member chosen basi specif scientif compet member appoint term year renew altern view coopt member committe identifi specif complementari scientif compet addit member coopt member chosen expert nomin member state agenc member committe accompani expert specif scientif technic field committe herbal medicin product establish commun herbal monograph herbal medicin product regard applic articl ii tradit herbal medicin product committe fulfil respons confer provis chapter commun law commun herbal monograph mean paragraph establish account member state examin applic commun herbal monograph establish monograph public data refer commun herbal monograph establish registr holder modifi registr dossier registr holder notifi modif compet author member state concern herbal monograph publish gener provis regul eec relat committe human medicin product appli analog committe herbal medicin product articl april commiss submit report european parliament council applic provis chapter report includ assess extens tradit registr categori medicin product quot articl member state measur compli direct octob forthwith inform commiss thereof member state adopt measur refer direct accompani refer occas offici public method make refer laid member state tradit herbal medicin product refer articl market entri forc direct compet author appli provis direct year entri forc 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 opinion european parliament novemb oj council common posit novemb oj posit european parliament decemb publish offici journal council decis march oj direct amend commiss direct ec oj oj regul amend regul ec oj oj