commiss regul ec march condit market authoris medicin product human fall scope regul ec european parliament council text eea relev commiss european commun regard treati establish european commun regard regul ec european parliament council march lai commun procedur authoris supervis medicin product human veterinari establish european medicin agenc articl thereof medicin product human authoris place market member state gener undergo extens studi ensur safe high qualiti effect target popul rule procedur obtain market authoris laid direct ec european parliament council novemb commun code relat medicin product human regul ec case categori medicin product order meet unmet medic patient interest public health grant market authoris basi complet data case subject specif oblig hereinaft quot condit market authoris quot categori concern medicin product aim treatment prevent medic diagnosi debilit life threaten diseas medicin product emerg situat respons public health threat recognis world health organis commun framework decis ec european parliament council septemb set network epidemiolog surveil control communic diseas commun medicin product design orphan medicin product accord regul ec european parliament council decemb orphan medicin product data opinion condit market authoris base complet risk benefit balanc defin articl direct ec posit benefit public health make medicin product concern immedi market outweigh risk inher fact addit data requir condit market authoris grant restrict situat clinic part applic dossier complet normal incomplet pre clinic pharmaceut data accept case product emerg situat respons public health threat order ensur balanc struck facilit access medicin patient unmet medic prevent authoris medicin unfavour risk benefit profil make market authoris subject specif oblig holder requir complet initi studi view confirm risk benefit balanc posit resolv question relat qualiti safeti efficaci product condit market authoris distinct market authoris grant except circumst accord articl regul ec case condit market authoris authoris grant data authoris intend remain condit indefinit miss data provid replac market authoris condit subject specif oblig contrast assembl full dossier respect market authoris grant except circumst made clear applic request condit market authoris subject acceler assess procedur accord articl regul ec provis regul ec appli condit market authoris provid regul procedur evalu condit market authoris normal procedur laid regul ec accord regul ec condit market authoris valid year renew basi deadlin submiss renew applic month prior expiri market authoris opinion european medicin agenc hereinaft agenc applic adopt dai receipt ensur medicin product remov market reason relat public health condit market authoris long renew applic submit deadlin remain valid commiss reach decis base renew assess procedur clear inform provid patient healthcar profession condit natur authoris inform state summari product characterist medicin product concern packag leaflet enhanc pharmacovigil medicin product grant condit market authoris import adequ provid direct ec regul ec time schedul submit period safeti updat report adapt accommod annual renew condit market authoris plan studi submiss applic market authoris occur earli stage develop medicin product plan critic depend condit market authoris possibl reason provid mechan agenc give compani advic medicin product fall scope regul advic addit servic exist scientif advic provid agenc measur provid regul accord opinion stand committe medicin product human adopt regul articl subject matter regul lai rule grant market authoris subject specif oblig accord articl regul ec hereinaft quot condit market authoris quot articl scope regul appli medicin product human fall articl regul ec belong categori medicin product aim treatment prevent medic diagnosi debilit diseas life threaten diseas medicin product emerg situat respons public health threat duli recognis world health organis commun framework decis ec medicin product design orphan medicin product accord articl regul ec articl request propos request condit market authoris present applic applic accord articl regul ec request accompani detail show product fall scope regul satisfi requir laid articl agenc immedi inform commiss applic request condit market authoris committe medicin product human hereinaft quot committe quot opinion applic submit accord articl regul ec propos condit market authoris consult applic articl requir condit market authoris grant committe find comprehens clinic data refer safeti efficaci medicin product suppli requir met risk benefit balanc medicin product defin articl direct ec posit applic posit provid comprehens clinic data unmet medic fulfil benefit public health avail market medicin product concern outweigh risk inher fact addit data requir emerg situat refer articl condit market authoris grant subject requir set point paragraph comprehens pre clinic pharmaceut data suppli purpos paragraph quot unmet medic quot mean condit exist satisfactori method diagnosi prevent treatment authoris commun method exist relat medicin product concern major therapeut advantag affect articl specif oblig specif oblig holder condit market authoris requir complet ongo studi conduct studi view confirm risk benefit balanc posit provid addit data refer articl addit specif oblig impos relat collect pharmacovigil data specif oblig refer paragraph timefram complet condit market authoris agenc make specif oblig timefram complet publicli articl renew period valid year condit market authoris renew annual applic renew submit agenc month expiri condit market authoris interim report fulfil specif oblig subject committe assess applic renew basi risk benefit balanc confirm take account specif oblig contain authoris timefram fulfil formul opinion specif oblig timefram retain modifi agenc ensur opinion committe dai receipt valid renew applic opinion made publicli renew applic submit accord paragraph condit market authoris remain valid decis adopt commiss accord articl regul ec articl market authoris subject specif oblig specif oblig laid accord articl fulfil committe time adopt opinion favour grant market authoris accord articl regul ec articl product inform medicin product grant condit market authoris accord regul inform includ summari product characterist packag leaflet clear mention fact summari product characterist date condit authoris due renew articl period safeti updat report period safeti updat report provid articl regul ec submit agenc member state immedi request month grant renew condit market authoris articl agenc advic prior market authoris applic potenti applic market authoris request advic agenc specif medicin product develop specif therapeut indic fall categori set articl fulfil requir laid articl articl guidelin agenc develop guidelin scientif applic practic arrang implement regul guidelin adopt consult stakehold favour opinion commiss articl transit provis regul appli applic pend time entri forc articl entri forc regul enter forc dai public offici journal european union regul bind entireti directli applic member state brussel march commiss günter verheugen vice presid oj oj direct amend direct ec oj oj decis amend regul ec oj oj