commiss regul ec june examin variat term market authoris medicin product human veterinari medicin product grant compet author member state text eea relev commiss european commun regard treati establish european commun regard direct ec european parliament council novemb commun code relat medicin product human articl thereof regard direct ec european parliament council novemb commun code relat veterinari medicin product articl thereof light practic experi applic commiss regul ec march examin variat term market authoris grant compet author member state amend regul ec simplifi procedur vari term market authoris procedur laid regul ec adjust depart gener principl procedur base consequ adopt direct ec ec codifi commun legisl field veterinari medicin product medicin product human refer provis legisl updat regul continu appli examin applic variat term market authoris grant council direct eec repeal direct eec provid simplifi rapid notif procedur enabl introduct minor affect approv qualiti safeti efficaci product prior evalu refer member state type minor variat evalu submit document refer member state requir case evalu procedur maintain refer member state evalu file behalf member state concern order avoid duplic work type minor variat classifi condit fulfil order determin procedur follow give precis definit type minor variat prior evalu need clarifi definit quot extens quot market authoris submit separ full applic market authoris medicin product authoris summari product characterist nation author refer member state reduc evalu period urgent case extend case major variat entail import time frame procedur compet author impos urgent safeti restrict clarifi clarif introduc revis summari product characterist label packag leaflet insert procedur laid regul appli label packag leaflet insert consequenti summari product characterist sake clariti replac regul ec measur provid regul accord opinion stand committe medicin product human stand committe veterinari medicin product adopt regul articl subject matter regul lai procedur examin notif applic variat term market authoris medicin product consid scope applic direct eec medicin product benefit procedur mutual recognit set articl direct ec articl direct ec medicin product referr procedur set articl direct ec articl direct ec articl scope regul appli extens market authoris fulfil condit set annex ii regul transfer market authoris holder maximum residu limit defin articl council regul eec extens refer point paragraph examin accord procedur refer articl direct ec articl direct ec articl definit purpos regul definit appli quot variat term market authoris quot mean medicin product human amend content document refer articl direct ec veterinari medicin product amend content document refer articl direct ec quot minor variat quot type ia type ib mean variat list annex fulfil condit set quot major variat quot type ii mean variat deem minor variat extens market authoris quot refer member state quot mean member state medicin product produc assess report serv basi procedur refer articl altern member state chosen respect market authoris holder view applic regul quot urgent safeti restrict quot mean interim chang product inform item summari product characterist indic posolog contraind warn target speci withdraw period due inform bear safe medicin product articl notif procedur minor variat type ia regard minor variat type ia market authoris holder hereinaft refer holder submit simultan compet author member state medicin product authoris notif accompani document includ amend result variat list member state concern indic refer member state medicin product consider relev fee provid applic nation rule member state concern notif concern type ia variat type ia variat made term singl market authoris separ notif submit respect type ia variat sought notif refer notif derog paragraph type ia variat market authoris lead consequenti type ia variat singl notif cover variat singl notif descript relat consequenti type ia variat variat requir consequenti revis summari product characterist label packag leaflet insert consid part variat notif fulfil requir set paragraph compet author refer member state dai receipt notif acknowledg valid notif inform compet author concern holder compet author concern updat market authoris grant pursuant articl direct ec articl direct ec articl notif procedur minor variat type ib regard minor variat type ib holder submit simultan compet author member state medicin product authoris notif accompani document includ amend result variat list member state concern indic refer member state medicin product consider relev fee provid applic nation rule member state concern notif concern type ib variat type ib variat made term singl market authoris separ notif submit respect type ib variat sought notif refer notif derog paragraph type ib variat market authoris lead consequenti type ia type ib variat singl type ib notif cover consequenti variat singl notif descript relat consequenti type variat variat requir consequenti revis summari product characterist label packag leaflet insert consid part variat notif fulfil requir set paragraph compet author refer member state acknowledg receipt valid notif start procedur set paragraph dai date acknowledg receipt valid notif compet author refer member state holder opinion provid paragraph notifi variat deem accept compet author member state concern compet author refer member state inform compet author member state concern effect compet author concern updat market authoris grant pursuant articl direct ec articl direct ec compet author refer member state opinion notif accept period refer paragraph inform holder submit notif state ground opinion base dai receipt opinion refer paragraph holder amend notif order due account ground set opinion case provis paragraph appli amend notif holder amend notif notif deem reject compet author refer member state forthwith inform holder compet author concern dai provid inform refer paragraph compet author member state concern holder refer matter agenc applic articl direct ec articl direct ec articl approv procedur major variat type ii regard major variat type ii holder submit simultan compet author member state medicin product authoris applic accompani relev particular support document refer articl direct ec articl direct ec support data relat variat appli document amend result applic addendum updat exist expert report overview summari account variat appli list member state concern applic major variat type ii indic refer member state medicin product consider relev fee provid applic nation rule member state concern applic concern type ii variat type ii variat made singl market authoris separ applic submit respect variat sought applic refer applic derog paragraph type ii variat lead consequenti variat singl applic cover variat singl applic descript relat consequenti variat variat requir consequenti revis summari product characterist label packag leaflet insert consid part variat applic fulfil requir set paragraph compet author member state concern forthwith notifi compet author refer member state receipt valid applic compet author refer member state inform compet author member state concern holder date start procedur set paragraph dai start procedur compet author refer member state prepar assess report draft decis address compet author concern period reduc regard urgenc matter safeti issu period extend dai variat addit therapeut indic period extend dai variat chang addit food produc target speci period laid paragraph compet author refer member state request holder provid supplementari inform time limit set compet author procedur suspend time supplementari inform provid case period laid paragraph extend period determin compet author refer member state compet author refer member state inform compet author concern dai receipt draft decis assess report compet author member state concern recognis draft decis inform compet author refer member state effect compet author refer member state close procedur inform compet author concern holder compet author concern amend market authoris concern grant pursuant articl direct ec articl direct ec conform draft decis refer paragraph decis variat relat safeti issu implement timefram agre compet author refer member state holder consult compet author member state concern period laid paragraph mutual recognit compet author draft decis compet author refer member state procedur refer articl direct ec articl direct ec appli dai end procedur mention paragraph case compet author member state concern applic opinion variat accept holder refer matter agenc applic articl direct ec articl direct ec articl human influenza vaccin regard variat term market authoris human influenza vaccin procedur set paragraph appli dai date start procedur compet author refer member state prepar assess report basi qualiti document refer modul annex direct ec draft decis address compet author concern period laid paragraph compet author refer member state request holder provid supplementari inform inform compet author member state concern dai receipt draft decis assess report compet author member state concern recognis draft decis inform compet author refer member state effect clinic data data stabil medicin product address holder compet author refer member state compet author member state concern latest dai end time limit laid paragraph compet author refer member state evalu data draft final decis dai receipt data compet author concern recognis final draft decis dai receipt draft final decis adopt decis conform final draft decis procedur laid paragraph compet author rais question public health pose obstacl mutual recognit decis procedur refer articl direct ec appli articl pandem situat respect human diseas case pandem situat respect human influenza viru duli recognis world health organis commun framework decis ec european parliament council compet author exception temporarili variat term market authoris human influenza vaccin accept applic receiv end procedur laid articl complet clinic safeti efficaci data submit procedur case pandem situat respect human diseas human influenza viru paragraph articl appli mutati mutandi articl urgent safeti restrict holder event risk public anim health take urgent safeti restrict forthwith inform compet author thereof compet author rais object hour receipt inform urgent safeti restrict deem accept urgent safeti restrict implement timefram agre compet author variat applic reflect urgent safeti restrict submit immedi case dai initi urgent safeti restrict compet author applic procedur set articl compet author impos urgent safeti restrict holder holder oblig submit applic variat take account safeti restrict impos compet author urgent safeti restrict implement timefram agre compet author variat applic reflect urgent safeti restrict includ document support chang submit immedi case dai initi urgent safeti restrict compet author concern applic procedur set articl paragraph prejudic articl direct ec articl direct ec articl repeal regul ec repeal refer repeal regul constru refer regul articl regul enter forc twentieth dai public offici journal european union appli octob regul bind entireti directli applic member state brussel june commiss erkki liikanen member commiss oj oj oj oj oj oj oj oj annex list condit minor variat type ia ib market authoris refer articl introductori statement titl variat number subcategori depict letter number smaller font condit variat follow type ia type ib procedur outlin subcategori list variat cover submit applic consequenti parallel variat link chang appli time describ relat variat notif includ certif suitabl european pharmacopoeia variat concern dossier submit certif document requir chang submit european director qualiti medicin edqm certif revis evalu chang market authoris concern updat case type ia notif biolog medicin product product activ substanc biolog substanc biolog substanc substanc produc extract biolog sourc combin physico chemic biolog test product process control need characteris determin qualiti result consid biolog medicin product immunolog medicin product medicin product deriv human blood human plasma defin articl direct ec immunolog veterinari medicin product defin articl direct ec medicin product fall scope part annex council regul eec advanc therapi medicin product defin part iv annex direct ec chang manufactur process proteinac compon due subsequ introduct biotechnolog step made accord provis variat type specif variat prejudic variat list annex appli context introduct proteinac compon obtain biotechnolog process list part annex council regul eec medicin product fall scope regul commun legisl applic specif group product compli notifi compet author updat monograph european pharmacopoeia nation pharmacopoeia member state case complianc updat monograph implement month public refer made quot current edit quot dossier authoris medicin product purpos document test procedur mean analyt procedur limit mean accept criteria commiss consult member state agenc interest parti draw publish detail guidanc document submit gt tabl gt oj food food ingredi compliant regul ec european parliament council oj colour foodstuff scope council direct ec oj food addit scope council direct eec oj extract solvent mean council direct eec oj amend direct eec oj food food ingredi deriv biotechnolog step introduc manufactur product requir notifi variat term market authoris annex ii market authoris lead extens applic refer articl list regard quot extens quot applic refer articl extens modif exist market authoris grant compet author medicin product extens exist market authoris medicin product commiss consult member state agenc interest parti draw publish detail guidanc document submit requir extens applic activ substanc replac activ substanc salt ester complex deriv therapeut moieti efficaci safeti characterist significantli ii replac isom mixtur isom mixtur isol isom racem singl enantiom efficaci safeti characterist significantli iii replac biolog substanc product biotechnolog slightli molecular structur modif vector produc antigen sourc materi includ master cell bank sourc efficaci safeti characterist significantli iv ligand coupl mechan radiopharmaceut chang extract solvent ratio herbal drug herbal drug prepar efficaci safeti characterist significantli strength pharmaceut form rout administr chang bioavail ii chang pharmacokinet chang rate releas iii chang addit strength potenc iv chang addit pharmaceut form chang addit rout administr specif veterinari medicin product administ food produc anim chang addit target speci parenter administr distinguish intra arteri intraven intramuscular subcutan rout administr poultri respiratori oral ocular nebulis rout vaccin consid equival rout administr