commiss regul ec june examin variat term market authoris medicin product human veterinari medicin product fall scope council regul eec text eea relev commiss european commun regard treati establish european commun regard council regul eec juli lai commun procedur authoris supervis medicin product human veterinari establish european agenc evalu medicin product amend commiss regul ec articl thereof light practic experi applic commiss regul ec march examin variat term market authoris fall scope council regul eec amend regul ec simplifi procedur vari term market authoris due technic adapt annex direct ec european parliament council novemb commun code relat medicin product human introduc regul provis variat relat plasma master file vaccin antigen master file procedur laid regul ec adjust depart gener principl procedur base provid simplifi rapid notif procedur enabl introduct minor affect approv qualiti safeti efficaci product prior evalu european agenc evalu medicin product hereinaft refer quot agenc quot type minor variat evalu submit document agenc requir type minor variat classifi 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 agenc reduc evalu period urgent case extend case major variat entail import simplifi administr procedur minor variat updat market authoris allow commiss group updat month singl decis time frame procedur commiss impos urgent safeti restrict clarifi clarif introduc revis label packag leaflet insert summari product characterist 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 applic variat term market authoris grant accord regul eec regul appli examin applic variat term plasma master file vaccin antigen master file defin annex 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 evalu accord procedur set articl articl regul eec medicin product human veterinari medicin product articl definit purpos regul definit appli quot variat term market authoris quot mean amend content document refer articl articl regul eec exist moment decis market authoris adopt accord articl articl regul approv previou variat 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 urgent safeti restrict quot mean interim chang due inform bear safe medicin product product inform item summari product characterist indic posolog contraind warn target speci withdraw period articl notif procedur minor variat type ia regard minor variat type ia market authoris holder hereinaft refer quot holder quot submit agenc notif accompani document includ amend result variat relev fee provid council regul ec 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 consequenti 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 agenc dai receipt notif acknowledg valid notif inform holder agenc dissemin amend document refer articl commiss base propos prepar agenc updat month market authoris grant pursuant articl articl regul eec updat market authoris notifi commiss holder commun regist medicin product provid articl regul eec updat articl notif procedur minor variat type ib regard minor variat type ib holder submit agenc notif accompani document demonstr condit laid annex request variat met includ document amend result applic relev fee provid regul ec notif concern type ib variat type ib variat made 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 applic descript relat consequenti type variat variat requir consequenti revis summari product characterist label packag leaflet insert consid part variat notif fulfil requir set paragraph agenc acknowledg receipt valid notif start procedur set paragraph dai date acknowledg receipt valid notif agenc holder opinion provid paragraph variat appli deem accept agenc inform holder agenc dissemin amend document refer articl commiss base propos prepar agenc updat month market authoris grant pursuant articl articl regul eec updat market authoris notifi commiss holder commun regist medicin product provid articl regul eec updat agenc 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 agenc inform holder articl approv procedur major variat type ii regard major variat type ii holder submit agenc applic accompani relev particular support document refer articl support data relat variat appli document amend result applic addendum updat exist expert report overview summari account variat appli relev fee provid regul ec 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 consequenti 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 agenc acknowledg receipt valid applic start procedur set paragraph compet committe agenc give opinion dai start procedur 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 committe send holder request supplementari inform time limit set committe procedur suspend time supplementari inform provid case period laid paragraph extend period determin committe compet committe deliv opinion agenc inform holder commiss forthwith send commiss amend made term market authoris accompani document set articl regul eec articl articl regul eec appli opinion adopt compet committe commiss base propos prepar agenc amend market authoris grant pursuant articl articl regul eec decis variat relat safeti issu implement time frame agre commiss holder amend market authoris notifi commiss holder commun regist medicin product provid articl regul eec updat articl human influenza vaccin regard variat term market authoris human influenza vaccin procedur set paragraph appli dai date receipt valid applic agenc give opinion qualiti document refer modul annex direct ec base assess report period laid paragraph agenc request holder provid supplementari inform agenc address forthwith opinion commiss commiss adopt decis updat market authoris grant pursuant articl regul eec decis implement condit final opinion agenc provid paragraph favour updat market authoris notifi commiss holder clinic data stabil medicin product address holder agenc latest dai end time limit laid paragraph agenc evalu data give final opinion dai recept data refer subparagraph agenc address final opinion commiss market authoris holder dai commun regist medicin product provid articl regul eec updat 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 commiss 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 agenc thereof agenc rais object hour receipt inform urgent safeti restrict deem accept urgent safeti restrict implement time frame agre agenc variat applic reflect urgent safeti restrict submit immedi case dai initi urgent safeti restrict agenc applic procedur set articl commiss impos urgent safeti restrict holder holder oblig submit applic variat take account safeti restrict impos commiss urgent safeti restrict implement time frame agre agenc applic procedur set articl variat applic reflect urgent safeti restrict includ document support chang submit agenc immedi case dai initi urgent safeti restrict subparagraph prejudic articl regul eec articl repeal regul ec repeal refer made repeal regul constru refer regul articl regul enter forc dai public offici journal european union appli octob examin applic variat term plasma master file vaccin antigen master file regul appli date entri forc commiss direct amend annex direct ec 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 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 quot test procedur quot mean quot analyt procedur quot quot limit quot mean quot accept criteria quot commiss consult member state agenc interest parti draw publish detail guidanc document submit gt tabl gt food food ingredi compliant regul ec european parliament council oj colour foodstuff scope council direct eec 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 commun medicin product quot extens quot 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 radio pharmaceut chang extract solvent ratio herbal drug herbal drug prepar efficaci safeti characterist significantli strength pharmaceut form rout administr chang bio avail ii chang pharmaco kinet 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 intraarteri intraven intramuscular subcutan rout administr poultri respiratori oral ocular nebulis rout vaccin consid equival rout administr