council regul ec novemb amend regul ec fee payabl european medicin agenc council european union regard treati establish european commun regard council regul ec februari fee payabl european agenc evalu medicin product articl thereof regard propos commiss regard opinion european parliament articl regul ec european parliament council march lai commun procedur authoris supervis surveil medicin product human veterinari establish european medicin agenc stipul revenu european medicin agenc hereinaft refer agenc consist contribut commun fee paid undertak obtain maintain commun market authoris servic provid agenc regul ec task agenc exist task chang amend direct ec european parliament council novemb commun code relat veterinari medicin product direct ec european parliament council novemb commun code relat medicin product human view experi gain maintain gener principl structur fee main oper procedur provis establish regul ec calcul level fee charg agenc base principl servic provid relat specif medicin product proportion fee assess relat cost applic provis servic request ensur regul ec lai provis post authoris activ carri agenc task includ record actual market medicin product authoris accord commun procedur mainten market authoris dossier databas manag agenc continu follow risk benefit balanc authoris medicin product addit reduc agenc depend fee relat applic annual fee increas accommod categori fee creat cover specif task provid agenc type scientif opinion relat medicin product manag board agenc compet provis applic regul propos execut director favour opinion commiss level fee laid regul set maximum fee manag board establish servic laid regul detail classif list reduc fee execut director compet decid except circumst reduct fee case relat specif medicin product reduct imper reason public anim health likewis execut director possibl decid exempt oblig pai fee case medicin product treatment rare diseas treatment diseas affect minor anim speci addit anim speci case determin maximum residu limit accord procedur laid council regul eec june lai commun procedur establish maximum residu limit veterinari medicin product foodstuff anim origin accord articl regul ec circumst small medium size enterpris pai reduc fee defer payment fee receiv administr assist cover regul order budgetis fee due date valid payabl number dai provis laid report implement regul experi gain review level fee includ index mechan automat adjust fee relat offici inflat rate indic sake consist regul appli time full enter forc regul ec appli valid applic pend time applic regul ec amend adopt regul articl regul ec amend paragraph articl replac quot amount fee laid euro quot articl amend titl replac quot medicin product human cover procedur laid regul ec paragraph amend point subparagraph replac quot full fee eur appli applic market authoris support full dossier fee cover singl strength pharmaceut form present fee increas eur addit strength pharmaceut form submit time initi applic authoris increas cover addit strength pharmaceut form present quot ii point replac quot reduc fee reduc fee eur appli applic market authoris pursuant articl articl direct ec european parliament council novemb commun code relat medicin product human fee cover singl strength pharmaceut form present specif reduc fee eur appli applic market authoris pursuant articl direct ec fee cover singl strength pharmaceut form present reduc fee refer subparagraph increas eur addit strength pharmaceut form submit time initi applic authoris increas cover addit strength pharmaceut form present reduc fee refer subparagraph increas eur addit present strength pharmaceut form submit time initi applic authoris extens fee extens fee eur appli extens market authoris mean annex ii commiss regul ec june examin variat term market authoris medicin product human veterinari medicin product fall scope council regul eec grant derog subparagraph reduc extens fee fall rang eur eur appli extens extens includ list drawn accord articl regul extens fee reduc extens fee increas eur addit present extens submit time extens applic paragraph amend point subparagraph replac quot type variat fee appli minor variat market authoris defin articl regul ec type ia variat fee eur type ib variat fee eur quot ii point subparagraph replac quot type ii variat fee eur appli major variat market authoris defin articl regul ec derog subparagraph reduc type ii variat fee fall rang eur eur appli variat variat includ list drawn accord articl regul quot paragraph amend sole subparagraph replac quot fee eur appli inspect commun inspect commun travel expens charg extra basi actual cost quot ii subparagraph ad quot derog subparagraph reduc inspect fee appli inspect extent natur inspect basi condit laid accord articl quot paragraph replac quot annual fee annual fee eur appli market authoris medicin product fee cover authoris present medicin product derog subparagraph reduc annual fee fall rang eur eur appli type medicin product medicin product includ list drawn accord articl quot articl replac quot articl medicin product human cover procedur laid direct ec referr fee referr fee eur appli procedur laid articl articl direct ec initi applic market authoris holder exist market authoris applic market authoris holder exist market authoris concern procedur refer subparagraph applic holder group purpos payment singl referr fee procedur concern ten applic holder fee charg applic abovement referr fee quot articl amend titl replac quot medicin product veterinari cover procedur laid regul ec quot paragraph amend point amend subparagraph replac quot full fee eur appli applic market authoris support full dossier fee cover singl strength pharmaceut form present fee increas eur addit strength pharmaceut form submit time initi applic authoris increas cover addit strength pharmaceut form present quot fourth subparagraph replac quot case immunolog veterinari medicin product full fee reduc eur addit strength pharmaceut form present entail increas eur quot ii point replac quot reduc fee reduc fee eur appli applic market authoris pursuant articl articl direct ec european parliament council novemb commun code relat veterinari medicin product fee cover singl strength pharmaceut form present specif reduc fee eur appli applic market authoris pursuant articl direct ec fee cover singl strength pharmaceut form present reduc fee refer subparagraph increas eur addit strength pharmaceut form submit time initi applic authoris increas cover addit strength pharmaceut form present reduc fee refer subparagraph increas eur addit present strength pharmaceut form submit time initi applic authoris case immunolog veterinari medicin product fee reduc eur addit strength pharmaceut form present entail increas eur purpos point number target speci irrelev iii point replac quot extens fee extens fee eur appli extens market authoris mean annex ii regul ec grant derog subparagraph reduc extens fee fall withn rang eur eur appli extens extens includ list drawn accord articl regul extens fee reduc extens fee increas eur addit present extens submit time extens applic quot paragraph amend point subparagraph replac quot type variat fee appli minor variat market authoris defin articl regul ec type ia variat fee eur type ib variat fee eur quot ii point replac quot type ii variat fee type ii variat fee eur appli major variat market authoris defin articl regul ec derog subparagraph reduc type ii variat fee fall rang eur eur appli variat variat includ list drawn accord articl regul case immunolog veterinari medicin product fee eur event variat introduc fee refer subparagraph cover authoris strength pharmaceut form present quot paragraph amend sole subparagraph replac quot fee eur appli inspect commun inspect commun travel expens charg extra basi actual cost quot ii subparagraph ad quot derog subparagraph reduc inspect fee appli inspect extent natur inspect basi condit laid accord articl quot paragraph replac quot annual fee annual fee eur appli market authoris medicin product fee cover authoris present medicin product derog subparagraph reduc annual fee fall rang eur eur appli type medicin product medicin product includ list drawn accord articl quot articl replac quot articl veterinari medicin product cover procedur laid direct ec referr fee referr fee eur appli procedur laid articl articl direct ec initi applic market authoris holder exist market authoris applic market authoris holder exist market authoris concern procedur refer subparagraph applic holder group purpos payment singl referr fee procedur concern ten applic holder fee charg applic abovement referr fee quot articl amend titl replac quot establish maximum residu limit mrl veterinari medicin product accord procedur laid regul eec paragraph subparagraph replac quot addit fee eur appli applic modifi exist mrl includ annex regul eec quot paragraph delet number paragraph delet articl replac quot articl fee fee scientif advic fee scientif servic cover articl articl fee administr servic fee fall rang eur eur appli administr servic document certif issu framework servic cover fee provid regul applic reject conclus administr valid relat dossier inform requir case parallel distribut check classif servic fee includ list drawn accord articl quot articl paragraph replac quot total partial exempt payment fee laid regul grant medicin product treat rare diseas diseas affect minor anim speci extens exist mrl addit anim speci medicin product compassion detail condit applic total partial exempt determin accord articl fee payabl opinion medicin product compassion deduct fee payabl applic market authoris medicin product applic submit applic quot articl replac quot articl due date deferr payment fee due date administr valid relev applic specif provis stipul payabl dai date notif administr valid applic paid euro annual fee due subsequ anniversari notif market authoris decis payabl dai due date annual fee relat preced year inspect fee payabl dai date inspect carri payment fee applic market authoris medicin product human pandem situat defer pandem situat duli recognis world health organis commun framework decis ec european parliament council septemb set network epidemiolog surveil control communic diseas commun deferr exce year fee payabl regul remain unpaid due date prejudic agenc capac institut legal proceed confer articl regul ec execut director decid provid request servic suspend servic procedur fee paid includ relev interest provid articl commiss regul ec euratom decemb lai detail rule implement council regul ec euratom financi regul applic gener budget european commun articl replac quot prejudic provis regul ec manag board agenc propos execut director favour opinion commiss provis applic regul provis made publicli quot articl amend paragraph replac quot amend amount fee establish regul adopt accord procedur laid articl regul ec except updat provid paragraph articl quot fourth paragraph replac quot novemb commiss present report implement council report analysi includ disput settlement procedur regul review fee base evalu agenc cost basi relat cost servic provid member state cost calcul accord gener accept intern cost method adopt accord articl quot paragraph ad quot effect april year commiss review fee refer inflat rate publish offici journal european union updat quot articl transit period regul appli valid applic pend novemb articl entri forc regul enter forc dai public offici journal european union appli novemb regul bind entireti directli applic member state brussel novemb council presid jowel oj regul amend commiss regul ec oj publish offici journal oj oj direct amend direct ec oj oj direct amend direct ec oj oj regul amend commiss regul ec oj oj quot oj direct amend direct ec oj oj quot oj direct amend direct ec oj quot oj regul amend commiss regul ec oj quot oj decis amend regul ec oj oj regul amend regul ec euratom oj quot