council regul ec decemb amend regul ec fee payabl european agenc evalu medicin product council european union regard treati establish european commun regard council regul ec februari fee payabl european agenc evalu medicin product hereinaft refer agenc articl thereof regard propos commiss regard opinion european parliament articl council regul eec juli lai commun procedur authoris supervis medicin product human veterinari establish european agenc evalu medicin product revenu agenc consist contribut fee paid undertak obtain maintain commun market authoris servic provid agenc amount structur fee establish regul ec review decemb view experi gain maintain gener principl structur fee main oper procedur provis establish abovement regul fee servic relat facilit collect improv transpar practic implement regul fee establish cover servic provid agenc annual fee introduc ensur coverag cost connect supervis authoris medicin product part fee alloc compet nation author requir term regul eec supervis market behalf commun rule distribut author adopt agenc manag board accord procedur laid regul except case imper reason public anim health reduc abovement fee prejudic specif provis commun law decis reduc fee execut director basi critic examin situat specif case consult compet scientif committe adopt regul articl regul ec amend articl replac articl scope fee obtain maintain commun authoris market medicin product human veterinari servic suppli agenc levi accord regul amount fee laid ecu articl replac articl medicin product human cover procedur laid regul eec authoris market medicin product full fee fee applic authoris market medicin product support full dossier ecu fee cover singl strength pharmaceut form fee increas ecu addit strength pharmaceut form submit time initi applic authoris increas cover addit strength pharmaceut form fee increas ecu addit present strength pharmaceut form submit time initi applic authoris reduc fee reduc fee ecu appli applic authoris market medicin product full dossier present provid articl paragraph point iii direct eec recours point ii paragraph articl direct fee cover singl strength pharmaceut form fee increas ecu addit strength pharmaceut form submit time initi applic authoris increas cover addit strength pharmaceut form fee increas ecu addit present strength pharmaceut form submit time initi applic authoris extens fee fee extens market authoris grant extens strength pharmaceut form indic method administr fee ecu extens present strength pharmaceut form method administr authoris fee ecu variat type variat fee fee variat minor import market authoris classif establish commiss regul applic matter ecu event variat introduc fee cover authoris strength pharmaceut form present type ii variat fee fee variat major import market authoris classif establish commiss regul applic matter ecu halv type ii variat involv detail scientif evalu list drawn accord procedur laid articl event variat introduc fee cover authoris strength pharmaceut form present renew fee fee examin inform time yearli renew authoris market medicin product ecu charg strength pharmaceut form inspect fee flat rate fee inspect commun ecu inspect commun travel expens charg extra basi actual cost transfer fee fee chang holder market authoris transfer relat ecu cover authoris present medicin product annual fee annual fee medicin product grant market authoris ecu cover authoris present medicin product articl medicin product human cover procedur laid direct eec arbitr fee fee ecu payabl procedur laid articl direct eec initi fee increas ecu procedur laid articl direct eec initi instig applic holder market authoris articl medicin product veterinari cover procedur laid regul eec authoris market medicin product full fee fee applic authoris market medicin product support full dossier ecu cover singl strength pharmaceut form fee increas ecu addit strength pharmaceut form submit time initi applic authoris increas cover addit strength pharmaceut form fee increas ecu addit present strength pharmaceut form submit time initi applic authoris case vaccin full fee reduc ecu addit strength pharmaceut form present entail increas ecu purpos point number target speci irrelev reduc fee reduc fee ecu appli applic authoris market medicin product full dossier present provid point iii paragraph articl direct eec recours point ii paragraph articl direct fee cover singl strength pharmaceut form medicin product fee increas ecu addit strength pharmaceut form submit time initi applic authoris increas cover addit strength pharmaceut form fee increas ecu addit present strength pharmaceut form submit time initi applic authoris case vaccin fee reduc ecu addit strength pharmaceut form present entail increas ecu purpos paragraph number target speci irrelev extens fee fee extens market authoris grant extens strength pharmaceut form speci indic method administr fee ecu extens present strength pharmaceut form method administr authoris fee ecu case vaccin extens strength pharmaceut form present method administr fee ecu variat type variat fee fee variat minor import market authoris classif establish commiss regul applic matter ecu fee charg respect vaccin event variat introduc fee cover authoris strength pharmaceut form present type ii variat fee fee variat major import market authoris classif establish commiss regul applic matter ecu halv type ii variat involv detail scientif evalu list drawn accord procedur laid articl case vaccin fee ecu event variat introduc fee cover authoris strength pharmaceut form present renew fee fee examin inform time yearli renew authoris market medicin product ecu charg strength pharmaceut form inspect fee flat rate fee inspect commun ecu inspect commun travel expens charg extra basi actual cost transfer fee fee chang holder market authoris transfer relat ecu cover authoris present medicin product annual fee annual fee medicin product grant market authoris ecu cover authoris present medicin product articl medicin product veterinari cover procedur laid direct eec arbitr fee arbitr fee ecu payabl procedur laid articl direct eec initi fee increas ecu procedur laid articl direct eec initi instig applic holder market authoris articl establish maximum residu limit mrl veterinari medicin product fee establish mrl full mrl fee ecu charg applic set initi mrl substanc addit mrl fee ecu payabl applic amend extend exist mrl cover speci mrl fee deduct fee payabl applic market authoris applic extend market authoris medicin product substanc mrl set applic submit applic deduct total half fee appli mrl fee fee ecu charg applic set mrl view clinic trial fee deduct amount full mrl fee laid point articl fee fee scientif advic fee charg applic made scientif technic advic research develop medicin product view submiss applic market authoris applic extend market authoris medicin product human maximum fee set ecu medicin product veterinari maximum fee set ecu detail procedur appli point adopt accord procedur laid articl fee administr charg fee payabl administr charg document certif issu framework servic cover fee provid regul conclus administr valid dossier result reject applic dossier submit unit amount fee exce ecu accord articl regul classif establish manag board agenc articl fee reduct prejudic specif provis commun law except circumst imper reason public anim health fee reduct grant case case execut director consult compet scientif committe decis pursuant articl state reason base total partial exempt grant medicin product treat rare diseas diseas affect minor speci articl due date belat payment fee payabl date receipt relev applic specif provis stipul arbitr fee payabl dai referr agenc annual fee payabl dai subsequ anniversari notif market authoris decis inspect fee payabl dai date inspect carri fee payabl regul remain unpaid due date prejudic agenc capac institut legal proceed confer articl regul eec execut director agenc decid provid request servic suspend servic procedur relev fee paid fee paid ecu nation currenc member state exchang rate forc fix daili commiss monthli convers rate base earlier rate fix calcul establish agenc manag board articl implement rule propos execut director favour opinion commiss agenc manag board fix rule repai part resourc deriv annual fee compet nation author involv commun market supervis prejudic provis regul regul eec agenc manag board propos execut director provis prove applic regul event disagr classif applic fee categori laid regul execut director give rule consult compet scientif committe articl amend amend regul adopt council act qualifi major consult european parliament propos commiss amend amount fee establish regul adopt accord procedur laid articl regul eec year entri forc regul commiss present report implement consult agenc manag board futur review fee base comprehens evalu agenc cost includ expenditur relat member state rapporteur oj direct amend direct eec oj exist articl articl articl regul enter forc dai public offici journal european commun regul bind entireti directli applic member state brussel decemb council presid molter oj oj oj regul amend commiss regul ec oj