council regul ec februari fee payabl european agenc evalu medicin product council european union regard treati establish european commun articl thereof regard propos commiss articl council regul eec juli lai commun procedur author supervis medicin product human veterinari establish european agenc evalu medicin product hereinaft refer agenc requir council establish structur amount fee refer articl articl regul establish revenu agenc consist contribut commun fee paid undertak obtain maintain commun market author servic provid agenc articl regul eec requir applic author medicin product applic variat accompani fee payabl agenc examin applic calcul amount fee charg agenc base principl servic provid amount fee laid regul determin factor applic author choic central procedur nation procedur basic fee defin fee charg initi applic author medicin product fee strength pharmaceut form ceil establish end extens fee laid subsequ applic medicin product author order account addit work expenditur applic choos submit applic gradual subsequ provis made reduc fee applic sustain detail dossier pursuant point paragraph articl council direct eec januari approxim provis laid law regul administr action relat medicin product point paragraph articl council direct eec septemb approxim law member state relat analyt pharmaco toxicolog clinic standard protocol respect test veterinari medicin product applic medicin product food produc anim examin variat term exist author requir full evalu product qualiti safeti efficaci charg complex variat real workload link rate lower standard applic work involv mandatori yearli renew commun market author justifi charg fee fee laid arbitr servic event disagr member state applic author submit decentr procedur fee levi flat rate basi inspect made success market author request interest holder market veterinari medicin product differ medicin product human justifi gener reduct fee account situat link market veterinari medicin product individu basi aim achiev mean special provis claus reduct waiver evalu applic establish maximum residu limit mrl applic decid appli separ establish mrl applic commun market author case fee incur evalu applic author cover establish mrl applic deliber choos appli separ establish mrl addit work expenditur recoup mean isol mrl fee fee evalu veterinari medicin product follow principl provis made waiver reduct fee state except circumst essenti public health anim health reason decis case director hear compet committe basi gener criteria laid agenc manag board provision period year laid experi gain enabl financi agenc assess practic reason provis made machineri permit rate updat shorter period treati provid power fix fee commun level framework commun system recours articl treati adopt regul articl scope fee obtain maintain commun author market medicin product human veterinari servic suppli agenc levi accord regul fee laid ecu articl agenc annual estim intend establish preliminari draft budget commiss estim fee financi year separ estim expenditur contribut commun articl applic author medicin product human central procedur full fee ecu fee applic commun author market medicin product support full dossier increas ecu addit strength pharmaceut form medicin product submit time initi applic author total amount fee exce ecu reduc fee ecu fee applic commun author market medicin product requir support full dossier provid except point paragraph articl direct eec increas ecu addit strength pharmaceut form medicin product submit time initi applic author total amount fee exce ecu extens fee ecu fee addit applic commun author market medicin product made strength pharmaceut form initi applic author submit agenc type variat fee ecu fee variat minor import classif establish commiss regul applic matter type ii variat fee ecu fee variat major import classif establish commiss regul applic matter renew fee ecu fee review inform medicin product time obligatori yearli renew commun market author product grant strength pharmaceut form inspect fee ecu flat rate fee inspect commun inspect commun travel expens charg extra basi actual cost transfer fee ecu fee chang holder market author transfer relat articl settlement disagr applic author medicin product human decentr procedur arbitr fee ecu flat rate fee paid undertak concern agenc arbitr disagr member state mutual recognit nation market author type ii variat made exist nation author fee charg procedur provid articl direct eec initi instig person respons place medicin product market articl applic author veterinari medicin product central procedur full fee ecu fee applic commun author market medicin product food produc anim support full dossier increas ecu addit strength pharmaceut form medicin product submit time initi applic total amount fee exce ecu case vaccin full fee ecu addit strength pharmaceut form entail increas ecu reduc fee ecu fee applic commun author market medicin product requir support full dossier provid except point paragraph articl direct eec applic medicin product food produc anim increas ecu addit strength pharmaceut form medicin product speci submit time initi applic total amount fee exce ecu case vaccin reduc fee ecu addit strength pharmaceut form entail increas ecu maximum residu limit mrl fee ecu fee applic mrl establish substanc fee request modif extens exist mrl ecu fee deduct charg market author medicin product substanc author appli undertak origin establish mrl extens fee ecu fee addit applic commun author market medicin product made strength pharmaceut form initi applic author submit agenc addit applic strength pharmaceut form made time fee paid addit applic market product addit speci case vaccin addit fee ecu type variat fee ecu fee variat minor import classif establish commiss regul applic matter type ii variat free ecu fee variat major import classif establish commiss regul applic matter renew fee ecu fee review inform medicin product time obligatori year renew commun market author product grant strength pharmaceut form speci provid speci subject extens fee mean paragraph articl inspect fee ecu flat rate fee inspect commun inspect commun travel expens charg extra basi actual cost transfer fee ecu fee chang holder market author transfer relat articl settlement disagr applic author veterinari medicin product decentr procedur arbitr fee ecu flat rate fee paid undertak concern agenc arbitr disagr member state mutual recognit nation market author type ii variat made exist nation author fee charg procedur provid articl direct eec amend initi instig person respons place medicin product market articl waiver fee reduct settlement disagr except circumst imper reason public anim health waiver fee reduct grant case case execut director consult compet committe medicin product limit number applic decis grant waiver reduct state reason base gener criteria grant waiver reduct determin agenc manag board procedur similar subparagraph paragraph appli disagr aris classif applic fee categori articl due date belat payment fee due date regul regul eec due date receipt relev applic fee payabl regul remain unpaid due date execut director decid provid suspend servic request relev fee paid fee paid ecu nation currenc member state exchang rate forc fix daili commiss accord regul eec agenc manag board fix monthli convers rate basi earlier rate articl implement rule prejudic provis regul regul eec implement rule adopt agenc manag board lai due date fee paid articl method payment consequ belat payment payment measur need appli regul articl year latest entri forc regul commiss submit report implement light experi propos definit regul council council act qualifi major consult european parliament adopt provis amount fee condit govern appli januari provis applic date amount fee condit govern regul continu appli provision amend amount fee laid regul made accord procedur laid articl regul eec articl entri forc legal effect regul enter forc dai public offici journal european commun regul bind entireti directli applic member state brussel februari council presid juppé oj oj direct amend direct eec oj oj direct amend direct eec oj oj direct amend direct eec oj oj regul amend regul eec oj