commiss regul ec decemb lai pursuant regul ec european parliament council rule payment fee receipt administr assist european medicin agenc micro small medium size enterpris text eea relev commiss european commun regard treati establish european commun regard european parliament council regul ec march lai commun procedur authoris supervis medicin product human veterinari establish european medicin agenc articl thereof regul ec replac council regul eec juli lai commun procedur authoris supervis medicin product human veterinari establish european agenc evalu medicin product revenu european medicin agenc hereinaft refer agenc consist contribut commun fee paid compani context system establish regul eec council regul ec fee payabl agenc pursuant regul ec situat micro small medium size enterpris sme consid separ order reduc cost sme market medicin product authoris centralis procedur regul forese adopt specif provis allow reduct fee defer payment fee provid administr assist provis appli equal human veterinari sector aim promot innov develop medicin product sme definit micro small medium size enterpris provid commiss recommend ec appli reason coher transpar experi gain adopt regul eec show main financi administr entri hurdl sme step involv pre market authoris procedur seek scientif advic submiss market authoris applic undergo inspect provis laid regul focus aspect fee market authoris applic relat inspect conduct purpos assess applic constitut signific financi constraint sme order avoid weaken financi situat undertak assess market authoris applic defer payment fee end procedur sme oper pharmaceut sector innov compani activ field gene somat cell therapi notabl benefit pool scientif expertis commun level scientif evalu market authoris applic favour case medicin product obtain scientif advic access agenc scientif advic sme seek market authoris facilit fee reduct addit incent condit fee exempt applic request advic account develop medicin product incent provid form fee reduct establish maximum residu limit mrl veterinari medicin product order support establish limit translat constitut signific administr burden sme agenc make arrang provid translat document requir grant market authoris draft summari product characterist draft text label packag leaflet lack experi centralis procedur agenc administr organis impair develop market medicin product creat sme offic sole remit offer administr assist sme sme offic provid singl interfac applic sme agenc facilit commun answer practic procedur enquiri order provid practic guidanc applic sme agenc publish user guid administr procedur aspect link centralis procedur relev sme agenc report annual oper provis laid regul feedback practic applic order ensur sme benefit largest extent derog provid regul enter forc immedi measur provid regul accord opinion stand committe medicin product human stand committe veterinari medicin product adopt regul chapter gener provis articl subject matter regul establish circumst derog relev provis regul ec micro small medium size enterpris sme pai reduc fee defer payment fee receiv administr assist submit applic regul ec european medicin agenc hereinaft quot agenc quot articl scope regul appli sme mean recommend ec version establish commun regul appli applic medicin product human applic veterinari medicin product mean direct ec ec european parliament council articl definit purpos regul applic mean undertak seek benefit applic provis laid chapter ii iii articl submiss inform sme wish benefit provis regul submit agenc inform demonstr complianc criteria mention articl chapter ii fee deferr reduct articl fee deferr payment fee defer notif final decis market authoris issu applic withdrawn fee applic market authoris medicin product refer point articl point articl regul ec fee inspect undertaken purpos assess market authoris applic medicin product refer articl articl regul ec fee refer paragraph payabl dai date notif final decis market authoris dai date notif withdraw applic articl condit fee exempt prejudic articl applic market authoris submit medicin product scientif advic agenc fee payabl agenc examin applic due market authoris grant articl fee reduct reduct appli case inspect reduct inspect fee refer articl articl regul ec case scientif advic reduct scientif advic fee refer articl regul ec case scientif servic reduct scientif servic fee refer articl regul ec administr servic refer articl regul ec provid free charg servic concern parallel distribut medicin product refer articl regul ec derog point paragraph scientif advic scientif servic design orphan medicin product refer regul ec european parliament council provid free charg articl fee reduct establish maximum residu limit veterinari medicin product reduct appli full addit maximum residu limit mrl fee refer articl regul ec reduct refer paragraph account calcul deduct mrl fee fee payabl applic market authoris applic extend market authoris medicin product substanc mrl concern set applic submit applic deduct exce half fee appli articl multipl fee reduct derog articl applic respect fee benefit reduct provid commun legisl provis favour applic appli cumul fee reduct fee applic allow chapter iii administr assist articl translat agenc provid translat document refer point articl point articl regul ec requir purpos grant commun market authoris articl sme offic execut director agenc set dedic administr structur specif procedur establish sme offic sme offic task give advic applic administr procedur step compli requir laid regul ec ensur monitor request applic submit applic relat medicin product organis workshop train session applic administr procedur step compli requir laid regul ec articl user guid agenc agreement commiss publish detail user guid administr procedur aspect provis laid regul ec relev sme user guid updat user guid refer exist nation provis sme applic pharmaceut sector purpos paragraph member state commun refer agenc chapter iv final provis articl report agenc includ annual report activ section experi acquir result applic regul articl transit provis regul appli valid applic pend date entri forc articl entri forc regul enter forc dai public offici journal european union regul bind entireti directli applic member state brussel decemb commiss günter verheugen vice presid oj oj oj regul amend regul ec oj oj oj oj oj