commiss regul ec novemb examin applic transfer market author medicin product fall scope council regul ec commiss european commun regard treati establish european commun regard council regul eec juli lai commun procedur author supervis medicin product human veterinari establish european agenc evalu medicin product articl thereof commiss regul ec march examin variat term market author fall scope council regul eec appli address holder market author holder author remain provis adopt examin applic transfer market author medicin product grant accord provis regul eec holder author previou holder institut administr procedur enabl market author decis quickli amend event provid transfer applic submit valid condit relat fulfil measur provid regul accord opinion stand committe medicin product human stand committe veterinari medicin product adopt regul articl regul lai procedur examin applic transfer market author grant accord regul ec situat cover point annex regul ec definit articl purpos regul transfer market author mean procedur chang addresse hereinaft refer holder market author decis adopt pursuant articl articl council regul eec holder previou holder administr procedur articl obtain transfer market author holder author submit applic european agenc evalu medicin product hereinaft refer agenc accompani document mention annex regul applic concern transfer market author accompani relev fee provid council regul ec fee payabl european agenc evalu medicin product articl agenc submit dai receipt applic mean articl opinion applic holder market author person transfer grant commiss articl agenc opinion refer articl unfavour document submit support applic incomplet appear person transfer grant establish commun articl case favour opinion prejudic applic provis commun law commiss immedi amend decis accord articl regul eec gener final provis articl transfer market author author date notif amend commiss decis refer articl date transfer take place set agenc mutual agreement holder market author person transfer grant agenc immedi inform commiss date transfer market author affect time limit provid articl regul ec articl regul enter forc dai public offici journal european commun regul bind entireti directli applic member state brussel novemb commiss martin bangemann member commiss oj oj oj annex document submit agenc evalu medicin product pursuant articl document mention point authent signatur holder market author person transfer grant medicin product concern author transfer author number date author grant identif address holder market author transfer identif address person transfer grant document certifi complet date file medicin product copi file made transfer person transfer grant prejudic final decis document state date person transfer grant respons holder market author medicin product concern previou holder person transfer grant provid document show capac perform respons requir market authoris holder commun pharmaceut legisl document identifi qualifi person mean articl articl regul eec curriculum vita address telephon fax number medicin product human concern document describ scientif servic charg inform medicin product mean articl council direct eec includ address telephon fax number summari product characterist mock up outer primari packag leaflet bear insert person transfer grant oj