decis eea joint committe amend protocol annex ii technic regul standard test certif eea agreement eea joint committe regard agreement european econom area adjust protocol adjust agreement european econom area hereinaft refer quot agreement quot articl thereof protocol agreement amend decis eea joint committe march annex ii agreement amend decis eea joint committe april case medicin product human criteria qualiti safeti efficaci extens harmonis council direct eec council direct eec council direct eec success amend case veterinari medicin product similar result achiev council direct eec council direct eec amend council direct eec establish mechan concert prior nation decis relat high technolog medicin product view arriv uniform decis experi commun entri forc direct eec show establish centralis commun procedur technolog advanc medicin product procedur person place market medicin product activ substanc intend human be food produc anim european agenc evalu medicin product hereinaft refer quot agenc quot establish council regul eec ensur close cooper agenc scientist work member state exclus respons prepar opinion agenc matt relat medicin product human entrust committe proprietari medicin product creat council direct eec respect veterinari medicin product respons entrust committe veterinari medicin product creat direct eec agenc respons coordin activ member state field monitor advers reaction medicin product pharmacovigil make provis supervis medicin product authoris commun end agenc coordin verif complianc principl good manufactur practic good laboratori practic good clinic practic interest public health decis autoris medicin product base object scientif criteria qualiti safeti efficaci medicin product concern exclus econom consider member state commun exception prohibit territori medicin product human infring object defin concept public order public moral veterinari medicin product authoris commun contraven legal measur laid commun framework common agricultur polici council direct eec june amend direct eec eec eec respect medicin product event disagr member state commun qualiti safeti efficaci medicin product subject decentralis commun authoris procedur matter resolv bind commun decis scientif evalu issu involv similar provis laid respect veterinari medicin product council direct eec june amend direct eec eec paramount ensur uniform protect human anim health protect consum medicin product european econom area secur proper function agreement adopt uniform regulatori decis primarili base object scientif criteria place market medicin product relev commun legisl principl centralis procedur technolog advanc medicin product medicin product activ substanc intend human be food produc anim legisl decentralis procedur provid event disagr contract parti qualiti safeti efficaci medicin product matter resolv bind decis scientif evalu issu involv incorpor agreement amend annex ii thereto call good function agreement repres compet author efta state concern work committe proprietari medicin product creat council direct eec committe veterinari medicin product creat direct eec amend protocol list committe work expert efta state call good function agreement amend annex ii agreement connect amend protocol order detail arrang associ decid articl protocol agreement amend annex decis articl annex ii agreement amend annex ii decis articl text direct eec eec eec regul eec ec regul ec ec ec ec iceland norwegian languag annex respect languag version decis authent articl date entri forc implement act mention annex ii decis purpos agreement read date entri forc implement act preced date entri forc decis date entri forc decis appli date entri forc implement act date entri forc decis date entri forc implement act appli articl decis enter forc provid notif articl agreement made eea joint committe articl decis publish eea section eea supplement offici journal european commun brussel eea joint committe presid barbaso oj page offici journal oj oj oj oj oj oj oj oj oj annex decis eea joint committe protocol list provid articl agreement amend ad protocol agreement quot committe proprietari medicin product council direct eec committe veterinari medicin product council direct eec quot annex ii decis eea joint committe annex ii technic regul standard test certif chapter xiii medicin product agreement amend text chapter xiii annex ii agreement insert paragraph quot decis approv medicin product commun procedur laid council regul eec council direct eec amend direct eec council direct eec amend direct eec efta state simultan decis basi relev act eea joint committe inform period publish list decis eea supplement offici journal efta surveil author monitor applic decis efta state provid articl agreement relev act provid commun procedur grant suspens withdraw market authoris supervis includ pharmacovigil inspect sanction similar task carri compet author efta state basi oblig compet author commun member state disagr contract parti aris administr provis part vii agreement appli mutati mutandi efta state contract parti agreement particip work european agenc evalu medicin product emea hereinaft refer quot agenc quot set regul eec liechtenstein particip contribut financi work agenc medicin control author dispos technic mean financi provis titl iv chapter regul eec appli particip efta state concern work agenc efta state concern entri forc decis particip commun contribut refer articl regul eec purpos procedur laid articl protocol agreement appli mutati mutandi regard financi contribut efta state concern abovement commun contribut efta state concern send observ meet agenc manag board efta state concern fulli work committe proprietari medicin product cpmp committe proprietari veterinari product cvmp detail arrang particip repres efta state accord provis titl iv chapter regul eec repres particip vote posit record separ posit chairman reserv member nomin member state commun intern rule procedur committe amend order give full effect efta state particip efta state concern fulli particip telemat exchang inform medicin product imp programm efta state concern provid nation compet author market authoris holder linguist version market authoris requir access market market authoris grant medicin product opinion adopt compet emea scientif committe accord articl articl regul eec subject fee refer articl articl regul eec efta state concern time limit set eea joint committe inform agenc nation compet author respons work type undertaken agenc nomin person repres author scientif committe refer agenc legal person enjoi state contract parti extens legal capac accord legal person law efta state concern appli agenc protocol privileg immun european commun derog articl condit employ servant european commun nation efta state enjoi full right citizen engag contract execut director agenc quot indent ad point council direct eec quot council direct eec june oj quot indent ad point council direct eec quot council direct eec june oj quot indent ad point council direct eec quot council direct eec june oj quot indent ad point council direct eec quot council direct eec june oj quot indent ad point council direct eec quot council direct eec june oj quot text point council direct eec replac quot council direct eec june repeal direct eec approxim nation measur relat place market high technolog medicin product deriv biotechnolog oj quot point insert point council direct eec quot council regul eec juli lai procedur authoris supervis medicin product human veterinari establish european agenc evalu medicin product oj council regul ec februari fee payabl european agenc evalu medicin product oj commiss regul ec march lai arrang report suspect unexpect advers reaction aris commun countri medicin product human veterinari authoris accord provis council regul eec oj commiss regul ec march examin variat term market authoris grant compet author member state oj commiss regul ec march examin variat term market authoris fall scope council regul eec oj commiss regul ec novemb examin applic transfer market authoris medicin product fall scope council regul eec oj quot