agreement mutual recognit european commun unit state america european commun unit state america hereinaft refer parti tradit link friendship exist unit state america european commun ec desir facilit bilater trade recognis mutual recognit conform assess activ import mean enhanc market access parti recognis agreement provid mutual recognit conform assess activ interest small medium size busi ec recognis mutual recognit requir confid continu reliabl parti conform assess recognis import maintain parti high level health safeti environment consum protect recognis mutual recognit agreement posit contribut encourag greater intern harmonis standard note agreement intend displac privat sector bilater multilater arrang conform assess bodi affect regulatori regim allow manufactur assess declar conform bear mind agreement technic barrier trade agreement annex agreement establish world trade organ wto impos oblig parti contract parti wto encourag contract parti enter negoti conclus agreement mutual recognit result conform assess recognis mutual recognit offer assur conform applic technic regul standard equival assur offer parti procedur recognis conclud agreement mutual recognit mra field conform assess sector annex bear mind respect commit parti bilater region multilater environ health safeti consum protect agreement agre articl definit term definit appli agreement design author mean bodi power design monitor suspend remov suspens withdraw conform assess bodi agreement design mean identif design author conform assess bodi perform conform assess procedur agreement regulatori author mean govern agenc entiti exercis legal control sale product parti jurisdict enforc action ensur product market jurisdict compli legal requir term conform assess agreement mean agreement definit contain guid edit intern organ standardis iso intern electrotechn commiss iec event inconsist iso iec guid definit agreement definit agreement prevail articl purpos agreement agreement specifi condit parti accept recognis result conform assess procedur produc parti conform assess bodi author assess conform import parti requir sector specif basi sector annex provid relat cooper activ object mutual recognit provid effect market access territori parti regard conform assess product cover agreement obstacl access aris consult promptli held absenc satisfactori outcom consult parti alleg market access deni dai consult invok termin agreement accord articl articl gener oblig unit state sector annex accept recognis result procedur assess conform legisl regulatori administr provis unit state produc parti conform assess bodi author european commun member state sector annex accept recognis result procedur assess conform legisl regulatori administr provis european commun member state produc parti conform assess bodi author sector transit arrang sector annex oblig appli success complet sector transit arrang understand conform assess procedur utilis assur conform satisfact receiv parti applic legisl regulatori administr provis parti equival assur offer receiv parti procedur articl gener coverag agreement agreement appli conform assess procedur product process relat cooper activ agreement sector annex includ descript relev legisl regulatori administr provis pertain conform assess procedur technic regul statement product scope coverag list design author list agre conform assess bodi author sourc obtain list bodi author statement scope conform assess procedur agre procedur criteria design conform assess bodi descript mutual recognit oblig sector transit arrang ident sector contact point parti territori statement establish joint sector committe agreement constru entail mutual accept standard technic regul parti sector annex entail mutual recognit equival standard technic regul articl transit arrang parti agre implement transit commit confid build sector annex parti agre sector transit arrang time period complet parti amend transit arrang mutual agreement passag transit phase oper phase proce sector annex parti document condit provid sector annex success transit met articl design author parti ensur design author sector annex power compet respect territori carri decis agreement design monitor suspend remov suspens withdraw conform assess bodi articl design list procedur procedur appli regard design conform assess bodi inclus bodi list conform assess bodi sector annex design author identifi sector annex design conform assess bodi accord procedur criteria set sector annex parti propos add conform assess bodi list bodi sector annex forward propos design conform assess bodi write parti view decis joint committe dai receipt propos parti posit confirm opposit confirm inclus sector annex propos conform assess bodi bodi effect event parti contest basi document evid technic compet complianc propos conform assess bodi write requir addit dai fulli verifi evid conform assess bodi includ list conform assess bodi applic sector annex instanc joint committe decid bodi concern verifi complet verif propos list conform assess bodi sector annex resubmit parti articl suspens list conform assess bodi procedur appli regard suspens conform assess bodi list sector annex parti notifi parti contest technic compet complianc conform assess bodi list sector annex contest parti intent suspend conform assess bodi contest exercis justifi object reason manner write parti conform assess bodi prompt notic parti opportun present inform order refut contest correct defici form basi contest contest discuss parti relev joint sector committe joint sector committe contest parti refer matter directli joint committe agreement suspend reach joint sector committe joint sector committe joint committe conform assess bodi suspend joint sector committe joint committe decid verif technic compet complianc requir carri time manner parti territori bodi question locat carri jointli parti justifi case matter resolv joint sector committe dai notic contest matter refer joint committe decis joint sector committe matter refer directli joint committe decis reach joint committe dai referr conform assess bodi suspend request contest parti suspens conform assess bodi list sector annex parti longer oblig accept recognis result conform assess procedur perform conform assess bodi subsequ suspens parti continu accept result conform assess procedur perform conform assess bodi prior suspens regulatori author parti decid base health safeti environment consider failur satisfi requir scope applic sector annex suspens remain effect agreement reach parti futur statu bodi articl withdraw list conform assess bodi procedur appli regard withdraw sector annex conform assess bodi parti propos withdraw conform assess bodi list sector annex forward propos write parti conform assess bodi promptli notifi parti provid period dai receipt provid inform order refut correct defici form basi propos withdraw dai receipt propos parti posit confirm opposit confirm withdraw list sector annex conform assess bodi effect event parti oppos propos withdraw support technic compet complianc conform assess bodi conform assess bodi time withdrawn list conform assess bodi applic sector annex instanc joint sector committe joint committe decid carri joint verif bodi concern complet verif propos withdraw conform assess bodi resubmit parti subsequ withdraw conform assess bodi list sector annex parti continu accept result conform assess procedur perform conform assess bodi prior withdraw regulatori author parti decid base health safeti environment consider failur satisfi requir scope applic sector annex articl monitor conform assess bodi appli regard monitor conform assess bodi list sector annex design author assur conform assess bodi list sector annex capabl remain capabl properli assess conform product process applic cover applic sector annex regard design author maintain maintain ongo surveil conform assess bodi mean regular audit assess parti undertak compar method verifi conform assess bodi list sector annex compli relev requir sector annex exist system evalu conform assess bodi part comparison procedur design author consult counterpart ensur mainten confid conform assess procedur consent parti consult includ joint particip audit inspect relat conform assess activ assess conform assess bodi list sector annex design author consult relev regulatori author parti ensur technic requir identifi satisfactorili address articl conform assess bodi parti recognis conform assess bodi list sector annex fulfil condit elig assess conform relat requir sector annex parti scope conform assess procedur bodi list articl exchang inform parti exchang inform implement legisl regulatori administr provis identifi sector annex parti notifi parti legisl regulatori administr relat subject matter agreement dai entri forc consider safeti health environment protect requir urgent action parti notifi parti practic parti promptli notifi parti design author conform assess bodi parti exchang inform procedur ensur list conform assess bodi respons compli legisl regulatori administr provis outlin sector annex regulatori author identifi sector annex consult counterpart ensur mainten confid conform assess procedur ensur technic requir identifi satisfactorili address articl sector contact point parti appoint confirm write contact point respons activ sector annex articl joint committe parti parti establish joint committe consist repres parti joint committe compris respons effect function agreement joint committe establish joint sector committe compris regulatori author deem parti vote joint committe joint committe make decis unanim consent joint committe determin rule procedur joint committe matter relat effect function agreement respons list suspens withdraw verif conform assess bodi accord agreement amend transit arrang sector annex resolv question relat applic agreement sector annex resolv respect joint sector committe provid forum discuss issu aris implement agreement wai enhanc oper agreement coordin negoti addit sector annex amend agreement sector annex accord articl parti introduc addit conform assess procedur affect sector annex parti discuss matter joint committe view bring addit procedur scope agreement relev sector annex articl preserv regulatori author agreement constru limit author parti determin legisl regulatori administr measur level protect consid safeti protect human anim plant life health environ consum regard risk scope applic sector annex agreement constru limit author regulatori author measur ascertain product compromis health safeti person territori meet legisl regulatori administr provis scope applic sector annex fail satisfi requir scope applic sector annex measur includ withdraw product market prohibit placement market restrict free movement initi product recal prevent recurr problem includ prohibit import regulatori author take action inform counterpart author parti dai take action provid reason articl suspens recognit oblig parti suspend oblig sector annex part parti suffer loss market access parti product scope sector annex result failur parti fulfil oblig agreement adopt addit conform assess requir referenc articl result loss market access parti product scope sector annex conform assess bodi design parti order meet requir recogn parti implement requir parti fail maintain legal regulatori author capabl implement provis agreement articl confidenti parti agre maintain extent requir law confidenti inform exchang agreement parti disclos public permit conform assess bodi disclos public inform exchang agreement constitut trade secret confidenti commerci financi inform inform relat ongo investig parti conform assess bodi exchang inform parti conform assess bodi parti design portion inform consid exempt disclosur parti precaut protect inform exchang agreement unauthoris disclosur articl fee parti endeavour ensur fee impos servic agreement commensur servic provid parti ensur sector conform assess procedur cover agreement charg fee respect conform assess servic provid parti articl agreement countri written agreement parti oblig contain mutual recognit agreement conclud parti parti signatori agreement parti forc effect regard parti term accept result conform assess procedur parti articl territori applic agreement appli hand territori treati establish european commun appli condit laid treati hand territori unit state articl entri forc amend termin agreement includ sector annex telecommun equip electromagnet compat electr safeti recreat craft pharmaceut good manufactur practic gmp medic devic enter forc dai month date parti exchang letter confirm complet respect procedur entri forc agreement agreement includ sector annex joint committe amend write parti parti add sector annex exchang letter annex enter forc dai date parti exchang letter confirm complet respect procedur entri forc sector annex parti termin agreement entireti individu sector annex thereof give parti month notic write case termin sector annex parti seek achiev consensu amend agreement view preserv remain sector annex accord procedur articl fail consensu agreement termin end month date notic termin agreement entireti individu sector annex thereof parti continu accept result conform assess procedur perform conform assess bodi agreement prior termin regulatori author parti decid base health safeti environment consider failur satisfi requir scope applic sector annex articl final provis sector annex refer articl sector annex ad pursuant articl form integr part agreement product sector provis contain relev sector annex appli place provis text addit provis case inconsist provis sector annex text sector annex prevail extent inconsist agreement affect right oblig parti intern agreement case sector annex medic devic parti review statu annex end year entri forc agreement sector annex drawn origin danish dutch english finnish french german greek italian portugues spanish swedish languag text equal authent event inconsist interpret english text determin hecho en londr el dieciocho de mayo de mil noveciento noventa ocho udfærdiget london den attend maj nitten hundred og otteoghalvfem geschehen zu london achtzehnten mai neunzehnhundertachtundneunzig london eighteenth dai year thousand hundr nineti fait londr le dix huit mai mil neuf cent quatr vingt dix huit fatto londra addì diciotto maggio millenovecentonovantotto gedaan te londen de achttiend mei negentienhonderd achtennegentig feito em londr em dezoito de maio de mil novecento noventa oito tehti lontoossa kahdeksantenatoista päivänä toukokuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäkahdeksan som skedd london den artond maj nittonhundranittioåtta por la comunidad europea det europæisk fællesskab für die europäisch gemeinschaft european commun pour la communauté européenn la comunità europea voor de europes gemeenschap pela comunidad europeia euroopan yhteisön puolesta på europeiska gemenskapen vägnar gt refer graphic gt por lo estado unido de américa amerika forened stater für die vereinigten staaten von amerika unit state america pour le état uni amériqu gli stati uniti america voor de verenigd staten van amerika pelo estado unido da américa amerikan yhdysvaltojen puolesta på amerika förenta staterna vägnar gt refer graphic gt sector annex telecommun equip preambl annex constitut sector annex agreement mutual recognit conform assess unit state european commun section legisl regulatori administr provis gt tabl gt section ii scope coverag sector annex appli equip interfac servic subject section gener term provis sector annex appli type telecommun termin equip satellit termin equip radio transmitt inform technolog equip equip intend connect public telecommun network order send process receiv inform equip connect directli termin network inter work network connect directli indirectli termin point system connect wire radio optic electro magnet mean equip capabl connect public telecommun network intend purpos includ inform technolog equip commun port radio transmitt subject equip authoris procedur parti exclus list equip interfac servic includ scope sector annex gt tabl gt section iii conform assess procedur telecommun equip descript mutual recognit oblig accord provis agreement result conform assess procedur produc parti conform assess bodi list section recognis regulatori author parti conform assess product pursuant section conform assess procedur take account legisl regulatori administr provis identifi section parti recognis conform assess bodi parti list section authoris perform procedur regard import parti technic requir telecommun termin satellit termin equip radio transmitt inform technolog equip test issu test report issu certif conform requir law regul applic territori parti product cover sector annex perform qualiti assur certif pursuant direct ec section iv author respons design conform assess bodi list section gt tabl gt section conform assess bodi gt tabl gt section vi design list suspend withdraw monitor conform assess bodi list section gt tabl gt section vii addit provis contract contract conform assess bodi accord contract requir parti notwithstand contract final result conform assess remain full respons list conform assess bodi ec requir council decis eec conform assess bodi record retain detail investig compet complianc subcontractor maintain regist contract detail parti request post market surveil border measur intern movement purpos post market surveil parti maintain exist label number requir assign number place territori export parti number alloc import parti number label system introduc addit requir mean sector annex sector annex prevent parti remov product market fact conform requir approv parti agre border inspect check product certifi label mark conform import parti requir section complet expediti regard inspect relat intern movement respect territori parti agre complet favour manner domest good joint sector committe combin joint sector committe sector annex electromagnet compat emc sector annex establish jsc jsc oper transit period complet transit arrang jsc meet discuss technic conform assess technolog issu relat sector annex emc sector annex jsc determin rule procedur jsc consist repres ec telecommun emc jsc repres invit manufactur entiti deem repres vote jsc repres ec vote jsc decis jsc made unanim consent event disagr ec repres rais matter joint committe jsc address matter relat effect function sector annex includ provid forum discuss issu resolv problem aris implement sector annex develop mechan ensur consist interpret legisl regul standard conform assess procedur advis parti matter relat sector annex provid guidanc develop guidelin transit period facilit success complet transit period contact point parti establish contact point provid answer reason inquiri parti procedur regul complaint sector annex regulatori updat sector annex event legisl regulatori administr provis referenc section introduct legisl regulatori administr provis affect parti conform assess procedur agreement effect purpos sector annex time effect domest territori parti parti updat sector annex reflect section viii transit arrang transit period month purpos transit arrang provid mean parti agreement build confid understand system design list conform assess bodi abil bodi test certifi product success complet transit arrang result determin conform assess bodi list section compli applic criteria compet conduct conform assess activ behalf parti success complet transit period result conform assess procedur perform export parti conform assess bodi list section export countri accept import parti transit period parti legisl need support object agreement initi regulatori need support object agreement exchang inform develop understand respect regulatori requir develop mutual agre mechan exchang inform technic requir method design conform assess bodi monitor evalu perform list conform assess bodi transit period parti design list suspend withdraw conform assess bodi transit period procedur section vi sector annex transit period parti accept evalu test report relat document issu design conform assess bodi parti end parti ensur receipt test report relat document evalu conform dossier promptli examin complet applic inform precis complet manner defici request addit inform limit omiss inconsist varianc technic regul standard procedur assess conform equip modifi subsequ determin complianc limit procedur determin continu conform parti ensur issuanc approv certif advic applic week receipt test report evalu design conform assess bodi territori parti propos made end transit period limit scope recognit design conform assess bodi exclud list bodi design sector annex base object criteria document bodi appli reconsider correct action extent parti implement action prior expiri transit period parti jointli sponsor seminar european commun relev technic product approv requir year sector annex enter forc passag transit phase oper phase sector annex place provid repres number conform assess bodi accept recognit electr safeti annex appendix list acronym glossari gt tabl gt sector annex electromagnet compat emc preambl annex constitut sector annex agreement mutual recognit conform assess unit state european commun section legisl regulatori administr provis gt tabl gt section ii scope coverag gt tabl gt section iii conform assess procedur equip identifi section ii descript mutual recognit oblig accord provis agreement result conform assess procedur produc parti conform assess bodi list section recognis regulatori author parti conform assess product pursuant section conform assess procedur take account legisl regulatori administr provis identifi section parti recognis conform assess bodi parti list section authoris perform procedur regard import parti technic requir equip identifi section ii test issu test report issu certif conform requir law regul applic territori parti product cover sector annex section iv author respons design conform assess bodi list section gt tabl gt section conform assess bodi gt tabl gt section vi design list suspend withdraw monitor conform assess bodi list section gt tabl gt section vii addit provis contract contract conform assess bodi accord contract requir parti notwithstand contract final result conform assess remain full respons list conform assess bodi ec requir council direct eec conform assess bodi record retain detail investig compet complianc contractor maintain regist contract detail parti request post market surveil border measur intern movement purpos post market surveil parti maintain exist label number requir assign number place territori export parti number alloc import parti number label system introduc addit requir mean sector annex sector annex prevent parti remov product market fact conform requir approv parti agre border inspect check product certifi label mark conform import parti requir section complet expediti regard inspect relat intern movement respect territori parti agre complet favor manner domest good joint sector committe combin joint sector committe sector annex telecommun equip sector annex establish jsc jsc oper transit period complet transit arrang jsc meet discuss technic conform assess technolog issu relat sector annex telecommun equip sector annex jsc determin rule procedur jsc consist repres ec telecommun emc jsc repres invit manufactur entiti deem repres vote jsc repres ec vote jsc decis jsc made unanim consent event disagr ec repres rais matter joint committe jsc address matter relat effect function sector annex includ provid forum discuss issu resolv problem aris implement sector annex develop mechan ensur consist interpret legisl regul standard conform assess procedur advis parti matter relat sector annex provid guidanc develop guidelin transit period facilit success complet transit period contact point parti establish contact point provid answer reason inquiri parti procedur regul complaint sector annex regulatori updat sector annex event legisl regulatori administr provis referenc section introduct legisl regulatori administr provis affect parti conform assess procedur agreement effect purpos sector annex time effect domest territori parti parti updat sector annex reflect section viii transit arrang transit period month purpos transit arrang provid mean parti agreement build confid understand system design list conform assess bodi abil bodi test certifi product success complet transit arrang result determin conform assess bodi list section compli applic criteria compet conduct conform assess activ behalf parti complet transit period result conform assess procedur perform export parti conform assess bodi list section accept import parti transit period parti legisl need support object agreement initi regulatori need support object agreement exchang inform develop understand respect regulatori requir develop mutual agre mechan exchang inform technic requir method design conform assess bodi monitor evalu perform list conform assess bodi transit period parti design list suspend withdraw conform assess bodi transit period procedur section vi sector annex transit period parti accept evalu test report relat document issu design conform assess bodi parti end parti ensur receipt test report relat document evalu conform dossier promptli examin complet applic inform precis complet manner defici request addit inform limit omiss inconsist varianc technic regul standard procedur assess conform equip modifi subsequ determin complianc limit procedur determin continu conform parti ensur issuanc approv certif advic applic week receipt test report evalu design conform assess bodi territori parti propos made end transit period limit scope recognit design conform assess bodi exclud list bodi design sector annex base object criteria document bodi appli reconsider correct action extent parti implement action prior expiri transit period parti jointli sponsor seminar european commun relev technic product approv requir year sector annex enter forc passag transit phase oper phase sector annex place provid repres number conform assess bodi accept recognit electr safeti annex sector annex electr safeti preambl annex constitut sector annex agreement mutual recognit unit state european commun section legisl regulatori administr provis gt tabl gt section ii scope coverag gt tabl gt section iii descript mutual recognit oblig accord provis agreement ec conform assess bodi list section annex recognis test certifi mark product scope nation recognis test laboratori nrtl recognit assess conform requir regard conform assess bodi list section annex event challeng european commun articl council direct eec februari test report issu conform assess bodi accept european commun author report european commun notifi bodi accept list conform assess bodi recognis articl council direct eec bodi make report accord articl section iv author respons design conform assess bodi list section gt tabl gt section conform assess bodi gt tabl gt section vi design list suspend withdraw conform assess bodi gt tabl gt section vii joint sector committe electr safeti joint sector committe electr safeti jsc es consist repres ec osha repres joint sector committe ec osha invit particip deem parti vote decis made unanim consent joint sector committe determin rule procedur joint committe address matter relat effect function sector annex includ develop improv procedur criteria design order facilit assess prepar propos design author view expedit period design list provid forum discuss issu aris implement sector annex advis parti matter relat sector annex enhanc oper sector annex sector annex recreat craft preambl annex constitut sector annex agreement mutual recognit unit state european commun purpos sector annex establish framework accept certif conform issu territori parti accord regulatori requir parti referenc sector annex facilit purpos transit period month arrang build confid defin sector annex section vi section legisl regulatori administr requir european commun direct ec european parliament council june approxim law regul administr provis member state relat recreat craft usc chapter cfr cfr section ii scope coverag sector annex appli recreat craft european commun unit state subject conform assess conform assess bodi approv procedur applic put market product coverag parti determin relev requir european commun recreat craft defin direct ec unit state product fall scope usc chapter cfr cfr parti agre mutual recognit oper sector annex arrang appli approv european commun requir conform assess bodi design establish complianc requir demonstr direct ec demonstr complianc recognis european commun product certifi unrestrict access ec market sale recreat craft pursuant section approv unit state requir conform assess bodi design european commun establish complianc requir demonstr set paragraph section product certifi unrestrict access market sale recreat craft pursuant section section iii author respons design conform assess bodi gt tabl gt section iv design list suspend withdraw conform assess bodi purpos sector annex parti design compet conform assess bodi carri conform assess approv requir parti design carri procedur set articl agreement list conform assess bodi product procedur list set section parti agre list conform assess bodi compli requir bodi establish parti european commun bodi notifi bodi accord direct ec deem complianc requir accord requir set regul list section conform assess bodi list section design nist evalu procedur contain en seri standard iso iec guid regard design list suspens withdraw conform assess bodi sector annex specif procedur articl agreement section conform assess bodi gt tabl gt section vi transit arrang transit period month prior oper sector annex purpos transit arrang provid parti agreement cooper establish system design conform assess bodi mutual build confid abil bodi success complet transit arrang intend result determin conform assess bodi compli applic criteria equip approv conform assess bodi export countri accept approv author import countri transit period parti exchang inform technic data conform assess criteria procedur develop greater familiar respect regulatori requir carri recommend applic polici legisl regulatori provis annex product scope product cover section ii annex cooper transit period parti endeavour sponsor jointli seminar purpos improv understand technic specif applic parti jurisdict inspect inspect audit permit verifi complianc conform assess bodi respons agreement scope inspect audit agre advanc parti section vii addit provis accord relev provis agreement parti ensur continu avail name respect notifi bodi conform assess bodi regularli suppli detail certif issu order facilit post market surveil parti note extent requir electr safeti electromagnet compat appli product cover sector annex provis sector annex electr safeti electromagnet compat appli section viii definit notifi bodi mean parti authoris perform conform assess task direct ec appoint member state bodi fall jurisdict notifi bodi qualif meet requir laid direct ec notifi commiss member state sector annex pharmaceut good manufactur practic gmp preambl annex constitut sector annex agreement mutual recognit unit state european commun chapter definit purpos scope coverag articl definit equival regulatori system mean system suffici compar assur process inspect ensu inspect report provid adequ inform determin respect statutori regulatori requir author fulfil equival requir respect regulatori system ident procedur enforc mean action author protect public product suspect qualiti safeti efficaci assur product manufactur complianc law regul standard commit made part approv market product good manufactur practic gmp ec agre revisit concept gmp requir found respect legisl regul administr provis method facil control manufactur process pack hold drug assur drug meet requir safeti ident strength meet qualiti puriti characterist purport repres possess gmp part qualiti assur ensur product consist produc control qualiti standard purpos annex gmp includ system manufactur receiv specif product process market authoris product authoris licens holder applic ensur product made complianc specif qualifi person certif ec inspect mean site evalu manufactur facil determin manufactur facil oper complianc good manufactur practic commit made part approv market product inspect report mean written observ good manufactur practic complianc assess complet author list appendix regulatori system mean bodi legal requir good manufactur practic inspect enforc ensur public health protect legal author assur adher requir articl purpos provis annex govern exchang parti normal endors receiv author offici good manufactur practic gmp inspect report transit period aim determin equival regulatori system parti cornerston annex articl scope provis annex appli pharmaceut inspect carri unit state member state european commun product market refer pre approv inspect market refer post approv inspect appendix name law regul administr provis govern inspect gmp requir appendix list author particip activ annex articl agreement appli annex articl product coverag provis appli medicin product human anim intermedi start materi refer ec drug human anim biolog product human activ pharmaceut ingredi refer unit state extent regul author parti list appendix human blood human plasma human tissu organ veterinari immunolog exclud scope annex human plasma deriv immunoglobulin albumin investig medicin product drug human radiopharmaceut medicin gase exclud transit phase situat reconsid end transit period product regul center biolog evalu research devic cover annex appendix indic list product cover annex chapter transit period articl length transit period year transit period start immedi effect date agreement articl equival assess criteria parti assess equival list appendix inform pertain criteria commun compet provid commun author parti establish commun draft programm assess equival respect regulatori system term qualiti assur product consum protect programm carri deem author post pre approv inspect product class process equival assess includ inform exchang includ inspect report joint train joint inspect purpos assess regulatori system author capabl conduct equival assess parti ensur effort made save resourc equival assess author ad appendix effect date agreement conduct annex practic articl particip equival assess determin author list appendix activ particip program build suffici bodi evid equival determin parti exercis good faith effort complet equival assess expediti extent resourc author articl transit activ author jointli determin essenti inform present inspect report cooper develop mutual agre inspect report format chapter end transit period articl equival determin equival establish place regulatori system cover criteria refer appendix demonstr pattern consist perform accord criteria list author determin equival agre joint sector committe end transit period refer limit term inspect type post approv pre approv product class process parti document insuffici evid equival lack opportun assess equival determin equival suffici detail author assess attain equival articl author list equival author list equival equival type inspect product class process appli reconsider statu correct measur addit experi gain chapter oper period articl start oper period oper period start end transit period provis appli inspect report gener author list equival inspect perform territori addit author list equival base adequ experi gain transit period food drug administr fda accept normal endors provid articl inspect report gener result inspect conduct jointli author territori author list equival provid author member state inspect perform guarante enforc find inspect report requir correct measur fda option particip inspect base experi gain transit period parti agre procedur exercis option ec qualifi person reliev respons carri control laid articl paragraph council direct eec provid control carri unit state batch lot accompani batch certif accord certif scheme qualiti medicin product issu manufactur certifi product compli requir market authoris sign person respons releas batch lot articl natur recognit inspect report inspect report inform establish articl includ gmp complianc assess prepar author list equival provid author import parti base determin equival light experi gain inspect report endors author import parti specif delin circumst exampl circumst includ indic materi inconsist inadequaci inspect report qualiti defect identifi post market surveil specif evid concern relat product qualiti consum safeti case author import parti request clarif author export parti lead request inspect author endeavour respond request clarif time manner diverg clarifi process author import countri carri inspect product facil articl transmiss post approv inspect report post approv gmp inspect report product cover annex transmit author import countri calendar dai request inspect need inspect report transmit calendar dai request articl transmiss pre approv inspect report preliminari notif inspect place made calendar dai relev author acknowledg receipt request confirm abil carri inspect ec request directli relev author copi european agenc evalu medicin product emea author receiv request carri inspect request request author conduct inspect report pre approv inspect calendar dai request transmit inform detail precis issu address inspect shorter time except case request articl monitor continu equival monitor activ purpos maintain equival includ review exchang inspect report qualiti timeli perform limit number joint inspect conduct common train session articl suspens parti contest equival author exercis object reason manner write parti issu discuss joint sector committe promptli notif jsc determin verif equival requir carri jointli parti time manner pursuant articl effort made joint sector committe reach unanim consent action agreement suspend reach joint sector committe author suspend immedi agreement reach joint sector committe matter refer joint committe unanim consent reach dai notif contest author suspend suspens author previous list equival parti longer oblig endors inspect report suspend author parti continu endors inspect report author prior suspens author receiv parti decid base health safeti consider suspens remain effect unanim consent reach parti futur statu author chapter joint sector committe articl role composit joint sector committe joint sector committe set monitor activ transit oper phase annex committe chair repres fda repres ec vote decis unanim consent joint sector committe function includ make joint assess agre parti equival respect author develop maintain list equival author includ limit term inspect type product commun list author joint committe provid forum discuss issu relat annex includ concern author longer equival opportun review product coverag consider issu suspens joint sector committe meet request parti chair agre year joint committe inform agenda conclus meet joint sector committe chapter inform exchang articl regulatori collabor parti author inform consult permit law propos introduc control chang exist technic regul inspect procedur provid opportun comment propos parti notifi write appendix articl inform relat qualiti aspect author establish mean exchang inform confirm problem report correct action recal reject import consign regulatori enforc problem product subject annex articl alert system detail alert system develop transit period system maintain place time element consid develop system appendix contact point agre parti permit author made awar speed case qualiti defect recal counterfeit problem qualiti necessit addit control suspens distribut product chapter safeguard claus articl parti recognis import countri fulfil legal respons take action ensur protect human anim health level protect deem includ suspens distribut product detent border import countri withdraw batch request addit inform inspect provid articl appendix list applic law regul administr provis european commun council direct eec januari approxim provis laid law regul administr action relat proprietari medicin product extend widen amend council direct eec approxim provis laid law regul administr action relat proprietari medicin product extend widen amend council direct eec septemb approxim law member state relat veterinari medicin product widen amend council direct eec june lai principl guidelin good manufactur practic medicin product human commiss direct eec juli lai principl guidelin good manufactur practic veterinari medicin product council regul eec juli lai commun procedur authoris supervis medicin product human veterinari establish european agenc evalu medicin product council direct eec march wholesal distribut medicin product human guid good distribut practic current version guid good manufactur practic rule govern medicin product european commun volum iv unit state relev section unit state feder food drug cosmet act unit state public health servic act relev section titl unit state code feder regul cfr part part part part relev section fda investig oper manual fda regulatori procedur manual fda complianc polici guidanc manual fda complianc program guidanc manual fda guidanc appendix list author unit state unit state regulatori author food drug administr european commun european commun regulatori author gt tabl gt appendix indic list product cover sector annex recognis precis definit medicin product drug found legisl refer indic list product cover agreement human medicin product includ prescript prescript drug human biolog includ vaccin immunolog veterinari pharmaceut includ prescript prescript drug exclus veterinari immunolog pre mix prepar veterinari medic feed ec type medic articl prepar veterinari medic feed intermedi product activ pharmaceut ingredi bulk pharmaceut start materi ec appendix criteria assess equival post pre approv legal regulatori author structur procedur provid post pre approv statutori mandat jurisdict abil issu updat bind requir gmp guidanc document author make inspect review copi document sampl collect evid abil enforc requir remov product found violat requir market substant current good manufactur requir account regulatori author inventori current product manufactur system maintain access inspect report sampl analyt data firm product inform relat matter cover sector annex ii mechan place assur profession standard avoid conflict interest iii administr regulatori author standard educ qualif train effect qualiti assur system measur ensur adequ job perform staf resourc enforc law regul iv conduct inspect adequ pre inspect prepar includ expertis investig team review firm product databas avail inspect equip adequ conduct inspect includ statutori access facil effect respons refus depth compet evalu oper system document collect evid durat inspect complet written report observ firm manag adequ post inspect activ includ complet inspector report inspect report review conduct follow inspect activ assur preserv retriev record execut regulatori enforc action achiev correct design prevent futur violat remov product found violat requir market vi effect surveil system sampl analysi recal monitor product defect report system routin surveil inspect verif approv manufactur process market authoris approv applic vii addit specif criteria pre approv inspect satisfactori demonstr jointli develop administ train program joint inspect assess author capabl pre inspect prepar includ review record includ site plan drug master file similar document enabl adequ inspect abil verifi chemistri manufactur control data support applic authent complet abil access evalu research develop data scientif sound transfer technolog pilot scale full scale product batch abil verifi conform site process procedur applic review evalu equip instal oper perform qualif data evalu test method valid appendix element consid develop alert system document defint crisi emerg circumst alert requir standard oper procedur sop mechan health hazard evalu classif languag commun transmiss inform crisi manag system crisi analysi commun mechan establish contact point report mechan enforc procedur follow mechan correct action procedur qualiti assur system pharmacovigil programm surveil monitor implement correct action contact point purpos agreement contact point alert system european commun execut director european agenc evalu medicin product westferri circu canari wharf uk london hb england telephon fax unit state provid sector annex medic devic preambl annex constitut sector annex agreement mutual recognit regul conform assess unit state european commun carri provis annex public health protect import mean facilit commerc medic devic lead reduc cost regul manufactur parti chapter purpos scope coverag sector annex articl purpos purpos annex condit parti accept result qualiti system relat evalu inspect premarket evalu parti regard medic devic conduct list conform assess bodi cab provid relat cooper activ annex intend evolv programm polici parti evolv parti review annex period order assess progress identifi potenti enhanc annex food drug administr fda ec polici evolv time articl scope provis annex appli exchang endors type report cab assess equival system surveil post market initi pre approv inspect report system premarket product evalu report ec system qualiti system evalu report ec system ec type examin verif report appendix name legisl regul relat procedur product regul medic devic parti cab design confirm report prepar purpos annex equival mean cab ec capabl conduct product qualiti system evalu regulatori requir manner equival conduct fda cab capabl conduct product qualiti system evalu ec regulatori requir manner equival conduct ec cab articl product coverag compon agreement cover discret rang product qualiti system evalu type surveil post market initi pre approv inspect report ec type qualiti system evalu report exchang regard product regul ec law medic devic product evalu type premarket product evalu report ec type test report exchang regard product classifi system class class ii tier medic devic list appendix post market vigil report post market vigil report exchang regard product regul ec law medic devic addit product procedur made subject annex agreement parti articl regulatori author regulatori author respons implement provis annex includ design monitor cab regulatori author appendix parti promptli notifi parti write chang regulatori author countri chapter transit period articl length purpos transit period year transit period immedi date entri forc agreement transit period parti engag confid build activ purpos obtain suffici evid make determin equival cab parti respect abil perform qualiti system product evalu review result report exchang annex articl list cab parti design cab particip confid build activ transmit parti list cab meet criteria technic compet independ identifi appendix list accompani support evid design cab list appendix particip confid build activ confirm import parti confirm justifi base document evid articl confid build activ begin transit period joint sector group establish joint confid build programm calcul provid suffici evid capabl design cab perform qualiti system product evalu specif parti joint confid build program includ action activ seminar design inform parti cab parti regulatori system procedur requir workshop design provid parti inform requir procedur design surveil cab exchang inform report prepar transit period joint train exercis observ inspect transit period signific problem identifi cab subject cooper activ resourc agre regulatori author aim resolv problem parti exercis good faith effort complet confid build activ expediti extent resourc parti ec prepar annual progress report describ confid build activ undertaken year transit period form content report determin parti joint sector committe articl transit period activ transit period parti jointli determin inform present qualiti system product evalu report parti jointli develop notif alert system case defect recal problem product qualiti necessit addit action inspect parti import countri suspens distribut product chapter end transit period articl equival assess final month transit period parti proce joint assess equival cab particip confid build activ cab determin equival provid demonstr profici submiss suffici number adequ report cab determin equival regard abil perform type qualiti system product evalu cover annex regard type product cover annex parti develop list contain appendix cab determin equival full explan scope equival determin includ limit regard perform type qualiti system product evalu parti cab list particip mra list particip type evalu appli particip mra measur suffici experi gain accord articl decis equival cab agre parti chapter oper period articl start oper period oper period start end transit period parti develop list cab found equival provis chapter appli regard list cab extent specif limit contain list regard cab oper period appli qualiti system evalu report product evalu report gener cab list accord annex evalu perform respect territori parti parti agre articl exchang endors qualiti system evalu report list ec cab provid fda report qualiti system evalu pre approv qualiti system evalu ec cab provid full report surveil qualiti system evalu ec cab provid abbrevi report list cab provid ec notifi bodi manufactur choic full report initi qualiti system evalu abbrevi report qualiti system surveil audit abbrevi report provid suffici inform import parti request addit clarif cab base determin equival light experi gain qualiti system evalu report prepar cab list equival endors import parti specif delin circumst exampl circumst includ indic materi inconsist inadequaci report qualiti defect identifi post market surveil specif evid concern relat product qualiti consum safeti case import parti request clarif export parti lead request inspect parti endeavour respond request clarif time manner diverg clarifi process import parti carri qualiti system evalu articl exchang endors product evalu report ec cab list purpos subject specif limit list provid fda premarket notif assess report prepar medic devic requir cab subject specif limit list provid ec notifi bodi manufactur choic type examin verif report prepar ec medic devic requir base determin equival light experi gain product evalu report prepar cab list equival endors import parti specif delin circumst exampl circumst includ indic materi inconsist inadequaci incomplet product evalu report specif evid concern relat product safeti perform qualiti case import parti request clarif export parti lead request evalu parti endeavour respond request clarif time manner endors remain respons import parti articl transmiss qualiti system evalu report qualiti system evalu report cover articl product cover annex transmit import parti calendar dai request import parti inspect request time period extend addit calendar dai parti request inspect identifi parti export parti perform inspect period time import parti perform inspect articl transmiss product evalu report transmiss product evalu report place import parti procedur articl monitor continu equival monitor activ carri accord articl agreement articl list addit cab oper period addit cab consid equival procedur criteria articl annex take account level confid gain regulatori system parti design author consid cab undergon procedur articl annex determin equival design bodi annual basi procedur satisfi procedur articl agreement annual design procedur confirm cab articl agreement appli chapter joint special committe articl role composit joint sector committe joint sector manag committe set monitor activ transit oper phase annex committe chair repres fda repres ec vote decis unanim consent jsc function includ make joint assess equival cab develop maintain list equival cab includ limit term scope activ commun list author joint committe provid forum discuss issu relat annex includ concern cab longer equival opportun review product coverag consider issu suspens chapter harmonis inform exchang articl harmonis transit oper phase agreement parti intend continu particip activ global harmonis task forc utilis result activ extent particip involv develop review document develop global harmonis task forc jointli determin applic implement agreement articl regulatori cooper parti author inform permit law consult propos introduc control chang exist technic regul inspect procedur provid opportun comment propos parti notifi write appendix articl alert system exchang post market vigil report alert system set transit period maintain parti notifi danger public health element system appendix attach sector annex part system parti notifi parti confirm problem report correct action recal report regard part ongo investig contact point agre parti permit author made awar speed case qualiti defect batch recal counterfeit problem qualiti necessit addit control suspens distribut product appendix relev legisl regul procedur european commun legisl appli articl council direct eec june approxim law member state relat activ implant medic devic conform assess procedur annex ii except section annex iv annex council direct eec june medic devic conform assess procedur annex ii except section annex iii annex iv annex annex vi unit state legisl appli articl feder food drug cosmet act seq public health servic act seq regul unit state food drug administr found part medic devic parti review select premarket notif pilot program fed reg april appendix scope product coverag initi coverag transit period entri forc annex product qualifi transit arrang agreement includ class product requir premarket evalu unit state tabl class ii product list tabl transit period parti jointli identifi addit product group includ relat accessori line respect prioriti review base primarili written guidanc parti effort prepar expediti review base primarili intern standard order parti gain requisit experi addit product list phase annual basi parti consult industri interest parti determin product ad commenc oper period commenc oper period product coverag extend class ii product cover transit period fda expand program categori class ii devic consist result pilot fda abil write guidanc document devic pilot parti review medic devic success mra cover maximum extent feasibl class ii devic list tabl fda accredit parti review explicitli includ joint decis parti agreement cover class ii tier class iii product system gt tabl gt gt tabl gt gt tabl gt appendix author respons design conform assess bodi gt tabl gt appendix conform assess bodi gt tabl gt understood date entri forc occur prior june parti decid joint declar agreement mutual recognit european commun unit state america parti agre except case agreement mutual recognit unit state america european commun sign consist linguist version agreement verifi notif complet respect procedur entri forc agreement refer articl agreement made parti complet verif text sign todai agreement parti discrep brought conform english text london eighteenth dai year thousand hundr nineti european commun gt refer graphic gt unit state america gt refer graphic gt