agreement mutual recognit relat conform assess certif mark european commun australia european commun govern australia hereinaft refer parti tradit link friendship exist share commit promot enhanc product qualiti view ensur health safeti environ citizen desir conclud agreement provid mutual recognit respect conform assess procedur requir market access territori parti take account improv condit trade parti mutual recognit test report certif conform bring awar posit contribut mutual recognit encourag greater intern harmonis standard regul note close relationship australia zealand confirm australian zealand closer econom relat trade agreement tran tasman mutual recognit arrang grow level integr australian zealand conform assess infrastructur agreement establish council joint accredit system australia zealand ja anz note close relationship european commun iceland liechtenstein norwai agreement european econom area make conclus parallel mutual recognit agreement australia countri equival agreement bear mind statu contract parti agreement establish world trade organis consciou oblig world trade organis agreement technic barrier trade agre articl definit gener term agreement annex mean definit contain iso iec guid gener term definit standardis relat activ en edit context requir addit term definit appli purpos agreement conform assess mean systemat examin determin extent product process servic fulfil requir conform assess bodi mean bodi activ expertis includ perform stage conform assess process design mean authoris design author conform assess bodi perform conform assess activ design mean design author mean bodi legal power design suspend withdraw design conform assess bodi jurisdict term conform assess bodi design author appli mutati mutandi bodi author function refer sector annex articl gener oblig govern australia accept attest conform includ test report certif authoris mark conform requir legisl regul identifi sector annex issu design conform assess bodi european commun accord agreement european commun accept attest conform includ test report certif authoris mark conform requir legisl regul identifi sector annex issu design conform assess bodi australia accord agreement agreement entail mutual accept standard technic regul parti mutual recognit equival standard technic regul articl sector coverag agreement concern conform assess procedur satisfi mandatori requir cover sector annex sector annex gener inform statement scope coverag legisl regulatori administr requir pertain conform assess procedur section list design conform assess bodi section ii design author section iii set procedur design conform assess bodi section iv addit provis requir section articl origin agreement appli product origin parti agreement preferenti rule origin case conflict rule preferenti rule parti territori good market determin extent product refer paragraph cover sector annex agreement mutual recognit relat conform assess european commun zealand agreement appli product zealand origin extent product refer paragraph cover sector annex agreement mutual recognit relat conform assess australia state contract parti convent european free trade associ efta agreement european econom area eea agreement appli product origin efta state articl conform assess bodi accord term annex sector annex parti recognis conform assess bodi design parti fulfil condit elig assess conform relat requir sector annex design bodi parti scope conform assess activ design articl design author parti ensur design author respons design conform assess bodi sector annex power compet design suspend remov suspens withdraw design bodi make design withdraw design author sector annex observ procedur design set articl annex case suspens design remov suspens design author parti concern immedi inform parti joint committe conform assess carri suspend conform assess bodi suspens remain valid determin design author articl verif design procedur parti exchang inform procedur ensur design conform assess bodi respons sector annex compli legisl regulatori administr requir outlin sector annex compet requir annex parti compar method verifi design conform assess bodi compli legisl regulatori administr requir outlin sector annex compet requir annex exist system accredit conform assess bodi parti comparison procedur comparison carri accord procedur determin joint committe establish articl articl verif complianc conform assess bodi parti ensur conform assess bodi design design author verif technic compet complianc relev requir parti contest technic compet complianc conform assess bodi jurisdict parti exercis except circumst contest justifi object argu manner write parti chair joint committe joint committe decid verif technic compet complianc requir carri time manner jointli parti particip relev design author result verif discuss joint committe view resolv issu decid joint committe contest conform assess bodi includ section ii sector annex suspend compet design author time disagr establish joint committe agreement reach joint committe statu bodi articl exchang inform parti exchang inform implement legisl regulatori administr provis identifi sector annex consist oblig world trade organis agreement technic barrier trade parti inform parti intend make legisl regulatori administr provis relat subject matter agreement consider safeti health environment protect warrant urgent action notifi parti provis dai entri forc articl uniform conform assess procedur interest promot uniform applic conform assess procedur provid law regul parti design conform assess bodi part coordin comparison exercis conduct parti relev area cover sector annex articl agreement countri parti agre mutual recognit agreement conclud parti countri parti agreement entail oblig parti accept test report certif authoris mark conform issu conform assess bodi countri save express agreement parti articl joint committe joint committe made repres parti establish respons effect function agreement joint committe determin rule procedur decis adopt recommend consensu decid deleg specif task subcommitte joint committe meet year decid requir effect function agreement request parti addit meet meet held joint committe matter relat function agreement respons amend sector annex give effect decis design author design conform assess bodi amend sector annex give effect decis design author withdraw design conform assess bodi exchang inform procedur parti ensur conform assess bodi sector annex maintain level compet accord articl appoint joint team team expert verifi technic compet conform assess bodi complianc relev requir exchang inform notifi parti modif legisl regulatori administr provis refer sector annex includ requir modif sector annex resolv question relat applic agreement sector annex facilit extens agreement sector amend sector annex made accord provis articl notifi promptli write chair joint committe parti procedur appli relat inclus withdraw sector annex conform assess bodi parti propos amend sector annex give effect decis design author design withdraw design conform assess bodi forward propos parti write ad support document request copi propos document chair joint committe event parti consent propos expiri dai object lodg inclus withdraw sector annex conform assess bodi effect event articl parti contest technic compet complianc conform assess bodi aforement dai period joint committe decid carri verif bodi concern accord articl event design conform assess bodi withdrawn sector annex conform assess carri conform assess bodi date effect withdraw remain valid determin joint committe case inclus conform assess bodi conform assess carri conform assess bodi valid date parti agre inclus sector annex parti introduc addit conform assess procedur affect sector cover sector annex joint committe parti agre bring procedur mutual recognit implement arrang establish agreement articl territori applic agreement appli hand territori treati establish european commun appli condit laid treati hand territori australia articl entri forc durat agreement enter forc dai month date parti exchang note confirm complet respect procedur entri forc agreement parti termin agreement give parti month notic write articl final provis annex agreement form integr part thereof amend agreement mutual agreement parti conclud sector annex articl appli provid implement arrang agreement amend sector annex determin parti joint committe agreement sector annex drawn origin danish dutch english finnish french german greek italian portugues spanish swedish languag text equal authent hecho en canberra el veinticuatro de junio de mil noveciento noventa ocho udfærdiget canberra den fireogtyvend juni nitten hundred og otteoghalvfem geschehen zu canberra vierundzwanzigsten juni neunzehnhundertachtundneunzig canberra twenti fourth dai june year thousand hundr nineti fait canberra le vingt quatr juin mil neuf cent quatr vingt dix huit fatto canberra addì ventiquattro giugno millenovecentonovantotto gedaan te canberra de vierentwintigst juni negentienhonderd achtennegentig feito em camberra em vint quatro de junho de mil novecento noventa oito tehti canberrassa kahdentenakymmenentenäneljäntenä päivänä kesäkuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäkahdeksan som skedd canberra den tjugofjärd juni 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 australia australien für australien australia pour australi australia voor australië pela austrália australian puolesta för australien gt refer graphic gt annex procedur design monitor conform assess bodi gener requir condit design author design legal identifi entiti conform assess bodi design author design conform assess bodi demonstr understand experi relev compet appli conform assess requir procedur legisl regulatori administr provis parti design demonstr technic compet base technolog knowledg relev product process servic understand technic standard gener risk protect requir design sought experi relev applic legisl regulatori administr provis physic capabl perform relev conform assess activ adequ manag conform assess activ concern circumst give assur conform assess activ adequ perform continu basi technic compet criteria base internation accept document supplement specif interpret document develop time time parti encourag harmonis design conform assess procedur cooper design author conform assess bodi mean coordin meet particip mutual recognit arrang work group meet accredit bodi particip design process encourag particip mutual recognit arrang system determin conform assess bodi compet design author appli process determin technic compet conform assess bodi parti design author wai demonstr compet accredit accredit constitut presumpt technic compet relat requir parti accredit process conduct conform relev intern document en seri iso iec guid ii accredit bodi particip mutual recognit arrang subject peer evalu involv evalu individu recognis expertis field work evalu compet accredit bodi conform assess bodi accredit iii accredit bodi oper author design author part accord procedur agre comparison programm exchang technic experi order ensur continu confid technic compet accredit bodi conform assess bodi programm includ joint assess special cooper programm peer evalu conform assess bodi accredit evalu product process servic complianc technic specif design limit technic specif conform assess bodi seek design evalu product process servic complianc essenti requir accredit process incorpor element permit assess capabl technolog knowledg understand gener state risk protect requir product process servic conform assess bodi evalu complianc essenti requir mean accredit special circumst appli design author requir conform assess bodi demonstr compet mean particip region intern mutual recognit arrang certif system regular peer evalu profici test comparison conform assess bodi evalu design system design system evalu compet conform assess bodi defin parti parti consult design author check system give suffici assur design conform assess bodi satisfi requir formal design design author consult conform assess bodi jurisdict order determin willing design term agreement consult includ conform assess bodi oper respect legisl regulatori administr requir parti interest capabl work legisl regulatori administr requir parti design author inform parti repres joint committe establish articl agreement conform assess bodi includ withdrawn section ii sector annex design suspens withdraw design conform assess bodi place accord provis agreement rule procedur joint committe advis parti repres joint committe establish agreement conform assess bodi includ sector annex design author provid detail respect conform assess bodi postal address fax number rang product process standard servic authoris assess conform assess procedur authoris carri design procedur determin compet monitor design author maintain maintain ongo surveil design conform assess bodi mean regular audit assess frequenc natur activ consist intern practic agre joint committe design author requir design conform assess bodi particip profici test comparison exercis exercis technic reason cost design author consult counterpart ensur mainten confid conform assess process procedur consult includ joint particip audit relat conform assess activ assess design conform assess bodi particip technic reason cost design author consult relev regulatori author parti ensur regulatori requir identifi satisfactorili address sector annex medicin product gmp inspect batch certif european commun australia agreement mutual recognit relat conform assess certif mark scope coverag provis sector annex cover medicin product industri manufactur australia european commun good manufactur practic gmp requir appli medicin product cover sector annex parti recognis conclus inspect manufactur carri relev inspect servic parti relev manufactur authoris grant compet author parti addit manufactur certif conform batch specif recognis parti control import medicin product mean product regul pharmaceut legisl european commun australia list appendix annex definit medicin product includ human veterinari product chemic biolog pharmaceut immunolog radiopharmaceut stabl medicin product deriv human blood human plasma pre mix prepar veterinari medic feedingstuff vitamin miner herbal remedi homeopath medicin product gmp part qualiti assur ensur product consist produc control manufactur qualiti standard intend requir market authoris grant import parti purpos sector annex includ system manufactur receiv specif product process market authoris holder applic ensur medicin product made complianc specif equival qualifi person certif european commun respect medicin product cover legisl parti manufactur compani request purpos agreement inspect made local compet inspect servic provis appli inter alia manufactur activ pharmaceut ingredi intermedi product product intend clinic trial agre pre market inspect oper arrang detail section iii item certif manufactur request export import compet author parti author respons grant manufactur authoris supervis manufactur medicin product certifi manufactur appropri authoris manufactur relev medicin product carri relev manufactur oper regularli inspect author compli nation gmp requir recognis equival parti list appendix sector annex case gmp requir refer line provis section iii item mention certif certif identifi site manufactur contract test laboratori format certif attach appendix modifi joint committe establish articl agreement certif issu expediti time exce calendar dai except case inspect carri period extend dai batch certif batch export accompani batch certif prepar manufactur certif full qualit analysi quantit analysi activ constitu test check ensur qualiti product accord requir market authoris certif attest batch meet specif import batch made request compet author issu certif manufactur account provis current certif scheme qualiti pharmaceut product move intern commerc certif detail agre specif product refer analyt method analyt result statement batch process packag record review found conform gmp batch certif sign person respons releas batch sale suppli european commun qualifi person refer articl council direct eec approxim provis laid law regul administr action relat proprietari medicin product australia respons person manufactur qualiti control therapeut good regul therapeut good act section legisl regulatori administr requir subject section iii oper provis gener gmp inspect carri accord gmp requir export parti legisl regulatori administr requir list appendix refer qualiti requir product export includ manufactur method product specif relev product market authoris grant import parti section ii gt tabl gt section iii oper provis transmiss inspect report reason request relev inspect servic forward copi inspect report manufactur site control site case analyt oper contract request concern full inspect report detail report item parti deal inspect report degre confidenti request parti origin manufactur oper medicin product question inspect recent inspect date back year inspect identifi specif detail inspect request parti ensur inspect report forward calendar dai period extend dai inspect carri inspect report full inspect report compris site master file compil manufactur inspector narr report inspector detail report respond specif queri firm parti refer gmp manufactur inspect accord applic gmp export countri appendix respect medicin product cover pharmaceut legisl import parti export local compet inspect servic carri inspect relev manufactur oper inspect accord gmp absenc specif gmp requir accord applic gmp import countri case local applic gmp consid equival term qualiti assur finish product gmp import parti equival gmp requir specif product class product investig medicin product start materi determin procedur establish joint committe natur inspect inspect routin assess complianc manufactur gmp call gener gmp inspect regular period routin inspect product process orient inspect pre market inspect relev focu manufactur seri product process es includ assess valid complianc specif process control aspect market authoris relev product inform qualiti dossier applic authoris dossier provid confid inspector inspect establish fee regim inspect establish fee determin manufactur locat inspect establish fee charg manufactur locat territori parti product cover agreement provid paragraph safeguard claus inspect parti reserv conduct inspect reason identifi parti inspect notifi advanc parti option join inspect recours safeguard claus except inspect place inspect cost recov exchang inform author approxim qualiti requir accord gener provis agreement parti exchang inform mutual recognit inspect addit relev author australia european commun inform technic guidanc inspect procedur parti consult adopt endeavour proce approxim offici batch releas offici batch releas procedur addit verif safeti efficaci immunolog medicin product vaccin blood deriv carri compet author distribut batch product agreement encompass mutual recognit offici batch releas offici batch releas procedur appli manufactur provid request import parti offici batch releas certif batch question test control author export parti european commun offici batch releas procedur medicin product human document administr ec batch releas procedur iii specif batch releas procedur australia offici batch releas procedur document technic report seri inspector train accord gener provis agreement train session inspector organis author access inspector parti parti agreement inform session joint inspect accord gener provis agreement mutual agreement parti joint inspect authoris inspect intend develop common understand interpret practic requir set inspect form agre procedur approv joint committe alert system contact point agre parti permit compet author manufactur inform author parti speed case qualiti defect batch recal counterfeit problem qualiti necessit addit control suspens distribut batch detail alert procedur agre parti ensur suspens withdraw total partial manufactur authoris base complianc gmp affect protect public health commun degre urgenc contact point purpos agreement contact point technic question exchang inspect report inspector train session technic requir gt tabl gt diverg view parti endeavour resolv diverg view inter alia complianc manufactur conclus inspect report unresolv diverg view refer joint committe section iv transit arrang veterinari medicin product parti note current gmp requir veterinari medicin product australia equival appli european commun australian veterinari medicin product manufactur inspect therapeut good administr tga behalf veterinari nation registr author tga refer gmp relev addit ec gmp veterinari medicin product year transit period tga inspect report routin import parti accept decid carri inspect accept european commun recognis australian manufactur certif batch conform year entri forc agreement european commun subject satisfactori verif australia gmp inspect programm recognis conclus inspect carri tga australian manufactur certif batch conform nation registr author nra begin carri inspect inspect report routin transmit import parti satisfactori verif nra gmp inspect programm appendix list applic legisl regulatori administr provis european commun council direct eec januari approxim provis laid law regul administr action relat 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 commiss 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 australia product human therapeut good act regul order determin thereund includ order set standard label determin establish manufactur principl therapeut good act therapeut good regul therapeut good charg act therapeut good charg regul therapeut good exclud good order therapeut good good therapeut devic order therapeut good manufactur principl determin australian code good manufactur practic therapeut good medicin product august includ appendix guidelin sterilis irradi octob appendix guidelin test steril juli appendix guidelin laboratori instrument novemb appendix guidelin industri ethylen oxid sterilis therapeut good april appendix guidelin estim microbi count process water august appendix guidelin good manufactur practic investig medicin product june australian code good manufactur practic blood blood product includ technic annex juli australian code good manufactur practic therapeut good sunscreen product februari australian code good manufactur practic therapeut good medicin gase juli product veterinari legisl commonwealth agricultur veterinari chemic administr act agricultur veterinari chemic act agricultur veterinari chemic code act agricultur veterinari chemic consequenti amend act legisl south wale stock food medicin act public health act poison act pesticid alli chemic act legisl victoria anim prepar act health act drug poison control substanc act legisl queensland agricultur standard act stock act health act legisl south australia stock medicin act stock food act danger drug act control substanc act stock diseas act legisl western australia veterinari prepar anim feed stuff act poison act health pesticid regul legisl tasmania veterinari medicin act poison act public health act pesticid act legisl northern territori poison danger drug act therapeut good cosmet act stock diseas act appendix certif pharmaceut manufactur framework agreement mutual recognit relat conform assess certif mark australia european commun sector annex medicin product gmp inspect batch certif gt start graphic gt request compet author australia date refer compet author confirm compani legal regist address authoris therapeut good act direct eec articl direct eec articl transpos nation legisl authoris refer number cover site manufactur contract test laboratori carri manufactur oper complet manufactur partial manufactur detail manufactur oper authoris medicin product human anim knowledg gain inspect manufactur latest conduct date consid compani compli good manufactur practic requir refer agreement mutual recognit relat conform assess certif mark australia european commun date compet author signatur offic respons insert european commun member state european commun requir delet appli gt end graphic gt sector annex medic devic european commun australia agreement mutual recognit relat conform assess certif mark scope coverag provis sector annex appli product gt tabl gt section legisl regulatori administr requir gt tabl gt section ii design conform assess bodi gt tabl gt section iii author respons design conform assess bodi list section ii gt tabl gt section iv procedur design conform assess bodi gt tabl gt section addit provis transit period high risk devic transit period purpos strengthen confid design system parti appli medic devic schedul therapeut good regul medic devic direct eec eec list activ implant devic intrauterin contracept devic heart valv intraocular lens intraocular visco elast fluid power drug infus pump implant breast prosthes salin water barrier contracept devic exclud condom instrument grade disinfect parti establish detail programm effect involv therapeut good administr european commun compet author confid build period complet month date entri forc agreement medic devic incorpor medicin substanc order meet european commun requir procedur appli medic devic incorpor medicin substanc refer articl council direct eec june medic devic medic devic incorpor substanc ancillari medicin action establish monograph european pharmacopoeia consult requir annex ii iii council direct eec june medic devic carri australian compet author medic devic incorpor substanc ancillari medicin action european pharmacopoeia therapeut good administr carri consult compet author european commun respons authoris place market medicin product order meet australian requir procedur appli medic devic incorpor medicin substanc refer articl council direct eec june medic devic medic devic incorpor substanc ancillari medicin action establish monograph european pharmacopoeia consult requir annex ii iii council direct eec june medic devic carri european commun compet author medic devic incorpor substanc ancillari medicin action european pharmacopoeia consult place depart health famili servic take decis registr list procedur parti recognis australian procedur therapeut good act registr list product market surveil purpos european commun procedur unaffect agreement framework agreement australian regulatori author work dai regist product european commun receipt applic accompani design fee assess product fee attach registr parti relat cost medic devic registr enforc post market surveil activ parti sector exchang inform parti agre inform incid context medic devic vigil procedur regard matter product safeti establish contact point purpos order facilit applic sector annex parti establish guidanc document set procedur requir equival legisl parti modal facilit registr requir legisl parti note possibl australia introduc legisl medic devic agre arrang respect principl mutual recognit agreement base notabl articl agreement diverg view parti endeavour resolv diverg view complianc manufactur conclus conform assess report unresolv diverg view refer joint committe sector annex telecommun termin equip european commun australia agreement mutual recognit relat conform assess certif mark scope coverag provis sector annex appli gt tabl gt section legisl regulatori administr requir gt tabl gt section ii design conform assess bodi gt tabl gt section iii author respons design conform assess bodi list section ii gt tabl gt section iv procedur design conform assess bodi gt tabl gt section addit provis accord part telecommun act australian commun author aca requir authoris manufactur import appli label custom equip prior place custom equip australian market framework agreement aca endeavour work dai case longer dai issu authoris accord procedur set telecommun label custom equip custom cabl notic agre parti relev council direct australian legisl regulatori requir mutual recognit separ element conform assess process parti accept test report issu conform assess bodi design parti meet requir regard legisl regulatori administr provis parti requir conform assess bodi subcontract part test subcontract test laboratori accredit accord claus section iv respect telecommun termin equip subject provis council direct eec februari harmonis law member state relat electr equip design voltag limit council direct eec approxim law member state relat electromagnet compat relev provis sector annex low voltag equip electromagnet compat appli aca technic standard ts ts ts ts ts ts ts ts ts ts ts ts ts ts ts ts ts ts ts ts ts ts ts ts sector annex low voltag equip european commun australia agreement mutual recognit relat conform assess certif mark scope coverag provis sector annex appli type low voltag equip product fall scope council direct eec februari harmonis law member state relat electr equip design voltag limit electr product scope australian state territori legisl safeti low voltag electr equip section legisl regulatori administr requir gt tabl gt section ii design conform assess bodi gt tabl gt section iii author respons design conform assess bodi list section ii gt tabl gt section iv procedur design conform assess bodi gt tabl gt section addit provis accord australian legisl set section annex type electr equip declar articl list requir regist market framework agreement australian state territori regulatori author work dai regist product european commun receipt applic accompani design fee assess product design fee relat cost electr equip registr enforc post market surveil activ australian regulatori author parti note regulatori complianc mark rcm introduc australia august adopt rcm australian regulatori requir result due remov arrang paragraph condit rcm respect principl mutual recognit agreement notabl articl agreement legisl regulatori administr provis parti requir conform assess bodi subcontract part test subcontract test laboratori accredit accord claus section iv event challeng european commun articl council direct eec februari harmonis law member state relat electr equip design voltag limit test report issu design conform assess bodi australia accept european commun author report european commun notifi bodi accept conform assess bodi australia recognis articl council direct bodi make report accord articl sector annex electromagnet compat european commun australia agreement mutual recognit relat conform assess certif mark scope coverag provis sector annex appli electromagnet compat equip defin council direct eec approxim law member state relat electromagnet compat exclud radiocommun equip connect public switch telecommun network electromagnet compat equip regul australian radiocommun act section legisl regulatori administr requir gt tabl gt section ii design conform assess bodi gt tabl gt section iii author respons design conform assess bodi list section ii gt tabl gt section iv procedur design conform assess bodi gt tabl gt section addit provis european commun australia agre report certif prepar european commun compet bodi accept australian regulatori author report certif prepar design conform assess bodi australia accept european commun author basi report certif prepar european commun compet bodi legisl regulatori administr provis parti requir conform assess bodi subcontract part test subcontract test laboratori accredit accord claus section iv parti note australian requir compet bodi member australian associ compet bodi commiss current consider propos establish technic secretariat notifi bodi compet bodi council direct eec approxim law member state relat electromagnet compat promot coordin activ bodi direct parti note european commiss intent encourag compet bodi particip coordin activ sector annex machineri european commun australia agreement mutual recognit relat conform assess certif mark scope coverag provis sector annex appli product list annex iv council direct eec june approxim law member state relat machineri tower crane mobil crane section legisl regulatori administr requir gt tabl gt section ii design conform assess bodi gt tabl gt section iii author respons design conform assess bodi list section ii gt tabl gt section iv procedur design conform assess bodi gt tabl gt section addit provis respect machineri subject provis council direct eec februari harmonis law member state relat electr equip design voltag limit council direct eec approxim law member state relat electromagnet compat relev provis sector annex low voltag equip electromagnet compat appli date applic provis direct european parliament council approxim law member state relat measur emiss gaseou particul pollut intern combust engin instal road mobil machineri present european commiss propos bodi australia design issu type approv direct directli author respons design fulfil notif oblig approv author relev provis direct note propos direct make refer conform assess requir set council direct eec june amend direct eec approxim law member state relat type approv motor vehicl trailer recognis provis direct manufactur accredit test laboratori permiss test laboratori equip subject approv design author sector annex pressur equip european commun australia agreement mutual recognit relat conform assess certif mark scope coverag provis sector annex appli product gt tabl gt section legisl regulatori administr requir gt tabl gt section ii design conform assess bodi gt tabl gt section iii author respons design conform assess bodi list section ii gt tabl gt section iv procedur design conform assess bodi gt tabl gt section addit provis respect pressur equip subject provis council direct eec februari harmonis law member state relat electr equip design voltag limit council direct eec approxim law member state relat electromagnet compat relev provis sector annex low voltag equip electromagnet compat appli sector annex automot product european commun australia agreement mutual recognit relat conform assess certif mark scope coverag accord term annex australia recognis accept result test conform product approv procedur regul adopt context ec agreement ec regul deem equival ec direct carri european commun regul substanti equival australian regulatori provis accord term annex european commun accept result test conform product procedur carri australia accord council direct ec regul fulli partial condition appli australia recognis substanti equival annex iv part council direct eec februari approxim law member state relat type approv motor vehicl trailer amend accord term annex parti recognis accept result test conform product procedur carri parti parti requir area substanti equival regulatori provis parti establish provis sector annex appli automot product vehicl compon regul econom commiss europ categori vehicl latest applic version ec direct adr speed limit devic defrost demist system windscreen wiper washer system amend scope coverag sector annex adapt posit substanti equival ec regul regulatori provis forc australia european commun section regulatori requir gt tabl gt section ii design conform assess bodi gt tabl gt section iii author respons design conform assess bodi gt tabl gt section iv procedur design conform assess bodi gt tabl gt section addit provis light parti note australian design rule concern vehicl light includ section sector annex australian design rule requir test filament globe compli australian design rule consid equival ec regul standstil area cover sector annex parti agre introduc certif arrang introduc establish agreement make arrang favour effect prevail review sector annex review year entri forc light develop relat intern standardis area vehicl part australia european commun concern extens parti advis adopt requir align regul econom commiss europ notif receiv australia european commun adopt ec regul joint committe adopt amend inclus list section sector annex final act plenipotentiari european commun hereinaft refer commun part plenipotentiari australia part meet signatur agreement mutual recognit relat conform assess european commun australia hereinaft refer agreement adopt text agreement includ annex sector annex relat medicin product gmp inspect batch certif medic devic telecommun termin equip low voltag equip electromagnet compat machineri pressur equip automot product plenipotentiari commun plenipotentiari australia adopt text joint declar list annex final act joint declar relat futur work implement arrang agreement joint declar mutual recognit voluntari sphere joint declar relat develop harmonis technic regul conform assess procedur joint declar relat review articl agreement hecho en canberra el veinticuatro de junio de mil noveciento noventa ocho udfærdiget canberra den fireogtyvend juni nitten hundred og otteoghalvfem geschehen zu canberra vierundzwanzigsten juni neunzehnhundertachtundneunzig canberra twenti fourth dai june year thousand hundr nineti fait canberra le vingt quatr juin mil neuf cent quatr vingt dix huit fatto canberra addì ventiquattro giugno millenovecentonovantotto gedaan te canberra de vierentwintigst juni negentienhonderd achtennegentig feito em camberra em vint quatro de junho de mil novecento noventa oito tehti canberrassa kahdentenakymmenentenäneljäntenä päivänä kesäkuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäkahdeksan som skedd canberra den tjugofjärd juni 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 australia australien für australien australia pour australi australia voor australië pela austrália australian puolesta för australien gt refer graphic gt annex joint declar relat futur work implement arrang agreement pressur equip parti extend scope sector annex pressur equip start negoti effect direct subject present examin council european union european parliament basi european commiss propos enter forc aircraft certif continu airworthi parti confirm intent continu negoti order complet sector annex respect aircraft certif continu airworthi view establish implement arrang agreement year entri forc inclus sector annex build agreement australia european commun commenc negoti extens sector coverag agreement year date agreement enter forc joint declar mutual recognit voluntari sphere parti encourag government bodi cooper view establish mutual recognit arrang voluntari sphere joint declar relat develop harmonis technic regul conform assess procedur parti give consider increas degre harmonis equival respect technic regul conform assess procedur consist good regulatori practic parti acknowledg object establish feasibl singl submiss evalu procedur applic parti product cover agreement joint declar relat review articl agreement parti broaden provis articl includ countri parti conclud equival agreement mutual recognit relat conform assess sector countri