agreement mutual recognit european commun japan european commun japan hereinaft refer quot parti quot tradit friendli relat exist european commun japan recognis signific mutual recognit result conform assess procedur facilit market access promot trade parti common interest enhanc product qualiti view ensur health safeti public protect environ recognis oecd principl good laboratori practic glp recal long fruit cooper activ european commun japan made contribut intern develop harmonis good manufactur practic gmp requir awar posit contribut mutual recognit agreement make encourag intern harmonis standard bear mind oblig parti member world trade organis consciou inter alia oblig agreement technic barrier trade hereinaft refer quot wto agreement technic barrier trade quot includ annex agreement trade relat aspect intellectu properti right hereinaft refer quot wto agreement trade relat aspect intellectu properti right quot includ annex marrakesh agreement establish world trade organis hereinaft refer quot wto agreement quot agre articl purpos agreement term quot conform assess procedur quot mean procedur determin directli indirectli product process fulfil relev technic requir set applic law regul administr provis parti term quot conform assess bodi quot mean bodi conduct conform assess procedur term quot regist conform assess bodi quot mean conform assess bodi regist pursuant articl agreement term quot design quot mean design conform assess bodi design author parti pursuant applic law regul administr provis parti term quot design author quot mean author parti power design monitor withdraw design suspend design withdraw suspens design conform assess bodi territori conduct conform assess procedur base requir set applic law regul administr provis parti term quot criteria design quot mean criteria conform assess bodi parti requir fulfil order design design author parti relev condit design conform assess bodi requir continu fulfil design set applic law regul administr provis parti relev sector annex term quot confirm quot mean confirm complianc manufactur facil test facil hereinaft refer quot facil quot criteria confirm compet author parti pursuant applic law regul administr provis parti term quot compet author quot mean author parti power conduct inspect studi audit facil territori confirm complianc criteria confirm set applic law regul administr provis parti term quot criteria confirm quot mean criteria facil parti requir continu fulfil order confirm cauthor parti set applic law regul administr provis parti relev sector annex term quot verif quot mean action verifi territori parti mean audit inspect complianc criteria design criteria confirm conform assess bodi facil term agreement defin mean assign iso iec guid edit quot standardis relat activ gener vocabulari quot articl parti accept accord provis agreement result conform assess procedur requir applic law regul administr provis parti relev sector annex includ certif mark conform conduct regist conform assess bodi parti parti accept accord provis agreement confirm facil conduct compet author parti base result verif accord criteria confirm stipul law regul administr provis parti relev sector annex data gener confirm facil parti articl agreement appli design conform assess bodi conform assess procedur product process confirm facil data gener cover sector annex sector annex consist part part part sector annex includ inter alia provis scope coverag part sector annex set matter applic law regul administr provis parti scope coverag applic law regul administr provis parti stipul requir cover agreement conform assess procedur cover agreement satisfi requir criteria design conform assess bodi applic law regul administr provis parti stipul criteria confirm facil cover agreement list design author compet author articl parti ensur design author power design monitor includ verif withdraw design suspend design withdraw suspens design conform assess bodi conduct conform assess procedur base requir set applic law regul administr provis parti relev sector annex parti ensur compet author power conduct accord applic law regul administr provis verif facil confirm complianc criteria confirm set applic law regul administr provis parti relev sector annex articl parti ensur mean audit inspect monitor regist conform assess bodi fulfil criteria design set applic law regul administr provis parti relev sector annex appli criteria design conform assess bodi design author parti account bodi understand experi relev requir set applic law regul administr provis parti parti accord applic law regul administr provis mean studi audit inspect monitor ensur confirm facil fulfil criteria confirm set applic law regul administr provis parti relev sector annex parti request parti indic write reason doubt regist conform assess bodi confirm facil compli criteria design criteria confirm set applic law regul administr provis relev sector annex conduct verif conform assess bodi facil accord law regul administr provis parti parti request particip observ verif conform assess bodi conduct design author verif facil conduct compet author parti prior consent conform assess bodi facil order maintain continu understand parti procedur verif parti accord procedur determin joint committe establish pursuant articl exchang inform method includ accredit system design conform assess bodi ensur regist conform assess bodi fulfil criteria design method ensur confirm facil fulfil criteria confirm parti encourag regist conform assess bodi cooper conform assess bodi parti articl case suspens design regist conform assess bodi parti design author suspend design immedi notifi parti joint committe effect registr conform assess bodi suspend time receipt notif chairman parti joint committe parti accept result conform assess procedur conduct conform assess bodi prior suspens design case lift suspens design regist conform assess bodi parti design author lift suspens design immedi notifi parti joint committe effect suspens registr conform assess bodi lift time receipt notif chairman parti joint committe parti accept result conform assess procedur conduct conform assess bodi time lift suspens registr articl parti contest complianc criteria design criteria confirm set applic law regul administr provis relev sector annex regist conform assess bodi confirm facil parti contest notifi joint committe parti write object explan reason contest joint committe discuss contest dai date notif made joint committe decid conduct joint verif conduct time manner parti particip design author design contest conform assess bodi prior consent conform assess bodi result joint verif discuss joint committe view resolv issu registr contest conform assess bodi suspend dai date notif made date joint committe decid suspend registr whichev sooner registr contest conform assess bodi remain suspend joint committe decid lift suspens registr conform assess bodi event suspens contest parti accept result conform assess procedur conduct conform assess bodi prior date suspens joint committe decid action parti parti view resolv issu contest facil contest parti oblig accept confirm data gener contest facil date chairman parti joint committe receiv notif refer paragraph date joint committe decid articl joint committe made repres parti establish date entri forc agreement bodi respons effect function agreement joint committe decis adopt recommend consensu meet request parti chairmanship parti joint committe establish subcommitte deleg specif task subcommitte adopt rule procedur joint committe matter relat oper agreement respons decid registr conform assess bodi suspens registr conform assess bodi lift suspens registr conform assess bodi termin registr conform assess bodi establish decid public sector sector basi list regist conform assess bodi confirm facil establish modal inform exchang refer agreement appoint expert parti joint verif refer articl articl problem aris interpret applic agreement parti seek amic solut joint committe joint committe respons coordin facilit negoti addit sector annex parti provid parti joint committe annual list confirm facil decis made joint committe notifi promptli write parti parti joint committe commun applic articl annex contain law regul administr provis set sector annex exchang inform implement applic law regul administr provis sector annex notifi schedul law regul administr provis relat agreement prior entri forc notifi schedul design author compet author regist conform assess bodi confirm facil articl procedur appli registr conform assess bodi parti make propos conform assess bodi parti design design author regist agreement present propos write support document parti joint committe parti propos conform assess bodi compli criteria design set applic law regul administr provis parti relev sector annex posit registr conform assess bodi dai receipt propos refer subparagraph consider parti assum propos conform assess bodi compli aforement criteria joint committe decis regist propos conform assess bodi dai receipt propos event joint committe decid regist propos conform assess bodi joint committe decid conduct joint verif request propos parti conduct verif propos bodi prior consent bodi complet verif joint committe reconsid propos propos parti provid inform propos registr conform assess bodi inform date address conform assess bodi product process conform assess bodi authoris assess conform assess procedur conform assess bodi authoris conduct design procedur inform determin complianc conform assess bodi criteria design parti ensur design author withdraw design regist conform assess bodi design author consid conform assess bodi longer compli criteria design set applic law regul administr provis parti relev sector annex parti propos termin registr conform assess bodi parti consid conform assess bodi longer compli criteria design set applic law regul administr provis parti relev sector annex design author parti withdraw design conform assess bodi propos termin registr conform assess bodi made joint committe parti registr conform assess bodi termin receipt propos chairman parti joint committe determin joint committe case registr conform assess bodi parti accept result conform assess procedur conduct conform assess bodi date registr event registr conform assess bodi termin parti accept result conform assess procedur conduct conform assess bodi prior termin prejudic articl articl agreement constru limit author parti measur consid protect health safeti environ prevent decept practic compet author parti visit manufactur facil parti condit parti manufactur facil concern consent visit parti request offici compet author parti join visit purpos decid continu accept confirm manufactur facil concern data gener pursuant articl emerg defin subparagraph paragraph take place visit carri manner inconsist law regul parti accord modal decid pursuant subparagraph paragraph parti inform obtain compet author connect visit purpos definit emerg modal visit refer subparagraph paragraph decid joint committe part preparatori work accord provis relev sector annex articl prejudic articl agreement entail mutual accept standard technic regul parti agreement constru entail oblig parti accept result conform assess procedur member countri agreement constru affect right oblig parti member wto agreement includ wto agreement technic barrier trade wto agreement trade relat aspect intellectu properti right articl agreement appli territori treati establish european commun appli condit laid treati territori japan articl parti disclos inform obtain agreement confidenti requir law regul parti articl agreement enter forc dai month date parti exchang diplomat note inform respect intern procedur give effect agreement complet parti termin agreement give parti month written notic articl sector annex agreement integr part agreement case conflict provis part sector annex articl agreement provis part sector annex prevail provis scope coverag paragraph part sector annex chang parti amend agreement accord sentenc subparagraph paragraph agreement amend agreement parti amend relat law regul administr provis design author compet author part sector annex amend made exchang diplomat note european commun govern japan conform applic domest procedur parti introduc addit conform assess procedur product coverag satisfi requir set applic law regul administr provis relev sector annex part sector annex amend set applic law regul administr provis stipul addit conform assess procedur accord procedur set sentenc subparagraph paragraph articl agreement annex drawn origin danish dutch english finnish french german greek italian portugues spanish swedish japanes languag case diverg english japanes version prevail languag version wit whereof undersign duli authoris sign agreement brussel fourth dai april year thousand european commun gt pic file quot en tif quot gt gt pic file quot en tif quot gt japan gt pic file quot en tif quot gt sector annex telecommun termin equip radio equip part scope coverag sector annex appli conform assess procedur telecommun termin equip radio equip european commun japan subject conform assess procedur conduct conform assess bodi set law regul administr provis parti section part sector annex understood term quot amend quot refer part sector annex includ case parti partial applic law regul administr provis list part sector annex name chang parti repeal applic law regul administr provis list part sector annex adopt law regul administr provis substitut previou law regul administr provis previou name chang parti incorpor relev part applic law regul administr provis list part sector annex law regul administr provis part section applic law regul administr provis stipul telecommun termin equip radio equip gt tabl gt section ii applic law regul administr provis stipul requir conform assess procedur gt tabl gt section iii design author gt tabl gt section iv applic law regul administr provis stipul criteria design gt tabl gt sector annex electr product part scope coverag sector annex appli conform assess procedur electr product european commun japan subject conform assess procedur conduct conform assess bodi set law regul administr provis parti section part sector annex understood term quot amend quot refer part sector annex includ case parti partial applic law regul administr provis list part sector annex name chang parti repeal applic law regul administr provis list part sector annex adopt law regul administr provis substitut previou law regul administr provis previou name chang parti incorpor relev part applic law regul administr provis list part sector annex law regul administr provis part section applic law regul administr provis stipul electr product gt tabl gt section ii applic law regul administr provis stipul requir conform assess procedur gt tabl gt section iii design author gt tabl gt section iv applic law regul administr provis stipul criteria design gt tabl gt sector annex good laboratori practic glp chemic part sector annex appli confirm complianc test facil principl glp test chemic substanc prepar set law regul administr provis parti section part sector annex accept data gener confirm test facil purpos sector annex quot criteria confirm quot principl glp stipul law regul administr provis parti section iii part sector annex consist annex ii oecd council decis final amend oecd council decis novemb final ii quot verif quot mean monitor complianc test facil principl glp procedur studi audit inspect set law regul administr provis parti section iii part sector annex consist oecd council decis recommend octob final annex ii amend oecd council decis march final purpos sector annex term defin agreement mean assign quot oecd principl good laboratori practic quot contain annex ii oecd council decis final quot guid complianc monitor procedur good laboratori practic quot contain annex oecd council decis recommend octob final glp consensu document quot applic glp principl field studi quot oecd seri principl good laboratori practic complianc monitor number amend made thereto understood term quot amend quot refer part sector annex includ case parti partial applic law regul administr provis list part sector annex name chang ii parti repeal applic law regul administr provis list part sector annex adopt law regul administr provis substitut previou law regul administr provis previou name chang iii parti incorpor relev part applic law regul administr provis list part sector annex law regul administr provis make amend law regul administr provis section iii sector annex parti account maintain consist relev decis recommend oecd respect articl agreement parti result accept confirm test facil compet author parti accept data test item gener confirm test facil equival data gener test facil confirm compliant principl glp take account equival glp complianc monitor programm parti consist oecd council decis recommend octob final amend oecd council decis march final provid certif altern document glp complianc statu test facil issu compet author parti accord applic law regul administr provis parti section iii part sector annex attach data test data gener cover principl glp parti pursuant applic law regul administr provis parti list confirm facil refer articl agreement provid agre format includ inform address test facil ii date verif confirm iii glp complianc statu iv area expertis list point appendix annex iii oecd council decis recommend octob final parti extent provid parti addit inform confirm facil reason request parti parti transmit parti delai inform withdraw certif confirm test facil facil found compliant principl glp parti request parti indic write reason doubt studi conduct accord principl glp conduct inspect studi audit confirm test facil accord applic law regul administr provis parti request parti inform request parti result inspect studi audit provid explan inspect studi audit carri request parti oblig accept data gener test facil concern date request made result inspect studi audit conduct compet author request parti confirm complianc test facil principl glp except case doubt persist request parti justifi specif concern parti contest complianc test facil concern accord provis articl agreement part section applic law regul administr provis stipul coverag chemic subject test accord principl glp gt tabl gt section ii compet author gt tabl gt section iii applic law regul administr provis stipul principl glp verif confirm gt tabl gt sector annex good manufactur practic gmp medicin product part sector annex appli confirm complianc gmp requir manufactur facil medicin product gmp requir parti appli accord law regul administr provis parti section part sector annex accept data gener confirm manufactur facil certif issu confirm manufactur facil accord provis part sector annex purpos sector annex term quot medicin product quot mean drug industri manufactur human defin law regul administr provis japan section part sector annex medicin product intermedi product industri manufactur human defin law regul administr provis european commun section part sector annex definit medicin product includ medicin product intend clinic trial activ ingredi chemic biolog pharmaceut immunolog radiopharmaceut stabl medicin product deriv human blood human plasma vitamin miner herbal medicin term quot criteria confirm quot mean gmp requir term quot good manufactur practic gmp quot mean part qualiti assur ensur product consist produc control accord qualiti standard intend requir applic market authoris product specif term quot inspect quot mean site evalu manufactur facil determin manufactur facil oper complianc gmp requir includ requir applic market authoris product specif inspect conduct accord law regul administr provis section part sector annex carri compet author list section ii part sector annex includ pre market post market inspect understood term quot amend quot refer part sector annex includ case parti partial applic law regul administr provis list part sector annex name chang ii parti repeal applic law regul administr provis list part sector annex adopt law regul administr provis substitut previou law regul administr provis previou name chang iii parti incorpor relev part applic law regul administr provis list part sector annex law regul administr provis agreement cover mutual recognit batch releas kentei refer articl pharmaceut affair law law japan batch releas refer articl council direct eec articl council direct eec june respect articl agreement parti result accept confirm manufactur facil carri compet author parti accept medicin product market authoris issu product specif applic certif issu confirm manufactur facil conform batch market authoris product specif exempt import test batch accord law regul administr provis parti section part sector annex take account equival gmp requir parti provid certif issu confirm manufactur facil result full qualit analysi quantit analysi activ constitu test check certif statement product manufactur conform gmp requir parti appli equival gmp requir product certif issu certif issu confirm manufactur facil relat batch export refer paragraph certifi test requir manufactur medicin product accord law regul administr provis parti section part sector annex batch medicin product manufactur requir applic market authoris product specif import parti subcommitte joint committe establish monitor progress preparatori work set paragraph sector annex oper sector annex report joint committe parti exchang inform gmp specif product class product ii technic guidanc inspect procedur iii qualiti defect batch recal counterfeit problem qualiti iv suspens withdraw manufactur authoris parti agre detail alert procedur subcommitte joint committe fulfil specif object sector annex equival gmp specif product class product coordin procedur establish subcommitte joint committe notwithstand articl agreement parti provid parti joint committe list confirm manufactur facil frequenc decid joint committe parti reason request parti provid copi recent inspect report confirm facil dai date request request parti conduct addit inspect parti provid copi report addit inspect request parti dai date request exchang inspect report remain concern manufactur facil parti compli gmp requir parti request parti conduct inspect facil compet author parti request export import compet author parti confirm manufactur facil territori appropri authoris manufactur medicin product accord law regul administr provis section part sector annex ii regularli inspect compet author iii compli gmp requir recognis parti equival regard articl export parti accord applic law regul administr provis inspect period manufactur facil order ensur facil fulfil gmp requir set law regul administr provis parti section part sector annex articl articl relat sector annex provis sector annex paragraph paragraph paragraph appli dai date exchang diplomat note confirm preparatori work complet exchang diplomat note expect place month entri forc agreement preparatori work parti reconfirm equival gmp requir implement joint committe joint committe decid detail procedur implement sector annex part section applic law regul administr provis stipul medicin product gmp requir medicin product verif confirm gt tabl gt section ii compet author gt tabl gt final act undersign repres european commun hereinaft refer quot commun quot part repres japan part meet signatur agreement mutual recognit european commun japan hereinaft refer quot agreement quot sign text agreement includ sector annex relat telecommun termin equip radio equip electr product good laboratori practic glp chemic good manufactur practic gmp medicin product repres commun repres japan made joint declar exchang letter list annex final act joint declar futur negoti agreement mutual recognit european commun japan joint declar intern guid recommend technic compet conform assess bodi cab joint declar facilit market access exchang letter complet sector annex exchang letter preparatori work sector annex gmp medicin product inform exchang exchang letter languag hecho en brusela el cuatro de abril de do mil uno udfærdiget bruxel den fjerd april tusind og en geschehen zu brüssel vierten april zweitausendundein brussel fourth dai april year thousand fait bruxel le quatr avril deux mill fatto bruxel addì quattro april duemilauno gedaan te brussel de vierd april tweeduizendeneen feito em bruxela em quatro de abril de doi mil um tehti brysselissä neljäntenä päivänä huhtikuuta vuonna kaksituhattayksi som skedd bryssel den fjärde april tjugohundraett gt pic file quot en tif quot gt 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 pic file quot en tif quot gt gt pic file quot en tif quot gt gt pic file quot en tif quot gt por el japón japan für japan japan pour le japon il giappon voor japan pelo japão japanin puolesta på japan vägnar gt pic file quot en tif quot gt gt pic file quot en tif quot gt joint declar agreement mutual recognit european commun japan sign agreement mutual recognit european commun japan european commun ec govern japan goj state regard agreement futur negoti agreement mutual recognit european commun japan build agreement goj ec commenc negoti extens sector coverag agreement year date agreement enter forc goj ec express intent commenc negoti medic devic pressur equip period intern guid recommend technic compet conform assess bodi cab goj ec express intent relev guid recommend issu intern standardis bodi indic adequ technic compet cab regard implement applic requir parti agreement facilit market access goj ec recognis signific agreement li promot trade facilit effect market access japan ec regard conform assess product confirm facil cover agreement exchang letter complet sector annex brussel april sir european commun confirm sector annex agreement mutual recognit european commun japan exist parti conform assess complianc procedur relat requir product data cover sector annex accept sir assur highest consider european commun gt pic file quot en tif quot gt gt pic file quot en tif quot gt brussel april sir govern japan confirm sector annex agreement mutual recognit european commun japan exist parti conform assess complianc procedur relat requir product data cover sector annex accept sir assur highest consider govern japan gt pic file quot en tif quot gt exchang letter preparatori work sector annex gmp medicin product inform exchang brussel april sir european commun underlin commit speedi implement preparatori work requir paragraph sector annex gmp medicin product guid task set phase preparatori work compon gmp complianc alert programm reconfirm equival place take account previou experi european commun organis exchang inform includ seminar inter alia cover criteria design criteria confirm come month accept sir assur highest consider european commun gt pic file quot en tif quot gt gt pic file quot en tif quot gt brussel april sir govern japan underlin commit speedi implement preparatori work requir paragraph sector annex gmp medicin product guid task set phase preparatori work compon gmp complianc alert programm reconfirm equival place take account previou experi govern japan organis exchang inform includ seminar inter alia cover criteria design criteria confirm come month accept sir assur highest consider govern japan gt pic file quot en tif quot gt exchang letter languag brussel april sir european commun exchang inform includ gmp inspect report agreement languag summari english agre joint committe matter earli opportun accept sir assur highest consider european commun gt pic file quot en tif quot gt gt pic file quot en tif quot gt brussel april sir govern japan exchang inform includ gmp inspect report agreement languag summari english agre joint committe matter earli opportun accept sir assur highest consider govern japan gt pic file quot en tif quot gt