agreement mutual recognit european commun canada european commun govern canada parti tradit link friendship exist canada european commun basi past experi framework agreement commerci econom cooper european commun canada order develop dialogu area standard declar ec canada relat parti express desir establish formal framework conduct collabor field mutual recognit relat conform assess parti interest strengthen rule govern free unhind intern trade improv condit trade parti mutual recognit test certif mark conform bring recognis import maintain respect high standard health safeti bear mind statu parti agreement establish world trade organis consciou oblig world trade organis agreement technic barrier trade agre articl definit gener term conform assess agreement annex mean definit contain guid edit intern organis standardis intern electrotechn commiss specif defin agreement sector annex addit term definit appli agreement agreement mean framework agreement sector annex conform assess mean systemat examin determin extent product process servic fulfil requir conform assess bodi mean bodi engag perform procedur determin relev requir technic regul standard fulfil design author mean bodi power design monitor suspend design withdraw design conform assess bodi jurisdict design mean authoris design author conform assess bodi perform conform assess activ regulatori author mean govern agenc entiti exercis legal control sale product parti jurisdict enforc action ensur product market jurisdict compli legal requir event inconsist iso iec guid definit agreement annex definit agreement prevail articl ii gener oblig sector annex framework agreement constitut integr part agreement govern canada accept result conform assess procedur includ certif complianc requir canadian legisl regul identifi sector annex produc design conform assess bodi author european commun accord agreement european commun accept result conform assess procedur includ certif complianc requir european commun member state legisl regul identifi sector annex produc design conform assess bodi author canada accord agreement transit rule sector annex rule appli success complet transit phase agreement constru entail mutual accept standard technic regul parti sector annex entail mutual recognit equival standard technic regul articl iii gener coverag agreement agreement appli conform assess procedur product cover sector annex sector annex item statement product scope coverag descript relev legisl regulatori administr provis pertain conform assess procedur technic regul list design conform assess bodi author sourc obtain list list author respons design conform assess bodi sourc procedur criteria descript mutual recognit oblig sector transit plan descript joint sector group sector contact point parti territori guidelin correct action product sector specif rule contain relev sector annex prevail gener provis framework agreement articl iv transit arrang parti agre implement transit commit confid build includ sector annex parti agre sector transit plan time period complet parti amend transit period mutual agreement joint committe establish agreement take account recommend made relev joint sector group passag transit phase condit full mutual recognit proce document evid demonstr lack technic compet parti conform assess articl civil liabil agreement intend chang modifi law territori parti applic civil liabil manufactur distributor supplier conform assess bodi design bodi regulatori author govern consum respect design manufactur test inspect distribut sale product undergon conform assess pursuant agreement parti agre respect conform assess bodi requir make adequ arrang liabil aris oper activ agreement parti joint committe time time respect conform assess bodi continu meet requir interest parti adequ protect parti promptli notifi parti suit proceed threaten commenc territori parti aris connect conform assess perform conform assess bodi parti parti cooper parti investig defenc suit proceed interest parti risk parti render reason assist obtain relev document access materi wit requir investig defenc suit proceed articl vi design author parti ensur design author respons design conform assess bodi sector annex author design monitor suspend withdraw design bodi case suspens design remov suspens design author parti concern immedi inform parti joint committe parti exchang inform procedur ensur design conform assess bodi continu compli legisl regulatori administr provis agreement articl vii conform assess bodi conform assess bodi design territori export parti oper requir import parti fulfil condit elig conform relat requir design bodi design author annex scope conform assess activ bodi design design constitut formal judgment parti conform assess bodi demonstr accept level technic compet provid servic identifi design agre compli requir parti set sector annex accord term sector annex design author make request statement technic compet design conform assess bodi articl viii verif suspens conform assess bodi parti challeng technic compet complianc conform assess bodi jurisdict parti exercis except circumst justifi object reason manner write joint committe joint committe discuss request joint committe initi recommend relev sector group conclus verif technic compet complianc conform assess bodi oper territori parti requir carri time manner parti territori bodi question locat parti jointli agre parti seek assist design author carri verif decid joint committe contest conform assess bodi suspend compet design author time disagr statu bodi confirm joint committe bodi question remain suspend agreement reach joint committe futur statu bodi certif conform document product issu conform assess bodi subsequ remov joint committe design author remain valid specif decis regulatori author base health safeti consider remov product market articl ix exchang inform parti exchang inform implement legisl regulatori administr provis identifi sector annex parti inform parti relat subject matter agreement consider safeti health environment protect requir urgent action notifi parti provis sixti dai entri forc parti promptli notifi parti design author conform assess bodi articl monitor agreement parti hold ad hoc consult joint committe ensur satisfactori function agreement parti request carri behalf audit evalu conform assess bodi work requir request parti request parti bear cost audit interest promot uniform applic conform assess procedur provid law regul parti design conform assess bodi part interpret session conduct regulatori author parti relev area cover sector annex agreement articl xi joint committe establish agreement joint committe parti respons effect function agreement joint committe decis adopt recommend consensu parti meet year decid determin rule procedur establish joint sector group sector annex deleg specif task group parti invit repres joint sector group attend meet joint committe sector interest subject agenda item joint committe matter relat oper agreement respons amend sector annex give effect decis design withdraw design conform assess bodi exchang inform procedur parti ensur conform assess bodi sector annex maintain level compet determin statu conform assess bodi technic compet contest exchang inform notifi parti modif legisl regulatori administr provis refer sector annex address question relat oper agreement sector annex includ question relat health safeti market access balanc right oblig agreement procedur appli inclus withdraw sector annex conform assess bodi parti design withdraw design conform assess bodi forward propos write parti event parti consent propos expiri dai object made inclus withdraw sector annex conform assess bodi effect event parti challeng technic compet complianc propos conform assess bodi dai period joint committe request propos parti carri verif includ audit bodi concern accord provis agreement articl xii joint sector group joint committe establish joint sector group individu sector annex compris design regulatori author expert parti group address specif conform assess regulatori issu relat sector respons joint sector group includ request parti examin specif problem aris implement transit plan mutual recognit give advisori opinion joint committe issu mutual concern furnish inform advic matter relat implement regul procedur conform assess system relat annex request parti review aspect implement oper sector annex includ health safeti aspect issu interpret requir sector annex make recommend joint committe articl xiii sector contact point manag inform assist emerg action parti appoint confirm write name address contact point respons activ sector annex commun confid build activ emerg action regulatori enforc product subject agreement handl directli sector contact point articl xiv safeguard regulatori author parti retain author applic law parti interpret set paragraph enforc respect legisl regulatori provis regulatori author import parti legal repres export parti parti regulatori author reason product parti cover sector annex compromis health safeti person territori fail satisfi requir applic sector annex parti receiv territori retain power applic domest law measur withdraw product market prohibit placement market restrict free movement initi product recal regulatori author territori action inform counterpart joint committe dai take action give reason parti agre border inspect check product certifi import parti requir complet expediti regard inspect relat intern movement respect territori parti agre complet manner favour domest good articl xv market access parti oblig accord mutual recognit term sector annex agreement condit parti continu provid access market product subject conform assess procedur demonstr meet applic technic requir maintain exist legal regulatori author capabl implement provis agreement parti introduc addit conform assess procedur affect sector cover sector annex joint committe parti agre bring procedur scope agreement relev annex implement addit requir conform assess bodi design parti order meet requir recognis parti implement requir parti suspend oblig sector annex question articl xvi fee parti ensur conform assess procedur carri pursuant agreement sector annex fee charg territori conform assess servic provid parti articl xvii agreement countri written agreement parti oblig contain mutual recognit agreement conclud parti countri parti agreement forc effect regard parti articl xviii territori applic agreement annex appli hand territori treati establish european commun appli condit laid treati hand territori canada articl xix entri forc modif durat agreement annex enter forc dai month date parti exchang diplomat note confirm complet respect procedur entri forc agreement agreement amend written agreement parti amend decis termin sector annex made parti joint committe parti add sector annex exchang diplomat note annex effect part agreement dai date parti exchang diplomat note confirm addit annex parti termin agreement give parti month notic write articl xx final provis agreement sector annex drawn origin danish dutch english finnish french german greek italian portugues spanish swedish languag text equal authent hecho en londr el catorc de mayo de mil noveciento noventa ocho udfærdiget london den fjortend maj nitten hundred og otteoghalvfem geschehen zu london vierzehnten mai neunzehnhundertachtundneunzig london fourteenth dai year thousand hundr nineti fait londr le quatorz mai mil neuf cent quatr vingt dix huit fatto londra addì quattordici maggio millenovecentonovantotto gedaan te london de veertiend mei negentienhonderd achtennegentig feito em londr em catorz de maio de mil novecento noventa oito tehti lontoossa neljäntenätoista päivänä toukokuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäkahdeksan som skedd london den fjortond 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 el gobierno de canadá canada reger für die regierung kanada govern canada pour le gouvern du canada il governo del canada voor de reger van canada pelo governo canadá kanadan hallituksen puolesta på kanada reger vägnar gt refer graphic gt sector annex telecommun termin equip inform technolog equip radio transmitt purpos purpos annex establish framework accept test report end transit period certif conform issu territori parti accord regulatori requir parti referenc attach annex constitut sector annex framework agreement mutual recognit canada european commun scope coverag provis annex appli type telecommun termin equip radio transmitt inform technolog equip equip intend connect public telecommun network order send process receiv inform equip connect directli termin network interwork network connect directli indirectli termin point system connect wire radio optic electromagnet mean equip capabl connect public telecommun network intend purpos includ inform technolog equip commun port categori radio transmitt defin attach list interfac servic cover parti referenc attach parti agre illustr exhaust list cover categori radio transmitt short rang devic includ low power devic cordless telephon microphon land mobil includ privat mobil radio pmr pamr mobil telecom page system terrestri fix satellit mobil satellit fix broadcast radio determin approv requir annex appli mandatori approv requir adopt territori parti govern organis bodi legal power enforc technic requir equip referenc attach relev technic requir legisl referenc attach requir conform assess procedur appli domest product appli addit requir variat product conform assess result origin parti conform assess activ parti affirm conform assess bodi recognis annex authoris perform activ regard technic requir telecommun termin equip radio transmitt inform technolog equip termin attach radio transmiss requir test issu accept test report perform requir technic evalu certif complianc requir law regul applic territori parti product cover annex electromagnet compat emc recognit certif complianc supplier declar technic construct file requir detail provis sector annex enc electr safeti low voltag accept test certif cover product electr safeti requir parti detail provis sector annex electr safeti qualiti manag recognit parti qualiti manag certif accord regulatori requir parti certif conform deliv design conform assess bodi parti provis annex recognis author parti assess product institut design author design author author organis respons design assur compet conform assess bodi test certifi equip cover annex requir parti design author purpos annex list attach design author seek servic accredit system carri respons parti notifi ten work dai ident design author author carri oblig annex design conform assess bodi purpos annex parti design compet conform assess bodi carri conform assess requir parti parti ensur design bodi compli criteria standard set regulatori requir parti make design parti product procedur design list design bodi indic product procedur design includ attach conform assess bodi design annex recognis compet perform conform assess activ design design suspens withdraw conform assess bodi annex conform procedur determin joint committe establish framework mutual recognit agreement complaint circumst aris conform assess bodi abil perform annex design author action mutual satisfact parti problem consid joint committe establish framework mutual recognit agreement order reach solut transit arrang transit period month provis annex notabl section fulli oper transit period parti exchang inform develop understand respect regulatori requir develop mutual agre mechan exchang inform technic requir method design conform assess bodi monitor evalu work carri design conform assess bodi oper transit period transit period parti reciproc recognis test report relat document issu design conform assess bodi parti accord provis annex end approv author list attach accept test report relat document evalu design bodi territori parti purpos approv impos addit requir 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 equip modifi subsequ determin complianc limit procedur determin continu conform requir conform assess procedur appli domest product appli addit requir variat product test result origin parti approv author commit issu approv advis applic week receipt test report evalu design bodi territori parti end transit period parti proce full mutual recognit certif complianc issu design bodi parti propos made end transit period limit scope recognit design conform assess bodi exclud list bodi design annex base object criteria document bodi appli reconsider correct action extent parti implement action prior expiri transit period addit provis subcontract subcontract accord subcontract requir parti conform assess bodi record retain detail investig compet complianc subcontractor maintain regist subcontract detail parti request post market surveil purpos post market surveil parti maintain exist label number requir assign number place territori export parti number alloc import parti report misus mark conform hazard involv approv product cover annex occur parti jointli determin scope misus natur degre correct action joint telecommun group joint committe establish framework mutual recognit agreement appoint joint telecommun group meet requir discuss technic conform assess technolog issu relat annex exchang inform mutual assist parti establish contact point provid answer reason inquiri parti procedur regul complaint provid transit arrang set section parti jointli sponsor seminar canada european commun relev technic product approv requir year annex enter forc parti inform relev regul specif test method standard administr procedur thirti work dai domest notif regulatori updat annex event regul referenc attach introduct regul affect conform assess procedur take place parti parti updat annex cross referenc product cover annex subject electr safeti emc requir relev provis sector annex electr safeti emc appli attach legisl regulatori administr provis gt tabl gt attach coverag gt tabl gt attach design author gt tabl gt attach design conform assess bodi give address telephon fax number contact point product standard conform assess procedur design made refer legisl requir parti attach approv author gt tabl gt appendix radio transmitt standard list radiocommun regul gt tabl gt gt tabl gt addit radio standard specif found broadcast regulatori section index gt tabl gt gt tabl gt sector annex electromagnet compat emc scope coverag provis annex appli electromagnet compat equip defin council direct eec approxim law member state relat electromagnet compat amend thereto electromagnet compat equip regul section canadian radiocommun act requir relev technic requir legisl regul referenc attach requir conform assess procedur appli parti domest product appli addit requir variat product conform assess result origin parti conform assess activ parti agre recognis parti report certif technic construct file requir respect legisl assess product parti agre recognis supplier declar complianc requir respect legisl institut design author design author purpos annex list attach parti notifi ten work dai ident design author author carri oblig annex design conform assess bodi conform assess bodi design annex recognis compet perform conform assess activ emc parti ensur design bodi compli criteria standard set regulatori requir parti list design bodi includ attach design suspens withdraw conform assess bodi annex conform procedur determin joint committe establish framework mutual recognit agreement transit arrang mutual recognit provis annex notabl section effect month entri forc annex period sign agreement come effect parti work enhanc respect familiar regulatori requir exchang inform review work carri design conform assess bodi demonstr satisfact capabl carri conform assess requir parti addit provis subcontract subcontract conform assess accord subcontract requir parti conform assess bodi record retain detail investig compet complianc subcontractor maintain regist subcontract detail promptli parti request post market surveil purpos post market surveil parti establish label number mark requir assign number affix label mark place territori export parti exchang inform mutual assist parti establish contact point provid answer reason inquiri parti procedur regul complaint parti inform relev regul specif test method standard administr procedur thirti work dai domest notif regulatori updat annex event technic regul conform assess procedur referenc attach event introduct regul jurisdict parti parti updat annex cross referenc product cover annex subject electr safeti radio telecommun attach requir relev provis sector annex electr safeti telecommun termin equip inform technolog equip radio transmitt appli attach legisl regulatori administr provis gt tabl gt attach design author design author canada industri canada design author european commun belgium ministèr de affair économiqu ministeri van economisch zaken denmark telecommun equip telestyrelsen equip danmark elektrisk materielkontrol demko germani bundesministerium für wirtschaft greec ministri transport commun spain telecommun equip ministerio de fomento equip ministerio de industria energía franc ministèr de économi de financ de industri ireland depart transport energi commun itali ministero dell industria del commercio dell artigianato luxembourg ministèr de transport netherland de minist van verkeer en waterstaat austria telecommun equip bundesministerium für wissenschaft und verkehr equip bundesministerium für wirtschaftlich angelegenheiten portug instituto da comunicaçõ de portug finland telecommun equip liikenneministeriö trafikministeriet equip kauppa ja teollisuusministeriö handel och industriministeriet sweden author govern sweden styrelsen för ackredit och teknisk kontrol swedac unit kingdom depart trade industri attach design conform assess bodi give address telephon fax number contact point product standard conform assess procedur design made refer legisl requir parti appendix interfer caus equip standard gt tabl gt sector annex electr safeti purpos purpos annex establish framework accept electr product recognit conform assess carri bodi compli requir parti maintain integr safeti system parti annex set procedur recognit conform assess bodi cab canada european commun ec cab ec canada scope coverag access ec safeti electr equip fall scope low voltag direct council direct eec februari amend direct eec access canada low voltag electr equip includ medic devic cover canadian electr code product specif exclud low voltag direct medic devic legisl regulatori administr requir applic parti regulatori author respons electr safeti list attach respons design author author set attach organis public author respons assur compet control cab certifi electr equip territori requir parti transit phase transit arrang oper term eighteen month time mra enter forc purpos transit phase provid respons design author opportun build confid understand procedur recognis cab abil bodi carri mandat success complet transit phase result determin respons author nomin cab compli applic criteria compet conduct conform assess activ accept parti transit phase author jointli sponsor seminar canada ec relev technic product approv requir oper transit phase transit phase canadian cab accept test report relat document issu nomin cab territori commun cab satisfi requir particip intern electrotechn commiss iec scheme iece recognit result test standard safeti electr equip certif bodi cb scheme iec system conform test standard safeti electr equip iece defin iece document contractu arrang accept test data certif organis accredit standard council canada transit phase commun cab test product canadian requir issu comprehens test evalu file assess data report submiss manufactur test product certif organis canada canadian certif organis ensur inform applic commun cab precis complet manner defici limit request addit inform sampl omiss inconsist varianc technic regul standard certif basi exist procedur includ applic mark mark conform transit phase joint committe develop mutual accept mechan procedur mark product export canada order conform canadian requir mark control cab recognis respons design author provid traceabl give suffici inform consum give rise confus mark conform access ec market ce mark appli oper phase oper phase parti proce full mutual recognit result conform assess activ requir respect legisl cab recognis respons design author oper access ec market product challeng low voltag direct report drawn canadian cab recognis agreement consid ec report drawn european notifi bodi access canadian market cab ec accredit accord standard council canada scc criteria accredit certif bodi recognis canada issu certif accredit condit deem equival prescrib criteria evid satisfactori perform transit phase ii accredit european accredit organis applic relev iso iec guid adapt canadian european condit accredit certif organis iii evid procedur follow certif activ includ identif contact point respons initi action manufactur product parti encourag establish mutual recognit agreement european accredit organis scc entri forc oper phase inclus addit cab accord rule set framework agreement annex limit scope denial recognit purpos certif request cab requir provid addit documentari evid facilit passag transit oper phase event propos made end transit phase request respons design author limit scope recognit design cab exclud list bodi accredit design accord procedur outlin framework agreement propos base object reason properli document write joint committe cab grant limit recognit deni recognit appli evalu correct action follow certif activ author parti attach retain question perform cab oper context annex reason request author parti request copi certif report prepar requir territori export parti report provid promptli charg cab place plan action certif client enabl withdraw conform hazard product market place plan identifi contact point respons initi action manufactur product question joint electr safeti group joint committe establish mutual recognit agreement appoint joint electr safeti group jesg group jesg consist equal number repres canada ec group review issu concern parti refus request address issu group issu recommend joint committe concern rais repres canada ec group establish rule procedur decis adopt recommend consensu parti categori equip phenomena scope direct electr equip explos atmospher electr equip radiolog medic purpos electr part good passeng lift electr meter plug socket outlet domest electr fenc control radio electr interfer specialis electr equip ship aircraft railwai compli safeti provis drawn intern bodi member state particip attach legisl regulatori administr requir regulatori author articl gt tabl gt attach design author author respons design conform assess bodi agreement european commun belgium ministèr de affair économiqu ministeri van economisch zaken denmark boligministeriet germani bundesministerium für arbeit und sozialordnung greec ministri develop spain ministerio de industria energía franc ministèr de économi de financ de industri ireland depart enterpris employ itali ministero dell industria del commercio dell artigianato luxembourg ministèr de transport netherland staat der nederlanden austria bundesministerium für wirtschaftlich angelegenheiten portug author govern portug instituto portuguê da qualidad finland kauppa ja teollisuusministeriö handel och industriministeriet sweden author govern sweden styrelsen för ackredit och teknisk kontrol swedac unit kingdom depart trade industri canada standard council canada feder crown corpor establish act parliament amend sector annex recreat craft section scope coverag annex appli recreat craft includ person watercraft european commun canada subject conform assess approv procedur independ conform assess approv bodi product coverag determin relev legisl parti european commun recreat craft defin articl direct ec canada pleasur craft defin canada ship act chapter small vessel regul referenc transport canada public tp parti agre mutual recognit oper annex arrang evalu european commun requir conform assess bodi design canada establish certif complianc provis direct ec certif recognis european commun assess product relat approv canadian requir conform assess bodi design european commun certifi product requir set chapter canada ship act small vessel regul issu complianc plate requir document product certifi canadian market undergo approv procedur section ii legisl regulatori administr requir european commun direct ec european parliament council june approxim law regul administr provis member state relat recreat craft canada regulatori requir canada ship act chapter small vessel regul referenc transport canada public tp construct standard small vessel includ person watercraft defin certifi iso di section iii author respons design conform assess bodi conform assess modul european commun member state administr entiti attach canada canadian coastguard section iv procedur design conform bodi purpos annex parti design compet conform assess bodi carri conform assess approv requir parti design carri procedur set mutual recognit framework agreement list design conform assess bodi product procedur design attach parti accept design conform assess bodi compli requir bodi establish parti european commun bodi notifi bodi accord direct ec deem complianc canadian requir notifi bodi ec 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 canada procedur criteria design conform assess bodi compli relev provis direct ec section transit arrang transit arrang month prior oper annex transit period parti exchang inform develop greater familiar respect regulatori requir carri polici legisl regulatori provis annex section vi addit provis accord relev provis mutual recognit framework 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 equip electromagnet compat appli attach design author gt tabl gt attach design conform assess bodi european commun notifi bodi notifi member state european commun name refer number publish offici journal european commun canada determin sector annex good manufactur practic gmp purpos mutual recognit agreement mra sector annex good manufactur practic gmp complianc certif pertain medicin product drug develop european commun ec canada enhanc bilater regulatori cooper establish mutual recognit gmp complianc certif accept manufactur authoris licenc directli issu author design equival success complet confid build exercis develop infrastructur commun consult canada european commiss regulatori author ec member state enabl regul determin maintain equival gmp complianc programm gener consider underli premis mra gmp complianc certif demonstr canada ec member state equival gmp complianc programm issuanc certif manufactur authoris licenc author parti certifi facil complianc gmp evid requir parti accept facil complianc manufactur control medicin drug product issu similar certif manufactur authoris licenc understood equival ident lead result accept author certif manufactur authoris licenc issu author depend success complet confid build exercis evalu result certif author gmp complianc programm includ support infrastructur regulatori requir standard process qualiti system mutual recognis equival accept mra medicin product drug gmp built pillar concept gmp complianc programm appendix alert system appendix transit period includ confid build exercis appendix scope coverag provis annex cover medicin product drug undergon seri manufactur process es fabric repackag label test wholes activ canada european commun good manufactur practic gmp requir appli jurisdict recognit limit manufactur process es carri subject inspect respect territori parti annex appli voluntari basi product cover legisl parti agre author concern product coverag determin relev legisl parti appendix name legisl indic list product concern purpos annex gmp includ system manufactur receiv specif product process market authoris ma drug identif number din licenc holder applic ensur product made complianc specif equival qualifi person certif ec good manufactur practic gmp part qualiti assur ensur product consist produc control qualiti standard intend requir market authoris product specif assign procedur drug identif number licenc product process orient inspect carri parti request parti pre approv inspect parti agre exchang pre approv inspect report extent requir import parti law regul purpos respect product approv procedur lot lot releas biolog exclud agreement confidenti parti protect public disclosur public confidenti technic commerci scientif inform includ trade secret proprietari inform provid parti parti reserv make public result conform assess includ conclus inspect report provid parti situat public health safeti affect manag mechan joint sector group establish purpos manag sector agreement joint sector group establish composit determin rule procedur role appendix group includ repres therapeut product programm health canada european commiss relev ec author chair member parti resolut diverg view diverg view resolv author refer joint sector group resolut case inabl joint sector group resolv diverg view parti bring matter attent joint committe transit period time frame confid build period commenc sign mra expect complet month confid build programm begin transit period joint sector group elabor joint confid build programm implement programm permit determin capabl parti author perform gmp complianc certif guidanc provid appendix budget parti mra respons cost particip confid build activ administr provis medicin product drug manufactur site good track record complianc import parti list qualifi site exempt retest requir list develop joint sector group end transit period end transit period joint sector group proce joint evalu equival capabl complianc programm particip author appendix determin equival parti gmp complianc programm list appendix end transit period propos limit recognit equival author exclud appendix base object criteria document evid author appendix specif categori manufactur process biolog radiopharmaceut exclud author includ manufactur process appli consider statu correct measur oper phase gener provis european commun canada agre medicin product drug cover annex parti recognis conclus gmp complianc programm carri parti territori relev certif manufactur authoris licenc grant deem equival author parti list appendix addit certif manufactur conform batch recognis parti control import manufactur locat canada member state european commun relev author list appendix includ relev categori manufactur process inspect carri author list appendix batch complianc certif issu procedur recognis parti provid equival enforc procedur facil subsequ ensur case complianc respect medicin product drug cover pharmaceut legisl import parti export local compet inspect servic carri inspect relev manufactur oper inspect gmp relev absenc specif gmp requir applic gmp import parti case local applic gmp consid equival term qualiti assur finish product gmp import parti provis appli manufactur activ pharmaceut ingredi intermedi product product intend clinic trial respons author cover annex ensur suspens withdraw total partial manufactur authoris affect protect public health commun parti degre urgenc defin alert programm contact point agre parti permit author manufactur inform author parti speed case qualiti defect batch recal counterfeit problem qualiti necessit addit control suspens distribut product certif manufactur request export import author parti author respons grant certif manufactur authoris licenc supervis manufactur medicin product drug certifi site manufactur control appropri authoris manufactur control relev medicin product drug carri relev oper regularli inspect author compli gmp requir recognis equival parti certif manufactur authoris licenc identifi site manufactur canadian european commun certif attach appendix illustr purpos certif manufactur authoris licenc issu expediti time exce dai case inspect carri period extend dai batch certif batch export accompani batch certif issu manufactur certif full qualit quantit analysi activ constitu ensur qualiti product compli requir market authoris product approv issu certif manufactur account provis current certif scheme qualiti medicin product drug move intern commerc certif attest batch meet specif manufactur accord relev market authoris product approv detail specif product analyt method referenc analyt result obtain statement batch process packag record review found conform gmp batch certif sign person respons releas batch sale suppli european commun qualifi person refer articl direct eec canada nomin person respons manufactur qualiti control food drug regul divis section fee regim inspect establish licenc fee determin locat manufactur cost recoveri programm fee pertain issuanc manufactur authoris licenc jurisdict remain respons jurisdict parti endeavour ensur fee impos servic cost orient account relev cost factor servic render parti fee charg parti reserv conduct inspect reason identifi parti inspect notifi advanc parti option join inspect recours safeguard claus except decis suspend revok licenc rest issu parti inform share accord gener provis annex parti exchang inform determin maintain equival gmp complianc programm addit relev author canada ec inform technic guidanc inspect procedur regul includ guidanc document public refer standard form document relat applic legal requir parti consult adopt ensur continu equival gmp complianc programm concern rais joint sector group reason request relev inspect servic forward copi inspect report manufactur control site case analyt oper contract request concern full inspect report detail report full inspect report compris site master file compil manufactur inspector narr report inspector detail report respond specif queri firm parti parti ensur inspect report forward dai period extend dai inspect carri alert system joint sector group ensur effici effect alert system place time element system appendix respons author cover annex ensur suspens cancel total partial certif complianc commun relev author degre urgenc parti notifi parti confirm problem report correct action recal relat product cover scope annex parti respond special request inform ensur author make relev inform request contact point identifi appendix monitor agreement continu monitor gmp complianc programm determin equival conclus confid build period subsequ decis equival made mutual develop manag equival mainten programm programm manag joint sector group parti undertak hold regular consult auspic joint sector group set annex ensur continu relev accuraci annex canada member state author organis meet discuss specif question issu author particip mainten activ establish joint sector group order maintain statu list appendix appendic appendic constitut integr part annex appendic gener guidelin appendix list applic legisl european commun direct eec modifi direct eec modifi direct eec modifi direct eec modifi direct eec modifi regul ec direct eec guid good distribut practic current version guid good manufactur practic volum iv rule govern medicin product european commun canada food drug act regul health anim act regul issuanc permit materi anim origin indic list product recognis precis definit medicin product drug found legisl refer indic list product cover agreement human pharmaceut includ prescript prescript drug medicin gase human biolog includ vaccin stabl medicin product deriv human blood human plasma biotherapeut immunolog human radiopharmaceut veterinari pharmaceut includ prescript prescript drug pre mix prepar veterinari medic feed vitamin miner herbal remedi homeopath medicin product activ pharmaceut ingredi bulk pharmaceut nb api gmp regul appendix author european commun gt tabl gt canada therapeut product programm health canada ottawa bureau veterinari drug food director health canada ottawa appendix joint sector group joint sector group jsg establish manag confid build process monitor oper mra jsg chair member parti determin composit ensur great degre consist membership role jsg ensur commun joint committe manag transit period monitor continu implement annex includ limit make decis activ requir defin establish equival complianc programm alert system assess result confid build exercis determin regulatori author deem equival jsg prepar list equival regulatori agenc provid recommend joint committe provid direct expert conduct evalu respect gmp complianc programm undertak joint activ inspect workshop make decis arrang mra mainten programm jsg meet need adopt confid build work plan resolv issu monitor progress confid build exercis joint committe inform agenda conclus meet progress made transit period appendix compon gmp complianc programm legisl regulatori requir scope empow legisl regul includ author enforc law regul power inspector conduct inspect author remov viol product market suitabl control conflict interest regulatori direct polici procedur design inspector enforc polici guidelin procedur inspect inspect correct action code conduct ethic train certif polici guidelin alert crisi manag polici procedur guidelin organis structur includ role respons report relationship good manufactur practic gmp standard scope detial gmp control manufactur drug product process valid requir inspect resourc staf initi qualif certif inspector number inspector relat size industri hous contract parti train certif programm process frequenc train qualiti assur mechan ensur effect train programm inspect procedur pre inspect inspect post inspect activ inspect strategi type scope schedul focu inspect notif inspect risk base inspect pre inspect prepar requir format content inspect report includ support tool hardwar inspect methodolog access review firm file databas collect evid data review sampl collect interview standard oper procedur sop inspect post inspect activ procedur report issuanc follow decis make storag inspect data inspect perform standard frequenc number inspect qualiti timeli inspect report norm frequencyprocedur inspect correct action enforc power procedur provis written notic violat firm complianc manag procedur mechan recal suspens quarantin product licenc revoc seizur prosecut appeal mechan measur promot voluntari complianc firm alert crisi system alert mechan crisi manag mechan alert perform standard appropri timeli alert analyt capabl access laboratori capac handl analysi standard oper procedur sop analyt support process valid analyt method surveil programm measur firm regulatori author sampl audit procedur recal monitor includ effect control verif procedur consum complaint system procedur advers reaction report system procedur drug product defect report system procedur qualiti manag system qualiti manag assur system procedur ensur ongo suitabl effect polici procedur guidelin system achiev object gmp complianc programm includ establish standard annual audit review appendix compon alert programm document definit 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 technic question exchang inspect report inspector train session technic requir canada director gener therapeut product programm health canada floor health protect build al tunnei pastur ottawa ontario ol canada tel fax european commun director european agenc evalu medicin product westferri circu canari wharf london hb unit kingdom tel fax appendix phase confid build period determin equival gmp complianc programm joint sector group design phase review evalu document exchang document legal instrument regul legisl direct guidelin gmp inspect programm scope polici direct procedur crisi manag system scope criteria polici direct procedur requir inspect report analyt laboratori system alert report evalu process procedur audit system procedur exchang evalu report monitor alert system includ handl recal joint inspect manufactur determin equival inspect method exchang inspector organis joint workshop option decis make success exercis conclus evalu result confid build exercis action develop option solut address issu determin compet agenc meet evalu criteria establish condit mechan mainten certif programm develop qualiti manag system audit mechan consult dialogu process appendix certif pharmaceut manufactur framework agreement mutual recognit canada european commun sector annex medicin product gmp inspect batch certif gt start graphic gt request date refer compet author confirm compani legal regist address authoris 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 canada european commun date compet author signatur offic respons insert export import firm health canada insert european commun member state european commun requir delet appli gt end graphic gt gt refer graphic gt gt refer graphic gt gt start graphic gt health santé canada canada establish licenc licenc number numéro de la licenc produit thérapeutiqu therapeut product licenc établiss licenc issu accord food drug act amp regul divis amp activ categori drug cett licenc est délivré conformé la loi aux règlement sur le aliment drogu titr pour le activité le catégori de drogu suivant steril stérile pharmaceut prod pharmaceutiqu vaccin vaccin blood sang schedul annex schedul annex fabric manufactur packag label embal étiquet test test distribut distribu import import wholesal vendr en gro perform test includ examin requir divis analys conformé au titr distribut set paragraph distribu au sen de alinéa ou blood compon sang entier se compos drug list schedul act vaccin blood compon drogu visé annex de la loi autr qu vaccin ou le sang entier se compos drug list schedul act drogu visé annex de la loi drug list schedul part food drug regul drug list schedul food drug regul narcot defin section narcot control regul drogu visé annex de la parti de règlement sur le aliment drogu drogu visé annex de règlement sur le aliment drogu stupéfiant au sen de articl de règlement sur le stupéfiant issu émise le minist health ministr de la santé countersign director gener therapeut product director contresigné par directeur général direct de produit thérapeutiqu licenc properti therapeut product director return demand cett licenc apparti la direct de produit thérapeutiqu doit être retourné sur demand gt end graphic gt gt refer graphic gt gt refer graphic gt gt start graphic gt health santé canada canada establish licenc licenc number numéro de la licenc produit thérapeutiqu therapeut product licenc établiss licenc issu accord food drug act amp regul divis amp activ categori drug cett licenc est délivré conformé la loi aux règlement sur le aliment drogu titr pour le activité le catégori de drogu suivant steril stérile pharmaceut prod pharmaceutiqu vaccin vaccin blood sang schedul annex schedul annex fabric manufactur packag label embal étiquet test test distribut distribu import import wholesal vendr en gro perform test includ examin requir divis analys conformé au titr distribut set paragraph distribu au sen de alinéa ou blood compon sang entier se compos drug list schedul act vaccin blood compon drogu visé annex de la loi autr qu vaccin ou le sang entier se compos drug list schedul act drogu visé annex de la loi drug list schedul part food drug regul drug list schedul food drug regul narcot defin section narcot control regul drogu visé annex de la parti de règlement sur le aliment drogu drogu visé annex de règlement sur le aliment drogu stupéfiant au sen de articl de règlement sur le stupéfiant licenc subject addit condit attach cett licenc est assujetti aux condit supplémentair indiqué dan le feuillet ci joint foreign site annex annex concern le site étranger issu émise le minist health ministr de la santé countersign director gener therapeut product director contresigné par directeur général direct de produit thérapeutiqu licenc properti therapeut product director return demand cett licenc apparti la direct de produit thérapeutiqu doit être retourné sur demand gt end graphic gt gt refer graphic gt gt refer graphic gt gt start graphic gt health santé canada canada establish licenc licenc number numéro de la licenc produit thérapeutiqu therapeut product licenc établiss foreign site annex annex concern le site étranger site consid gmp complianc le site suivant sont considéré comm étant conform aux bpf compani nom de entrepris street rue citi vill countri pai activ activit fabric fabric packag conditionn categori catégori pharmaceut médicament steril stérile gt end graphic gt sector annex medic devic purpos mutual recognit agreement mra annex conform assess complianc certif pertain medic devic develop european commun canada enhanc bilater medic devic regulatori cooper facilit global trade maintain high standard health safeti jurisdict annex call develop infrastructur commun consult regulatori design author conform assess bodi parti enabl regul determin maintain equival medic devic conform assess capabl develop cooper approach post market vigil scope coverag annex appli medic devic canada european commun subject conform assess procedur includ scientif technic evalu high risk medic devic qualiti system assess conform assess bodi product coverag determin relev legisl parti european commun council direct eec june approxim law member state relat activ implant medic devic amend council direct eec june medic devic canada food drug act medic devic regul propos promulg amend time time canadian electr code relat medic devic radiat emit devic act regul amend time time relat medic devic appli product vitro diagnost medic devic devic incorpor integr part substanc separ consid medicin product breast implant medic devic incorpor tissu human anim origin medic devic incorpor tissu anim origin devic intend contact intact skin includ scope sector annex parti decid common agreement extend applic annex aforement medic devic confidenti parti protect public disclosur public confidenti technic commerci scientif inform includ trade secret proprietari inform provid parti parti reserv make public result conform assess report situat public health affect resolut diverg view diverg view resolv regulatori author refer joint sector group resolut event joint sector group unabl resolv diverg view parti bring matter attent joint committe manag mechan joint sector group establish purpos manag sector annex role make decis definit establish evalu conform assess procedur programm establish alert programm manag confid build period definit mainten programm support continu oper mra group includ repres health canada european commun compet author chair member parti transit period time frame confid build period commenc sign mra expect complet month confid build programm begin transit period joint sector group elabor joint confid build programm guidanc provid attach iii implement programm establish parti capabl perform conform assess complianc requir procedur parti evid provid practic relev decis oper phase confid build programm includ action activ organis seminar aim inform regulatori design author conform assess bodi parti regulatori system procedur requir conduct workshop aim provid regulatori design author common understand exchang inform requir procedur design surveil conform assess bodi cab scientif technic evalu inter comparison exercis consist parallel evalu doubl blind evalu made conform assess bodi territori manufactur technic submiss requir intend market devic undertaken full report recommend exchang comparison certif complianc issu bodi respons relev market inter comparison studi inter comparison studi place sampl basi compris suffici number case spread rang medium high risk technolog involv parti regulatori design author cab addit evid respect compet regulatori design author cab request parti qualiti system assess inter comparison exercis consist particip regulatori design author audit carri cab parti basi requir parti audit manag method report compar inter comparison studi place sampl basi compris suffici number case spread rang technolog involv parti regulatori design author cab addit evid respect compet regulatori design author cab request parti design develop test alert system guidanc attach iv establish contact point regulatori design author cab parti particip inform exchang meet focu conform assess vigil includ particip staff train session exchang staff encourag confid build programm parti develop suffici confid evalu method result discret establish relev document complianc permit market access jurisdict base evalu report parti full submiss particip activ referenc understood mean provid exemplari basi supplementari evid relat process design surveil cab budget parti mra respons cost particip confid build activ end transit period month entri forc agreement joint sector group proce joint evalu experi gain evalu cover adequaci confid build programm capabl regulatori design author capabl design conform assess bodi recommend list cab attach ii annex made particip regulatori design author list attach joint sector group basi result confid build programm conform assess bodi accept joint sector group list attach ii indic specif conform assess expertis field medic devic technolog recognis regulatori design author respons cab list attach ii propos limit recognit capabl cab base object evid document joint sector group recommend cab list attach ii provid document evid demonstr lack capabl exclud cab appli reconsider statu correct measur confirm agreement matter reach joint sector group matter refer joint committe framework agreement parti enter oper phase provid represent parti cab attach ii agreement examin end transit period account regulatori evolut parti consider singl submiss evaluationqu system assess simultan satisfi requir jurisdict oper phase gener oblig provis section appli conform assess carri parti respect territori conform assess bodi recognis sector annex european commun canada agre medic devic cover annex parti recognis conclus conform assess carri parti certif complianc grant conform assess bodi parti reassess evalu european requir health canada conform assess bodi design canada establish conclus complet conform assess refer activ implant medic devic medic devic direct issu certif complianc respons author european commun reassess accept certif evid complianc premarket requir relev european direct evalu canadian requir european cab establish conclus examin submit health canada abbrevi support report certif complianc includ conclus base document reassess health canada accept certif evid complianc premarket requir canadian medic devic regul parti make parti reason request inform review part assess medic devic purpos issu certif complianc parti reserv time question inform respect design process perform conform assess requir regulatori regim parti reserv conduct conform assess reason identifi parti justif action base document evid notif provid advanc parti recours action except procedur design cab procedur design author parti design cab respect criteria laid parti regul guidelin bind guidanc provid attach inform share accord gener provis annex parti exchang inform determin maintain equival conform assess procedur addit parti share parti inform gener framework regulatori system relev oper conform assess procedur guidanc document public refer standard form document relat applic legal requir parti associ regulatori design author conform assess bodi parti activ exchang inform experi special case emerg situat involv implement annex endeavour provid document request parti expediti manner alert system joint sector group ensur effici effect alert system place time element system attach iv parti notifi parti confirm problem report correct action recal relat product evalu term agreement parti respond special request inform devic ensur design author conform assess bodi make relev inform devic request respons regulatori author cover annex ensur suspens cancel total partial certif complianc commun degre urgenc fee regim registr conform assess fee determin locat manufactur cost recoveri programm fee pertain issuanc certif complianc jurisdict remain respons jurisdict conform assess fee charg parti manufactur locat territori parti conform assess conduct conform assess bodi locat parti territori monitor agreement continu monitor equival design process conform assess parti requir determin equival conclus confid build programm subsequ decis equival made mutual develop manag equival mainten implement activ manag joint sector group parti undertak hold regular consult joint sector group set annex ensur continu relev accuraci annex regulatori design author conform assess bodi organis meet discuss specif question issu conform assess bodi regulatori design author continu particip mainten activ establish joint sector group framework annex order maintain statu annex attach ii parti request addit regulatori design author conform assess bodi attach ii procedur accept regulatori design author confid build programm conform assess bodi ad attach ii recommend regulatori design author joint decis joint sector group contact point contact point identifi order permit regulatori author manufactur inform regulatori author parti speed case qualiti defect recal advers incid necessit addit control suspens distribut product suspens cancel certif complianc purpos agreement contact point gt start graphic gt canada european commun member state commiss gt end graphic gt attach attach ii constitut integr part annex attach iii iv gener guidelin attach regulatori design author elig particip agreement gt tabl gt attach ii gt tabl gt attach iii phase element confid build programm review evalu element conform assess exchang document legisl regulatori requir scope empow legisl regul includ author enforc law regul power evalu auditor author remov viol product market suitabl control conflict interest regulatori direct polici procedur determin compet evalu auditor enforc polici guidelin procedur code conduct ethic train certif polici guidelin alert crisi manag polici procedur guidelin organis structur includ role respons report relationship qualiti audit manag methodolog practic scope detail oper standard auditor qualif number train qualiti assur contract scientif technic evalu methodolog practic scope detail oper standard evalu qualif number train qualiti assur contract evalu audit report scope format report content requir storag retriev access report scope format abbrevi report conclus conform assess certif audit evalu procedur audit evalu strategi type scope schedul focu notif risk pre audit evalu prepar requir methodolog access review firm file databas collect evid data review sampl collect interview post audit evalu activ procedur report issuanc follow decis make collect storag access data audit evalu perform standard frequenc number qualiti timeli report norm frequenc procedur audit evalu correct action enforc power procedur provis written notic violat firm complianc manag procedur mechan recal suspens quarantin product certif revoc seizur prosecut appeal mechan measur promot voluntari complianc firm alert crisi system alert mechan crisi manag mechan alert perform standard appropriatio timeli alert analyt capabl access laboratori capac handl analysi standard oper procedur analyt support process valid analyt method surveil programm measur manufactur regulatori author sampl audit procedur recal monitor includ effect control verif procedur consum complaint system procedur advers incid report system procedur qualiti manag system qualiti manag assur system procedur ensur suitabl effect polici procedur guidelin system achiev object conform assess programm includ establish standard annual audit review inter comparison exercis audit system procedur conduct parallel evalu doubl blind criteria clinic trial data exchang evalu report monitor alert system includ handl recal joint audit manufactur determin equival audit method exchang evalu auditor organis joint workshop option decis make success inter comparison studi evalu result action develop option solut address issu determin compet conform assess bodi meet evalu criteria establish condit mechan mainten mra develop qualiti manag system audit mechan consult dialogu process attach iv compon alert programm document definit 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 access manufactur submiss advers incid report conform assess bodi report establish contact point report mechan enforc procedur follow mechan correct action procedur qualiti assur system vigil programm surveil monitor implement correct action attach guidelin 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 capabl 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 capabl 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 capabl design author appli process determin technic capabl conform assess bodi parti design author wai demonstr capabl accredit accredit constitut presumpt technic capabl 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 capabl accredit bodi conform assess bodi accredit iii accredit bodi oper author design author take 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 capabl mean particip region intern mutual recognit arrang certif system regular peer evalu profici test comparison conform assess bodi evalu design system design system evalu capabl 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 sector group establish agreement conform assess bodi includ withdrawn section xx sector annex design suspens withdraw design conform assess bodi place accord provis agreement rule procedur joint sector group advis parti repres joint sector group 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 capabl monitor design author maintain maintain surveil design conform assess bodi mean regular audit assess frequenc natur activ consist intern practic agre joint sector group 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