agreement european commun swiss confeder mutual recognit relat conform assess european commun hereinaft refer quot commun quot swiss confeder hereinaft refer quot switzerland quot hereinaft refer quot parti quot close ti exist commun switzerland free trade agreement juli switzerland european econom commun desir conclud agreement provid mutual recognit result conform assess procedur requir access respect market parti mutual recognit relat conform assess facilit trade parti ensur protect health safeti environ consum align legisl facilit mutual recognit oblig contract parti agreement establish world trade organis agreement technic barrier trade encourag negoti mutual recognit agreement mutual recognit agreement contribut harmonis intern level technic regul standard principl govern implement conform assess procedur close ti commun switzerland part iceland liechtenstein norwai make conclus parallel agreement countri switzerland agre conclud agreement articl purpos commun switzerland grant mutual accept report certif authoris conform mark issu bodi list annex manufactur declar conform certifi conform requir parti area cover articl order avoid duplic procedur swiss commun requir deem equival commun switzerland mutual accept report certif authoris issu bodi list annex manufactur declar conform certifi conform respect requir area cover articl report certif authoris manufactur declar conform conform commun legisl conform mark requir legisl parti affix product market parti committe provid articl case paragraph appli articl definit purpos agreement quot conform assess quot systemat examin determin extent product process servic fulfil requir quot conform assess bodi quot public privat law bodi activ includ perform stage conform assess process quot design author quot author legal power design suspend withdraw design remov suspens conform assess bodi jurisdict definit laid iso iec guid edit european standard en edit relat quot gener term definit standardis relat activ quot establish mean gener term relat conform assess contain agreement articl scope agreement cover obligatori conform assess procedur ensu legisl regulatori administr provis list annex annex defin product sector cover agreement annex divid sector chapter subdivid principl section legisl regulatori administr provis section ii conform assess bodi section iii design author section iv special rule relat design conform assess bodi section addit provis annex set gener rule applic design conform assess bodi articl origin agreement cover product origin parti prejudic special provis laid annex event product cover agreement mutual recognit relat conform assess switzerland member state efta eea present agreement cover product efta member state origin determin accord rule govern preferenti origin applic parti countri refer paragraph event diverg rule rule parti good market appli proof origin provid present certif origin certif requir case import cover eur movement certif invoic declar issu accord protocol free trade agreement juli switzerland eec provid document countri origin parti member state efta eea articl conform assess bodi parti recognis bodi list annex fulfil condit elig assess conform articl design author parti undertak ensur design author power compet design withdraw design suspend remov suspens bodi list annex design conform assess bodi author observ gener principl design set annex subject provis respect section iv annex author observ principl withdraw design suspend remov suspens decis includ conform assess bodi remov annex propos parti accord procedur set articl event suspens withdraw suspens design author conform assess bodi list annex jurisdict parti concern immedi notifi parti chairman committe report certif authoris conform mark issu conform assess bodi suspens recognis parti articl verif design procedur parti exchang inform procedur ensur conform assess bodi jurisdict list annex compli gener principl design outlin annex subject provis respect section iv annex parti compar method verifi conform bodi gener principl design outlin annex subject provis respect section iv annex exist system accredit conform assess bodi parti purpos comparison verif carri accord procedur implement committe articl articl verif complianc conform assess bodi parti except circumst contest technic compet conform assess bodi propos parti list annex jurisdict parti purpos submit write object reason argument parti chairman committe event disagr parti confirm committe verif technic compet conform assess bodi question undertaken accord requir jointli parti particip compet author concern result verif discuss committe view resolv issu parti ensur conform assess bodi jurisdict verif technic compet requir decid committe disput bodi suspend compet design author time disagr establish agreement reach committe articl implement agreement parti cooper view ensur satisfactori applic legisl regulatori administr provis list annex design author ascertain mean conform assess bodi jurisdict list annex observ gener principl design list annex subject provis list respect section iv annex conform assess bodi list annex cooper framework coordin comparison work conduct parti respect sector cover annex order ensur conform assess procedur provid law regul parti cover agreement appli consist manner articl committe committe mutual recognit relat conform assess hereinaft refer quot committe quot establish compos repres parti respons manag monitor smooth function agreement end issu recommend decis circumst provid agreement act mutual agreement committe establish rule procedur inter alia provis conven meet appoint chairman chairman term offic committe meet year parti request conven meet committe matter relat agreement respons inclus conform assess bodi annex remov conform assess bodi annex draw procedur carri verif provid articl draw procedur carri verif provid articl examin legisl regulatori administr provis notifi parti pursuant articl order assess repercuss agreement amend section annex committe propos parti modifi annex agreement articl inclus conform assess bodi annex remov committe decid includ conform assess bodi annex remov annex accord procedur parti wish add remov annex conform assess bodi notifi chairman committe parti propos decis effect ad inform request parti agre propos rais object dai notif propos propos decis adopt committe parti rais object dai period procedur provid articl appli chairman committe notifi parti delai decis committe effect date fix decis committe decid includ conform assess bodi annex parti recognis report certif authoris conform mark issu bodi effect date entri forc decis committe decid remov bodi annex parti recognis report certif authoris conform mark issu bodi date decis take effect articl inform exchang parti exchang relev inform implement applic legisl regulatori administr provis list annex parti inform parti intend make legisl regulatori administr provis relat subject matter agreement notifi parti provis dai entri forc legisl parti stipul specif item inform made compet author person establish territori author approach compet author parti enter direct contact manufactur agent territori parti order obtain inform parti immedi notifi parti safeguard measur territori articl confidenti repres expert agent parti requir duti ceas disclos inform acquir agreement kind cover oblig profession secreci inform purpos envisag agreement articl disput settlement parti refer disput relat interpret applic agreement committe committe endeavour settl disput suppli inform facilit examin situat view find accept solut purpos committe mean maintain smooth function agreement articl agreement countri parti agre mutual recognit agreement conclud parti countri parti agreement circumst entail oblig parti term accept manufactur declar conform report certif authoris mark issu conform assess bodi countri explicit agreement parti articl annex annex agreement form integr part thereof articl territori applic agreement appli commun territori treati establish european commun appli condit laid treati hand territori switzerland articl revis parti wish agreement revis inform committe modif agreement enter forc respect intern procedur complet committe modifi annex agreement propos parti articl suspens parti establish parti fail compli condit agreement consult committe suspend applic annex full part articl acquir right parti continu recognis report certif authoris conform mark manufactur declar conform issu accord prior expiri agreement provid request conform evalu start made notic renew denunci articl entri forc durat agreement ratifi approv parti accord procedur enter forc dai month notif deposit instrument ratif approv agreement agreement mutual recognit relat conform assess agreement free movement person agreement air transport agreement carriag good passeng rail road agreement trade agricultur product agreement aspect public procur agreement scientif technic cooper agreement conclud initi period year tacitli extend commun switzerland notifi parti contrari expiri period notif provis paragraph appli commun switzerland denounc agreement notifi parti notif provis paragraph appli agreement refer paragraph ceas appli month receipt renew notic paragraph denunci notic paragraph hecho en luxemburgo el veintiuno de junio de mil noveciento noventa nuev el present acuerdo se establecerá por duplicado en lengua alemana danesa española finesa francesa griega inglesa italiana neerlandesa portuguesa sueca cada uno de esto texto será auténtico udfærdiget luxembourg den enogtyvend juni nitten hundred og nioghalvfem eksemplar på dansk engelsk finsk fransk græsk italiensk nederlandsk portugisisk spansk svensk og tysk idet hver af diss tekster har samm gyldigh geschehen zu luxemburg einundzwanzigsten juni neunzehnhundertneunundneunzig zwei urschriften dänischer deutscher englisch finnisch französisch griechisch italienisch niederländisch portugiesisch schwedisch und spanisch sprach wobei jeder wortlaut gleichermaßen verbindlich ist luxembourg twenti dai june year thousand nineti agreement drawn duplic danish dutch english finnish french german greek italian portugues spanish swedish languag text equal authent fait luxembourg le vingt juin mil neuf cent quatr vingt dix neuf en doubl exemplair en langu allemand anglais danois espagnol finnois français grecqu italienn néerlandais portugais suédois chacun de ce text faisant également foi fatto lussemburgo addì ventuno giugno millenovecentonovantanov due copi nell lingu danes finlandes frances greco ingles italiano olandes portoghes spagnolo svedes tedesco tutt facenti ugualment fede gedaan te luxemburg de eenentwintigst juni negentienhonderd negenennegentig tweevoud de deens de duits de engels de fins de frans de grieks de italiaans de nederlands de portuges de spaans en de zweeds taal zijnd all teksten gelijkelijk authentiek feito em luxemburgo em vint um de junho de mil novecento noventa nove em doi exemplar em língua alemã inglesa dinamarquesa espanhola finlandesa francesa grega italiana neerlandesa portuguesa sueca toda versõ fazendo igualment fé tehti luxemburgissa kahdentenakymmenentenäensimmäusenä päivänä kesäkuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäyhdeksän kahtena kappaleena englannin espanjan hollannin italian kreikan portugalin ranskan ruotsin saksan suomen ja tanskan kielellä ja jokainen teksti yhtä todistusvoimainen utfärdat luxemburg den tjugoförsta juni nittonhundranittionio två exemplar på det danska engelska finska franska grekiska italienska nederländska portugisiska spanska svenska och tyska språket vilka samtliga texter är lika giltiga 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 por la confederación suiza det schweizisk edsforbund für die schweizerisch eidgenossenschaft swiss confeder pour la confédérat suiss la confederazion svizzera voor de zwitsers bondsstaat pela confederação suíça sveitsin valaliiton puolesta på schweiziska edsförbundet vägnar gt pic file quot en tif quot gt gt pic file quot en tif quot gt annex product sector gt tabl gt chapter machineri section legisl regulatori administr provis provis cover articl paragraph gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list conform assess bodi section iii design author european commun gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author compli gener principl contain annex annex vii direct ec section supplementari provis hand machineri legisl regulatori administr provis list section appli hand machineri principl contain articl paragraph agreement appli machineri legal market put servic parti export hand machineri market parti provis relat hand machineri relat safeti place work forc import state remain applic chapter person protect equip section legisl regulatori administr provis provis cover articl paragraph gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list conform assess bodi section iii design author gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author compli gener principl contain annex annex direct eec chapter toi section legisl regulatori administr provis provis cover articl paragraph gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list conform assess bodi section iii design author gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author compli gener principl contain annex annex iii direct eec section supplementari provis inform certif technic file accord articl direct eec author list section iii obtain request copi certif reason request copi technic file report examin test carri notif ground refus approv bodi accord articl direct eec swiss bodi inform swiss feder offic public health refus issu ec type examin certif feder offic likewis notifi commiss european commun thereof chapter medic devic section legisl regulatori administr provis provis cover articl gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list conform assess bodi section iii design author european commun gt tabl gt section iv special rule relat design conform assess bodi list section ii design conform assess bodi design author compli gener principl contain annex agreement annex xi direct eec respect bodi design direct annex viii direct eec respect bodi design thereund section supplementari provis registr person respons place devic market manufactur place market parti medic devic refer articl direct eec inform compet author parti regist place busi particular refer articl parti mutual recognis registr manufactur oblig design person respons place devic market establish territori parti label medic devic manufactur parti trade address label medic devic annex point direct eec oblig address person respons place devic market repres import establish territori parti label outer packag instruct inform exchang accord articl agreement parti exchang inform refer articl direct eec articl direct eec chapter ga applianc boiler section legisl regulatori administr provis provis cover articl gt tabl gt provis cover articl gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list conform assess bodi section iii design author provis cover articl gt tabl gt provis cover articl gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author compli gener principl contain annex agreement annex direct eec respect bodi design direct annex direct eec respect bodi design thereund chapter pressur vessel section legisl regulatori administr provis provis cover articl gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list conform assess bodi section iii design author european commun gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author compli gener principl contain annex annex iii direct eec section supplementari provis recognit certif switzerland provis swiss legisl list section lai conform assess procedur switzerland recognis certif issu design commun bodi list section ii certifi product conform standard en chapter telecommun termin equip section legisl regulatori administr provis provis cover articl gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list conform assess bodi section iii design author european commun gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author compli gener principl contain annex annex direct ec section supplementari provis administr decis parti mutual recognis administr decis art direct ec art feder law april telecommun ltc ro articl feder council order telecommun instal itu ro approv connect termin equip concern public telecommun network notif manufactur supplier declar place market parti telecommun equip refer articl direct ec person respons notifi manufactur supplier declar notifi bodi parti equip market test laboratori parti notifi test laboratori design carri test pertain procedur refer articl direct ec criteria fix relev harmonis standard design laboratori appli exchang inform conform assess bodi accord annex point direct ec conform assess bodi list section ii annex make bodi relev inform type examin certif issu withdrawn accord annex iii point annex iv point direct ec conform assess bodi list section ii annex make bodi relev inform qualiti system approv issu withdrawn chapter equip protect system intend potenti explos atmospher section legisl regulatori administr provis provis cover articl gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list conform assess bodi section iii design author gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author compli gener principl contain annex annex xi direct ec section supplementari provis inform exchang conform assess bodi list section ii provid member state compet swiss author conform assess bodi inform provid articl direct eec technic document suffici manufactur authoris repres person respons place product market hold technic document requir nation author inspect purpos dispos territori parti period ten year date manufactur product parti undertak forward relev technic document request author parti chapter electr equip electromagnet compat section legisl regulatori administr provis provis cover articl gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list conform assess bodi section iii design author european commun gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author compli gener principl contain annex annex ii direct eec section supplementari provis technic document suffici manufactur authoris repres person respons place product market hold technic document requir nation author inspect purpos dispos territori parti period ten year date manufactur product parti undertak forward relev document request author parti standardis bodi accord articl direct eec parti notifi bodi respons draw standard refer articl direct compet bodi parti inform mutual recognis bodi made respons draw technic report certif pursuant articl direct eec articl direct eec special measur accord articl direct eec parti inform special measur pursuant paragraph articl compet author accord articl direct eec parti notifi compet author refer articl chapter construct plant equip section legisl regulatori administr provis provis cover articl gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list conform assess bodi section iii design author gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author compli gener principl contain annex annex ii council direct eec amend council direct eec chapter measur instrument prepackag section legisl regulatori administr provis provis cover articl gt tabl gt provis cover articl gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list conform assess bodi section iii design author provis cover articl gt tabl gt provis cover articl gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author compli gener principl contain annex annex direct eec product cover direct section supplementari provis inform exchang conform assess bodi list section ii period provid member state compet swiss author inform provid point annex ii direct eec conform assess bodi list section ii request inform provid point annex ii direct eec prepackag switzerland recognis check carri accord provis commun legisl list section commun bodi list section ii case commun prepackag market switzerland statist check quantiti declar prepackag european commun recognis swiss method laid articl quot ordonn sur le déclarat quot rs equival commun method laid annex ii direct eec eec amend direct eec swiss produc prepackag conform commun legisl check swiss method affix quot quot mark product export ec chapter motor vehicl section legisl regulatori administr provis provis cover articl gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list author respons type approv technic servic test bodi european commun switzerland author respons type approv swiss feder road offic section de homolog ch bern section iii design author european commun gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author refer respect legisl regulatori administr provis list section section supplementari provis provis section appli exclus relat switzerland commun inform exchang compet type approv author switzerland member state exchang inform refer articl direct eec amend direct eec adapt technic progress commiss direct ec event refus switzerland member state grant type approv accord articl direct eec amend direct eec adapt technic progress commiss direct ec compet author notifi decis give reason compet swiss author likewis inform commiss thereof recognit vehicl type approv switzerland recognis vehicl type approv grant entri forc agreement accord direct eec amend direct eec adapt technic progress commiss direct ec author respons type approv list section ii chapter approv valid ec european commun recognis swiss type approv switzerland requir deem equival direct eec amend direct eec adapt technic progress commiss direct ec recognit swiss issu type approv suspend switzerland fail adapt legisl commun type approv legisl forc vehicl type approv safeguard claus registr entri servic member state switzerland regist permit sale entri servic vehicl ground relat construct function accompani valid certif conform case incomplet vehicl member state switzerland prohibit sale vehicl refus perman registr entri servic long complet member state switzerland permit sale entri servic compon separ technic unit compli requir relev separ direct requir swiss legisl equival relev separ direct member state switzerland find vehicl compon separ technic unit type risk road safeti accompani valid certif conform properli mark maximum period month refus regist vehicl prohibit sale entri servic territori vehicl compon separ technic unit forthwith notifi member state switzerland commiss thereof state reason decis base member state switzerland grant type approv disput risk road safeti notifi member state switzerland concern endeavour settl disput commiss committe inform hold consult purpos reach settlement measur relat conform product member state switzerland grant type approv measur accord annex framework direct eec amend direct eec adapt technic progress commiss direct ec relat approv verifi cooper approv author member state switzerland adequ arrang made ensur vehicl system compon separ technic unit produc conform approv type member state switzerland grant type approv measur accord annex framework direct eec amend direct eec adapt technic progress commiss direct ec relat approv verifi cooper approv author member state switzerland arrang refer paragraph continu adequ vehicl system compon separ technic unit produc continu conform approv type verif ensur product conform approv type limit procedur set section annex framework direct eec amend direct eec adapt technic progress commiss direct ec separ direct specif requir nonconform approv type failur conform approv type deviat particular type approv certif inform packag found exist deviat authoris articl member state switzerland grant type approv vehicl consid deviat approv type toler permit separ direct toler respect member state switzerland grant type approv find vehicl compon separ technic unit accompani certif conform bear approv mark conform type approv measur ensur vehicl compon separ technic unit produc conform approv type approv author member state switzerland notifi member state switzerland measur extend withdraw type approv member state switzerland demonstr vehicl compon separ technic unit accompani certif conform bear approv mark conform approv type request member state switzerland grant type approv verifi vehicl compon separ technic unit produc conform approv type action case month date request case vehicl type approv nonconform vehicl aris exclus nonconform system compon separ technic unit multi stage type approv nonconform complet vehicl aris exclus nonconform system compon separ technic unit part incomplet vehicl incomplet vehicl vehicl approv author request member state switzerland grant relev system compon separ technic unit incomplet vehicl type approv action ensur vehicl produc conform approv type action case month date request conjunct member state switzerland make request failur conform establish approv author member state switzerland grant system compon separ technic unit type approv approv incomplet vehicl measur set paragraph direct eec amend direct eec adapt technic progress commiss direct ec approv author member state switzerland inform month withdraw type approv reason measur member state switzerland grant type approv disput failur conform notifi member state concern switzerland endeavour settl disput commiss committe inform hold consult purpos reach settlement chapter agricultur forestri tractor section legisl regulatori administr provis provis cover articl gt tabl gt section ii conform assess bodi committe establish articl agreement draw date procedur articl agreement list author respons type approv technic servic test bodi european commun switzerland author respons type approv swiss feder road offic ch bern section iii design author european commun gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author refer respect legisl regulatori administr provis list section section supplementari provis inform exchang compet member state swiss author notifi conform art direct eec conform art direct eec vehicl devic system market chapter good laboratori practic glp scope coverag provis chapter appli test chemic glp substanc prepar cover legisl regulatori administr provis list section purpos chapter provis articl agreement origin appli specif definit definit term quot oecd principl good laboratori practic quot appendix ii oecd council decis final quot guid complianc monitor procedur good laboratori practic quot appendix council decis recommend octob final glp consensu document oecd seri principl good laboratori practic complianc monitor amend made thereto appli parti recognis equival complianc monitor programm good laboratori practic accord oecd decis recommend mention legisl regulatori administr procedur principl list section iv parti mutual accept studi data gener therefrom produc test facil parti list section ii provid particip good laboratori practic complianc monitor programm parti accord principl provis state parti mutual accept conclus studi audit test facil inspect perform monitor author refer section iii section legisl regulatori administr provis regard test chemic glp relev part legisl regulatori administr provis list appli provis cover articl gt tabl gt provis cover articl gt tabl gt section ii conform assess bodi purpos sector chapter quot conform assess bodi quot mean test facil recognis parti glp monitor programm basi inform provid parti section chapter committe refer articl agreement establish date procedur articl agreement list test facil found conform glp principl section iii design author purpos sector chapter quot design author quot mean offici glp monitor author parti european commun gt tabl gt switzerland environment studi product feder offic environ forest landscap ch bern health studi pharmaceut product intercanton offic control medicin erlachstraß po box ch bern health studi product pharmaceut feder offic public health chemic divis ch bern section iv special principl design conform assess bodi purpos sector chapter quot design conform assess bodi quot mean procedur glp monitor author recognis test facil compli glp principl end appli principl procedur provis list recognis equival conform aforement oecd council act final final gt tabl gt section addit provis inform exchang accord articl agreement parti provid annual list test facil light result inspect studi audit conform good laboratori practic date inspect audit complianc statu accord articl agreement parti inform time manner test facil come term section ii sector chapter state appli good laboratori practic fail conform practic extent jeopardis integr authent studi conduct parti suppli addit inform test facil inspect studi audit respons reason request parti test facil inspect parti request test facil inspect studi audit document doubt test conduct accord good laboratori practic except case doubt persist request parti justifi special concern accord articl agreement design expert author list section iii particip laboratori inspect audit studi conduct author parti confidenti conform articl agreement parti confidenti inform brought knowledg pursuant sector chapter knowledg framework particip inspect studi audit fall definit trade secret confidenti commerci financi inform treat inform confidenti accord provid parti ensur author inform transmit treat cooper base articl agreement parti request particip observ inspect test facil conduct author parti consent test facil concern order maintain continu understand parti inspect procedur chapter medicin product gmp inspect batch certif scope coverag provis sector chapter cover medicin product industri manufactur switzerland european commun good manufactur practic gmp requir appli medicin product cover chapter parti recognis conclus inspect manufactur carri relev inspect servic parti relev manufactur authoris grant compet author parti manufactur certif conform batch specif recognis parti recontrol import addit offici batch releas carri author export parti recognis parti quot medicin product quot mean product regul pharmaceut legisl european commun switzerland list section chapter definit medicin product includ human veterinari product chemic biolog pharmaceut immunolog radio pharmaceut stabl medicin product deriv human blood human plasma pre mix prepar veterinari medic feedingstuff vitamin miner herbal remedi homeopath medicin product quot gmp quot part qualiti assur ensur product consist produc control qualiti standard intend requir market authoris product specif purpos chapter includ system manufactur receiv specif product process market authoris holder applic ensur medicin product made complianc specif equival quot qualifi person quot certif ec respect medicin product cover legisl parti manufactur compani request purpos agreement inspect made local compet inspect servic provis appli manufactur activ pharmaceut ingredi intermedi product investig medicin product pre market inspect oper arrang detail section iii paragraph certif manufactur request export import compet author parti author respons grant manufactur authoris supervis manufactur medicin product certifi manufactur appropri authoris manufactur relev medicin product carri relev manufactur oper regularli inspect author compli nation gmp requir recognis equival parti list section chapter gmp requir refer mention certif certif identifi site manufactur contract qualiti control laboratori certif issu expediti time exce thirti calendar dai except case inspect carri period extend sixti dai batch certif batch export accompani batch certif establish manufactur certif full qualit analysi quantit analysi activ ingredi test check ensur qualiti product accord requir market authoris certif attest batch meet specif import batch made request compet author issu certif manufactur account provis current certif scheme qualiti pharmaceut product move intern commerc certif detail agre specif product refer analyt method analyt result statement batch process packag record review found conform gmp batch certif sign person respons releas batch sale suppli european commun quot qualifi person quot refer articl direct eec switzerland respons person refer articl ordin immunobiolog product articl ordin immunobiolog product veterinari articl direct iocm manufactur medicin product offici batch releas offici batch releas procedur appli offici batch releas carri author export parti list section ii recognis parti manufactur provid certif offici batch releas commun offici batch releas procedur document quot control author batch releas vaccin blood product septemb quot specif batch releas procedur switzerland offici batch releas procedur articl ordin immunobiolog product articl ordin immunobiolog product veterinari articl direct iocm author batch releas section regard gmp relev part legisl regulatori administr provis list appli refer qualiti requir product export includ manufactur method product specif relev market authoris grant compet author import parti provis cover articl gt tabl gt section ii conform assess bodi purpos chapter quot conform assess bodi quot mean offici gmp inspect servic parti european commun germani bundesministerium für gesundheit propsthof bonn tel fax immunolog paul ehrlich institut feder agenc sera amp vaccin postfach po box langen tel fax austria bundesministerium für gesundheit und konsumentenschuzt radetzkystrass wien tel fax belgium inspect générale de la pharmaci algemen farmaceutisch inspecti cité administr de état rijksadministratief centrum quartier vésale vesaliu gebouw bruxel brussel tel fax denmark sundhedsstyrelsen medicin divis frederikssundsvej dk brønshøj tel fax spain ministerio de sanidad consumo subdirección gener de control farmaceutico paseo del prado madrid tel fax finland nation agenc medicin po box fin helsinki tel fax franc medicin product human agenc du médicament boulevard anatol franc saint deni tel fax veterinari medicin product agenc national du médicament véterinair la haut march javené fougèr tel fax greec nation drug organ eof mesogion gr athen tel fax ireland nation drug advisori board adelaid road dublin ireland tel fax itali ministero della sanità direzion general del servizio farmaceutico vial della civiltà romana roma tel fax luxembourg divis de la pharmaci de médicament rue spoo luxembourg tel fax netherland ministeri van volksgezondheid welzijn en sport inspecti voor de gezondheidszorg postbu hk rijswijk netherland tel fax portug instituto nacion da farmácia medicamento infarm av brasil lisboa tel fax unit kingdom human veterinari immunolog medicin control agenc elm lane london sw nq unit kingdom tel fax veterinari immunolog veterinari medicin director woodham lane haw addleston surrei kt nb unit kingdom tel fax sweden läkemedelsverket medic product agenc husargatan box uppsala tel fax switzerland swiss feder offic public health divis biolog ch bern immunobiolog product human institut virolog immunoprophylaxi research station swiss feder veterinari offic ch mittelhäusern immunobiolog product veterinari intercanton offic control medicin ch bern medicin product human veterinari section iii addit provis transmiss inspect report reason request relev inspect servic forward copi inspect report manufactur site case analyt oper contract control site request concern quot full inspect report quot quot detail report quot item parti deal inspect report degre confidenti request provid parti parti ensur inspect report forward calendar dai period extend dai inspect carri inspect report quot full inspect report quot compris site master file compil manufactur inspector narr report inspector quot detail report quot respond specif queri firm parti gmp refer manufactur inspect applic gmp export parti section respect medicin product cover pharmaceut legisl import parti export local compet inspect servic carri inspect relev manufactur oper inspect gmp absenc specif gmp requir applic gmp import parti specif product class product investig medicin product start materi limit activ pharmaceut ingredi equival gmp requir determin procedur establish committe natur inspect inspect routin assess complianc manufactur gmp call gener gmp inspect regular period routin inspect quot product process orient quot inspect quot pre market quot inspect relev focu manufactur seri product process es includ assess valid complianc specif process control aspect market authoris relev product inform qualiti dossier applic authoris dossier provid confid inspector fee regim inspect establish fee determin manufactur locat inspect establish fee charg manufactur locat territori parti safeguard claus inspect parti reserv inspect conduct reason identifi parti inspect notifi advanc parti accord articl agreement carri jointli compet author parti recours safeguard claus except exchang inform author approxim qualiti requir accord gener provis agreement parti exchang inform mutual recognit inspect relev author switzerland commun inform technic guidanc inspect procedur parti consult adopt endeavour proce approxim inspector train accord articl agreement train session inspector organis author access inspector parti parti agreement inform session joint inspect accord articl agreement mutual agreement parti joint inspect organis inspect intend develop common understand interpret practic requir set inspect form agre procedur approv committe establish articl agreement alert system contact point agre parti permit author manufactur inform author parti speed case qualiti defect batch recal counterfeit problem qualiti necessit addit control suspens distribut batch detail alert procedur agre parti ensur suspens withdraw total partial manufactur authoris base complianc gmp public health implic commun degre urgenc contact point purpos agreement contact point technic question exchang inspect report inspector train session technic requir ec director european agenc evalu medicin product switzerland offici gmp inspect servic list section ii diverg view parti endeavour resolv diverg view inter alia complianc manufactur conclus inspect report unresolv diverg view refer committe establish articl agreement context agreement express quot public telecommun network quot interpret purpos swiss law quot instal provid telecommun servic provid quot annex gener rule design conform assess bodi gener term condit agreement design author remain sole respons compet capac bodi design design legal identifi bodi jurisdict design author design conform assess bodi demonstr object mean understand requisit experi compet appli requir certif procedur laid legisl regulatori administr provis refer annex applic specif product product categori sector design demonstr technic compet cover conform assess bodi technic knowledg relev product process servic treat understand technic standard legisl regulatori administr provis design sought physic capabl perform conform assess activ adequ manag activ concern circumst give assur conform assess activ adequ perform time technic compet criteria base internation accept document en seri standard equival supplement interpret document document interpret account type requir laid applic legisl regulatori administr provis parti encourag harmonis design procedur coordin conform assess procedur cooper design author conform assess bodi base coordin meet particip mutual recognit arrang ad hoc work parti meet parti encourag accredit bodi particip mutual recognit arrang system verif conform assess bodi compet order verifi technic compet conform assess bodi author concern procedur ensur level trust parti parti design author wai demonstr compet accredit accredit constitut presumpt technic compet conform assess bodi relat applic requir parti provid compet accredit bodi compli relev intern provis forc en standard iso iec guid signatori multilater arrang subject peer evalu take part author design author accord condit decid programm conduct comparison exchang technic experi interest ensur continu trust technic compet accredit conform assess bodi programm includ joint evalu special cooper exercis conform assess criteria applic conform assess bodi requir assess conform product process servic directli standard technic specif design author accredit presumpt conform assess bodi technic compet provid enabl assess bodi abil appli standard technic specif design limit activ conform assess bodi criteria applic conform assess bodi requir assess conform product process servic directli standard technic specif gener essenti requir design author accredit presumpt conform assess bodi technic compet provid incorpor element enabl assess capac conform assess bodi technic knowledg product assess conform product essenti requir design limit activ conform assess bodi mean accredit scheme ground author concern requir conform assess bodi demonstr compet mean particip region intern mutual recognit arrang certif system regular peer evalu base clear criteria conduct expertis aptitud test comparison conform assess bodi evalu verif system verif system evalu compet conform assess bodi defin parti invit check system guarante conform design process legal requir check focu appropri effect verif system conform assess bodi formal design parti submit propos committe inclus conform assess bodi annex provid detail respect bodi postal address fax number sector chapter product categori product process servic cover design conform assess procedur cover design method establish bodi compet final act plenipotentiari quot european commun quot swiss confeder meet twenti dai june year thousand hundr nineti luxembourg signatur agreement european commun swiss confeder mutual recognit relat conform assess adopt joint declar mention attach final act joint declar contract parti revis articl joint declar mutual recognit good clinic practic inspect relat thereto joint declar contract parti updat annex joint declar negoti note declar annex final act declar swiss attend committe hecho en luxemburgo el día ventiuno de junio del año mil noveciento noventa nuev udfærdiget luxembourg den enogtyvend juni nitten hundred og nioghalvfem geschehen zu luxemburg einundzwanzigsten juni neunzehnhundertneunundneunzig luxembourg twenti dai june year thousand hundr nineti fait luxembourg le vingt juin mil neuf cent quatr vingt dix neuf fatto lussemburgo addì ventuno giugno millenovecentonovantanov gedaan te luxemburg de eenentwintigst juni negentienhonderd negenennegentig feito luxemburgo em vint um de junho de mil novecento noventa nove tehti luxemburgissa kahdentenakymmenentenäensimmäisenä päivänä kesäkuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäyhdeksän som gjord luxemburg den tjugoförsta juni nittonhundranittionio 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 por la confederación suiza det schweizisk edsforbund für die schweizerisch eidgenossenschaft swiss confeder pour la confédérat suiss la confederazion svizzera voor de zwitsers bondsstaat pela confederação suíça sveitsin valaliiton puolesta på schweiziska edsförbundet vägnar gt pic file quot en tif quot gt gt pic file quot en tif quot gt joint declar contract parti revis articl contract parti undertak revis articl agreement mutual recognit relat conform assess includ product origin countri parti conclud agreement mutual recognit relat conform assess agreement conclud point provis chapter section agreement revis joint declar mutual recognit good clinic practic inspect relat thereto medicin product result clinic trial carri territori parti agreement accept inclus applic market authoris variat extens principl parti agre continu accept clinic trial purpos market authoris applic agre work approxim good clinic practic implement current declar helsinki tokyo guidanc relev clinic trial adopt framework intern confer harmonis due legisl develop inspect authoris clinic trial european commun detail arrang mutual recognit offici supervis trial consid futur laid specif chapter joint declar contract parti updat annex contract parti undertak updat annex agreement mutual recognit relat conform assess month entri forc joint declar negoti european commun swiss confeder declar intent undertak negoti conclud agreement area common interest updat protocol free trade agreement swiss particip commun train youth media statist environment programm preparatori work negoti proce rapidli current bilater negoti conclud declar swiss attend committe council agre switzerland repres item concern attend meet committe expert work parti observ committe research programm includ scientif technic research committe crest administr commiss social secur migrant worker coordin group mutual recognit higher educ diploma advisori committe air rout applic competit rule field air transport switzerland repres present committe vote case committe deal area cover agreement switzerland adopt acqui communautair equival measur commiss consult swiss expert method articl eea agreement inform relat entri forc agreement swiss confeder sector free movement person air land transport public procur scientif technolog cooper mutual recognit relat conform assess trade agricultur product final notif complet procedur entri forc agreement sector free movement person air land transport public procur scientif technolog cooper mutual recognit relat conform assess trade agricultur product european commun member state hand swiss confeder hand sign luxembourg june place april agreement enter forc simultan june