decis januari committe establish agreement european commun swiss confeder mutual recognit relat conform assess modif annex agreement ec committe regard agreement european commun swiss confeder mutual recognit agreement relat conform assess sign june articl thereof agreement enter forc june text sector chapter annex modifi account legisl design author switzerland commun decid articl respect section sector chapter annex agreement delet replac text attach chapter machineri section iii chapter person protect equip section iii chapter medic devic section iii iv chapter ga applianc boiler section iii chapter pressur vessel section iii iv chapter telecommun termin equip titl section iii iv chapter equip protect system intend potenti explos atmospher section iii chapter electr equip electromagnet compat section iii chapter construct plant equip section iii iv chapter measur instrument prepackag section iii chapter motor vehicl section iii chapter agricultur forestri tractor section iii chapter good laboratori practic glp quot scope coverag quot section iii iv chapter medicin product gmp inspect batch certif quot scope coverag quot section ii articl decis duplic sign chair person authoris act behalf parti decis effect date signatur sign bern decemb behalf swiss confeder oscar zosso sign brussel januari behalf european commiss paul de lusignan annex attach chapter machineri section legisl regul administr provis provis cover articl gt tabl gt section iii design author european commun gt tabl gt gt tabl gt chapter person protect equip section legisl regul administr provis provis cover articl gt tabl gt section iii design author european commun gt tabl gt gt tabl gt chapter medic devic section legisl regul administr provis provis cover articl gt tabl gt section iii design author european commun gt tabl gt 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 annex viii direct eec annex ix direct ec respect bodi design direct section addit provis registr person respons place devic market manufactur place market parti medic devic refer articl direct eec articl direct ec inform compet author parti regist place busi particular refer articl parti reciproc 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 vitro diagnost medic devic annex point direct ec 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 articl direct ec european databank compet swiss author access european databank establish articl direct ec articl direct eec transmit commiss bodi respons manag databank data provid articl collect switzerland entri european databank chapter ga applianc boiler section legisl regul administr provis provis cover articl gt tabl gt provis cover articl gt tabl gt section iii design author european commun gt tabl gt gt tabl gt chapter pressur vessel section legisl regul administr provis provis cover articl gt tabl gt section iii design author european commun gt tabl gt 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 annex iv direct ec section addit 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 direct eec direct ec 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 chapter radio equip telecommun termin equip section legisl regul administr provis provis cover articl gt tabl gt section iii design author european commun gt tabl gt 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 vi direct ec section addit provis tcam switzerland particip observ tcam work subgroup market surveil parti notifi author establish territori respons carri surveil task involv implement legisl set section parti notifi market surveil activ bodi design purpos regul interfac parti inform interfac regul territori establish equival notifi interfac determin equip class identifi european commun account interfac regul switzerland interfac offer public telecommun network oper parti inform interfac offer territori public telecommun network oper applic essenti requir commiss intend adopt decis appli requir set articl direct ec consult switzerland issu submit formal committe switzerland intend adopt technic administr regul appli requir set articl ordin telecommun equip consult commiss issu submit formal committe authoris disconnect parti consid apparatu declar compli legisl damag network radioelectr interfer degrad network oper parti authoris oper refus connect apparatu disconnect withdraw servic inform parti authoris harmonis standard switzerland consid complianc harmonis standard guarante essenti requir legisl list section fulfil inform committe give reason committe case european commun act accord procedur provid articl direct ec committe inform result procedur mutual notif radiocommun equip conform requir intend spectrum parti parti adopt measur prohibit restrict place market requir withdraw market radiocommun equip includ type radio equip caus consid harm interfer includ interfer exist plan servic nation alloc frequenc band notifi parti thereof give reason name countri concern safeguard claus relat industri product parti take measur prohibit place market telecommun instal declar complianc direct ec immedi inform parti give reason decis state complianc establish parti measur evid present notifi result investig parti agre result investig measur ensur product market parti disagre result investig case forward committe decid expert studi carri committe consid measur unjustifi nation author parti measur withdraw justifi measur ensur product market chapter equip protect system intend potenti explos atmospher section legisl regul administr provis provis cover articl gt tabl gt section iii design author european commun gt tabl gt gt tabl gt chapter electr equip electromagnet compat section legisl regul administr provis provis cover articl gt tabl gt section iii design author european commun gt tabl gt gt tabl gt chapter construct plant equip section legisl regul administr provis provis cover articl gt tabl gt section iii design author european commun gt tabl gt gt tabl gt section iv special rule relat design conform assess bodi design conform assess bodi design author compli gener principl contain annex annex ix direct ec european parliament council chapter measur instrument prepackag section legisl regul administr provis provis cover articl gt tabl gt provis cover articl gt tabl gt section iii design author provis cover articl european commun gt tabl gt gt tabl gt provis cover articl european commun gt tabl gt gt tabl gt section addit 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 ordin technic provis declar quantiti industri pre packag 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 mark purpos agreement provis council direct eec juli read adapt indent point annex indent point annex ii ad text bracket quot ch switzerland quot draw annex ii point refer supplement letter sign quot ch quot purpos agreement ordin qualif measur instrument rs read amend annex text point sign identifi servic issu stamp ad quot offic member state commun quot member state european commun identifi acronym defin annex ii direct eec derog sentenc articl agreement rule mark measur instrument swiss market swiss commun legisl deem equival mean articl agreement mark affix ce mark nation sign ec member state concern provid indent point annex indent point annex ii council direct eec juli measur instrument subject legisl refer articl agreement mark affix swiss sign provid point approv mark verif mark annex ordin qualif measur instrument rs combin ce mark nation sign ec member state concern provid annex point indent annex ii point indent direct eec weigh instrument derog articl agreement switzerland recognis certif confirm complianc weigh instrument direct eec chapter motor vehicl section legisl regul administr provis provis cover articl gt tabl gt section iii design author european commun gt tabl gt gt tabl gt 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 commiss direct ec decemb event refus switzerland member state grant type approv accord articl direct eec amend 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 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 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 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 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 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 articl direct eec amend 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 regul administr provis provis cover articl gt tabl gt section iii design author european commun gt tabl gt gt tabl gt section supplementari provis provis section appli exclus relat switzerland commun inform exchang compet member state swiss author notifi conform articl direct eec amend conform articl direct eec amend commiss direct ec vehicl devic system market event refus switzerland member state grant type approv accord articl direct eec amend direct ec compet author notifi decis give reason recognit vehicl type approv switzerland recognis tractor separ technic unit type approv grant entri forc agreement accord direct eec amend commiss direct ec author respons type approv eu member state approv valid ec european commun recognis swiss type approv switzerland requir deem equival direct eec amend 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 permit registr sale entri servic tractor ground relat construct oper accompani valid certif conform member state switzerland permit sale entri servic separ technic unit compli requir relev separ direct requir swiss legisl equival relev separ direct member state switzerland find tractor type hazard safeti road work accompani valid certif conform maximum period month refus regist tractor type prohibit sale entri servic territori forthwith notifi member state switzerland commiss thereof state reason decis base commiss week consult state concern disput member state switzerland commiss deliv opinion delai step measur relat conform product member state switzerland grant type approv measur verifi cooper approv author member state switzerland product model conform approv prototyp verif limit spot check member state switzerland grant type approv measur ensur inform cessat product chang particular appear inform document state question find amend inform document warrant fresh check fresh test amend exist type approv certif complet type approv certif compet author state inform manufactur thereof month document complet send compet author member state switzerland nonconform approv type failur conform approv type deviat particular inform document found exist deviat authoris articl direct eec amend direct ec member state switzerland grant type approv tractor consid deviat approv type toler permit separ direct toler respect member state switzerland grant type approv find number tractor accompani certif conform conform type approv measur ensur product model conform approv type approv author member state switzerland notifi member state switzerland measur extend withdraw type approv author measur inform type approv author member state switzerland failur conform approv author member state switzerland inform month withdraw ec type approv reason measur member state switzerland grant type approv disput failur conform notifi state member state switzerland concern endeavour settl disput commiss committe inform hold consult purpos reach settlement 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 revis env mc chem base oecd council decis final amend novemb final 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 regul 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 iii design author purpos sector annex term quot design author quot mean glp monitor author parti european commun gt tabl gt gt tabl gt 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 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 control 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 respect medicin product cover legisl parti manufactur compani request purpos agreement inspect made local compet inspect servic provis appli inter alia manufactur activ pharmaceut ingredi intermedi product 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 inter alia 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 ec articl direct ec switzerland quot respons person quot refer articl ordin establish licenc 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 quot subsequ version specif batch releas procedur switzerland offici batch releas procedur articl feder law medicin product medic devic articl ordin swiss agenc therapeut product requir market authoris medicin product 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 paul ehrlichstr langen tel fax austria bundesministerium für sozial sicherheit und generationen radetzkystraß wien tel fax belgium inspect générale de la pharmaci algemen farmaceutisch inspecti vesaliusgebouw pachecolaan bu bruxel tel fax denmark lægemiddelstyrelsen frederikssundsvej dk bronshoj tel fax spain agencia española del medicamento paseo del prado madrid tel fax finland lääkelaito feld fin helsinki tel fax franc medicin product human agenc français de sécurité sanitair de produit de santé boulevard anatol franc saint deni cedex tel fax veterinari medicin product agenc français de sécurité sanitair de aliment agenc national du médicament vétérinair afssa anmv bp fouger tel fax greec nation organis medicin eof mesogion avenu holargo gr athinai tel fax ireland irish medicin board bord leigheasra na héireann earlsfort centr earlsfort terrac dublin ireland tel fax itali medicin product human ministero della salut vial della civiltà romana roma tel fax medicin product veterinari ministero della salut direzion general sanità pubblica veterinaria alimenti nutrizion ufficio xi piazzal marconi roma tel fax luxembourg direct de la santé villa louvigni allé marconi luxembourg tel fax netherland staatstoezicht op de volksgezondheid inspecti voor de gezondheidszorg postbu bc den haag netherland tel fax portug instituto nacion da farmácia medicamento infarm parqu de saúd de lisboa av brasil lisboa tel fax unit kingdom human veterinari immunolog medicin control agenc market tower elm lane london sw nq unit kingdom tel fax veterinari immunolog veterinari medicin director woodham lane haw addleston surrei kt ls unit kingdom tel fax sweden läkemedelsverket medic product agenc husargatan po box uppsala tel fax switzerland swiss agenc therapeut product swissmed erlachstraß ch bern product human veterinari immunolog product veterinari tel fax institut virolog immunoprophylaxi research station swiss feder veterinari offic sensemattstr ch mittelhäusern immunobiolog product veterinari tel fax date contact point confirm emea