protocol europ agreement establish associ european commun member state part czech republ part conform assess accept industri product peca european commun czech republ hereinaft refer quot parti quot czech republ appli membership european union membership impli effect implement acqui european commun recognis progress adopt implement commun law czech republ opportun extend benefit intern market ensur effect oper sector access sector cover protocol czech nation law substanti take commun law share commit principl free movement good promot product qualiti ensur health safeti citizen protect environ includ technic assist form cooper desir conclud protocol europ agreement conform assess accept industri product hereinaft refer quot protocol quot provid applic mutual accept industri product fulfil requir lawfulli market parti mutual recognit result conform assess industri product subject commun nation law note articl europ agreement conclus agreement mutual recognit note close relationship european commun iceland liechtenstein norwai agreement european econom area make conclus parallel european conform assess agreement czech republ countri equival protocol bear mind statu contract parti agreement establish world trade organis consciou oblig world trade organis agreement technic barrier trade agre articl purpos purpos protocol facilit elimin parti technic barrier trade respect industri product mean end progress adopt implement czech republ nation law equival commun law protocol mutual accept industri product list annex mutual accept industri product fulfil requir lawfulli market parti mutual recognit result conform assess industri product subject commun law equival czech nation law list annex mutual recognit result conform assess articl definit purpos protocol quot industri product quot mean product articl europ agreement protocol thereto quot commun law quot mean legal act implement practic european commun applic situat risk categori industri product interpret court justic european commun quot nation law quot mean legal act implement practic czech republ take commun law applic situat risk categori industri product term protocol mean commun law czech nation law articl align legisl purpos protocol czech republ agre measur consult commiss european commun maintain complet commun law field standardis metrolog accredit conform assess market surveil gener safeti product produc liabil articl mutual accept industri product parti agre purpos mutual accept industri product list annex mutual accept industri product fulfil requir lawfulli market parti market parti restrict prejudic articl europ agreement articl mutual recognit result conform assess procedur parti agre recognis result conform assess procedur carri accord commun nation law list annex mutual recognit result conform assess parti requir procedur repeat impos addit requir purpos accept conform articl safeguard claus parti find industri product territori virtu protocol accord intend compromis safeti health user person legitim concern protect legisl identifi annex measur withdraw product market prohibit place market put servic restrict free movement annex provid procedur appli case articl extens coverag czech republ adopt implement nation law take commun law parti amend annex add annex accord procedur laid articl articl origin provis protocol appli industri product origin parti preferenti rule origin case diverg rule rule parti territori product market determin proof origin demonstr certif origin certif requir case import product cover proof origin protocol europ agreement articl oblig parti author bodi parti ensur author jurisdict respons effect implement commun nation law continu appli ensur author notifi suspend remov suspens withdraw notif bodi ensur conform industri product commun nation law requir withdraw market parti ensur bodi notifi respect jurisdict assess conform relat requir commun nation law annex continu compli requir commun nation law step ensur bodi maintain compet carri task notifi articl notifi bodi initi bodi notifi purpos protocol includ list czech republ commun exchang complet procedur entri forc procedur appli notif bodi assess conform relat requir commun nation law annex parti forward notif parti write acknowledg parti write bodi consid notifi compet assess conform relat requir annex date parti decid withdraw notifi bodi jurisdict inform parti write bodi ceas assess conform relat requir annex date withdraw latest conform assess carri date remain valid decid associ council articl verif notifi bodi parti request parti verifi technic compet complianc notifi bodi jurisdict request justifi order parti respons notif carri request verif report speedili parti parti jointli examin bodi particip relev author end parti ensur full cooper bodi jurisdict parti step mean view resolv problem detect problem resolv satisfact parti notifi chairman associ council dissent give reason associ council decid action decid associ council notif bodi recognit compet assess conform relat requir commun nation law annex suspend part total date disagr parti notifi chairman associ council articl exchang inform cooper order ensur correct uniform applic interpret protocol parti author notifi bodi exchang relev inform implement law practic includ procedur ensur complianc notifi bodi part relev mechan inform coordin relat activ parti encourag bodi cooper view establish mutual recognit arrang voluntari sphere articl confidenti repres expert agent parti requir duti ceas disclos inform acquir protocol kind cover oblig profession secreci inform purpos envisag protocol articl manag protocol respons effect function protocol held associ council conform articl europ agreement power decis amend annex ad annex appoint joint team team expert verifi technic compet notifi bodi complianc requir exchang inform propos actual modif commun nation law refer annex addit conform assess procedur affect sector cover annex resolv question relat applic protocol associ council deleg respons set protocol conform articl europ agreement articl technic cooper assist commun provid technic cooper assist czech republ order support effect implement applic protocol articl agreement countri agreement conform assess conclud parti countri parti protocol entail oblig parti accept result conform assess procedur carri countri explicit agreement parti associ council articl entri forc protocol enter forc dai month date parti exchang diplomat note confirm complet respect procedur entri forc protocol articl statu protocol protocol constitut integr part europ agreement protocol drawn origin danish dutch english finnish french german greek italian portugues spanish swedish czech languag text equal authent hecho en brusela el veintisei de febrero del do mil uno udfærdiget bruxel den seksogtyvend februar tusind og en geschehen zu brüssel sechsundzwanzigsten februar zweitausendundein brussel twenti sixth dai februari year thousand fait bruxel le vingt février deux mill fatto bruxel addì ventisei febbraio duemilauno gedaan te brussel de zesentwintigst februari tweeduizendeneen feito em bruxela em vint sei de fevereiro de doi mil um tehti brysselissä kahdentenakymmenentenäkuudentena päivänä helmikuuta vuonna kaksituhattayksi som skedd bryssel den tjugosjätt februari tjugohundraett dáno bruselu dne dvacátého sestého února roku dvoutisícího prvního 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 za evropské spolecenství gt pic file quot en ep quot gt por la república checa den tjekkisk republik für die tschechischen republik czech republ pour la républiqu tchèque la repubblica ceca voor de tsjechisch republiek pela república checa tsekin tasavallan puolesta på tjeckiska republiken vägnar za ceskou republiku gt pic file quot en ep quot gt annex annex mutual accept industri product record annex mutual recognit result conform assess tabl content gt tabl gt annex mutual recognit result conform assess machineri section commun nation law commun law parliament council direct ec june approxim law member state relat machineri oj amend european parliament council direct ec octob oj nation law act coll part technic requir product amend act amend act coll part act coll part czech nation council czech trade inspect amend act coll part act coll part act coll part act coll part govern order coll part lai technic requir machineri amend govern order coll part govern order coll part section ii notifi author european commun belgium ministèr de affair economiqu ministeri van economisch zaken denmark direktoratet arbejdstilsynet germani bundesministerium für arbeit und sozialordnung greec ministri develop gener secretariat industri spain ministerio de ciencia tecnología franc ministèr de emploi de la solidarité direct de relat du travail bureau ct ireland depart enterpris employ itali ministero dell industria del commercio dell artigianato luxembourg ministèr du travail inspect du travail de mine netherland ministeri van social zaken en werkgelegenheid austria bundesministerium für wirtschaft und arbeit portug author govern portug instituto portuguê da qualidad finland sosiaali ja terveysministeriö social och hälsovårdsministeriet sweden author govern sweden styrelsen för ackredit och teknisk kontrol swedac unit kingdom depart trade industri czech republ úrad pro technick normalizaci metrologii státní zkusebnictví czech offic standard metrolog test section iii notifi bodi european commun bodi notifi member state commun accord commun law section notifi czech republ accord articl protocol czech republ bodi authoris czech republ accord czech nation law section notifi commun accord articl protocol section iv specif arrang safeguard claus safeguard claus relat industri product parti measur deni free access market industri product bear ce mark subject annex immedi inform parti indic reason decis complianc assess parti matter evid brought knowledg report result investig case agreement parti measur ensur product market case disagr outcom investig matter forward associ council decid expertis carri associ council find measur unjustifi nation author parti measur withdraw justifi parti measur ensur product market safeguard claus relat harmonis standard czech republ consid harmonis standard refer legisl defin annex meet essenti requir legisl inform associ council give reason thereof associ council matter request commun proce accord procedur provid commun legisl identifi annex commun associ council parti inform proceed outcom procedur notifi parti annex mutual recognit result conform assess lift section commun nation law commun law european parliament council direct ec june approxim law member state relat lift oj nation law act coll part technic requir product amend act amend act coll part act coll part czech nation council czech trade inspect amend act coll part act coll part act coll part act coll part govern οrder coll part lai technic requir lift amend govern οrder coll part govern order coll part section ii notifi author european commun belgium ministèr de affair economiqu ministeri van economisch zaken denmark direktoratet arbejdstilsynet germani bundesministerium für arbeit und sozialordnung greec ministri develop gener secretariat industri spain ministerio de ciencia tecnología franc ministèr de équipement de transport du logement direct générale de urbanism de habitat de la construct ireland depart enterpris employ itali ministero dell industria del commercio dell artigianato luxembourg ministèr du travail inspect du travail de mine netherland ministeri van social zaken en werkgelegenheid austria bundesministerium für wirtschaft und arbeit 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 czech republ úrad pro technick normalizaci metrologii státní zkusebnictví czech offic standard metrolog test section iii notifi bodi european commun bodi notifi member state commun accord commun law section notifi czech republ accord articl protocol czech republ bodi authoris czech republ accord czech nation law section notifi commun accord articl protocol section iv specif arrang safeguard claus safeguard claus relat industri product parti measur deni free access market industri product bear ce mark subject annex immedi inform parti indic reason decis complianc assess parti matter evid brought knowledg report result investig case agreement parti measur ensur product market case disagr outcom investig matter forward associ council decid expertis carri associ council find measur unjustifi nation author parti measur withdraw justifi parti measur ensur product market safeguard claus relat harmonis standard czech republ consid harmonis standard refer legisl defin annex meet essenti requir legisl inform associ council give reason thereof associ council matter request commun proce accord procedur provid commun legisl identifi annex commun associ council parti inform proceed outcom procedur notifi parti annex mutual recognit result conform assess person protect equip section commun nation law commun law council direct eec decemb approxim law member state relat person protect equip oj amend parliament council direct ec septemb oj nation law act coll part technic requir product amend act amend act coll part act coll part czech nation council czech trade inspect amend act coll part act coll part act coll part act coll part govern order coll part lai technic requir person protect equip amend govern order coll part section ii notifi author european commun belgium ministèr de affair economiqu ministeri van economisch zaken denmark direktoratet arbejdstilsynet germani bundesministerium für arbeit und sozialordnung greec ministri develop gener secretariat industri spain ministerio de ciencia tecnología franc ministèr de emploi de la solidarité direct de relat du travail bureau ct ministèr de économi de financ de industri direct générale de industri de technolog de inform de post digitip squalpi ireland depart enterpris employ itali ministero dell industria del commercio dell artigianato luxembourg ministèr du travail inspect du travail de mine netherland ministeri van volksgezondheid welzijn en sport austria bundesministerium für wirtschaft und arbeit portug author govern portug instituto portuguê da qualidad finland sosiaali ja terveyministeriö social och hälsovårdsministeriet sweden author govern sweden styrelsen för ackredit och teknisk kontrol swedac unit kingdom depart trade industri czech republ úrad pro technick normalizaci metrologii státní zkusebnictví czech offic standard metrolog test section iii notifi bodi european commun bodi authoris czech republ accord czech nation law section notifi commun accord articl protocol czech republ bodi authoris czech republ accord czech nation law section notifi commun accord articl protocol section iv specif arrang safeguard claus safeguard claus relat industri product parti measur deni free access market industri product bear ce mark subject annex immedi inform parti indic reason decis complianc assess parti matter evid brought knowledg report result investig case agreement parti measur ensur product market case disagr outcom investig matter forward associ council decid expertis carri associ council find measur unjustifi nation author parti measur withdraw ustifi parti measur ensur product market safeguard claus relat harmonis standard czech republ consid harmonis standard refer legisl defin annex meet essenti requir legisl inform associ council give reason thereof associ council matter request commun proce accord procedur provid commun legisl identifi annex commun associ council parti inform proceed outcom procedur notifi parti annex mutual recognit result conform assess electr safeti section commun nation law commun law council direct eec februari approxim law member state relat electr equip design voltag limit oj amend direct eec juli oj nation law act coll part technic requir product amend act amend act coll part act coll part czech nation council czech trade inspect amend act coll part act coll part act coll part act coll part govern order coll part lai technic requir low voltag electr equip amend govern order coll part section ii notifi author european commun belgium ministèr de affair economiqu ministeri van economisch zaken denmark boligministeriet germani bundesministerium für arbeit und sozialordnung greec ministri develop gener secretariat industri spain ministerio de ciencia tecnología franc ministèr de économi de financ de industri direct générale de industri de technolog de inform de post digitip squalpi ireland depart enterpris employ itali ministero dell industria del commercio dell artigianato luxembourg ministèr de economi servic de energi de etat ministèr du travail inspect du travail de mine netherland ministeri van volksgezondheid welzijn en sport verbrauchsgüt ministeri van social zaken en werkgelegenheid sonstig austria bundesministerium für wirtschaft und arbeit 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 czech republ úrad pro technick normalizaci metrologii státní zkusebnictví czech offic standard metrolog test section iii notifi compet bodi european commun bodi notifi member state commun accord commun law section notifi czech republ accord articl protocol czech republ bodi authoris czech republ accord czech nation law section notifi commun accord articl protocol section iv specif arrang safeguard claus safeguard claus relat industri product parti measur deni free access market industri product bear ce mark subject annex immedi inform parti indic reason decis complianc assess parti matter evid brought knowledg report result investig case agreement parti measur ensur product market case disagr outcom investig matter forward associ council decid expertis carri associ council find measur unjustifi nation author parti measur withdraw justifi parti measur ensur product market safeguard claus relat harmonis standard czech republ consid harmonis standard refer legisl defin annex meet essenti requir legisl inform associ council give reason thereof associ council matter request commun proce accord procedur provid commun legisl identifi annex commun associ council parti inform proceed outcom procedur notifi parti annex mutual recognit result conform assess electromagnet compat section commun nation law commun law council direct eec approxim law member state relat electromagnet compat oj amend direct eec juli oj nation law act coll part technic requir product amend act amend act coll part act coll part czech nation council czech trade inspect amend act coll part act coll part act coll part act coll part govern order coll part lai technic requir product relat electromagnet compat amend govern order coll part section ii notifi author european commun belgium ministèr de affair economiqu ministeri van economisch zaken denmark telestyrelsen germani bundesministerium für wirtschaft und technologi greec ministri develop gener secretariat industri spain ministerio de ciencia tecnología franc ministèr de économi de financ de industri direct générale de industri de technolog de inform de post digitip squalpi ireland depart enterpris employ itali ministero dell industria del commercio dell artigianato luxembourg ministèr de economi servic de energi de etat netherland ministeri van verkeer en waterstaat austria bundesministerium für wirtschaft und arbeit portug author govern portug instituto portuguê da qualidad finland kauppa ja teollisuusministeriö handel och industriministeriet emc aspect telecommun radio equip liikenn ja viestintäministeriö kommunikationsministeriet sweden author govern sweden styrelsen för ackredit och teknisk kontrol swedac unit kingdom depart trade industri czech republ úrad pro technick normalizaci metrologii státní zkusebnictví czech offic standard metrolog test section iii notifi compet bodi european commun bodi notifi member state commun accord commun law section notifi czech republ accord articl protocol czech republ bodi authoris czech republ accord czech nation law section notifi commun accord articl protocol section iv specif arrang safeguard claus safeguard claus relat industri product parti measur deni free access market industri product bear ce mark subject annex immedi inform parti indic reason decis complianc assess parti matter evid brought knowledg report result investig case agreement parti measur ensur product market case disagr outcom investig matter forward associ council decid expertis carri associ council find measur unjustifi nation author parti measur withdraw justifi parti measur ensur product market safeguard claus relat harmonis standard czech republ consid harmonis standard refer legisl defin annex meet essenti requir legisl inform associ council give reason thereof associ council matter request commun proce accord procedur provid commun legisl identifi annex commun associ council parti inform proceed outcom procedur notifi parti annex mutual recognit result conform assess equip protect system intend potenti explos atmospher section commun nation law commun law european parliament council direct ec march approxim law member state equip protect system intend potenti explos atmospher oj nation law act coll part technic requir product amend act amend act coll part act coll part czech nation council czech trade inspect amend act coll part act coll part act coll part act coll part govern order coll part lai technic requir equip protect system intend potenti explos atmospher amend govern order coll part section ii notifi author european commun belgium ministèr de affair economiqu ministeri van economisch zaken denmark elektricitetsrådet germani bundesministerium für arbeit und sozialordnung greec ministri develop gener secretariat industri spain ministerio de ciencia tecnología franc ministèr de économi de financ de industri direct de action régional de la petit moyenn industri darpmi sou direct de la sécurité industriel ireland depart enterpris employ itali ministero dell industria del commercio dell artigianato luxembourg ministèr de economi servic de energi de etat netherland ministeri van social zaken en werkgelegenheid austria bundesministerium für wirtschaft und arbeit 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 czech republ úrad pro technick normalizaci metrologii státní zkusebnictví czech offic standard metrolog test section iii notifi bodi european commun bodi notifi member state commun accord commun law section notifi czech republ accord articl protocol czech republ bodi authoris czech republ accord czech nation law section notifi commun accord articl protocol section iv specif arrang transit arrang certif issu ec member state conform direct eec eec eec recognis proof conform assess articl act coll technic requir product amend act amend act coll base certif import product czech republ issu declar conform relev product applic requir refer paragraph safeguard claus safeguard claus relat industri product parti measur deni free access market industri product bear ce mark subject annex immedi inform parti indic reason decis complianc assess parti matter evid brought knowledg report result investig case agreement parti measur ensur product market case disagr outcom investig matter forward associ council decid expertis carri associ council find measur unjustifi nation author parti measur withdraw justifi parti measur ensur product market safeguard claus relat harmonis standard czech republ consid harmonis standard refer legisl defin annex meet essenti requir legisl inform associ council give reason thereof associ council matter request commun proce accord procedur provid commun legisl identifi annex commun associ council parti inform proceed outcom procedur notifi parti annex mutual recognit result conform assess hot water boiler section commun nation law commun law council direct eec effici requir hot water boiler fire liquid gaseou fuel oj amend council direct eec juli oj nation law act coll part technic requir product amend act amend act coll part act coll part czech nation council czech trade inspect amend act coll part act coll part act coll part act coll part govern order coll part lai technic requir hot water boiler fire liquid gaseou fuel amend govern order coll part section ii notifi author european commun belgium ministèr de affair economiqu ministeri van economisch zaken denmark boligministeriet germani bundesministerium für wirtschaft und technologi greec ministri develop gener secretariat industri spain ministerio de ciencia tecnología franc ministèr de économi de financ de industri direct de action régional de la petit moyenn industri darpmi sou direct de la sécurité industriel ireland depart enterpris employ itali ministero dell industria del commercio dell artigianato luxembourg ministèr de environn netherland ministeri van economisch zaken austria bundesministerium für wirtschaft und arbeit portug author govern portug instituto portuguê da qualidad finland ympäristöministeriö miljöministeriet sweden author govern sweden styrelsen för ackredit och teknisk kontrol swedac unit kingdom depart environ transport region czech republ úrad pro technick normalizaci metrologii státní zkusebnictví czech offic standard metrolog test section iii notifi bodi european commun bodi notifi member state commun accord commun law section notifi czech republ accord articl protocol czech republ bodi authoris czech republ accord czech nation law section notifi commun accord articl protocol section iv specif arrang safeguard claus safeguard claus relat industri product parti measur deni free access market industri product bear ce mark subject annex immedi inform parti indic reason decis complianc assess parti matter evid brought knowledg report result investig case agreement parti measur ensur product market case disagr outcom investig matter forward associ council decid expertis carri associ council find measur unjustifi nation author parti measur withdraw justifi parti measur ensur product market safeguard claus relat harmonis standard czech republ consid harmonis standard refer legisl defin annex meet essenti requir legisl inform associ council give reason thereof associ council matter request commun proce accord procedur provid commun legisl identifi annex commun associ council parti inform proceed outcom procedur notifi parti annex mutual recognit result conform assess ga applianc section commun nation law commun law council direct eec june approxim law member state relat applianc burn gaseou fuel oj amend council direct eec juli oj nation law act coll part technic requir product amend act amend act coll part act coll part czech nation council czech trade inspect amend act coll part act coll part act coll part act coll part govern order coll part lai technic requir applianc burn gaseou fuel amend govern order coll part section ii notifi author european commun belgium ministèr de affair economiqu ministeri van economisch zaken denmark danmark gasmateriel prøvning germani bundesministerium für arbeit und sozialordnung greec ministri develop gener secretariat industri spain ministerio de ciencia tecnología franc ministèr de économi de financ de industri direct de action régional de la petit moyenn industri darpmi sou direct de la sécurité industriel ireland depart enterpris employ itali ministero dell industria del commercio dell artigianato luxembourg ministèr du travail inspect du travail de mine netherland ministeri van economisch zaken austria bundesministerium für wirtschaft und arbeit 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 czech republ úrad pro technick normalizaci metrologii státní zkusebnictví czech offic standard metrolog test section iii notifi bodi european commun bodi notifi member state commun accord commun law section notifi czech republ accord articl protocol czech republ bodi authoris czech republ accord czech nation law section notifi commun accord articl protocol section iv specif arrang safeguard claus safeguard claus relat industri product parti measur deni free access market industri product bear ce mark subject annex immedi inform parti indic reason decis complianc assess parti matter evid brought knowledg report result investig case agreement parti measur ensur product market case disagr outcom investig matter forward associ council decid expertis carri associ council find measur unjustifi nation author parti measur withdraw justifi parti measur ensur product market safeguard claus relat harmonis standard czech republ consid harmonis standard refer legisl defin annex meet essenti requir legisl inform associ council give reason thereof associ council matter request commun proce accord procedur provid commun legisl identifi annex commun associ council parti inform proceed outcom procedur notifi parti annex mutual recognit result conform assess pressur equip section commun nation law commun law council direct eec june approxim law member state relat simpl pressur vessel oj amend council direct eec juli oj european parliament council direct ec approxim law member state pressur equip oj nation law act coll part technic requir product amend act amend act coll part act coll part czech nation council czech trade inspect amend act coll part act coll part act coll part act coll part govern order coll part lai technic requir simpl pressur vessel amend govern order coll part govern order coll part govern order coll part lai technic requir pressur equip amend govern order coll part section ii notifi author european commun belgium ministèr de affair economiqu ministeri van economisch zaken denmark direktoratet arbejdstilsynet germani bundesministerium für arbeit und sozialordnung greec ministri develop gener secretariat industri spain ministerio de ciencia tecnología franc ministèr de économi de financ de industri direct de action régional de la petit moyenn industri darpmi sou direct de la sécurité industriel ireland depart enterpris employ itali ministero dell industria del commercio dell artigianato luxembourg ministèr du travail de emploi netherland ministeri van social zaken en werkgelegenheid austria bundesministerium für wirtschaft und arbeit 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 czech republ úrad pro technick normalizaci metrologii státní zkusebnictví czech offic standard metrolog test section iii notifi bodi european commun bodi notifi member state commun accord commun law section notifi czech republ accord articl protocol czech republ bodi authoris czech republ accord czech nation law section notifi commun accord articl protocol section iv specif arrang safeguard claus safeguard claus relat industri product parti measur deni free access market industri product bear ce mark subject annex immedi inform parti indic reason decis complianc assess parti matter evid brought knowledg report result investig case agreement parti measur ensur product market case disagr outcom investig matter forward associ council decid expertis carri associ council find measur unjustifi nation author parti measur withdraw justifi parti measur ensur product market safeguard claus relat harmonis standard czech republ consid harmonis standard refer legisl defin annex meet essenti requir legisl inform associ council give reason thereof associ council matter request commun proce accord procedur provid commun legisl identifi present annex commun associ council parti inform proceed outcom procedur notifi parti annex mutual recognit result conform assess good manufactur practic gmp medicin product inspect batch certif section commun nation law commun law council direct eec januari approxim provis laid law regul administr action relat medicin product oj amend council direct eec june oj council direct eec approxim law member state relat analyt pharmaco toxicolog clinic standard protocol respect test proprietari medicin product oj amend commiss direct ec ec septemb oj council direct eec approxim provis laid law regul administr action relat medicin product oj amend council direct eec june oj council direct eec septemb approxim law member state relat veterinari medicin product oj amend council direct eec decemb oj direct eec septemb approxim law member state relat analyt pharmacotoxicolog clinic standard protocol respect test veterinari medicin product oj amend commiss direct ec decemb oj commiss direct eec june lai principl guidelin good manufactur practic medicin product human oj commiss direct eec juli lai principl guidelin good manufactur practic veterinari medicin product oj council regul eec juli lai commun procedur authoris supervis medicin product human veterinari establish european agenc evalu medicin product oj amend commiss regul ec march oj council direct eec march sale distribut medicin product human oj guid good distribut practic guid good manufactur practic volum iv rule govern medicin product european commun compil commun procedur administr collabor harmonis inspect iii en nation law act coll part pharmaceut amend act amend act coll part decre ministri health ministri agricultur coll part good manufactur practic good distribut practic specif condit permit drug manufactur distribut includ medic feedingstuff recommend procedur implement good manufactur practic good distribut practic offici journal sukl special issu februari gener requir state institut drug control praha sukl valid manufactur process offici journal sukl vyr gener requir sukl clean procedur valid offici journal sukl vyr clean room offici journal sukl vyr principl control activ sukl field good manufactur practic gmp manufactur distributor pharmaceut offici journal sukl vyr issu gmp certif offici journal sukl vyr gener requir sukl valid asept procedur offici journal sukl vyr requir sukl distributor medicin gase offici journal sukl di guidelin institut state control veterinari immunolog medica brno uskvbl recommend procedur implement good distribut practic offici journal uskvbl section ii offici gmp inspect servic parti european commun belgium ministèr de la santé publiqu de environn de intégrat social inspect pharmaceutiqu ministeri van volksgezondheid leefmilieu en social integrati farmaceutisch inspecti denmark lægemiddelstyrelsen danish medicin agenc germani bundesministerium für gesundheit greec ministri health welfar nation drug organis spain agencia española del medicamento franc ministèr de emploi de la solidarité direct générale de la santé pour le médicament usag humain human medicin product agenc français de sécurité sanitair de produit de santé afssap pour le médicament usag vétérinar veterinari medicin product agenc français de sécurité sanitair de aliment afssa agenc national du médicament vétérinair ireland irish medicin board itali ministero della sanità dipartimento farmaci farmacovigilanza human medicin product ministero della sanità dipartimento alimenti nutrizion sanità pubblica veterinaria veterinari medicin product luxembourg direct de la santé divis de la pharmaci de médicament netherland ministeri van volksgezondheid welzijn en sport inspecti volksgezondheid austria bundesministerium für sozial sicherheit und generationen portug author govern portug finland sosiaali ja terveysministeriö social och hälsovårdsministeriet sweden läkemedelsverket medic product agenc unit kingdom medicin control agenc veterinari medicin director czech republ státní ústav pro kontrolu léciv sukl state institut drug control praha ústav pro státní kontrolu veterinárních biopreparátu léciv uskvbl institut state control veterinari immunolog medica brno section iii specif arrang definit quot medicin product quot mean product regul pharmaceut legisl commun czech republ list section quot good manufactur practic gmp quot defin commiss direct eec commiss direct eec relev legisl czech republ list section quot inspect quot mean site evalu manufactur facil carri inspect servic list section ii determin manufactur facil oper complianc good manufactur practic commit made part market authoris quot inspect report quot mean written observ good manufactur practic complianc assess complet author list section ii scope coverag provis annex cover medicin product human veterinari industri manufactur czech republ commun gmp requir appli medicin product cover annex parti recognis conclus inspect carri relev inspect servic parti relev manufactur authoris grant compet author parti addit manufactur certif conform batch specif recognis parti control import pre oper phase pre oper phase activ carri effect implement legisl regulatori administr requir commun gmp czech republ determin procedur establish commun practic implement requir commun gmp determin joint inspect examin inspect report document link inspect length pre oper phase month result activ pre oper phase discuss compet expert group european commun inspector work parti particip compet author czech republ parti decid prolong termin pre oper phase associ council oper phase start immedi success termin pre oper phase parti decid associ council renounc pre oper phase time light demonstr implement mainten gmp czech republ oper phase certif manufactur request export import compet author parti author respons grant manufactur authoris supervis manufactur control medicin product certifi manufactur medicin product appropri authoris manufactur control relev medicin product carri relev oper compli commun czech republ gmp requir regularli inspect compet inspect servic certif identifi site manufactur guidanc common format certif certif issu expediti time exce calendar dai except case inspect carri period extend dai batch certif batch export accompani batch certif issu manufactur certif full qualit analysi quantit analysi activ constitu test check ensur qualiti product accord requir market authoris certif attest batch meet specif manufactur accord relev market authoris certif retain import batch made request compet author issu certif manufactur account provis current commun certif system batch certif sign person respons releas batch export quot qualifi person quot refer articl direct eec articl direct eec section act coll offici batch releas offici batch releas procedur addit verif safeti efficaci immunolog medicin product vaccin blood deriv carri compet author distribut batch product protocol encompass mutual recognit offici batch releas inspect gmp inspect carri local compet inspect servic gmp requir list section type inspect carri gener system inspect carri verifi manufactur compli gener gmp requir routin inspect cover fundament requir gmp process inspect carri verifi manufactur conduct process es gmp requir product steril water product inspect carri verifi manufactur produc medicin product seri product gmp requir focus valid complianc specif process control aspect market authoris quot pre market quot inspect inspector convers relev inform qualiti dossier applic authoris dossier regim inspect establish fee determin manufactur locat inspect establish fee charg manufactur locat territori parti product cover protocol transmiss inspect report reason request relev inspect servic forward copi inspect report manufactur control site case control oper contract parti deal inspect report degre confidenti request parti origin manufactur oper medicin product question inspect recent inspect date back year inspect identifi specif detail inspect request parti ensur inspect report forward calendar dai period extend dai inspect carri alert system compet author inform author parti speed case qualiti defect batch recal counterfeit problem qualiti necessit addit control suspens distribut batch detail alert procedur agre parti parti ensur suspens withdraw total partial manufactur authoris base complianc gmp affect protect public health commun degre urgenc exchang inform author approxim qualiti requir accord gener provis protocol parti exchang inform mutual recognit inspect addit relev compet author inform technic guidanc inspect procedur parti consult adopt endeavour proce approxim inspector train accord gener provis protocol train session inspector organis compet author access inspector parti parti inform session joint inspect accord gener provis protocol mutual agreement parti joint inspect authoris inspect intend develop common understand interpret practic requir set inspect form agre procedur approv parti contact point purpos protocol contact point alert system technic question exchang inspect report inspector train session technic requir commun director european agenc evalu medicin product czech republ case human medicin product director state institut drug control case veterinari medicin product director institut state control veterinari immunolog medica diverg view parti endeavour resolv diverg view inter alia complianc manufactur conclus inspect report unresolv diverg view refer associ council safeguard claus parti establish write object reason manner parti fail compli condit annex consult associ council associ council decid measur parti reserv conduct inspect reason identifi parti inspect notifi advanc parti option join inspect recours safeguard claus except inspect place inspect cost recov declar exchang inform parti merit adopt annex protocol concern exchang inform refer articl thereof object prevent potenti technic barrier extens czech republ principl contain direct ec european parliament council june lai procedur provis inform field technic standard regul end simplifi procedur prepar annex protocol oj direct amend direct ec oj declar commun attend czech repres committe meet order ensur understand practic aspect applic acqui communautair commun declar czech republ invit condit meet committe establish refer commun law machineri lift person protect equip electromagnet compat equip protect system intend potenti explos atmospher ga applianc simpl pressur vessel pressur equip particip limit meet part thereof applic acqui discuss entail attend meet intend prepar issu opinion implement manag power deleg commiss council invit extend case case basi group expert conven commiss