direct ec european parliament council march amend direct ec commun code relat veterinari medicin product european parliament council european union regard treati establish european commun articl articl thereof regard propos commiss regard opinion european econom social committe consult committe region act accord procedur refer articl treati direct ec european parliament council octob commun code relat veterinari medicin product codifi consolid previou commun legisl veterinari medicin product singl text interest clariti rationalis commun legisl adopt made major contribut achiev object free safe movement veterinari medicin product elimin obstacl trade product light experi gain clear measur elimin remain obstacl free movement align nation law regul administr provis differ regard basic principl order promot oper intern market advers affect public health main purpos regul manufactur distribut veterinari medicin product safeguard anim health welfar public health legisl market authoris veterinari medicin product criteria govern grant authoris strengthen protect public health aim achiev mean hinder develop pharmaceut industri trade veterinari medicin product commun articl council regul eec juli lai commun procedur authoris supervis medicin product human veterinari establish european agenc evalu medicin product provid year entri forc commiss requir publish gener report experi acquir result oper market authoris procedur laid regul commun legal provis light commiss report experi acquir prove improv oper market authoris procedur veterinari medicin product commun result scientif technic progress field anim health definit scope direct ec clarifi order achiev high standard qualiti safeti efficaci veterinari medicin product order account emerg therapi grow number call quot borderlin quot product medicin product sector sector definit quot medicin product quot modifi avoid doubt applic legisl product whilst fulli fall definit medicin product fall definit regul product view characterist pharmaceut legisl provis made legisl appli object clarifi situat product definit veterinari medicin product fall definit regul product case doubt order ensur legal certainti state explicitli provis compli product definit product categori food feed feed addit biocid direct appli improv consist terminolog pharmaceut legisl veterinari medicin product sector number specif featur veterinari medicin product food produc anim authoris condit guarante foodstuff produc harmless consum residu medicin product cost research develop meet increas requir qualiti safeti efficaci veterinari medicin product lead gradual reduct rang product authoris speci indic repres smaller market sector provis direct ec adapt specif featur sector meet health welfar food produc anim term guarante high level consum protect context adequ econom interest veterinari medicin product industri circumst type pet concern obtain market authoris veterinari medicin product accord commun provis disproportion absenc authoris market immunolog product commun obstacl intern movement live anim purpos bind health measur provis authoris medicin product account measur combat infecti anim diseas commun level adapt evalu oper market authoris procedur reveal revis mutual recognit procedur order improv opportun cooper member state cooper process formalis set coordin group procedur defin oper settl disagr framework revis decentralis procedur regard referr experi acquir reveal procedur case referr relat entir therapeut class veterinari medicin product activ substanc market authoris veterinari medicin product limit initi year renew market authoris valid unlimit period authoris consecut year led place market veterinari medicin product member state concern period consid invalid order avoid administr burden maintain authoris exempt rule grant justifi public anim health ground biolog medicin product similar refer medicin product meet condit consid gener medicin product due manufactur process characterist raw materi molecular characterist therapeut mode action biolog product meet condit consid gener medicin product result test provid order fulfil requir relat safeti pre clinic test efficaci clinic test criteria qualiti safeti efficaci enabl risk benefit balanc veterinari medicin product assess market time compet author deem connect harmonis adapt criteria refus suspens revoc market authoris veterinari sector medicin product authoris speci disord possibl exist product made straightforward matter prejud consum health case medicin product intend administr food produc anim medicin product condit guarante foodstuff produc harmless consum residu medicin product stimul interest veterinari pharmaceut industri market segment order encourag develop veterinari medicin product period administr data protect vi vi gener harmonis clarifi oblig divis respons applic market authoris holder market authoris compet author charg monitor qualiti foodstuff complianc provis veterinari medicin product addit order facilit test medicin product guarante high level protect consum suffici long withdraw period laid foodstuff anim involv test produc prejudic provis aim guarante consum protect specif characterist homeopath veterinari medicin product organ farm account establish simplifi procedur registr term defin advanc order increas inform user improv consum protect case food produc anim provis label veterinari medicin product accompani packag leaflet strengthen requir veterinari medicin product dispens veterinari prescript made gener principl extend medicin product food produc anim grant exempt administr procedur suppli medicin product pet hand simplifi qualiti veterinari medicin product manufactur commun guarante requir activ substanc composit compli principl good manufactur practic prove reinforc commun provis inspect compil commun regist result inspect provis offici releas batch immunolog medicin product review order account improv gener system monitor qualiti medicin product reflect technic scientif progress order make mutual recognit fulli effect environment impact studi consider case case basi specif provis seek limit pharmacovigil gener market surveil sanction event failur compli provis step field pharmacovigil account facil offer inform technolog improv exchang member state measur implement direct adopt accord council decis ec june lai procedur exercis implement power confer commiss direct ec amend adopt direct articl direct ec amend articl amend point delet point replac quot veterinari medicin product substanc combin substanc present properti treat prevent diseas anim substanc combin substanc administ anim view restor correct modifi physiolog function exert pharmacolog immunolog metabol action make medic diagnosi quot point delet point replac quot homeopath veterinari medicin product veterinari medicin product prepar substanc call homeopath stock accord homeopath manufactur procedur european pharmacopoeia absenc thereof pharmacopoeia offici member state homeopath veterinari medicin product number principl withdraw period period administr veterinari medicin product anim normal condit accord provis direct product foodstuff anim order protect public health ensur foodstuff residu quantiti excess maximum residu limit activ substanc laid pursuant regul eec advers reaction reaction veterinari medicin product harm unintend occur dose anim prophylaxi diagnosi treatment diseas restor correct modifi physiolog function quot point insert quot repres market authoris holder person commonli local repres design market authoris holder repres member state concern quot point replac quot agenc european medicin agenc establish regul ec quot point replac quot risk relat product risk relat qualiti safeti efficaci veterinari medicin product anim human health risk undesir effect environ quot point ad quot risk benefit balanc evalu posit therapeut effect veterinari medicin product relat risk defin veterinari prescript prescript veterinari medicin product issu profession person qualifi accord applic nation law veterinari medicin product invent liabl confus common common scientif accompani trademark market authoris holder common intern proprietari recommend world health organis exist usual common strength content activ substanc express quantit dosag unit unit volum weight dosag form packag contain form packag direct contact medicin product outer packag packag packag label inform outer packag packag leaflet leaflet inform user accompani medicin product quot articl replac quot articl direct appli veterinari medicin product includ pre mix medic feedingstuff intend market member state prepar industri method involv industri process case doubt take account characterist product fall definit veterinari medicin product definit product cover commun legisl provis direct appli notwithstand paragraph direct appli activ substanc start materi extent set articl addition substanc veterinari medicin product anabol anti infecti anti parasit anti inflammatori hormon psychotrop properti extent set articl articl direct appli medic feedingstuff defin council direct eec march lai condit govern prepar place market medic feedingstuff commun inactiv immunolog veterinari medicin product manufactur pathogen antigen obtain anim anim hold treatment anim anim hold local veterinari medicin product base radio activ isotop addit cover council direct eec novemb addit feedingstuff incorpor anim feedingstuff supplementari anim feedingstuff accord direct prejudic articl medicin product veterinari intend research develop trial medic feedingstuff refer subparagraph prepar pre mix authoris direct provis possess prescript dispens administr veterinari medicin product direct appli medicin product prepar pharmaci accord veterinari prescript individu anim small group anim commonli magistr formula medicin product prepar pharmaci accord prescript pharmacopoeia intend suppli directli end user commonli officin formula quot articl replac quot case veterinari medicin product intend sole aquarium fish cage bird home pigeon terrarium anim small rodent ferret rabbit exclus pet member state permit exempt territori provis articl provid product substanc requir veterinari control measur prevent unauthoris product anim quot articl replac quot articl veterinari medicin product market member state market authoris grant compet author member state accord direct market authoris grant accord regul ec veterinari medicin product grant initi authoris accord subparagraph addit speci strength pharmaceut form administr rout present variat extens grant authoris accord subparagraph includ initi market authoris market authoris consid belong global market authoris purpos applic articl market authoris holder respons market medicin product design repres reliev market authoris holder legal respons articl veterinari medicin product subject market authoris purpos administ food produc speci pharmacolog activ substanc annex ii iii regul eec amend annex regul eec warrant market authoris holder compet author measur amend revok market authoris dai date amend annex regul publish offici journal european union derog paragraph veterinari medicin product pharmacolog activ substanc includ annex ii iii regul eec authoris anim equida famili declar accord commiss decis eec octob establish identif document passport accompani regist equida commiss decis ec decemb amend decis eec establish identif equida breed product intend slaughter human consumpt veterinari medicin product includ activ substanc annex iv regul eec intend treatment condit detail authoris summari product characterist veterinari medicin product authoris anim equida famili quot articl replac quot articl event epizoot diseas member state provision immunolog veterinari medicin product market authoris absenc suitabl medicin product inform commiss detail condit commiss avail option set paragraph explicit provis made option commun rule epizoot diseas anim import export countri subject specif bind health rule member state permit anim question immunolog veterinari medicin product cover market authoris member state question authoris legisl countri member state measur supervis import immunolog product quot articl replac quot articl member state measur ensur authoris veterinari medicin product member state condit affect food produc speci except veterinarian respons direct person respons avoid caus unaccept suffer treat anim concern veterinari medicin product authoris member state concern direct regul ec anim speci condit speci product refer point medicin product authoris human member state concern accord direct ec european parliament council regul ec ii accord specif nation measur veterinari medicin product authoris member state accord direct speci speci condit question condit product refer subparagraph limit law member state concern veterinari medicin product prepar extemporan person authoris nation legisl accord term veterinari prescript veterinarian administ medicin product person person veterinarian respons derog articl provis paragraph articl appli treatment veterinarian anim belong equida famili provid declar accord commiss decis eec ec intend slaughter human consumpt derog articl accord procedur refer articl commiss establish list substanc essenti treatment equida withdraw period month control mechan laid commiss decis eec ec articl member state measur ensur authoris veterinari medicin product member state condit affect food produc speci except veterinarian respons direct person respons avoid caus unaccept suffer treat anim concern hold veterinari medicin product authoris member state concern direct regul ec anim speci condit speci product refer point medicin product human authoris member state concern accord direct ec regul ec ii veterinari medicin product authoris member state accord direct speci food produc speci condit question condit product refer subparagraph limit law member state concern veterinari medicin product prepar extemporan person authoris nation legisl accord term veterinari prescript veterinarian administ medicin product person person veterinarian respons paragraph appli provid pharmacolog activ substanc includ medicin product list annex ii iii regul eec veterinarian specifi withdraw period medicin product withdraw period speci concern withdraw period dai egg dai milk dai meat poultri mammal includ fat offal degre dai fish meat specif withdraw period modifi accord procedur refer articl regard homeopath veterinari medicin product activ principl figur annex ii regul eec withdraw period refer subparagraph paragraph reduc veterinarian recours provis paragraph articl adequ record date examin anim detail owner number anim treat diagnosi medicin product prescrib dose administ durat treatment withdraw period recommend make record inspect compet author period year prejudic provis direct member state measur import distribut dispens inform medicin product permit administr food produc anim accord paragraph ii articl purpos obtain market authoris respect veterinari medicin product procedur establish regul ec applic lodg compet author member state concern case veterinari medicin product intend food produc speci pharmacolog activ substanc includ speci question annex ii iii regul eec market authoris appli valid applic made establish maximum residu limit accord regul month elaps valid applic establish maximum residu limit applic market authoris case veterinari medicin product refer articl market authoris appli valid applic accord regul eec scientif document demonstr qualiti safeti efficaci veterinari medicin product provid paragraph submit market authoris grant applic establish commun applic market authoris includ administr inform scientif document demonstr qualiti safeti efficaci veterinari medicin product question file submit accord annex inform busi perman address regist place busi person respons place product market manufactur manufactur involv site manufactur veterinari medicin product qualit quantit particular constitu veterinari medicin product includ intern proprietari inn recommend inn exist chemic descript method manufactur therapeut indic contra indic advers reaction dosag speci anim veterinari medicin product intend pharmaceut form method rout administr propos shelf life reason precautionari safeti measur store veterinari medicin product administ anim dispos wast indic potenti risk veterinari medicin product pose environ human anim health plant indic withdraw period case medicin product intend food produc speci descript test method emploi manufactur result pharmaceut physico chemic biolog microbiolog test safeti test residu test pre clinic clinic trial test assess potenti risk pose medicin product environ impact studi consider case case basi specif provis seek limit detail descript pharmacovigil system risk manag system applic put place summari accord articl product characterist mock packag outer packag veterinari medicin product packag leaflet accord articl document show manufactur authoris countri produc veterinari medicin product copi market authoris obtain member state countri relev veterinari medicin product list member state applic authoris submit accord direct examin copi summari product characterist propos applic accord articl approv compet author member state accord articl copi packag insert propos detail decis refus authoris commun countri reason decis inform updat regular basi proof applic servic qualifi person respons pharmacovigil mean notif advers reaction suspect occur commun countri case veterinari medicin product intend food produc speci pharmacolog activ substanc includ speci question annex ii iii regul eec document certifi valid applic establish maximum residu limit submit agenc accord aforement regul document particular relat result test refer point subparagraph accompani detail critic summari drawn articl articl derog point subparagraph articl prejudic law relat protect industri commerci properti applic requir provid result safeti residu test pre clinic clinic trial demonstr medicin product gener refer medicin product authoris articl year member state commun gener veterinari medicin product authoris pursuant provis market ten year elaps initi authoris refer product subparagraph appli refer medicin product authoris member state applic gener medicin product submit case applic applic member state refer medicin product authoris request compet author member state applic submit compet author member state transmit period month confirm refer medicin product authoris full composit refer product relev document ten year period provid subparagraph extend year case veterinari medicin product fish bee speci design accord procedur refer articl purpos articl refer medicin product product authoris mean articl accord provis articl gener medicin product medicin product qualit quantit composit activ substanc pharmaceut form refer medicin product bioequival refer medicin product demonstr bioavail studi salt ester ether isom mixtur isom complex deriv activ substanc consid activ substanc differ significantli properti regard safeti efficaci case addit inform intend provid proof safeti efficaci salt ester deriv authoris activ substanc suppli applic releas oral pharmaceut form consid pharmaceut form bioavail studi requir applic demonstr gener medicin product meet relev criteria defin detail guidelin case veterinari medicin product fall definit gener medicin product set paragraph bio equival demonstr bioavail studi case activ substanc therapeut indic strength pharmaceut form rout administr vi vi refer medicin product result safeti residu test pre clinic test clinic trial provid biolog veterinari medicin product similar refer biolog veterinari medicin product meet condit definit gener medicin product ow differ relat raw materi manufactur process biolog veterinari medicin product refer biolog veterinari medicin product result pre clinic test clinic trial relat condit provid type quantiti supplementari data provid compli relev criteria state annex relat detail guidelin result test trial refer medicin product dossier provid case veterinari medicin product intend food produc speci activ substanc authoris commun april ten year period provid subparagraph paragraph extend year extens market authoris food produc speci authoris year grant initi market authoris period exce total year market authoris food produc speci extens ten year period year veterinari medicin product intend food produc speci grant market authoris holder origin appli determin maximum residu limit establish speci cover authoris conduct studi test trial view applic paragraph consequenti practic requir regard contrari patent relat right supplementari protect certif medicin product quot articl insert quot articl derog point subparagraph articl prejudic law protect industri commerci properti applic requir provid result safeti residu test pre clinic test clinic trial demonstr activ substanc veterinari medicin product establish veterinari commun ten year recognis efficaci accept level safeti term condit set annex event applic provid scientif literatur assess report publish agenc evalu applic establish maximum residu limit accord regul eec manner literatur safeti test applic make scientif literatur obtain authoris food produc speci submit respect medicin product view obtain authoris food produc speci residu studi accord regul eec clinic trial permiss parti studi trial pursuant articl period year grant authoris carri articl case veterinari medicin product activ substanc composit authoris veterinari medicin product hitherto combin therapeut purpos result safeti residu test pre clinic test clinic trial relat combin provid accord point subparagraph articl provid scientif refer relat individu activ substanc articl market authoris grant market authoris holder made pharmaceut safeti residu pre clinic clinic document contain file veterinari medicin product view examin subsequ applic veterinari medicin product qualit quantit composit activ substanc pharmaceut form articl derog point subparagraph articl except circumst respect immunolog veterinari medicin product applic requir provid result field trial target speci trial carri duli substanti reason account commun provis quot articl replac quot articl summari product characterist order inform veterinari medicin product strength pharmaceut form qualit quantit composit term activ substanc constitu excipi knowledg essenti proper administr medicin product usual common chemic descript pharmaceut form clinic particular target speci indic target speci contra indic special warn target speci special precaut includ special precaut person administ medicin product anim advers reaction frequenc serious pregnanc lactat lai interact medicin product form interact amount administ administr rout overdos symptom emerg procedur antidot withdraw period foodstuff includ withdraw period pharmacolog properti pharmacodynam properti pharmacokinet particular pharmaceut particular list excipi major incompat shelf life reconstitut medicin product packag open time special precaut storag natur composit packag special precaut dispos unus veterinari medicin product wast materi deriv product market authoris holder market authoris number date authoris date renew authoris date revis text authoris articl part summari product characterist refer medicin product refer indic dosag form cover patent law time gener medicin market includ articl applic ensur detail critic summari refer subparagraph articl draft sign person requisit technic profession qualif set curriculum vita submit compet author person technic profession qualif refer paragraph justifi made scientif literatur refer articl accord condit set annex curriculum vita person refer paragraph append detail critic summari articl member state ensur homeopath veterinari medicin product manufactur market commun regist authoris accord articl veterinari medicin product cover registr authoris grant accord nation legisl decemb case homeopath medicin product regist accord articl articl articl appli member state establish simplifi registr procedur homeopath veterinari medicin product refer articl derog articl homeopath veterinari medicin product administ food produc anim respons veterinarian derog articl member state permit administr homeopath veterinari medicin product intend food produc speci activ constitu annex ii regul eec respons veterinarian member state measur control veterinari homeopath medicin product regist authoris member state accord direct speci quot articl amend paragraph replac quot prejudic provis regul eec establish maximum residu limit pharmacolog activ substanc intend food produc anim homeopath veterinari medicin product satisfi condit subject special simplifi registr procedur administ rout european pharmacopoeia absenc thereof pharmacopoeia offici member state specif therapeut indic appear label veterinari medicin product inform relat thereto suffici degre dilut guarante safeti medicin product medicin product part mother tinctur appear justifi light scientif evid point subparagraph adapt accord procedur refer articl time registr member state determin classif dispens medicin product quot paragraph delet articl amend indent replac quot manufactur control file pharmaceut form descript method dilut potentis quot sixth indent replac quot mock up outer packag packag medicin product regist quot eighth indent ad quot propos withdraw period requisit justif quot articl replac quot articl homeopath veterinari medicin product refer articl authoris accord articl member state introduc retain territori specif rule safeti test pre clinic clinic trial homeopath veterinari medicin product intend pet speci food produc exot speci refer articl accord principl characterist homeopathi practis member state case member state concern notifi commiss specif rule forc quot articl replac quot articl member state measur ensur procedur grant market authoris veterinari medicin product complet maximum dai submiss valid applic applic market authoris veterinari medicin product member state submit accord articl member state note market authoris applic medicin product examin member state member state concern declin assess applic advis applic articl appli articl member state inform accord point articl member state authoris veterinari medicin product subject applic authoris member state concern member state reject applic submit complianc articl articl order examin applic submit pursuant articl member state compet author check document submit support applic compli articl ascertain condit issu market authoris fulfil submit medicin product start materi intermedi product constitu materi test offici medicin control laboratori laboratori member state design purpos order ensur test method emploi manufactur applic document accord point subparagraph articl satisfactori similarli check consult nation commun refer laboratori analyt method detect residu present applic purpos articl indent satisfactori requir applic provid inform item list articl compet author action time limit articl suspend data requir provid similarli time limit suspend period applic provid oral written explan quot articl replac quot articl grant market authoris compet author inform holder summari product characterist approv compet author measur ensur inform veterinari medicin product label packag leaflet conform summari product characterist approv market authoris grant subsequ compet author make market authoris publicli delai summari product characterist veterinari medicin product authoris compet author draw assess report comment file result pharmaceut safeti residu test pre clinic clinic trial veterinari medicin product concern assess report updat inform import evalu qualiti safeti efficaci veterinari medicin product concern compet author make assess report reason opinion publicli delai delet inform commerci confidenti natur quot articl amend paragraph replac quot market authoris requir holder packag outer wrap packag leaflet requir particular essenti safeti health protect includ special precaut relat warn result clinic pharmacolog trial prescrib articl articl experi gain veterinari medicin product market quot paragraph delet paragraph replac quot except circumst consult applic authoris grant subject requir applic introduc specif procedur safeti veterinari medicin product notif compet author incid relat action authoris grant object verifi reason continu authoris link annual reassess condit quot articl amend paragraph replac quot compet author requir applic market authoris holder provid suffici quantiti substanc enabl control made identif presenc residu veterinari medicin product question compet author request market authoris holder provid technic expertis facilit implement analyt method detect residu veterinari medicin product nation refer laboratori design council direct ec april measur monitor substanc residu thereof live anim anim product authoris holder immedi suppli compet author inform entail amend particular document refer articl annex immedi inform compet author prohibit restrict impos compet author countri veterinari medicin product market inform influenc assess benefit risk veterinari medicin product concern order permit continu assess risk benefit balanc compet author time market authoris holder forward data demonstr risk benefit balanc remain favour quot paragraph delet paragraph replac quot market authoris holder immedi inform compet author view authoris alter propos make particular document refer articl quot articl insert quot articl market authoris grant holder authoris inform compet author authoris member state date actual place market veterinari medicin product member state take account present authoris holder notifi compet author product ceas market member state temporarili perman notif except circumst made month interrupt place market product request compet author context pharmacovigil market authoris holder provid compet author data relat volum sale veterinari medicin product data possess relat volum prescript quot articl replac quot articl prejudic paragraph market authoris valid year authoris renew year basi evalu risk benefit balanc end market authoris holder submit consolid list document submit respect qualiti safeti efficaci includ variat introduc market authoris grant month market authoris ceas valid accord paragraph compet author requir applic submit list document time renew market authoris valid unlimit period compet author decid justifi ground relat pharmacovigil proce addit year renew accord paragraph authoris year grant actual place market authoris veterinari medicin product authoris member state ceas valid authoris veterinari medicin product previous market authoris member state longer present market member state period consecut year authoris grant veterinari medicin product ceas valid compet author except circumst human anim health ground grant exempt paragraph exempt duli justifi quot articl replac quot articl market authoris refus file submit compet author compli articl articl authoris refus examin document particular list articl clear risk benefit balanc veterinari medicin product authoris condit unfavour applic concern veterinari medicin product zootechn regard benefit anim health welfar consum safeti product therapeut effect applic provid suffici proof effect speci anim treat qualit quantit composit state withdraw period recommend applic long ensur foodstuff obtain treat anim residu constitut health hazard consum insuffici substanti label packag leaflet propos applic compli direct veterinari medicin product offer sale prohibit commun provis commun legisl framework adopt compet author refus authoris veterinari medicin product action protect public health consum anim health applic market authoris holder respons accuraci document data submit quot titl chapter replac quot chapter mutual recognit procedur decentralis procedur quot articl replac quot articl coordin group set examin question relat market authoris veterinari medicin product member state accord procedur laid chapter agenc provid secretariat coordin group coordin group compos repres member state appoint renew period year member group arrang accompani expert coordin group draw rule procedur enter forc favour opinion commiss rule procedur made public articl view grant market authoris veterinari medicin product member state applic submit applic base ident dossier member state dossier administr inform scientif technic document articl document submit includ list member state concern applic applic request member state act refer member state prepar assess report respect veterinari medicin product accord paragraph assess report evalu purpos articl articl veterinari medicin product receiv market authoris time applic concern member state recognis market authoris grant refer member state end market authoris holder request refer member state prepar assess report respect veterinari medicin product updat exist assess report refer member state prepar updat assess report dai receipt valid applic assess report approv summari product characterist label packag leaflet forward concern member state applic veterinari medicin product receiv authoris time applic applic request refer member state prepar draft assess report draft summari product characterist label packag leaflet refer member state prepar draft dai receipt valid applic send concern member state applic dai receipt document refer paragraph member state concern approv assess report summari product characterist label packag leaflet inform refer member state refer member state record agreement parti close procedur inform applic member state applic paragraph submit adopt decis conform approv assess report summari product characterist label packag leaflet dai acknowledg agreement articl member state period allow articl agre assess report summari product characterist label packag leaflet ground potenti risk human anim health environ detail statement reason provid refer member state member state concern applic point disagr refer delai coordin group member state applic submit invok reason refer articl longer regard member state concern chapter commiss adopt guidelin defin potenti risk human anim health environ coordin group member state refer paragraph endeavour reach agreement action provid applic opportun make point view oral write dai commun reason disagr coordin group member state reach agreement refer member state record agreement close procedur inform applic articl appli period dai member state fail reach agreement agenc immedi inform view applic procedur laid articl agenc provid detail descript matter agreement reach reason disagr applic provid copi inform applic inform matter refer agenc forthwith forward agenc copi inform document refer subparagraph articl case refer paragraph member state approv assess report summari product characterist label packag leaflet refer member state request applic grant market authoris veterinari medicin product wait outcom procedur laid articl case authoris grant prejudic outcom procedur articl applic submit accord articl made market authoris veterinari medicin product member state adopt diverg decis authoris veterinari medicin product suspens revoc authoris member state commiss market authoris holder refer matter committe medicin product veterinari hereinaft refer committe applic procedur laid articl view promot harmonis veterinari medicin product authoris commun strengthen effici provis articl member state send coordin group april list veterinari medicin product harmonis summari product characterist prepar coordin group agre list medicin product basi propos member state forward list commiss medicin product list subject provis paragraph accord timet establish cooper agenc commiss act collabor agenc take consider view interest parti agre final list timet articl member state commiss applic market authoris holder specif case interest commun involv refer matter committe applic procedur laid articl decis reach request market authoris suspens withdraw authoris variat term market authoris account inform collect accord titl vii member state concern commiss identifi question refer committe consider inform applic market authoris holder member state applic market authoris holder forward committe inform relat matter question referr committe concern rang medicin product therapeut class agenc limit procedur specif part authoris case articl appli medicin product cover market authoris procedur refer chapter articl refer made procedur laid articl committe matter concern issu reason opinion dai date matter refer case submit committe accord articl period extend committe period dai take account view market authoris holder concern emerg propos chairman committe agre shorter deadlin order matter committe appoint member act rapporteur committe appoint independ expert advis specif question appoint expert committe defin task time limit complet task issu opinion committe provid applic market authoris holder opportun present written oral explan time limit opinion committe includ draft summari product characterist draft label packag leaflet consid committe invit person provid inform relat matter committe suspend time limit refer paragraph applic market authoris holder prepar explan agenc forthwith inform applic market authoris holder opinion committe applic satisfi criteria authoris summari product characterist propos applic market authoris holder accord articl amend authoris grant subject condit regard condit consid essenti safe effect veterinari medicin product includ pharmacovigil market authoris suspend vari revok dai receipt opinion applic market authoris holder notifi agenc write intent request examin opinion case forward agenc detail ground request dai receipt opinion dai receipt ground request committe examin opinion accord fourth subparagraph articl regul ec reason conclus reach annex assess report refer paragraph articl dai adopt agenc forward final opinion committe member state commiss applic market authoris holder report describ assess veterinari medicin product reason conclus event opinion favour grant maintain market authoris document annex opinion draft summari product characterist refer articl reflect differ veterinari condit member state condit affect authoris mean paragraph detail recommend condit restrict regard safe effect veterinari medicin product draft label packag leaflet articl dai receipt opinion commiss prepar draft decis respect applic take account commun law event draft decis envisag grant market authoris document refer subparagraph articl annex exception draft decis accord opinion agenc commiss annex detail explan reason differ draft decis forward member state applic market authoris holder quot articl amend paragraph replac quot commiss final decis accord dai end procedur refer articl quot paragraph indent replac quot member state dai forward written observ draft decis commiss decis urgent shorter time limit set chairman degre urgenc involv time limit except circumst shorter dai member state option submit written request draft decis discuss plenari meet stand committe quot paragraph replac quot decis refer paragraph address member state commun market authoris holder applic inform concern member state refer member state grant withdraw market authoris vari term market authoris compli decis dai notif refer inform commiss agenc quot articl subparagraph paragraph delet articl paragraph replac quot ten year commiss publish report experi gain basi procedur provid chapter propos amend improv procedur commiss submit report european parliament council quot articl replac quot articl articl appli homeopath veterinari medicin product refer articl articl appli homeopath veterinari medicin product refer articl quot articl paragraph ad quot member state forward agenc copi manufactur authoris refer paragraph agenc enter inform commun databas refer articl quot articl point replac quot compli principl guidelin good manufactur practic medicin product start materi activ substanc manufactur accord detail guidelin good manufactur practic start materi quot articl insert quot articl purpos direct manufactur activ substanc start materi includ complet partial manufactur import activ substanc start materi defin part section annex process divid packag present prior incorpor veterinari medicin product includ repackag label carri start materi distributor amend adapt provis articl scientif technic progress adopt accord procedur refer articl quot articl paragraph ad quot principl good manufactur practic manufactur activ substanc start materi refer articl adopt form detail guidelin commiss publish guidelin form content authoris refer articl report refer articl form content certif good manufactur practic refer articl quot articl paragraph replac quot member state ensur qualifi person refer articl fulfil condit qualif refer paragraph quot articl paragraph replac quot person engag member state activ person refer articl date direct eec applic compli provis articl elig continu engag activ commun quot articl paragraph replac quot case veterinari medicin product come countri manufactur commun product batch import undergon member state full qualit analysi quantit analysi activ substanc test control ensur qualiti veterinari medicin product accord requir market authoris quot articl amend paragraph amend introductori word replac quot case medicin product refer articl compet author approv packag outer packag veterinari medicin product packag bear inform conform particular document provid pursuant articl summari product characterist legibl charact quot ii point replac quot medicin product strength pharmaceut form common medicin product activ substanc invent statement activ substanc express qualit quantit unit form administr volum weight common name quot iii point replac quot corpor perman address regist place busi market authoris holder repres design market authoris holder quot iv point replac quot speci anim veterinari medicin product intend method rout administr space provid prescrib dose quot point replac quot withdraw period veterinari medicin product administ food produc speci speci concern foodstuff concern meat offal egg milk honei includ withdraw period quot vi point replac quot specif precaut relat dispos unus medicin product wast deriv veterinari medicin product refer collect system place quot vii point replac quot word anim treatment case medicin product refer articl word anim treatment suppli veterinari prescript quot paragraph ad quot case medicin product grant market authoris regul ec member state permit requir outer packag bear addit inform distribut possess sale precaut provid inform infring commun law term market authoris promot addit inform box blue border separ inform refer paragraph quot articl amend introductori word paragraph replac quot ampoul particular list paragraph articl outer packag packag particular quot paragraph replac quot small packag singl dose ampoul imposs give particular mention paragraph requir articl appli outer packag particular mention sixth indent paragraph outer packag packag medicin product languag languag countri market quot articl replac quot articl outer packag particular featur packag pursuant articl shown packag quot articl amend paragraph replac quot inclus packag leaflet packag veterinari medicin product obligatori inform requir articl convei packag outer packag member state measur ensur packag leaflet relat sole veterinari medicin product includ packag leaflet written term comprehens gener public offici languag languag member state medicin product market subparagraph prevent packag leaflet written languag provid inform ident languag compet author exempt label packag leaflet specif veterinari medicin product oblig particular leaflet offici languag languag member state product market product intend administ veterinarian quot paragraph amend introductori word replac quot compet author approv packag leaflet leaflet inform order conform particular document provid pursuant articl approv summari product characterist quot ii point replac quot corpor perman address regist place busi market authoris holder manufactur repres market authoris holder veterinari medicin product strength pharmaceut form common product activ substanc invent medicin product authoris procedur provid articl name member state concern list name authoris member state quot paragraph delet articl replac quot articl provis titl observ formal notic address person concern ineffectu member state compet author suspend revok market authoris quot articl amend introductori word replac quot addit clear mention word homeopath veterinari medicin product approv therapeut indic label packag leaflet homeopath veterinari medicin product refer articl bear inform inform quot indent replac quot scientif stock stock degre dilut symbol pharmacopoeia accord point articl homeopath veterinari medicin product compos stock label mention invent addit scientif name stock quot titl titl vi replac quot titl vi possess distribut dispens veterinari medicin product quot articl amend paragraph insert quot holder distribut authoris emerg plan guarante effect implement recal oper order compet author undertaken cooper manufactur medicin product question holder market authoris quot paragraph insert quot distributor market authoris holder import product member state notifi market authoris holder compet author member state product import intent import case product grant authoris pursuant regul ec notif compet author prejudic addit procedur provid legisl member state quot articl amend paragraph amend introductori word replac quot person permit paragraph suppli veterinari medicin product requir detail record veterinari medicin product suppli prescript inform record respect incom outgo transact quot ii subparagraph replac quot record inspect compet author period year quot paragraph replac quot member state permit suppli territori veterinari medicin product food produc anim veterinari prescript requir supervis person regist purpos guarante respect qualif record keep report accord nation law member state notifi commiss relev provis nation law provis appli suppli veterinari medicin product oral parenter treatment bacteri infect quot paragraph delet articl amend paragraph amend introductori word replac quot prejudic stricter commun nation rule relat dispens veterinari medicin product serv protect human anim health veterinari prescript requir dispens public veterinari medicin product quot ii point insert quot aa veterinari medicin product food produc anim member state grant exempt requir criteria establish accord procedur refer articl member state continu appli nation provis date applic decis adopt accord subparagraph ii januari decis adopt decemb quot iii indent point delet iv point replac quot offici formula mean articl intend food produc anim quot paragraph replac quot member state measur ensur case medicin product suppli prescript quantiti prescrib suppli restrict minimum amount requir treatment therapi concern addit prescript requir veterinari medicin product activ substanc authoris veterinari medicin product fewer year quot paragraph articl replac quot member state ensur owner keeper food produc anim provid proof purchas possess administr veterinari medicin product anim year administr includ anim slaughter year period quot introductori word articl replac quot derog articl prejudic articl member state ensur veterinarian provid servic member state administ anim small quantiti veterinari medicin product exceed daili requir immunolog veterinari medicin product authoris member state servic provid hereinaft host member state provid condit satisfi quot subparagraph ad articl quot member state invok provis subparagraph order withhold market authoris accord decentralis procedur provid articl quot articl paragraph replac quot member state impos specif requir veterinari practition health care profession respect report suspect unexpect advers reaction human advers reaction quot articl amend paragraph replac quot order ensur adopt harmonis regulatori decis veterinari medicin product authoris commun regard inform obtain suspect advers reaction veterinari medicin product normal condit member state administ veterinari pharmacovigil system system collect inform surveil veterinari medicin product refer advers reaction anim human be relat veterinari medicin product evalu inform scientif quot paragraph paragraph insert quot member state ensur suitabl inform collect system commun member state agenc inform record databas refer point subparagraph articl regul ec perman access member state delai public quot articl insert quot articl manag fund intend activ connect pharmacovigil oper commun network market surveil perman control compet author order guarante independ quot introductori word paragraph articl replac quot qualifi person resid commun respons quot articl replac quot articl market authoris holder maintain detail record suspect advers reaction occur commun countri save except circumst reaction commun electron form report accord guidelin refer articl market authoris holder record suspect advers reaction human advers reaction relat veterinari medicin product brought attent report promptli compet author member state territori incid occur dai receipt inform market authoris holder record suspect advers reaction human advers reaction relat veterinari medicin product expect knowledg report promptli compet author member state territori incid occur dai receipt inform market authoris holder ensur suspect unexpect advers reaction human advers reaction suspect transmiss veterinari medicin product infecti agent occur territori countri report promptli accord guidelin refer articl agenc compet author member state veterinari medicin product authoris dai receipt inform derog paragraph case veterinari medicin product cover direct eec benefit authoris procedur articl direct subject procedur provid articl direct market authoris holder addition ensur suspect advers reaction human advers reaction occur commun report access refer member state compet author design refer member state refer member state assum respons analysi follow advers reaction requir laid condit grant market authoris subsequ guidelin refer articl report advers reaction submit compet author form period safeti updat report immedi request month authoris place market period safeti updat report submit immedi request month year initi place market year year report submit yearli interv immedi request period safeti updat report includ scientif evalu risk benefit balanc veterinari medicin product amend paragraph adopt accord procedur refer articl light experi gain oper grant market authoris holder authoris request amend period refer paragraph articl accord procedur laid commiss regul ec holder market authoris commun inform relat pharmacovigil concern gener public relat authoris veterinari medicin product give prior simultan notif compet author case market authoris holder ensur inform present object mislead member state measur ensur market authoris holder fail discharg oblig subject effect proportion dissuas penalti quot articl replac quot agenc collabor member state commiss set data process network facilit exchang pharmacovigil inform veterinari medicin product market commun order compet author share inform time quot articl subparagraph replac quot accord guidelin market authoris holder internation agre veterinari medic terminolog transmiss report advers reaction commiss publish guidelin account intern harmonis work achiev field pharmacovigil quot articl amend paragraph replac quot urgent action protect human anim health member state concern suspend market authoris veterinari medicin product provid agenc commiss member state inform work dai latest quot paragraph ad quot agenc inform accord paragraph give opinion urgenc matter basi opinion commiss request member state veterinari medicin market temporari measur immedi final measur adopt accord procedur refer articl quot articl amend paragraph replac quot compet author member state concern ensur mean repeat inspect unannounc inspect offici medicin control laboratori laboratori design purpos conduct test sampl legal requir relat veterinari medicin product compli compet author carri unannounc inspect premis manufactur activ substanc start materi veterinari medicin product premis market authoris holder consid ground suspect complianc provis articl inspect carri request member state commiss agenc order verifi data submit order obtain conform certif compli monograph european pharmacopoeia standardis bodi nomenclatur qualiti norm mean convent relat elabor european pharmacopoeia european director qualiti medicin commiss agenc request inspect start materi concern subject european pharmacopoeia monograph compet author member state concern carri inspect start materi manufactur manufactur request inspect carri authoris repres compet author empow inspect manufactur trade establish laboratori entrust holder manufactur authoris task carri control test pursuant articl sampl includ view independ analysi offici medicin control laboratori laboratori design purpos member state examin document relat object inspect subject provis forc member state octob place restrict power regard descript manufactur method inspect premis record document market authoris holder firm perform activ titl vii articl thereof behalf market authoris holder quot paragraph replac quot authoris repres compet author report inspect mention paragraph principl guidelin good manufactur practic refer articl requir set titl vii compli inspect manufactur market authoris holder inform content report quot paragraph ad quot prejudic arrang conclud commun countri member state commiss agenc requir manufactur establish countri undergo inspect refer paragraph dai inspect refer paragraph certif good manufactur practic issu manufactur inspect establish manufactur question compli principl guidelin good manufactur practic provid commun law event inspect carri request european pharmacopoeia certif complianc monograph issu member state enter certif good manufactur practic issu commun databas manag agenc behalf commun outcom inspect refer paragraph manufactur compli principl guidelin good manufactur practic provid commun legisl inform enter commun databas refer paragraph quot articl replac quot articl consid reason human anim health member state requir market authoris holder immunolog veterinari medicin product submit sampl batch bulk product veterinari medicin product control offici medicin control laboratori product put circul request compet author market authoris holder promptli suppli sampl refer paragraph report control refer articl compet author inform member state veterinari medicin product authoris european director qualiti medicin intent control batch batch question case compet author member state appli provis paragraph studi control report refer articl laboratori respons control repeat sampl provid test carri manufactur finish product accord relev provis shown dossier market authoris list test repeat laboratori respons control restrict justifi test provid member state concern european director qualiti medicin agre immunolog veterinari medicin product authoris regul ec list test repeat control laboratori reduc agreement agenc member state concern recognis result test commiss inform longer period conduct test member state ensur control complet dai receipt sampl compet author notifi member state concern european director qualiti medicin market authoris holder manufactur result test period time compet author conclud batch veterinari medicin product conform control report manufactur specif provid market authoris measur vi vi market authoris holder manufactur inform member state veterinari medicin product authoris quot articl amend paragraph amend introductori word replac quot member state compet author suspend revok withdraw vari market authoris clear quot ii point replac quot risk benefit assess veterinari medicin product authoris condit unfavour regard benefit anim health welfar consum safeti authoris concern veterinari medicin product zootechn quot iii subparagraph point delet iv point replac quot inform applic document pursuant articl incorrect quot point delet vi subparagraph ad quot commun legisl framework adopt compet author refus authoris veterinari medicin product action protect public health consum anim health quot paragraph amend introductori word replac quot market authoris suspend revok withdrawn vari establish quot ii point replac quot particular support applic provid articl amend accord articl quot articl point paragraph replac quot clear risk benefit assess veterinari medicin product authoris condit unfavour regard benefit anim health welfar safeti health benefit consum authoris concern veterinari medicin product zootechn quot articl paragraph ad quot member state prohibit advertis gener public veterinari medicin product accord articl veterinari prescript psychotrop drug narcot cover unit nation convent quot articl paragraph replac quot refer made paragraph articl decis ec appli regard provis articl thereof period laid articl decis ec set month refer made paragraph articl decis ec appli regard provis articl thereof period laid articl decis ec set month stand committe adopt rule procedur rule procedur made public quot articl replac quot articl member state measur ensur compet author concern commun inform complianc requir adopt authoris refer articl certif refer articl authoris place product market reason request member state forthwith commun report refer articl compet author member state conclus reach inspect refer articl carri inspector member state concern valid commun except member state reason human anim health accept conclus inspect refer articl member state forthwith inform commiss agenc agenc inform member state concern commiss inform reason consult member state concern inspector compet supervisori author carri inspect inspector accompani inspector member state parti disagr quot articl subparagraph replac quot decis grant revok market authoris made publicli quot articl replac quot articl member state permit foodstuff human consumpt test anim compet author establish withdraw period withdraw period laid articl includ safeti factor reflect natur substanc test maximum residu limit establish commun accord regul eec ensur maximum limit exceed foodstuff quot articl insert quot articl member state ensur collect system place veterinari medicin product unus expir articl veterinari medicin product authoris accord regul ec scientif committe opinion refer recommend condit restrict regard safe effect veterinari medicin product provid articl regul decis address member state adopt accord procedur laid articl direct implement condit restrict quot articl period protect provid articl point amend articl direct ec appli refer medicin product applic authoris submit date transposit refer articl paragraph articl member state bring forc law regul administr provis compli direct octob latest immedi inform commiss thereof member state adopt measur refer direct accompani refer occas offici public method make refer laid member state articl direct enter forc dai public offici journal european union articl direct address member state strasbourg march european parliament presid cox council presid roch oj oj opinion european parliament octob oj council common posit septemb oj posit european parliament decemb publish offici journal council decis march oj oj regul repeal regul ec offici journal oj oj oj oj direct amend regul ec oj oj decis amend commiss decis ec oj oj oj direct amend regul ec oj oj oj