direct ec european parliament council novemb commun code relat veterinari medicin product european parliament council european union regard treati establish european commun articl thereof regard propos commiss regard opinion econom social committe act accord procedur laid articl treati council direct eec septemb approxim law member state relat veterinari medicin product council direct eec septemb approxim law member state relat analyt pharmaco toxicolog clinic standard protocol respect test veterinari medicin product council direct eec decemb extend scope direct eec approxim law member state relat veterinari medicin product lai addit provis immunolog veterinari medicin product council direct eec septemb widen scope direct eec approxim provis laid law regul administr action relat veterinari medicin product lai addit provis homeopath veterinari medicin product frequent substanti amend interest clariti ration direct codifi assembl singl text primari purpos rule product distribut veterinari medicin product safeguard public health object achiev mean hinder develop industri trade medicin product commun member state provis laid law regul administr action govern veterinari medicin product provis differ essenti principl result hinder trade medicin product commun directli affect function intern market hindranc remov entail approxim relev provis point view public health free movement veterinari medicin product compet author dispos inform author veterinari medicin product form approv summari characterist product except medicin product subject centralis commun author procedur establish council regul eec juli lai commun procedur author supervis medicin product human veterinari establish european agenc evalu medicin product market author member state recogn compet author member state ground suppos author veterinari medicin product concern present risk human anim health environ event disagr member state qualiti safeti efficaci medicin product scientif evalu matter undertaken commun level lead singl decis area disagr bind member state concern decis adopt rapid procedur ensur close cooper commiss member state purpos committe veterinari medicin product set accord european agenc evalu medicin product laid aforement regul eec direct stage achiev aim freedom movement veterinari medicin product purpos measur prove light experi gain committe veterinari medicin product remov remain barrier freedom movement medic feedingstuff scope direct public health econom reason prohibit unauthor medicin product manufactur medic feedingstuff concept harm therapeut efficaci examin relat rel signific depend progress scientif knowledg medicin product intend particular document accompani applic market author demonstr potenti hazard outweigh benefit due efficaci fail demonstr applic reject market author refus medicin product lack therapeut effect insuffici proof effect concept therapeut effect understood effect promis manufactur market author refus withdraw period long elimin health hazard aris residu author market immunolog veterinari medicin product grant manufactur demonstr abil attain batch batch consist compet author empow prohibit immunolog veterinari medicin product immunolog respons treat anim interfer nation commun programm diagnosi erad control anim diseas desir instanc provid user homeopath medicin product clear indic homeopath charact suffici guarante qualiti safeti rule relat manufactur control inspect homeopath veterinari medicin product harmonis permit circul commun medicin product safe good qualiti regard characterist homeopath veterinari medicin product low level activ principl difficulti appli convent statist method relat clinic trial desir provid special simplifi registr procedur tradit homeopath medicin product market therapeut indic pharmaceut form dosag present risk anim usual rule govern author market veterinari medicin product appli homeopath veterinari medicin product market therapeut indic form present risk balanc desir therapeut effect member state appli rule evalu result test trial intend establish safeti efficaci medicin product pet anim exot speci provid notifi commiss order protect human anim health avoid unnecessari duplic effort examin applic market author member state systemat prepar assess report respect veterinari medicin product author exchang report request member state suspend examin applic author place veterinari medicin product market activ consider member state view recogn decis reach member state order facilit movement veterinari medicin product prevent check carri member state repeat minimum requir manufactur import countri grant author appli veterinari medicin product qualiti veterinari medicin product manufactur commun guarante requir complianc principl good manufactur practic medicin product irrespect final destin medicin product measur ensur distributor veterinari medicin product author member state maintain adequ record standard protocol perform test trial veterinari medicin product effect mean control product protect public health facilit movement product lai uniform rule applic test compil dossier allow compet author arriv decis basi uniform test refer uniform criteria help obviat differ evalu advis stipul precis case result pharmacolog toxicolog test clinic trial provid view obtain author veterinari medicin product essenti similar innov product ensur innov form disadvantag reason public polici repeat test carri anim overrid establish intern market specif control guarante qualiti veterinari medicin product import countri waiv arrang made commun ensur control carri export countri order ensur continu safeti veterinari medicin product ensur pharmacovigil system commun continu adapt account scientif technic progress public health protect relev data advers effect human relat veterinari medicin collect evalu pharmacovigil system data lack efficaci addit collect inform advers reaction due label investig valid withdraw period potenti environment problem contribut improv regular monitor good usag veterinari medicin account aris result intern harmonis definit terminolog technolog develop field pharmacovigil increas electron mean commun inform advers reaction veterinari medicin product market commun intend singl report point advers reaction time ensur inform share compet author member state interest commun ensur veterinari pharmacovigil system central authoris medicin product authoris procedur consist holder market authoris proactiv respons ongo pharmacovigil veterinari medicin product place market measur implement direct adopt accord council decis ec june lai procedur exercis implement power confer commiss order improv protect public health foodstuff human consumpt anim clinic trial veterinari medicin product maximum residu limit laid residu veterinari medicin product concern accord provis council regul eec june lai commun procedur establish maximum residu limit veterinari medicin product foodstuff anim origin commiss empow adopt order adapt annex scientif technic progress direct prejudic oblig member state time limit transposit direct set annex ii part adopt direct titl definit articl purpos direct term bear mean proprietari medicin product readi prepar medicin product market special special pack veterinari medicin product substanc combin substanc present treat prevent diseas anim substanc combin substanc administ anim view make medic diagnosi restor correct modifi physiolog function anim likewis consid veterinari medicin product readi made veterinari medicin product veterinari medicin product prepar advanc compli definit proprietari medicin product market pharmaceut form process substanc matter irrespect origin human human blood human blood product anim micro organ anim part organ anim secret toxin extract blood product veget micro organ plant part plant veget secret extract chemic element natur occur chemic materi chemic product obtain chemic chang synthesi pre mix medic feedingstuff veterinari medicin product prepar advanc view subsequ manufactur medic feedingstuff medic feedingstuff mixtur veterinari medicin product product feed feed readi prepar market intend fed anim process cur prevent properti properti medicin product cover point immunolog veterinari medicin product veterinari medicin product administ anim order produc activ passiv immun diagnos state immun homeopath veterinari medicin product veterinari medicin product prepar product substanc composit 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 product foodstuff anim order ensur foodstuff residu quantiti excess maximum limit laid applic regul eec advers reaction reaction harm unintend occur dose anim prophylaxi diagnosi treatment diseas modif physiolog function human advers reaction reaction noxiou unintend occur human exposur veterinari medicin advers reaction advers reaction result death life threaten result signific disabl incapac congenit anomali birth defect result perman prolong sign anim treat unexpect advers reaction advers reaction natur sever outcom consist summari product characterist period safeti updat report period report record refer articl post market surveil studi pharmacoepidemiolog studi clinic trial carri accord term market author conduct aim identifi investig safeti hazard relat author veterinari medicin product label veterinari medicin product accord summari product characterist includ misus abus product wholesal deal veterinari medicin product activ includ purchas sale import export commerci transact veterinari medicin product profit suppli manufactur veterinari medicin product manufactur retail suppli veterinari medicin product person entitl carri suppli accord articl agenc european agenc evalu medicin product establish regul eec risk human anim health environ risk relat qualiti safeti efficaci veterinari medicin product titl ii scope articl provis direct appli veterinari medicin product intend market inter alia form medicin product readi made veterinari medicin product pre mix medic feeedingstuff articl direct appli medic feedingstuff defin council direct eec march lai condit govern prepar place market medic feedingstuff commun medic feedingstuff prepar pre mix author direct inactiv immunolog veterinari medicin product manufactur pathogen antigen obtain anim anim hold treatment anim anim hold local medicin product prepar pharmaci accord prescript individu anim commonli magistr formula medicin product prepar pharmaci accord prescript pharmacopoeia intend suppli directli end user commonli officin formula veterinari medicin product base radio activ isotop addit cover council direct eec novemb addit feedingstuff incorpor anim feedingstuff supplementari anim feedingstuff accord direct member state implement articl acount medicin product refer point paragraph nonetheless member state implement articl account medicin product refer point paragraph articl member state provid direct appli inactiv immunolog veterinari medicin product manufactur pathogen antigen obtain anim anim hold treatment anim anim hold local member state permit exempt territori respect veterinari medicin product intend sole aquarium fish cage bird home pigeon terrarium anim small rodent provis articl provid product substanc requir veterinari control measur prevent unauthor product anim titl iii market chapter market author articl veterinari medicin product market member state market author issu compet author member state accord direct market author grant accord regul eec articl order veterinari medicin product subject market author purpos administ food produc anim activ substanc shown annex ii iii regul eec articl health situat requir member state authoris market administr anim veterinari medicin product author member state accord direct articl event diseas epidem member state provision immunolog veterinari medicin product author place market absenc suitabl medicin product inform commiss detail condit articl veterinari medicin product administ anim market author issu test veterinari medicin product refer articl accept compet nation author notif author accord nation rule forc articl author medicin product condit member state exception order avoid caus unaccept suffer anim concern permit administr veterinarian direct person respons anim small number anim hold veterinari medicin product author member state concern direct regul eec anim speci condit speci product refer point medicin product author member state concern human be accord direct ec european parliament council novemb commun code relat medicin product human regul eec product refer point limit law member state concern veterinari medicin product prepar extemporan person author nation legisl accord term veterinari prescript purpos paragraph phrase quot anim small number anim hold quot cover pet interpret flexibl minor exot anim speci produc food provis paragraph appli provid medicin product administ food produc anim substanc found veterinari medicin product author anim member state concern case food produc anim veterinarian respons specifi withdraw period medicin product withdraw period speci concern withdraw period gt tabl gt regard homeopath veterinari medicin product level activ principl equal part million withdraw period refer subparagraph reduc articl veterinarian recours provis articl adequ record date examin anim detail owner number anim treat diagnosi medicin product prescrib dosag administ durat treatment withdraw period recommend make record inspect compet author period year requir extend member state food produc anim articl purpos obtain market author respect veterinari medicin product procedur establish regul eec applic lodg compet author member state concern market author grant applic establish commun particular document accompani applic accord annex busi perman address regist place busi person respons place product market manufactur manufactur involv site manufactur veterinari medicin product brand proprietari trademark manufactur scientif formula trademark manufactur qualit quantit particular constitu veterinari medicin product usual terminolog empir chemic formula give intern proprietari recommend world health organ exist descript method manufactur therapeut indic contra indic advers reaction dosag speci anim veterinari medicin product intend pharmaceut form method rout administr propos shelf life applic explan precautionari safeti measur product store administ anim wast therefrom dispos indic potenti risk medicin product pose environ health human anim plant indic withdraw period applic propos justifi toler level residu accept foodstuff risk consum routin analysi method compet author trace residu descript control test method emploi manufactur qualit quantit analysi constitu finish product specif test steril test test presenc pyrogen presenc heavi metal stabil test biolog toxic test test intermedi product result physico chemic biolog microbiolog test toxicolog pharmacolog test clinic trial summari accord articl product characterist specimen mock up sale present veterinari medicin product packag insert document show manufactur author countri produc veterinari medicin product copi market author obtain member state countri relev veterinari medicin product list member state applic author 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 author commun countri reason decis inform updat regular basi case medicin product activ substanc mention annex ii iii regul eec copi document submit commiss accord annex regul articl derog point articl prejudic law relat protect industri commerci properti applic requir provid result toxicolog pharmacolog test clinic trial demonstr veterinari medicin product essenti similar medicin product author member state concern applic market author holder agre toxicolog pharmacolog clinic refer contain file origin veterinari medicin product purpos examin applic question ii constitu constitu veterinari medicin product establish medicin recogn efficaci accept level safeti mean detail refer scientif literatur iii veterinari medicin product essenti similar medicin product author commun accord commun provis forc year market member state applic made period extend year case high technolog medicin product author pursuanc procedur establish articl council direct eec member state extend period year singl decis cover medicin product market territori consid interest public health member state liberti appli year period date expiri patent protect origin medicin product case veterinari medicin product constitu hitherto combin therapeut purpos result toxicolog pharmacolog test clinic trial relat combin provid provid relev document individu constitu annex appli manner pursuant point ii paragraph refer publish data submit articl summari product characterist inform veterinari medicin product qualit quantit composit term activ substanc constitu excipi knowledg essenti proper administr medicin product intern proprietari name recommend world health organ name exist fail usual proprietari chemic descript pharmaceut form pharmacolog properti inform therapeut purpos pharmacokinet particular clinic particular target speci indic target speci contra indic undesir effect frequenc serious special precaut pregnanc lactat interact medica form interact posolog method administr overdos symptom emerg procedur antidot special warn target speci withdraw period special precaut person administ medicin product anim pharmaceut particular major incompat shelf life reconstitut medicin product contain open time special precaut storag natur content contain special precaut dispos unus medicin product wast materi corpor address regist place busi author holder articl member state make arrang ensur document particular list articl articl draft expert requisit technic profession qualif submit compet author document particular sign expert question qualif role expert carri work fall disciplin analysi pharmacolog similar experiment scienc clinic trial describ object result obtain quantit qualit term describ find accord annex state case analyst medicin product conform state composit provid reason control test method manufactur ii case pharmacologist appropri qualifi specialist toxic medicin product pharmacolog properti observ administr veterinari medicin product normal condit observ recommend withdraw period foodstuff obtain treat anim residu constitut health hazard consum iii case clinician found anim treat medicin product effect inform furnish manufactur pursuant articl medicin product toler dosag recommend contra indic advers reaction give reason refer publish data refer point ii articl expert detail report form part document applic lodg compet author curriculum vita expert append report chapter provis applic homeopath veterinari medicin product articl member state ensur homeopath veterinari medicin product manufactur market commun regist author accord provis articl member state due account registr author previous grant member state member state refrain establish special simplifi registr procedur homeopath veterinari medicin product refer articl member state appli provis inform commiss member state concern decemb latest territori homeopath veterinari medicin product regist member state accord articl articl articl homeopath veterinari medicin product satisfi condit subject author mean special simplifi registr procedur intend administr pet anim exot speci food produc 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 smallest dose allopathi regard activ principl presenc allopath medicin product result oblig submit veterinari prescript time registr member state determin classif dispens medicin product criteria rule procedur provid chapter except articl appli analog special simplifi registr procedur homeopath veterinari medicin product refer paragraph except proof therapeut effect proof therapeut effect requir homeopath veterinari medicin product regist accord paragraph articl admit accord articl articl special simplifi applic registr cover seri medicin product deriv homeopath stock stock document includ applic order demonstr pharmaceut qualiti batch batch homogen product concern scientif pharmacopoeia homeopath stock stock statement rout administr pharmaceut form degre dilut regist dossier describ homeopath stock stock obtain control justifi homeopath natur basi adequ bibliographi case homeopath veterinari medicin product biolog substanc descript measur ensur absenc pathogen manufactur control file pharmaceut form descript method dilut potenti manufactur author medicin product concern copi registr author obtain medicin product member state specimen mock up outer packag packag medicin product regist data stabil medicin product articl homeopath veterinari medicin product refer articl author accord provis articl chapter member state introduc retain territori specif rule pharmacolog toxicolog test clinic trial homeopath veterinari medicin product intend pet anim exot speci food produc refer articl accord principl characterist homeopathi practis member state case member state concern notifi commiss specif rule forc articl chapter appli immunolog homeopath veterinari medicin product provis titl vi vii appli homeopath veterinari medicin product chapter procedur market author articl member state measur ensur procedur grant author place veterinari medicin product market complet dai submiss valid applic member state note applic author submit activ examin member state respect veterinari medicin product member state concern decid suspend detail examin applic order await assess report prepar member state accord articl member state concern inform member state applic decis suspend detail examin applic question complet examin applic reach decis member state forward copi assess report member state concern articl member state inform accord articl member state author veterinari medicin product subject applic author member state concern member state forthwith request author member state grant author forward assess report refer articl dai receipt assess report member state concern recognis decis member state summari product characterist approv consid ground suppos author veterinari medicin product concern present risk human anim health environ appli procedur set articl articl order examin applic submit pursuant articl compet author member state check document submit support applic compli articl basi report drawn expert pursuant articl ascertain condit issu market author fulfil submit medicin product raw materi intermedi product constitu materi test state laboratori laboratori design purpos order ensur test method emploi manufactur applic document accord articl 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 requir applic submit substanc quantiti verifi analyt detect method propos applic accord articl put effect part routin check reveal presenc residu veterinari medicin product concern articl member state measur ensur compet author ascertain manufactur import veterinari medicin product countri manufactur complianc detail suppli pursuant articl carri control test accord method applic document articl compet author author manufactur import veterinari medicin product countri circumst justifi stage manufactur control test refer carri parti case check compet author carri establish concern articl market author issu holder inform compet author member state concern summari product characterist approv compet author measur ensur inform summari conform accept market author issu subsequ compet author forward agenc copi author summari product characterist compet author draw assess report comment dossier result analyt pharmacotoxicolog test clinic trial veterinari medicin product concern assess report updat inform import evalu qualiti safeti efficaci veterinari medicin product concern articl market author requir holder contain outer wrap packag insert requir particular essenti safeti health protect includ special precaut relat warn result clinic pharmacolog trial prescrib articl experi gain veterinari medicin product market author requir inclus tracer substanc veterinari medicin product except circumst consult applic author grant subject specif oblig subject annual review includ carri studi grant author notif advers reaction veterinari medicin product except decis adopt object verifi reason articl market author issu holder respect manufactur method control method provid articl account scientif technic progress introduc requir enabl veterinari medicin product manufactur check mean gener accept scientif method subject approv compet author member state concern request compet author market author holder review analyt detect method provid articl propos account scientif technic progress market author holder forthwith inform compet author inform entail amend particular document refer articl approv summari product characterist forthwith inform compet author prohibit restrict impos compet author countri veterinari medicin product market unexpect advers effect occur anim concern human be market author holder requir maintain record advers reaction observ anim human be record establish year made compet author request market author holder immedi inform compet author view author alter propos make particular document refer articl articl author valid year renew year period applic holder month expiri date consider dossier updat inform previous submit articl grant author diminish gener legal liabil manufactur author holder articl market author withheld examin document particular list articl establish veterinari medic product harm condit state time applic author 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 veterinari medicin product offer sale prohibit commun provis pend commun rule compet author refus grant author veterinari medicin product action protect public health consum anim health author withheld applic document submit compet author compli articl chapter mutual recognit author articl order facilit adopt common decis member state author veterinari medicin product basi scientif criteria qualiti safeti efficaci achiev free movement veterinari medicin product commun committe veterinari medicin product hereinaft refer quot committe quot set committe part agenc addit respons confer commun law committe examin question relat grant variat suspens withdraw market author submit accord provis direct examin question relat test veterinari medicin product committe adopt rule procedur articl submit applic mutual recognit market author holder author inform member state grant author applic base hereinaft refer member state applic made accord direct notifi addit origin dossier member state requir applic provid particular document enabl check dossier file ident addit holder author request refer member state grant initi author prepar assess report respect veterinari medicin product concern updat member state prepar dai receipt request time applic submit accord paragraph refer member sate grant initi author forward assess report member state member state concern applic order obtain recognit procedur laid chapter member state market author issu member state holder author submit applic compet author member state member state concern inform particular refer articl testifi dossier ident accept refer member state identifi addit amend case certifi summari product characterist propos accord articl ident accept refer member state accord articl certifi dossier file part procedur ident holder market author transmit applic agenc inform member state concern date submiss applic send copi author grant refer member state send agenc copi author grant member state respect veterinari medicin product concern applic author consider member state save except case provid articl member state recognis market author grant refer member state dai receipt applic assess report inform refer member state member state concern applic agenc holder author place product market articl member state consid ground suppos market author veterinari medicin product concern present risk human anim health environ forthwith inform applic refer member state member state concern applic agenc member state state reason detail action correct defect applic member state concern endeavour reach agreement action respect applic provid applic opportun make point view oral write member state reach agreement time limit refer articl forthwith refer matter agenc referr committe applic procedur laid articl time limit refer articl member state concern provid committe detail statement matter unabl reach agreement reason disagr applic provid copi inform inform matter refer committe applic forthwith forward committe copi inform particular refer articl articl applic submit accord articl made market author veterinari medicin product member state adopt diverg decis author veterinari medicin product suspens withdraw author member state commiss market author holder refer matter committe applic procedur laid articl member state concern market author holder commiss identifi question refer committe consider inform aforement holder thereof member state market author holder forward committe inform relat matter question articl member state commiss applic holder market author specif case interest commun involv refer matter committe applic procedur laid articl reach decis request market author suspens withdraw author variat term market author appear account inform collect accord titl vii member state concern commiss identifi question refer committe consider inform market author holder member state holder forward committe inform relat matter question articl refer made procedur articl committe matter concern issu reason opinion dai date matter refer case submit committe accord articl period extend dai case urgenc propos chairman committe agre shorter deadlin order matter committe appoint member act rapporteur committe appoint individu expert advis specif question appoint expert committe defin task time limit complet task case refer articl issu opinion committe provid market author holder opportun present written oral explan case refer articl market author holder ask explain oral write consid committe invit person provid inform relat matter committe suspend time limit refer paragraph order market author holder prepar explan agenc forthwith inform market author holder opinion committe applic satisfi criteria author summari product characterist propos applic accord articl amend author grant subject condit regard condit consid essenti safe effect veterinari medicin product includ pharmacovigil market author suspend vari withdrawn dai receipt opinion holder notifi agenc write intent appeal case forward detail ground appeal agenc dai receipt opinion dai receipt ground appeal committe opinion revis conclus reach appeal annex assess report refer paragraph dai adopt agenc forward final opinion committe member state commiss market author holder report describ assess veterinari medicin product reason conclus event opinion favour grant maintain author place veterinari medicin product concern market document annex opinion draft summari product characterist refer articl reflect differ veterinari condit pertain member state condit affect author mean paragraph articl dai receipt opinion commiss prepar draft decis respect applic take account commun law event draft decis envisag grant market author document refer articl annex exception draft decis accord opinion agenc commiss annex detail explan reason differ draft decis forward member state applic articl final decis applic adopt accord procedur refer articl rule procedur stand committe set articl adjust account task incumb accord chapter adjust involv case refer paragraph articl opinion stand committe obtain write member state allow dai forward written observ draft decis commiss member state requir write draft decis discuss stand committe give reason detail opinion commiss written observ member state rais import question scientif technic natur address opinion agenc chairman suspend procedur refer applic back agenc consider provis implement paragraph adopt commiss accord procedur refer articl decis refer paragraph address member state concern matter commun market author holder member state grant withdraw market author vari term market author compli decis dai notif inform commiss agenc thereof articl applic market author holder vari market author grant accord provis chapter submit member state previous author veterinari medicin product concern commiss consult agenc adopt arrang examin variat term market author arrang includ notif system administr procedur minor variat defin precis concept quot minor variat quot arrang adopt commiss form implement regul accord procedur refer articl case arbitr submit commiss procedur laid articl appli analog variat made market author articl member state consid variat term market author grant accord provis chapter suspens withdraw protect human anim health environ member state concern forthwith refer matter agenc applic procedur laid articl prejudic provis articl except case urgent action essenti protect human anim health environ definit decis adopt member state suspend market veterinari medicin product concern territori inform commiss member state work dai reason action articl articl appli analog veterinari medicin product author member state opinion committe accord articl direct eec januari articl agenc publish annual report oper procedur laid chapter forward european parliament council inform januari commiss publish detail review oper procedur laid chapter propos amend improv procedur council decid condit provid treati commiss propos year submiss articl provis articl appli homeopath veterinari medicin product refer articl titl iv manufactur import articl member state measur ensur manufactur veterinari medicin product territori subject hold author manufactur author likewis requir veterinari medicin product intend export author refer paragraph requir total partial manufactur process divid packag present author requir prepar divid packag present process carri sole retail suppli pharmacist dispens pharmaci person legal author member state carri process author refer paragraph requir import countri member state titl articl appli import manufactur member state measur ensur veterinari medicin product brought territori countri destin member state accompani copi author refer paragraph articl order obtain manufactur author applic meet requir veterinari medicin product pharmaceut form manufactur import place manufactur control dispos manufactur import suitabl suffici premis technic equip control facil compli legal requir member state concern lai manufactur control storag product accord articl dispos servic qualifi person mean articl applic provid particular applic establish complianc requir articl compet author member state issu manufactur author establish accuraci particular suppli pursuant articl mean inquiri carri repres order ensur requir refer articl compli author made condit fulfil oblig impos author grant date author appli premis applic veterinari medicin product pharmaceut form applic articl member state measur ensur time procedur grant manufactur author exce dai dai compet author receiv applic articl holder manufactur author request chang particular refer articl paragraph time procedur relat request exce dai except case period time extend dai articl compet author member state requir applic inform particular suppli pursuant articl qualifi person refer articl compet author concern exercis applic time limit refer articl suspend addit data requir suppli articl holder manufactur author oblig dispos servic staff compli legal requir exist member state concern manufactur control dispos author veterinari medicin product accord legisl member state concern give prior notic compet author make particular suppli pursuant articl compet author event immedi inform qualifi person refer articl replac unexpectedli repres compet author member state concern access premis time enabl qualifi person refer articl carri duti place dispos facil compli principl guidelin good manufactur practic medicin product laid commun law detail record veterinari medicin product suppli includ sampl accord law countri destin inform record respect transact made payment date veterinari medicin product quantiti suppli address recipi batch number record inspect compet author period year articl principl guidelin good manufactur practic veterinari medicin product refer articl adopt form direct address member state accord procedur refer articl detail guidelin publish commiss revis account scientif technic progress articl member state measur ensur holder manufactur author perman continu dispos servic qualifi person fulfil condit laid articl respons carri duti articl person fulfil condit laid articl holder author assum respons refer paragraph articl member state ensur qualifi person refer articl fulfil minimum condit qualif set paragraph qualifi person possess diploma certif evid formal qualif award complet univers studi recogn equival member state concern extend period year theoret practic studi scientif disciplin pharmaci medicin veterinari scienc chemistri pharmaceut chemistri technolog biologi minimum durat univers half year period theoret practic train year includ train period month pharmaci open public corrobor examin univers level univers recogn equival cours coexist member state extend year year diploma certif evid formal qualif award complet year univers recogn equival consid fulfil condit durat refer subparagraph diploma certif evid formal qualif award complet cours recogn equival state question includ theoret practic tuition bear basic subject experiment physic gener inorgan chemistri organ chemistri analyt chemistri pharmaceut chemistri includ analysi medicin product gener appli biochemistri medic physiolog microbiolog pharmacolog pharmaceut technolog toxicolog pharmacognosi studi composit effect activ principl natur substanc plant anim origin tuition subject balanc enabl person concern fulfil oblig articl diploma certif evid formal qualif mention paragraph fulfil criteria laid compet author member state ensur person concern evid subject involv knowledg requir manufactur control veterinari medicin product qualifi person acquir practic experi year undertak author manufactur activ qualit analysi medicin product quantit analysi activ substanc test check ensur qualiti veterinari medicin product durat practic experi reduc year univers last year year half last year articl person engag member state activ person refer articl date direct eec applic compli provis articl elig continu engag activ state concern holder diploma certif evid formal qualif award complet univers recogn equival member state concern scientif disciplin allow engag activ person refer articl accord law state began prior octob consid qualifi carri state duti person refer articl provid previous engag activ year octob undertak manufactur author product supervis qualit quantit analysi activ substanc test check direct author person refer articl ensur qualiti veterinari medicin product person concern acquir practic experi refer subparagraph octob year practic experi accord condit refer subparagraph complet immedi engag activ articl member state measur ensur qualifi person refer articl prejudic relationship holder manufactur author respons context procedur refer articl ensur case veterinari medicin product manufactur member state concern batch veterinari medicin product manufactur check complianc law forc member state accord requir market author case veterinari medicin product come countri product batch import undergon import member state full qualit analysi quantit analysi activ substanc test check ensur qualiti veterinari medicin product accord requir market author batch veterinari medicin product undergon control member state exempt control market member state accompani control report sign qualifi person case veterinari medicin product import countri arrang made commun export countri ensur manufactur veterinari medicin product appli standard good manufactur practic equival laid commun ensur control refer point subparagraph paragraph carri export countri qualifi person reliev respons carri control case veterinari medicin product releas sale qualifi person certifi regist equival document provid purpos product batch satisfi provis articl regist equival document date oper carri remain dispos repres compet author period provis member state concern event year articl member state ensur oblig qualifi person refer articl fulfil mean administr measur make person subject profession code conduct member state provid temporari suspens person commenc administr disciplinari proceed failur fulfil oblig articl provis titl appli homeopath veterinari medicin product titl label packag insert articl inform conform particular document provid pursuant articl approv compet author legibl charact contain outer packag medicin product veterinari medicin product brand proprietari accompani trade mark manufactur scientif formula trade mark manufactur special medicin product activ substanc brand accompani legibl charact intern proprieti recommend world health organ exist exist usual proprietari statement activ substanc express qualit quantit dosag unit form administr volum weight intern proprietari name recommend world health organ name exist name exist usual proprietari name manufactur batch number market author number corpor perman address regist place busi market author holder manufactur speci anim veterinari medicin product intend method rout administr withdraw period nil case veterinari medicin product administ food produc anim expiri date plain languag special storag precaut special precaut dispos unus medicin product wast materi medicin product particular requir pursuant articl word quot anim treatment quot pharmaceut form content weight volum number dose unit shown outer packag provis part annex concern qualit quantit composit veterinari medicin product respect activ substanc appli particular provid paragraph particular mention paragraph outer packag contain medicin product languag languag countri market articl ampoul particular list paragraph articl outer packag contain particular veterinari medicin product quantiti activ substanc rout administr manufactur batch number date expiri word quot anim treatment quot small singl dose contain ampoul imposs give particular mention paragraph requir articl appli outer packag particular mention sixth indent paragraph outer packag contain medicin product languag languag countri market articl outer packag particular featur packag pursuant articl shown contain articl inclus packag insert packag veterinari medicin product obligatori inform requir articl convei contain extern packag member state measur ensur insert relat sole veterinari medicin product includ insert offici languag languag member state medicin product market packag insert inform conform particular document provid pursuant articl approv compet author corpor perman address regist place busi market author holder manufactur veterinari medicin product statement activ substanc express qualit quantit intern proprietari name recommend world health organ exist therapeut indic contra indic advers reaction particular veterinari medicin product speci anim veterinari medicin product intend dosag speci method rout administr advic correct administr withdraw period nil case veterinari medicin product administ food produc anim special storag precaut particular requir pursuant articl special precaut dispos unus medicin product wast materi medicin product particular refer paragraph languag languag countri product market inform separ particular articl provis titl observ formal notic address person concern ineffectu compet author member state suspend withdraw market author articl requir member state condit suppli public mark price medicin product veterinari industri properti right affect provis titl articl prejudic paragraph homeopath veterinari medicin product label accord provis titl identifi inclus label legibl form word quot homeopath medicin product veterinari quot addit clear mention word quot homeopath veterinari medicin product approv therapeut indic quot label packag insert homeopath veterinari medicin product refer articl bear inform inform scientif stock stock degre dilut symbol pharmacopoeia accord point articl address market author holder manufactur method administr rout expiri date clear term month year pharmaceut form content sale present special storag precaut target speci special warn medicin product manufactur batch number registr number titl vi possess wholesal distribut dispens veterinari medicin product articl member state measur ensur wholesal distribut veterinari medicin product subject hold author ensur time procedur grant author exce dai date compet author receiv applic member state exclud suppli small quantiti veterinari medicin product retail scope definit wholesal distribut order obtain author distribut applic dispos technic compet staff suitabl suffici premis compli requir laid member state concern storag handl veterinari medicin product holder author distribut requir detail record minimum inform record respect incom outgo transact date precis ident veterinari medicin product manufactur batch number expiri date quantiti receiv suppli address supplier recipi year detail audit carri compar incom outgo medicin suppli suppli held stock discrep record record inspect compet author period year member state measur ensur wholesal suppli veterinari medicin product person permit carri retail activ accord articl person lawfulli permit receiv veterinari medicin product wholesal articl member state measur ensur retail suppli veterinari medicin product conduct person permit carri oper legisl member state concern person permit paragraph sell veterinari medicin product requir detail record inform record respect incom outgo transact date precis ident veterinari medicin product manufactur batch number quantiti receiv suppli address supplier recipi relev address prescrib veterinarian copi prescript year detail audit carri incom outgo veterinari medicin product reconcil product held stock discrep record record inspect compet author period year member state limit number detail document requir refer paragraph requir appli case veterinari medicin product intend administr food produc anim veterinari prescript respect withdraw period observ januari member state commun commiss list veterinari medicin product prescript note commun member state commiss examin suitabl measur propos draw commun list medicin product articl prejudic stricter commun nation rule relat dispens veterinari medicin product protect human anim health prescript requir dispens public veterinari medicin product product subject offici restrict suppli restrict result implement relev unit nation convent narcot psychotrop substanc restrict veterinari medicin product result commun law product respect special precaut veterinarian order avoid unnecessari risk target speci person administ product anim consum foodstuff obtain treat anim environ product intend treatment patholog process requir precis prior diagnosi effect imped interfer subsequ diagnost therapeut measur magistr formula intend anim addit prescript requir veterinari medicin product activ substanc author veterinari medicin product year regard inform particular provid applic experi acquir practic veterinari medicin product compet author satisfi criteria refer paragraph appli articl member state measur ensur person empow nation legisl forc possess control veterinari medicin product substanc veterinari medicin product anabol anti infecti anti parasit anti inflammatori hormon psychotrop properti member state maintain regist manufactur dealer permit possess activ substanc manufactur veterinari medicin product properti refer paragraph person maintain detail record deal substanc manufactur veterinari medicin product record inspect compet author period year amend made list substanc refer paragraph adopt accord procedur refer articl articl member state ensur owner keeper food produc anim provid proof purchas possess administr veterinari medicin product substanc set articl member state extend scope oblig veterinari medicin product member state requir mainten record give inform date veterinari medicin product quantiti address supplier medicin product identif anim treat articl notwithstand articl member state ensur veterinarian provid servic member state administ anim small quantiti readi made veterinari medicin product exceed daili requir immunolog veterinari medicin product author member state servic provid hereinaft host member state provid condit satisfi author place product market provid articl issu compet author member state veterinarian establish veterinari medicin product transport veterinarian origin manufactur packag veterinari medicin product intend administr food produc anim qualit quantit composit term activ substanc medicin product author accord articl host member state veterinarian provid servic member state acquaint good veterinari practic appli member state ensur withdraw period label veterinari medicin product concern compli expect longer withdraw period compli good veterinari practic veterinarian furnish veterinari medicin product owner keeper anim treat host member state permiss basi rule host member state case suppli relat anim care minimum quantiti veterinari medicin product complet treatment anim concern occas veterinarian requir detail record anim treat diagnosi veterinari medicin product administ dosag administ durat treatment withdraw period appli record inspect compet author host member state period year rang quantiti veterinari medicin product carri veterinarian exce gener requir daili good veterinari practic articl absenc specif commun legisl immunolog veterinari medicin product erad control anim diseas member state accord nation legisl prohibit manufactur import possess sale suppli immunolog veterinari medicin product part territori establish administr product anim interfer implement nation programm diagnosi control erad anim diseas difficulti certifi absenc contamin live anim foodstuff product obtain treat anim diseas product intend confer immun larg absent territori question compet author member state inform commiss instanc provis paragraph appli titl vii pharmacovigil articl member state measur encourag report compet author suspect advers reaction veterinari medicin product member state impos specif requir veterinari practition health care profession respect report suspect unexpect advers reaction human advers reaction report condit market author articl order ensur adopt regulatori decis veterinari medicin product authoris commun regard inform obtain suspect advers reaction veterinari medicin product normal condit member state establish veterinari pharmacovigil system system collect inform surveil veterinari medicin product refer advers reaction anim human be relat veterinari medicin product evalu inform scientif inform collat data sale prescript veterinari medicin product system take account inform relat lack expect efficaci label investig valid withdraw period potenti environment problem aris product interpret accord commiss guidelin refer articl impact evalu benefit risk articl market author holder perman continu dispos appropri qualifi person respons pharmacovigil qualifi person respons establish mainten system ensur inform suspect advers reaction report personnel compani includ repres collect collat order access point commun prepar compet author report refer articl form laid author accord guidanc refer articl ensur request compet author provis addit inform evalu benefit risk afford veterinari medicin product answer fulli promptli includ provis inform volum sale prescript veterinari medicin product concern provis compet author inform relev evalu benefit risk afford veterinari medicin product includ inform post market surveil studi articl market author holder requir maintain detail record suspect advers reaction occur commun countri market author holder requir record report suspect advers reaction human advers reaction relat veterinari medicin product expect knowledg brought attent immedi compet author member state territori incid occur case calendar dai receipt inform market author holder ensur suspect unexpect advers reaction human advers reaction occur territori countri report immedi accord guidanc refer articl agenc compet author member state veterinari medicin product author case calendar dai receipt inform case veterinari medicin product consid scope direct eec benefit procedur mutual recognit articl direct veterinari medicin product referr procedur articl direct market authoris holder addition ensur suspect advers reaction human advers reaction occur commun report format interv agre refer member state compet author design refer member state access refer member state requir laid condit grant author record advers reaction submit compet author form period safeti updat report immedi request period monthli year author annual subsequ year time renew period safeti updat report submit yearli interv applic renew author period safeti updat report includ scientif evalu benefit risk afford veterinari medicin product grant market author market author holder request amend period refer articl procedur laid commiss regul ec applic articl agenc collabor member state commiss set data process network facilit exchang pharmacovigil inform medicin product market commun make network foreseen paragraph member state ensur report suspect advers reaction human advers reaction accord guidanc refer articl place territori immedi made agenc member state case calendar dai notif latest member state ensur report suspect advers reaction human advers reaction place territori immedi made market authoris holder case calendar dai notif latest articl order facilit exchang inform pharmacovigil commun commiss consult agenc member state interest parti draw guidanc collect verif present advers reaction report includ technic requir electron exchang veterinari pharmacovigil inform accord internation agre terminolog guidanc publish volum rule govern medicin product european commun account intern harmonis work carri field pharmacovigil interpret definit refer articl point principl outlin titl market authoris holder compet author refer detail guidanc refer paragraph articl result evalu veterinari pharmacovigil data member state consid market author suspend withdrawn vari restrict indic avail amend posolog add contraind add precautionari measur forthwith inform agenc member state market author holder case urgenc member state concern suspend market author veterinari medicin product provid agenc commiss member state inform latest work dai articl amend updat provis articl account scientif technic progress adopt accord procedur refer articl titl viii supervis sanction articl compet author member state concern ensur mean repeat inspect legal requir relat veterinari medicin product compli inspect carri author repres compet author empow inspect manufactur trade establish laboratori entrust holder manufactur author task carri control test pursuant articl sampl examin document relat object inspect subject current provis member state octob place restrict power regard descript manufactur method member state measur ensur manufactur processess manufactur immunolog veterinari medicin product complet valid batch batch consist ensur offici repres compet author report inspect mention paragraph manufactur compli principl guidelin good manufactur practic refer articl inspect manufactur inform content report articl member state measur ensur market author holder holder manufactur author furnish proof control test carri veterinari medic product constitu intermedi product manufactur process accord method laid purpos market author purpos implement paragraph member state requir market author holder immunolog veterinari medicin product submit compet author copi control report sign qualifi person accord articl market author holder immunolog veterinari medicin product ensur adequ number repres sampl batch veterinari medic product held stock expiri date provid sampl promptli compet author request articl consid member state requir market author holder immunolog product submit sampl batch bulk medic product examin state laboratori approv laboratori entri circul case batch manufactur member state examin compet author member state declar conform nation specif control carri control report batch question examin commiss inform differ veterinari condit member state concern justifi commiss inform longer period complet analys member state ensur examin complet dai receipt sampl market author holder notifi result examin time limit januari member state notifi commiss immunolog veterinari medicin product subject compulsori offici control market articl compet author member state suspend withdraw market author clear veterinari medicin product prove harm condit state time applic author subsequ veterinari medicin product therapeut effect speci anim treatment intend qualit quantit composit state recommend withdraw period inadequ ensur foodstuff obtain treat anim residu constitut health hazard consum veterinari medicin product offer sale prohibit commun provis pend commun rule compet author refus grant author veterinari medicin product action protect public consum anim health inform applic document pursuant articl incorrect control test refer articl carri oblig refer articl fulfil author suspend withdrawn establish particular support applic provid articl amend accord articl inform refer articl commun compet author articl prejudic articl member state measur ensur suppli veterinari medicin product prohibit medicin product concern withdrawn form market clear veterinari medicin product harm condit state time applic author subsequ pursuant articl veterinari medicin product therapeut effect speci anim treatment intend qualit quantit composit veterinari medicin product state recommend withdraw period inadequ ensur foodstuff obtain treat anim residu constitut health hazard consum control test refer articl carri requir oblig relat grant manufactur author refer articl compli compet author confin prohibit suppli withdraw market sole contest product batch articl compet author member state suspend withdraw manufactur author categori prepar prepar requir laid articl longer met compet author member state addit measur provid articl suspend manufactur import veterinari medicin product countri suspend withdraw manufactur author categori prepar prepar event complianc provis manufactur import countri articl provis titl appli homeopath veterinari medicin product articl member state measur encourag veterinarian profession concern report compet author advers reaction veterinari medicin product titl ix stand committe articl order adapt annex account technic progress adopt accord procedur refer articl articl commiss assist stand committe veterinari medicin product adapt technic progress direct remov technic barrier trade veterinari medicin product sector hereinaft refer quot stand committe quot refer made paragraph articl decis ec appli regard provis articl thereof period provid articl decis ec set month stand committe adopt rule procedur titl gener provis articl member state measur ensur compet author concern commun inform complianc requir adopt manufactur author author place product market reason request member state forthwith commun report refer articl compet author member state report member state receiv report consid accept conclus reach compet author member state report establish inform compet author concern reason request inform member state concern attempt reach agreement event differ opinion member state concern inform commiss articl member state measur ensur agenc inform immedi decis grant market author decis refus withdraw market author cancel decis refus withdraw market author prohibit suppli withdraw product market reason decis base market author holder oblig notifi member state forthwith action suspend market veterinari medicin product withdraw product market reason action concern effect veterinari medicin product protect public health member state ensur inform brought attent agenc member state ensur inform action pursuant paragraph affect protect health countri forthwith brought attent relev intern organ copi agenc articl member state commun inform guarante qualiti safeti homeopath veterinari medicin product manufactur market commun inform refer articl articl request manufactur export veterinari medicin product author import countri member state certifi manufactur possess manufactur author issu certif member state compli condit regard prevail administr arrang world health organ veterinari medicin product intend export author territori suppli summari product characterist approv accord articl absenc thereof equival document manufactur possess author place product market provid author respons establish certif refer paragraph declar explain author articl decis refer direct compet author member state ground set direct state detail reason base decis notifi parti concern time inform remedi current legisl time allow seek remedi market author revoc author publish member state offici gazett articl member state permit foodstuff human consumpt test anim maximum residu limit establish commun accord provis regul eec withdraw period establish ensur maximum limit exceed foodstuff titl xi final measur articl direct eec eec eec eec refer annex ii part repeal prejudic oblig member state respect deadlin transposit laid annex ii part refer made repeal direct constru refer direct read accord correl tabl set annex iii articl direct enter forc dai public offici journal european commun articl direct address member state brussel novemb european parliament presid fontain council presid reynder oj opinion european parliament juli publish offici journal council decis septemb oj direct amend commiss direct ec oj oj direct amend commiss direct ec oj oj oj oj regul amend commiss regul ec oj oj oj regul amend commiss regul ec oj oj oj direct amend commiss regul ec oj edit offici journal oj direct repeal direct eec oj oj regul amend regul ec oj annex requir analyt protocol safeti test pre clinic clinic test veterinari medicin product introduct particular document accompani applic market author pursuant articl present accord requir set annex take account guidanc contain quot notic applic market author veterinari medicin product member state european commun quot publish commiss rule govern medicin product european commun volum veterinari medicin product assembl dossier applic market author applic account commun guidelin relat qualiti safeti efficaci veterinari medicin product publish commiss rule govern medicin product european commun inform relev evalu medicin product concern includ applic favour unfavour product relev detail incomplet abandon test trial relat veterinari medicin product market author inform origin applic pertin benefit risk assess submit forthwith compet author member state ensur experi anim conduct accord council direct eec novemb approxim law regul administr provis member state protect anim experiment scientif purpos provis titl annex appli veterinari medicin product immunolog veterinari medicin product provis titl ii annex appli immunolog veterinari medicin product titl requir veterinari medicin product immunolog veterinari medicin product part summari dossier administr data veterinari medicin product subject applic identifi activ substanc strength pharmaceut form method rout administr descript final sale present product address applic address manufactur site involv stage manufactur includ manufactur finish product manufactur activ substanc relev address import applic identifi number titl volum document submit support applic sampl provid annex administr data document show manufactur author produc veterinari medicin product concern defin articl list countri author grant copi summari product characterist accord articl approv member state list countri applic submit summari product characterist applic propos summari product characterist accord articl direct addit applic provid specimen mock up sale present veterinari medicin product packag insert requir expert report accord articl expert report provid analyt document pharmacotoxicolog document residu document clinic document expert report consist critic evalu test trial carri accord direct bring data relev evalu expert give opinion suffici guarante provid qualiti safeti efficaci product concern factual summari suffici import data summar appendix expert report tabular graphic form expert report summari precis cross refer inform contain main document expert report prepar suitabl qualifi experienc person sign date expert attach report inform educ background train occup experi expert profession relationship expert applic declar part analyt physico chemic biolog microbiolog test veterinari medicin product immunolog veterinari medicin product test procedur correspond state scientif progress time valid procedur result valid studi provid test procedur suffici precis detail reproduc control test carri request compet author special apparatu equip adequ detail possibl accompani diagram formula laboratori reagent supplement method prepar case test procedur includ european pharmacopoeia pharmacopoeia member state descript replac detail refer pharmacopoeia question qualit quantit particular constitu particular document accompani applic market author pursuant articl submit accord requir qualit particular quot qualit particular quot constitu medicin product design descript activ substanc constitu excipi natur quantiti includ colour matter preserv adjuv stabilis thicken emulsifi flavour aromat substanc constitu intend ingest administ anim outer cover medicin product capsul gelatin capsul particular supplement relev data contain manner closur detail devic medicin product administ deliv medicin product quot usual terminolog quot describ constitu medicin product notwithstand applic provis articl respect substanc european pharmacopoeia fail nation pharmacopoeia member state main titl head monograph question refer pharmacopoeia concern respect substanc intern proprietari recommend world health organ accompani proprietari fail exact scientif design substanc intern proprietari exact scientif design statement prepar supplement relev detail respect colour matter design quot quot code assign council direct eec decemb approxim rule member state colour matter author medicin product quantit particular order give quot quantit particular quot activ substanc medicin product depend pharmaceut form concern mass number unit biolog activ dosag unit unit mass volum activ substanc unit biolog activ substanc defin chemic intern unit biolog activ defin world health organ intern unit defin unit biolog activ express provid unambigu inform activ substanc biolog activ unit mass volum inform supplement respect inject prepar mass unit biolog activ activ substanc unit contain take account usabl volum product reconstitut respect medicin product administ drop mass unit biolog activ activ substanc contain number drop ml prepar respect syrup emuls granular prepar pharmaceut form administ measur quantiti mass unit biolog activ activ substanc measur quantiti activ substanc present form compound deriv quantit total mass relev mass activ entiti entiti molecul medicin product activ substanc subject applic market author member state time quantit statement activ substanc salt hydrat systemat express term mass activ entiti entiti molecul subsequ author medicin product member state quantit composit state activ substanc develop pharmaceut explan provid regard choic composit constitu contain intend function excipi finish product explan support scientif data develop pharmaceut overag justif thereof state descript manufactur method descript manufactur method accompani applic market author pursuant articl draft give adequ synopsi natur oper emploi purpos includ mention stage manufactur assess made process emploi produc pharmaceut form produc advers chang constitu case continu manufactur full detail precaut ensur homogen finish product actual manufactur formula quantit particular substanc quantiti excipi approxim term pharmaceut form make mention made substanc disappear manufactur overag justifi statement stage manufactur sampl carri process control test data document support applic show test qualiti control finish product experiment studi valid manufactur process standard method manufactur critic product steril product detail steril process asept procedur control start materi purpos paragraph quot start materi quot constitu medicin product contain refer section point case activ substanc european pharmacopoeia pharmacopoeia member state activ substanc european pharmacopoeia pharmacopoeia member state prepar method liabl leav impur mention pharmacopoei monograph monograph inappropri adequ control qualiti manufactur person applic arrang detail descript manufactur method qualiti control manufactur process valid suppli directli compet author manufactur activ substanc case manufactur provid applic data respons medicin product manufactur confirm write applic ensur batch batch consist modifi manufactur process specif inform applic document particular support applic chang suppli compet author particular document accompani applic market author pursuant articl articl includ result test includ batch analys activ substanc relat qualiti control constitu submit accord provis start materi list pharmacopoeia monograph european pharmacopoeia applic substanc appear respect substanc member state requir observ nation pharmacopoeia regard product manufactur territori constitu fulfil requir european pharmacopoeia pharmacopoeia member state deem compli suffici articl case descript analyt method replac detail refer pharmacopoeia question start materi european pharmacopoeia pharmacopoeia member state prepar method liabl leav impur control pharmacopoeia monograph impur maximum toler limit declar suitabl test procedur colour matter case satisfi requir council direct eec routin test carri batch start materi state applic market author test mention pharmacopoeia proof suppli start materi meet qualiti requir pharmacopoeia case specif contain monograph european pharmacopoeia nation pharmacopoeia member state insuffici ensur qualiti substanc compet author request specif market author holder compet author inform author respons pharmacopoeia question market author holder provid author pharmacopoeia detail alleg insuffici addit specif appli case start materi european pharmacopoeia pharmacopoeia member state complianc monograph countri pharmacopoeia accept case applic submit copi monograph accompani valid test procedur contain monograph translat start materi pharmacopoeia constitu pharmacopoeia form monograph head substanc meet requir section point supplement trade scientif synonym definit substanc set form similar european pharmacopoeia accompani explanatori evid molecular structur accompani descript method synthesi substanc manufactur method descript suffici detail characteris substanc constant composit effect method identif form complet techniqu product substanc form test carri routin matter puriti test relat sum total predict impur harm effect regard combin substanc applic refer advers affect stabil medicin product distort analyt result regard complex substanc plant anim origin distinct made case multipl pharmacolog effect render chemic physic biolog control princip compon case substanc group principl similar activ respect method assai accept materi anim origin measur ensur freedom potenti pathogen agent special precaut storag start materi maximum period storag retest physico chemic characterist liabl affect bioavail item inform activ substanc list pharmacopoeia provid part gener descript activ substanc bio avail medicin product depend crystallin form solubl coeffici particl size pulver state solvat oil water coeffici partit indent applic substanc sole solut sourc materi micro organ tissu plant anim origin cell fluid includ blood human anim origin biotechnolog cell construct manufactur veterinari medicin product origin histori start materi document descript start materi includ manufactur strategi purif inactiv procedur valid process control procedur design ensur qualiti safeti batch batch consist finish product cell bank cell characterist shown remain unchang passag level product seed materi cell bank pool serum materi biolog origin sourc materi deriv test adventiti agent presenc potenti pathogen adventiti agent inevit materi process ensur elimin inactiv valid specif measur prevent transmiss anim spongiform encephalopathi applic demonstr veterinari medic product manufactur accord note guidanc minimis risk transmit anim spongiform encephalopathi agent veterinari medicin product updat publish european commiss volum public quot rule govern medicin product european commun quot control test carri intermedi stage manufactur process particular document accompani applic market author pursuant articl articl includ particular relat product control test carri intermedi stage manufactur process view ensur consist technic characterist product process test essenti check conform medicin product formula exception applic propos analyt method test finish product includ assai activ substanc excipi compon subject requir activ substanc appli qualiti control finish product depend process control test substanc essenti defin manufactur method test finish product control finish product batch finish product compris unit pharmaceut form made initi quantiti materi undergon seri manufactur steril oper case continu product process unit manufactur period time applic market author list test carri routin batch finish product frequenc test carri routin state releas limit particular document accompani applic market author pursuant articl articl includ particular relat control test finish product releas submit accord requir provis gener monograph european pharmacopoeia fail member state applic product defin test procedur limit mention gener monograph european pharmacopoeia fail nation pharmacopoeia member state proof suppli finish product test accord monograph meet qualiti requir pharmacopoeia pharmaceut form concern gener characterist finish product test gener characterist product includ test finish product test applic relat control averag mass maximum deviat mechan physic microbiolog test organolept characterist physic characterist densiti ph refract index characterist standard toler limit applic case condit test equip apparatu emploi standard precis detail european pharmacopoeia pharmacopoeia member state appli case method prescrib pharmacopoeia applic solid pharmaceut form administ oral subject vitro studi liber dissolut rate activ substanc substanc studi carri administr mean compet author member state concern identif assai activ substanc identif assai activ substanc carri repres sampl product batch number dosag unit analys individu justif maximum accept deviat activ substanc content finish product exce time manufactur basi stabil test manufactur propos justifi maximum accept toler limit activ substanc content finish product end propos shelf life except case complex mixtur assai activ substanc numer present low amount necessit intric investig difficult carri respect product batch assai activ substanc finish product omit express condit assai made intermedi stage product process relax extend character substanc concern simplifi techniqu supplement method quantit evalu enabl compet author conform medicin product specif verifi market vivo vitro biolog assai obligatori physico chemic method provid adequ inform qualiti product assai includ refer materi statist analysi allow calcul confid limit test carri finish product perform intermedi stage late manufactur process particular section show signific overag activ substanc emploi manufactur medicin product descript control test finish product includ chemic toxico pharmacolog investig substanc undergon possibl character assai degrad product identif assai excipi compon excipi compon subject identif test test procedur propos identifi colour matter enabl verif made matter list annex direct eec upper lower limit test obligatori respect preserv agent upper limit test excipi compon liabl affect advers physiolog function upper lower limit test obligatori respect excipi liabl affect bio avail activ substanc bio avail guarante test safeti test toxico pharmacolog test submit applic market author particular safeti test steril bacteri endotoxin pyrogen local toler anim includ analyt particular test undertaken matter routin order verifi qualiti product stabil test particular document accompani applic market author pursuant articl submit accord requir descript investig shelf life recommend storag condit specif end shelf life propos applic determin case pre mix medic feedingstuff inform shelf life medic feedingstuff manufactur pre mix accord recommend instruct finish product requir reconstitut prior administr detail propos shelf life reconstitut product requir support relev stabil data case multi dose vial stabil data present justifi shelf life vial punctur time finish product liabl give rise degrad product applic declar character method test procedur conclus result analys justifi propos shelf life recommend storag condit specif finish product end shelf life finish product recommend storag condit maximum accept level degrad product end shelf life studi interact product contain submit risk interact regard inject prepar aerosol intern concern part safeti residu test particular document accompani applic market author pursuant articl submit accord requir member state ensur test carri accord provis relat good laboratori practic laid council direct eec decemb harmon law regul administr provis relat applic principl good laboratori practic verif applic test chemic substanc council direct eec june inspect verif good laboratori practic glp safeti test chapter perform test introduct safeti document show potenti toxic medicin product danger undesir effect occur propos condit anim evalu relat sever patholog condit concern potenti harm effect man residu veterinari medicin product substanc foodstuff obtain treat anim difficulti residu creat industri process foodstuff potenti risk result exposur human be medicin product administr anim potenti risk environ result medicin product result reliabl valid gener mathemat statist procedur design experiment method evalu result addition clinician inform therapeut potenti product hazard connect case test metabolit parent compound repres residu concern excipi pharmaceut field time treat activ substanc pharmacolog pharmacolog studi fundament import clarifi mechan medicin product produc therapeut effect pharmacolog studi conduct experiment target speci anim includ part pharmacolog studi assist understand toxicolog phenomena medicin product produc pharmacolog effect absenc toxic respons dose lower requir elicit toxic pharmacolog effect account evalu safeti medicin product safeti document preced detail pharmacolog investig undertaken laboratori anim relev inform observ clinic studi target anim toxicolog singl dose toxic singl dose toxic studi predict effect acut overdosag target speci effect accident administr human dose usefulli emploi repeat dose studi singl dose toxic studi reveal acut toxic effect substanc time onset remiss studi carri mammalian speci mammalian speci replac anim speci medicin product intend rout administr studi similar propos target speci substanti exposur user medicin product anticip inhal dermal contact rout studi order reduc number suffer anim involv protocol singl dose toxic test continu develop studi carri accord procedur properli valid accept studi carri accord establish internation recogn guidelin repeat dose toxic repeat dose toxic test intend reveal physiolog patholog induc repeat administr activ substanc combin activ substanc examin determin relat dosag case substanc medicin product intend sole food produc anim repeat dose toxic studi speci experiment anim suffici studi replac studi conduct target anim frequenc rout administr durat studi chosen regard propos condit clinic investig give reason extent durat trial dosag chosen case substanc medicin product intend food produc anim studi conduct speci rodent investig give reason choic speci regard knowledg metabol product anim man test substanc administ oral durat test dai investig state give reason method frequenc administr length trial maximum dose select bring harm effect light lowest dose level produc evid toxic evalu toxic effect base observ behaviour growth haematolog physiolog test relat excretori organ autopsi report accompani histolog data choic rang group test depend speci anim state scientif knowledg time case combin substanc investig accord provis direct repeat dose test toxic test demonstr potenti toxic effect suitabl modifi investig submit reason modif toler target speci detail provid sign intoler observ studi conduct target speci accord requir part chapter section studi concern dosag intoler occur speci breed concern identifi detail unexpect physiolog provid reproduct toxic includ teratogen studi effect reproduct purpos studi identifi impair male femal reproduct function harm effect progeni result administr medicin product substanc investig case substanc medicin product intend food produc anim studi effect reproduct carri form gener studi speci rodent substanc product investig administ male femal time prior mate administr continu wean gener dose level maximum dose select bring harm effect light lowest dose level produc evid toxic evalu effect reproduct base fertil pregnanc matern behaviour suckl growth develop offspr concept matur develop offspr wean studi embryotox fetotox effect includ teratogenec case substanc medicin product intend food produc anim studi embryotox fetotox effect includ teratogen carri studi carri mammalian speci rodent rabbit detail test number anim dose time administ criteria evalu result depend state scientif knowledg time applic lodg level statist signific result attain rodent studi combin studi effect reproduct function case substanc medicin product intend food produc anim studi embryotox fetotox effect includ teratogen requir speci target speci product intend anim breed mutagen mutagen test intend assess potenti substanc transmiss genet materi cell substanc intend veterinari medicin product assess mutagen properti number type test criteria evalu result depend state scientif knowledg applic submit carcinogen long term anim carcinogen studi requir substanc human be expos close chemic analog carcinogen mutagen test produc result indic possibl carcinogen effect rise suspect sign toxic test state scientif knowledg time applic submit account design carcinogen studi evalu result except medicin product intend topic system absorpt investig target speci anim prove system absorpt neglig repeat dose toxic test test reproduct toxic carcinogen test omit condit laid oral ingest medicin product anim expect medicin enter foodstuff obtain treat anim intramammari prepar requir immunotox effect observ repeat dose studi anim includ specif lymphoid organ weight histolog cellular lymphoid tissu bone marrow peripher leukocyt investig addit studi effect product immun system state scientif knowledg time applic submit account design studi evalu result microbiolog properti residu potenti effect human gut flora microbiolog risk present residu anti microbi compound human intestin flora investig accord state scientif knowledg time applic submit potenti effect microorgan industri food process case carri test determin residu difficulti affect technolog process industri foodstuff process observ human inform provid show constitu veterinari medicin product medicin product human therapi report made effect observ includ advers reaction human extent import assess veterinari medicin product light trial result bibliograph document constitu veterinari medicin product longer medicin product human therapi reason state ecotox purpos studi ecotox veterinari medicin product assess potenti harm effect product environ identifi precautionari measur reduc risk assess ecotox compulsori applic market author veterinari medicin product applic submit accord articl assess conduct phase phase investig assess potenti extent exposur environ product activ substanc relev metabolit take account target speci propos pattern mass medic individu anim medic method administr extent product enter directli environment system excret product activ substanc relev metabolit environ treat anim persist excretia dispos unus wast product phase regard extent exposur product environ inform physic chemic pharmacolog toxicolog properti compound obtain conduct test trial requir direct investig specif investig effect product eco system investig requir fate behaviour soil fate behaviour water air effect aquat organ effect target organ investig carri accord test protocol laid annex council direct eec june approxim law regul administr provis relat classif packag label danger substanc end point adequ cover protocol accord internation recogn protocol veterinari medicin product activ substanc excret metabolit number type test criteria evalu depend state scientif knowledg time applic submit chapter ii present particular document scientif work dossier safeti test includ introduct defin subject accompani bibliograph refer detail identif substanc review includ intern proprietari inn intern union pure appli chemistri iupac chemic abstract servic ca number therapeut pharmacolog classif synonym abbrevi structur formula molecular formula molecular weight degre impur qualit quantit composit impur descript physic properti melt point boil point vapour pressur solubl water organ solvent express indic temperatur densiti spectra refract rotat detail experiment protocol give reason omiss test list descript method apparatu materi detail speci breed strain anim obtain number condit hous fed state inter alia free specif pathogen spf result obtain favour unfavour origin data suffici detail result critic evalu independ interpret author explan result accompani illustr statist analysi result call test programm varianc data object discuss result obtain lead conclus safeti substanc safeti margin test anim target anim side effect field applic activ dose level incompat detail descript discuss result studi safeti residu food relev evalu potenti risk present residu human discuss propos ensur danger man elimin appli internation recogn assess criteria observ effect level anim propos choic safeti factor accept daili intak adi discuss risk person prepar medicin product administ anim propos measur reduc risk discuss risk veterinari medicin product practic condit propos repres environ propos reduc risk inform acquaint clinician fulli util propos product discuss supplement suggest side effect treatment acut toxic reaction anim product administ conclud expert report detail critic analysi inform refer light state scientif knowledg time applic submit detail summari result relev safeti test precis bibliograph refer residu test chapter perform test introduct purpos direct quot residu quot mean activ substanc metabolit thereof remain meat foodstuff produc anim medicin product question administ purpos studi residu determin condit extent residu persist foodstuff produc treat anim ascertain withdraw period adher order obviat hazard human health difficulti industri process foodstuff assess hazard due residu entail establish residu present anim treat recommend condit investig effect residu case veterinari medicin product intend food produc anim residu document show extent long residu veterinari medicin product metabolit persist tissu treat anim foodstuff obtain therefrom order prevent risk health consum foodstuff treat anim difficulti industri process foodstuff establish realist withdraw period observ practic farm condit practic analyt method suitabl routin verifi complianc withdraw period metabol residu kinet pharmacokinet absorpt distribut biotransform excret purpos pharmacokinet studi respect residu veterinari medicin product evalu absorpt distribut biotransform excret product target speci final product formul bioequival administ target speci maximum recommend dose regard method administr extent absorpt medicin product fulli demonstr system absorpt product topic applic neglig residu studi requir distribut medicin product target anim possibl plasma protein bind passag milk egg accumul lipophil compound consid pathwai excret product target anim major metabolit identifi characteris deplet residu purpos studi measur rate residu deplet target anim administr medicin product permit determin withdraw period vari time test anim receiv final dose medicin product quantiti residu present determin physic chemic biolog method technic procedur reliabl sensit method emploi routin analyt method detect residu analyt procedur propos carri routin examin level sensit enabl violat legal permit maximum residu limit detect certainti analyt method propos detail valid suffici rug normal condit routin monitor residu characterist specif accuraci includ sensit precis limit detect limit quantit practic applic normal laboratori condit suscept interfer suitabl analyt method propos evalu light state scientif technic knowledg time applic submit chapter ii present particular document scientif work dossier residu test includ introduct defin subject accompani bibliograph refer detail identif medicin includ composit puriti batch identif relationship final product specif activ radio puriti label substanc posit label atom molecul detail experiment protocol give reason omiss test list descript method apparatu materi detail speci breed strain anim obtain number condit hous fed result obtain favour unfavour origin data suffici detail result critic evalu independ interpret author result accompani illustr statist analysi result call test programm varianc data object discuss result obtain propos maximum residu limit activ substanc contain product marker residu target tissu concern propos withdraw period ensur residu constitut hazard consum present foodstuff obtain treat anim conclud expert report detail critic analysi inform refer light state scientif knowledg time applic submit detail summari result residu test precis bibliograph refer part pre clinic clinic test particular document accompani applic market author pursuant articl submit accord provis part chapter pre clinic requir pre clinic studi requir establish pharmacolog activ toler product pharmacolog pharmacodynam studi pharmacodynam follow distinct line approach mechan action pharmacolog effect recommend applic practic base adequ result express quantit term dose effect curv time effect curv comparison substanc activ higher efficaci claim activ substanc differ demonstr shown statist signific investig give pharmacolog assess activ substanc special refer possibl side effect gener main function investig investig identifi effect rout administr formul pharmacolog activ activ substanc investig intensifi recommend dose approach liabl produc advers reaction experiment techniqu standard procedur detail reproduc investig establish valid experiment result set type test statist signific quot good reason contrari quantit modif respons result repeat administr substanc investig medicin combin prompt pharmacolog ground clinic indic case pharmacodynam pharmacokinet studi demonstr interact make combin clinic case scientif justif medicin combin sought clinic experiment investig determin effect expect combin demonstr anim import advers reaction check combin includ activ substanc previous studi depth pharmacokinet basic pharmacokinet inform activ substanc gener clinic context pharmacokinet object divid main area descript pharmacokinet lead evalu basic paramet bodi clearanc volum distribut resid time ii paramet investig relationship dosag regimen plasma tissu concentr pharmacolog therapeut toxic effect target speci pharmacokinet studi rule order emploi drug greatest efficaci safeti studi assist clinician establish dosag regimen rout site administr dose dose interv number administr adopt dosag regimen popul variabl ag diseas studi effici number anim gener provid inform classic dose titrat studi case combin substanc investig accord provis direct pharmacokinet studi fix combin requir justifi administr activ substanc fix combin chang pharmacokinet properti bioavail bioequival bioavail studi undertaken establish bioequival compar reformul medicin product exist compar method rout administr establish case refer articl toler target speci anim purpos studi carri anim speci medicin product intend carri anim speci local gener toler trial design establish toler dosag wide adequ safeti margin clinic symptom intoler recommend rout rout achiev increas therapeut dose durat treatment report trial detail expect pharmacolog effect advers reaction assess due regard fact anim high medicin product administ recommend rout administr resist data emerg resist organ case medicin product prevent treatment infecti diseas parasit infest anim chapter ii clinic requir gener principl purpos clinic trial demonstr substanti effect veterinari medicin product administr recommend dosag indic contra indic speci ag breed sex direct advers reaction safeti toler normal condit justifi clinic trial carri control anim control clinic trial effect obtain compar placebo absenc treatment effect author medicin product therapeut result obtain posit neg report method make diagnosi result set make quantit convent clinic criteria adequ statist method justifi case veterinari medicin product intend primarili perform enhanc attent yield anim produc qualiti anim produc organolept nutrit hygien technolog qualiti nutrit effici growth anim gener statu health anim experiment data confirm data obtain practic field condit respect therapeut indic applic show unabl provid comprehens data therapeut effect indic medicin product question intend encount rare applic expect provid comprehens evid present state scientif knowledg comprehens inform provid market author grant subject condit medicin product question suppli veterinari prescript case administ strict veterinari supervis packag insert inform draw attent veterinari practition fact respect particular medicin product question incomplet perform trial veterinari clinic trial conduct accord fulli consid detail trial protocol record write prior commenc trial welfar trial anim subject veterinari supervis fulli consider elabor trial protocol conduct trial pre establish systemat written procedur organ conduct data collect document verif clinic trial requir commenc trial inform consent owner anim trial obtain document anim owner inform write consequ particip trial subsequ dispos treat anim take foodstuff treat anim copi notif countersign date anim owner includ trial document trial conduct blind design provis articl label veterinari medicin product appli analog label formul intend veterinari clinic trial case word quot veterinari clinic trial quot promin indel label chapter iii particular document scientif work dossier efficaci includ introduct defin subject accompani bibliograph document pre clinic clinic document suffici detail enabl object judgement made studi trial report favour unfavour applic record pre clinic observ particular result test demonstr pharmacolog action test demonstr pharmacolog mechan underli therapeut effect test demonstr main pharmacokinet process unexpect result occur test detail addition particular provid pre clinic studi summari detail experiment protocol give descript method apparatu materi detail speci ag weight sex number breed strain anim identif anim dose rout schedul administr statist analysi result relev object discuss result obtain lead conclus safeti efficaci product total partial omiss data explain record clinic observ particular suppli investig individu record sheet case individu treatment collect record sheet case collect treatment particular suppli form address function qualif investig charg place date treatment address owner anim detail trial protocol give descript method includ method random blind detail rout administr schedul administr dose identif trial anim speci breed strain ag weight sex physiolog statu method rear feed state composit feed natur quantiti addit contain feed case histori full occurr inter current diseas diagnosi mean make symptom sever diseas convent criteria precis identif clinic trial formul trial dosag medicin product method rout frequenc administr precaut administr durat inject durat treatment period subsequ observ detail medicin product studi administ period examin prior concurr test product case detail interact observ result clinic trial includ unfavour neg result full statement clinic observ result object test activ laboratori analys physiolog test requir evalu applic techniqu signific variat result explain varianc method varianc individu effect medic demonstr pharmacodynam effect anim suffic justifi conclus therapeut effect particular unintend effect harm measur consequ effect relationship investig effect anim perform egg lai milk product reproduct function effect qualiti foodstuff obtain treat anim case medicin product intend perform enhanc conclus individu case collect treatment concern collect case omiss item justifi market author holder make arrang ensur origin document form basi data suppli year veterinari medicin product longer author summari conclus clinic observ respect clinic trial clinic observ summar synopsi trial result thereof indic number control number anim treat individu collect breakdown speci breed strain ag sex number anim withdrawn prematur trial reason withdraw case control anim receiv treatment receiv placebo receiv author medicin product effect receiv activ substanc investig formul rout frequenc observ advers reaction observ effect perform egg lai milk product reproduct function food qualiti detail test anim increas risk ow ag mode rear feed purpos intend anim physiolog patholog condit requir special consider statist evalu result call test programm final investig draw gener conclus experiment evid express opinion harmless medicin product propos condit therapeut effect inform relat indic contra indic dosag averag durat treatment interact observ medicin product feed addit special precaut treatment clinic symptom overdosag case fix combin product investig draw conclus safeti efficaci product compar separ administr activ substanc involv conclud expert report conclud expert report provid detail critic analysi pre clinic clinic document light state scientif knowledg time applic submit detail summari result test trial submit precis bibliograph refer titl ii requir immunolog veterinari medicin product prejudic specif requir laid commun legisl control erad anim deseas requir appli immunolog veterinari medicin product part summari dossier administr data immunolog veterinari medicin product subject applic identifi activ substanc strength pharmaceut form method rout administr descript final sale present product address applic address manufactur site involv stage manufactur includ manufactur finish product manufactur activ substanc relev address import applic identifi number titl volum document submit support applic sampl provid annex administr data copi document show manufactur author produc immunolog veterinari medicin product defin articl descript product site list organ handl product site applic submit list countri author grant copi summari product characterist accord articl approv member state list countri applic submit summari product characterist applic propos summari product characterist accord articl addit applic provid specimen mock up sale present immunolog veterinari medicin product packag insert requir expert report accord articl expert report provid aspect document expert report consist critic evalu test trial carri accord direct bring data relev evalu expert give opinion suffici guarante provid qualiti safeti efficaci product concern factual summari suffici import data summar appendix expert report tabular graphic form expert report summari precis cross refer inform contain main document expert report prepar suitabl qualifi experienc person sign date expert attach report inform educ background train occup experi expert profession relationship expert applic declar part analyt physico chemic biolog microbiolog test immunolog veterinari medicin product test procedur correspond state scientif progress time valid procedur result valid studi provid test procedur suffici precis detail reproduc control test carri request compet author special apparatu equip adequ detail possibl accompani diagram formula laboratori reagent supplement manufactur method case test procedur includ european pharmacopoeia pharmacopoeia member state descript replac detail refer pharmacopoeia question qualit quantit particular constitu particular document accompani applic market author pursuant articl submit accord requir qualit particular quot qualit particular quot constitu immunolog veterinari medicin product design descript activ substanc constitu adjuv constitu excipi natur quantiti includ preserv stabilis emulsifi colour matter flavour aromat substanc marker constitu pharmaceut form administ anim particular supplement relev data contain manner closur detail devic immunolog veterinari medicin product administ deliv medicin product quot usual terminolog quot describ constitu immunolog veterinari medicin product notwithstand applic provis articl respect substanc european pharmacopoeia fail nation pharmacopoeia member state main titl monograph question obligatori substanc refer pharmacopoeia concern respect substanc intern proprietari recommend world health organ accompani proprietari fail exact scientif design substanc intern proprietari exact scientif design statement prepar supplement relev detail respect colour matter design quot quot code assign direct eec quantit particular order give quot quantit particular quot activ substanc immunolog veterinari medicin product number organ specif protein content mass number intern unit iu unit biolog activ dosag unit volum regard adjuv constitu excipi mass volum due allow detail provid section intern unit biolog activ defin unit biolog activ publish data exist express provid unambigu inform activ ingredi state immunolog effect method determin dose base develop pharmaceut explan provid regard composit compon contain support scientif data develop pharmaceut overag justif thereof state efficaci preserv system demonstr descript manufactur method finish product descript manufactur method accompani applic market author pursuant articl draft give adequ descript natur oper emploi purpos descript includ stage manufactur includ purif procedur assess made reproduc manufactur procedur risk advers effect finish product microbiolog contamin case continu manufactur full detail precaut ensur homogen consist batch finish product mention substanc recov manufactur detail blend quantit particular substanc statement stage manufactur sampl carri process control test product control start materi purpos paragraph quot start materi quot mean compon product immunolog veterinari medicin product cultur media product activ substanc consid singl start materi case activ substanc european pharmacopoeia pharmacopoeia member state activ substanc european pharmacopoeia pharmacopoeia member state prepar method liabl leav impur mention pharmacopoei monograph monograph inappropri adequ control qualiti manufactur person applic arrang detail descript manufactur method qualiti control manufactur process valid suppli directli compet author manufactur activ substanc case manufactur provid applic data respons medicin product manufactur confirm write applic ensur batch batch consist modifi manufactur process specif inform applic document particular support applic chang suppli compet author particular document accompani applic market author pursuant articl articl includ result test relat qualiti control compon submit accord provis start materi list pharmacopoeia monograph european pharmacopoeia applic substanc appear respect substanc member state requir observ nation pharmacopoeia regard product manufactur territori compon fulfil requir european pharmacopoeia pharmacopoeia member state deem compli suffici articl case descript analyt method replac detail refer pharmacopoeia question refer pharmacopoeia countri permit case substanc european pharmacopoeia nation pharmacopoeia concern case monograph submit accompani translat applic respons colour matter case satisfi requir council direct eec routin test carri batch start materi state applic market author test mention pharmacopoeia proof suppli start materi meet qualiti requir pharmacopoeia case specif provis contain monograph european pharmacopoeia nation pharmacopoeia member state insuffici ensur qualiti substanc compet author request specif applic market author compet author inform author respons pharmacopoeia question applic market author provid author pharmacopoeia detail alleg insuffici addit specif appli case start materi european pharmacopoeia pharmacopoeia member state complianc monograph countri pharmacopoeia accept case applic submit copi monograph accompani valid test procedur contain monograph translat activ ingredi demonstr abil monograph adequ control qualiti present start materi list pharmacopoeia start materi biolog origin descript form monograph vaccin product base seed lot system establish cell bank product immunolog veterinari medicin product consist serum origin gener health immunolog statu produc anim defin pool sourc materi origin histori start materi document genet engin start materi inform includ detail descript start cell strain construct express vector origin function replicon promot enhanc regul element control sequenc dna rna effect insert oligonucleotid sequenc plasmid vector cell plasmid cotransfect ad delet gene biolog properti final construct gene express copi number genet stabil seed materi includ cell bank raw serum anti serum product test ident adventiti agent inform provid substanc biolog origin stage manufactur procedur inform includ detail sourc materi detail process purif inactiv appli data valid process process control detail test contamin carri batch substanc presenc adventiti agent detect suspect materi discard except circumst process product ensur elimin inactiv elimin inactiv adventiti agent demonstr cell bank cell characterist shown remain unchang highest passag level product live attenu vaccin proof stabil attenu characterist seed requir sampl biolog start materi reagent test procedur provid enabl compet author arrang check test carri start materi biolog origin descript form monograph head start materi meet requir point section supplement trade scientif synonym descript start materi set form similar descript item european pharmacopoeia function start materi method identif puriti relat sum total predict impur harm effect regard combin substanc applic refer advers effect stabil medicin product distort analyt result descript provid test undertaken establish puriti batch start materi special precaut storag start materi storag life specif measur prevent transmiss anim spongiform encephalopathi applic demonstr veterinari medic product manufactur accord note guidanc minimis risk transmit anim spongiform encephalopathi agent veterinari medicin product updat publish european commiss volum public quot rule govern medicin product european commun quot control test product particular document accompani applic market author pursuant articl articl includ particular relat control test carri intermedi product view verifi consist product process final product inactiv detoxifi vaccin inactiv detoxif test product run immedi inactiv detoxif process control test finish product particular document accompani applic market author pursuant articl articl includ particular relat control test finish product monograph exist test procedur limit mention monograph european pharmacopoeia fail nation pharmacopoeia member state proof suppli finish product test accord monograph meet qualiti requir pharmacopoeia pharmaceut form concern applic market author list test carri repres sampl batch finish product frequenc test carri batch state releas limit gener characterist finish product test gener characterist product includ test finish product carri manufactur process test applic relat control averag mass maximum deviat mechan physic chemic microbiolog test physic characterist densiti ph refract index characterist specif confid limit establish applic case identif assai activ substanc test descript techniqu analyz finish product set suffici precis detail reproduc readili assai biolog activ activ substanc carri repres sampl product batch number dosag unit analys individu specif test identif carri except case assai activ substanc numer present low amount necessit intric investig difficult carri respect product batch assai activ substanc finish product omit express condit assai made intermedi stage late product process relax extend character substanc concern simplifi techniqu supplement method quantit evalu enabl compet author verifi immunolog veterinari medicin product accord formula market identif assai adjuv test procedur quantiti natur adjuv compon verifi finish product identif assai excipi compon excipi subject identif test test procedur propos identifi colour matter enabl verif made matter permit direct eec upper lower limit test obligatori respect preserv agent upper limit test excipi compon liabl give rise advers reaction obligatori safeti test result test submit accord part annex particular safeti test submit test prefer overdosag studi carri sensit target speci recommend rout administr pose greatest risk steril puriti test test demonstr absenc contamin adventiti agent substanc carri natur immunolog veterinari medicin product method condit manufactur inactiv applic test verifi inactiv carri product final contain residu humid batch lyophilis product test residu humid batch batch consist order ensur efficaci product reproduc batch batch demonstr conform specif potenc test base vitro vivo method includ refer materi carri final bulk batch finish product confid limit except circumst potenc test carri intermedi stage late product process stabil test particular document accompani applic market author pursuant articl submit accord requir descript test undertaken support shelf life propos applic test real time studi carri suffici number batch produc product process product store final contain test includ biolog physico chemic stabil test conclus result analys justifi propos shelf life propos storag condit case product administ feed inform shelf life product stage mix mix accord recommend instruct finish product requir reconstitut prior administr detail propos shelf life requir product reconstitut recommend data support propos shelf life reconstitut product submit part safeti test introduct safeti test show potenti risk immunolog veterinari medicin product occur propos condit anim evalu relat potenti benefit product immunolog veterinari medicin product consist live organ shed vaccin anim potenti risk unvaccin anim potenti expos speci evalu particular document accompani applic market author pursuant articl submit accord requir section member state ensur laboratori test carri conform principl good laboratori practic laid council direct eec eec gener requir safeti test carri target speci dose quantiti product recommend maximum titr potenc applic submit sampl safeti test batch batch produc manufactur process applic market author laboratori test safeti administr dose immunolog veterinari medicin product administ recommend dose recommend rout administr anim speci categori intend includ anim minimum ag administr anim observ examin sign system local reaction studi includ detail post mortem macroscop microscop examin inject site object criteria record rectal temperatur perform measur anim observ examin reaction longer expect case observ examin period dai administr safeti administr overdos overdos immunolog veterinari medicin product administ recommend rout administr anim sensit categori target speci anim observ examin sign system local reaction object criteria record rectal temperatur perform measur anim observ examin dai administr safeti repeat administr dose repeat administr dose requir reveal advers effect induc administr test carri sensit categori target speci recommend rout administr anim observ examin dai administr sign system local reaction object criteria record rectal temperatur perform measur examin reproduct perform examin reproduct perform consid data suggest start materi product deriv potenti risk factor reproduct perform male pregnant pregnant femal investig recommend dose recommend rout administr addit harm effect progeni teratogen abortifaci effect investig studi form part safeti studi paragraph examin immunolog function immunolog veterinari medicin product advers affect immun respons vaccin anim progeni suitabl test immunolog function carri special requir live vaccin spread vaccin strain spread vaccin strain vaccin unvaccin target anim investig recommend rout administr result spread investig spread target speci highli suscept live vaccin strain dissemin vaccin anim faec urin milk egg oral nasal secret test presenc organ studi requir dissemin vaccin strain bodi attent paid predilect site replic organ case live vaccin establish zoonot diseas food produc anim studi undertaken revers virul attenu vaccin revers virul investig materi passag level attenu master seed final product initi vaccin carri recommend rout administr lead revers virul serial passag anim target speci undertaken technic due failur organ replic adequ passag carri target speci vitro propag organ carri passag vivo passag undertaken rout administr lead revers virul biolog properti vaccin strain test determin precis intrins biolog properti vaccin strain neurotrop recombin genom reassort strain probabl recombin genom reassort field strain discuss studi residu immunolog veterinari medicin product undertak studi residu adjuv preserv manufactur immunolog veterinari medicin product consider possibl residu remain foodstuff effect residu investig case live vaccin zoonot diseas determin residu inject site requir addit studi paragraph propos withdraw period made adequaci discuss relat residu studi undertaken interact interact product field studi justifi result laboratori studi supplement support data field studi ecotox purpos studi ecotox immunolog veterinari medicin product assess potenti harm effect product environ identifi precautionari measur reduc risk assess ecotox compulsori applic market author immunolog veterinari medicin product applic submit accord articl assess conduct phase phase assess carri investig assess potenti extent exposur environ product activ substanc relev metabolit take account target speci propos pattern mass medic individu anim medic method administr extent product enter directli environment system excret product activ substanc relev metabolit environ treat anim persist excretia dispos unus wast product conclus phase potenti exposur environ product applic proce phase evalu potenti ecotox product purpos extent durat exposur environ product inform physic chemic pharmacolog toxicolog properti compound obtain conduct test trial requir direct investig impact product soil water air aquat system target organ carri investig carri accord test protocol laid annex council direct eec end point adequ cover protocol accord internation recogn protocol immunolog veterinari medicin product activ substanc excret metabolit number type test criteria evalu depend state scientif knowledg time applic submit part efficaci trial introduct purpos trial part demonstr confirm efficaci immunolog veterinari medicin product claim made applic regard properti effect product fulli support result specif trial contain applic market author particular document accompani applic market author pursuant articl submit accord provis veterinari clinic trial conduct accord fulli consid detail trial protocol record write prior commenc trial welfar trial anim subject veterinari supervis fulli consider elabor trial protocol conduct trial pre establish systemat written procedur organ conduct data collect document verif clinic trial requir commenc trial inform consent owner anim trial obtain document anim owner inform write consequ particip trial subsequ dispos treat anim take foodstuff treat anim copi notif countersign date anim owner includ trial document trial conduct blind design provis articl appli analog label formul intend veterinari clinic trial case word quot veterinari clinic trial quot promin indel label gener requir choic vaccin strain justifi basi epizoolog data efficaci trial carri laboratori control trial includ untreat control anim gener trail support trial carri field condit includ untreat control anim trial suffici precis detail reproduc control trial carri request compet author investig demonstr valid techniqu involv result present precis result obtain favour unfavour report efficaci immunolog veterinari medicin product demonstr categori speci recommend vaccin recommend rout administr propos schedul administr influenc passiv acquir matern deriv antibodi efficaci vaccin adequ evalu claim onset durat protect support data trial efficaci compon multival combin immunolog veterinari medicin product demonstr product recommend administr combin time veterinari medicin product shown compat product form part vaccin scheme recommend applic prime booster effect contribut product efficaci scheme demonstr dose quantiti product recommend minimum titr potenc applic submit sampl efficaci trial batch batch produc manufactur process applic market author diagnost immunolog veterinari medicin product administ anim applic reaction product interpret laboratori trial principl demonstr efficaci undertaken control laboratori condit challeng administr immunolog veterinari medicin product target anim recommend condit condit challeng carri mimic natur condit infect regard amount challeng organ rout administr challeng immun mechan cell mediat humor local gener class immunoglobulin initi administr immunolog veterinari medicin product target anim recommend rout administr document field trial justifi result laboratori trial supplement data field trial laboratori trial support efficaci perform field trial accept part particular document safeti test efficaci trial immunolog veterinari medicin product introduct scientif work dossier safeti efficaci studi includ introduct defin subject indic test carri complianc part summari refer publish literatur omiss test trial list part discuss laboratori studi provid studi summari bodi carri studi detail experiment protocol give descript method apparatu materi detail speci breed strain anim categori anim obtain identif number condit hous fed state inter alia free pathogen antibodi natur quantiti addit contain feed dose rout schedul date administr descript statist method case control anim receiv placebo treatment gener individu observ result obtain averag standard deviat favour unfavour data suffici detail result critic evalu independ interpret author raw data present tabular form explan illustr result accompani reproduct record photomicrograph natur frequenc durat observ side effect number anim withdrawn prematur studi reason withdraw statist analysi result call test programm varianc data occurr intercurr diseas detail medicin product product studi administr studi object discuss result obtain lead conclus safeti efficaci product field studi particular field studi suffici detail enabl object judgement made includ summari address function qualif investig charg place date administr address owner anim detail trial protocol give descript method apparatu materi detail rout administr schedul administr dose categori anim durat observ serolog respons investig carri anim administr case control anim receiv placebo treatment identif treat control anim collect individu speci breed strain ag weight sex physiolog statu descript method rear feed state natur quantiti addit contain feed particular observ perform result averag standard deviat individu data test measur individu carri observ result studi favour unfavour full statement observ result object test activ requir evalu product techniqu signific variat result explain effect anim perform egg lai milk product reproduct perform number anim withdrawn prematur studi reason withdraw natur frequenc durat observ advers reaction occurr intercurr diseas detail medicin product product studi administ prior concurr test product observ period detail interact observ object discuss result obtain lead conclus safeti efficaci product gener conclus gener conclus result test trial carri complianc part object discuss result obtain lead conclus safeti efficaci immunolog veterinari medicin product bibliograph refer bibliograph refer cite summari mention section list detail oj oj direct amend act access compet author request pk ph valu inform essenti oj direct amend commiss direct ec oj oj direct amend commiss decis ec oj oj direct amend commiss direct ec oj annex ii part repeal direct success amend refer articl council direct eec oj council direct eec oj council direct eec oj council direct eec oj council direct eec oj commiss direct ec oj council direct eec oj council direct eec oj council direct eec oj council direct eec commiss direct ec oj part time limit transposit nation law refer articl gt tabl gt annex iii correl tabl gt tabl gt