regul ec european parliament council march lai commun procedur authoris supervis medicin product human veterinari establish european medicin agenc european parliament council european union regard treati establish european commun articl articl thereof regard propos commiss regard opinion european econom social committe consult committe region accord procedur laid articl treati articl council regul eec juli lai commun procedur authoris supervis medicin product human veterinari establish european agenc evalu medicin product year entri forc regul commiss publish gener report experi acquir result oper procedur laid regul light commiss report experi gain prove improv oper authoris procedur place medicin product market commun amend administr aspect european agenc evalu medicin product addit agenc simplifi chang european medicin agenc hereinaft refer quot agenc quot emerg conclus report amend made centralis procedur set regul eec consist correct oper procedur adapt account probabl develop scienc technolog futur enlarg european union emerg report gener principl previous establish govern centralis procedur maintain european parliament council adopt direct ec novemb commun code relat medicin product human direct ec novemb commun code relat veterinari medicin product refer codifi direct regul eec updat sake clariti replac regul regul preserv commun mechan set repeal commun legisl concert prior nation decis relat high technolog medicin product experi gain adopt council direct eec decemb approxim nation measur relat place market high technolog medicin product deriv biotechnolog shown creat centralis authoris procedur compulsori high technolog medicin product result biotechn process order maintain high level scientif evalu medicin product european union preserv confid patient medic profess evalu import context emerg therapi gene therapi cell therapi xenogen somat therapi approach maintain view ensur effect oper intern market pharmaceut sector view harmonis intern market medicin product procedur made compulsori orphan medicin product medicin product human activ substanc authoris commun therapeut indic treatment acquir immun defici syndrom cancer neurodegen disord diabet year date entri forc regul procedur compulsori medicin product human activ substanc therapeut indic treatment auto immun diseas immun dysfunct viral diseas review provis point annex simplifi decis make procedur earlier year entri forc regul medicin product human option access centralis procedur provid case singl procedur produc ad patient procedur remain option medicin product belong abovement categori therapeut innov access procedur medicin product innov benefit societi patient authoris outset commun level medicin product suppli medic prescript option extend gener medicin product authoris commun provid undermin harmonis achiev refer medicin product evalu result evalu field veterinari medicin product administr measur laid order account specif featur field due region distribut diseas centralis procedur authoris veterinari medicin product framework commun provis prophylact measur epizoot diseas option access centralis procedur maintain veterinari medicin product activ substanc medicin product human period protect data relat pre clinic test clinic trial provid direct ec medicin product veterinari period protect data relat pre clinic test clinic trial safeti residu test provid direct ec order reduc cost small medium size enterpris market medicin product authoris centralis procedur provis adopt reduct fee defer payment fee take respons translat offer administr assist respect enterpris interest public health authoris decis centralis procedur basi object scientif criteria qualiti safeti efficaci medicin product concern exclus econom consider member state exception prohibit territori medicin product human infring object defin concept public polici public moral veterinari medicin product authoris commun contraven rule laid framework common agricultur polici present prohibit commun provis inter alia direct ec provis made qualiti safeti efficaci criteria direct ec ec appli medicin product authoris commun assess risk benefit balanc medicin product market time renew authoris time compet author deem commun requir pursuant articl treati account develop polici aspect measur promot creation condit fit human be worldwid pharmaceut law continu ensur efficaci safe top qualiti medicin product export commiss creat incent carri research medicin product widespread tropic diseas provid ethic requir direct ec april european parliament council approxim law regul administr provis member state relat implement good clinic practic conduct clinic trial medicin product human appli medicin product authoris commun respect clinic trial conduct commun medicin product destin authoris commun time evalu applic authoris verifi trial conduct accord principl good clinic practic ethic requir equival provis direct commun mean carri scientif assess medicin product present accord decentralis commun authoris procedur view ensur effect harmonis administr decis member state regard medicin product present accord decentralis authoris procedur endow commun mean resolv disagr member state qualiti safeti efficaci medicin product structur oper bodi make agenc design account constantli renew scientif expertis cooper commun nation bodi adequ involv civil societi futur enlarg european union bodi agenc establish develop contact parti concern repres patient health care profession chief task agenc provid commun institut member state scientif opinion enabl exercis power authoris supervis medicin product confer commun legisl field medicin product singl scientif evalu procedur address qualiti safeti efficaci high technolog medicin product conduct agenc appli highest standard market authoris grant commun mean rapid procedur ensur close cooper commiss member state order ensur close cooper agenc scientist oper member state composit manag board guarante compet author member state close involv manag commun system authoris medicin product agenc budget compos fee paid privat sector contribut paid commun budget implement commun polici paragraph interinstitut agreement european parliament council commiss budgetari disciplin improv budgetari procedur financi perspect adjust order cover result enlarg exclus respons prepar agenc opinion question medicin product human vest committe medicin product human veterinari medicin product concern respons vest committe medicin product veterinari orphan medicin product task fall committe orphan medicin product set regul ec european parliament council decemb orphan medicin product lastli herbal medicin product respons vest committe herbal medicin product set direct ec creation agenc make reinforc scientif role independ committe set perman technic administr secretariat field activ scientif committe enlarg oper method composit modernis scientif advic futur applic seek market authoris provid gener greater depth similarli structur allow develop advic compani small medium size enterpris put place committe deleg evalu duti stand work parti open expert scientif world appoint purpos whilst retain total respons scientif opinion issu examin procedur amend provid guarante applic right number member scientif committe particip centralis procedur establish view ensur committe remain effici size enlarg european union reinforc role scientif committe enabl agenc particip activ intern scientif dialogu develop activ intern scientif harmonis technic cooper world health organis order creat greater legal certainti defin respons transpar rule agenc work set condit market medicin product authoris commun confer agenc power monitor distribut medicin product authoris commun sanction procedur implement event failur observ provis regul condit contain authoris grant procedur establish measur supervis medicin product authoris commun intens supervis undesir effect medicin product framework commun pharmacovigil activ ensur rapid withdraw market medicin product present neg risk benefit balanc normal condit order enhanc effici market surveil agenc respons coordin member state pharmacovigil activ number provis introduc put place stringent effici pharmacovigil procedur compet author provision emerg measur includ introduct amend market authoris final permit reassess made time risk benefit balanc medicin product entrust commiss close cooper agenc consult member state task coordin execut supervisori respons vest member state task provid inform medicin product check observ good manufactur laboratori clinic practic provid coordin implement commun procedur authoris medicin product nation procedur member state harmonis consider degre direct ec ec oper procedur laid regul examin commiss ten year basi experi gain order meet legitim expect patient account increasingli rapid progress scienc therapi acceler assess procedur set reserv medicin product major therapeut interest procedur obtain temporari authoris subject annual review condit field medicin product human common approach criteria condit compassion medicin product member state legisl member state develop evalu compar efficaci medicin product aim posit medicin product respect exist therapeut class similarli council conclus medicin product public health adopt june emphasis import identifi medicin product present ad therapeut evalu conduct context market authoris agre fundament criteria retain respect possibl gather inform method member state determin therapeut benefit obtain medicin product line current provis direct ec ec term valid commun market authoris limit initi period year expiri renew market authoris unlimit valid authoris consecut year led place market medicin product commun period consid invalid order avoid administr burden maintain authoris rule subject exempt justifi public health ground environment risk aris medicin product consist genet modifi organ subject product environment risk assess procedur similar procedur direct ec european parliament council march deliber releas environ genet modifi organ conduct parallel evalu singl commun procedur qualiti safeti efficaci product concern measur implement regul adopt accord council decis ec june lai procedur exercis implement power confer commiss provis regul ec amend regul ec budgetari financi rule applic agenc access agenc document fulli incorpor regul adopt regul titl definit scope articl purpos regul lai commun procedur authoris supervis pharmacovigil medicin product human veterinari establish european medicin agenc hereinaft refer quot agenc quot provis regul affect power member state author set price medicin product inclus scope nation health system social secur scheme basi health econom social condit member state free choos particular shown market authoris therapeut indic pack size cover social secur bodi articl definit laid articl direct ec laid articl direct ec appli purpos regul holder market authoris medicin product cover regul establish commun holder respons place market medicin product person design effect articl medicin product appear annex market commun market authoris grant commun accord provis regul medicin product appear annex grant market authoris commun accord provis regul medicin product activ substanc date entri forc regul authoris commun applic show medicin product constitut signific therapeut scientif technic innov grant authoris accord regul interest patient anim health commun level immunolog veterinari medicin product treatment anim diseas subject commun prophylact measur grant authoris gener medicin product refer medicin product authoris commun authoris compet author member state accord direct ec direct ec condit applic authoris submit accord articl direct ec articl direct ec summari product characterist relev respect consist medicin product authoris commun part summari product characterist refer indic dosag form cover patent law time gener medicin market gener medicin product authoris member state applic made purpos provis linguist version inn intern proprietari consid compet committe agenc consult annex examin light technic scientif progress view make amend extend scope centralis procedur amend adopt accord procedur refer articl articl applic market authoris refer articl submit agenc commun grant supervis market authoris medicin product human accord titl ii commun grant supervis market authoris veterinari medicin product accord titl iii titl ii authoris supervis medicin product human chapter submiss examin applic authoris articl committe medicin product human establish committe part agenc prejudic articl task commun law confer committe medicin product human respons draw opinion agenc matter admiss file submit accord centralis procedur grant variat suspens revoc authoris place medicin product human market accord provis titl pharmacovigil request execut director agenc commiss repres committe medicin product human draw opinion scientif matter evalu medicin product human committe due account request member state opinion committe formul opinion disagr evalu medicin product mutual recognit procedur opinion committe made publicli access articl applic authoris medicin product human specif complet includ particular document refer articl annex direct ec document includ statement effect clinic trial carri european union meet ethic requir direct ec particular document account uniqu commun natur authoris request except case relat applic law trade mark includ singl medicin product applic accompani fee payabl agenc examin applic case medicin product human consist genet modifi organ mean articl direct ec applic accompani copi compet author written consent deliber releas environ genet modifi organ research develop purpos provid part direct ec part council direct eec april deliber releas environ genet modifi organ complet technic dossier suppli inform requir annex iii iv direct ec environment risk assess accord principl set annex ii direct ec result investig perform purpos research develop articl direct ec appli medicin product human consist genet modifi organ agenc ensur opinion committe medicin product human dai receipt valid applic durat analysi scientif data file applic market authoris dai case rapporteur rapporteur declar complet assess time basi duli reason request committe call durat analysi scientif data file applic market authoris extend case medicin product human consist genet modifi organ opinion committe respect environment safeti requir laid direct ec process evalu applic market authoris medicin product human consist genet modifi organ rapporteur carri consult bodi commun member state set accord direct ec commiss consult agenc member state interest parti draw detail guid form applic authoris present articl order prepar opinion committe medicin product human verifi particular document submit accord articl compli requir direct ec examin condit regul grant market authoris satisfi request offici medicin control laboratori laboratori member state design purpos test medicin product human start materi intermedi product constitu materi order ensur control method emploi manufactur applic document satisfactori request applic supplement particular accompani applic specif time period committe avail option time limit laid articl subparagraph suspend time supplementari inform request provid likewis time limit suspend time allow applic prepar oral written explan articl receipt written request committe medicin product human member state forward inform show manufactur medicin product import countri manufactur medicin product concern carri control test accord particular document suppli pursuant articl consid order complet examin applic committe requir applic undergo specif inspect manufactur site medicin product concern inspect made unannounc inspect carri time limit laid subparagraph articl inspector member state hold qualif accompani rapporteur expert appoint committe articl agenc forthwith inform applic opinion committe medicin product human applic satisfi criteria authoris set regul summari product characterist propos applic amend label packag leaflet product complianc titl direct ec authoris grant subject condit provid articl dai receipt opinion refer paragraph applic give written notic agenc wish request examin opinion case applic forward agenc detail ground request dai receipt opinion dai receipt ground request committe examin opinion accord condit laid fourth subparagraph articl reason conclus reach annex final opinion dai adopt agenc send final opinion committe commiss member state applic report describ assess medicin product committe state reason conclus opinion favour grant relev authoris place medicin product concern market document annex opinion draft summari product characterist refer articl direct ec detail condit restrict impos suppli medicin product concern includ condit medicin product made patient accord criteria laid titl vi direct ec detail recommend condit restrict regard safe effect medicin product draft text label packag leaflet propos applic present accord titl direct ec assess report articl dai receipt opinion refer articl commiss prepar draft decis respect applic draft decis envisag grant market authoris includ make refer document mention articl draft decis accord opinion agenc commiss annex detail explan reason differ draft decis forward member state applic commiss final decis accord dai end procedur refer articl stand committe medicin product human refer articl adjust rule procedur account task incumb regul adjust provid opinion stand committe write member state dai forward written observ draft decis commiss decis urgent shorter time limit set chairman degre urgenc involv time limit except circumst shorter dai member state request write draft decis refer paragraph discuss plenari meet stand committe state reason detail opinion commiss member state written observ rais import question scientif technic natur opinion deliv agenc address chairman suspend procedur refer applic back agenc consider commiss adopt provis implement paragraph accord procedur refer articl agenc dissemin document refer articl articl applic withdraw applic market authoris submit agenc opinion applic applic commun reason agenc agenc make inform publicli access publish assess report delet inform commerci confidenti natur articl market authoris refus verif particular document submit accord articl appear applic properli suffici demonstr qualiti safeti efficaci medicin product authoris likewis refus particular document provid applic accord articl incorrect label packag leaflet propos applic accord titl direct ec refus commun market authoris constitut prohibit place market medicin product concern commun inform refus reason made publicli access articl prejudic articl direct ec market authoris grant accord regul valid commun confer right oblig member state market authoris grant member state accord articl direct ec authoris medicin product human enter commun regist medicin product number packag notif market authoris publish offici journal european union quot date authoris registr number commun regist intern proprietari inn activ substanc medicin product pharmaceut form anatom therapeut chemic code atc agenc immedi publish assess report medicin product human drawn committe medicin product human reason opinion favour grant authoris delet inform commerci confidenti natur european public assess report epar includ summari written manner understand public summari section relat condit medicin product market authoris grant holder authoris inform agenc date actual market medicin product human member state take account present authoris holder notifi agenc product ceas market temporarili perman notif except circumst made month interrupt place market product request agenc context pharmacovigil market authoris holder provid agenc data relat volum sale medicin product commun level broken member state data holder possess relat volum prescript articl prejudic paragraph market authoris valid year market authoris renew year basi evalu agenc risk benefit balanc end market authoris holder provid agenc consolid version file respect qualiti safeti efficaci includ variat introduc market authoris grant month market authoris ceas valid accord paragraph renew market authoris valid unlimit period commiss decid justifi ground relat pharmacovigil proce addit year renew accord paragraph authoris actual place medicin product human commun market year authoris ceas valid authoris medicin product previous market longer present market consecut year authoris ceas valid except circumst public health ground commiss grant exempt paragraph exempt duli justifi consult applic authoris grant subject specif oblig review annual agenc list oblig made publicli access derog paragraph authoris valid year renew basi provis grant authoris laid commiss regul adopt accord procedur refer articl except circumst consult applic authoris grant subject requir applic introduc specif procedur safeti medicin product notif compet author incid relat action authoris grant object verifi reason base ground set annex direct ec continu authoris link annual reassess condit applic submit market authoris respect medicin product human major interest point view public health viewpoint therapeut innov applic request acceler assess procedur request duli substanti committe medicin product human accept request time limit laid articl subparagraph reduc dai adopt opinion committe medicin product human includ propos criteria prescript medicin product accord articl direct ec prejudic law protect industri commerci properti medicin product human authoris accord provis regul benefit year period data protect ten year period market protect connect period extend maximum year year ten year market authoris holder obtain authoris therapeut indic scientif evalu prior authoris held bring signific clinic benefit comparison exist therapi articl grant authoris affect civil crimin liabil manufactur holder market authoris pursuant applic nation law member state chapter supervis penalti articl authoris grant accord regul holder market authoris medicin product human respect method manufactur control provid articl direct ec account technic scientif progress make variat requir enabl medicin product manufactur check mean gener accept scientif method appli approv variat accord regul holder market authoris forthwith suppli agenc commiss member state inform entail variat particular document refer articl direct ec annex thereto articl regul forthwith inform agenc commiss member state prohibit restrict impos compet author countri medicin product human market inform influenc evalu benefit risk medicin product human concern order risk benefit balanc continu assess agenc time holder market authoris forward data demonstr risk benefit balanc remain favour holder authoris medicin product human propos make variat particular document refer paragraph submit relev applic agenc commiss consult agenc adopt provis examin variat market authoris form regul accord procedur refer articl articl applic holder market authoris respons accuraci document data submit articl case medicin product human manufactur commun supervisori author compet author member state member state grant manufactur authoris provid articl direct ec respect medicin product concern case medicin product import countri supervisori author compet author member state member state grant authoris provid articl direct ec import agreement made commun export countri ensur control carri export countri manufactur appli standard good manufactur practic equival laid commun member state request assist member state agenc articl supervisori author respons verifi behalf commun holder market authoris medicin product human manufactur import establish commun satisfi requir laid titl iv ix xi direct ec accord articl direct ec commiss inform differ opinion member state holder market authoris medicin product human manufactur import establish commun satisfi requir refer paragraph commiss consult member state concern request inspector supervisori author undertak inspect market authoris holder manufactur import inspector question accompani inspector member state parti disput expert nomin committe medicin product human subject agreement conclud commun countri accord articl commiss reason request member state committe initi requir manufactur establish countri submit inspect inspect undertaken inspector member state possess qualif accompani rapporteur expert appoint committe report inspector made commiss member state committe articl supervisori author compet author member state opinion manufactur import establish commun territori longer fulfil oblig laid titl iv direct ec forthwith inform committe medicin product human commiss state reason detail indic action propos appli member state commiss consid measur envisag titl ix xi direct ec appli respect medicin product concern committe deliv opinion effect accord articl regul commiss request opinion agenc time limit determin light urgenc matter order examin reason advanc practic holder authoris place medicin product human market invit provid oral written explan opinion agenc commiss adopt provision measur appli immedi final decis adopt month accord procedur refer articl urgent action essenti protect human health environ member state initi commiss request suspend territori medicin product human authoris accord regul initi inform commiss agenc reason action latest work dai suspens agenc inform member state delai commiss immedi initi procedur provid paragraph case member state ensur health care profession rapidli inform action reason action network set profession associ effect member state inform commiss agenc action purpos suspens measur refer paragraph maintain forc time definit decis reach accord procedur refer articl agenc request inform person concern final decis make decis publicli access immedi chapter pharmacovigil articl purpos chapter articl direct ec appli articl agenc act close cooper nation pharmacovigil system establish accord articl direct ec receiv relev inform suspect advers reaction medicin product human authoris commun accord regul committe medicin product human accord articl regul draw opinion measur opinion made publicli access measur refer paragraph includ amend market authoris grant accord articl adopt accord procedur refer articl holder market authoris compet author member state ensur relev inform suspect advers reaction medicin product authoris regul brought attent agenc accord provis regul patient encourag commun advers reaction health care profession articl holder authoris medicin product human grant accord provis regul perman continu dispos appropri qualifi person respons pharmacovigil qualifi person resid commun respons establish manag system ensur inform suspect advers reaction report personnel compani medic repres collect evalu collat access singl point commun prepar report refer articl compet author member state agenc accord requir regul ensur request compet author provis addit inform evalu risk benefit medicin product answer fulli promptli includ provis inform volum sale prescript medicin product concern provid compet author inform relev evalu risk benefit medicin product inform post authoris safeti studi articl holder market authoris medicin product human ensur suspect advers reaction medicin product authoris accord regul occur commun health care profession bring attent record report promptli member state territori incid occur dai receipt inform holder market authoris record suspect advers reaction occur commun accord guid refer articl expect awar promptli notifi compet author member state territori incid occur agenc dai receipt inform holder market authoris medicin product human ensur suspect unexpect advers reaction suspect transmiss medicin product infecti agent occur territori countri report promptli member state agenc dai receipt inform provis report suspect unexpect advers reaction occur commun countri adopt accord procedur refer articl save except circumst reaction transmit electron form report accord guid refer articl holder market authoris medicin product human maintain detail record suspect advers reaction commun report health care profession requir laid condit grant market authoris commun record submit form period safeti updat report agenc member state immedi request month authoris place market period safeti updat report submit immedi request month year initi place commun market year year report submit yearli interv immedi request report accompani scientif evalu risk benefit balanc medicin product commiss lai provis amend paragraph view experi gain oper commiss adopt provis accord procedur refer articl holder market authoris commun inform relat pharmacovigil concern gener public relat authoris medicin product give prior simultan notif agenc case market authoris holder ensur inform present object mislead member state measur ensur market authoris holder fail discharg oblig subject effect proportion dissuas penalti articl member state ensur suspect advers reaction occur territori medicin product human authoris accord regul brought attent record report promptli agenc market authoris holder dai receipt inform agenc forward inform nation pharmacovigil system set accord articl direct ec articl commiss consult agenc member state interest parti draw guid collect verif present advers reaction report guid benefit health care profession recommend commun inform advers reaction accord guid holder market authoris medic terminolog accept intern level transmiss advers reaction report agenc consult member state commiss set data process network rapid transmiss inform compet commun author event alert relat faulti manufactur advers reaction pharmacovigil data medicin product authoris accord articl direct ec data made publicli access relev evalu period year initi place market commun agenc request market authoris holder arrang specif pharmacovigil data collect target group patient agenc state reason request market authoris holder collat assess data collect submit agenc evalu articl agenc collabor world health organis matter intern pharmacovigil step submit promptli adequ inform measur commun bear public health protect countri send copi thereof commiss member state articl agenc member state compet author cooper continu develop pharmacovigil system capabl achiev high standard public health protect medicin product rout authoris includ collabor approach maximis resourc commun articl amend updat provis chapter order account scientif technic progress adopt accord procedur refer articl titl iii authoris supervis veterinari medicin product chapter submiss examin applic authoris articl committe medicin product veterinari establish committe part agenc prejudic articl task commun law confer regul eec committe medicin product veterinari respons draw opinion agenc question admiss file submit accord centralis procedur grant variat suspens revoc authoris place veterinari medicin product market aris accord provis titl pharmacovigil request execut director agenc commiss repres committe medicin product veterinari draw opinion scientif matter evalu veterinari medicin product committe due account request member state opinion committe formul opinion disagr assess veterinari medicin product mutual recognit procedur opinion committe made publicli access articl applic authoris medicin product veterinari specif exhaust includ particular document refer articl annex direct ec particular document account uniqu commun natur authoris request except case relat applic law trade mark includ singl medicin product applic accompani fee payabl agenc examin applic case veterinari medicin product consist genet modifi organ mean articl direct ec applic accompani copi written consent compet author deliber releas environ genet modifi organ research develop purpos provid part direct ec part direct eec complet technic file suppli inform requir annex iii iv direct ec environment risk assess accord principl set annex ii direct ec result investig perform purpos research develop articl direct ec appli veterinari medicin product consist genet modifi organ agenc ensur opinion committe medicin product veterinari dai receipt valid applic case veterinari medicin product consist genet modifi organ opinion committe respect environment safeti requir laid direct ec process evalu applic market authoris veterinari medicin product consist genet modifi organ consult held rapporteur bodi set commun member state accord direct ec commiss consult agenc member state interest parti draw detail guid form applic authoris present articl order prepar opinion committe medicin product veterinari verifi particular document submit accord articl compli requir direct ec examin condit regul grant market authoris satisfi request offici medicin control laboratori laboratori member state design purpos test veterinari medicin product start materi intermedi product constitu materi order ensur control method emploi manufactur applic satisfactori request commun refer laboratori offici medicin control laboratori laboratori member state design purpos verifi sampl provid applic analyt detect method propos applic purpos articl indent direct ec satisfactori suitabl reveal presenc residu level maximum residu level accept commun accord provis regul eec request applic supplement particular accompani applic specif time limit committe avail option time limit laid articl subparagraph suspend time supplementari inform request provid likewis time limit suspend time allow applic prepar oral written explan case analyt method subject verif abovement laboratori procedur establish regul eec verif carri framework articl articl receipt written request committe medicin product veterinari member state forward inform establish manufactur veterinari medicin product import countri manufactur veterinari medicin product concern carri control test accord particular document suppli pursuant articl consid order complet examin applic committe requir applic undergo specif inspect manufactur site veterinari medicin product concern inspect made unannounc inspect complet time limit refer articl subparagraph undertaken inspector member state possess qualif accompani rapporteur expert appoint committe articl agenc forthwith inform applic opinion committe medicin product veterinari applic satisfi criteria authoris set regul summari product characterist amend label packag leaflet product complianc titl direct ec authoris grant subject condit provid articl dai receipt opinion refer paragraph applic provid written notic agenc wish request examin opinion case applic forward agenc detail ground request dai receipt opinion dai receipt ground request committe examin opinion accord condit laid articl fourth subparagraph reason conclus reach annex final opinion dai adopt agenc forward final opinion committe commiss member state applic report describ assess veterinari medicin product committe state reason conclus opinion favour grant relev authoris place relev veterinari medicin product market document annex opinion draft summari product characterist refer articl direct ec draft reflect differ veterinari condit member state case veterinari medicin product intend administr food produc anim statement maximum residu level accept commun accord regul eec detail condit restrict impos suppli veterinari medicin product concern includ condit veterinari medicin product made user conform criteria laid direct ec detail recommend condit restrict regard safe effect medicin product draft text label packag leaflet propos applic present accord titl direct ec assess report articl dai receipt opinion refer articl commiss prepar draft decis respect applic draft decis envisag grant market authoris includ make refer document mention articl draft decis accord opinion agenc commiss annex detail explan reason differ draft decis forward member state applic commiss final decis accord dai end procedur refer articl stand committe veterinari medicin product refer articl adjust rule procedur account task assign regul adjust provid opinion stand committe write member state dai forward written observ draft decis commiss decis urgent shorter time limit set chairman degre urgenc involv time limit except circumst shorter dai member state request write draft decis refer paragraph discuss plenari meet stand committe state reason detail opinion commiss written observ member state rais import question scientif technic natur address opinion deliv agenc chairman suspend procedur refer applic back agenc consider provis implement paragraph adopt commiss accord procedur refer articl agenc dissemin document refer articl articl applic withdraw applic market authoris submit agenc opinion applic applic commun reason agenc agenc make inform publicli access publish assess report delet inform commerci confidenti natur articl market authoris refus verif particular document submit accord articl appear applic properli suffici demonstr qualiti safeti efficaci veterinari medicin product case zootechn veterinari medicin product perform enhanc safeti welfar anim consum safeti suffici account withdraw period recommend applic long ensur foodstuff obtain treat anim residu constitut health hazard consum insuffici substanti veterinari medicin product present prohibit commun provis authoris likewis refus particular document provid applic accord articl incorrect label packag leaflet propos applic accord titl direct ec refus commun market authoris constitut prohibit place market veterinari medicin product concern commun inform refus reason made publicli access articl prejudic articl direct ec market authoris grant accord regul valid commun confer right oblig member state market authoris grant member state accord articl direct ec authoris veterinari medicin product enter commun regist medicin product number packag notif market authoris publish offici journal european union quot date authoris number commun regist intern proprietari inn activ substanc medicin product pharmaceut form anatom therapeut chemic veterinari code atc vet code agenc immedi publish assess report veterinari medicin product drawn committe medicin product veterinari reason opinion favour grant authoris delet inform commerci confidenti natur european public assess report epar includ summari written manner understand public summari section relat condit medicin product market authoris grant holder authoris inform agenc date actual place market veterinari medicin product member state take account present authoris holder notifi agenc product ceas market temporarili perman notif except circumst made month interrupt place product market request agenc context pharmacovigil market authoris holder provid agenc data relat volum sale medicin product commun level broken member state data holder possess relat volum prescript articl prejudic paragraph market authoris valid year market authoris renew year basi evalu agenc risk benefit balanc end market authoris holder submit consolid list document submit respect qualiti safeti efficaci includ variat introduc market authoris grant month market authoris ceas valid accord paragraph agenc requir applic submit list document time renew market authoris valid unlimit period commiss decid justifi ground relat pharmacovigil proce addit year renew accord paragraph authoris actual place medicin product veterinari commun market year authoris ceas valid authoris medicin product previous market longer present market consecut year authoris ceas valid except circumst public anim health ground commiss grant exempt provis paragraph exempt duli justifi except circumst consult applic authoris grant subject requir applic introduc specif procedur product safeti notif relev author incid relat action authoris grant object verifi reason continu authoris link annual reassess condit applic submit market authoris respect veterinari medicin product major interest point view anim health viewpoint therapeut innov applic request acceler assess procedur request duli substanti committe medicin product veterinari accept request time limit laid articl subparagraph reduc dai adopt opinion committe includ propos condit prescript veterinari medicin product veterinari medicin product authoris accord provis regul benefit provis protect articl direct ec articl grant authoris affect civil crimin liabil manufactur holder market authoris pursuant applic nation law member state chapter supervis sanction articl authoris grant accord regul holder market authoris respect method manufactur control provid articl direct ec account technic scientif progress make variat requir enabl medicin product manufactur check mean gener accept scientif method appli approv variat accord regul compet author member state agenc requir holder market authoris provid substanc suffici quantiti perform test detect presenc residu veterinari medicin product concern foodstuff anim origin request compet author member state agenc holder market authoris provid technic expertis facilit implement analyt method detect residu veterinari medicin product commun refer laboratori nation refer laboratori design accord council direct ec april measur monitor substanc residu thereof live anim anim product holder market authoris forthwith suppli agenc commiss member state inform entail variat particular document refer articl direct ec annex thereto articl regul forthwith inform agenc commiss member state prohibit restrict impos compet author countri veterinari medicin product market inform influenc evalu benefit risk veterinari medicin product concern order risk benefit balanc continu assess agenc time holder market authoris forward data justifi risk benefit balanc remain favour holder market authoris veterinari medicin product propos make variat particular document refer paragraph submit relev applic agenc commiss consult agenc adopt provis examin variat market authoris form regul accord procedur refer articl articl applic holder market authoris respons accuraci document data submit articl case veterinari medicin product manufactur commun supervisori author compet author member state member state grant manufactur authoris provid articl direct ec respect manufactur medicin product concern case veterinari medicin product import countri supervisori author compet author member state member state grant authoris provid articl direct ec import agreement made commun export countri ensur control carri export countri manufactur appli standard good manufactur practic equival laid commun member state request assist member state agenc articl supervisori author respons verifi behalf commun holder market authoris veterinari medicin product manufactur import establish commun satisfi requir laid titl iv vii viii direct ec accord articl direct ec commiss inform differ opinion member state holder market authoris veterinari medicin product manufactur import establish commun satisfi requir refer paragraph commiss consult member state concern request inspector supervisori author undertak inspect holder market authoris manufactur import inspector question accompani inspector member state parti disput expert nomin committe medicin product veterinari subject agreement conclud commun countri accord articl commiss receipt reason request member state committe initi requir manufactur establish countri submit inspect inspect undertaken inspector member state possess qualif accompani rapporteur expert appoint committe report inspector made commiss member state committe articl supervisori author compet author member state opinion manufactur import establish commun longer fulfil oblig laid titl vii direct ec forthwith inform committe medicin product veterinari commiss state reason detail indic action propos appli member state commiss consid measur envisag titl viii direct ec appli respect veterinari medicin product concern committe deliv opinion effect accord articl regul commiss request opinion agenc time limit determin light urgenc matter order examin reason advanc practic holder market authoris medicin product invit provid oral written explan opinion agenc commiss adopt provision measur appli immedi final decis adopt month accord procedur refer articl urgent action essenti protect human anim health environ member state initi commiss request suspend territori veterinari medicin product authoris accord regul initi member state inform commiss agenc reason action latest work dai suspens agenc inform member state delai commiss immedi initi procedur provid paragraph case member state ensur health care profession rapidli inform action reason action network set profession associ effect member state inform commiss agenc action purpos suspens measur refer paragraph maintain time definit decis reach accord procedur refer articl agenc request inform person concern final decis make decis publicli access immedi chapter pharmacovigil articl purpos chapter articl direct eec appli articl agenc act close cooper nation pharmacovigil system establish accord articl direct ec receiv relev inform suspect advers reaction veterinari medicin product authoris commun accord regul committe medicin product veterinari accord articl regul draw opinion measur opinion made publicli access measur includ amend market authoris grant accord articl adopt accord procedur refer articl holder market authoris compet author member state ensur relev inform suspect advers reaction veterinari medicin product authoris regul brought attent agenc accord provis regul anim owner breeder encourag commun advers reaction health care profession compet nation author respons pharmacovigil articl holder market authoris veterinari medicin product grant accord provis regul perman continu dispos appropri qualifi person respons pharmacovigil qualifi person resid commun respons establish manag system ensur inform suspect advers reaction report personnel compani medic repres collect evalu collat access singl point commun prepar report refer articl compet author member state agenc accord requir regul ensur request compet author provis addit inform evalu risk benefit veterinari medicin product answer fulli promptli includ provis inform volum sale prescript veterinari medicin product concern provid compet author inform relev evalu risk benefit veterinari medicin product inform post authoris safeti studi includ inform valid withdraw period lack expect efficaci potenti environment problem articl holder market authoris veterinari medicin product ensur suspect advers reaction advers human reaction veterinari medicin product authoris accord provis regul occur commun health care profession bring attent record report promptli member state territori incid occur dai receipt inform holder market authoris record suspect advers reaction human advers reaction occur commun accord guidelin refer articl expect awar promptli notifi member state territori incid occur agenc dai receipt inform holder market authoris veterinari medicin product ensur suspect unexpect advers reaction advers human reaction suspect transmiss medicin product infecti agent occur territori countri report promptli member state agenc dai receipt inform provis report suspect unexpect advers reaction occur commun countri adopt accord procedur refer articl save except circumst reaction transmit electron form report accord guid refer articl holder market authoris veterinari medicin product maintain detail record suspect advers reaction occur commun report requir laid condit grant market authoris commun record submit form period safeti updat report agenc member state immedi request month authoris place market period safeti updat report submit immedi request month year initi place commun market year year report submit yearli interv immedi request report accompani scientif evalu risk benefit balanc medicin product commiss lai provis amend paragraph view experi gain oper commiss adopt provis accord procedur refer articl holder market authoris commun inform relat pharmacovigil concern gener public relat authoris medicin product give prior simultan notif agenc case market authoris holder ensur inform present object mislead member state measur ensur market authoris holder fail discharg oblig subject effect proportion dissuas penalti articl member state ensur suspect advers reaction advers human reaction occur territori veterinari medicin product authoris accord provis regul brought attent record report promptli agenc holder market authoris veterinari medicin product dai receipt inform agenc forward inform nation pharmacovigil system set accord articl direct ec articl commiss consult agenc member state interest parti draw guid collect verif present advers reaction report guid benefit health care profession recommend commun inform advers reaction accord guid holder market authoris medic terminolog accept intern level transmiss advers reaction report agenc consult member state commiss set data process network rapid transmiss data compet commun author event alert relat faulti manufactur advers reaction pharmacovigil data veterinari medicin product authoris accord articl direct ec period year initi place market commun agenc request market authoris holder arrang specif pharmacovigil data collect target group anim agenc state reason request market authoris holder collat assess data collect submit agenc evalu articl agenc cooper intern organis concern veterinari pharmacovigil articl agenc member state compet author cooper continu develop pharmacovigil system capabl achiev high standard public health protect medicin product rout authoris includ collabor approach maximis resourc commun articl amend updat provis chapter order account scientif technic progress adopt accord procedur refer articl titl iv european medicin agenc respons administr structur chapter task agenc articl european medicin agenc establish agenc respons coordin exist scientif resourc put dispos member state evalu supervis pharmacovigil medicin product articl agenc compris committe medicin product human respons prepar opinion agenc question relat evalu medicin product human committe medicin product veterinari respons prepar opinion agenc question relat evalu medicin product veterinari committe orphan medicin product committe herbal medicin product secretariat provid technic scientif administr support committe ensur coordin execut director exercis respons set articl manag board exercis respons set articl committe refer paragraph establish stand temporari work parti committe refer paragraph establish scientif advisori group connect evalu specif type medicin product treatment committe concern deleg task draw scientif opinion refer articl establish work parti scientif advisori group committe rule procedur refer articl provid appoint member work parti scientif advisori group basi list expert refer subparagraph articl consult work parti scientif advisori group execut director close consult committe medicin product human committe medicin product veterinari set administr structur procedur allow develop advic undertak refer articl develop therapi committe establish stand work parti sole remit provid scientif advic undertak committe medicin product human committe medicin product veterinari seek guidanc import question gener scientif ethic natur articl agenc provid member state institut commun scientif advic question relat evalu qualiti safeti efficaci medicin product human veterinari refer accord provis commun legisl relat medicin product end agenc act committe undertak task coordin scientif evalu qualiti safeti efficaci medicin product subject commun market authoris procedur transmit request make publicli assess report summari product characterist label packag leaflet insert medicin product coordin supervis practic condit medicin product authoris commun provis advic measur ensur safe effect product evalu coordin implement pharmacovigil oblig monitor implement ensur dissemin inform advers reaction medicin product authoris commun mean databas perman access member state health care profession market authoris holder public level access databas person data protect guarante assist member state rapid commun inform pharmacovigil health care profession distribut pharmacovigil inform gener public advis maximum limit residu veterinari medicin product accept foodstuff anim origin accord regul eec provid scientif advic antibiot food produc anim order minimis occurr bacteri resist commun advic updat need coordin verif complianc principl good manufactur practic good laboratori practic good clinic practic verif complianc pharmacovigil oblig request provid technic scientif support order improv cooper commun member state intern organis countri scientif technic issu relat evalu medicin product context discuss organis framework intern confer harmonis record statu market authoris medicin product grant accord commun procedur creat databas medicin product access gener public ensur updat manag independ pharmaceut compani databas facilit search inform authoris packag leaflet includ section medicin product authoris treatment children inform provid public word comprehens manner assist commun member state provis inform health care profession gener public medicin product evalu agenc advis undertak conduct test trial demonstr qualiti safeti efficaci medicin product check condit laid commun legisl medicin product market authoris observ case parallel distribut medicin product authoris accord regul draw commiss request scientif opinion evalu medicin product start materi manufactur medicin product view protect public health compil scientif inform pathogen agent biolog warfar includ exist vaccin medicin product prevent treat effect agent coordin supervis qualiti medicin product market request test complianc authoris specif offici medicin control laboratori laboratori member state design purpos forward annual budgetari author inform relev outcom evalu procedur databas provid paragraph includ summari product characterist patient user packag leaflet inform shown label databas develop stage prioriti medicin product authoris regul authoris chapter titl iii direct ec direct ec databas subsequ extend includ medicin product market commun databas includ refer data clinic trial carri complet contain clinic trial databas provid articl direct ec commiss consult member state issu guidelin data field includ access public articl agenc give scientif opinion context cooper world health organis evalu medicin product human intend exclus market commun purpos applic submit agenc accord provis articl committe medicin product human consult world health organis draw scientif opinion accord articl provis articl appli committe establish specif procedur rule implement paragraph provis scientif advic articl agenc care ensur earli identif potenti sourc conflict scientif opinion bodi establish commun law carri similar task relat issu common concern agenc identifi potenti sourc conflict contact bodi concern order ensur relev scientif inform share identifi scientif point potenti conflict fundament conflict scientif point bodi concern commun agenc scientif committe agenc bodi concern work resolv conflict submit joint document commiss clarifi scientif point conflict document publish immedi adopt save provid regul direct ec direct ec fundament conflict scientif point bodi concern bodi member state agenc nation bodi concern work resolv conflict prepar joint document clarifi scientif point conflict document publish immedi adopt articl request commiss agenc respect authoris medicin product collect inform method member state compet author determin ad therapeut medicin product articl member state consult manag board appoint year term renew member altern committe medicin product human member altern committe medicin product veterinari altern repres vote member absenc act rapporteur accord articl member altern chosen role experi evalu medicin product human veterinari repres compet nation author committe opt maximum addit member chosen basi specif scientif compet member appoint term year renew altern view opt member committe identifi specif complementari scientif compet addit member opt member chosen expert nomin member state agenc member committe accompani expert specif scientif technic field execut director agenc repres repres commiss entitl attend meet committe work parti scientif advisori group meet conven agenc committe addit task provid object scientif opinion commun member state question refer member committe ensur coordin task agenc work compet nation author includ consult bodi concern market authoris member committe expert respons evalu medicin product reli scientif evalu resourc nation market authoris bodi compet nation author monitor scientif level independ evalu carri facilit activ nomin committe member expert member state refrain give committe member expert instruct incompat individu task task respons agenc prepar opinion committe endeavour reach scientif consensu consensu reach opinion consist posit major member diverg posit ground base committe establish rule procedur rule lai procedur appoint replac chairman procedur relat work parti scientif advisori group procedur urgent adopt opinion relat provis regul market surveil pharmacovigil enter forc receiv favour opinion commiss manag board articl accord provis regul committe medicin product human committe herbal medicin product committe medicin product veterinari requir evalu medicin product appoint member act rapporteur coordin evalu committe concern appoint member act rapporteur consult scientif advisori group refer articl committe forward draft assess report drawn rapporteur rapporteur opinion issu scientif advisori group forward chairman relev committe ensur deadlin laid articl articl met substanc opinion includ assess report publish pursuant articl articl request examin opinion committe concern appoint rapporteur rapporteur appoint initi opinion examin procedur deal point opinion initi identifi applic base scientif data committe adopt initi opinion applic request committe consult scientif advisori group connect examin member state transmit agenc name nation expert proven experi evalu medicin product serv work parti scientif advisori group committe medicin product human committe herbal medicin product committe medicin product veterinari indic qualif specif area expertis agenc date list accredit expert list includ expert refer subparagraph expert appoint directli agenc list updat provis servic rapporteur expert govern written contract agenc person concern agenc employ person concern employ remuner accord scale fee includ financi arrang establish manag board perform scientif servic potenti provid result call express interest scientif technic context compat task agenc ensur high level public health protect manag board adopt procedur propos execut director agenc committe refer articl servic expert discharg specif task respons articl membership committe refer articl made public appoint publish profession qualif member member manag board member committe rapporteur expert financi interest pharmaceut industri affect imparti undertak act public interest independ manner make annual declar financi interest indirect interest relat industri enter regist held agenc access public request agenc offic agenc code conduct provid implement articl refer accept gift member manag board member committe rapporteur expert particip meet work group agenc declar meet specif interest consid prejudici independ respect item agenda declar made public articl execut director appoint manag board propos commiss period year basi list candid propos commiss call express interest publish offici journal european union appoint candid nomin manag board invit forthwith make statement european parliament answer question put member mandat renew manag board propos commiss remov execut director post execut director legal repres agenc respons dai dai administr agenc manag agenc resourc conduct activ committe refer articl includ make scientif technic support ensur time limit laid commun legisl adopt opinion agenc compli ensur coordin committe refer articl prepar draft statement estim agenc revenu expenditur execut budget staff matter provid secretariat manag board year execut director submit draft report cover activ agenc previou year draft work programm come year manag board approv make distinct agenc activ medicin product human herbal medicin product veterinari medicin product draft report cover activ agenc previou year includ inform number applic evalu agenc time complet evalu medicin product authoris reject withdrawn articl manag board consist repres member state repres commiss repres european parliament addit repres patient organis repres doctor organis repres veterinarian organis appoint council consult european parliament basi list drawn commiss includ appreci name post fill list drawn commiss forward european parliament relev background document quickli month notif european parliament submit view consider council appoint manag board member manag board appoint guarante highest level specialist qualif broad spectrum relev expertis broadest geograph spread european union member manag board appoint basi relev expertis manag experi field medicin product human veterinari member state commiss appoint member manag board altern replac member absenc vote behalf term offic repres year term offic renew manag board elect chairman member term offic chairman year expir ceas member manag board term offic renew decis manag board adopt major third member manag board adopt rule procedur manag board invit chairmen scientif committe attend meet vote manag board approv annual work programm agenc programm forward european parliament council commiss member state manag board adopt annual report agenc activ forward june latest european parliament council commiss european econom social committe court auditor member state articl manag board adopt opinion rule procedur committe medicin product human committe medicin product veterinari articl adopt procedur perform scientif servic articl appoint execut director articl adopt annual work programm forward european parliament council commiss member state articl approv annual report agenc activ forward june latest european parliament council commiss european econom social committe court auditor member state articl adopt budget agenc articl adopt intern financi provis articl adopt provis implement staff regul articl develop contact stakehold stipul condit applic articl adopt provis provid assist pharmaceut compani articl adopt rule ensur avail public inform authoris supervis medicin product articl chapter financi provis articl estim revenu expenditur agenc prepar financi year calendar year shown budget agenc revenu expenditur shown budget balanc agenc revenu consist contribut commun fee paid undertak obtain maintain commun market authoris servic provid agenc european parliament council hereinaft refer quot budgetari author quot examin level commun contribut basi evalu take account level fee activ relat pharmacovigil oper commun network market surveil receiv adequ public fund commensur task confer expenditur agenc includ staff remuner administr infrastructur cost oper expens expens result contract enter parti year manag board basi draft drawn execut director produc estim revenu expenditur agenc financi year estim includ draft establish plan forward manag board commiss march latest estim forward commiss budgetari author preliminari draft gener budget european union basi estim commiss enter preliminari draft gener budget european union estim deem establish plan amount subsidi charg gener budget place budgetari author accord articl treati budgetari author authoris appropri subsidi agenc budgetari author adopt establish plan agenc budget adopt manag board final final adopt gener budget european union adjust modif establish plan budget subject amend budget forward purpos inform budgetari author manag board notifi budgetari author intent implement project signific financi implic fund budget project relat properti rental purchas build inform commiss thereof branch budgetari author notifi intent deliv opinion forward opinion manag board period week date notif project articl execut director implement budget agenc march latest financi year agenc account offic commun provision account commiss account offic report budgetari financi manag financi year commiss account offic consolid provision account institut decentralis bodi accord articl financi regul applic gener budget european commun hereinaft refer quot gener financi regul quot march latest financi year commiss account offic submit agenc provision account court auditor report budgetari financi manag financi year report budgetari financi manag financi year forward european parliament council receipt court auditor observ agenc provision account pursuant articl gener financi regul execut director draw agenc final account respons submit manag board opinion manag board agenc deliv opinion agenc final account execut director juli latest financi year forward final account european parliament council commiss court auditor manag board opinion final account publish agenc execut director send court auditor repli observ septemb latest send repli manag board execut director submit european parliament request inform requir smooth applic discharg procedur financi year question laid articl gener financi regul european parliament recommend council act qualifi major april year give discharg execut director respect implement budget year financi rule applic agenc adopt manag board commiss consult depart commiss regul ec euratom novemb framework financi regul bodi refer articl council regul ec euratom financi regul applic gener budget european commun specif requir agenc oper commiss prior consent articl order combat fraud corrupt unlaw activ provis regul ec european parliament council investig conduct european anti fraud offic olaf appli restrict agenc acced interinstitut agreement intern investig european anti fraud offic olaf issu delai provis applic employe agenc articl structur level fee refer articl establish council act condit provid treati propos commiss commiss consult organis repres interest pharmaceut industri commun level provis adopt accord procedur refer articl establish circumst small medium size enterpris pai reduc fee defer payment fee receiv administr assist chapter gener provis govern agenc articl agenc legal person member state enjoi extens legal capac accord legal person law acquir dispos movabl immov properti parti legal proceed articl contractu liabil agenc govern law applic contract question court justic european commun jurisdict pursuant arbitr claus contain contract conclud agenc case contractu liabil agenc accord gener principl common law member state make good damag caus servant perform duti court justic jurisdict disput relat compens damag person liabil servant agenc govern relev rule appli staff agenc articl regul ec european parliament council public access european parliament council commiss document appli document held agenc agenc set regist pursuant articl regul ec make document publicli access pursuant regul manag board adopt arrang implement regul ec month entri forc regul decis agenc pursuant articl regul ec give rise lodg complaint ombudsman form subject action court justic condit laid articl treati articl protocol privileg immun european commun appli agenc articl staff agenc subject rule regul applic offici staff european commun respect staff agenc exercis power devolv appoint author manag board agreement commiss adopt implement provis articl member manag board member committe refer articl expert offici servant agenc requir duti ceas disclos inform kind cover oblig profession secreci articl commiss agreement manag board relev committe invit repres intern organis interest harmonis regul applic medicin product particip observ work agenc condit particip determin commiss articl manag board agreement commiss develop contact agenc repres industri consum patient health profess contact includ particip observ aspect agenc work condit determin manag board agreement commiss committe refer articl work parti scientif advisori group establish accord articl gener matter establish contact advisori basi parti concern medicin product patient organis health care profession associ rapporteur appoint committe advisori basi establish contact repres patient organis health care profession associ relev indic medicin product concern articl manag board case veterinari medicin product limit market case veterinari medicin product intend diseas region distribut adopt measur provid assist compani time submiss applic articl ensur level transpar manag board basi propos execut director agreement commiss adopt rule ensur avail public regulatori scientif technic inform authoris supervis medicin product confidenti natur intern rule procedur agenc committe work group made public agenc internet titl gener final provis articl decis grant refus vari suspend withdraw revok market authoris accord regul state detail reason base decis notifi parti concern authoris place medicin product govern regul market grant refus vari suspend withdrawn revok procedur ground set regul articl authoris grant applic specif medicin product commiss authoris applic submit applic agenc medicin product object verifi reason relat public health avail medicin product health care profession patient market reason medicin product human articl direct ec appli medicin product authoris regul prejudic uniqu commun natur content document refer articl articl regul prohibit commerci design medicin product cover singl authoris articl exempt articl direct ec member state make medicin product human belong categori refer articl regul compassion purpos articl quot compassion quot make medicin product belong categori refer articl compassion reason group patient chronic debilit diseas diseas consid life threaten treat satisfactorili authoris medicin product medicin product concern subject applic market authoris accord articl regul undergo clinic trial member state make possibl provid paragraph notifi agenc compassion envisag committe medicin product human consult manufactur applic adopt opinion condit condit distribut patient target opinion updat regular basi member state account opinion agenc date list opinion adopt accord paragraph publish websit articl articl appli mutati mutandi opinion refer paragraph affect civil crimin liabil manufactur applic market authoris compassion programm set applic ensur patient take part access medicin product period authoris place market articl prejudic direct ec articl direct ec articl prejudic protocol privileg immun european commun member state determin penalti appli infring provis regul regul adopt pursuant measur implement penalti effect proportion dissuas member state inform commiss provis decemb notifi subsequ alter member state inform commiss immedi litig institut infring regul agenc request commiss impos financi penalti holder market authoris grant regul fail observ oblig laid connect authoris maximum amount condit method collect penalti laid accord procedur refer articl commiss publish name market authoris holder involv amount reason financi penalti impos articl regul affect compet vest european food safeti author creat regul ec articl ten year commiss publish gener report experi acquir result oper procedur laid regul chapter titl iii direct ec chapter titl iii direct ec articl commiss assist stand committe medicin product human set articl direct ec stand committe veterinari medicin product set articl direct ec refer made paragraph articl decis ec appli regard provis articl thereof period laid articl decis ec set month refer made paragraph articl decis ec appli regard provis articl thereof period laid articl decis ec set month committe adopt rule procedur articl regul eec ec repeal refer repeal regul constru refer regul articl period protect provid articl appli refer medicin product applic authoris submit date refer articl paragraph articl regul enter forc twentieth dai public offici journal european union derog paragraph titl ii iii appli novemb point sixth indent annex appli regul bind entireti directli applic member state strasbourg march european parliament presid cox council presid roch oj oj publish offici journal oj opinion european parliament octob oj council common posit septemb oj posit european parliament decemb publish offici journal council decis march oj regul amend regul ec oj oj direct amend council direct ec offici journal oj direct amend council direct ec offici journal oj direct repeal direct eec oj council direct ec april prohibit stockfarm substanc hormon thyrostat action agonist oj oj oj oj oj oj direct amend regul ec european parliament council oj oj oj oj direct repeal direct ec continu legal effect council regul eec june lai commun procedur establish maximum residu limit veterinari medicin product foodstuff anim origin oj regul amend commiss regul ec oj oj direct amend regul ec oj council regul ec euratom june financi regul applic gener budget european commun oj oj oj oj regul ec european parliament council januari lai gener principl requir food law establish european food safeti author lai procedur matter food safeti oj annex medicin product authoris commun medicin product develop mean biotechnolog process recombin dna technolog control express gene code biolog activ protein prokaryot eukaryot includ transform mammalian cell hybridoma monoclon antibodi method medicin product veterinari intend primarili perform enhanc order promot growth treat anim increas yield treat anim medicin product human activ substanc date entri forc regul authoris commun therapeut indic treatment diseas acquir immun defici syndrom cancer neurodegen disord diabet effect auto immun diseas immun dysfunct viral diseas commiss consult agenc present propos modifi point council decis propos qualifi major medicin product design orphan medicin product pursuant regul ec