Medicines and Allied Substances (Pharmaceutical Licence) Regulations 2018

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"re.. pJ.ckiDj ot rncdli::.lne'• rt1e:irr" ~hi! ~Cl of n:111ov11tt~ j 1i1cr,.a1":lcfa1\ IC\11n 1ti c;irigiruu prim,V)' containtr alld ptJC-in_g ,t inft:1u p;u;em jl~tt. but.th>'e:\nut lih:hJ<fr.tJ.w au.t of~uHirtJ Hbl.iii.Cl p acl.;, 1 ' re'Sr,ot't~lhl~ p,e~otl'' means J. p htuilUt!!iSl. vctccim~r,) s11tg<o11. \le\t-.zinnl') pant: pr'!fc..~siom,t L1r phami:acy tec-n1wlc:~1~r. 'seCl"l'O~U)' 1't'lpack{t_gin.g'' LJltl.l4n'1 t.h.t pail oi" m ~ 11\Jl :1t.. H1ri o ~ chal im·oh-t :s rep:1d<l.o~ 9{ m ,·1.U('ll}~~ lT\1•' J't.l"t1nm.lsry <ti' w:r1ia1•y i,-:,ck~ ing trnlfcri1;1 w h;d1Uni:.~ nc11 come iu <l11·ct11 contact '"'itb U1c. fi.m :;hcJ. a~"~~ lo mi r11 JI.!\' ,~c., ··f;;uiptbl}1 q1111lificcl (lt:i'f.Oo' • me.ill\$ a pbaunaCJ~1 or v~t.,;rl ':liff)' stffgt:cl'I pl'J"ittlu,t! ~1Jpui\. l~u1y G~rvkr11 to ,, whnh•,11h: Oiillot; ·,•eter.i,flµfY b 10 lng(caf' 1111.'::tnt ~ \'h·i;11 1 w 1.·u.1n~, A-c--u111 fil ... ~1t.\l1\!WU~ Jll l)J i.JCJ,..\ used f(lf 1he rurrr.st• 1,r dt~r)e<,1~ 1'5r lret1lrn1--nt of t'fTiiHML Aii..ea,:-e~: '' \'eie.ri lhll') parJ. prufos~bn:ll' 1 nit.:1m¼ ~ r~·-,... ,n ,e.~i'Mi:-l'ed :..;; .;i. 11v~:i-lt•Lk o.ificer or vclt.·tm:a1·y Jb~h ,aul 1n :tt't:t11d,,i1t.'.t1 .\r:1xc.. -1i wi,1, H:e: Veterimrn und Vch."l.'ln;.trJ P-e1~ Prf-tttS.siolJS .l\ct. flf:Nl,J 20 1a; ''Veterinncr :itur ge,oll"" mc,i D') ~ pc,,'>;1);~ ,c-!'.lS:tt.'t!'d c~ ,:j vel~t.inar~ s1.Jr~ton_ m <1.cc:01·d;)tll"\.. wl1h the Verenn~~~and ~ICJ 111~1) Pnrn: Profe~~mh ACL. lO I 0., l!1d 1 ·,,hc\ks.tlt-'' me~n'i 111,: hu,yin!' ,pt me-dit: 1oe1; t'f 1,1UJ..:d 1it1b:-.tauc-c~ in lw1k A,r th,' r ,inio!\e ot 1'f' "'~mng h) Jutburi~:::cl DhllmiAct'UUl.•I wlmle~.al< J tt,;dt'1¾-retail pk\!jtm,u.•y , ,n1kl.1i, bo!'apil~tpllflr1u1di:", 1)! !•11 Veuuinw-y -;h,"fl\, he:t11h ; hc,p.g hr\1lht;r ll.:.lhi1 f.w:iliri·e-1 t1;►r h umun bdnis lWfv,l,r;rtl~ -Afph,;)l1h'II'! :i (': Afim':.()Jl wh~ in1eJ1r;-,.: t \) m :.inu1r1C~ , dtMribul!!ordi:ul lrcli).:..t.:llQ! •t 1toy n1~li\"111e ~w aJI 1-:,d :-.uh&lu.n:u sh11II MP.P h liJ U1u A.uU,u1ir.... fo1 11 t,t-<--n.Ce i h fi<•rm I ~'t't out Jn rht S.dtcdufo, on 1,ay111e1t1 nt 1h~ pr cm:il:<•d fee (Z) A.pt.~1«10 Wh1)111,end:-. to num u l~cu1re-, Ch'1rllnu4; u1 Jc...i ,o JO\• n\t:dii:int oc ulJit:d $Ull:;tnnL·~ :.11 -mcrc rh:1rt on~ pr,!ITTli¢) ~1,.1.lf apply for n 1ii:i•flL'l.' l 11 1~:-.t~!ct pt ea,:h o:i the 1)(..-:.n tt~es. (3) lt1L"Auth o.rily sh"il :n!-1,etLlht! ps\'mf:':;e.'-1 tn t~~tl :>f 'l'•l1.kl1 .u..tJ ·Jpplicaoon ·1or ~ lk ·~1\te' ~:; n,.~d~ H) <ll!lCnnlru: 1l thc i1rrliu.m1 n1ee1.,; ~he r1tqturomc.nu~,t Jlw ..\.utisrr.:l l'Jlt':g_u;dt!lit\~ N1u1r,l1 liy 1he AculJor.h y ht·un Hnli! h; ume. JOtb ~·ovC:'.•T!h~c~ '!Ill ~ The-Aut.holi~ inn.~ ,~u~1 tto ~,pplic.mt lth1.1bi11lt,ui 1ti1it,110.l l{.:-,11.ie,t t11r- ~11ff'1,m:irio11 in 1cb1lr.n 10 ()ll appll.l."ftl1ritt t'N'a IIIXncc u, f nrm l l ~er t•tkllil,,Jlitl tniOljl!.lfll!•I 11111 10 iha!)c-hsdule, 5~ 1I I TtreA111h¢dty~hiill re,ici:'hUl ap11llc,1tron lc1r II Ii<t:ru·~ H lk11.1~1mn nr I/l~- JPJ1,l~i•UU1 l t•i;hti:t1\('C!' <«J nppllconl r~i!s IOCOlllply With a conditio11 r ••t«J~nl \<> Iha isifu.t or llw l ieence:

rb) tippl ico1u ½al~.$ 1..i r11c.c1.tht' r¢t1um·m<.:nl:,; 01' the Acr. (t J lt.~C{Jce pre\.·1m1~I!' 1/i~uc,1 m 1hc upp!lum11 '"•l$ l~\"c~i::J I •J "'he Auihon1y w;1hit1 ,he {'trhi<I nr tiH• yu;nt- pr.t..'"i>'1:<Hn,1:- tho d;\; qf-apphaaliou; w 1rfi ut_,i,li¢J\nl is t,;i1n\lJttH:.tl o(an oi't'~nc~ u11derthc- Act <~I' ti n ) cithi!I rcJcvanr wrin.en taw wultin u ptriod of LWO year~ r...,c,;ili,1g lh~ d;11c vi d,c appllca,ion, t.2 1 Th" Ai1Uh.1rny .sh;itl, whe1•t il rejea:~ Hh HppM1J.t1lh)n llnckt ~,1br()J.lUfat1oll t f >, infortn cheaDJllk:111111)f1hu r"'ll,litm lffi 1hnt J~j~1h.111 1U f.'tmu Ill "'"'"" V~tl l n 1h1,• s~h~dllt~. "• (I> 'fhc ,AUllwn1)' siuiU whete- tbd ilJl(JlkufU 1111.--e:1.s lhc. h\111'111.'l 11 reqUJre,nem'i- ,,f' lhc. A\'I, is;s1,.;- 4 liX:n{'I! in form JV i;e, vur in d1j,? lro:;,rc:e i,,.<hcdulc, (2) A Jicen« ,~-, ,,Ii.\ (i'lr l 'f')•.1) y~,a:r-, from (-fiQ J .11~ ..,f i~w~ (..41 A n'!l-l)llll!.lhJ~ pi:,~ou ihilll hlJU-.u1;e- the p1·em1.-.e:s iu •·e.,,)t"di iii whkh ti ltc.cncc.has Oet..·n 1s.!iud . J ( I ) I\ Hcen~e.: ~1110 11'!tC-J11h. 1,, m 11~\" ,h,11 1iccn..~\.·c 1i:. ltce.nct." ~h~,11, .01lc:as1 nint:ry 1l,1yN b,;.~fom th\' .-:1'pit}' ot U\t' lftd U:c!.. •t•Ph t._, U-1..1 A uthonly tor renewal nfl-he lic~occ· 111 Pom, V ::..st vut Jn l b.: Schedillo, uo ~,tYli\"11I 1lf 1hc p,-c,crlbed feo. \-2> TIii! A ltll11Jr.it)' m:ty rtn~w J lic.e,\'c'e m n!SpC(.:.I 01 tul appllc.o.11011 LI 111~ :1ppl k:mi 4110.c.ls tbt r,:qutreru~~nt/ii 9-r the ~ct u1\•I ,crnr1ptic-i. w,111lht.: knn> und condlCJom, l)f lht" ~11'l ie1 lice.nc:t I}) T he ;\utb,Jnl) ~,huth t,1!,~Jc ff , t-.1,~\..,._ .a. li~L•no.v, 1~1>111.· --11 nL·\~ licern:.e. •--ll A 1~~1h.~ 111~1 i~ uutJ\-nc;.,\lt:d !.,y l.h~.J\'.!lhcricvshc:.11 lnp~~ l'r,uj\fl.!I 111 .m, It,; 1l0tc \Jf c.xpll "/ IN·ls1..· K. l I J /\ Ucen~~ (\hill! b~ ,i~l!d sek--ly hy the liccniit~and {:( flo·, U t1!~fon,1l,Je If' ;.1,ny ot."'1.eJ pcncn wuhout \he 11r:nr1.ppmv.d o r lhe A,1lboriLv. Swtuton l ,t:J'i ,unJt•111 Y f'2J A hce-nstt wt1t., f1nc.1ub, to 1n1n~f,;-: Ill\: hcer:,Xi!!,:', licence •luUt UJ'll)Jy i,) 1.hc A,1u1or11.y h)r t1p11nwnl to l~tn.sfor lht: hc~o..-~ " ' fam1 V1 ~.c-1 01.11 in \IW S.ch~dule-, n11 puyrne,u of the ptd.cribt:!.l fo...~ \ J } fbt Authority oh:1°11, \vlwa.e 11 .i1 1pro\f'e.s tilt.~ lr.:m-.frr (1f 11 1,cen,:e. is}:1,1c \he lf'ansfo!"tc \~tH1 ;i li~~nr."· tor file- 1t1,11.tO'ld?'I nf the vahlllly pl.'.1in(I ,~~~1c litt.'uttrt,~ued 1.01he ,ranl-.fc"tor, ,4} The A\ilhf.)11r~• !ih~H rejf.X'.t-an uprl.t~~tir111 !or the \1mtsle, ot- n t,ccnooif 1h,· •r•rllc,,rt\ 1.,b '" co..Htily 1111h llt~condid1m~ (or ,ho N't.1.1t~oC'thc lt<..l!m:c hn~I thi:. 1mwi)-(10i1,:;-of the Ace and JJ1:: 1,,•1.ud~Jmc, hi.sued h) 1he Au1horJly, l't) nie J\uthvJll}' sb~U. wh:-!rtl 11 ttjc.c~ a n apJ)lt<.:~\ior1 lU' tnrn.'lfl"t l! 1kt.:.11t•c iu HLcor<l;mL'(:. w,1 Ii s1tbret1tluwln ~ 41, in.fonn the ~1ppllcant nr !Im rt.:11So1"K t.w• tt11? reiccu'1rtm form OJ bt101.11111 4hc. ,s~·11edult'1 - .\mendou•.ul 9, ( I J A b ..cn~Q\.''Vt'hO i1111.:nih. ,n ::i.m~ud tbO JJc:t:n~e•'\: Hceuce •Al ''".::mi.. -.h~lll\pJ>l~• LO 1hcAuth\1rity few :unendfflent Qf lhl' (ic.cru,.ti in r,1;-m. Vil bC:i 1.,m 111 (he Sc'bedule. upvt1 p\lyJ))c-111 u1'1ho ,,n.scribth.l f1.1c.

\°:2} The. A111honiy llltlY .'llllt:U(l 11 licence whL'rt: the ,um,u nl .tlw bu-i:i:fltM 01 1!1c s-11it!lbl~· q11,1J1il\!d pur~"'' :..'1iuJ1~'!.!;-.. ,J) t'l>e i\Ulb(ml)' ,hW, willlm 101111,~n , lay ~ 01 1eceJ pt"( il1e ·r1~i~Li('11\ r,wa.tntt~Q,n~III lll lltC Hcenc,e, ~PflfQ-Vt.• •)r l'~j~..it tl\t! Jm1md,ue111 14) Where 1.hc. J\ tlthorlly f:.11h Lo info1n, 1h!! l 1ccns,•t· •11I 'jr,; de~i~fon w1Jl\ 1n fl.)111 ~e.e11 d~1)·~_(fo.~ u111c-ndmt;t1'r "h1111 I 1e t:nn!-ii.ckrcd ffi :i.e .:pprnvcd LO A lltc:.11~~ m;iy, ",%:.re J lli:<...1u,,-.: i~ h>'>I, ,Ln1M-£t.-d 01· d0fJc.ctl1 11ppl )1 r\t 1ht- Aulh~ritJ l\U' , 1 tllfJJlkatl! Jt~ncc in rc)rut Vllt s~\ ciul ; II \ht ~cheJ.ule., Upl)!l Y,ltY!lll.'.Cll or lhi.! pre,t,ihed f,?t' S,U'•J!l' l 4'\III! 11 , ( 1l The t\mbonly :-:ihall .,.,u\pet,d tt fo.•c11.e~ II ~1,q lh1tmXt:1.~ ·Jt h«;1·, (c:i)-.lf.h.-.(t.\t.c!io ill,., nusi.nt'X!li in Jl"<"oP~~1M whirli 11:..; 1:sw..:U ,1r11.J1i:1 111i,.:111iu1ry condlnor,:,.., 1bJ ohw,rn, fi1 !S'f"ll~ tttL'U1.:im.~ rmn, 1w Wl t1uthorpid:I :ruppht, or Mock \II' se.l I 511uriau1hnrJ'<::1;tl t1rvdUCL (() lmT; 11, nwh1~in lhl.1•c,4u1.rtJ l'<.'CUh.h ® mc1liL rn~H lr dlU~d , ubs-1t1n~~ 111 (JJ c1.•ntn1woM rltc ·ft:lll'h '11lid C0Dth!hl11Ji u( lilt' lit.:t'llt'>?' m Lhc pro,·ll)IONS ,::ir lht.! /\<!I t,t uny 01hur rel,•'\lo.Mf ~v1lt1e.11 1..... 81 1 l1} nlel\ml\Ol'li.y ~hal!, f'ieif'lfe,;;u"rei\Ol11g.i ht;:t.•/1ad, gt\'C m'Jlicr: IC.J ,he lice.11-~te of tile lntr.nticln 10 stU,pc-nd tJte-llc.e11c-, and request the licensee TO ~how c~\JS¢, w1thjn :l~pectfied pernv.t. wh)• c1w~ he(Jl\'C , hu11l<l nvl IN ~11>11eiid.,,r. <l) A uoliocuf inJouU•Jntost:~1>:on<l aUc~uc..:sbldl be in Fann IX ae1 N.11 in I.he Schct.!ule :4-1 rh.e AUth!tr1t) srutll ~u!rpeod n Jiceni:e ft' Lh~ I ,ceMee t!iil~ 1u l ~ tt:1m:diat m~a:.uri:,ei WlH1it11hit pi:1iod ..it~Cif1ed 111 th< n<Hk.: is,ucJ lJ\ =ord.mct w1ili ,ubJ;(:;;ulntl~n (2)_ t5J A rwtt(lt" \,r su,pentu·w or n hc:c11ce~lrnl f l>e in ,~orm X ~l ,;)Uf i n m:i Sdledule. ((;) A r1oduct , d'.li:CJ!!d b~ tht', ::,US-J)Ctl~t•ii 01 t.Jru 1h.:.ttnl.'-u ~h111tl br \,#UaraiuillW al CIJ~ COM ol Ou: 11~\'ll~l,!t- ,,u, 11~ 1t1t:: ft:!li\tl1 ot'·1t1~ r;l 1.:ip~n.s:lon uf 1hl' l1Ccnci'., ( 7, ll'(cAutll◊Jiry~ha.lL wh.ere it i<..esf.l.lblclhe~th'il! tfre-f?censee rn,tnuf&tllh'e'i. .n,., rctm.t~ urJ..:ol., mu m!:<ht uic or ulli~d bUh!)ta11C<: ,11111..., in~~Jllilll')' c.onriirlon~. {hre;.troe fken, ee.10 d1.i;pose or lhal rnedltin~ nr idfii. .-"d I\Yb'-1.JlO(.:t. 12 1! ) Tu-c A!Jthort1y \.hJ11 re:,ul-.::- a li('L'th.,I.! 1fl t11• 1i<.tt~11~c:c- R\!-1toe;,iw,11 id l 1i)>111•1· lll) ..;n11!ll-1'¥"(~n('°' ,lie iJHt~ji~WQS o t ~he 1\..:1 1Yt l\fe.uchf-"!I th~ rerm~ ,md .:.onduit.v;ro t)f ili!! 11...·cn<x.: / hJ f11W, l.(' hlk~-.1nrN:nkr rn1»:N1-n.:.. 1t1n(H-\.J(lgtl\(!.!,iu:spei)sinti l.)f the l ite11ce: fr I th~nr es lb~ tiuslnesi.- prelfl"i~-e.s wi1hout i\.Ulhnrlsttllon; fr.JI nJl, hi t·•:11iJ1ly w11h-:i.n)' l,tht, ,clt•\l(uu 'W-tim:.Li. lnw, ,:,t ,el ohtf( rn<:ll lhc Hc~ni.!~ b_y frnu1i ~,tdelibe1·:.\tt, tit Tlt.•,gl iil'cnl i.u'bmi:,Smn oJ r~lse infon r1A1io11 l,-;,~ta1w:1~ri1~. (.].J J..1u.:, ,\.uthul'liy 1,hJI I h~tnn.i rrvn"fng :, ht l'nn.:-, giw ,,rlic=,~ •n thtr li;:r.11.$ce J t th~ ,nr~nlion ttl re.;·ok.C the ltccQcc ~in« rc<.lllt!-.l th~ l1c.c11~c1<1,.,h11w1.:Au:--c, ,\ itl\,u1~iq'ec1fieq p¢,:nhd,1 Why thclict?-l'l1,,i:! 1-houltl not ko revoke.cl, (J } r'\ nolict- ('!j' mt1, r.l1<ln IP i:,••.,11k.c tt Jtl't!nvt:. '>h,JJI hi:' -i,t l r.m r1 4 4

f>. 4-1.~I \\UI 111 tbt! S~b.cduJc- !-!) l h• /\u~mrlly shall rt,vok«hoetcciJ' 1ho llCcu,;,;e fHlh 1, , pkr ! Nw.!tl1.sl Itt.:Muu:..~., dmitlt Lnc ~1iod !Q'){,-ciffod by 1hllAm'l<>rity) <-") A uc;,11ce ot rc,•w<;;\UO.n ur \' lif .c:i1c~ sh"'U bi:- I 11 F(1t111 X M.11 ul.lt in lhc Sc:br<luk, (Ol \Vltt.·ict £1 Jlc12.ncc is- rcv<.;\1i:d, Ilic. prpe1tt'-'.IS 011 lhc- ptemii;v~ 1111rJ rhr n.:t.<.,ttlh:.1.} prorllmls ll'haJJ b,.• <W?o\i"f!ntiJ\cd ~:. Jtn .."vlc;:d by \Ill' Au1hu1 ity ~, 1hc J~)J'111l\r Jieenxec',; .:v,:,l, l'!rdudi,i8 !hd d 1:.w·;:-.at ••f f~\e f1rl)clul.~t>:. 11 J ll1c· Auttm,i,y 1my, ,>;here1bef0)11Jt,1·Jlcc11S<:e fails ,u cornpl\' whh 11 dtrecm:e: i•;sueii by thi~ Auttwrit.Y ,n uccwd:uu'. t whb .-subn.1tul,11Jon (6). de&.! wh.h tht! prodJJi;le. IJ1 Huw1u1u1 llh.~ Au:hoi'll) .illa}' co~-id~ :1ppct;p1rnle, I ttw•Uin1,(.)i 1:~, 11 l A lkc,,~~f' !tJWlf'Sl+)I..!~ withch' a¥-n, nbso?e,e. Ull\\aflted. CAJ'i•~• tXpi1 t:.d 1uc:dtc:ilu~~ Ol iilli~tJ suh';iHtflCl.' :.fl llll apprljprn(~c conlilipc, Wtlh•it'/lt\'-IJ, ,tb~ttkt~ t!l C'leJlfl_y lab.dfo.d .. ((.'ll 4cS~fl.\l'llt.lf1 v.·itlu.n U:-ip-..·Wfic.11 verj9-1j vi', h 1i ~" ill\'1\-)rtte..J 1ll<Jth1il,i.i- os sil_ptilu"d m 1\\t g111,Mi,rc, 1~ 1 A person v.·ho co11Lr1wcnc..°' sub r.;gl)lnlion I I I ~ronmu,~ a11 offence ~nd 1~ liabfa. upon <:cuvicli•ll\1w :, fitri.!' th)I t,'>.,:;(;:-t<li11!' lwo 1hoas-and five tn1nd1•1;1d p~n:?-.hy uuits.. 11114 in th~ c~~~of:1;:omfoui1l,!? c,rfent~ L\.'l ,1 f:n~ tHll ·t,.~;ee.dinf rwe111y ihe pcnn:lty units for-t•"-ch , 111y llm1 lh~ nflem~t.: t:<-m(uHr~~. \ 1J J11 acld,i11rin to Iba tx:n!.!:Uypt(l\'J~k.d 1111,.1bteS-\.llajil•t\ (2), Utt,. 4-• vurt bid'c•r1,;. w-.hk.h :i p~ao,u Ii n1Jl\ltite.i.1 of .. 1~ ',lt'iil\c.·t1 ll• ai:oortl~uife,,v/Jlit ll!b rt~iuh:111w1 m~y hf.CL~r 1,, , lh!\t f1t1}' ,11...-;Jic:.in<r ~ff nlited s:ubstID1Ct.' 111 n.:~peicr <)[ wlli'°h 1lte ._11fonL"e 11 t'.(;lfilnit1etl b~ 1'0 1ll.>itcrt 10 1t-M Smle-:. anri rhJ LIUJ.H l)l!.Cill'>\:t Con.lisp,ol5>1I <H<\ 111i.:<licim!:ru i:11{100:mh;,tiance. bt borne by 1t1e .:011v1:...1 1~1. lhc...Altlhorny o,ay C·QllCii,~1 Hn 1"'1p~dt011 hi cnsun: t'-Orup.4urtn~ wlJh lb\, 1mni/r 111tn pt¢..,,"fih!!d ,:e.quirtin~ms tor lhE- 1n;-m~fu-.:tuh:, (i.t!ltribu1100 or,1i::,;11ln_g. ul a •twJiqmt, or fiJl.io:.t~,1~wn.w l 5'. Tl\tM f\\~uJl!!lOn!) di) noi ~~p1,) ' iu 11 1n1..'fli i.,dn~ 01 .i..Hled r:ul:Y.-t.!.'lnct 1n~rnuf!-1cturc..J iu :1ccurd<Uli!!.! win1 g\1i11~~li1ttz.£ j.s,;.ucd h) t.l\e AulhC$ril)' tfrh,3 nti!Qk'iua: i:,. ru1 rot 11 rre clim...:al rrioi. prrn..•h~- l 1..tlln1cal tnnl i•,r rh11w f l cli1~it;.Ul ltfo1. .'J,1 cetmpourtdcd fl$ i;- !) t::1h~t1nuc-J:i;1 t'ur i,ipµly wi1hi11 fl1l· phat11111C) or hlli.'t)illll '.S~(lin-g ; '>I' •ij) 1,ot1~;im1r_y !i\Ugt.:oi1 t \W ~uppl)' -whhh1 -. in ~Jgcn 1,•ett>.rinary :;hc:ip.-..::rhcal th f:.iciltly lr,r :.i,J1111d~ f &J a l1m11M1 ◊r v...:wrinnry b10Jf.S~c11J 111eJicine- ma:1ufa~tu1t.~t t>~ .:,; (.;-t,,·e.cnUtl,')lll ;ll$\i(tili,t 1; (o1 plll'jJ~)~~:.: rar .llse..r.'-(! p 1'<..'-Vtnl 10 11 ,utcl toutmh 1,1

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