6
OqeH no ETHKA 3A MHOrOL|EHTPOBH CraHflapxHa oneparneHa npoueAypa 07 fl0KyMeHTaL|M3 33 KJ1HHMMHO M3nMTB3He C fl-p AneKcand npedcedame. MHO8OU,eHm no emuKa sa "*S I L dupeKmop, no OUEHKA HA ^OKVMEHTAUim 3A KJIHHHMIIO IOIIMTBAHE cx- na npoue^ypaxa e aa ce onpeflejiH peatx 3a ouenKa na nocxtnHJio HOBO 3ajiBJieHHe 3a KJIHHHHHO H3HHXBaHe. 2.O6xBaiua BCHHKH KJIHHHHHH H3HHXBaHHH, npe^cxaBenH 3a cxaHOBHiue na 3.OrroBopHocTTa no H3ntjiHeHHexo e na npeace^axejifl, HJienoBexe, H eKcnepxH KtM KoMHCHJixa. na no , Heo6xoamviH 3 COn_07_4)opMyjuip_02_Ocenka 1 Checklist S.Hop.MariiBHH aKTOBe H AOKyivieHTH, n3noji3Bann 3a ujroTBHuero na ra3H COn 5.1.Hape,a6a31,o6H. flB, 6p. 67 ox 17. 8. 2007 r., 5.1.1. IlpHjio>KeHHe 1 - npHHunnnxe na /JoOpaxa KjiHHHHHa RpaKXHKa (/],Kn) 6.1. 6.2. KoMHCHHxa no exHKa 3a MHorouenxpOBH HsnnxBaHHJi CJIC/IH 3a najiHHne H ci.oxBexcxBHe na npejacxasenaxa ^OKyMCHxauna c H3HCKBaHHHxa na Hape/i6a JY" 3 1 H ocxanajiHxe HopMaxHBHH ai<xoBe, perjiaMCHXHpamH peaa H ycjiOBHaxa 3a H3Bi.piuBaHe na KJIHHHHHH H3nnxBaHHM B P. Bx.jirapH» Kaxo H3BX,pniBa oueHKa na ntjiHoxaxa H ctoxBexcxBHexo na saaBJieHHaxa H npeacxaBenaxa ^OKyivieHxauHa, Ha Haynnnxe, Me^HUHHCKnxe H exHHHHxe acneKXH na H3nHXBaH6XO. Cjiezi nocxtHBane na sajiBJieHnexo KoMCHH^xa Ha CBOC 3aceaanHe onpe^ejia: 1.2.1. EKcnepx c ropH^nnecKO oGpasosaHHe - xexHHnecKH cvrpyiiHHK HJIH HJICH Ha KoMHcnaxa, KOHXO ^a H3Bx.pniH oueHKaxa Ha numoxaxa Ha aoKyMenxauHaxa H ctoxBexcxBHe Ha saHEjiennexo H npeflcxaBenaxa ^OKyMenxaizHa c HOpiviaxHBHHxe aKXOBe (COn_07_({)OpMyji5ip_01_Check_list) B onpe^ejien ox KOMHCHHxa cpoK, KOHXO He M0>i<e fla 6tae HO-^tJitr ox !/2 ox onpe^ejieHHa ox 3HHXM cpoK 3a npoH3HacHHe Ha KOMHCHHxa. 1.2.2. PeueH3eHX ox cx>cxaBa H HJIH BbHmeH peueH3CHX, KOHXO fla HSFOTBH cxaHOBHUj,e no oGpaseu OXHOCHO Haynnaxa, Me^HUHHCKaxa H exHHHa ouenKa Ha H3HHXBaHeXO B OnpeaejICH OX KOMHCHflXa CpOK, KOHXO HC MO>K6 Ra 6x>JJ,C HO- ox !/2 ox onpe^ejieHHa ox 3JIHXM cpoK 3a npOH3HacaHe na KOMncnaxa. Jlnuaxa no x. 1.2.1. H 1.2.2. nnc^opMnpax ceKpexapa na KOMncnaxa Ha paSoxaxa CH H npeacxBJix cxanoBHuiaxa CH . B cjiynafi, ne con 07 S/Hoewiepn 2014 cjp.1 or 6

Оценка на документацията за многоцентрови клинични изпитвания

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Page 1: Оценка на документацията за многоцентрови клинични изпитвания

OqeH

no ETHKA 3A MHOrOL|EHTPOBHCraHflapxHa oneparneHa npoueAypa N° 07

fl0KyMeHTaL|M3 33 KJ1HHMMHO M3nMTB3He C

fl-p AneKcandnpedcedame.MHO8OU,eHm

no emuKa sa"*S I L

dupeKmop,no

OUEHKA HA ^OKVMEHTAUim 3A K J I H H H M I I O IOIIMTBAHE cx-

na npoue^ypaxa e aa ce onpeflejiH peatx 3a ouenKa nanocxtnHJio HOBO 3ajiBJieHHe 3a KJIHHHHHO H3HHXBaHe.

2.O6xBaiua BCHHKH KJIHHHHHH H3HHXBaHHH, npe^cxaBenH 3a cxaHOBHiue na3.OrroBopHocTTa no H3ntjiHeHHexo e na npeace^axejifl, HJienoBexe, H

eKcnepxH KtM KoMHCHJixa.

na

no

, Heo6xoamviH 3COn_07_4)opMyjuip_02_Ocenka

1 Checklist

S.Hop.MariiBHH aKTOBe H AOKyivieHTH, n3noji3Bann 3a ujroTBHuero na ra3H COn5.1.Hape,a6a31,o6H. flB, 6p. 67 ox 17. 8. 2007 r.,5.1.1. IlpHjio>KeHHe 1 - npHHunnnxe na /JoOpaxa KjiHHHHHa RpaKXHKa (/],Kn)

6.1.

6.2.

KoMHCHHxa no exHKa 3a MHorouenxpOBH HsnnxBaHHJi CJIC/IH 3a najiHHne Hci.oxBexcxBHe na npejacxasenaxa ^OKyMCHxauna c H3HCKBaHHHxa na Hape/i6a JY"3 1 H ocxanajiHxe HopMaxHBHH ai<xoBe, perjiaMCHXHpamH peaa H ycjiOBHaxa 3aH3Bi.piuBaHe na KJIHHHHHH H3nnxBaHHM B P. Bx.jirapH» Kaxo H3BX,pniBa oueHKana ntjiHoxaxa H ctoxBexcxBHexo na saaBJieHHaxa H npeacxaBenaxa^OKyivieHxauHa, Ha Haynnnxe, Me^HUHHCKnxe H exHHHHxe acneKXH naH3nHXBaH6XO.

Cjiezi nocxtHBane na sajiBJieHnexo KoMCHH^xa Ha CBOC 3aceaanHe onpe^ejia:

1.2.1. EKcnepx c ropH^nnecKO oGpasosaHHe - xexHHnecKH cvrpyiiHHK HJIH HJICHHa KoMHcnaxa, KOHXO ^a H3Bx.pniH oueHKaxa Ha numoxaxa Ha aoKyMenxauHaxaH ctoxBexcxBHe Ha saHEjiennexo H npeflcxaBenaxa ^OKyMenxaizHa cHOpiviaxHBHHxe aKXOBe (COn_07_({)OpMyji5ip_01_Check_list) B onpe^ejien oxKOMHCHHxa cpoK, KOHXO He M0>i<e fla 6tae HO-^tJitr ox !/2 ox onpe^ejieHHa ox3HHXM cpoK 3a npoH3HacHHe Ha KOMHCHHxa.

1.2.2. PeueH3eHX ox cx>cxaBa H HJIH BbHmeH peueH3CHX, KOHXO fla HSFOTBHcxaHOBHUj,e no oGpaseu OXHOCHO Haynnaxa, Me^HUHHCKaxa H exHHHa ouenKa HaH3HHXBaHeXO B OnpeaejICH OX KOMHCHflXa CpOK, KOHXO HC MO>K6 Ra 6x>JJ,C HO-

ox !/2 ox onpe^ejieHHa ox 3JIHXM cpoK 3a npOH3HacaHe na KOMncnaxa.

Jlnuaxa no x. 1.2.1. H 1.2.2. nnc^opMnpax ceKpexapa na KOMncnaxaHa paSoxaxa CH H npeacxBJix cxanoBHuiaxa CH . B cjiynafi, ne

con 07S/Hoewiepn 2014

cjp.1 or 6

Page 2: Оценка на документацията за многоцентрови клинични изпитвания

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^HUiroaodgotT amaedtre BH oxsHBnxBiniEE BH oxsHHSirsrrsduEBdH Bd3W£Bd OHIT3XHhOXLT>I3 '3HBaXMU£H OXOHhHHHLO) 3 3XHHHHX3Bh/(

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Be Heirou HHhHxasuBdax 3XHHBa>iBho - sarorond H Heirou gxHHBaNBhoBH OXaHHOmOHXOlO BH BMH3ITO BHI^XBUndxC HUH BH1T3XH>KO1TOU BHlfSXBhHOMO -

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BIT BE 'dBX3d>I30 KHH3BIJX HlfH MHHlTXdxa.O KHM03HHHX3X BH ITH3W OH

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toBJKdilTio '(B>[U30O~20~dKirXwdo(|)~/_o~LJO3) BXKHOHWO^ BH dKirXwdo(|)HSXdBlTHBXO 3 K3BXOLT3du 30 H OH9WOHU 3 BXH3£H3U3d BH

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HaOdlH3nOJOHIAl V£ VMI/I13 OU

Page 3: Оценка на документацията за многоцентрови клинични изпитвания

KOMUCHfl no ETHKA 3A MHOTOMEHTPOBM HSnMTBAHl/mCOn N° 07: OqeHKa Ha flOKyMeHTaqufl aa KnuHMHHO nannxsaHe c neKapcxseHu npoflyxrn

na Bpean HJIH iia cMtpx, nacxtrnijin npn HJIH no HOBOZI ynacxHexo BKJ1HHHHHOXO IBriMXBane;

• OueHKa Ha rjiauHHfl H3cjie:jOBaxeji, H3CJie,iioBaxejicKHH eKHn HH3ncKBaHHxe no npoxoKOJi ycJioBHfl H oGopy/iBaHe;

• OueHKa Ha 3acxpaxoBi<axa. noKpHBama oxroBOpnocTTa naH3CJie^oBaxeji H

6.4.1 . OueHKaxa Ha npoxoKona

noTBtp>K,fl(aBane Ha H,neHXH(pHKaropHxe na H3nHXBanexo (xeivia,xa; BX.3Jio>KHxejr);

HCHO H no^poGno JIH e onncano npoy-iBaHCTO B npoxoKona;

oueHKa Ha naynnaxa CXOHHOCX na npoeKxa - IIPHJIO/KHMOCT Ha flnsaHHa KX.MnocoMCHMxe 3aaaHnxe M nen na npoy-iBanexo; BSCXH JIH ca npeaBn^ny6jiHKyBariHxe ox EK H EMEA nayqnn px^KOBo^cxBaxa 3a npoBe>ic^aHe naK.1HHHHHH H3HHXBailH5I B C'bOXBeXHaxa H030,10rHHHa CZIHHHUa, CtFJiaCHO

Mji.84,aji.2o-r3JinXM:

Kpnxepnn 3a BKJiioHBaHe H H3KJiioHBane na VHacxnum-i;

KpnxepHH 3a npei<pax>iBane Ha ynacxHexo B npoy-iBanexo;

npouejiypn no npoyHBanexo - PHCKOBC, GonKa H zwcKOMCpopx, cB-bpsann cHsriHXBanexo;

jieneHHe na yiacxHnnnxe (najninne na HHCXO njiaueGo paMo n Mepi<n 3aKonxpoji na saGojiflBanexo B nepHO/jnxe na npnjio^KeHne na njiaueGo -oGocHOBanocx na cpoica, Bi>3MO>KHOcxH 3a noam.p>i<ama xepanna, necxoxa na

n Ap.nperjiejjH sa npeuenKa BjiomaBane OCHOBHOXO saGonaBane)

i-ia KpnxepHHxe H cpOKOBexe sa oueni<a na ecpeKTHBHOCTxa HcpoKoeexe 3a oneiiKa (B saBiici-iMocx ox noiaoanuMxa - ecxecxBen xo/i na3aooji>iBaHexo, xnn H xapaKxep na /icncxBHexo na irsnnxBanna npoziyKx);

KpnxepnH 3a ouenKa na 6e3onacnocxxa na HsnnxBaiiMH npoayKx;

cxaxiicxHiieci<a oGocnoBKa na H3i'inxBanexo (Gpon njianHpaiin naunenxn,KpuxepiiH 3a ecpeKXHBiiocx H Gesonacnocx);

xepaneBxnnnH noji3H 3a ynacxunnnxe B n3imxBanexo, 3a nacxoamnxeH GvieinHTe naunenxii H noji3Hxe 3a 3/ipaBeona3BaHexo;

I-UIHHH 3a rapanxnpane (])H3HHeci<axa H ncnxHHecKaxa nenpnKocnoBeHOCx nayiacTHHKa B

3a rapanxnpane na npasoxo na HenpHKOCHOBenocx na JIHMHHH >KHBOX Hnpasoxo Ha samnxa Ha JIHHHHXC jianHH na ynacxuHKa;

6.4.2. OueHKaxa na 6pouiypaxa na H3CJiezioBaxejiM BionoMBa:

oueHKa 3a aicryajmocx na Hii^opMamiMxa (nocjie^naxa BepCHH xpaGsa ^a eH3iiazieHa npejin ne noBeiie ox 1 ro^iina ox no,xaBanexo na flOKyMenxauHHxaHJin jja ce ctntxcxBa ox ijoKyMenx. y,aocxoBep>iBam, Lie HMMQ HOBH ^annn 33

con 07Bepcufl 3/HoeMBpn 2014

cxp.3 016

Page 4: Оценка на документацията за многоцентрови клинични изпитвания

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ndai/\iaoH/£ bsnodag

ZOUOO

'WXLJlf£ 10 10 1 'lfh H 001 'Uh '86 'Uh 'Z.6 'Uh '96 -i

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HUAdj

BH 9HXOGhX H HXH3HHGU GH SHGdHgGH G£ 9XHdXtT9nodu GH GMH9nQ 'W9

•9XHXH9HHBU BH

r. HLTH/H BxxooHOGiioe.og H Gxcasdu BII sHBaf^iroe ur. 3HH3hBHe BIVH sHiisiiir^uotrBOOX OXBXOM 'BMHXMBdu BHhHHHL'M ndgo^/ U£. BXBIi"H{TGd]J[ J.O Ql '8 ' t7 '^ a B1BHCOH1IO XO

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XMBXHOM BE 9XHHIIBC' H 9HH1T OWHDHaB£9H 3 XMBXHOM B£ gXHUHBtf GH

!9HH9h9IT H H>KHdx HnTSl/ig K9H/OX9H G£ 3XHHBXBKOU GH

93 T3V B3OX E9g H B3OX BE KHH9HDKgO B3B1? BtT E9g '3JAI3da OMK33 OU OX3HBalT9ir3EH

XO HKJ3XXO 93 VV H9tfOgOa3 9 XaXHSHTlBU 3h 'KHTlBlMdO(|)HH BH OX3HhHIH3H

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Page 5: Оценка на документацията за многоцентрови клинични изпитвания

no ETMKA 3A MHOTOUEHTPOBHCOn N° 07: OueHKa na flOKyMeHTaunn aa KJIUHUHHO nsnuxeane c neKapcxeenn

Koraxo 3a npoBe>K^aHexo na ne-xepaneBXHHHO H3HHXBane e HeoGxo^HMO ctrjiacnexona 3aKOH6H npe,acxaBHxeji Ha ynacxHHKa HJIH npoxoKOJitx na KJIHHHHHO H3nHXBanenosBOJiHBa BKjitOHBane Ha nauneHX, 6e3 ,aa e B^SMOKHO Herosoxo Henocpe^cxBeHonncMeiio ctrjiacne HJIH ctrjiacnexo na HeroBna saKoneH npe/icxaBHxeji, KoMHCHsnra cenpoHsnacfl no Btnpoca, ziajin npeAJio>KeHHHX npoxoKon H/HJIH zipyrH ^OKyivieHXHcibBnaziax c exn^nnxe nopMH, cnope^ npaBHiiaxa 3a Ro6pa KjiHHHHHa npaKXHKa HJI,eKjiapauHHxa ox XCJISHHKH, H .najin oxroBapax Ha npHjio>KHMHxe nopMaxHBHHH3HCKBaHHfl 33 XaKtB XHH H3nHXBaHHfl (3J1E[XM H 3aKOH 3a 3ApaBCXO, KoHBCHUHfl 33

3am,Hxa npasaxa na HOBCKa H HOBemKoxo AOCXOHHCXBO BX>B Bpt3Ka c npHjiaranexo HanocxH>KeHHaxa na GHOJiornaxa H

6.4.5. OuenKaxa na ycJioBnaxa H pe^a 3a Bt.3Harpa>i<fleHHe HJIH oGesmexeHHe HayHacxHHHHxe B KJIHHHHHOXO H3nHXBane,

pasMepa na sanjiamaHexo na 3^paBHxe

paanpe^ejieHHexo na 3anjiamaHexo Ha sapaBHxe

rapanxnpaHO nponopuHOHajino Ha ynacxnexo BtB Bpeiviexo

jiHnca na (J)HHaHCOBn cxHMyjiH 3a npoatJi>KaBamo ynacxne npn >KejiaHne nay-iacxHHKa aa ce OXXCFJIH;

oueHKa AajiH Bt3Harpa>K^eHHexo oxpasasa peanno peniviGypcHpaHe 3a BpeMexo,ycnjiHaxa H paBxoanxe HM, HJIH cyMaxa e no-3HaLiHxejiHa H MOKCnpe^y6efleHo noBJinaBane na H3CJieziBaHHxe m ynacxBax;

H pea 3a Bt3cxaHOBflBaHe na pa3xo/iH;

rapaHXHpano 3ana3Bane Ha npasaxa na 3acxpaxoBaxejiHO noKpHXHe,ox nojiynaBaHoxo sanjiamane 3a ynacxnexo.

6.4.6. OueHKaxa na rjiaBHna H3CJie^OBaxeji n H3CJie^,OBaxejiCKHa CKHH BKJiiOHBa:

CnajBane na HSHCKBanexo Ha Hji.86, an. 2 ox 3J1EIXM - KjiHHHHHa cneimanHocxB ctoxBexnaxa oGnacx;

cnasBanexo na H3HCKBaHexo Ha MJi.86, an.l ox 3J1F1XM

O BT>3MO>KHOCX Ha CKHHa Ra H3BtpmBa CneUHCJ)HHHH

jiene6HH npoue^ypH, cstpsaHH c

o OHHX B npOBOKAanexo Ha KJIHHHHHH H3HHXBaHHH (ycxaHOBCH cno MJi.6, an.l x.3 ox Hape^6a JV»31);

o nojiyHeno JIH e ct-rjiacnexo na ptKOBo^Hxejia na jiene6Hoxo saBe^eHHe, BKoexo me ce npoBe>K,aa KJIHHHHHOXO H3nnxBaHe, ctrjiacno HJi.87 an. 2;

o HanHHHe Ha cneunanHCXH c ^pyrH npoc})HJiHH cneunanHOcxH (H3Bi>HOCHOBHOXO 3a6oJIHBaH6, 33 KOCTO C6 HSFIHXBa npOflyKXa) npH H3B6CXHH

cneun(J)HHHH HOicejiaHH peaKunn, nanaramH npocjieaHBane B xo^a nanpoyHBanexo.

6.4.7. KoMHCHflxa no exHKa ^asa oueHKa na Heo6xo,UHMHxe ycjiOBHH H oGopyztBane 3aH3ntJiHeHHe Ha npoxoKOJia:

con 073/HoewiBpn 2014

crp.5 or6

Page 6: Оценка на документацията за многоцентрови клинични изпитвания

KOMMCMfl no ETMKA 3A MHOrOMEHTPOBH l/ISFlHTBAHUflCOD N° 07: OMeHKa Ha flOKyivieHxaMHE 3a K/IUHUHHO nannreaHe c neKapcreeHu npo,qyKxn

Cna3Bane Ha HSHCKBaHnaxa Ha HJi.87, an.l OT 3JIFIXM;

HaJIHHHC Ha HCO6XO/1HMOTO XCXKHHCCKO o6opyABaH6 3a H3HX,JIHeHHe Ha

npOTOKOJia - aKpeflHxnpaHH JiOKanHH / ueHipajiHH jia6opaxopHH, .npynixexHHHecKH ctopDKeHHfl c HeoGxoflHMaxa cnopejj npoxoKona cneuH(})HKauH5i(5IMP, KAT, cneuH(]}HHHM MCTOAH Ha H3CJie^BaHe); npn H3non3BaHe na

xexHHHecKO o6opy,n,BaHe - onepaxHBHOcx H yflo6cxBo 3a; ype/inxe, cJ)yHKUHOHHpaiHH c HSXOHHHUH na HOHH3Hpaiij,H

aa pasnonarax etc ctoxBexHH axxyannH JIHHCHSHH, HSAa^eHH ox3a HApeno peryjinpaHe.

Bt3Mo>i<HOCT 3a npoBOK^aHc Ha cneuiHH peaHHiviauHOHHH MeponpHaxHH (Box noi<a3aHii>ixa H (J)a3axa i-ia pa3Bnxne na

oueHKaxa Ha ycjioeHflxa 3a HsntJineHHe Ha npoei<xa ce npaBH 3a BCCKH oxnpezi,Jio>i<eHHxe uenxpoBe.

6.4.8. OueHKaxa na 3acxpaxoBi<axa BKjiiOHsa

noKpHBane Ha oxroBopnocxxa na Bi>3Jio>KHxejia H rjiaBiiHH/xe

oueHKa na npe^BHaeiioxo HH^HBHayajiHO H arperaxHo noi-cpHXHe;

ycjioBnaxa 3a noflHOBMBane na 3acxpaxoBi<axa;

cpoKOBexe na HOKPHXHCXO;

cpoKOBexe H ycnoBHJixa sa npe^iB^BaHe na HCKose ox(o6ocHOBaHH JIH ca cnpaMo onaKBanaxa npo/n>ji>KHxejiHocx na npoyMBanexo,xapaxxepa H MexaHH3Ma na ACHCXBHe na HSHHXBaHHH neKapcxBCH npo^yKx);

HannHHe/jinnca B o6m,Hxe ycnoBHJi Ha H3HCKBanHJi, KOHXO npoxHBOpenax naBKJTK)LIBaiHHXe H

6.4.9. OueHKaxa Ha ycjioBHHxa H pezia 3a Bt3Harpa>KaeHHe HUH oGesmexenne naB KJIMHHHHOXO H3iiHXBaHe

JiHnca na 4)HnaHCOBH cxHMyjiH 3a npozitJi>KaBaHe na ynacxnexo na nauneux(Hanp.sannaiuaHe 3a nauweHX "sae-bpiuHJi" npoyHBanexo, vs. nponopUHonajiHO

HSlXbJlHCHH BH3HXH) B KJ1HHH4HO H3HHXBaH6;

na BtsHarpa^AeHnexo ne HO/IJIOKH na oxAenna

6.4.10. OueHKaxa na eneivieHxuxe na AoroBOpa Me>K^y Bt3Jio>KHxe;i>i H

Ha Me^nuHHCKHxe rpn^KH 3a ynacxHHUHxe;

H cpOKOBe 3a apxHBHpane Ha AOKyMCHxauHHxa no KJIHHHHHOXO, aKo e npe/iBHzieHo apxHBMpane ox ueLie6HOxo

3a npeKpaxHBane na aoroBOpnxe - cpOKOBe na(no3BOJi«Bax JIH npexB-bpiiHHexo na rpn>i<axa PI npocjie^5iBanexo na ynacxHHUHxeB npoy-iBanexo B apyra ueuxpOBe, ycjiOBHH 3a ctxpaneHHe naHa H3CJieflOBaxejia npn npeKpax^iBane Ha zioroBopa c Jiene6HOxo s

con 07Bepcua S/Hoewepn 2014

crp.6 016