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Page 1: LJ:OrOBOPsbaloz-sofobl.com/wp-content/uploads/2016/04/dogovor-lekarstva... · Per NQ 2318 OT 19.05.2015 r., 3aBepeHo oT 5IHI.JO HecTOpoB - HoTapHyc c paifoH Ha neifcTBHe P.C. BapHa,

LJ:OrOBOP

.N2 31131.08.2016 r.

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npaB:HJiaTa Ha .IJ:o6paTa np0113BO,lJ,CTBeHa H ,l],HCTpH6yTOpCKa npaKTHKa H ,lJ,eKJiapHpaHOTO B

Texm:rqecKoToiTe npe.uno:>KeHHe/51 Ha li3llbJIHliTEJUI. (2) JleKapCTBeHHTe npO.UYKTH Tp.si6Ba ,lla Ca CbC CbOTBeTHaTa MapKHpOBKa 3a ,lJ,aTa Ha

npOH3BO,lJ,CTBO, H ,l],a Ca C OCTaT'bqeH CpOK Ha fO.UHOCT KbM MOMeHTa Ha ,lJ,OCTaBKaTa He no­

MaJI'bK OT 60 % (rueCT,lleCeT Ha CTO) OT 0651BeHH51 OT npOH3BO.UHTeJ151 CpOK Ha fO,lJ,HOCT, yKa3aH

Bbpxy onaKOBKaTa.

(3) f1pO,ll,YKTHTe CJie,UBa ,Ua ca onaKOBaHH no Haq}IH, KOHTO fH 3aiTa3Ba OT BC51KaKBH nOBpe.UH,

,l],'bJI)I(aiUH Ce Ha aTMOCcpepHHTe YCJIOBH51 H TpaHcnopT, KaTO Ce ,ll,bp)I(H CMeTKa 3a BpeMeTpaeHeTO Ha

TpaHcnopTa.

(4) MapKHpOBKaTa Tp516Ba ,ll,a e nOCTaBeHa Bbpxy BCeKH KaWOH, C'bOTBeTHO onaKOBKa.

(5) lfJIJhJIHlfTEJIJIT HOCH OTfOBOpHOCT 3a Bpe,ll,H, npOH3TeKJIH OT HenpaBHJIHa HJIH

He,lJ,OCTaT'bqHa onaKOBKa HJIH HenpaBHJIHa HJIH He,lJ,OCTaT'bqHa MapKHpOBKa.

(6) JleKapcTBeHHTe npO,ll,yKTH, nOKa3aJIH OTKJIOHeHH51 OT CTaH,ll,apTHTe H ,lJ,eQJeKTH no BpeMe

Ha npHJIO)!(eHHeTO HM B paMKHTe Ha CpOKa Ha fO,lJ,HOCT, ce nO,lJ,MemiT OT lf3IIbJIHlfTEJIJI C

pe.UOBHH TaKHBa, KaTO 3a UeJITa ce H3f0TB51 ,lJ,BYCTpaHeH npOTOKOJl.

(7) ITpH HeB'b3MO)!(HOCT 3a ,lJ,OCTassme Ha 3MBeHHTe npo,ll,yKTH cornacHo 3MBeHoTo no BH,ll,,

KOJIHqeCTBO, ,l],OfOBOpeHa QeHa HJIH ,ll,pyra xapaKTepHCTHKa Ha JieKapCTBeHHTe npo,ll,yKTH,

lf3IIbJIHlfTEJIJIT e ,lJ,JI'b)!(eH ,ll,a yse,ll,OMH nHCMeHO (nHCMeHaTa QJOpMa ce cqHTa 3a Cna3eHa I1

npH yse,lJ,OM51BaHe qpe3 en. noma, <)JaKe) Bb3J10)KIITEJIJI B cpoK He no-K'bCHO oT 2 /,ll,sa/ qaca

CJie.U noJiyqasaHe Ha 3MBKaTa.

(8) B CJiyqaJ.i qe He .IlOCTaBH 3a51BeHHTe CTOKH B CpOK .IlO 24 qaca CJie.U .UOfOBOpeHHSI CpOK

npH cneWHH 3MBKI1 HJIH ,[1,0 72 qaca CJle,lJ, ,lJ,OfOBOpeHH51 CpOK npM peryJI51pHH 3MBKH CJie,lJ,

yrosopeHH51 cpoK w/HJIH He yse.uoMH B yKa3aHH51 cpoK Bb3JIO:>KHTeJI51 3a HeB'b3MO)I(HOCTTa 3a

I13BbpWBaHe Ha ,lJ,OCTaBKaTa, TOBa ce cqHTa 3a MbJiqaJIHB OTKa3 I1 H3nbJIHHTeJI51T ,lJ,'bJI)!(H HeyCTOHKa

no qJI. 11, arr. 5. MoJiqarrHBH51T OTKa3 ce o6eKTHBHpa B npoTOKOJI Ha B'b3JIO)!(HTeJI51.

(9) 3a KOJmqecTBa, ,l],OCTaBeHH H3B'bH 06XBaTa Ha C'bOTBeTHaTa, OTnpaBeHa OT B'b3JIQ)KHTeJI51

3aSIBKa, HJlH HeC'bOTBeTCTBaiUH Ha npHJIO)I(eHH51Ta K'bM HaCT051lUH51 .norosop, Bb3JIQ)KIITEJ151T H51Ma 3a,lJ,'bJI)I(eHHe 3a nnawaHe.

(10) lf3IIbJIHlfTEJIJIT He HOCH OTfOBOpHOCT 3a .ue<}JeKTH, Bb3HHKHaJIH B pe3yJITaT Ha

HenpaBHJIHH MaHHnyrraUHH H CbXpaHeHHe OT CTpaHa Ha Bb3JIQ)KlfTEJI51.

IV. IIPABA H 3A,ll.b)KEHH51 HA CTPAHHTE

qJI, 7 (1) Bb3JIO)I(liTEJUIT HMa npaso:

}. ,Ua noJiyqasa JieKapCTBeHHTe npO,ll,YKTH, npe,ll,MeT Ha HaCT051IUH51 ,lJ,OfOBOp npH YCJIOBH51Ta,

yrosopeHH B Hero;

2. CB060,ll,HO ,ll,a onpe,ll,eJI51 KOJlHqecTBOTO Ha .UOCTaBKHTe, Cb06pa3HO KOHKpeTHHTe CH

CTp.4 OT 10

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(2) Bb3JIOJKIITEJUIT ce 3a.D.omKasa:

1. .D.a ITpe.D.aBa Ha II3llbJIHIITEJ151 3MBKH 3a Heo6xo.D.HMHTe KOJmqecTBa ITpO.D.)'KTH,

C'ho6pa3HO ymqHeHaTa ciTeumtmKauH.s~;

2. ,ll,a Bb3JIO)KH Ha CBOH CJIY)KHTeJI ITOJiyqasaHeTO Ha 3MBeHHTe KOJIHqeCTBa ITO pe,ll,a Ha

HaCTO.ll:UlH.ll: .ll.OfOBOp;

3 . .D.a 3aiTrrama ITorryqeHHTe rrpO.D.)'KTH rrpH. ycrroBmiTa Ha HaCTO.SilllH.SI .D.OroBop;

4. ,ll,a rrpe,ll,.ll:B.ll:Ba peKJiaMai.lHH B MOMeHTa Ha rrpe,ll,aBaHe - IIpHeMaHe 3a BH,ll,HMH

He,ll,OCTaT'bllH - H3TeKJIH CpOKOBe Ha rO,ll,HOCT, IIO-KpaTbK OT H3HCKyeMH.ll: OCTaTbqeH cpOK Ha

rO,ll,HOCT, KOJIH.qeCTBO, JIHITCH l1 .D.p.

lJJI. 8 (1) II3IlbJIHIITEJUIT HMa npaso .D.a ITorryqH ueHaTa Ha ITpo.D.yKTHTe B pa3Mep, no

HaqHH l1 B CpOKOBeTe, OITpe,ll,eJieHH B HaCTO.ll:UlH.ll: ,ll,OfOBOp

(2) II3llbJIHIITEJ151T ce 3a.D.bJI)Kasa:

1. ,ll,a l13II'hJIH.ll:Ba IIOJiyqeHaTa 3a51BKa B CpOKOBeTe, CbOTBeTHO ITO qJI. 4, an. 2 l1 an. 3, CbC

C06CTBeH CIIeUHanH3HpaH TpaHCIIOpT l1 3a CB051 CMeTKa.

2. ,ll,a OIIaKOBa JieKapcTBeHH:Te rrpO.D.YKTH ITO HaqH.H, fO,ll,eH 3a DIXHOTO TpaHCIIOpTHpaHe ,ll,O

CKJia,ll,a Ha Bb3JI0JKIITEJIH, 6e3 pHCKOBe 3a yBpe)K.lJ.aHeTO HM.

3. ,ll,a OCHrypHBa pa3TOBapBaHeTO Ha JieKapCTBeHH:Te ITpO,ll,)'KTH ,ll,O OIIpe,ll,eJieHOTO OT

Bb3J10)KHTemi ITOMellleHH:e, rrpe,ll,CTaBJI51BalllO cppaHKO M.ll:CTOTO Ha ,ll,OCTaBKa;

4. ,ll,a rrpe,ll,aBa C ,ll,OCTaBKaTa He06XO,ll,HMaTa HHcpOpMaUH.ll: l1 IIpH.D.py)KaBalllH JieKapcTBeHHTe

ITpO,ll,)'KTH ,ll,OKYMeHTH, KOraTO e He06XO,ll,HMO.

5 . .D.a CITa3Ba HOMeHKJiaTypaTa 11 ueHHTe c'hrrracHo TexHHqecKoTo 11 ueHoso ITpe.D.JIO)KeHH.ll:,

Hepa3.n;eJIHa qacT OT .n;orosopa, H .n;a HHcpOpMHpa He3a6aBHO Bb3JI0JKJITEJUI IIpH HaCTbiiBaHe Ha

l13MeHeHH.ll: ITO ITpHqHHH, He3aBH:CelllH OT l13II'hJIHHTeJI.ll:.

6. rrpH o.n;o6peHa peKJiaMaUH.ll: Ha .ll:OCTaBeHHTe JieKapcTBeHH rrpo.n;yKTH, .n;a B'h3CTaHOBSJBa

CbOTBeTHHTe KOJIH:qeCTBaTa Ha Bb3JIQ)KlfTEJIH B ITpe.n;sapHTeJIHO yrosopeH Me)K,ll,y .n;BeTe

CTpaHH CpOK.

7 . .n;a rrpe.n;asa rrpO.LJ:)'KTHTe B CbCTO.SIHHe, fO.ll:HH 3a yrrOTpe6a H C OCTaTbqeH CpOK Ha fO.ll:HOCT

He ITO-ManKO OT 60 /ruecT.n;eceT/ Ha CTO OT 06SJBeHHSI OT ITpOH3BO.ll:HTeJISJ KbM .n;aTaTa Ha ,ll,OCTaBKa Ha

BC.ll:Ka IT03HU:H.ll: OT 3a5.!BKaTa.

8. ,ll,a ,ll,OCTaB5I JieKapCTBeHH:Te ITpO.D.YKTH, ITpe,ll,MeT Ha HaCT05IUll151 ,ll,OfOBOp, C KaqecTBO,

KOeTO OTfOBap51 Ha TeXHHqecKHTe H3HCKBaHH5I Ha ITpOH3BO,ll,HTeJI5I, KOeTO Ce Y.ll.OCTOBep5IBa C'hC

cepTHcpHKaT 3a KaqecTBO, H3.LJ:a,ll,eH OT KOMIIeTeHTeH OpraH B CTpaHaTa Ha IIpOH.3BO.LJ:HTeJISJ.

V. PEKJIAMAU:IIII

qJI, 9 (1) II3llbJIHHTEJ151T rapaHTHpa rD.D.HOCTTa Ha .D.OCTaB5IHHTe rrpo.D.yKTH coo6pa3HO

l13HCKBaHH51Ta Ha .D.eHCTBalllOTO 3aKOHO,ll,aTeJICTBO.

(2) Bb3JIO)KlfTEJUIT MO)Ke .D.a npeJUIB5IBa peKrraMaUHH ITpe.D.li3llbJIHIITEJUI3a:

a) KOJIHqecTBo 11 HeoKOMITJieKToBaHOCT Ha npo.D.yKTHTe HIHJIH TeXHHqecKaTa .D.OKYMeHTaUH5I

(.SIBHH He,ll,OCTaTbi.lH), BKJIIQqH:TeJIHO:

- 3a KOJIHqeCTBO, KOeTO He OTfOBap5I Ha 3MBeHOTO;

- 3a HeCITa3eHH ycJIOBH5I H pe.n; IIpH TpaHCITOpTHpaHeTO Ha IIpO.D.YKTHTe;

- IIpH HapyrueHa J.lSIJIOCT H OIIaKOBKH;

- rrpH HeCbOTBeTCTBHe Me)K,ll,y rrapTH,ll,HHTe HOMepa Ha JieKapCTBeHHTe rrpO.D.YKTH, BIIHCaHH B

IlpHeMO-npenaBaTeJIHHSI IIpOTOKOJI H cpaKTypaTa, C napTHllHHTe HOMepa, BIIHCaHH Bopxy

OIIaKOBKHTe HM.

crp.5 or 10

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6) KatJeCTBO (cKpHTH He.lJ:OCTaThU:H):

- IIpH .ll:OCTaBSIHe Ha CTOKH He OT .ll:OrOBOpeHH.si BH.ll: C'brJiaCHO HaCTO.siiUH.si .ll:OrOBOp;

- npH KOHCTaTHpaHe Ha .ll:eQJeKTH npH yrrOTpe6a Ha CTOKHTe.

(3) B cnyqaif qe rrpH nO.ll:IIHCBaHeTo Ha npHeMo-npe.ll:aBaTeJIHH.si npoToKon 3a rronyqaaaHe Ha

C'bOTBeTHOTO KOJIH1JeCTBO OT JieKapCTBaTa Bb3JIQJKHTEJUIT ycTaHOBH .siBHH He.lJ:OCTaThU:H,

OTIIpaa.sr nHCMeHO HCKaHe .ll:O ll3llbJIHHTEJUI .ll:a OTCTpaHH He.ll:OCTaT'bUHTe B cpoK, YKa3aH B

IIHCMeHOTO HCKaHe.

(4) PeKJiaMaU:HH npH OTKJIOHeHH.si B KatJeCTBOTO (HJIH .ll:pyrH CKpHTH He.ll:OCTaT'bU:H) ce

rrpeMB.siBaT OT cTpaHa Ha B'b3JIOiKHTEJUI B paMKHTe Ha cpoKa Ha ro.ll:HOCT, YKa3aH aopxy

onaKOBKaTa Ha C'bOTBeTHH.si rrpO.ll:YKT. Bb3JIOiKHTEJUIT 1-nnpama Ha II3fibJIHJITEJIH KOHCTaTHBHH.si npOTOKOJI H OTnpaB.sr nHCMeHO HCKaHe .ll:O Hero .ll:a .ll:OCTaBH KatJeCTBeH npO.ll:YKT B

cpoK, yKa3aH B nHcMeHoTo HCKaHe.

(5) ITpH peKnaMauH.sr 3a .siBHH Hec'bOTBeTCTBmiiHe.ll:OCTaThUH HIHnH oTKJIOHeHH.si

ll3llbJIHHTEJI.HT e .ll:Jl"b)KeH B TpH,n:HeBeH cpoK OT rronyqaaaHe Ha peKJiaMau:mna 3a CBO.si

CMeTKa H pHCK .ll:a 3aMeHHf.lJ:OCTaBH .lJ:OrOBOpeHOTO.

(6) ITpH peKnaMaU:mi 3a cKpHTH HeCoOTBeTCTBH.siiHe,n:ocTan.u:H II3llbJIHIITEJUIT e

.ll:Jl'h)KeH B TpH.ll:HeBeH CpOK OT nonyqaBaHe Ha peKJiaMaU:H.siTa 3a CBO.si CMeTKa H pHCK .ll:a 3aMeHH

rrpO.lJ:YKTHTe 6e3 He06XO.ll:HMOTO KatJeCTBO C'hrJiaCHO ,n:orOBOpeHOTO HJIH .ll:a BopHe IIOJiytieHaTa U:eHa

3a npO.ll:YKTHTe, 3a KOHTO Ca HarrpaBeHH peKJiaMaU:HH, KaKTO H ,n:a 3aiiJiaTH HeyCTOifKa.

(7) AKO ll3llbJIHHTEJI.HT H.siMa B HanHtiHOCT OT IIOCOtieHH.siT 3a nO.ll:M.siHa JieKapcTBeH

npO.ll:YKT, Toil ce 3a.ll:'hJI)I(asa .ll:a BopHe cToiiHocrra Ha Bb3JIOiKHTEJUI B YKa3aHH.sr cpoK a

IIHCMeHOTO HCKaHe ITO an. 3 H 4.

VI. OTrOBOPHOCTll

l.IJI. 10 AKo Bb3JIOiKHTEJI.HT npocpo'IH 3a,n:'hmKeHHeTo CH no 'IJI. 3, an. 3 oT .ll:Orosopa c

TIOBe'Ie OT I 0 JJ:HH, TO if JJ:bJI)KH HeyCTOHKa B pa3Mep Ha 0, I o/o Ha .ll:eH Bopxy CTOifHOCTTa Ha

.ll:OCTaBeHOTO KOJIH'IeCTBO JieKapCTBeH npO.ll:YKT, HO He IIOBe':le OT neT Ha CTO OT CTOifHOCTTa Ha

CoOTBeTHOTO KOJIH1JeCTBO.

qJI, 11 (1) l13BbH cnyqaHTe no 'IJI. II, an. 6 ll3llbJIHHTEJI.HT .ll:'hJI)I(H HeycToiiKa B

pa3Mep Ha 0,7 % Ha .ll:eH OT CTOHHOCTTa Ha C'bOTBeTHOTO KOJIWieCTBO npO.ll:YKTH, aKO He H3n'hJIHH

H3U.siJIO HJIH 'IaCTH'IHO 3MbJI)KeHmiTa CH no 'IJI. 4, an. l.

(2) Bb3JIQJKJITEJI.HT MO)I(e .ll:a OTKa)Ke npHeMaHeTO Ha CTOKHTe, aKO B .ll:eH.si Ha T.siXHOTO

npHeMaHe OCTaThlJHH.si cpOK Ha rO.ll:HOCT e nO-Man'bK OT Onpe.ll:eJieHH.si B qn. 6, an. 2 H qJl, 8, an. 2, T.

7 OT HaCTO.sill{HSI ,n:orOBOp.

(3) B cnyYaHTe no an. 2 Bb3JIOiKHTEJUIT MO)I(e .ll:a npHeMe H .ll:a He 3arrnaTH

.ll:OCTaBeHOTO C no-Man'bK OT .ll:OrOBOpeHH.si OCTaTh':leH CpOK, KaTO TOBa Ce OT6eJI.si3Ba B npHeMO­

npe.ll:aBaTeJIHH.si npoTOKOJI . B cnyqaH. qe CTOKHTe 6'h.ll:aT .ll:apeHH, Bb3JIOiKHTEJUIT MO)l(e .ll:a rH

IIpHeMe H C no-ManoK OCTaTO':IeH cpOK Ha rO.lJ:HOCT, KaTO B T03H cnyqai1: , no Herosa npeu:eHKa MO)l(e

.ll:a He npHnara pa3IIOpe.ll:6HTe OTHOCHO .ll:'hJI)I(HMaTa OT H3n'hJIHHTeJI.si 3a KOHKpeTHaTa .ll:OCTaBKa

HeycTOHKa HJIH .ll:a HaManH pa3Mepa H. ToBa 06CTO.siTeJICTBO Ce OTpa3.siBa B npHeMO-npe.ll:aBaTeJIHH.si

npOTOKOJI. }J,OCTaBKaTa Ha JieKapCTBeH npO.ll:YKT C OCTaTD'IeH CpOK Ha rO.ll:HOCT no-ManoK OT 40 /qeTHpH.ll:eCeT/ Ha CTO OT o6.srBeHH.si OT IIpOH3BO.lJ:HTeJI.sr MO)I<e .ll:a Ce H3BopiiiH CaMO C MOTHBHpaHO

perneHHe Ha Bb3JIOiKHTEJI.H. Ee3 H3pH'IHO nHcMeHo comacHe Ha Bb3JIOiKHTEJUI npO.ll:YKTH C no-Man'bK OT .ll:OrOBOpeHH51 CpOK He Ce 3arrnamaT.

( 4) B cnyLiaii Ha .ll:OCTaBKa Ha neKapcTBeHH rrpO.ll:YKTH c rro-KpanK oT .ll:OrosopeHH.si cpoK Ha

rO.lJ:HOCT, H3II'bJIHHTeJI.siT .lJ:'bJI)KH HeycTOHKa, KaKTO CJie.ll:Ba:

59,99- 50 % - 5% Bopxy CTOifHOCTTa Ha C'bOTBeTHOTO KOJIH'IeCTBO;

CTp.6 OT 10

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49,99-40%- 10% Bopxy CTOHHOCTTa Ha C'bOTBeTHOTO KOJUPieCTBO;

39,99- 30 % - 30% Bnpxy CTOHHOCTTa Ha C'bOTBeTHOTO KOJUiqecTBO;

29,99-20%- 60% B'bpxy CTOHHOCTTa Ha C'bOTBeTHOTO KOJUJ:qecTBo;

no.n 20 % - 90% Bnpxy CTOHHOCTTa Ha C'bOTBeTHOTO KOJIH:qecTBO.

(5) flpH OTK8.3 /nHCMCH HJIH MbJlqaJlHB/ Ha lf31I'hJIHlfTEJUI, B cnyqaHTe Ha qJI, 6 an. 8, TOH .LJ:'brr:>KH HeyCTOHKa B pa3Mep Ha 10 % /.neceT Ha CTO/ OT CTOHHOCTTa Ha He.LJ:OCTaBeHHTe

rreKapcTBeHH npo.nyKTH.

(6) B crr~aHTe no npe.uxo.uHaTa arrHHe51 HJIH npH 3a6asa c noseqe OT 48 qaca npH cneUIHH

3a51BKH HJIH noseqe OT 72 qaca npH peryrr51pHH 3a51BKH, B'h3JIOJKIITEJI51T e cso6o.ueH .na 3aKynH

JieKapCTBeHHTe npO.LJ:)'KTH, 3a KOHTO lfJII'hJIHlfTEJUIT e HanHu;e OTK8.3 3a L(OCTaBKa HJIH

nocoqeHaTa 3a6asa.

(7) flpH 3aKynysaHe Ha JieKapCTBeHHTe npO.LJ:YKTH Ha nO-BHCOKa u;eHa OT Ta3H B HaCT051lUH51

.uorosop, 3a pa3rrHKaTa B CTOH:Hocrra B'h3JIOJKIITEJI51T ce y.uosneTsop51sa oT npe.uocTaBeHaTa

rapaHUH51 3a H3n'bJ1HeHHe Ha T03H .uorosop.

l.J:Jl. 12 (1) AKO li31I'hJIHliTEJUIT H3na.uHe s 3a6asa Ha 3a.UbJI)I(eHHeTO CH no qJI, 4, an. 2 H an. 3, C'bOTBeTHO liJl. 8, an. 2, T. 1:

- C noseqe OT 2 /.usa/ qaca npH L(OCTaSKH, 3a51SeHH KaTO cneiiiHH;

- c noseqe OT 12 /.usaHa.ueceT/ qaca npH perymipHH .uocTasKH no qn. 4, an. 2, Bn3JIO)I(HTeJ151T MO)I(e .na 3a.Unp)KH 50% OT rapaHUH51Ta 3a H3n'bJIHeHHe no HaCT051lUH51

.uorosop.

(2) I1pH KOHCTaTHpaHe Ha nOSTOpHa 3a6aBa Bn3J10)1(HTeJI51T MO)I(e .[(a 3a.Ubp)I(H 100% OT

rapaHUH51Ta 3a H3nonHeHHe no HacT051UlH51 .uorosop.

(3) B cnyqaH: qe B cpoKa Ha .uorosopa, yqacTHHK'bT .uonycHe .use HeH3nonHeHH51 Ha .npyrH

CBOH 3a.[('bJI)I(eHH51Ta, Bo3JlO)I(HTen51T MO)I(e .ua 3a.U'bp)KH 100% oT rapaHUH51Ta 3a H3nonHeHHe.

(4) HeH3n'bnHeHH51 Ha .uorosopa ce KOHCTaTHpaT s npHeMo-npe.uasaTeJlHHTe npoTOKOJlH 3a

.LJ:OCTaBKa HfHJIH npH npe.U51B51SaHe Ha OT.UeJlHH peKJiaMaUHH, KaKTO H npH ycTaHOSeH ITHCMeH HJIH

M'bJillanHB OTK8.3.

l.J:Jl. 13 (1) I1pH HeToqHO H3n'bJIHeHHe Ha 3a.LJ:bJI)I(eHH51Ta no .LJ:OfOBOpa OT CTpaHa Ha

H3n'bJIHHTeJ151, S'b3J10)1(HTemiT 3arrnarn:a L('bJI)I(HMOTO CJie.U KaTO npHXBaHe CTOHHOCTTa Ha

HeycTOHKHTe no T03H .uorosop

(2) Bn3JIO)I(HTeJI51T y.nosneTBop51sa npeTeHUHHTe CH 3a HeycTOHKH B.Bp. c HeH3nonHeHHe no

T03H .LJ:OfOBOp B CJie.LJ:HH51 pe.u: nnpBO, qpe3 npHXSaiUaHe Ha .LJ:bJI)I(HMH CYMH, npH JIHnCa Ha TaKHBa­

OT rapaHUH51Ta 3a .uo6po H3n'bnHeHHe, a cne.u H3qepnsaHeTo ir - no C'bOTBeTHH51 3aKoHos pe.u.

(3) HaliHCJl51BaHeTo Ha HeycToH:Ka He rrmnasa H3npasHaTa cTpaHa .na npcH o6e3meTeHHe 3a

npenpneHH spe.uH H nponycHaTH norr3H Ha.u pa3Mepa Ha HeycmH:KaTa.

VII. rAPAHU:li513A l13II'hJIHEHME

lJJl. 14 (1) l13II'hJIHl1TEJI51T rapaHTHpa H3n'bJ1HeHHeTO Ha npOH3THqarn:HTe OT

HaCT051UlH51 .UOfOSOp CSOH 3a.[('bJ1)1(eHHSI C rapaHUHSI 3a .U06po H3n'bJ1HeHHe S pa3Mep Ha 4% (qeTHpH

Ha CTO) OT o6maTa CTOHHOCT Ha .LJ:OfOBOpa. fapaHIJ;H51Ta o6e3neqasa TOliHOTO H IT'bJlHO H3n'bJ1HeHHe

3a.[('bJI)I(eHH51Ta Ha li31I'hJIHliTEJUI no HaCTOS!UlH51 .uorosop.

(2) li3II'hJIHliTEJUIT npe.ncTaB51 .LJ:OKYMeHT 3a UJoaoeHa 6 no!l3a Ha B'b3JIO)[(HTEJIH 6e3yC!l06Ha u HeomMeHfleMa 6aHK06a zapaHl,JUfl 3a U3nb!lHeHue Ha HacmoflUJUfl oozoBop B

OCOlleHH51 pa3Mep C BanHL(HOCT, Ha.[(BHUiaBalUa MHHHMYM C 30 .LJ:HH CpOKa Ha .UOfOBOpa.

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(3) rapaHUH.sna no npenxo.rmaTa aJIHHesr ce ocBo6mK.uaBa B 30-.uHeBeH cpoK OT naTaTa Ha

npeKpaTSIBaHe Ha HaCTOSIIUHSillOfOBOp, aKO He Ca HaJIHUe OCHOBaHHSI 3a 3allbp)KaHe Ha rapaHUHSITa.

(4) B'b3JIQJKJITEJUIT HMa npaBO na ce YllOBJieTBOpH OT CTOHHOCTTa Ha rapaHUHSITa

H3USIJIO HJIH OT"'aCTH 3a CBOH B3eMaHHSI KbM JIJII'bJIHJITEJHI, Bb3HHKHaJIH Ha OCHOBaHHe 'ill. 11 H "'JI. 12 OT HaCTOSIIUHSI llOfOBOp.

VIII. HEIIPE,[(BII,[(EHII OliCTOSITEJICTBA

qJI. 15 (1) CTpaHHTe no HaCT051UUJJI norosop He llbJDKaT o6e3IUeTeHHe 3a npenpneHH

BpenH H 3ary6H, B crryqaif qe nocrrenHHTe ca npHtiHHeHH oT HenpeonorrHMa cHrra.

(2) B crryqaif qe CTpaHaTa, KOSITO e cne.usaJio .ua H3IIbJIHH cBoe 3a.UbJI)KeHHe no .uoroBopa, e

6Hrra B 3a6aBa, TSI He MO)Ke .ua ce no3oBaBa Ha HerrpeonorrHMa cHrra.

(3) CTpaHaTa, 3aCerHaTa OT HenpeO,UOJIHMa CHJia, e llJlb)KHa na npe.unpHeMe BCH"'KH

,UeHCTBH.si C rpH)KaTa Ha ll06bp CTOnaHHH, 3a ,Ua HaMaJIH .UO MHHHMYM nOHeCeHHTe Bpe,UH H 3ary6H,

KaKTO H .ua yse.uoMH rrHCMeHo .upyraTa cTpaHa B cpoK 3 ITpH/ .UHH oT HacnnsaHeTo Ha

HerrpeOllOJIHMaTa CHJia.

( 4) IT pH HeyBellOMHBaHe Ce llbJI)KH o6e3IUeTeHHe 3a HaCTbilHJIHTe OT TOBa Bpe.UH.

(5) .IJ:oKaTO Tpae HerrpeOllOJI.HMaTa CHJia, H3IlbJIHeHHeTO Ha 3allbJI)KeHHSITa Ha CBbp3aHHTe C

THX HacpeiUHH 3allbJI)KeHHSI Ce CI1Hpa.

IX. II3MEHEHIIE, IIPEKPAT51BAHE ,[(EHCTBIIETO HA ,[(OrOBOPA.

qJI. 16 (1) CTpaHHTe MOraT ,Ua H3MeH.sJ.T L{OfOBOpa CaMO B CJiy"'a.HTe ITO "'JI. 43, a.JI. 2 H a.JI. 3 OT 30I1.

(2) .IJ:eHCTBHeTO Ha HaCTOSIIUHSI llOfOBOp ce rrpeKpaTSIBa:

1. c H3TH"'aHe Ha yroBopeHH.sJ. cpoK;

2. no B3aHMHO CbrJiaCHe Ha CTpaHHTe, H3pa3eHO B nHCMeHa ¢opMa.

3. npe.ucpO"'HO, B cnyqaHTe, rrpellBHlleHH B 3Qf1 H HaCTOSIIUH.sJ. ,UOfOBOp.

(3) ITp.H B.HHOBHa 3a6asa Ha II3II'hJIHIITEAA, rrpO.UbJI)K.HJia c rroBe"'e oT rronoB.HHaTa oT

cpoKa 3a H3IlbJIHeH.He Ha CbOTBeTHOTO 3allbJI)KeHHe, B'b3JIQJKJITEJI51T HMa rrpaBO na npeKpaTH

.uoroBopa e.uHocTpaHHO 6e3 rrpe.U.H3BeCTHe.

(4) B'b3JIOJKIITEJI51T HMa rrpaso .ua rrpeKpaTH e.uHocTpaHHO 6e3 rrpe.UH3BeCTHe

HaCTOSIIUHSlllOfOBOp:

1. B cnyqaif Ha HeTO"'HO H3IlbJIHeHHe HJIH npellSIBeHH peKJiaMaUHH noBe"'e OT llBa nbTH IlO

BpeMe Ha cpoKa Ha .uorosopa 3a e.uHa H coma o6oco6eHa no3HU.H.sJ., .HJIH 3a6aBa B cpoKoBeTe 3a

,UOCTaBKa OT CTpaHa Ha JI311'bJIHJITEJUI, 6e3 3Ha"'eHHe OT o6oco6eHaTa II03HUHSI HJI.H

KOHKpeTH.HTe rrpO.UYKTH;

2. Koram JI311'bJIHJITEJI51T H3IIOJI3Ba IIO.UH3IlbJIHHTeJI, 6e3 .ua e ,UeKJiapHpaJI TOBa B

o¢epTaTa CH, HJIH H3IIOJI3Ba IIO.UH3nbJIHHTeJI, KOHTO e pa3JIH"'eH OT T03H, IIOCOlfeH B o¢epTaTa My;

3. KOraTO JI3II'bJIHJITEJUIT 6nlle o6srBeH B HeCbCTOSlTeJIHOCT HJIH KoraTO e B

npOH3BOllCTBO no HeCbCTOSITeJIHOCT HJIH JlHKBHllaUHSI;

4. He OTCTpaH.H B Pa3YMeH CpOK, onpe.uerreH OT Bb3JIO)KHTeJISI, KOHCTanrpaHH He,UOCTaThUH;

5. KOraTO Ca HaCTinHJIH CbiUeCTBeHH npOMeHH BbB ¢HHaHCHpaHeTO Ha 06IUeCTBeHaTa

rropb"'Ka - rrpe.uMeT Ha .uoroBopa, H3BbH rrpaBOMOIUH51Ta Ha B'b3JIQJKJITEJI51, KOHTO TOH He e

MOIDJI HJIH He e 6HJI llJlb)KeH .Ua rrpe.UBHllH HJIH .ua npe.UOTBpaTH - C nHCMeHO yBellOMJieHHe OT

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Bb3JIOJKIITEJUI cne.u HacnnsaHe Ha o6cTOSITencTBaTa;

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(5) B cn~a:H 'fe rro OTHorneHHe Ha II3TibJIHIITEJIH HacTbmiT o6cTO~ITencTBaTa rro 'in.

4 7, an. 1 HIHnH an. 5 HI HnH noco'-l:eHHTe B o6~mneHHeTo H .ueKnapHpaHHTe B o<PepTaTa

o6CTOS!TenCTBa no an. 2 OT 3aKOHa 3a o6mecTBeHHTe IIOpb'-IKH, Bb3JIQJKIITEJUIT HMa npaBO .ua

npeKpaTH HaCTOSimHS! .UOfOBOp e,UHOCTpaHHO 6e3 rrpe.UH3BeCTHe H 6e3 .ua .Ubn:>KH HeyCTOHKH.

(6) Bb3JIOJKIITEJUIT HMa npaso .ua npeKpaTH e.uHocTpaHHO c 30-.uHeBHO npe.UH3BeCTHe

HaCTOSimHSI .UOfOBOp 6e3 .Ubn:>KHMH HeyCTOHKH H o6e3meTeHIDI H 6e3 He06XO.UHMOCT OT

.UOnbnHHTenHa o60CHOBKa. TipeKpaTSIBaHeTO CTaBa cne.u ype)l()l:aHe Ha <PimaHCOBHTe

B3aHMOOTHOllleHH5I Me)l()l:y CTpaHHTe 3a H3BbpllleHHTe OT CTpaHa Ha H3nbnHHTen5I H O.U06peHH OT

Bb3nO:>KHTemi .ueH:HOCTH no .uorosopa.

X. CbOli~EHIIH

qJI. 17. (1) BCH'-IKH Cb06meHHS! H yBe.UOMneHHS! Me:>KllY CTpaHHTe no T03H llOfOBOp me

6b.UaT B nHCMeHa <PopMa 3a ,UeHCTBHTenHOCT. TIHCMeHaTa <PopMa ce CM5ITa 3a Cna3eHa H KOfaTO

Cbo6meHHeTO e H3npaTeHO ITO cpaKC H/HnH eneKTpOHHa noma HnH llpyr, H3pH'1HO llOfOBOpeH Me:>KllY

CTpaHHTe Ha'-IHH 3a rrony'faBaHe. BCS!Ka nHCMeHa KOMYHHKa:I.J;HS!, OTHaCS!ma Ce .UO T03H .UOfOBOp

Me)l()l:y Bb3JIOJKIITEJUI H II311bJIHIITEJUI, TpSI6Ba .ua Cbllbp:>Ka 3arJiaBHeTo HIHnH

H.UeHTH<i>HKaUHOHHH5I HOMep Ha .UOfOBOpa H .ua 6blle H3IIpaTeHa Ha IIOCOT.IeHHTe B T03H llOfOBOp

a.upeCH 3a KOHTaKTH.

(2) 3a .uam Ha cbo6meHHeTo ce CMSITa:

a) .uaTaTa Ha rrpe.uasaHeTo- rrpH pb'-IHO npe.uasaHe Ha c'ho6meHHeTo;

6) .uaTaTa Ha rromeHcKoTo KJieH:Mo Ha o6paTHaTa pa3rrHCKa - rrpH H3rrpamaHe rro rromaTa;

B) .uaTaTa Ha rrpHeMaHeTO- rrpH H3rrpamaHe rro Tene<PaKc;

r) .UaTaTa H 'faCbT Ha CHCTeMHOTO Cbo6meHHe 3a IIOn~aBaHe HnH o6paTeH e-mail 3a

noTBop)K,UaBaHe- npH H3npamaHe no eneKTpOHHa noma.

qJI. 18. (1) 3a H3IIbnHeHHeTO Ha T03H llOfOBOp CTpaHHTe onpe.uemiT nHUa H a.upeCH 3a

KOHTaKTH, KaKTO cne.usa:

• 3a Bb3JIOJKIITEJIH:rp. Co<Pmi 1233, 6yn . "CToneToB" NQ 67,

Ten.: 02/ 8013948

<PaKc: 02/ 8321156 nHue 3a KOHTaKT: BacHnKa ApaHrenosa

• 3a II3llbJIHIITEJUI: A.upec: rp. CocpHSI, rr.K.1839, M-CT ,5Irra.u)Ka NQ 6 flHue 3a KOHTaKT, oTrosopHo 3a H3II'hnHeHHeTo Ha .uorosopa: flHnH PH.u)KanCKa

Ten: 02/9421736

<l>aKc:02/9421717

En. noma: Lridjalska@ pharmnet.bg

(2) TipH npOM5IHa Ha IIOCO'feHHTe B an. 1 .UaHHH Cl:.OTBeTHaTa CTpaHa e lln'h)KHa .ua yBellOMH

IIHCMeHO .upyraTa B ce.ueM.UHeBeH CpOK OT HaCTbiiBaHe Ha npOM5IHaTa. AKO H5IK05I OT CTpaHHTe

rrpoMeHH rroco'feHHTe B rrpe.uxo.uHaTa TOT.IKa a.upecH H .up. , 6e3 .ua yse.uoMH .upyraTa cTpaHa,

HerronyT.IeHHTe cl:.o6meHH5I, yse.uoMneHH5I H .upym rro.uo6HH, H3rrpaTeHH Ha rrocoT.IeHH5I a.upec, ce

C'-IHTaT 3a Bpb'-IeHH Ha CTpaHaTa, Ha .UaTaTa Ha llOCTaB5IHeTO HM Ha a.upeca.

CTp.9 OT JQ

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XI. OEUJ;H PA3llOPEj];EH

qJI. 19. 3a Heype.uemne B HaCTOjiW,J1jl .uorosop sorrpoc11 ce rrp11naraT pa:mope.u611Te Ha

.ueikTBaW,oTo 3aKOHO.UaTencTBO Ha Perry6n11Ka .5onrap11j{.

qJI. 20 (1) Bo3HI1KHaJII1 HeHCHOTI1 11 rrpoTHBopetii1H no 113II'hJIHeHHeTo ua HaCTOHW.11H

.uorosop ce pewasaT c rrperosop11 Me)K.llY cTpaHI1Te 11 .uorroJIHI1TeJIHI1 rr11cMeu11 crropa3YMeH11H K'hM

.uorosopa.

(2) CTpaHI1Te no uacTOSillli1SI .uorosop me pewasaT crroposeTe, B'h3HI1KHaJII1 rrp11 11 no rroso.u

113Il'bJIHeHI1eTO Ha ,llOfOBOpa 11JII1 CBop3aHI1 C ,llOfOBOpa, C HerOBOTO T'bJIKyBaHe, He,lleHCTBI1TeJIHOCT,

Hel13n'bJIHemie HJII1 npeKpanmaHe no B3aHMHO C'brJiaCI1e H C nHCMeHH cnOpa3YMeHIUI, a npl:l

HeiiOCTI1raHe Ha Comac11e BoiipOC'bT Ce OTHaCH 3a peruaBaHe rrpe,ll KOMIIeTeHTHI1H C'b)l no

ce,llaJII1llleTO Ha B'b3JIOJKHTEJUI. Ha Tep11TOp11HTa Ha Perry6n11Ka .5onrap11H, no pe.ua Ha

fpa)K.uaHcKI1H npouecyaneH KO.UeKc.

HacTOHW.11HT .uorosop ce C'hCTaBI1 11 rro.urr11ca s .usa e.uHoo6pa3HI1 eK3eMnnHpa Ha 6onrapcKI1 e3HK -

ITO e)lHH 3a BCHKa OT CTpaHHTe.

fipHJIOJKeHHSI:

1. TexHHtiecKa cneumlmKaUI1SI Ha B'b3JIOJKHTEJUI.; 2. TexHI1tiecKo rrpe.uno)KeHI1e Ha H3ll'bJIHHTEJUI.; 3 .IJ;eHOBO npe.UJIO)KeHI:Ie Ha H3II'bJIHHTEJUI.; 4. ,lJ;oKyMeHTI1 ITO l!JI. 47, aJI. 10 OT 30f1;

5. fapaHU11H 3a 113II'bJIHeHI1e Ha ,llOfOBOpa;

6. 06o6meHa non'hJIHeHa err 11(pHKaU11H.

YllPABHTEJI , ~

/.u-p j];uaua Hop.uauooa/

rJI. cqETOBO.lJ:HTEJI

/JlHJIHSI .lJ:HKOBa/

H3II'bJIHHTEJI:

ll'bJIHOMO

!llJiaMeu TpU(l>OHOB XpncToB/

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Pe4>epetm<3 rlpOI"HOlHO npeAflan.Ha ~eHa .1a 3a Cl.OT11e'Ttfi1Ta

NIIHa neapCTBeHa cf>opMa palcf>,aCOBKa, Cl.OTBeTH3Ta ~Apoc AtiaTOMO- CTOMHOCTU tCOnM'teCTBO fo15oco6eH TepaneeTMoteH

MeJKAyttapoAHO ttenaTeKTHO /noco'tet4.ra oT MApKa DOD/ lcl:.O'IacNO Tl.proacKo HaMMeHo&aHMe

KonM'feCTBO MIMnM ISpoM npoMlBOAMTen/ 0ropMJ.al4MR: IJA.I MApK.a6e3MC AAC(Ao

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Keytruda 50 mg powder for concentrate pow~er for concentrate for EN II 9BU, 06en1ntetto 60 L01 XC18 Pembrolizumab 50 mg. napeHTepanHa q>op!-4a mg 84,027BC --- -~OQC for solution for infusion x l _o_!_utit:>n for infusion x1 oq>anCTIIO Aa 70,023 1>4,0276

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06oco6eHa no3HD;HH .N2 60-Pembrolizumab 50 mg. ,<I>apMHeT"A)l [HaUMeHoemwe HayttacmHuKa],c EYJICTAT/EHKIHoMep Ha pemcTp~IDI B CbOTBeTHaTa .Ubp)l(aBa BG202513217 I 202513217 pemcrpHpaHo B ToproBCKHX perHcTDp Ha AreHI.{lUl no BnHCBaHHXTa, C ,ZJ;aHHH no perHCTpa~HXTa:EHK 202513217, perHCTpaUHX no )l)lC:BG202513217, C'bC ce.n;rum:m:e rp.BapHa H a.n;pec Ha yrrpaBrreHHe rp.BapHa,9020,)1(.K.Mrra.n;ocT,6yn.Peny6nHKa-crpa.n;a Ha MQ Mna.uocT ,a.upec 3a KOpecnOH.lleHI.{HH:rp.CocpHH, 1839,M-CT ,,..5Ina,U)I(a ,6 ,TerrecpOH 3a KOHTaKT 029421736 , cpaKC 02 942 17 17, eneKTpoHHa noma [email protected] ,6aHKOBa cMeTKa: BG48STSA93000019065449 ,npe.ucTaBJIHBaHO OT ITnaMeH TpHcpOHOB XpHCTOB [mpume UMeHa] B Ka'ieCTBOTO Ha ITbJIHOMOIIJ;HHK Ha l13n'bJIHHTenHHX ,UHpeKTOp [Ollb.:JICHOCm, UJZU opyzo K.attecmeo]

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3a KOHTO yqaCTBaMe, B CpOK .UO:

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Bo3nO)I(HTemr perymrpHHTe .nocTaBKH me H3BLpmBaMe no yroBopeH rpacpHK.

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