Post on 08-Aug-2020
transcript
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IIl7) 06~a CTOHHOCT Ha o6~ecTBeHaTa nopbIKa (6e3 tJa ce BKJIIOlBa MC) CTOHHOCT 4331 7 9 (MoM 110COleme 06114ama cmoihLOC111 lia 06114ecmaeliama 110polKa 3a UIi(jjopMaijWl omlioclio W1ouaUOYaJlliU 110POlKU MOM U3110Jl3aaiime pa30eJI V) llJIll Harr-HHCKa oltpepTa HaM-BllCOKa oltpepTa
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II21) HaHMeHOBaHHe 2
Heparir1 06oco6eHa I1031iIlIiH NQ 1 2
II22) J]onbJIHHTerIHH CPV KOtJOBe 2
OCHOBeH CPV KOIl 1 33692800 llOIIbJIHIiTeJIeH CPV KOIl 1 2
II23) MHCTO Ha H3nbJIHeHHe
OCHOBHO MHCTO Ha 113IIbJIHeHlle
60J1HYlQHa aJ1TeKa Ha YMBAfl Byprac AIJ
KOIl NUTS 1 BG341
II24) OnHcaHHe Ha 06~eCTBeHaTa nOpblKa (eCTeCTBO M KOJIllleCTBO Ha CTpOllTeJIHll pa60Tll pOCTaBKll llJIll yCJIyrll llJIll YKa3BaHe Ha I1oTpe6HOCTll II
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II2U) IIHq0PMauHH OTHOCHO OnDHHTe
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II2l3) IIHqOPMauHH OTHOCHO cpetJCTBa OT EBponeHcKHH CbI03
06~eCTBeHaTa IIOphlKa e BbB Bpb3Ka C npoeKT HllJIli IIporpaMa ltpHHaHcllpaHa CbC J]a 0 Hel8l cpepCTBa OT EBponeMcKllH Cb103
MpeHTHltpHKalllH Ha npoeKTa
PA3lJEJI II OnHcaHHe 06oco6eHa n03HIJHH
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1121) HaHMeHoBaHHe 2 I
Saccharateci Iron Oxid
060c06eHa II03HIJHH NQ 2 I2
1122) llonbJIHHTeJIHH CPV KOllOBe 2 I
IOCHOBeH CPV KOll 1 33692800 i
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1123) MuCTo Ha HanbJIHeHHe i
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2 0D KpHTepydi 3a KaleCTBO - HMe Te)KeCT 1 2
D KpHTepHH CBbp3aH C pa3XOllH HMe Te)KeCT 1 2 0
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II214) llonbJIHHTeJIHa HH4gt0pMaUHu
PA3)lElI II OnHCaHHe I 06oco6eHa II03HIJHH
112) OnHcaHHe 1
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Iron ( II) - ide dextran compex
060c06eHa n03HllHH NQ 3 2
II22) llonbJIHHTeJIHH CPV KOllOBe 2
OCHOBeH CPV KOP 1 3369280
lloIlbJIHHTeneH CPV KOP 1 2
II23) MucTO Ha H3nbJIHeHHe OCHOBHO MRCTO Ha H3llhJIHeHHe 60nHMYHa aI1TeKa Ha YMBAJ1 Byprac AU
KOP NUTS 1 BG341
1124) OnHcaHHe Ha ooweCTBeHaTa nOphlKa (ecTeCTBo H KOnl1eCTBO Ha crPOHTeuroJIHH pa6oTH llOCTaBKH HJ1H yCJ1yrH HJ1H YKa3BaHe Ha IIoTpe6HoCTH H H3HcKBaHHR) B03XAOIEpoetin a fa so bull
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OnHcaHHe Ha OIlUHHTe 11a 0 He 181 i
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11213) HHcpopMauHH OTHOCHO cpetJcTBa OT EBponeiicKHH Cb103
06meCTBeHaTa IlOphlKa e BhB Bpb3Ka C IlpoeKT HHJIH nporpaMa ltpHHaHCHpaHa ChC cpetCTlla OT EllpOIleMCKHH Ch103
MteHTI1ltpHKaUHR Ha npoeKTa
11a 0 Hel8l
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PA3ZJEJI II OnHcaHHe 06oco6eHa n03HuIUI
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KOA NlITS 1 BG341 J II24) OnHcaHHe Ha 06meCTBeHaTa IIOpblKa
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H3I1CKllaHHR)
B03XAOIEpoetin alfasoltn]930001000IJ837967
II25) KpHTepHH 3a Bb3JIaraHe 1 2 o KpHTepHM 3a KaQeCTBO liMe Te)KeCT 1 2 20
o KpHTepHM CBbp3aH C pa3xOtH - liMe Te)KeCT 1 2deg
~ UeHa - Te)KeCT 21
11211) HHCPOPMaIJHH OTHOCHO OIIlJHHTe
OmHH 11a 0 Hel8l
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II213) HHcpopMaIQIH OTHOCHO cpetJCTBa OT EBpOIIeiicKHH Cb103
06meCTBeHaTa rrOpbQKa e BhB Bph3Ka C rrpoeKT HHJ1H rrpOrpalVIa QmHaHCHpaHa ChC llaD Hel8l cpeACTBa OT EBponeiicKHR Ch103
lIAeHTHQgtHKalUR Ha rrpoeKTa
II214) llOIIbJIHHTeJIHa HHcpopMalJHH
PA3ZJEJI II OnHCaHHe 06oco6eHa n03HuHJl
112) OIIHcaHHe 1
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tin beta 06oco6eHa rr03HlHH NQ 5
1122) llOIIyenHHTeJIHH CPV KOtJOBe 2
OCHoBeHCPYKOt 1 33692800
YHn 111103302-058-42cc-9484-e iaedOfae6e4
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OliJlBJIEHHE 3A Bmiddoth3rtOJ(EHA nOPblKA (BCPC 7)
llOI1hJIHHTeJIeH CPV KO~ 1 2
II23) MHCTO Ha H3IIbJIHeHHe
OCHOBHO MJlCTO Ha H3nbJIHeHHe
60nHMQHa anTeKa Ha Y~BAn KO~ NUTSl BG341
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H3HCKBaHHJI)
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II25) KpHTepHH 3a Bh31IaraHe 1 2
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0o KpHTepHH CBbp3aH C pa3XO~H - lIMe I Te)J(eCT 1 2
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11211) IIHcpopMa~H OTHOCHO on~HTe I On~HH Qa 0 Hejgl OnHcaHHe Ha on~HHTe I
11213) IIHcpopMa~HH OTHOCHO cpe)JCTBa OT EBponeHCKHH Ch103
06rueCTBeHaTa nOphlKa e BhB Bph3Ka C npoeKT HHJIH nporpaMa ltlgtHHaHcHpaHa ChC
cpeACTBa OT EBponeikKHJI CDJ03
lI~eHTHltIgtHKalJHR Ha npOeKTa
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1122) QonbJIHHTeJIHH CPV KO)JOBe 2
OCHOBeH CPV KO~ 1 3369 8 0 lloflbJIHHTeJIeH CPV KO~ 1 2
II23) MHCTO Ha H3nbJIHeHHe
OCHOBHO MHCTO Ha H3nbJIHeHHe
6onEW~Ea dOTeKa Ea YMBAn KO[l NUTS 1 BG341
II24) OnucaHue Ha 06meCTBeHaTa nOphlKa
(ecTecTBo H KOJIHleCTBO Ha CTPOHTeJIHH pa60TH AOCTaBKH HJlH yCJlyrH HJIH YKa3BaHe Ha nOTpe6HocTH H
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cpeACTBa OT EBporreHCKHH CbJ03
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Methoxy yet ene gl -epoetin beta 060co6eHa Il03lUJllJI NQ 8 2
II22) l1onbJIHHTeJIHH CPV KOAoBe 2
OCHoseH CPV KOp 1 3 692800 UOIlbJIHllTeJ1eH CPV KOp 1 2
II23) MHCTO Ha H3nbJIHeHHe OCHOSHO MHCTO Ha 113nbJIHenlle
6onH~~Ha anTeKa Ha YMBATI KOll NUTS BG341
1124) OnHCaHHe Ha 06weCTBeHaTa nOpblKa (ecTecTBo II KOJIllteCTBO Ha CTPOllTeJ1Hll pa60Tll llOCTaSKllllJlll yCJlyrll llJ111 YKa3saHe na nOTpe6HocTli H
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o KpHTepHH CSbp3aH C pa3XOLlH - liMe Te)KeCT 1 2deg
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II2H) HH(I)OpMa~H OTHOCHO onnHHTe Omllll l1a 0 He ~ OIIllcaHlie Ha OIlUHHTe
IIa13) HH(pOpManHH OTHOCHO cpeACTBa OT EBponeHcKHH Cb103 06ll1eCTBeHaTa nOpblKa e BbB Bpb3Ka C npoeKT 1lllJ111 nporpaMa ltpllHaHclipaHa CbC l1a 0 He ~ CpellCTBa 01 EBpoilellcKHH Ch103
lIlleHTfIltpllKaUIiH Ha npoeKTa
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PA3LlEJI II OnHcaHHC OOOCOOCHa n03HIlHJI
II a) OnHcaHHe 1
1121) HaHMeHoBaHHe 2
Cina leet 06oco6eHa 1l03HUHH NQ 9 2
IIaa) l1onbJIHHTeJIHH CPV KOAOBe 2
OCHOBen CPV KOll 1 33692800 UollbJlHllTeJIeH CPV KOll 1 2
II23) MJlCTO Ha HSnbJIHeHHe OCHOBHO MHCTO Ha 113IlbJlHeHlle
6onHwIHa ailTeKa Ha YMBAJ] Af( ROll NUTS BG341
1124) OnHcaHHe Ha o6weCTBeHaTa nOpblKa (eCTeCTso H KOJlHqecrso Ha CTPOllTeJ1HH pa60TH lIOCTaBKH llJ111 yCJlyrH llJ1H YKa3BaHe Ha nOTpe6HoCTH II
H311cKBaHllH)
HC5BXOlCinaealeettablets760060mg1536786
1125) KpHTe~HH 3a Bb3J1araHe 1 2 J
YIfl tb203b2~Oa58-42tc~)484~e7aedotae6e4
OnRBlEHI1E 3A Bb3JIOlKEHA nOPblKA (BepCIH 7gt
o KpHTepHH 3a KaIeCTBO - lIMe TeiKeCT 1 2 2deg
o KpIITepIIH CB1gtp3aH C pa3XOll1I - lIMe TeiKeCT 1 2deg
UeHa - TeiKeCT 21
II2U) IIHq0pMauHH OTHOCHO onuHHTe
OIIl1I1I lIaO Helgj
OIII1CaHIIe Ha OI1lHIITe
11213) IIHq0pMauHH OTHOCHO CpelJCTBa OT EBpOnenCKHH Cb103
06~eCTBeHaTa nOp1gt4Ka e B1gtB Bp1gt3Ka C npOeKT IIIIJIII npOrpaMa qHtHaHCHpaHa CDC
CpepCTBa OT EBpOneHCKIIH CDI03
lIlleHTHltpIIKaI~IIH Ha npOeKTa
lIaO He~
11214) lIonbJIHHTeJIHa HHq0PMaUHH
PA3llEJI II OnHCaHHe 06oco6eHa n03HIJHJI
II2) OnHCaHHe 1
1121) HaHMeHOBaHHe 2
Parica cito1 060c06eHa fl03HlHH NQ 10 2
II22) lIonbJIHHTeJIHH CPV KOlJOBe 2
OCHOBeH CPV KOll 1 33692800 UonDJIHI1TeJIeH CPV KOll 1 2 I
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1123) MHCTO Ha H3nbJIHeHHe I
iOCHOBHO MHC(Q Ha H3fl1gtJIHeHIIe I
OOjlEV1Lf-la aI1TeKa Ha ytvlBATI AU I
KOll NUTS 1 BG341
II24) OnHCaHHe Ha OOllJeCTBeHaTa nOpblKa
(eCTeCTBO H KOJIHIeCTBO Ha CTPOHTeJIHH pa60TII llOCTaBIltH IDIH yCJIyrH IDIII YKa3BaHe Ha nOTpe6HOCTII II
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II25) KpHTepHH 3a Bb3JIaraHe 1 2 o KpHTepHH 3a Ka4eCTBO liMe TeiKeCT 1 2 2deg
o KpHTepIIH CB1gtp3aH C pa3XOllH - liMe TeiKeCT 1 2deg
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II2U) IIHq0pMauHH OTHOCHO onuHHTe
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II213) IIHq0pMauHH OTHOCHO CpelJCTBa OT EBponenCKHH Cb103
06~eCTBeHaTa nOpDlKa e B1gtB BpD3Ka C npoeKT IIIDIH nporpata ltpHHaHCHpaHa CDC lIaD He~ cpepCTBa 01 EBponeHCKllH CDI03
lipeHTHltpHKaliHH Ha npoeKTa
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PA3llEJI II OnHcaHHe 06oco6eHa II03HIJHJI
II2) OnHcauHe 1
1121) HaHMeHOBaHHe 2
Parica ci tol 06oc06eHa n03HlIIIH NQ 11
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L(onbIJHHTeJJeH CPV KOl 1 2
1123) MHCTO Ha H311hIIHeHHe
OCHOBHO MHCTO Ha 113nbIJHeHHe
OOJIHY1tJHa dflTeKa Ha YMBAll
KOA NUTS 1 BG 41
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(eCTeCTBO H KOnllleCTBO Ha CTpoHTenHH pa6oTH JlOCTaBKH MH ycnyrH MH YKa3BaHe Ha nOTpe6HOcTli H
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II23) MHCTO Ha H3nbJIHeHHe
OCHOBHO MHCTO Ha 113IIbJIHeHlle
60J1HYlQHa aJ1TeKa Ha YMBAfl Byprac AIJ
KOIl NUTS 1 BG341
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II2U) IIHq0PMauHH OTHOCHO OnDHHTe
Onlllll J]a 0 Hel8l OI1HcaHlle Ha OnlllllTe
II2l3) IIHqOPMauHH OTHOCHO cpetJCTBa OT EBponeHcKHH CbI03
06~eCTBeHaTa IIOphlKa e BbB Bpb3Ka C npoeKT HllJIli IIporpaMa ltpHHaHcllpaHa CbC J]a 0 Hel8l cpepCTBa OT EBponeMcKllH Cb103
MpeHTHltpHKalllH Ha npoeKTa
PA3lJEJI II OnHcaHHe 06oco6eHa n03HIJHH
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Saccharateci Iron Oxid
060c06eHa II03HIJHH NQ 2 I2
1122) llonbJIHHTeJIHH CPV KOllOBe 2 I
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II214) llonbJIHHTeJIHa HH4gt0pMaUHu
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Iron ( II) - ide dextran compex
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lIAeHTHQgtHKalUR Ha rrpoeKTa
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PA3ZJEJI II OnHCaHHe 06oco6eHa n03HuHJl
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YHn 111103302-058-42cc-9484-e iaedOfae6e4
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llOI1hJIHHTeJIeH CPV KO~ 1 2
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II23) MHCTO Ha H3nbJIHeHHe
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II24) OnucaHue Ha 06meCTBeHaTa nOphlKa
(ecTecTBo H KOJIHleCTBO Ha CTPOHTeJIHH pa60TH AOCTaBKH HJlH yCJlyrH HJIH YKa3BaHe Ha nOTpe6HocTH H
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06rueCTBeHaTa rrOphlKa e BhB Bph3Ka C npoeKT HHJIH I1pOrpaMa ltlgtHHaHcHpaHa CDC Qa 0 Hejgl
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OCHoseH CPV KOp 1 3 692800 UOIlbJIHllTeJ1eH CPV KOp 1 2
II23) MHCTO Ha H3nbJIHeHHe OCHOSHO MHCTO Ha 113nbJIHenlle
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1124) OnHCaHHe Ha 06weCTBeHaTa nOpblKa (ecTecTBo II KOJIllteCTBO Ha CTPOllTeJ1Hll pa60Tll llOCTaSKllllJlll yCJlyrll llJ111 YKa3saHe na nOTpe6HocTli H
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IIaa) l1onbJIHHTeJIHH CPV KOAOBe 2
OCHOBen CPV KOll 1 33692800 UollbJlHllTeJIeH CPV KOll 1 2
II23) MJlCTO Ha HSnbJIHeHHe OCHOBHO MHCTO Ha 113IlbJlHeHlle
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1124) OnHcaHHe Ha o6weCTBeHaTa nOpblKa (eCTeCTso H KOJlHqecrso Ha CTPOllTeJ1HH pa60TH lIOCTaBKH llJ111 yCJlyrH llJ1H YKa3BaHe Ha nOTpe6HoCTH II
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II2U) IIHq0pMauHH OTHOCHO onuHHTe
OIIl1I1I lIaO Helgj
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06~eCTBeHaTa nOp1gt4Ka e B1gtB Bp1gt3Ka C npOeKT IIIIJIII npOrpaMa qHtHaHCHpaHa CDC
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1125) KpHTepHH 3a Bh3JlaraHe 1 2
YHn tb2033b2-0a58-42cc-Q484-e7aedOfae6e4
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napTlLl3 OliBlEHHE 3A Bb310lKEHA nOPb4KA leepc 7)
I ~ KpHTepHM CBhp3aH C pa3XOtH - liMe Te)KeCT 1 2deg
UeHa - Te)KecT 21
11211) HHCpopMaIQIH OTHOCHO onuHHTe
OIlUHH
OnHcaHHe Ha OIlUHHTe 11a 0 He 181 i
i
11213) HHcpopMauHH OTHOCHO cpetJcTBa OT EBponeiicKHH Cb103
06meCTBeHaTa IlOphlKa e BhB Bpb3Ka C IlpoeKT HHJIH nporpaMa ltpHHaHCHpaHa ChC cpetCTlla OT EllpOIleMCKHH Ch103
MteHTI1ltpHKaUHR Ha npoeKTa
11a 0 Hel8l
11214) 110IIbJIHHTeJIHa HHCPOpl1aIJHH
PA3ZJEJI II OnHcaHHe 06oco6eHa n03HuIUI
112) OIIHcaHHe 1
I
I
1121) HaHMeHOBaHHe 2
Epoetin a fa 06oco6eHa rr03HUIDI NQ 4 2
1122) 110IIbJIHHTeJIHH CPV KOtJOBe 2
OCHOBeH CPV KOA 1 33692 00 IlOIlbJIHlfTeIeH CPV KOt 1 2 I 1123) MHCTO Ha H3IIbJIHeHHe
iOCHOBHO MRCTO Ha H3IlbJIHeHHe
fjcIHYIIHa dflTeKa Ha YJV15AJl
KOA NlITS 1 BG341 J II24) OnHcaHHe Ha 06meCTBeHaTa IIOpblKa
(eCTeCTBO H KOJ1I1QeCTllO Ha CTpOHTeJ1HH pa60TH AOCTaBKH MH yCllyrH MH YKa3BaHe Ha rroTpe6HOCTH H
H3I1CKllaHHR)
B03XAOIEpoetin alfasoltn]930001000IJ837967
II25) KpHTepHH 3a Bb3JIaraHe 1 2 o KpHTepHM 3a KaQeCTBO liMe Te)KeCT 1 2 20
o KpHTepHM CBbp3aH C pa3xOtH - liMe Te)KeCT 1 2deg
~ UeHa - Te)KeCT 21
11211) HHCPOPMaIJHH OTHOCHO OIIlJHHTe
OmHH 11a 0 Hel8l
OrrHcaHHe Ha OnlHHTe
II213) HHcpopMaIQIH OTHOCHO cpetJCTBa OT EBpOIIeiicKHH Cb103
06meCTBeHaTa rrOpbQKa e BhB Bph3Ka C rrpoeKT HHJ1H rrpOrpalVIa QmHaHCHpaHa ChC llaD Hel8l cpeACTBa OT EBponeiicKHR Ch103
lIAeHTHQgtHKalUR Ha rrpoeKTa
II214) llOIIbJIHHTeJIHa HHcpopMalJHH
PA3ZJEJI II OnHCaHHe 06oco6eHa n03HuHJl
112) OIIHcaHHe 1
1121) HaHMeHOBaHHe 2
tin beta 06oco6eHa rr03HlHH NQ 5
1122) llOIIyenHHTeJIHH CPV KOtJOBe 2
OCHoBeHCPYKOt 1 33692800
YHn 111103302-058-42cc-9484-e iaedOfae6e4
2
OliJlBJIEHHE 3A Bmiddoth3rtOJ(EHA nOPblKA (BCPC 7)
llOI1hJIHHTeJIeH CPV KO~ 1 2
II23) MHCTO Ha H3IIbJIHeHHe
OCHOBHO MJlCTO Ha H3nbJIHeHHe
60nHMQHa anTeKa Ha Y~BAn KO~ NUTSl BG341
AD
II24) OnHCaHHe Ha 06meCTBeHaTa nOphlKa
(eCTeCTBO H KOJIHleCTBO Ha CTPOHTeJIHH pa60TH ~OCTaBKH HJIH yCJlyrH HJlH YKa3BaHe Ha nOTpe6HOCTH H
H3HCKBaHHJI)
B03XAOIEpoetin betasolinj14600l000IU837967
II25) KpHTepHH 3a Bh31IaraHe 1 2
o KpHTepHH 3a KaleCTBO shy lIMe I Te)J(eCT 1 2 20
0o KpHTepHH CBbp3aH C pa3XO~H - lIMe I Te)J(eCT 1 2
~ QeHa - Te)J(eCT 21
11211) IIHcpopMa~H OTHOCHO on~HTe I On~HH Qa 0 Hejgl OnHcaHHe Ha on~HHTe I
11213) IIHcpopMa~HH OTHOCHO cpe)JCTBa OT EBponeHCKHH Ch103
06rueCTBeHaTa nOphlKa e BhB Bph3Ka C npoeKT HHJIH nporpaMa ltlgtHHaHcHpaHa ChC
cpeACTBa OT EBponeikKHJI CDJ03
lI~eHTHltIgtHKalJHR Ha npOeKTa
Qa 0 Hejgl
II214) QonbJIHHTeJIHa HHcpopMa~
PA3lJEJI II OnHcaHHe OoocooeHa n03HIJHH 112) OnHcaHHe 1
II21) HaHMeHOBaHHe 2
in alfa 06oc06eHa n03HUHR NQ 7 2
1122) QonbJIHHTeJIHH CPV KO)JOBe 2
OCHOBeH CPV KO~ 1 3369 8 0 lloflbJIHHTeJIeH CPV KO~ 1 2
II23) MHCTO Ha H3nbJIHeHHe
OCHOBHO MHCTO Ha H3nbJIHeHHe
6onEW~Ea dOTeKa Ea YMBAn KO[l NUTS 1 BG341
II24) OnucaHue Ha 06meCTBeHaTa nOphlKa
(ecTecTBo H KOJIHleCTBO Ha CTPOHTeJIHH pa60TH AOCTaBKH HJlH yCJlyrH HJIH YKa3BaHe Ha nOTpe6HocTH H
H3HcKBaHHH) I B03XA02Da tin alfasolution for ection pre-filled nge 4400 I
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II25) KpHTepHH 3a Bh31IaraHe 1 2
o KpHTepHH3a KaleCTBO - HMe I Te)J(ecT 1 2 20
0o KpHTepHH CBhp3aH C pa3Xo[lH - HMe I Te)J(eCT 1 2
~ QeHa - Te)J(ecT 21
11211) IIH4gtOPM~ OTHOCHO on~e Orr~HH Qa 0 Hejgl
OrrHcaHHe Ha orr~HHTe
II213) IIHcpopMa~ OTHOCHO cpe)JCTBa OT EBponeHCKHH Cb103
06rueCTBeHaTa rrOphlKa e BhB Bph3Ka C npoeKT HHJIH I1pOrpaMa ltlgtHHaHcHpaHa CDC Qa 0 Hejgl
cpeACTBa OT EBporreHCKHH CbJ03
H~eHTHltIgtHKa~HI Ha npoeKTa
j
YllJl tb2033b~-Oa58M42cc-948~-e7aedmae6c4
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llapTIlCla ObRBlEHI1E 3A Bb3iIOl(IHA 1I0PbliKA ltpn 7)
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P A3LlEJI II OnHcaHHC OOOCOOCHa n03HIlHJI
112) OnHcaHHe 1
1121) HaHMeHoBaHHe 2
Methoxy yet ene gl -epoetin beta 060co6eHa Il03lUJllJI NQ 8 2
II22) l1onbJIHHTeJIHH CPV KOAoBe 2
OCHoseH CPV KOp 1 3 692800 UOIlbJIHllTeJ1eH CPV KOp 1 2
II23) MHCTO Ha H3nbJIHeHHe OCHOSHO MHCTO Ha 113nbJIHenlle
6onH~~Ha anTeKa Ha YMBATI KOll NUTS BG341
1124) OnHCaHHe Ha 06weCTBeHaTa nOpblKa (ecTecTBo II KOJIllteCTBO Ha CTPOllTeJ1Hll pa60Tll llOCTaSKllllJlll yCJlyrll llJ111 YKa3saHe na nOTpe6HocTli H
113IICKSaHHH)
BJ3XAO po -epoetin betasolution for ec~ionf
pre-filled syringe 75004meg1299640
1125) KpHTepHH 3a Bb3IIaraHe 1 2 o KpliTepllll3a KaqeCTBO - liMe Te)Kecr 2 20
o KpHTepHH CSbp3aH C pa3XOLlH - liMe Te)KeCT 1 2deg
UeHa shy Te)KeCT 21
II2H) HH(I)OpMa~H OTHOCHO onnHHTe Omllll l1a 0 He ~ OIIllcaHlie Ha OIlUHHTe
IIa13) HH(pOpManHH OTHOCHO cpeACTBa OT EBponeHcKHH Cb103 06ll1eCTBeHaTa nOpblKa e BbB Bpb3Ka C npoeKT 1lllJ111 nporpaMa ltpllHaHclipaHa CbC l1a 0 He ~ CpellCTBa 01 EBpoilellcKHH Ch103
lIlleHTfIltpllKaUIiH Ha npoeKTa
lIa14) l1onbJIHHTeJIHa HHltp0pManHH
PA3LlEJI II OnHcaHHC OOOCOOCHa n03HIlHJI
II a) OnHcaHHe 1
1121) HaHMeHoBaHHe 2
Cina leet 06oco6eHa 1l03HUHH NQ 9 2
IIaa) l1onbJIHHTeJIHH CPV KOAOBe 2
OCHOBen CPV KOll 1 33692800 UollbJlHllTeJIeH CPV KOll 1 2
II23) MJlCTO Ha HSnbJIHeHHe OCHOBHO MHCTO Ha 113IlbJlHeHlle
6onHwIHa ailTeKa Ha YMBAJ] Af( ROll NUTS BG341
1124) OnHcaHHe Ha o6weCTBeHaTa nOpblKa (eCTeCTso H KOJlHqecrso Ha CTPOllTeJ1HH pa60TH lIOCTaBKH llJ111 yCJlyrH llJ1H YKa3BaHe Ha nOTpe6HoCTH II
H311cKBaHllH)
HC5BXOlCinaealeettablets760060mg1536786
1125) KpHTe~HH 3a Bb3J1araHe 1 2 J
YIfl tb203b2~Oa58-42tc~)484~e7aedotae6e4
OnRBlEHI1E 3A Bb3JIOlKEHA nOPblKA (BepCIH 7gt
o KpHTepHH 3a KaIeCTBO - lIMe TeiKeCT 1 2 2deg
o KpIITepIIH CB1gtp3aH C pa3XOll1I - lIMe TeiKeCT 1 2deg
UeHa - TeiKeCT 21
II2U) IIHq0pMauHH OTHOCHO onuHHTe
OIIl1I1I lIaO Helgj
OIII1CaHIIe Ha OI1lHIITe
11213) IIHq0pMauHH OTHOCHO CpelJCTBa OT EBpOnenCKHH Cb103
06~eCTBeHaTa nOp1gt4Ka e B1gtB Bp1gt3Ka C npOeKT IIIIJIII npOrpaMa qHtHaHCHpaHa CDC
CpepCTBa OT EBpOneHCKIIH CDI03
lIlleHTHltpIIKaI~IIH Ha npOeKTa
lIaO He~
11214) lIonbJIHHTeJIHa HHq0PMaUHH
PA3llEJI II OnHCaHHe 06oco6eHa n03HIJHJI
II2) OnHCaHHe 1
1121) HaHMeHOBaHHe 2
Parica cito1 060c06eHa fl03HlHH NQ 10 2
II22) lIonbJIHHTeJIHH CPV KOlJOBe 2
OCHOBeH CPV KOll 1 33692800 UonDJIHI1TeJIeH CPV KOll 1 2 I
-
1123) MHCTO Ha H3nbJIHeHHe I
iOCHOBHO MHC(Q Ha H3fl1gtJIHeHIIe I
OOjlEV1Lf-la aI1TeKa Ha ytvlBATI AU I
KOll NUTS 1 BG341
II24) OnHCaHHe Ha OOllJeCTBeHaTa nOpblKa
(eCTeCTBO H KOJIHIeCTBO Ha CTPOHTeJIHH pa60TII llOCTaBIltH IDIH yCJIyrH IDIII YKa3BaHe Ha nOTpe6HOCTII II
II3IICKBaHllH)
H05BX02Parica1cito1 capsJles soft90002ctcg277
II25) KpHTepHH 3a Bb3JIaraHe 1 2 o KpHTepHH 3a Ka4eCTBO liMe TeiKeCT 1 2 2deg
o KpHTepIIH CB1gtp3aH C pa3XOllH - liMe TeiKeCT 1 2deg
I jgj UeHa - TemeCT 21 I
II2U) IIHq0pMauHH OTHOCHO onuHHTe
OnllHH lIaO He~ OnHcaHIIe Ha onllHHTe
II213) IIHq0pMauHH OTHOCHO CpelJCTBa OT EBponenCKHH Cb103
06~eCTBeHaTa nOpDlKa e B1gtB BpD3Ka C npoeKT IIIDIH nporpata ltpHHaHCHpaHa CDC lIaD He~ cpepCTBa 01 EBponeHCKllH CDI03
lipeHTHltpHKaliHH Ha npoeKTa
I
II214) lIonbJIHHTeJIHa HHq0PMaUHH i I
PA3llEJI II OnHcaHHe 06oco6eHa II03HIJHJI
II2) OnHcauHe 1
1121) HaHMeHOBaHHe 2
Parica ci tol 06oc06eHa n03HlIIIH NQ 11
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YHIl tl)203Jb2-0a58-42cc-9484-e7aedOfaeoe4
2
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OEtB~~EHI1E 1A 8b3~10JKEHA nOPblJKA (OCPOII 7)
L(onbIJHHTeJJeH CPV KOl 1 2
1123) MHCTO Ha H311hIIHeHHe
OCHOBHO MHCTO Ha 113nbIJHeHHe
OOJIHY1tJHa dflTeKa Ha YMBAll
KOA NUTS 1 BG 41
1124) OIlHcaHHe Ha o6meCTBeHaTa IlOphlKa
(eCTeCTBO H KOnllleCTBO Ha CTpoHTenHH pa6oTH JlOCTaBKH MH ycnyrH MH YKa3BaHe Ha nOTpe6HOcTli H
113HCKBaHllH)
H05BX02Paricalcit solJtion for ction22500 509840
1125) KpHTepHH 3a Bh3JlaraHe 1 2 o KpwrepliH 3a KaqeCTSO liMe Te)(eCT 1 2 2deg o KpHTepllH CSbp3aH C pa3XOJl1l - liMe Te)(eCT 1 2deg
[(eHa - Te)(ecT 21
11211) IIHlpopMauHH OTHOCHO OIluHHTe
Om~lll1
OrlllcaHlie Ha onuHllTe
lla 0 Heamp
II213) IIHcpopMauHH OTHOCHO Cpel)CTBa OT EBpOlleiicKHH Ch103
06meCTBeHaTa nOpblKa e BbB Bpb3Ka C npoeKT HHJIH nporpaMa ltpHHaHCHpaHa CDC lla 0 Heamp CpeJlCTBa OT EsponeiicKl1H CDlO3
lIleHTHltpHKauHH Ha npOeKTa
11214) llollhIIHHTeJIHa HHcpopMalJHH
PA3JJEJI II OnuCaHue 06oco6eHa n03UIJUJl II 2) OIlHcaHHe 1
1121) HaHlteHoBaHHe 2
Etelcalcetide 060co6eHa n0311ul1H N) 12 2 I 1122) llollhIIHHTeJIHH CPV KOl)OBe 2
OCHoseH CPV KOJl 1 33692800 I I
L(ollbJIHHTeJleH CPV KOJl 1 2 i I
1123) MHCTO Ha H311hIIHeHHe
OCHOBHO MHCTO Ha H3nbJIHeHHe
OOJIHMcHa aflLeKa Ea YMB JlIJ
KOJl NUTSl BG3Al
II204) OIIHcaHHe Ha 06meCTBeHaTa IlOphlKa
(eCTeCTBO 11 KOnHIeCTBO Ha crpoHTenHH pa60TH JlOCTaBKH HnH ycnyrn MH YKa3BaHe Ha nOTpe6HOCTH H
H3HCKBaHHH)
H05BX04EtelcalcetideSolution for injection150001mg1438567
1125) KPHTePHH 3a Bh3JlaraHe 1 2 o KpHTepHH 3a KaleCTBO - liMe Te)(eCT 1 2 20
o KpHTepHH CBbp3aH C pa3XOlH - liMe Te)(eCT 1 2deg
i ~ [(eHa - TemecT 21
11211) IIHlaquopopMaIJHH OTHOCHO OIIIJHHTe
OrruMl1 lla 0 Heamp OnHcaHlie Ha onuHHTe
J 11213) IIHcpopMalJHJI OTHOCHO Cpel)cTBa OT EBpOlleiicKHH Ch103
06meCTIleHaTa nopb4Ka e BbB BpD3Ka C npoeKT HMH nporpaMa ltpHHaHClipaHa CDC lla 0 He 1amp1 I
cpencTBa OT EsponeHCKHH CblO3
lIJleHTltltpHKaul1H Ha npoeKTa
I I I I
YUrt f6203 Jb2-0a58~42cc-9484-e 7acdOfaeoe4
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06RBJIEHHE IA Bh3J10lKEHA nOPbYKA (3CP 7)
i
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PA3l1EJI II OnHCaHHe 06oc06eHa n03HDHlI
112) OllHCaHHe 1
1121) HaHMeHOBaHHe 2
Sevelamer 06oco6eHa 1103HLIUI NQ 13 2
1122) j]OllhJIHHTeJIHH CPV KOAOBe 2
OCHOBeH CPV KO[( 1 33692800 [(OI1bJIHI1TeJIeH CPV KO[( 1 2
1123) MJlCTO Ha HallhJIHeHHe OCHOBHO MHcrO Ha H3IThIHeHHe
OOflHHLHa aITeKa Ha YMEAJl ac AD KO[( NUTS 1 BG341
1124) OllHcaHHe Ha 061IJeCTBeHaTa llOpbtlKa (cCTecTBo H KOJIH4eCTBO Ha cTpoHTeRHH pa6oTH [(OCTaBKH HJIH yCJIyrH I1RH YKa3BaHe Ha rroTpe6HocTH H H3HcKBaHHR)
V03AE02Sevelamerfllm-coated tablets15 0006400mg656889
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1125) KpHTepHH aa Bb3JIaraHe 1 2
D KpHTepllH 3a Ka4eCTBO liMe Temecr 1 2 2 0
D KpllTepllH CBhp3aH C pa3XO[(H - liMe Temecr 1 2 0
I ~ UeHa - TemeCT 21
11211) HHfpopMaIQIJI OTHOCHO OlllQlHTe OrrQllH
OrrHcaHHe Ha OmlHHTe
j]a D Hel8l
11213) HH4gtOPMauHH OTHOCHO cpeACTBa OT EBpOlleHCKHH CblOa 061llecrBeHaTa rrOpb4Ka e BbB Bpb3Ka CrrpoeKT llHJIll nporpaMa ltpHHaHCHpaHa CDC
cpe[(CTBa OT EBporreiicKHH CDI03
lI[(eHTHltpHKaQll51 Ha I1pOeKTa
j]a D Hel8l
1I214) j]OllhJIHHTeJIHa HH4gt0pMaUHJI
PA3l1EJI II OnHcaHHe 06oco6eHa n03HDHlI
1I2) OllHcaHHe 1
1I21) HaHMeHOBaHHe 2
Ca c rl 1 06oco6eHa 1103HQllR NQ 14 2
1I22) j]OllhJIHHTeJlHH CPV KOAOBe 2
OCHOBeH CPVKOA 1 336928 00 [(orrbJIHHTeneH CPV KOA 1 2
1I23) MJlCTO Ha HallhJIHeHHe OCHOBHO MHCTO Ha M3fibJIHeHMe
60flHHLHa anTeKa Ha YMBlJl EypIa AJ
KOll NUTSl BG3 1
1124) OllHcaHHe Ha 061IJeCTBeHaTa llOpblJKa (ecrecTBo H KOIIHIeCTBO Ha crpollTeJIHH pa6oTH [(OCTaBKll HJIH yCJIyrH HJIH YKa3BaHe Ha rroTpe6HocTH H
H3HcKsaHHR)
AI1CC04Cal itrio_ es soft 9500 78133
1125) KpHTepHH aa Bb3JIaraHe 1 2 K T~~~ 1 2 2 0
VHH tn2m3b2-0a5X~42cc-q484-e7aedOf3e6e4
IlapTliu OIgt51BJlEHHE 3A BlJlOlKEHA nOPV1KA (ltpm 7)
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o KpHTeplIii CBbp3aH C pa3XOllH - HMe I TeJKeCT 1 2deg
~ lJcHa - TCJKeCT 21
II2u) HHqOPMa1lHJI OTHOCHO OnQHHTe
OIllJHH
OIUiCaHHC Ha OnlJHHTC
tJa 0 Helamp
II213) HHqOpMaQHH OTHOCHO CpetJCTBa OT EBpOneHCKHH CblOa
06~eCTBeHaTa nOpblKa e BbB BpbSKa C npOeKT lllUIH npOrpaMa ltpllHaHclipaHa CbC
CpellCTBa OT EBpOneifcKHlI CblO3
HllCHTllltplKaIJHlI Ha npOeKTa
tJa 0 He~
II214) tJOnbJIHHTeJIHa HHq0pMaQHH
PA3lJEJI IV npO~ElJypA IVI) OnHCaHHe
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DYcKopeHa np0IJellypa
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OCbCTe3aTCJIeH llHaJIOr
OrrapTHbOpCTBO 3a IIHOBaIJHH
OBb3JlaraHe Ha rrOpblKa 6e3 npellBapHTCJIHO rry6JIHKyBaHe Ha 0611BJleHHe 3a nOpbIKa B OltpHllHaJIeH
BeCTHHK Ha EBpOrreHCKHR CblO3 B CJIyqaHTe ll36poeHll rrO-AOJlY (MOJlR rrOrrbJlHeTe rrpHJlOJKeHlle [1)
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fJrrpRKO AOrOBapRHe (MOJlll nOnbJlHeTe npHJlOJKCHllC [S)
IVI3) HHqOpMaQHJI OTHOCHO paMKOBO cnOpaaYMeHHe HlIH tJHHaMHIHa CHCTeMa aa
nOKYJIKH
DTa3H 06~eCTBeHa rrOpbIKa 06XBaIIJa CKJlIOIBaHCTO Ha paMKOBO crropa3YMeHHe
DYCTaHoBeHa e AllHaMllIHa CllCTeMa 3a rrOKVIIKH
IVI6) HHqOpMa~ OTHOCHO eJIeKTPOHHHJI ThPI
n1l3rroJl3BaH e CJleKTpOHCH Thpr
IVI8) HHqOpMa~ OTHOCHO CnOpaaYMeHHeTO aa tJbplKaBHH nOpblKH (GPA) 06IIJeCTBeHam nOpbIKa nOnaAa B 06XBaTa Ha CnOpa3YMCHlleTO 3a AbpJKaBHH nOpbIKll tJa 0 He ~ (GPA)
IV2) AtJMHlJHCTJ)aTHBHa HHlPOpMaIUlH
IV21) llpetJHlUHa ny6JIHKaQHJI OTHOCHO TaaH npoQetJYPa 2
HOMep Ha 06RBJleHHeTO B OB Ha EC 20188214-489991 HOMep Ha 06RBJIeHHeTO B POll876S3S (Eo11O om clleo11ume 06RBJ1e11Ue 3a npeoBapUmeilHa UHg50PMQijUR U3nO13BaH0 Kama nOKaHa 3a yttQC11lue B CbCme3amelliQ npOijeoypa 06RB1el-lUe 3Q 110pblKQ 06RB1e11Ue 3Q 006POBOIIHQ IlP03PQttuocm ex ante)
IV28) HHqopMaQHH OTHOCHO npeKpaTHBaHe Ha tJHHaMHIHa CHCTeMa aa nOKynKH
006RBJIeHHeTO 06XBaIIJa npeKpaTlIBaHeTO Ha AHHaMllIHam CHCTeMa 3a IlOKynKH ny6JIllKYBaHa C
roperrOCOIeHOTO 06RBJIeHlle 3a nOpbIKa
IV29) HHqopMaQHH OTHOCHO npeKpaTHBaHe Ha CbCTeaaTeJlHa npoQetJYPa 06HBeHaipea
06HBJleHHe aa npetJBapHTeJIHa HHqopMaQHH
D Bb3JIaraIIJHRT opraH HRMalla B1gt3JIara nOBeIe IlOpbIKH B1gt3 OCHOBa Ha roperrOCOIeHOTO 06RBJIeHlle sa
npellBapllTeJIHa llmj)OPMaIJllR
ynn Ib201lb2-0a58-42cc-9484-e7aedOfae6e4 10
OSilBjlEHHE lA BlilJlOlKEHA 1I0Pb4KA (Bepc 7)
PA3tJEJIV Bh3JIArAHE HAllOPhIKATA 1
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I YMBAJ1 ~ Byplac All lp Byplac no o6oco6eHM n03Mlll1l1 nocotJeHI1 B
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006weCTBeHaTa nOphlKa e 3a yCJIym lIO lIpHJlOJKeHHe NQ 2 H e Ha CTOI1HOCT no )] 20 aJI 2 T 2 OT 30I1
2 06HCHeHHe
MOJIR 06RCHeTe no RceH H pa36HpaeM HalHH 3aw0 Bh3JlaraHeTO Ha nOphQKaTa 4pe3 npRKO AorOBapRHe e
3aKOHOCbo6pa3HO KaTO lIOC04HTe CbOTHOCHMHTe cpaKTH H KoraTO e YMeCTHO npaBHHTe 3aKJIIOQeHHR B
CbOTBeTCTBHe ChC 30I1 (MaKcHMYM 500 AYMH)
Bh3JlarawHRT opraHBh3JlOJKHTeJlRT HOCH oTroBopHoCT 3a rapaHTHpaHe Ha cna3BaHe Ha
3aKOHOAaTeJICTBOTO Ha EBponeHcKHR Cb103 H Ha BCHIKH npHJIOJKHMH 3aKOHH
MOIlR nOBTOpeTe KOIlKOTO nbH1 e Heo6xollI1MO
B npl11l0lKI1MI1Te CIlY4al1
aKO Ta311 I1HQgtopMa4I1R e 113BeCTHa
3allblllKl1TellHa I1HQgtOPMa4I1R KORTO He ce ny61ll1KYBa
MOlKe Ila 6blle npl1CblleHa 3Ha411MOCT BMeCTO TelKeCT 21 MOlKe Qa 6bQe npl1CblleHa 3Ha411MOCT BMeCTO TelKeCT aKO 4eHaTa e ellI1HCTBeHI1RT
Kpl1Tepl1H 3a Bb3llaraHe TelKeCTTa He ce 113nOll3Ba
YHn to2033b2~Oa58~421middotc~9484~e7aedOfae6e4 In
napTlLl3 OliBlEHHE 3A Bb310lKEHA nOPb4KA leepc 7)
I ~ KpHTepHM CBhp3aH C pa3XOtH - liMe Te)KeCT 1 2deg
UeHa - Te)KecT 21
11211) HHCpopMaIQIH OTHOCHO onuHHTe
OIlUHH
OnHcaHHe Ha OIlUHHTe 11a 0 He 181 i
i
11213) HHcpopMauHH OTHOCHO cpetJcTBa OT EBponeiicKHH Cb103
06meCTBeHaTa IlOphlKa e BhB Bpb3Ka C IlpoeKT HHJIH nporpaMa ltpHHaHCHpaHa ChC cpetCTlla OT EllpOIleMCKHH Ch103
MteHTI1ltpHKaUHR Ha npoeKTa
11a 0 Hel8l
11214) 110IIbJIHHTeJIHa HHCPOpl1aIJHH
PA3ZJEJI II OnHcaHHe 06oco6eHa n03HuIUI
112) OIIHcaHHe 1
I
I
1121) HaHMeHOBaHHe 2
Epoetin a fa 06oco6eHa rr03HUIDI NQ 4 2
1122) 110IIbJIHHTeJIHH CPV KOtJOBe 2
OCHOBeH CPV KOA 1 33692 00 IlOIlbJIHlfTeIeH CPV KOt 1 2 I 1123) MHCTO Ha H3IIbJIHeHHe
iOCHOBHO MRCTO Ha H3IlbJIHeHHe
fjcIHYIIHa dflTeKa Ha YJV15AJl
KOA NlITS 1 BG341 J II24) OnHcaHHe Ha 06meCTBeHaTa IIOpblKa
(eCTeCTBO H KOJ1I1QeCTllO Ha CTpOHTeJ1HH pa60TH AOCTaBKH MH yCllyrH MH YKa3BaHe Ha rroTpe6HOCTH H
H3I1CKllaHHR)
B03XAOIEpoetin alfasoltn]930001000IJ837967
II25) KpHTepHH 3a Bb3JIaraHe 1 2 o KpHTepHM 3a KaQeCTBO liMe Te)KeCT 1 2 20
o KpHTepHM CBbp3aH C pa3xOtH - liMe Te)KeCT 1 2deg
~ UeHa - Te)KeCT 21
11211) HHCPOPMaIJHH OTHOCHO OIIlJHHTe
OmHH 11a 0 Hel8l
OrrHcaHHe Ha OnlHHTe
II213) HHcpopMaIQIH OTHOCHO cpetJCTBa OT EBpOIIeiicKHH Cb103
06meCTBeHaTa rrOpbQKa e BhB Bph3Ka C rrpoeKT HHJ1H rrpOrpalVIa QmHaHCHpaHa ChC llaD Hel8l cpeACTBa OT EBponeiicKHR Ch103
lIAeHTHQgtHKalUR Ha rrpoeKTa
II214) llOIIbJIHHTeJIHa HHcpopMalJHH
PA3ZJEJI II OnHCaHHe 06oco6eHa n03HuHJl
112) OIIHcaHHe 1
1121) HaHMeHOBaHHe 2
tin beta 06oco6eHa rr03HlHH NQ 5
1122) llOIIyenHHTeJIHH CPV KOtJOBe 2
OCHoBeHCPYKOt 1 33692800
YHn 111103302-058-42cc-9484-e iaedOfae6e4
2
OliJlBJIEHHE 3A Bmiddoth3rtOJ(EHA nOPblKA (BCPC 7)
llOI1hJIHHTeJIeH CPV KO~ 1 2
II23) MHCTO Ha H3IIbJIHeHHe
OCHOBHO MJlCTO Ha H3nbJIHeHHe
60nHMQHa anTeKa Ha Y~BAn KO~ NUTSl BG341
AD
II24) OnHCaHHe Ha 06meCTBeHaTa nOphlKa
(eCTeCTBO H KOJIHleCTBO Ha CTPOHTeJIHH pa60TH ~OCTaBKH HJIH yCJlyrH HJlH YKa3BaHe Ha nOTpe6HOCTH H
H3HCKBaHHJI)
B03XAOIEpoetin betasolinj14600l000IU837967
II25) KpHTepHH 3a Bh31IaraHe 1 2
o KpHTepHH 3a KaleCTBO shy lIMe I Te)J(eCT 1 2 20
0o KpHTepHH CBbp3aH C pa3XO~H - lIMe I Te)J(eCT 1 2
~ QeHa - Te)J(eCT 21
11211) IIHcpopMa~H OTHOCHO on~HTe I On~HH Qa 0 Hejgl OnHcaHHe Ha on~HHTe I
11213) IIHcpopMa~HH OTHOCHO cpe)JCTBa OT EBponeHCKHH Ch103
06rueCTBeHaTa nOphlKa e BhB Bph3Ka C npoeKT HHJIH nporpaMa ltlgtHHaHcHpaHa ChC
cpeACTBa OT EBponeikKHJI CDJ03
lI~eHTHltIgtHKalJHR Ha npOeKTa
Qa 0 Hejgl
II214) QonbJIHHTeJIHa HHcpopMa~
PA3lJEJI II OnHcaHHe OoocooeHa n03HIJHH 112) OnHcaHHe 1
II21) HaHMeHOBaHHe 2
in alfa 06oc06eHa n03HUHR NQ 7 2
1122) QonbJIHHTeJIHH CPV KO)JOBe 2
OCHOBeH CPV KO~ 1 3369 8 0 lloflbJIHHTeJIeH CPV KO~ 1 2
II23) MHCTO Ha H3nbJIHeHHe
OCHOBHO MHCTO Ha H3nbJIHeHHe
6onEW~Ea dOTeKa Ea YMBAn KO[l NUTS 1 BG341
II24) OnucaHue Ha 06meCTBeHaTa nOphlKa
(ecTecTBo H KOJIHleCTBO Ha CTPOHTeJIHH pa60TH AOCTaBKH HJlH yCJlyrH HJIH YKa3BaHe Ha nOTpe6HocTH H
H3HcKBaHHH) I B03XA02Da tin alfasolution for ection pre-filled nge 4400 I
i 4 5mcgl2 99640
II25) KpHTepHH 3a Bh31IaraHe 1 2
o KpHTepHH3a KaleCTBO - HMe I Te)J(ecT 1 2 20
0o KpHTepHH CBhp3aH C pa3Xo[lH - HMe I Te)J(eCT 1 2
~ QeHa - Te)J(ecT 21
11211) IIH4gtOPM~ OTHOCHO on~e Orr~HH Qa 0 Hejgl
OrrHcaHHe Ha orr~HHTe
II213) IIHcpopMa~ OTHOCHO cpe)JCTBa OT EBponeHCKHH Cb103
06rueCTBeHaTa rrOphlKa e BhB Bph3Ka C npoeKT HHJIH I1pOrpaMa ltlgtHHaHcHpaHa CDC Qa 0 Hejgl
cpeACTBa OT EBporreHCKHH CbJ03
H~eHTHltIgtHKa~HI Ha npoeKTa
j
YllJl tb2033b~-Oa58M42cc-948~-e7aedmae6c4
i
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llapTIlCla ObRBlEHI1E 3A Bb3iIOl(IHA 1I0PbliKA ltpn 7)
r
P A3LlEJI II OnHcaHHC OOOCOOCHa n03HIlHJI
112) OnHcaHHe 1
1121) HaHMeHoBaHHe 2
Methoxy yet ene gl -epoetin beta 060co6eHa Il03lUJllJI NQ 8 2
II22) l1onbJIHHTeJIHH CPV KOAoBe 2
OCHoseH CPV KOp 1 3 692800 UOIlbJIHllTeJ1eH CPV KOp 1 2
II23) MHCTO Ha H3nbJIHeHHe OCHOSHO MHCTO Ha 113nbJIHenlle
6onH~~Ha anTeKa Ha YMBATI KOll NUTS BG341
1124) OnHCaHHe Ha 06weCTBeHaTa nOpblKa (ecTecTBo II KOJIllteCTBO Ha CTPOllTeJ1Hll pa60Tll llOCTaSKllllJlll yCJlyrll llJ111 YKa3saHe na nOTpe6HocTli H
113IICKSaHHH)
BJ3XAO po -epoetin betasolution for ec~ionf
pre-filled syringe 75004meg1299640
1125) KpHTepHH 3a Bb3IIaraHe 1 2 o KpliTepllll3a KaqeCTBO - liMe Te)Kecr 2 20
o KpHTepHH CSbp3aH C pa3XOLlH - liMe Te)KeCT 1 2deg
UeHa shy Te)KeCT 21
II2H) HH(I)OpMa~H OTHOCHO onnHHTe Omllll l1a 0 He ~ OIIllcaHlie Ha OIlUHHTe
IIa13) HH(pOpManHH OTHOCHO cpeACTBa OT EBponeHcKHH Cb103 06ll1eCTBeHaTa nOpblKa e BbB Bpb3Ka C npoeKT 1lllJ111 nporpaMa ltpllHaHclipaHa CbC l1a 0 He ~ CpellCTBa 01 EBpoilellcKHH Ch103
lIlleHTfIltpllKaUIiH Ha npoeKTa
lIa14) l1onbJIHHTeJIHa HHltp0pManHH
PA3LlEJI II OnHcaHHC OOOCOOCHa n03HIlHJI
II a) OnHcaHHe 1
1121) HaHMeHoBaHHe 2
Cina leet 06oco6eHa 1l03HUHH NQ 9 2
IIaa) l1onbJIHHTeJIHH CPV KOAOBe 2
OCHOBen CPV KOll 1 33692800 UollbJlHllTeJIeH CPV KOll 1 2
II23) MJlCTO Ha HSnbJIHeHHe OCHOBHO MHCTO Ha 113IlbJlHeHlle
6onHwIHa ailTeKa Ha YMBAJ] Af( ROll NUTS BG341
1124) OnHcaHHe Ha o6weCTBeHaTa nOpblKa (eCTeCTso H KOJlHqecrso Ha CTPOllTeJ1HH pa60TH lIOCTaBKH llJ111 yCJlyrH llJ1H YKa3BaHe Ha nOTpe6HoCTH II
H311cKBaHllH)
HC5BXOlCinaealeettablets760060mg1536786
1125) KpHTe~HH 3a Bb3J1araHe 1 2 J
YIfl tb203b2~Oa58-42tc~)484~e7aedotae6e4
OnRBlEHI1E 3A Bb3JIOlKEHA nOPblKA (BepCIH 7gt
o KpHTepHH 3a KaIeCTBO - lIMe TeiKeCT 1 2 2deg
o KpIITepIIH CB1gtp3aH C pa3XOll1I - lIMe TeiKeCT 1 2deg
UeHa - TeiKeCT 21
II2U) IIHq0pMauHH OTHOCHO onuHHTe
OIIl1I1I lIaO Helgj
OIII1CaHIIe Ha OI1lHIITe
11213) IIHq0pMauHH OTHOCHO CpelJCTBa OT EBpOnenCKHH Cb103
06~eCTBeHaTa nOp1gt4Ka e B1gtB Bp1gt3Ka C npOeKT IIIIJIII npOrpaMa qHtHaHCHpaHa CDC
CpepCTBa OT EBpOneHCKIIH CDI03
lIlleHTHltpIIKaI~IIH Ha npOeKTa
lIaO He~
11214) lIonbJIHHTeJIHa HHq0PMaUHH
PA3llEJI II OnHCaHHe 06oco6eHa n03HIJHJI
II2) OnHCaHHe 1
1121) HaHMeHOBaHHe 2
Parica cito1 060c06eHa fl03HlHH NQ 10 2
II22) lIonbJIHHTeJIHH CPV KOlJOBe 2
OCHOBeH CPV KOll 1 33692800 UonDJIHI1TeJIeH CPV KOll 1 2 I
-
1123) MHCTO Ha H3nbJIHeHHe I
iOCHOBHO MHC(Q Ha H3fl1gtJIHeHIIe I
OOjlEV1Lf-la aI1TeKa Ha ytvlBATI AU I
KOll NUTS 1 BG341
II24) OnHCaHHe Ha OOllJeCTBeHaTa nOpblKa
(eCTeCTBO H KOJIHIeCTBO Ha CTPOHTeJIHH pa60TII llOCTaBIltH IDIH yCJIyrH IDIII YKa3BaHe Ha nOTpe6HOCTII II
II3IICKBaHllH)
H05BX02Parica1cito1 capsJles soft90002ctcg277
II25) KpHTepHH 3a Bb3JIaraHe 1 2 o KpHTepHH 3a Ka4eCTBO liMe TeiKeCT 1 2 2deg
o KpHTepIIH CB1gtp3aH C pa3XOllH - liMe TeiKeCT 1 2deg
I jgj UeHa - TemeCT 21 I
II2U) IIHq0pMauHH OTHOCHO onuHHTe
OnllHH lIaO He~ OnHcaHIIe Ha onllHHTe
II213) IIHq0pMauHH OTHOCHO CpelJCTBa OT EBponenCKHH Cb103
06~eCTBeHaTa nOpDlKa e B1gtB BpD3Ka C npoeKT IIIDIH nporpata ltpHHaHCHpaHa CDC lIaD He~ cpepCTBa 01 EBponeHCKllH CDI03
lipeHTHltpHKaliHH Ha npoeKTa
I
II214) lIonbJIHHTeJIHa HHq0PMaUHH i I
PA3llEJI II OnHcaHHe 06oco6eHa II03HIJHJI
II2) OnHcauHe 1
1121) HaHMeHOBaHHe 2
Parica ci tol 06oc06eHa n03HlIIIH NQ 11
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YHIl tl)203Jb2-0a58-42cc-9484-e7aedOfaeoe4
2
I
OEtB~~EHI1E 1A 8b3~10JKEHA nOPblJKA (OCPOII 7)
L(onbIJHHTeJJeH CPV KOl 1 2
1123) MHCTO Ha H311hIIHeHHe
OCHOBHO MHCTO Ha 113nbIJHeHHe
OOJIHY1tJHa dflTeKa Ha YMBAll
KOA NUTS 1 BG 41
1124) OIlHcaHHe Ha o6meCTBeHaTa IlOphlKa
(eCTeCTBO H KOnllleCTBO Ha CTpoHTenHH pa6oTH JlOCTaBKH MH ycnyrH MH YKa3BaHe Ha nOTpe6HOcTli H
113HCKBaHllH)
H05BX02Paricalcit solJtion for ction22500 509840
1125) KpHTepHH 3a Bh3JlaraHe 1 2 o KpwrepliH 3a KaqeCTSO liMe Te)(eCT 1 2 2deg o KpHTepllH CSbp3aH C pa3XOJl1l - liMe Te)(eCT 1 2deg
[(eHa - Te)(ecT 21
11211) IIHlpopMauHH OTHOCHO OIluHHTe
Om~lll1
OrlllcaHlie Ha onuHllTe
lla 0 Heamp
II213) IIHcpopMauHH OTHOCHO Cpel)CTBa OT EBpOlleiicKHH Ch103
06meCTBeHaTa nOpblKa e BbB Bpb3Ka C npoeKT HHJIH nporpaMa ltpHHaHCHpaHa CDC lla 0 Heamp CpeJlCTBa OT EsponeiicKl1H CDlO3
lIleHTHltpHKauHH Ha npOeKTa
11214) llollhIIHHTeJIHa HHcpopMalJHH
PA3JJEJI II OnuCaHue 06oco6eHa n03UIJUJl II 2) OIlHcaHHe 1
1121) HaHlteHoBaHHe 2
Etelcalcetide 060co6eHa n0311ul1H N) 12 2 I 1122) llollhIIHHTeJIHH CPV KOl)OBe 2
OCHoseH CPV KOJl 1 33692800 I I
L(ollbJIHHTeJleH CPV KOJl 1 2 i I
1123) MHCTO Ha H311hIIHeHHe
OCHOBHO MHCTO Ha H3nbJIHeHHe
OOJIHMcHa aflLeKa Ea YMB JlIJ
KOJl NUTSl BG3Al
II204) OIIHcaHHe Ha 06meCTBeHaTa IlOphlKa
(eCTeCTBO 11 KOnHIeCTBO Ha crpoHTenHH pa60TH JlOCTaBKH HnH ycnyrn MH YKa3BaHe Ha nOTpe6HOCTH H
H3HCKBaHHH)
H05BX04EtelcalcetideSolution for injection150001mg1438567
1125) KPHTePHH 3a Bh3JlaraHe 1 2 o KpHTepHH 3a KaleCTBO - liMe Te)(eCT 1 2 20
o KpHTepHH CBbp3aH C pa3XOlH - liMe Te)(eCT 1 2deg
i ~ [(eHa - TemecT 21
11211) IIHlaquopopMaIJHH OTHOCHO OIIIJHHTe
OrruMl1 lla 0 Heamp OnHcaHlie Ha onuHHTe
J 11213) IIHcpopMalJHJI OTHOCHO Cpel)cTBa OT EBpOlleiicKHH Ch103
06meCTIleHaTa nopb4Ka e BbB BpD3Ka C npoeKT HMH nporpaMa ltpHHaHClipaHa CDC lla 0 He 1amp1 I
cpencTBa OT EsponeHCKHH CblO3
lIJleHTltltpHKaul1H Ha npoeKTa
I I I I
YUrt f6203 Jb2-0a58~42cc-9484-e 7acdOfaeoe4
I
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06RBJIEHHE IA Bh3J10lKEHA nOPbYKA (3CP 7)
i
I
I i
I
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PA3l1EJI II OnHCaHHe 06oc06eHa n03HDHlI
112) OllHCaHHe 1
1121) HaHMeHOBaHHe 2
Sevelamer 06oco6eHa 1103HLIUI NQ 13 2
1122) j]OllhJIHHTeJIHH CPV KOAOBe 2
OCHOBeH CPV KO[( 1 33692800 [(OI1bJIHI1TeJIeH CPV KO[( 1 2
1123) MJlCTO Ha HallhJIHeHHe OCHOBHO MHcrO Ha H3IThIHeHHe
OOflHHLHa aITeKa Ha YMEAJl ac AD KO[( NUTS 1 BG341
1124) OllHcaHHe Ha 061IJeCTBeHaTa llOpbtlKa (cCTecTBo H KOJIH4eCTBO Ha cTpoHTeRHH pa6oTH [(OCTaBKH HJIH yCJIyrH I1RH YKa3BaHe Ha rroTpe6HocTH H H3HcKBaHHR)
V03AE02Sevelamerfllm-coated tablets15 0006400mg656889
i
1125) KpHTepHH aa Bb3JIaraHe 1 2
D KpHTepllH 3a Ka4eCTBO liMe Temecr 1 2 2 0
D KpllTepllH CBhp3aH C pa3XO[(H - liMe Temecr 1 2 0
I ~ UeHa - TemeCT 21
11211) HHfpopMaIQIJI OTHOCHO OlllQlHTe OrrQllH
OrrHcaHHe Ha OmlHHTe
j]a D Hel8l
11213) HH4gtOPMauHH OTHOCHO cpeACTBa OT EBpOlleHCKHH CblOa 061llecrBeHaTa rrOpb4Ka e BbB Bpb3Ka CrrpoeKT llHJIll nporpaMa ltpHHaHCHpaHa CDC
cpe[(CTBa OT EBporreiicKHH CDI03
lI[(eHTHltpHKaQll51 Ha I1pOeKTa
j]a D Hel8l
1I214) j]OllhJIHHTeJIHa HH4gt0pMaUHJI
PA3l1EJI II OnHcaHHe 06oco6eHa n03HDHlI
1I2) OllHcaHHe 1
1I21) HaHMeHOBaHHe 2
Ca c rl 1 06oco6eHa 1103HQllR NQ 14 2
1I22) j]OllhJIHHTeJlHH CPV KOAOBe 2
OCHOBeH CPVKOA 1 336928 00 [(orrbJIHHTeneH CPV KOA 1 2
1I23) MJlCTO Ha HallhJIHeHHe OCHOBHO MHCTO Ha M3fibJIHeHMe
60flHHLHa anTeKa Ha YMBlJl EypIa AJ
KOll NUTSl BG3 1
1124) OllHcaHHe Ha 061IJeCTBeHaTa llOpblJKa (ecrecTBo H KOIIHIeCTBO Ha crpollTeJIHH pa6oTH [(OCTaBKll HJIH yCJIyrH HJIH YKa3BaHe Ha rroTpe6HocTH H
H3HcKsaHHR)
AI1CC04Cal itrio_ es soft 9500 78133
1125) KpHTepHH aa Bb3JIaraHe 1 2 K T~~~ 1 2 2 0
VHH tn2m3b2-0a5X~42cc-q484-e7aedOf3e6e4
IlapTliu OIgt51BJlEHHE 3A BlJlOlKEHA nOPV1KA (ltpm 7)
I
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I
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o KpHTeplIii CBbp3aH C pa3XOllH - HMe I TeJKeCT 1 2deg
~ lJcHa - TCJKeCT 21
II2u) HHqOPMa1lHJI OTHOCHO OnQHHTe
OIllJHH
OIUiCaHHC Ha OnlJHHTC
tJa 0 Helamp
II213) HHqOpMaQHH OTHOCHO CpetJCTBa OT EBpOneHCKHH CblOa
06~eCTBeHaTa nOpblKa e BbB BpbSKa C npOeKT lllUIH npOrpaMa ltpllHaHclipaHa CbC
CpellCTBa OT EBpOneifcKHlI CblO3
HllCHTllltplKaIJHlI Ha npOeKTa
tJa 0 He~
II214) tJOnbJIHHTeJIHa HHq0pMaQHH
PA3lJEJI IV npO~ElJypA IVI) OnHCaHHe
IVII) BlIJI npoQetJYPa
~OTKpHTa npOIJeA)pa
OYcKopeHa npOIJeA)pa
060CHOBKa
OOrpaHHleHa np0IJellypa
OYcKopeHa npOIJetJypa
060CHOBKa
DCbcTe3aTCJIHa npoIJellypa CllOrOBapRHe
DYcKopeHa np0IJellypa
060CHOBKa
OCbCTe3aTCJIeH llHaJIOr
OrrapTHbOpCTBO 3a IIHOBaIJHH
OBb3JlaraHe Ha rrOpblKa 6e3 npellBapHTCJIHO rry6JIHKyBaHe Ha 0611BJleHHe 3a nOpbIKa B OltpHllHaJIeH
BeCTHHK Ha EBpOrreHCKHR CblO3 B CJIyqaHTe ll36poeHll rrO-AOJlY (MOJlR rrOrrbJlHeTe rrpHJlOJKeHlle [1)
Orry6JlHIHO CbCTe3aHlle
fJrrpRKO AOrOBapRHe (MOJlll nOnbJlHeTe npHJlOJKCHllC [S)
IVI3) HHqOpMaQHJI OTHOCHO paMKOBO cnOpaaYMeHHe HlIH tJHHaMHIHa CHCTeMa aa
nOKYJIKH
DTa3H 06~eCTBeHa rrOpbIKa 06XBaIIJa CKJlIOIBaHCTO Ha paMKOBO crropa3YMeHHe
DYCTaHoBeHa e AllHaMllIHa CllCTeMa 3a rrOKVIIKH
IVI6) HHqOpMa~ OTHOCHO eJIeKTPOHHHJI ThPI
n1l3rroJl3BaH e CJleKTpOHCH Thpr
IVI8) HHqOpMa~ OTHOCHO CnOpaaYMeHHeTO aa tJbplKaBHH nOpblKH (GPA) 06IIJeCTBeHam nOpbIKa nOnaAa B 06XBaTa Ha CnOpa3YMCHlleTO 3a AbpJKaBHH nOpbIKll tJa 0 He ~ (GPA)
IV2) AtJMHlJHCTJ)aTHBHa HHlPOpMaIUlH
IV21) llpetJHlUHa ny6JIHKaQHJI OTHOCHO TaaH npoQetJYPa 2
HOMep Ha 06RBJleHHeTO B OB Ha EC 20188214-489991 HOMep Ha 06RBJIeHHeTO B POll876S3S (Eo11O om clleo11ume 06RBJ1e11Ue 3a npeoBapUmeilHa UHg50PMQijUR U3nO13BaH0 Kama nOKaHa 3a yttQC11lue B CbCme3amelliQ npOijeoypa 06RB1el-lUe 3Q 110pblKQ 06RB1e11Ue 3Q 006POBOIIHQ IlP03PQttuocm ex ante)
IV28) HHqopMaQHH OTHOCHO npeKpaTHBaHe Ha tJHHaMHIHa CHCTeMa aa nOKynKH
006RBJIeHHeTO 06XBaIIJa npeKpaTlIBaHeTO Ha AHHaMllIHam CHCTeMa 3a IlOKynKH ny6JIllKYBaHa C
roperrOCOIeHOTO 06RBJIeHlle 3a nOpbIKa
IV29) HHqopMaQHH OTHOCHO npeKpaTHBaHe Ha CbCTeaaTeJlHa npoQetJYPa 06HBeHaipea
06HBJleHHe aa npetJBapHTeJIHa HHqopMaQHH
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OHe06xo[(HMO e HeOTJlOJKHO Bb3JlaraHe Ha IIOphqKaTa nOpallH H3KJIIOIHTeJIHH 06CTORTeJICTBa
npeAH3BHKaHH OT Ch6HTHR KOHTO He MoraT Aa 6hllaT npe[(BHLeHH OT Bh3JIOJKHTeJlR H He e Bh3MOJKHO
cna3BaHe Ha cpOKOBeTe IIO 4Jl 178 aJI 2 H 3 OT 30I1
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ocpepTH HJlH nOAalIeHHTe ocpepTll ca HelIOAXOARWH H lIhpBOHaqaJIHO o6RBeHHTe YCJIOBHR He ca
ChweCTBeHO npOMeHeHH
03a MHoro KpaTKo BpeMe Bb3HHKHe Bh3MOJKHOCT Aa ce IIOJlyqaT AOCTaBKH HJIH yCJIyrH lIpH oco6eHo
H3rOAHH YCJIOBHR H Ha leHa 3HaqHTeJlHO nO-HHCKa OT 06HQal1HHTe lIa3apHH leHH
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nhpBOHa4aJIHHR H3IIbJIHHTeJl lIpH HaJIHqHe Ha YCJIOBHRTa IIOCOqeHH B 30I1
006weCTBeHaTa nOphlKa e 3a yCJIym lIO lIpHJlOJKeHHe NQ 2 H e Ha CTOI1HOCT no )] 20 aJI 2 T 2 OT 30I1
2 06HCHeHHe
MOJIR 06RCHeTe no RceH H pa36HpaeM HalHH 3aw0 Bh3JlaraHeTO Ha nOphQKaTa 4pe3 npRKO AorOBapRHe e
3aKOHOCbo6pa3HO KaTO lIOC04HTe CbOTHOCHMHTe cpaKTH H KoraTO e YMeCTHO npaBHHTe 3aKJIIOQeHHR B
CbOTBeTCTBHe ChC 30I1 (MaKcHMYM 500 AYMH)
Bh3JlarawHRT opraHBh3JlOJKHTeJlRT HOCH oTroBopHoCT 3a rapaHTHpaHe Ha cna3BaHe Ha
3aKOHOAaTeJICTBOTO Ha EBponeHcKHR Cb103 H Ha BCHIKH npHJIOJKHMH 3aKOHH
MOIlR nOBTOpeTe KOIlKOTO nbH1 e Heo6xollI1MO
B npl11l0lKI1MI1Te CIlY4al1
aKO Ta311 I1HQgtopMa4I1R e 113BeCTHa
3allblllKl1TellHa I1HQgtOPMa4I1R KORTO He ce ny61ll1KYBa
MOlKe Ila 6blle npl1CblleHa 3Ha411MOCT BMeCTO TelKeCT 21 MOlKe Qa 6bQe npl1CblleHa 3Ha411MOCT BMeCTO TelKeCT aKO 4eHaTa e ellI1HCTBeHI1RT
Kpl1Tepl1H 3a Bb3llaraHe TelKeCTTa He ce 113nOll3Ba
YHn to2033b2~Oa58~421middotc~9484~e7aedOfae6e4 In
OliJlBJIEHHE 3A Bmiddoth3rtOJ(EHA nOPblKA (BCPC 7)
llOI1hJIHHTeJIeH CPV KO~ 1 2
II23) MHCTO Ha H3IIbJIHeHHe
OCHOBHO MJlCTO Ha H3nbJIHeHHe
60nHMQHa anTeKa Ha Y~BAn KO~ NUTSl BG341
AD
II24) OnHCaHHe Ha 06meCTBeHaTa nOphlKa
(eCTeCTBO H KOJIHleCTBO Ha CTPOHTeJIHH pa60TH ~OCTaBKH HJIH yCJlyrH HJlH YKa3BaHe Ha nOTpe6HOCTH H
H3HCKBaHHJI)
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0o KpHTepHH CBbp3aH C pa3XO~H - lIMe I Te)J(eCT 1 2
~ QeHa - Te)J(eCT 21
11211) IIHcpopMa~H OTHOCHO on~HTe I On~HH Qa 0 Hejgl OnHcaHHe Ha on~HHTe I
11213) IIHcpopMa~HH OTHOCHO cpe)JCTBa OT EBponeHCKHH Ch103
06rueCTBeHaTa nOphlKa e BhB Bph3Ka C npoeKT HHJIH nporpaMa ltlgtHHaHcHpaHa ChC
cpeACTBa OT EBponeikKHJI CDJ03
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OCHOBeH CPV KO~ 1 3369 8 0 lloflbJIHHTeJIeH CPV KO~ 1 2
II23) MHCTO Ha H3nbJIHeHHe
OCHOBHO MHCTO Ha H3nbJIHeHHe
6onEW~Ea dOTeKa Ea YMBAn KO[l NUTS 1 BG341
II24) OnucaHue Ha 06meCTBeHaTa nOphlKa
(ecTecTBo H KOJIHleCTBO Ha CTPOHTeJIHH pa60TH AOCTaBKH HJlH yCJlyrH HJIH YKa3BaHe Ha nOTpe6HocTH H
H3HcKBaHHH) I B03XA02Da tin alfasolution for ection pre-filled nge 4400 I
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11211) IIH4gtOPM~ OTHOCHO on~e Orr~HH Qa 0 Hejgl
OrrHcaHHe Ha orr~HHTe
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06rueCTBeHaTa rrOphlKa e BhB Bph3Ka C npoeKT HHJIH I1pOrpaMa ltlgtHHaHcHpaHa CDC Qa 0 Hejgl
cpeACTBa OT EBporreHCKHH CbJ03
H~eHTHltIgtHKa~HI Ha npoeKTa
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Methoxy yet ene gl -epoetin beta 060co6eHa Il03lUJllJI NQ 8 2
II22) l1onbJIHHTeJIHH CPV KOAoBe 2
OCHoseH CPV KOp 1 3 692800 UOIlbJIHllTeJ1eH CPV KOp 1 2
II23) MHCTO Ha H3nbJIHeHHe OCHOSHO MHCTO Ha 113nbJIHenlle
6onH~~Ha anTeKa Ha YMBATI KOll NUTS BG341
1124) OnHCaHHe Ha 06weCTBeHaTa nOpblKa (ecTecTBo II KOJIllteCTBO Ha CTPOllTeJ1Hll pa60Tll llOCTaSKllllJlll yCJlyrll llJ111 YKa3saHe na nOTpe6HocTli H
113IICKSaHHH)
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pre-filled syringe 75004meg1299640
1125) KpHTepHH 3a Bb3IIaraHe 1 2 o KpliTepllll3a KaqeCTBO - liMe Te)Kecr 2 20
o KpHTepHH CSbp3aH C pa3XOLlH - liMe Te)KeCT 1 2deg
UeHa shy Te)KeCT 21
II2H) HH(I)OpMa~H OTHOCHO onnHHTe Omllll l1a 0 He ~ OIIllcaHlie Ha OIlUHHTe
IIa13) HH(pOpManHH OTHOCHO cpeACTBa OT EBponeHcKHH Cb103 06ll1eCTBeHaTa nOpblKa e BbB Bpb3Ka C npoeKT 1lllJ111 nporpaMa ltpllHaHclipaHa CbC l1a 0 He ~ CpellCTBa 01 EBpoilellcKHH Ch103
lIlleHTfIltpllKaUIiH Ha npoeKTa
lIa14) l1onbJIHHTeJIHa HHltp0pManHH
PA3LlEJI II OnHcaHHC OOOCOOCHa n03HIlHJI
II a) OnHcaHHe 1
1121) HaHMeHoBaHHe 2
Cina leet 06oco6eHa 1l03HUHH NQ 9 2
IIaa) l1onbJIHHTeJIHH CPV KOAOBe 2
OCHOBen CPV KOll 1 33692800 UollbJlHllTeJIeH CPV KOll 1 2
II23) MJlCTO Ha HSnbJIHeHHe OCHOBHO MHCTO Ha 113IlbJlHeHlle
6onHwIHa ailTeKa Ha YMBAJ] Af( ROll NUTS BG341
1124) OnHcaHHe Ha o6weCTBeHaTa nOpblKa (eCTeCTso H KOJlHqecrso Ha CTPOllTeJ1HH pa60TH lIOCTaBKH llJ111 yCJlyrH llJ1H YKa3BaHe Ha nOTpe6HoCTH II
H311cKBaHllH)
HC5BXOlCinaealeettablets760060mg1536786
1125) KpHTe~HH 3a Bb3J1araHe 1 2 J
YIfl tb203b2~Oa58-42tc~)484~e7aedotae6e4
OnRBlEHI1E 3A Bb3JIOlKEHA nOPblKA (BepCIH 7gt
o KpHTepHH 3a KaIeCTBO - lIMe TeiKeCT 1 2 2deg
o KpIITepIIH CB1gtp3aH C pa3XOll1I - lIMe TeiKeCT 1 2deg
UeHa - TeiKeCT 21
II2U) IIHq0pMauHH OTHOCHO onuHHTe
OIIl1I1I lIaO Helgj
OIII1CaHIIe Ha OI1lHIITe
11213) IIHq0pMauHH OTHOCHO CpelJCTBa OT EBpOnenCKHH Cb103
06~eCTBeHaTa nOp1gt4Ka e B1gtB Bp1gt3Ka C npOeKT IIIIJIII npOrpaMa qHtHaHCHpaHa CDC
CpepCTBa OT EBpOneHCKIIH CDI03
lIlleHTHltpIIKaI~IIH Ha npOeKTa
lIaO He~
11214) lIonbJIHHTeJIHa HHq0PMaUHH
PA3llEJI II OnHCaHHe 06oco6eHa n03HIJHJI
II2) OnHCaHHe 1
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Parica cito1 060c06eHa fl03HlHH NQ 10 2
II22) lIonbJIHHTeJIHH CPV KOlJOBe 2
OCHOBeH CPV KOll 1 33692800 UonDJIHI1TeJIeH CPV KOll 1 2 I
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iOCHOBHO MHC(Q Ha H3fl1gtJIHeHIIe I
OOjlEV1Lf-la aI1TeKa Ha ytvlBATI AU I
KOll NUTS 1 BG341
II24) OnHCaHHe Ha OOllJeCTBeHaTa nOpblKa
(eCTeCTBO H KOJIHIeCTBO Ha CTPOHTeJIHH pa60TII llOCTaBIltH IDIH yCJIyrH IDIII YKa3BaHe Ha nOTpe6HOCTII II
II3IICKBaHllH)
H05BX02Parica1cito1 capsJles soft90002ctcg277
II25) KpHTepHH 3a Bb3JIaraHe 1 2 o KpHTepHH 3a Ka4eCTBO liMe TeiKeCT 1 2 2deg
o KpHTepIIH CB1gtp3aH C pa3XOllH - liMe TeiKeCT 1 2deg
I jgj UeHa - TemeCT 21 I
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OnllHH lIaO He~ OnHcaHIIe Ha onllHHTe
II213) IIHq0pMauHH OTHOCHO CpelJCTBa OT EBponenCKHH Cb103
06~eCTBeHaTa nOpDlKa e B1gtB BpD3Ka C npoeKT IIIDIH nporpata ltpHHaHCHpaHa CDC lIaD He~ cpepCTBa 01 EBponeHCKllH CDI03
lipeHTHltpHKaliHH Ha npoeKTa
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PA3llEJI II OnHcaHHe 06oco6eHa II03HIJHJI
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L(onbIJHHTeJJeH CPV KOl 1 2
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OCHOBHO MHCTO Ha 113nbIJHeHHe
OOJIHY1tJHa dflTeKa Ha YMBAll
KOA NUTS 1 BG 41
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(eCTeCTBO H KOnllleCTBO Ha CTpoHTenHH pa6oTH JlOCTaBKH MH ycnyrH MH YKa3BaHe Ha nOTpe6HOcTli H
113HCKBaHllH)
H05BX02Paricalcit solJtion for ction22500 509840
1125) KpHTepHH 3a Bh3JlaraHe 1 2 o KpwrepliH 3a KaqeCTSO liMe Te)(eCT 1 2 2deg o KpHTepllH CSbp3aH C pa3XOJl1l - liMe Te)(eCT 1 2deg
[(eHa - Te)(ecT 21
11211) IIHlpopMauHH OTHOCHO OIluHHTe
Om~lll1
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lla 0 Heamp
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06meCTBeHaTa nOpblKa e BbB Bpb3Ka C npoeKT HHJIH nporpaMa ltpHHaHCHpaHa CDC lla 0 Heamp CpeJlCTBa OT EsponeiicKl1H CDlO3
lIleHTHltpHKauHH Ha npOeKTa
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L(ollbJIHHTeJleH CPV KOJl 1 2 i I
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H3HCKBaHHH)
H05BX04EtelcalcetideSolution for injection150001mg1438567
1125) KPHTePHH 3a Bh3JlaraHe 1 2 o KpHTepHH 3a KaleCTBO - liMe Te)(eCT 1 2 20
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06meCTIleHaTa nopb4Ka e BbB BpD3Ka C npoeKT HMH nporpaMa ltpHHaHClipaHa CDC lla 0 He 1amp1 I
cpencTBa OT EsponeHCKHH CblO3
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OCHOBeH CPV KO[( 1 33692800 [(OI1bJIHI1TeJIeH CPV KO[( 1 2
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OOflHHLHa aITeKa Ha YMEAJl ac AD KO[( NUTS 1 BG341
1124) OllHcaHHe Ha 061IJeCTBeHaTa llOpbtlKa (cCTecTBo H KOJIH4eCTBO Ha cTpoHTeRHH pa6oTH [(OCTaBKH HJIH yCJIyrH I1RH YKa3BaHe Ha rroTpe6HocTH H H3HcKBaHHR)
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D KpHTepllH 3a Ka4eCTBO liMe Temecr 1 2 2 0
D KpllTepllH CBhp3aH C pa3XO[(H - liMe Temecr 1 2 0
I ~ UeHa - TemeCT 21
11211) HHfpopMaIQIJI OTHOCHO OlllQlHTe OrrQllH
OrrHcaHHe Ha OmlHHTe
j]a D Hel8l
11213) HH4gtOPMauHH OTHOCHO cpeACTBa OT EBpOlleHCKHH CblOa 061llecrBeHaTa rrOpb4Ka e BbB Bpb3Ka CrrpoeKT llHJIll nporpaMa ltpHHaHCHpaHa CDC
cpe[(CTBa OT EBporreiicKHH CDI03
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PA3l1EJI II OnHcaHHe 06oco6eHa n03HDHlI
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1I21) HaHMeHOBaHHe 2
Ca c rl 1 06oco6eHa 1103HQllR NQ 14 2
1I22) j]OllhJIHHTeJlHH CPV KOAOBe 2
OCHOBeH CPVKOA 1 336928 00 [(orrbJIHHTeneH CPV KOA 1 2
1I23) MJlCTO Ha HallhJIHeHHe OCHOBHO MHCTO Ha M3fibJIHeHMe
60flHHLHa anTeKa Ha YMBlJl EypIa AJ
KOll NUTSl BG3 1
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H3HcKsaHHR)
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1125) KpHTepHH aa Bb3JIaraHe 1 2 K T~~~ 1 2 2 0
VHH tn2m3b2-0a5X~42cc-q484-e7aedOf3e6e4
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II213) HHqOpMaQHH OTHOCHO CpetJCTBa OT EBpOneHCKHH CblOa
06~eCTBeHaTa nOpblKa e BbB BpbSKa C npOeKT lllUIH npOrpaMa ltpllHaHclipaHa CbC
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roperrOCOIeHOTO 06RBJIeHlle 3a nOpbIKa
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06HBJleHHe aa npetJBapHTeJIHa HHqopMaQHH
D Bb3JIaraIIJHRT opraH HRMalla B1gt3JIara nOBeIe IlOpbIKH B1gt3 OCHOBa Ha roperrOCOIeHOTO 06RBJIeHlle sa
npellBapllTeJIHa llmj)OPMaIJllR
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Ol106peH C aKT Ha MHHHCTePCKHR CbBeT no npelVIOJKeHHe Ha MHHHCTbpa Ha cpHHaHCHTe
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DOT [(OCTaB4HK KOMTO OKOHqaTeJIHO npeKpaTRBa CBORTa CTonaHCKa AeiiHoCT
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KOHKYpca 3a npoeKT IIpaBHJIa Ha II06eAHTeJlR HJlH Ha eAHH OT II06e[(HTeJlHTe B Hero
OHe06xo[(HMO e HeOTJlOJKHO Bb3JlaraHe Ha IIOphqKaTa nOpallH H3KJIIOIHTeJIHH 06CTORTeJICTBa
npeAH3BHKaHH OT Ch6HTHR KOHTO He MoraT Aa 6hllaT npe[(BHLeHH OT Bh3JIOJKHTeJlR H He e Bh3MOJKHO
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3aKOHOCbo6pa3HO KaTO lIOC04HTe CbOTHOCHMHTe cpaKTH H KoraTO e YMeCTHO npaBHHTe 3aKJIIOQeHHR B
CbOTBeTCTBHe ChC 30I1 (MaKcHMYM 500 AYMH)
Bh3JlarawHRT opraHBh3JlOJKHTeJlRT HOCH oTroBopHoCT 3a rapaHTHpaHe Ha cna3BaHe Ha
3aKOHOAaTeJICTBOTO Ha EBponeHcKHR Cb103 H Ha BCHIKH npHJIOJKHMH 3aKOHH
MOIlR nOBTOpeTe KOIlKOTO nbH1 e Heo6xollI1MO
B npl11l0lKI1MI1Te CIlY4al1
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YHn to2033b2~Oa58~421middotc~9484~e7aedOfae6e4 In
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HRMa oltpepTH HJIH HRMa nOllXOllR~H 0ltpepTH3aHlJleHHR 3a yqacTHe B oTrOBop Ha
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llHpeKTHBaTa (caMO 3a llOCTaBKH)
CTPOHTeJlCTBOTO llOCTaBKHTe HllH YCJlyrHTe MoraT lla 6hllaT npellOCTaBeHH Cal1O OT onpelleJIeH
HKOHOMHIeCKH onepaTop nOpallH CJlellHaTa npHIHHa
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KOHKypca 3a npoeKT npaBHlla Ha n06ellHTeJlH HllH Ha ellHH OT n06ellllTeJIHTe B Hero
DOcHIYPRBaHe Ha llOCTaBKH KOHTO ca KOTHpaHH H 3aKyneHH Ha CTOKOBa 60pca
IIoKYIlKa Ha llOCTaBKH HJIH yCJlym I1pH oco6eHO H3rOllHH YCJlOBHR
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(MaKcHMYM 500 AYMH)
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OElIlLlEfUlElA BbJIOJKEHA flOP [11 (HltPC 7)
nPHJIOiKEHHE rS - OBIIJECTBEHH nOPbQKH HA HHCKA CTOHHOCT OCHOBaHHH 3a Bb3JIaraHe Ha nOpblKa Ipe3 npHKO AorOBapHHe
3011
(MOJIH H36epeTe CbOTBeTHaTa OnlJHH H npeACTaBeTe 06HCHeHHe)
1 OCHOBaHHR 3a H360p Ha npOlellypa Ha npRKO lIOrOBapRHe
CTpOHTeJICTBOTO lIOCTaBKHTe HJIH yCJIynne MOraT lIa 6bllaT UpellOCTaBeHH CalVlO OT OnpelleJIeH
HKOHOMH4eCKH OnepaTOp rrOpallH CJIe[(HaTa npH4HHa
OOTCbCTBHe Ha KOHKYPeHlHR nOpallH TeXHH4eCKH npH4HHH
006weCTBeHa rrOpb4Ka C leJI Cb3l1aBaHe HJIH npHlIo6HBaHe Ha YHHKaJIHO rrpOH3Be[(eHHe Ha H3KYCTBOTO
HJIH TBOp4eCKO H3nbJIHeHHe
03awHTa Ha H3KJl104HTeJIHH npaBa BKJIlOqHTeJIHO npaBa BbPXY HHTeJIeKTyaJIHa C06CTBeHOCT
03a YCJIymjCTOKH 3a HayqHOH3CJIellOBaTeJICKa H pa3BOHHa [(eHHOCT UpH CTpOfHTe YCJIOBHR YKa3aHH B
30I1 (CaMO 3a AOCTaBKH)
OnOllbJIHHTeJIHH AOCTaBKH OT llbpBOHa4aJIHHR lIOCTaBqHK Bb3JlOJKeHH llpH YCJIOBHRTa YKa3aHH B 30I1
OI1pe[(MeT Ha nOpbqKaTa e lIOCTaBKa Ha CTOKa KORTO ce TbpryBa Ha CTOKOBa 60pca CbfJIaCHO CnHCbK
Ol106peH C aKT Ha MHHHCTePCKHR CbBeT no npelVIOJKeHHe Ha MHHHCTbpa Ha cpHHaHCHTe
I10KynKa Ha [(OCTaBKH HJIH yCJIyrH npH oc06eHO H3rO[(HH YCJIOBHR
DOT [(OCTaB4HK KOMTO OKOHqaTeJIHO npeKpaTRBa CBORTa CTonaHCKa AeiiHoCT
DOT JIHKBHLaTOpH HJIH CHHAHlH npH HeCbCTORTeJIHOCT crropa3YMeHHe C KpelunOpH HJIH CXOllHa
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OUOpbqKaTa e 3a yCJIyfH npeAXOJKlaHa OT KOHKYpC 3a IIpOeKT Bh3JlOJKeHa CbrnaCHO npeABHLeHl1Te B
KOHKYpca 3a npoeKT IIpaBHJIa Ha II06eAHTeJlR HJlH Ha eAHH OT II06e[(HTeJlHTe B Hero
OHe06xo[(HMO e HeOTJlOJKHO Bb3JlaraHe Ha IIOphqKaTa nOpallH H3KJIIOIHTeJIHH 06CTORTeJICTBa
npeAH3BHKaHH OT Ch6HTHR KOHTO He MoraT Aa 6hllaT npe[(BHLeHH OT Bh3JIOJKHTeJlR H He e Bh3MOJKHO
cna3BaHe Ha cpOKOBeTe IIO 4Jl 178 aJI 2 H 3 OT 30I1
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2 06HCHeHHe
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CbOTBeTCTBHe ChC 30I1 (MaKcHMYM 500 AYMH)
Bh3JlarawHRT opraHBh3JlOJKHTeJlRT HOCH oTroBopHoCT 3a rapaHTHpaHe Ha cna3BaHe Ha
3aKOHOAaTeJICTBOTO Ha EBponeHcKHR Cb103 H Ha BCHIKH npHJIOJKHMH 3aKOHH
MOIlR nOBTOpeTe KOIlKOTO nbH1 e Heo6xollI1MO
B npl11l0lKI1MI1Te CIlY4al1
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MOlKe Ila 6blle npl1CblleHa 3Ha411MOCT BMeCTO TelKeCT 21 MOlKe Qa 6bQe npl1CblleHa 3Ha411MOCT BMeCTO TelKeCT aKO 4eHaTa e ellI1HCTBeHI1RT
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YHn to2033b2~Oa58~421middotc~9484~e7aedOfae6e4 In
OElIlLlEfUlElA BbJIOJKEHA flOP [11 (HltPC 7)
nPHJIOiKEHHE rS - OBIIJECTBEHH nOPbQKH HA HHCKA CTOHHOCT OCHOBaHHH 3a Bb3JIaraHe Ha nOpblKa Ipe3 npHKO AorOBapHHe
3011
(MOJIH H36epeTe CbOTBeTHaTa OnlJHH H npeACTaBeTe 06HCHeHHe)
1 OCHOBaHHR 3a H360p Ha npOlellypa Ha npRKO lIOrOBapRHe
CTpOHTeJICTBOTO lIOCTaBKHTe HJIH yCJIynne MOraT lIa 6bllaT UpellOCTaBeHH CalVlO OT OnpelleJIeH
HKOHOMH4eCKH OnepaTOp rrOpallH CJIe[(HaTa npH4HHa
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006weCTBeHa rrOpb4Ka C leJI Cb3l1aBaHe HJIH npHlIo6HBaHe Ha YHHKaJIHO rrpOH3Be[(eHHe Ha H3KYCTBOTO
HJIH TBOp4eCKO H3nbJIHeHHe
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03a YCJIymjCTOKH 3a HayqHOH3CJIellOBaTeJICKa H pa3BOHHa [(eHHOCT UpH CTpOfHTe YCJIOBHR YKa3aHH B
30I1 (CaMO 3a AOCTaBKH)
OnOllbJIHHTeJIHH AOCTaBKH OT llbpBOHa4aJIHHR lIOCTaBqHK Bb3JlOJKeHH llpH YCJIOBHRTa YKa3aHH B 30I1
OI1pe[(MeT Ha nOpbqKaTa e lIOCTaBKa Ha CTOKa KORTO ce TbpryBa Ha CTOKOBa 60pca CbfJIaCHO CnHCbK
Ol106peH C aKT Ha MHHHCTePCKHR CbBeT no npelVIOJKeHHe Ha MHHHCTbpa Ha cpHHaHCHTe
I10KynKa Ha [(OCTaBKH HJIH yCJIyrH npH oc06eHO H3rO[(HH YCJIOBHR
DOT [(OCTaB4HK KOMTO OKOHqaTeJIHO npeKpaTRBa CBORTa CTonaHCKa AeiiHoCT
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OUOpbqKaTa e 3a yCJIyfH npeAXOJKlaHa OT KOHKYpC 3a IIpOeKT Bh3JlOJKeHa CbrnaCHO npeABHLeHl1Te B
KOHKYpca 3a npoeKT IIpaBHJIa Ha II06eAHTeJlR HJlH Ha eAHH OT II06e[(HTeJlHTe B Hero
OHe06xo[(HMO e HeOTJlOJKHO Bb3JlaraHe Ha IIOphqKaTa nOpallH H3KJIIOIHTeJIHH 06CTORTeJICTBa
npeAH3BHKaHH OT Ch6HTHR KOHTO He MoraT Aa 6hllaT npe[(BHLeHH OT Bh3JIOJKHTeJlR H He e Bh3MOJKHO
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ChweCTBeHO npOMeHeHH
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006weCTBeHaTa nOphlKa e 3a yCJIym lIO lIpHJlOJKeHHe NQ 2 H e Ha CTOI1HOCT no )] 20 aJI 2 T 2 OT 30I1
2 06HCHeHHe
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3aKOHOCbo6pa3HO KaTO lIOC04HTe CbOTHOCHMHTe cpaKTH H KoraTO e YMeCTHO npaBHHTe 3aKJIIOQeHHR B
CbOTBeTCTBHe ChC 30I1 (MaKcHMYM 500 AYMH)
Bh3JlarawHRT opraHBh3JlOJKHTeJlRT HOCH oTroBopHoCT 3a rapaHTHpaHe Ha cna3BaHe Ha
3aKOHOAaTeJICTBOTO Ha EBponeHcKHR Cb103 H Ha BCHIKH npHJIOJKHMH 3aKOHH
MOIlR nOBTOpeTe KOIlKOTO nbH1 e Heo6xollI1MO
B npl11l0lKI1MI1Te CIlY4al1
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3allblllKl1TellHa I1HQgtOPMa4I1R KORTO He ce ny61ll1KYBa
MOlKe Ila 6blle npl1CblleHa 3Ha411MOCT BMeCTO TelKeCT 21 MOlKe Qa 6bQe npl1CblleHa 3Ha411MOCT BMeCTO TelKeCT aKO 4eHaTa e ellI1HCTBeHI1RT
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YHn to2033b2~Oa58~421middotc~9484~e7aedOfae6e4 In