Upload
others
View
6
Download
0
Embed Size (px)
Citation preview
~) )1,0 "CiiAJI03- CO<DIUI OliJIACT" EOO)J, rp.CmJJuH, 6yJI. "CroJieTOB" .N!! 67
TEXHifqECKO llPE)l,JI OJKEHIIE
3a yqacTHe B OTKpHTa rrpoue.nypa 3a B'b3rraraHe Ha o6mecTBeHa rropo'-!Ka c rrpe.nMeT:
IIPHJI OJKEHIIE .N2 2 06pme4
")l,ocTaBKa ua JieKapcTseuu npo)J.yKTH Ja HYJKAHTe ua "CneuuaJiulnpaua 6oJiuuua Ja aKTHBHO Jie'-lenue ua OHKOJioruquu Ja6ommanuH - Co!J»uH o6JiacT" EOO~ no o6oco6euu noJuuuu"
06oco6eua nOJHUHH N!! 196 rmoKOJa I HaTp.XJIOpH)J., 500ml. nJI. 6anKa napeuTepaJiua cbopMa [u3nucea ce 1-/0Mepa u HQUMei-I06QUUemo 1/Q
o6oco6e1-tama no3Ul-fU5L]. , <l>bOHI1KC <l>apMa" EOO,[{ c EI1K: 203283623, perHCTpauiDI no ,[{,[{C: , coc ce.naJIHme 11 a.npec Ha ynpaBneHHe rp. Co<jmH 1700, paH:oH p-H CTy.neHTCKH, yn. "OKonospocTeH noT" N!! l99A,Ten.:02/96581 OO,¢aKc:02/9658172, e-mail: [email protected], I1HTepHeT CTpaHHua: http://www.phoenixpharma.bg ,a.npec Ja KopecnoH.neHUHH: fp. Co<iJHH 1700, o6nacT Co¢m1, o6tUHHa CTOJlHYHa, p-H CTy.neHTCKH, yn. "OKonoBpocTeH noT" N!! 199a TenecpoH Ja KOHTaKm: 02 I 965 81 09; <l>aKc: 02 /965 88 28; e -mail: kr.nikolae•@phoenixplwrma.bg, I1HTepHeT a.npec: http://www.phoenixpharma.bg/ ,6aHKOBa cMeTKa: BG91 UNCR96601 030899522, npe.ncTaBJT51BaHo OT KpacHMHp HHKonaes HHKonaes, EfH 7712023968, Ha .[{Jlo)KHOCT ,[{HpeKTop EonHH4eH naJap H ,[{aHHerra ITeTposa HHKorrosa, EfH 7106114033 Ha .[{Jl'h)KHOCT Marwcop <l>apMauesT EonHHlfeH naJap, B Ka'-!eCTBOTO HH Ha nonHOMOW:HHUH Ha yrrpaBHTemne Ha "<l>bOHI1KC <l>apMa" EOO,D,
YBAJKAEMA rOCIIOJKO YIIP ABIITEJI,
Crre.n JanoJHasaHe c .ll:OK)'MeHTal.{H51Ta 3a yqacTHe s OTKpwra opoue.nypa 3a B'h3narm-re Ha o6tUeCTBeHa rropol.!Ka c rrpe.nMeT: ")l,ocTaBKa na
JieKapcTBenu npo)J.yKTH Ja uy:>K)J.HTe ua "CneuuaJIHlHpaua 6oJiunua Ja aKTHBHO Jie'-lenue ua OHKOJioruquu Ja6oJIHBanuH - Co«jJuH
o6JiacT" EOO)J, no o6oco6euu noJuuuu", cMe corrracHH c nocTaBeHHTe oT Bac ycrroBH51 H rH npHeMaMe 6e3 Bo3p3)1{eHHX.
c H3CTOS!IJJ:OTO BH npe.ncTaB51Me HaweTo npe.[{JlO)KeHHe 3a H3IToJ1HeHHe Ha nopoqKaTa no 06oco6eua DOJHUHH .N! 196 r JIIOKOJa I
naTp.xJiopu)J., SOOml. nJI. 6anKanapeunpaJiua <bopMa U3nucea ce IIOMepa u T-LauMertaemtuemo ua o6oco6eT-Lama no3UZJUfl], npH cne.nH
YCJTOBH51:
1. CpoKOBe no o6mecTBenaTa nopbt.JKa:
~) 1 . 1 . CpOK 3a H3ITbJIHeHHe Ha IIOpb':IKaTa- 12 (ABaHa)leCeT) Meceua, C':IHTaHO OT )laTaTa Ha CKJIIO':IBaHe Ha )lOfOBOpa HJIH
113TH':IaHe/ rrpeKpanmaHe Ha rrpe)lXO)lHO CKJIIO':IeHH~ )lOfOBOp CbC CbmHH rrpe)lMeT, KOeTO OT Cb6HTH~Ta HaCTbiTH IIO-KbCHO.
1 . 2 . CbrJlaCHM CMe )la )lOCTaBHMe JieKapCTBeHHTe npO)l)'KTM, npe)lMeT Ha Il03Jfl{HJ1Te, 3a KOHTO yqacTBaMe, B CpOK )lO:
ue noee4e om 48 4aca qaca cne)l rronyqasaHe Ha rrHCMeHa 3a5lsKa, BKJIIO':IHTenHo H3rrpaTeHa no <jJaKc, en. noma HJIM )lpyr, 113pH'IHO
)lOfOBOpeH C aHeKC KbM AOfOBOpa Ha':IHH Me)K)ly CTpaHMTe - 3a peryJt51pH11 3a51BKH. DpH >KeJlaHHe OT CTpaHa Ha Bb3JIO)KHTeJI~ peryJIHpHl1Te
)lOCTaBKH me M3BbpwsaMe no yrosopeH rpa<jJHK.
ue noee4e om 2 4aca qaca cne)l nonyqasaHe Ha 3a51BKa OT B'b3JIOlKIITEJHl, oTrrpaseHa BKJUO':IHTeJIHO no cpaKc, en. noma HJIH .llpyr,
H3pH':IHO )lOfOBOpeH C aHeKC K'bM )lOfOBOpa Ha':IHH Me)l(LJ:Y CTpaHHTe, a npH He06XO)lHMOCT - H nO TenecpoH- 3a CIIellJHH 3a51BKH
)J,OCTaBKHTe )lO onpe)leJieHOTO OT Bb3Jl0)KHTeJI51 cppaHKO M51CTO 3a )lOCTaBKa, me 113Bbpll1BaMe B pa60THM )lHH, OT 08.00 )lO 16.00 qaca. B cnyqaif Y:e cpoKbT 3a ,nocTaBKa H3TH':Ia s Hepa6oTeH )leH, .nocTaBKaTa cne)lsa )la ce H3IIbJ1HH HaH-KbCHO s nbpBHH pa6oTeH )leH,
cne)lsam )leHH, s KOHTO H3THY:aT cpoKoseTe.
Dp11 113pHY:HO yKa3aHHe OT cTpaHa Ha Bb3JIO)I<HTeJ151 me )lOCTaBHM 3a51BeHHTe npH cnernHH 3aHBKH KOJIHY:eCTsa H3BbH yKa3aHH51 no-
rope Y:acoBH )lHarra3oH. ~
CbrnacHH cMe )la )lOCTaB51Me neKapCTBeHHTe rrpo)lyKTH, npe)lMeT Ha no3HUH51Tahne, 3a KOHTO yy:acTsaMe, Cb06pa3HO npe)lsapHTenHo
yrosopeH rpa<jJHK, npH )](eJiaHHe OT CTpaHa Ha B1l3JIO>KHTeJ151. ~
2.MBCTO Ha H3UbJIHenue:
<t>paHKO MHCTOTO Ha )lOCTaBKa no HacTo.simaTa nopb'IKa, s qacTTa H: / o6oco6eHHTe no3HQHHI , 3a KOHTO Y'-IaCTBaMe, me
6b)le:"Crreu;~-faJIH3HpaHa 6oJIHHUa 3a aKTHBHO neqeHHe Ha OHKonorH':IHH 3a6o~saH1151 - Co<jJHH o6nacT" EOO)J,, rp.CocpHH 1123, 6yn.
,CToneTos" N2 67, AnTeKa
3.TexnuqecKnTe xapaKTepucTHKH Ha npe)lnaraHHTe OT Hac neKapCTseHH npo)lyKTH no 06oco6eHa no3HUH51 N2 196 ca no)lpo6Ho
onHcaHH B Ta6nH':IeH BHA B H3rOTBeHoTo no o6pa1eua Ha DpHJlO)l(eHHe N2 2.1. 196 "CrreuHcpHKaQH51 no 06oco6eHa rro3HUH51 N2 196", Hepa3)leJIHa ':laCT OT HaCTOHI.IJ.OTO TeXHH':IeCKO npe)lJIO)l(eHHe.
4. KaqecTBO u cpoK ua ro.nuocT ,[(eKnapHpaMe, Y:e rrpe)lnaraHHTe OT Hac neKapcTBeHH rrpo)lyKTH:
• Ca pemcTpHpaHH 33 ynoTpe6a B CTpaHaTa H npHTeJKaBaT pa3pelllHTeJ1HH 3a ynoTpe6a, CbfJiaCHO 3JJIJXM, rrpMTe)l(aBaT
cepTH<jJHKaTH, YAOCTOBepHBall(H Ka':leCTBOTO Ha rrpo)lyKTHTe, JlHnCBaT O<jJHQHaJIHH Cb06Il(eHH51 HJlH orpaHH':IHTeJIHH MepKH 3a
ynoTpe6a Ha neKapcTBeHHTe npo)lyKTH;
• OTfOBapHT Ha HOpMaTHBHO ycTaHOBeHHTe H3HCKB3HHH 3a Ka':leCTBO H esponeHCKH CTaH)lapTH.
~ • OTfOBap51T Ha CbOTBeTHHTe L{eHCTBall.(H HOpMaTHBHH 113HCKBaHH5I 3a rrpOL{a)l(6a - BaJIHL{HH pa3perneHI15I 3a yrrotpe6a H UeHa,
<j:>opMapaHa s cbornercTBHe c 113HCKBaHH.HTa Ha Hapen6ara 3a ycnosa5ITa, rrpan11nara H pena 3a perynHpaHe H
perHCTpHpaHe Ha UeH!fTe Ha JieKapCTBeHHTe rrpo,D,yKTif.
,[(eKnapHpaMe, qe rrpH JJ:OCTaBKaTa Ha neKapcTBeHHTe rrponyKTH, ll.(e ce cbo6pa35IBaMe c H3HCKBaHH5ITa Ha Hapen6a N2 39 or 13
cerrTeMBpH 2007 r. 3a npHHUHTIHTe H Jf311CKBaHH5ITa 3a L{06paTa ,D,HCTpH6yTOpCKa npaKT!fKa.
fapaHTHpaMe L{OCTaBKH C OCTaTblfeH CpOK Ha 10,D,HOCT KbM L{aTaTa Ha ,D,OCTaBKa He TIO-MaJibK OT 60% OT CpOKa Ha fO,D,HOCT, YKa3aH Bbpxy
OTiaKOBKaTa Ha CbOTBeTHH51 npOJJ:YKT.
5. OnaKOBKa u MapKuponKa IJpeL{JiaraHHTe OT HaC MeL{Hl(HHCKH H3L{eJIH5I Ca B CbOTBeTCTBHe C H311CKBaH!f5ITa Ha Bb3JIO)I(HTeAA H npH ,D,OCTaBKaTa ll.(e OTfOBapH Ha
H311CKBaHif5ITa H ll.l,e 6b,D,aT:
• OIIaKOBaHH B OpHrHHaJlHa onaKOBKa Ha I1pOH3BOL{HTeml, CbC CbOTBeTHaTa MapKapOBKa 3a npOH3BOL{I1TeJl 11 rrapTHL{HH
HOMepa, C HaHeCeHa "CE" MapK11pOBKa, HaHeCeH HL{eHTHC~HKal(HOHeH HOMep Ha HOTH<j:>lfl(HpaHH5! OpraH, KOfaTO TaKbB Ce
lf31fCKBa OT L{eHCTBall(OTO 3aKOHOL{aTeJICTBO, KaTO C TIOCTaBeHa MapKHpOBKaTa ll.l,e e TIOCTaBeHa Ha BCeKH KalliOH, CbOTBeTHO - Ha
BC5IKa OTiaKOBKa. ~ • OTiaKOBaHJf B oparHHaJIHaTa OIIaKOBKa Ha npOH3BOL{HTeml, C HeHapyrueHa U5IJIOCT, 6e3 ,D,a Ca MOKpH.
• OIIaKOBaHH ITO Ha4HH, KOHTO r11 3alla3Ba OT BC5!KaKBH IIOBpeJJ:H , ,D,bJI)Kall(Jf ce Ha aTMOC<j:>epHH YCJIOBH5I H TpaHCIIOpT. ~
I.IJ:e H3IIbJIHHM rrpe.nMera Ha noronopa B ITbJIHO CbOTBeTCTBHe c H31fCKBaHH5ITa Ha 8b3JIO)I(HTemi, rrocolfeHH B TexHHlfeCKHTe
cneuHqmKaUHH 11 JJ:OK)'MeHTaUHHa 3a yqacnre.
K LM uacroHmoTo TexuuqecKo npeUJIO)Keuue npuJiaraMe: 1. ITpHJIO)I(eHJfe N2 2.1. 196"CneuHciJMKal(H5I no 06oco6eHa rro3Hl(lf5I N2 196"
IIOlliiHC
3
I
No Ha o6oco6 eHaTa
n03MW1 R
1
196
TipRJlO)I(eHHe NQ 2.1.
~) K'bM TipHJlO)I(eHRe NQ 2 "TexHwiecKo npeAJlO)I(eHHe"
Cneu.ucJmKaU.HH no o6oco6eua noJHU.HH .N"!! 196 OT npou.etJ.ypa Ja B"hJJJaraue ua o6mecTBeua nop"L'lKa c npeJlMeT: ",l.J,ocTaBKa ua JieKapcTBeuu npotJ.yKTH Ja uyiK)J,nTe ua
"CneuuaJJu3upaua 6oJJuuu.a Ja aKTHBHO JJe'leuue ua ouKoJJorH'lHH Ja6oJIHBaHHH- Coc)mH o6JJacT" EOO,ll, no 50 o6oco6euu noJHQnn"
. JleKapcrseHa npeAJ18r8H8 cpopMa PecpepeHTHa npc>nro3Ho pa3cpacoeKa,
AH8TOMO- '~-' lnOCO'IeHaTa CTOMHQCT38 '' K6nl4'-le¢TBO Komt'leCTBO
Tepaneant\leH MeJKAyttapo;&Ho HenaTeHT~o OT DDO/ /C"bmaCHo TbproacKo H8MMeHOB8HMe I MIMJ1M 6pollt B npOM3BOAMTeJ1/n
H81o1MeHdeaHMe /INN/ Bb3110)f(Ml"emt TepaneBTr.NeH cn~cf.J~~~tKSW1 On8KOBK8T8 pMTelKaTen PY KOA /ATC-KoAf $'
B K)'pc . 11T8H8 "' npeAJlaraHa cneW'!cpMKa~H ~"B"b3110>KHTenR/ J19K8pCTB9H8
RTa/ .·;. d>opMa 2 3 4 5 ;:;- 6 7 8 9
C05BB56 rntOK03a I Harp.XIlOPI'IA, napeHrepanHa
1,36 1000 Serum glucosae sol. 500 ml B.Braun
500ml. nn. 6aHKa cPOPMa
3a6eJJe)I(Ka: C1-mara •meT or ra6n11uara ce nonbJJBa or cneuH<j>HKaUH.HTa Ha Bb3JJO)I(HTen.H - npHJJO)I(eHHe KbM .uoKyMeHTaUH.HTa - KOJJOHH A - G. B JlHCHaTa/)l(bJJTa 'lacr ce nonbJJBaT .uaHHHTe 3a npennaraHHH or yLJaCTHHKa npo.uyKT.
20.05.2016 r. llOllllMC
llEqAT
KpacHMHp HHKonaes HH /TibJlHOMOJ.IJ;HHK Ha" <f>b
0TOpH38L!, Mfl: ,QA I
HE
10
AA
~
~) )1;0 "CliA.JI03- CO<IliUI OliJIACT" EOO,ll, rp.Cocjmn, 6yJI. "CTOJICTOB" .N'2 67
TEXHHlJ:ECKO IIPE.l(JIOJKEHIIE
3a yqacn1e B OTKpiiTa npoueAypa 3a Bb3JiaraHe Ha o6mecTseHa nopb'IKa c npe,ll,MeT:
IIPHJIOJKEHIIE .N2 2 06pme14
")];ocT3BK3 H3 JieK3pCTBeuu npoJJ.yKTH 33 HYiKJJ.UTe H3 "Cneu,uaJIH3Hp3H3 6oJIHHU,3 33 3KTHBHO Jie11euue ua onKoJiorn"IHH 336omiBaHHH
- Cocllun o6JI3CT" EOO,n: no o6oco6euu no3uu,uu" 06oco6eua n03HgHH .N'!! 197 rmoK033 5% 500 MJI, DJI. 63HK3 napeuTep3JIH3 cbOpM3 [U3nUC6Q Ce 1-IOMepa U HQUlvteH06Ql-IUemo IIQ o6oco6eHama no3UlJUfl]. ,<l>bOHHKC <l>apMa" EOO)J; c EHK: 203283623, pemcTpaUJUI no LJ:,D.C: , c'bc ce.namn.u:e II a.upec Ha ynpasneHHe rp. Co<l>II51 1700, paifoH p-H CTy.LJ.eHTCKll, yn. "OKoJioBpncTeH II'hT" NQ 199A,Ten.:02/9658100,<l>aKc:02/9658172, e-mail: [email protected], 11HTepHeT cTpaHHu,a: http://www.phoenixphanna.bg ,a.LJ:pec 3a KopecnoH.LJ:eHIJ,II51: fp. Co4Jmr 1700, o6nacT Co¢1151, o6mHHa CToJIHIJHa, p-H CTy.LJ:eHTCKH, yn. "OKonospncTeH noT" NQ 199a
Tene4JoH 1a KOHTaKTH: 02 I 965 81 09; <l>aKc: 02 /965 88 28; e -mail: [email protected], 11HTepHeT a.D.pec: http ://www.phoenixpharma.bg/ ,6aHKOBa cMeTKa: BG91 UNCR96601030899522, npe.ucTasmrnaHo oT KpacHMHp HllKonaes HaKonaes, EfH 7712023968, Ha .LJ:JI'h)I<HOCT ,lJ;HpeKTOp I>onHH'IeH rra3ap 11 ,D;amrena OeTposa HHKonosa, EfH 7106114033 Ha .LJ.JI'h)I(HOCT Mamcnp <l>apMauesT I>onHH'IeH rra3ap, B KaqecTBOTO HH Ha II'hJIHOMOIUHHUH Ha yrrpaBMTeJlHTe Ha "<l>bOHHKC <l>apMa" EOO)J,
YBAJKAEMA rOCIIOJKO YIIP ABIITEJI,
Cne.u 3arro3HaBaHe c .uoKyMeHTaUH51Ta 3a y•-mcTHe B OTKpHTa npoue.uypa 3a B'h3JiaraHe Ha o6mecTBeHa rrop'h'IKa c npe.uMeT: ".l(ocT3BKa H3
JieK3pcTseuu npOJJ.YKTH 33 HYiKJJ.UTe H3 "Cneu,u3JIH3Hp3H3 6oJIHJt.U.3 1a 3KTHBHO Jie'lenue H3 oHimJioruqun 3360JIHB3HHH - CociJuH
o6JI3CT" EOO,n: no o6oco6euu no3uu,uu", cMe comacHH c ooCTaBeHHTe OT Bac ycnoBH51 H rll rrpHeMaMe 6e3 Bb3pa)l(eHmL
C HaCT051DJ.OTO 811 rrpe.LJ:CTaB51Me HaweTo npe.uno)l(eHHe 3a H3II'hJIHeHHe Ha nopb'IKaTa no 06oco6en3 no1uguH .N!! 197 rmoK033 5% 500
MJI, nJJ. 63HK3n3peuTepaJIH3 d!opMa uJnucea ce HOM epa u 1-tawweHoeauuemo Ha o6oco6e1-1ama no3UlJUfl ] , rrpH cne.umne ycnoBH51:
1. CpoKoBe no o6m.ecTBeH3T3 nopb'IK3:
1 . 1 . CpoK 3a H3ri'hJIHeHHe Ha nopo'IKaTa- 12 (.unaHa.ueceT) Meceua, cqJnaHo OT .uaTaTa Ha CKJIIO'IBaHe Ha
H3TH'IaHe/npeKpaT51BaHe Ha npe)J.XO.[(HO CKJTIO'IeHH51 .[{OfOBOp CbC CblUM51 npe.[(MeT, KOeTO OT Cb6HTH51Ta HaCTbriH UO-KbCHO.
1. 2. ComaCHH CMe Jla~e neKapcTBeHHTe npO!lYKTH, rrpei{MeT ua ll03HUHHTe, 33 KOHTO yqaCTBaMe, B CpOK JlO:
ue noeelle om 48 IJaca qaca cne.n nonyqasaHe Ha rii1CMeHa 3aSIBKa, BKJllOLJinenHo 113rrpaTeHa no <)JaKe, en. rroma 111111 .npyr, 113pwmo
)lOfOBOpeH C aHeKC KbM )J;OfOBOpa HaLJI1H Me)K,Uy CTpaHI1Te - 3a perynSipH11 3aSIBKH. J1pH )KeJiaHHe OT CTpaHa Ha Bb3J10)KH.TeJ1SI peryJISipHine
)lOCTaBKI1 me H3BbplllBaMe ITO yrosopeH rpaQJHK.
1-1e noee!Je om 2 '-/aca LJaca cnea nony'-raBaHe Ha 3aSIBKa or Bb3JIOJKHTEJUI, OTrrpaseHa BKJlJOLJHTeJIHO no <PaKc, en. noma HJIH apyr,
H3pwmo aorosopeH c aHeKc KbM aorosopa HaLJHH Me)K.n:y crpaHH.re, a np11 Heo6xo.LJ:H.Mocr - 11 no rene¢oH- 3a cnernHI1 3aSIBKH
~OCTaBKHTe )J;O onpe)leJleHOTO OT Bb3J10)KHTeml <lJpaHKO MSICTO 3a )lOCTaBKa, me H3BbplllBaMe B pa60THH )lHH, OT 08.00 )lO 16.00
qaca. B cnyqali qe cpOK'hT 3a aocTaBKa H3THqa s Hepa6oTeH .neH, aocrasKara cneasa aa ce 113II'hJIHI1 HaM-K'hCHo s nnpBHSI pa6oreH .neH,
cneasam aeHSI, s Kotiro H3TH4ar cpoKosere.
J1p11 H3pH'-JHO yKa3aHHe OT CTpaHa Ha B'b3JIO)!(J1TenSI me ,UOCTaBI1M 3aSIBeHHTe npH CIIeWH11 3aSIBKH KOJIHLJeCTBa 113B'bH yKa3aHHSI no
rope qacos11 .LJ:I1ana30H.
CbrnacH11 CMe .na .nocraBSIMe rreKapcTBeHHTe npo.n:yKT11, npe.nMeT Ha rro3HUHSITaiine, 3a KOHTO yqacrsaMe, cbo6pa3HO npeasap11~TJIHO ·
yrosopeH rpa<)J11K, np11 )!(enaHH.e OT crpaHa Ha B'h3J10)l(I1Ten5!.
2.MBCTO Ha HlflbJIHCHHe: ~
cDpaHKo Msrcroro Ha .nocrasKa no HacroSimara nopnL£Ka, s qacrra I1 /o6oco6eHI1Te no3MLU-m/, 3a KOSlTO yqacrsaMe, rue 9:' 6n.ne:"Cneul1arrH311paHa 6onHHUa 3a aKTHBHO neqeHI1e Ha OHKOJIOrHLJHI1 3a6ommaHI1SI - Co<)Jasr o6nacr" EOO~, rp.Co<}J11SI 1123, 6yn.
,CroneTos" NQ 67, AnreKa
3.Texuu~:~ecKJITe xapaKTepucTnKu Ha npeanaramne or Hac neKapcrBeHM npo)l,yKTH no 06oco6eHa no3HUHSI NQ 197 ca no.npo6Ho
on11caHM s ra6na'leH sn.n B H3rorseHoro no o6pa3eua Ha 11pHnO)!(eHHe NQ 2.1. 197 "CneuHcpHKaUHSI no 06oco6eHa no311UI1Sl NQ 197",
Hepa3,nenHa 'laCT OT HaCT051mOTO TeXHHLJeCKO npe)l,JIO)KeHHe.
4. Ka~:~ecTBO u cpoK ua roauocT ~eKnapHpaMe, qe rrpe.nnaraHHTe or Hac neKapcrseHH npo)l.yKrH:
• ca pemcrp11pauH 3a ynorpe6a B CTpauara 11 npHTe)!(aaar pa3peumTenHH 3a ynorpe6a, cunacHo 3J1ITXM, npH.Te)l<aBar cepTHQJI1KarH, yaocrosepSisamn Kaqecrsoro Ha npoayKTHTe, nHrrcsar octmuHarrHH C'ho6meHH51 HJIH orpaHHLJI1TeJIHH MepKH 3a yrrorpe6a Ha neKapcrseHaTe npo.nyKTH;
• OTfOBap51T Ha HOpMaTHBHO ycraHOBeHHTe H3H:CKBaHH51 3a KaLJeCTBO H esponeHCKH CTaH)l,apTH.
• OTfOBapSIT Ha CbOTBeTHHTe ,UCHCTBaLJ.J,H HOpMaTHBHH H3MCKBaHHSI 3a npO)l,a)K6a - BaJIH)J;HI1 pa3perueHH51 3a yrrorpe6a H UCHa, cpopMRpaHa s C'hOTsercrsHe c H311CKBaHI1SITa Ha Hape.n6ara 3a ycnos11srra, npas11nara 11 pe.na 3a peryn11paue perHcrpapaHe Ha ueHHTe Ha neKapcrseHH.Te npo.nyKTa.
L(eKnapH:paMe, qe npH nocrasKaTa Ha neKapcrseHHTe nponyKTH, me ce cno6p<mmaMe c H3HCKBaHmna Ha Hapen6a N2 39 or 13 CenTeMBpH 2007 f. 3a npHHIJ,HllHTe H H3HCKBaHH51Ta 3a )l.06paTa )l.HCTpH6yropcKa npaKTH:Ka.
fapaHTHpaMe )l.OCTaBKH C OCTaT'bLJeH CpOK Ha I'O)lHOCT KbM ,llaTaTa Ha ,llOCTaBKa He llO-MaJlbK OT 60% OT CpOKa Ha I'O)lHOCT, YKa3aH Bbpxy
onaKOBKaTa Ha CbOTBeTHH:51 npO.llYKT.
i~ 5. OnaKOBKa u MapKuposKa
flpennaraHHTe OT HaC Me)lHL{HHCKH ll3)leJlH51 Ca B CbOTBeTCTBHe C H3HCKBaHH51Ta Ha Bb3Jl0)1(HTeJU£ H npH )lOCTaBKaTa rue OTrosapHT Ha
H3MCKBaHH51Ta H me 6b)laT:
•
• •
onaKOBaHM B OpHI'HHaJlHa onaKOBKa Ha np01BBO)lHTeJ151, CbC CbOTBeTHaTa MapKHpOBKa 3a npOH3BO)lHTeJl ¥1 napTH)lHH
HOMepa, C HaHeCeHa "CE" MapKMpOBKa, HaHeCeH H)leHTHQmKal{HOHeH HOMep Ha HOT11QJHUHpaHH51 OpraH, KOLaTO TaKbB Ce
H3HCKBa OT ,lleMCTBamOTO 3aKOHO)laTeJlCTBO, KaTO C TIOCTaBeHa MapKHpOBKaTa IIJ,e e llOCTaBeHa Ha BCeKH KallJOH, CbOTBeTHO
BC51Ka Oll3KOBKa.
OTiaKOBaHH B OpHI'HHaJlHaTa OTiaKOBKa Ha npOH3BO)lH:TeJI51, C HeHapyrneHa IJ,51JlOCT, 6e3 )la Ca MOKpH .
OTiaKOBaHH TIO Ha'IHH, KOMTO I'H 3ana3Ba OT BCHKaKBH TIOBpe)lH, )lbJI)I(amH ce Ha aTMOCQJepHH YCJIOBJUI H TpaHCTIOpT .
lll,e H3nbnHHM npenMeTa Ha norosopa B nbnHo CbOTBeTCTBHe c H3HCKBaHID~Ta Ha Bb3JIO)I(HTeJU£, noco'!eHH s TexHHLJeCKHTe
cneU:MQJHKal{HH H )lOKYMeHTal{IDITa 3a yqacTHe.
KLM uacToHmoTo Texuut.tecKo npe,UJIOil\euue npuJiaraMe: 1. ITpHJlO)I(eHHe N2 2.1. 197"CneuHQJHKaUHH no 06oco6eHa no3HU:HH N2 197"
IIOlliiHC
IIEqAT
NiHa o6oco6 eHaTa
no3ML4111 $1
1
197
ITpuno:>KeHue N!1 2.1 . KbM ITpuno:>KeHHe N!1 2 "TexHuqecKo npe.uno:>KeHue"
\ ~" CneQnc!JnKaQHH no o6oco6ena noJHIIHH .N't 197 ~}o~Jyp3 33 Bb3JI3r3He H3 o6m.ecTBeH3 nopbqK3 c npeJJ.MeT: ").(ocT3BK3 H3 JieK3pCTBeHH npo.llyKTH 33 Hy~uTe H3 "Cneu;u3JIH3Hp3H3 6oJIHHQ3 33 3KTHBHO Jieqeuue H3 OHKOJioruquu 3300JIHB3HHH- CocJmH o6JI3CT" EOO).( no 50 o6oco6euu no3uuuu"
. ,, JleKapcTBeHa ,zc:;..z npeAnaraHa
cpopMa PecpepeHTHa nporH03HO pa3q>acoeKa,
AHaToMo- lnocol.feHaTa CTOMHOCT 38 KOmNeCTBO Komtl.feCTBO
TepaneBTKI.feH Me>KAyHaJ)OAHO HenaTeHTHO OT DOD/ /C'brllSCHO TbproecKo HaMMeHoaaHMe I MIMnM 6pol7t e npo1113BOAMTenln
H8MMel'iONHM8 /INN/ B'b3110>KMTens:t TepaneaTIIII.feH cnet.tMQ>IIIK81.41t onaKOBKaTa pMTB)IC8Ten py ' KOA /ATC-t<OIJ/
· .... B Kypc ·Jir8 HS 111 npeAnaraHa cne1.4Mq>MKS4M 8'b311Q>KMTemt/ neKapcTaeHa
$ITa/ q>opMa 2 3 4 5 ' 6 7 8 9
B05CX01 rmoKo3a 5% 500 Mil, nn. napeHTepanHa 1,68 1500 Glucose sol. 5%500 ml
B. Braun 6aHKa cDOPMa
3a6enemKa: C~<IBaTa 4aCT OT Ta6nHuam ce nonbnsa oT cneuH<j>HKaumna Ha Bb3JlOJKHTemt - npHnomeHHe KbM .uoKyMeHTaUHstTa - KOJlOHH A- G. B .UstCHaTa!JKbllTa 4aCT ce nOnbllBaT .UaHHHTe 3a npe.unaraHHSI OT y4aCTHHKa npO.llYKT.
20.05.2016 r. IIOlUIHC
IIE~T
KpacHMHp HHKonaeB / JlbJIHOMOIUHHK Ha"
---
0Top•ua1.1 IIIJI: AA I
HE
10
fJA
1
~)
):(0 "CJ>AJI03- CO<DIUI OnJIACT" EOO):(
rp.CocJmn, 6yJI. "CroJieToB" .N'!.! 67
TEXHJiqECKO flPE)J;JIO)I(EHifE
3a yqacnie s OTKpH.Ta npoue;::r:ypa 3a Bb3JiaraHe Ha o6r.u:ecTBeHa nopo~IKa c npe;::r:MeT:
flPIIJIO)I(EHHE .N!.! 2 06pa3eLf
")J;ocT3BK3 H3 Jie..:apcTseuu npo.uyKTH 3a HYiKllHTe ua "CneUH3Jiu:mp3ua 6oJiuuu.a 33 3KTHBHO Jieqeuue H3 ouKoJiorn'-IHH 3360JIHB3HHH
- Co«<»nH o6JI3CT" EOO)J. no o6oco6eHn no3HUHH" 06oco6eu3 n03HUHH .N'!.! 199 fJIIDK033 10% 500 MJI, nJI. 63uKa n3peHTepaJIH3 d!OpM3 [wnucea ce HOMepa u HGUMe1-I06'GT-lUemo ua o6oco6e11ama noJU1-fUR]. , <l>bOHMKC <l>apMa" EOO,a c EMK: 203283623, perHcTpaumi no MC: , coc ce;::r:aJTHr.u:e 11 a;::r:pec ua ynpasJieHH:e rp. Coq:m51 1700, paifou p-H CTy;::r:eHTCKH, yJI. "OKorrospocTeH noT" N2 199A,TeJI. :02/9658 1 OO,Q>aKc:02/9658172, e-mail: [email protected], l1HTepueT cTpamiua:
http://www.phoenixphanna.bg ,a;::r:pec 3a Kopecnou.neHUH51: fp. CorpH51 1700, o6rracT CoQ>ru1, o6r.u:I-ma CToJuPma, p-H CTy;::r:eHTCKH, yrr. "OKorrospocTeH noT" N2 199a
TerrecpoH 3a KOHTaKTH: 02 I 965 81 09; <l>aKc: 02 /965 88 28; e - mail: kr.nikoffw,@phoenixpharma.bg, l1uTepHeT a;::r:pec:
http://www.phoenixphanna.bg/ ,6aHKOBa cMeTKa: BG91 UNCR96601030899522, npe;::r:cTaBJI51BaHo OT KpacHMHp HHKorraeB HwKorraes, EfH
7712023968, ua .LJ.Jib)l(HOCT ,awpeKTOp Eonuwqeu na3ap H ,aauweJia TieTposa HHKOJIOBa, EfH 7106114033 ua .JJ.Jib)l(HOCT Mamcop <l>apMaueBT
EoJIHHl.feH na3ap, B KaqecTBOTO HH ua n'hJIHOMOI.IJ:HHUH Ha ynpaBHTeJIHTe Ha "<l>bOHMKC <l>apMa" EOO,[(
YBA)I(AEMA f0Cll0)1(0 YDPABHTEJI,
Cne;::r: 3an03Hasaue c ;::r:OKYMeHTaUHSITa 3a yqacTHe B OTKpHTa npoue;::r:ypa 3a Bb3JiaraHe Ha o6r.u:ecTBeHa nopb4Ka c npe.nMeT: "):(ocT3BKa Ha
JieKapcTBeHH npo.uyKTH 33 HYiK.JJ.HTe Ha "Cneuu3JIH3Hp3Ha 6oJIHHU3 3a aKTHBHO Jleqeune Ha OHKOJIOrH'-IHH 3360JIHBaHHH - CocJmH
o6JiacT" EOO)J; no o6oco6eun noJHUHH", cMe comacmi c nocTaBeHHTe OT Bac ycJIOBH51 H rH npHeMaMe 6e3 Bb3pa)l(eHH51.
C uacT051TUOTO 811 npe;::r:cTaB51Me HarneTo npe.nJio)l{eHHe 3a H3TibJIHemte Ha nopb4KaTa no 06oco6eua D03HUHH .N'!.! 199 fJIIOK033 10°/o 500 MJI, nJI. 63HK3napeuTep3JIH3 d!OpM3 u3nucea ce 1-toMepa u HGW\1/eHoeaHuemo 11a o6oco6e1-tama noJUl{Wl], rrpH cne.uHHTe ycnoBH51:
1. CpoKose no o61IJ,eCTBeH3T3 nopL'-1K3:
1 .1. CpoK 3a H3nbJIHeHHe ua nopbLIKaTa- 12 (;::r:saua.neceT) Meceua, cqHTaHo oT ;::r:aTaTa Ha CKJIIOLIBaHe Ha
H3THLiaHe/npeKpaT51BaHe Ha npe;::r:XO;::J:HO CKJIIOLieHH51 ;::J:OfOBOp CbC CbiUH51 npe;::r:MeT, KOeTO OT Cb6HTHSITa HaCTbn
~) 1 . 2 . CbrJiacmt cMe L{a LJ:OCTaB.SIMe neKapcrsemne npo.zzyKTH, rrpeLJ:MeT Ha no3Hl\HHTe, 3a KOHTO yqacTBaMe, B cpoK .no:
fie no6elle om 48 1./aca LJaca cneL{ nonyqasaHe Ha IIHCMeHa 3a.SIBKa, BKJIIO':IHTenHo rnrrpareHa no <jlaKc, en. nolll,a HJIH LJ:pyr, YI3pHLJHO
L{OfOBOpeH C aHeKC KbM L{OfOBOpa HaLJYIH Me){{L{y CTpaHH:Te - 3a peryrr.SipHH 3a.SIBKH. IJpH )[{eJiaHHe OT CTpaHa Ha Bb3nO)[{H:TeJI.SI perymipHHTe
LJ:OCTaBKYI me 113BbprnsaMe no yrosopeH rpa<j)YIK.
1-te no6e'-le om 2 tJaca LJaca cneL{ nonyqasaHe Ha 3a.SIBKa or Bb3JIOJKMTEJUI, ornpaseHa BKJHO'mTeJIHO no cpaKc, en. noma 11JIYI LJ:pyr,
YI3pH4HO L{OrOBOpeH C aHeKC KbM L{OfOBOpa Ha':IYIH Me)[{L{y CTpai-IYITe, a np11 He06XOL{IiMOCT - 1i no TeJie<jlOH- 3a cneUIHH 3a.SIBKH
_aocTaBKHTe L{O onpeL{eJieHOTO OT Bb3J10)£{!1TeJI.SI <jJpaHKO M.SI.CTO 3a L{OCTaBKa, W,e H3BbplliBaMe B pa60THH L{HH, OT 08.00 L{O 16.00
qaca. B cny1:1ai1: qe cpoKbT 3a LJ:OCTasKa H3TI1'la B Hepa6oTeH .n.eH, .n.ocTasKaTa cneL{sa L{a ce H3nbJIHH HaH-KbCHO B nbpB1151 pa6oteH L{eH,
cneL{Ball.( L{eH.SI, B KOHTO H3TWiaT cpoKosere.
f1p11 H3p!i1:1HO yKa3aHHe OT CTpaHa Ha Bb3J10)£{HTeJ151 W,e L{OCTaBHM 3a.SIBeHine npH cnelllHii 3a.SIBKH KOJIYI':IeCTBa 113BbH yKa3aHYI.SI no
rope qacosH L{I1ana30H.
CbmacHH CMe L{a LJ:OCTaB.SIMe neKapcTBeHHTe npOLJ:YKTH, npeLJ:MeT Ha no3HUH.SITa!HTe, 3a KOI1TO yqacrsaMe, Cbo6pa3HO npeLJ:BapHTenao
yrosopeH rpa¢HK, npH )[{enaHYie OT cTpaHa Ha Bb3J10)[{HTen.SI.
2.MHCTO Ha H3UbJJHeHHe: <DpaHKo M.SICTOTO Ha LJ:OCTaBKa no HaCTO.SIIIJ,aTa nopb':IKa, B qacTTa if /o6oco6emne no3YIUHH/, 3a KO.SITO yqacTBaMe, me
6bL{e:"CrreuHanH3HpaHa 6onHYIUa 3a aKTHBHO neiJeHYie Ha OHKonora':IHH 3a6oJI.SIBaHH51 - Co¢a.SI o6nacT" EOO,a, rp.Co¢HH 1123, 6yn.
,Croneros" N~ 67, ArrTeKa
3. TexuuqecKHTe xapaKTepncTHKH Ha npeLJ:naraHHTe or Hac neKapcTBeHH npoLJ:yKTH rro 06oco6eHa rro3HUYI.SI N~ 199 ca rroLJ:po6ao
orrYicami B Ta6JIYI':IeH BH.ll. B YI3fOTBeHoTo no o6pa3eua Ha IIpHnmKeHHe N~ 2.1. 199 "Crreu,HcPHKaUYI.SI no 06oco6eHa rro3HU.H5I N2 199", Hepa3L{eJIHa LJaCT OT HaCTO.Silll,OTO TeXHYILJeCKO rrpeL{JIO)[{eHHe.
4. KaqecTBo u cpoK ua rot:t.uocT ,[(eKnapHpaMe, qe npeL{rraraHHTe OT Hac neKapcTBeHH npo.uyKTH:
• ca pemcTpHpaHH 3a yrrorpe6a s cTpaHara 11 npHTe)l(asaT propewrnerrHH 3a ynoTpe6a, cbrnacHo 3JII1XM, rrpHTe)l(aBaT cepTH¢HKaTH, y.LJ:ocrosep.S!.sama Ka':leCTBOTO Ha rrpOLJ:YKTYITe, JIYincsaT ocpHU.HaJIHH Cb06Il.(eHI1H YIJIH orpaHwmTenHH MepKH 3a yrroTpe6a Ha neKapcTBeHHTe npoLJ:yKtH;
• OTfOBap5IT Ha HOpMaTHBHO ycTaHOBeHHTe l13HCKBaHYI.SI 3a KaLJ.eCTBO 11 eBpOneHCKYI CTaHL{apTH.
• OTfOBap51T Ha CbOTBeTHH:Te L{eikTBaW,YI HOpMaTYIBHH H3HCKBaHYI.SI 3a rrpOL{a)[<6a - BanHL{HYI pa3perneHYI.SI 3a ynoTpe6a H ueHa, <jlopMHpaHa B CbOTBeTCTBYie c H3HCKBaHH5ITa Ha HapeLJ:6aTa 3a ycnoBH5ITa, npasHnara H peLJ:a 3a perynYipa~
pemCTpHpaHe Ha UCHHTe Ha neKapCTBCHHTC nponyKTH. @-;;, \~"'"'~ ~~ ~~0~ ~
~) ,[J;eKJiapHpaMe, qe npH ):(OCTaBKaTa Ha JieKapcTBeHHTe npO.Z:lYKTH, me ce cbo6pa351BaMe c H3HCKBaHH51Ta Ha Hape):(6a N2 39 oT 13 cenTeMBpH 2007 f. 3a npHHl{HTIHTe H H3HCKBaHHSITa 3a ):(06paTa ):(HCTpH6yTopcKa npaKTHKa.
fapaHTHpaMe ):(OCTaBKH C OCTaTbl.feH CpOK Ha r0):(HOCT KbM ):(aTaTa Ha ):(OCTaBKa He TIO-MaJlbK OT 60% OT CpOKa Ha fO):(HOCT, YKa3aH Bbpxy
onaKOBKaTa Ha CbOTBeTHH51 I1pO):(YKT.
5. OnaKOBKa H MapKupoBKa Dpe.n.JiaraHHTe oT Hac Me):(HUHHCKH H3):(emm ca B CbOTBeTCTBHe c H3HCKBaHMTa Ha Bb3JIO)I{HTeJ151 H npH ):(OCTaBKaTa me oTroaapHT Ha
H3HCKBaHH51Ta H me 6b):(aT:
• OITaKOBaHH B OpHrHHaJIHa OllaKOBKa Ha npOH3BO):(HTeJI51, CbC CbOTBeTHaTa MapKHpOBKa 3a npOH3BO):(HTeJI H rrapTH,ll.HH
HOMepa, C HaHeCeHa "C£" MapKHpOBKa, HaHeCeH M):(eHTH<J>HKal{HOHeH HOMep Ha HOTH<J>HUHpaHH51 OpraH, KOraTO TaKbB Ce
H3HCKBa OT ,ll.eHCTBamoTO 3aKOHO):(aTeJICTBO, KaTO C TIOCTaBeHa MapKHpOBKaTa me e TIOCTaBeHa Ha BCeKH KaWOH, CbOTBeTHO - Ha
BC51Ka OllaKOBKa.
• OflaKOBaHH B OpHfHHaJIHaTa OITaKOBKa Ha npOH3BO):(HTeJI51, C HeHapyweHa l{5IJIOCT, 6e3 .[(a Ca MOKpH.
• onaKOBaHM flO Ha~mH, KOHTO fH 3arra3Ba OT BC51KaKBH TIOBpe):(H, ,ll.bJI)I{aU.lH ce Ha aTMoc<J>epHH ycJIOBH51 M TpaHCTIOpT.
I.IJ,e H3ITbJIHHM rrpe.n.MeTa Ha noroaopa B TibJIHO CbOTBeTCTBHe c H3HCKBaHHHTa Ha Bb3JIO)I{HTeJI51, nocol.feHH B TexHH1.feCKI1Te
cneuw<PuKal(HH H ):(OKyMeHTaUHHTa 3a yqacTHe.
K'hM nacToHu_.oTo TeXHH"IeCKO npe.ll.JIOjKenue npHJiaraMe: 1. DpHJIO)I{eHHe N2 2.1. 199"CrreuH<PHKaUHSI no 06oco6eH~ rro3HUH51 N2 199"
HOLlHIIC
IIEqAT
KpacHMHp HHKOJiaeB
/ f1bJIHOMOmHHK Ha" <l>b ~ 0
..D e
,[J;aHHeJla DeTposa HuKoJI<\1!
/ fhJIHOMOW:HMK Ha "<l>b0
3
N!! Ha o6oco6 eHara
!103fiii.IM A
1
199
~ flpHJJO)l(emte .NQ 2. 1.
KbM IlpHJJO)l(eHHe .NQ 2 "TeXHJ1qeCKO npe)l.JlO)l(eHHe"
CneQucJluK3U.HH no o6oco6eu3 noJHU.HH .N!! 199 OT npou.e.!lyp3 13 Bb3.11ar3ue H3 o6mecToeua nopb'IK3 c npeAMCT: ",lJ:ocT3BKa H3 .lleKapcToeuu npOAYKTH 1a HYJKAHTe H3
"Cneu.na.11u3upaua 6oJIHHQa 33 aKTHBHO .lle'lenue ua OHKO.Iloruqun 3a6o.I1HBauuH- Cocl>nH o6.113CT 11 EOO,LJ: no 50 o6oco6eun D0311IJ.HH"
JleKapcTBeHa npeAtlaraHa <f>opMa PeQ>epeHTHa nporH03HO paacf>acoeKa,
AHaToMo- . /n~eHaTa CTOMHOCT38 KOnM"lecTBO Komt-.ecreo
TepanesnNeH MeliCAyHapoAHO HenareHTHo OT ODD/ /cl>rnacHo TbproecKo H8f/IMeHoeaHMe I f/1/MnM 6pOM B npofiiJBOAMTen/n
KOA /ATC-Kop/ H8MM8HOB8HM8 /INN/ i + Bl>anOlKMTenR TepaneeTk"'eH COOI.Ifll<f>HK81.1fll On8KOBK8T8 pMTeJKaren PY
B KYPC ;;~ RT8 Ha H npeAtlaraHa cnei.IMcf>HKaLIH BoanolKfiiTenst/ neKapcraeHa
RTa/ 1 cf>opMa 2 3 4 5 6 7 8 9
B05CX01 rntOK03a 10% 500 Mil, nn. napeHrepanHa 2,03 100 Glucose sol. 10% 500 ml B. Braun
--6aHKa cpopMa
3a6ene)J(Ka: C1-maTa YaCT OT Ta6nHuam ce nonbnBa OT cneuH<J>HKaUIUITa Ha Bb3JlO)J(HTellll - npHllO)J(eHHe KbM noKyMeHTaUHHTa - KOJlOHH A -G. 8 LlliCHaTa/)J(bJlTa YaCT ce
nonbnBaT naHHHTe 3a npennaraHHJI oT yyacTHHKa nponyKT.
20.05.2016 r. llOllllliC
fiEqAT
KpacHMHp HHKonaeB H / IlbJJHOMOW:HHK Ha" <l>h·
0TOpM38L( fll.fl: .QA I
HE
10
AA
~
.[(0 "CiiAJI03- CO<I>IUI OliJIACT" EOO.[(
rp.Co~nH, 6yJI. "CTOJICTOB" .N'!! 67
TEXHifqECKO IlPE.[(JI OJKEHHE
3a Y'·:IaCTJie B OTKpHTa rrpou:e.nypa 3a B'h3naraHe Ha o6ll.l,eCTBeHa nopbl.JKa c rrpe.nMeT:
llPHJIOJKEHME .N'! 2 06pa3elJ
",[(OCT3BK3 H3 JICK3pCTBCHH Dp0.11,YKTH 33 HY~.l1.HTC H3 "CneUH3JIH3Hp3H3 60JIHHU:3 33 3KTHBHO JIC"IJCHHC H3 OHKOJIOrH"lfHH 3360JIHB3HHH
- Co~na o6JI3CT" EOO,l( no o6oco6eun no1nu,uu" 06oco6eu3 no3HUHH .N'!! 200 H3Tpnes XJIOpH)l 0,9% 100 MJI, nJI. 63UK3 n3peuTep3.TIH3 dwpM3 [uJnucea ce 1-IOMepa u 1-taUMeHoeaHuemo 11a o6oco6e1-1ama noJUl,fUJl]. ,<I>bOHHKC <I>apMa" EOO)J, c EHK: 203283623, pemcTpau;H.H no ,ZJJJ,C: , CbC ce.nanHll.l,e H a.npec Ha ynpaaneHHe rp. Co<}mSI 1700, paM"oH p-1-1 CTy.nenTCKH, yn. "OKonoapbcTeH IIbT" NC2 199A, Ten. :02/96581 00,<paKc:02/9658172, e-mail: office@phoenixpharma. bg, HnTepneT cTpaHHll,a:
http://www.phoenixphanna.bg ,a.npec 3a KopecnOH,ll.CHU:H.H: rp. Co<}m5r 1700, o6nacT Coqm5r, o6Il.I,HHa CTOJIH 1-1Ha, p-H CTy.neHTCKH, yn. "OKonospbcTeH nbT" NQ 199a
Terrecpou 3a KOHTaKnr: 02 I 965 81 09; <l>aKc: 02 /965 88 28; e -mail: [email protected], HnTepneT a.npec: http://www.phoenixphanna.bg/ ,6aHKOBa cMeTKa: BG91 UNCR96601 030899522, npe.ncTaBrr.Hsauo OT Kpaci1MHp H11Korraea HH:KorraeB, EfH
7712023968, ua JlJib)J(HOCT LJ:11peKTOP I>orrHH1.feH na3ap 11 )J,amrena I1eTposa HHKonosa, ErH 7106114033 ua .LJ.Jib)KHOCT Marl1cbp <I>apMau;esr
EonnwieH naJap, B Ka1.feCTBOTO HH ua IIb11HOMOil.I,H11l.U1 Ha ynpaBHTeJIHTe ua "<l>bOHHKC <l>apMa" EOO,D,
YBAJKAEMA rOCllOJKO YllP ABHTEJI,
Cne)l3arro3nasaue c .noKyMeiuau;H.HTa 3a yl.JaCTI1e s oTKpHTa npoue.11.ypa 3a Bb3naraue Ha o6mecTaeua rropbl.£Ka c npe.11,MeT: ".LI:ocT3BK3 ua
JieK3pcTseun npo.11,yKn1 33 uy)K)J.nTe ua "Cneun3JIH3Hp3H3 6oJIHHU.3 33 aKTHBHO Jieqeuue H3 ouKoJioruquu 3360JIHB3HIIH - C01Jma
o6JI3CT" EOO,l( no o6oco6eun noJuuuu", CMe cbrrracHH c nocTaBeHHTe OT Bac ycnoBHH 11 r11. npHeMaMe 6e3 Bb3pa)KeHI15r.
C uacT05lll.I,OTO B11 rrpe.ncTaB5rMe uaweTO npe.nrro)KeHI1e 3a H3IIbrrHeHue ua rropbl.£KaTa no 06oco6eu3 no3HUHH .N'!! 200 H3Tpues xJiopua
0,9°/o 100 MJI, nJI. 63uKan3peuTep3JIH3 dwpM3 UJnucea ce HOMepa u HGWvterweauuemo Ita o6oco6e1-1ama noJUJ..fUfL], npH crre.nHHTe ycrroBHSI:
1. CpoKose no o6mecTseu3T3 nopb"lfK3:
1 .1. CpoK 3a H3llbJIHemre ua nopbl.£KaTa- 12 (.naaHa)leceT) Meceu:a, Cl.JI1Tano OT .naTaTa ua CKJIIO'-IBane
li3Tlfl.Jaue/npeKpaT.HBaHe Ha npe,ll.XO,ll.HO CKJ1IOl.JeHI151 ,ll.OfOBOp CbC Cb!UI15f npe)J.MeT, KOeTO OT Cb6HTH5fTa HaCTbfiH
1 . 2 . C'brnacmt CMe .na .nocTaB51Me neKapcTsemne npo;zyKTH, npe.nMeT Ha no3HU.HHTe, 3a KOHTO yqacTBaMe, B cpoK .no:
ue noeel.fe om 48 ttaca qaca crre.n nonyqasaHe Ha nHcMeHa 3a5!BKa, BKJJIO'lHTeJIHO H3npaTeHa no cpaKc, en. noma HJIH .npyr, H3pwmo
)lOfOBOpeH C aHeKC K'bM )lOfOBOpa Ha'GHH Me:>K)ly CTpaHHTe - 3a perymipHH 3a51BKH. flpH )KeJiaHHe OT CTpaHa Ha B'b3JIO:>KHTeJI5! peryn5IpHHTe
.nocTaBKH me H3B'bpwsaMe no yrosopeH rpacpHK.
He nofJette om 2 '-laca qaca cne.n rrony•msaHe Ha 3a5IBKa OT Bb3JIOJKMTEJHI, oTrrpaseHa BKJIJO'lHTeJIHO no cpaKc, en. noma HJJH .npyr,
~H3pH'IHO )l0r0BOpeH C aHeKC K'bM )lOfOBOpa HaqJ1H Me:>K)ly CTpaHHTe, a npH He06XO)lHMOCT - H no TeJie(pOH- 3a CITelllHH 3llii.BKH
,[(OCTaBKHTe )lO onpe)leJieHOTO OT Bb3JIO:>KHTeJI5! cppaHKO M5ICTO 3a )lOCTaBKa, me H3B'bpU1BaMe B pa60THH )l,HH, OT 08.00 )],0 16.00 ~aca. B cnyqaJ1: qe cpoKbT 3a )lOCTasKa H3THLfa s Hepa6oTeH .neH, .nocTasKaTa cne)l,sa .na ce H3n'bJIHH HaH-KbCHO s n'bpBH5! pa6oTeH .neH,
cne)l,sam )leH5!, B Koi1To H3THl.faT cpoKoBeTe.
ITpH H3pH'IHO yKa3aHHe OT cTpaHa Ha B'b3llO:>KHTeJI5! me .nocTaBHM 3a5!BeHHTe npH cnelllHH 3a5IBKH KOJIH'-IeCTBa H3BbH yKa3aHH5! rro
rope qacoBH .UHana3oH.
C'hrrracHH CMe .na )lOCTaB51Me neKapcTBeHHTe npo)lyKTH, rrpe)lMeT Ha no3HUH5!Ta!HTe, 3a KOHTO y<racTBaMe, C'bo6pa3HO rrpe.nsapHTeJl
yrosopeH rpacpHK, npH :>KeJiaHHe OT cTpaHa Ha B'b3JIO:>KHTell5!.
2.MHCTO ua H3DbJIHeHUe:
<l>paHKO M5ICTOTO Ha )lOCTaBKa no HaCT05ImaTa rropbGKa, s qacrra if. /o6oco6eHHTe rro3HIJ.HH/, 3a K05!TO yqacTBaMe, me
6'b)le:"Cneu.HarrH3HpaHa 6oJIHHIJ.a 3a aKTHBHO neqeHHe Ha OHKonon:PIHH 3a6orr5!BaHH51 - CocpH51 o6nacT" EOO,[(, rp.Cocpm1 1123, 6yn.
,CToJieTos" N2 67, AnTeKa
3.TeXHH'IeCKHTe xapaKTepHCTHKH Ha npe)lJiaraHHTe OT HaC JieKapCTBeHH rrpO.L\YKTH ITO 06oco6eHa n03HUHH NQ 200 ca no)lp06HO
onwcaHH B Ta6mJ'leH BH)l B H3fOTBeHoTo no o6pa3eu.a Ha ITpHJIO)KeHHe NQ 2.1. 200 "Crreu.HcpHKaiJ.H51 no 06oco6eHa n03HU.H51 NQ 200", Hepa3)leJIHa 'laCT OT HaCT05ImOTO TeXHH'leCKO npe)lJIO:>KeHHe.
4. Ka'leCTBO u cpoK ua ro}J.HOCT
,[(eKJiapHpaMe, 'le npe)l,JiaraHHTe OT HaC JleKapCTBeHH npOAYKTH:
• ca pemcTpwpaHH 3a ynoTpe6a s cTpaHaTa H rrpHTe:>KaBaT pa3pewHTeJIHH 3a ynoTpe6a, c'hrJiacHo 3JIITXM, npHTe:>KasaT
cepnrcpHKaTH, y.nocTosep51samH Ka'-leCTBOTO Ha npo)lyKTHTe, JIHncsaT ocpl:IU.HaJJHH C'bo6meHHSI HJJH orpaHH'lHTeJIHH MepKH 3a
ynoTpe6a Ha JieKapCTBeHHTe npOAYKTH;
3a ycnoBHSITa, rrpaBHJiaTa l:l pe.[{a 3a
perHCTpHpaHe Ha U.eHHTe Ha JieKapCTBeHHTe npo,nyKTH.
)J:eKJTap11paMe, qe npH .nocTaBKaTa I-Ia neKapcTBeHI1Te npo.nyKTH, lll,e ce Cbo6p,miBaMe c 11311CKBaHI1KTa Ha Hape.n6a NQ 39 OT 13 cenTeMBpH 2007 f. 3a np11HI.(HITI1Te H 113HCKBaHI1HTa 3a .D;06paTa .D;I1CTp116yTopcKa npaKTHKa.
fapaHT11paMe .D;OCTaBKH C OCTaTb'IeH CpOK Ha fO.D;HOCT KbM .D;aTaTa Ha ,L\OCTaBKa He ITO-MaJlbK OT 60% OT CpOKa Ha 10.[\HOCT, YKa3aH BbpXy
onaKOBKaTa Ha CbOTBeTHH5l npO.L\YKT.
~ ) 5. OnaKOBKa u MapKnpoBKa
I1pe.nnaraHI1Te OT HaC Me,L\HIJ,I1HCKI1 H3,L\eJillil Ca B CbOTBeTCTBI1e C H3HCKBaHI15ITa Ha Bb3Jlo:lKHTellil H npH ,L\OCTaBKaTa lll,e OTfOBap5IT Ha
H311CKBaHM5ITa H lll,e 6b.D;aT:
•
• •
OITaKOBaHH B OpHfHHaJlHa OITaKOBKa Ha npOH3BO,L\HTeJ15l, CbC CbOTBeTHaTa MapKHpOBKa 3a npOH3BO.D;I1TeJ1 H napTH.L\HH
HOMepa, C HaHeCeHa "CE" MapK11pOBKa, HaHeCeH H.D;eHTHQmKai.J,I10HeH HOMep Ha HOTmpHUHpaHHH optaH, KOfaTO TaKbB ce
H311CKBa OT .D;eHCTBali.(OTO 3aKOHO.D;aTeJ1CTBO, KaTO C ITOCTaBeHa MapKHpOBKaTa LI.(e e ITOCTaBeHa Ha BCeK11 KalllOH, CbOTBeTHO - Ha
BC5IKa onaKOBKa.
onaKOBaHH B Op11rHHaJ1HaTa OITaKOBKa Ha np0113BO.D;I1TeJUI, C HeHapyweHa UKJlOCT, 6e3 .D;a Ca MOKp11 .
OnaKOBaHI1 ITO Ha'-:IMH, KOHTO 111: 3ana3Ba OT BCHKaKBH nospe.D;H, .D;bJl)I<alli,H Ce Ha aTMOC<jJepH11 ycnOBI1H 11 TpaHCITOpT .
I..Qe 113ITbJTHMM npe.nMeTa Ha .norosopa B nbnHo CbOTBeTCTBI1e c M3HCKBaH!f5ITa Ha Bb3J1o:lKHTenH, noco'-:leHM B TexHaqecKI1Te
CneumimKaUif11 11 .D;OKYMeHTaU115ITa 3a yqaCTHe.
KbM uacTOHIIJ,OTO TexuuqecKo npe!lJI03\euue npunaraMe: 1. ITpwno)[{eHMe NQ 2.1. 200"CneuHcpHKaUHH no 06ocoqeHa no3HUH5I NQ 200"
nOliTIMC
fiEqAT
KpacMM11p HMKon
/ l1bJ1HOMOLI.(HHK H
3
NIIHa o6oco6
~j
aHara 0031114111
R
1
200
TipHJIO)I(eHHe NQ 2.1. KbM flpHJIO)I(eHHe }[Q 2 "TeXHJ1qecKO rrpe)lJIO)I(eHHe"
~~ Cneunol>nKann• no o6oco6ena noluuun X• 200 t ~) ~ou,e~ypa Ja B'h3Jiaraue ua o6mecTseua nop'hqKa c npe~MeT: ",LI.ocTaBKa ua JJeKapcTseuu npOJJ.YKTH Ja uyiK)J.nTe ua "Cneu,naJIH3Hpaua 6oJiuuua Ja aKTHBHO JJeqeuue ua OHKOJioruquu Ja6oJJHBannH- CoclmH o6JiaCT" EOO,ll, no 50 o6oco6euu noJuuuu"
.IJeKapCTBeHa npeAJ18raHa cpopMa Pe<PepeHTHa npoi'H03HO pa3~8COBK8,
AHaroMo- /oQCO\feHara CTOMHOCT38 KOflllll.feCTBO Komtl.fecrao Me)I(AyH&pc>AHO HeR8TeHTHO ODD/ /c'brnacHo 111/111n111 6poi4 a npo1113BOAIIITen/n
repaneaTIIII.feH OT TbproacKo HaHMeHoaaHMe I KOA /ATC-KO!J/
H8KM8H088HI1e /INN/ B'b3110>IG1TeJ1R TepaneaTIIII.feH cnel.p,cpMKBL.tM On8KOBK8T8 pr.1T8JK8T8Jl py a t<ypc SITS Ha 1.1 npeAnaraHa
cn&LIMtPI.1KBL\fll B'b3,110>1G1T8J1R/ neKapcraeHa SIT a/ q,opMa
2 3 4 5 6 7 8 9
B05CB01 HaTpl.lee XI10PI.1Jl 0,9% 100 napeHTepanHa 1,29 3550 Natrium choratum sol. 0 ,9% 100 ml
B.Braun Mil, nn. 6aHKa cjlopMa
3a6eJJe)I(Ka: CHBaTa 4acT OT Ta6JJHUaTa ce nonbJJBa oT cneuHij>HKaUHl!Ta Ha Bb3JJO)I(HTeJJll - npHJJO)J{eHHe KbM llOKyMeHTaU.HliTa - KOJJOHH A- G. B ll»CHaTa/)l(bJJTa 4aCT ce
nOnbJJBaT llaHHHTe 3a npellJJaraHHll OT y4aCTHHKa npOllYKT.
20.05.2016 r . IIOLUIHC
llKlJ.AT
KpacHMHp HHKOJiaes H11
/ ITbJIHOMOill,HHK Ha" <Db0'
0TOpM3al.\ MR: AA I
HE
10
fJA L --- --
,_
~J ~0 "CI>AJI03- CO<I>Jii.H OI>JIACT" EOO~
rp.Co«JluH, 6yJI. "CroneToB" .N2 67
TEXHifqECKO fiPE~JIOJKEHHE
3a yqacTMe s OTKpHTa npou:e.nypa 3a Bb3Jiar3He Ha o6meCTBeHa nopb'lKa c rrpe,nMeT:
IIPHJIOJKEHHE .N!! 2 06pa3e71
"~ocTaBK3 ua JieK3pCTBeuu npo.LJ.yKTH 3a uyJK)J.nTe ua "Cneu,naJin3npau3 6onuuu,a 33 aKTHBHO Jieqeuue ua OHKOJiorut.tuu 3a6oJJHBaHHH
- Co«JluH o6JI3CT" EOO,LI; no o6oco6euu no3uu,uu" 06oco6eua D03UJJ,UH .N!! 203 HaTpHeB XJIOQH!l 0,9% 250 MJI, nJI. 63HK3 n3peHTepaJJH3 d!OpMa [u3nUC(W ce IIOMepa U 1-taUMeH06GltUemo HG o6oco6e1wma no3UZJUfl]. ,<l>bOHMKC <l>3pMa" EOO,n: c EMK: 203283623, perHcTp3U:M5I no MC: , Cbc ce..QaJIHUJ,e 11 a.npec Ha ynp3BJieHI1e rp. Cocjm.5I 1700, pai1oH p-H CTy.neHTCKH, yn. "OKonospncTeH IInT" NQ 199A,Ten.:02/9658 1 OO,cpaKc:02/9658172, e-mail: [email protected], MuTepHeT CTpamlu:a:
http://www.phoenixpharma.bg ,a.npec 3a KOpeCIIOH..QeHUH.5I: rp. Coqm5I 1700, o6JI3CT Cocj_)H.5I, o6UU1H3 CTOJIHqH3, p-H CTy..QeHTCKH, yn. "OKonospncTeH nnT" NQ 199a
TenecjJoH 33 KOHT3KTH: 02 I 965 81 09; <l>aKc: 02 /965 88 28; e - mail: kr.nikolaev(ii)p/weuixplumna.bg, l1HTepueT a.npec:
http://www.phoenixphanna.bg/ ,6auKOB3 cMeTKa: BG91 UNCR96601030899522, rrpe.ncTaBJI5IB3HO OT Kp3CHMHp HHKonaes HHKonaes, EfH
7712023968, Ha ..QJI'b)KHOCT ,ll;HpeKTOp nOJIHMqeH Ila33p H ,[(3HHeJia Ile'rposa HHKOJIOB3, ErH 7106114033 H3 )J,JI'b)KHOCT M3rHCnp <l>apMal{eBT
nOJIHH'leH IIa3ap, B Ka'leCTBOTO HH H3 IlbJIHOMOillHHl{H H3 yrrp3BHTeJIHTe Ha "<l>bOHMKC <l>apMa" EOO,ll,
YBAJKAEMA rOCIIOJKO YIIP ABMTEJI,
Cne.n 33IT03HaBaHe c ,noKyMeHTaUH.5ITa 33 yqacTHe s OTKpHTa rrpouenypa 3a Bb3JI3raHe H3 o6UJ,ecTseHa rropn'fKa c rrpenMeT: "~ocTaBK3 ua
JieKapcTBeuu npo.LJ.yKTH 3a uyiK)J.nTe ua "Cneu.uaJJu3up3H3 6onuuu.a 33 aKTHBHO Jiet.teuue H3 OHIWJJorut.tuu 3a6oJJHBaHHH - CocjmH
o6JI3CT" EOO)J. no o6oco6euu no1uu,uu", cMe CbrJI3CHH c rroCT3BeHMTe oT Bac ycnosH.5I 11m npHeM3Me 6e3 Bb3pa>I<eHH5I.
C HaCT05IlllOTO BH rrpe.ncTaB5IMe H3llieTo rrpe.nno)KeHHe 33 H3IIbJIHeHHe Ha rropbqK3Ta no 06oco6eua no3111J,HH .N2 203 H3Tpues xnopua
0,9% 250 MJI, nn. 6aHK3napeuTepaJIH3 d!OpMa UJnucea ce uoMepa u uauMeHoeauuemo Ha o6oco6eHama no3UZJUfl], rrpH cne..QHHTe ycnoBH5I:
1. CpoKoBe no o6mecTBeuaTa nopbt.tK3:
1 . 1 . CpoK 33 H3IInJIHeHHe Ha nopb'lKaT3- 12 (.D.B3Ha.neceT) Meceua, C'lHTaHo oT naTaTa H3 CKJIIO'fBaHe Ha
H3TH'l3He/npeKpaT.5IBaHe Ha rrpe..QXO..QHO CKJIIO'-leHM5I )J,OfOBOp CbC ClllllH5I rrpe..QMeT, KOeTO OT Cb6HTH.5IT3 H3CThiiM IIO-KbCHO.
~
1. 2. CbrJiaCHM CMe .na .nocTaB51Me JieKapcTBeHMTe npo.uyKTH, npe.nMeT Ha no3MU.mne, 3a KOMTO yt.IaCTBaMe, B cpoK .no:
He noee11e om 48 11aca I.Jaca cJie.u noJiyqasaHe Ha nMcMeHa 3a51BKa, BKJIIQlJMTenHo H3npaTeHa no cpaKc, en. noma HJIM .npyr, H3pH'IHO
)]OfOBOpeH C aHeKC KbM )lOfOBOpa H31JMH Me)K)]y CTp3HHTe - 33 peryJI51pHH 3a51BK11 . IlpH )KeJiaHHe OT CTpaHa Ha Bb3JI0)KHTeJ15I perymrpHHTe
.nocTaBKH me M3Bbp1I1BaMe no yrosopeH rpa<f>MK.
He noee11e om 2 11aca I.Jaca cne.u rronyqasaHe Ha 3351BKa OT Bb3JI0)KHTEJUI, OTnpaseHa BKJII()I.JHTerrHo no cpaKc, eJI. noma HJIH D.pyr,
H3pHYHO )lOfOBOpeH C aHeKC KbM )lOfOBOpa H31JHH Me)K)]y CTpaHHTe, a np11 He06XO)lHMOCT - H no TenecpOH- 3a CneWHI{ 3MBKI1
,li.OCTaBKMTe )]0 onpe)leJieHOTO OT Bb3Jl0)KHTeJI51 cppaHKO M51CTO 3a )]OCTaBKa, ru:e M3BbpWBaMe B pa60THH )lHH, OT 08.00 .[{0 16.00
qaca. B crryYaif qe cpoKbT 3a D,OCTaBKa H3TMlfa B Hepa6oTeH D,eH, .nocTaBKaTa cneD,Ba .na ce H3nbJIHM HaH-KbcHo B nbpBHSI pa6oTeH .neH,
cne.usaw: .uemr, B KOMTO M3TMLiaT cpoKoBeTe.
)
DpH H3p11'IHO YKa3aHHe OT cTpaHa Ha Bb3JIO:>KMTemr me .uocTaBMM 3aSIBeHHTe npH cnelllHM 3aHBKlf KOJIHLJeCTBa lf3BbH yKa3aHlfjl no-
rope LJaCOBH )lM3n330H.
CbrnacHM cMe .na .nocTaBRMe rrexapcTBeHMTe npo.nyKTM, npe.nMeT Ha no3H~MsrTa!MTe, 3a KOHTO yqacTBaMe, Cb06pa3HO rrpe.nsapHTeJIHO
yroBopeH rpacpHK, npM. )KeJiaHHe OT cTpaHa Ha Bb3JIO)KJHenSI.
2.MHCTO Ha H3llbJIHeHHe:
<l>paHKo MHCTOTO Ha .nocTasKa no HacToRmaTa nopb'IKa, B qacrra 11 / o6oco6eHHTe no3HUMHI , 3a KOHTO yqacTBaMe, m~ 6b.ne:"Crreu.J.JaJIM3lfpaHa 6onHM~a 3a aKTHBHo nei.JeHHe Ha OHKonomt.IHH 3a6on51B3HHSI - CocpHjl o6nacT" EOO,ll., rp.Co<~M.sr 1123, 6yrr.
,CToneToB" NQ 67, ArrTeKa
3.TeXHH'leCKHTe xapaKTepHCTHKH Ha npe.nnaraHHTe OT HaC neKapCTBeHM rrpO.LJ:YKTM ITO 06oco6eHa TI03HIJ,HSI ,NQ 203 Ca TIO)lp06HO
orrMcaHH B Ta6JIM.IJeH BM.ll B H3fOTBeHoTo no o6pa3e~a Ha IlpMJIO)KeHMe NQ 2.1. 203 "Crre~HcpMKaiJ.M51 no 06oco6eHa rr03111J.H51 N2 203 ", Hepa3)]eJIH3 lJ3CT OT H3CT051IUOTO TeXHHl.J:eCKO ope)]JIO:>KeHHe.
4. Kal.feCTBO u cpoK ua rOJ(HOCT
,ll.eKJiapwpaMe, qe npe.nnaraHHTe OT Hac neKapcTBeHM. npo.nyKTH:
• ca perHCTpHpaHH 3a ynoTpe6a B CTpaHaTa H rrpHTe)KaBaT pa3peWMTeJIHH 3a ynoTpe6a, CbfJiaCHO 3JITIXM, npHTe)KaBaT
cepTHcpM.KaTH, y.nocToBepR:samH KaiJecTBOTo Ha rrpo.nyxTMTe, nMrrcsaT o<f>M~ManHH cbo6meHlf51 MJIM orpaHH'IHTerrHM MepKH 3a
yrroTpe6a Ha JieKapCTBeHMTe npO.llYKTM;
• OTfOBap51T Ha HOpMaTMBHO ycTaHOBeHMTe M3HCKB3HM51 3a KaLJeCTBO M esporreHCKH CT3H)l3pTH.
• OTrOB3p51T Ha CbOTBeTHHTe )leHCTBamH HOpMaTHBHH M3HCKB3HH51 33 npO)la)£(63- B3JIH)]HH pa3perneHM51 33 ynOTpe6a H \U~H~,
cpopMHpaHa B CbOTBeTCTBMe c H3HCKBaHHSITa Ha Hape.n6aTa 33 ycnoBM51Ta, rrpaBMJiaTa H pe.ua 3a peryrrH_EE.
perMcTpHpaHe Ha QeHHTe Ha rreKapcTBeHlfTe npo,nyKTH. I _ ~A~
.ff; ~\ 0 ~
P"'
,lJ,eKnapHpaMe, lfe npH .LlOCTaBKaTa Ha neKapcrseHHTe npO.LlYKTH, me ce cbo6pa~umaMe c H3HCKBaHH51Ta Ha Hape.u6a NQ 39 OT 13 cenTeMBpli 2007 r. 3a npHHl{liflHTe H 113liCKBaHI151Ta 3a .L{06paTa ,UliCTpH6yTOpCKa npaKTHKa.
fapaHTlipaMe .L{OCTaBKli C OCTaT'blfeH CpOK Ha fO.L{HOCT KbM ,L{aTaTa Ha .L{OCTaBKa He flO-MaJ!bK OT 60% OT cpoKa Ha fO,L{HOCT, YKa3aH BbpXy
onaKOBKaTa Ha CbOTBeTHH51 npOAYKT.
~
5. OnaKOBKa u MapKnpoBKa flpe.L{JiaraHI1Te OT HaC Me.L{lillliHCKH H3,UeJIHH Ca B CbOTBeTCTBHe C H3HCKBaHJ151Ta Ha Bb3JIO)KHTeJI51 11 npH .IJ:OCTaBKaTa me OTfOBap51T Ha
H3HCKBaHHHTa H me 6b.IJ:aT:
•
• •
OnaKOBaHH B OpHTHHaJIHa onaKOBKa Ha np0113BO.L{HTeJIH, C'bC C'bOTBeTHaTa MapKHpOBKa 3a npOH3BO,UHTeJI H napTH,L{HH
HOMepa, C HaHeCeHa "CE" MapKllpOBKa, HaHeCeH li,L{eHTHcpHKal{HOHeH HOMep Ha HOTlicpHl{HpaHHH OpraH, KOfaTO TaKbB Ce
If3HCKBa OT ,L{eHCTBaW:OTO 3aKOHO,L{aTeJ1CTBO, KaTO C flOCTaBeHa MapKHpOBKaTa Il(e e f10CTaBeHa Ha BCeKH KalllOH, C'bOTBeTHO - Ha
BC51Ka OflaKOBKa.
OnaKOBaHH B OpHrHHaJIHaTa OITaKOBKa Ha npOH3BO.L{HTeJI51, C HeHapyrneHa l{51JIOCT, 6e3 ,Ua Ca MOKpH .
OnaKOBaHH flO Ha'-!HH, KOMTO fH 3ana3Ba OT BC51KaKBH flOBpe.L{ll, ,UbJI)KaW:H Ce Ha aTMOCcpepHH YCJIOBH51 H TpaHCriOpT .
LIJ:e H3IIbJ1HHM npe.L{MeTa Ha .IJ:Orosopa B nbJIHO CbOTBeTCTBHe c H3HCKBaHH.HTa Ha Bb3JIO)KHTeJI.H, nocoqeHH B TexHH"leCKMTe
Cflel{HcpHKaUHli H ;::J:OKyMeHTaUH.HTa 3a ylfaCTHe.
KbM uacToH~oTo TexunttecKo npe;::J:Jiomeune npnJiaraMe: 1. TipHJIO)KeHHe NQ 2.1. 203 "CneuHqmKaUHSI no 06oco6eHa(Qo3HUH51 NQ 203"
TIOllllHC
TIEqAT
KpacHMHp HH
/ flbJ1HOMOI.UH11
,lJ,aHMeJ1a TierpoBa~ /flbJIHOMOm~
<l>apMa" EOO)J/
~
3
).1,0 "CiiAJI03- CO<DHH OliJIACT" EOO)l,
rp.Co~HH, 6yJJ, "CTOJICTOB" .N'2 67
TEXHifqECKO IIPE)l,JIOJKEHHE
3a yqacTHe B OTKpHTa rrpoQe.IJ:ypa 3a B'h3naraHe Ha o6mecTBeHa rropb'-!Ka c rrpe.[{MeT:
UPHJIOJKEHHE .N'!! 2 06pme4
")l,ocT3BI~a H3 Jie~~o:apcTseuu npo.ll,yKTH Ja HYJK.lJ.HTe H3 "CneuuaJIH3Hp3H3 6oJJHHI{3 Ja aKTHBHO Jieqeuue ua OHKOJJoru .. uu Ja6oJJHB3HHH
- Co~HH o6JJ3CT" EOO,L( no o6oco6euu nOJHUHH" 06oco6eu3 II03HUHH .N'!! 206 HaTpHeB XJIOpH)J, 0,9°/o 1000 MJJ, nJJ.6auKa IIapeuTepaJIH3 «bopM3 [U3nucea ce JWMepa u J-tauMeuoemmemo ua o6oco6euama noJUlfUR].
,<l>bOHI1KC <l>apMa" EOO,[( c EJ1K: 203283623, pemcTpau;a.sr no ,l])J,C: , C'bC ce,[{aJlHIIJ,e H a.npec Ha ynpaBneHI-re rp. Cocpn.sr 1700, paifoH p-H CTy.neHTCKH, yn. "OKOJIOBpoCTeH noT" N!! 199A,TeJI.:02/96581 OO,cpaKc:02/9658172, e-mail : [email protected], 11HTepHeT cTpamrua:
http://www.phoenixpharma.bg ,a.npec 3a KopecrroH.neHu;H.sr: fp. Cocpa.sr 1700, o6nacT CocpiDI, o6IIJ,HHa Cr oJIH'-!Ha, p-H CTy.IJ:eHTCKH:, yii . "0KOJIOBpbCTeH Ilb T" .N!! 199a
Tene<J:>oH 3a KOHTaKTH: 02 I 965 81 09; <l>aKc: 02 /965 88 28; e -mail: kr.nikolae•@ phoenixpllarma.bg, 11HTepHeT a.npec: http ://www.phoeni x phanna.bg/ ,6aHKOBa cMeTKa: BG91 UNCR96601030899522, npe.ncTaBn.srsaHo OT KpacHMHp HHKOJiaeB HHKorraeB, EfH 7712023968, Ha .[(Jib)l(HOCT ,[(HpeKTop EoJIHH'-IeH rra3ap H LJ:aHHerra llerposa HHKOJIOBa, EfH 7106114033 Ha .ll,Jlb)l(HOCT Mamcop <l>apMau;eBT
I>o;mwreH rra3ap, B KaqecTBOTO HH Ha n'hJIHOMOIIJ,HH:UH Ha ynpaBnTemne Ha "<l>bOHHKC <t>apMa" EOO.IJ:
YBAJKAEMA rOCTIOJKO YllPABHTEJI,
Cne.n 3ano3HaBaHe c .noKyMeHTaua.srTa 3a yqacnre B OTKpr-na rrpoue.nypa 3a Bo3rraraHe Ha o6mecTBeHa nopb'-!Ka c npe.nMer: ",LJ:ocTaBKa ua
JJeK3pCTBeuu npo~yKTH 33 uyJK~HTe H3 "CneUH3JIH3Hpaua 6oJIHHU3 33 3KTHBHO JJe'leuue H3 ou~~o:oJiorH'IHH 3a6oJJHBaHHH - CoclmH
o6JI3CT" EOO,LJ: no o6oco6euu no3HUHH", CMe C'brrracHH c rrocTaBemne or Bac ycnoBa.sr a ra npaeMaMe 6e3 Bb3pa)l(eHIUL
C HacTo.srmoTo Bn npe.IJ:cTaB.srMe Hawero npe.nJTo)l(eHHe 3a 113II'hJIHeHHe Ha nopo'-!Kara no 06oco6eu3 no3HUHH .N'!! 206 HaTpues xJiopua
0,9% 1000 MJJ, nJI.6au~~.:anapeuTep3JIHa «bopM3 uJnucea ce I-IOMepa u HaUMenoem-memo Ha o6oco6e1-1ama noJmJWl] , np11 crre.nHRTe ycrroBR.sr:
1. Cpo~~.:ose no o6IUeCTBeH3Ta IIOpb .. ~~.:a:
1. 1 . CpoK 3a H:3IIbJlHeHne Ha nopo'-!Kara- 12 (.nBaHa.necer) Meceua, C'-IHTaHO oT .naTar a Ha CKJliO'IBaHe Ha
H3TH'-IaHe/rrpeKpaT.srBaHe Ha rrpe.[(XO.[(HO CKJliO'-IeHH.sJ .[(OfOBOp C'bC CbiiJ,HH rrpe.[(MeT, KOeTO OT Cb6HTHHTa HaCTbilH IlO-K'bCHO.
1 . 2 . CornaCHH CM< na ~ ReKapcTB<HHTe rrpOII)'KTH, np<!lM<T Ha 003HUHHT<, 3a KOHTO }"!aCTBaMe, B CpOK no:
He noae'-le om 48 liaca qaca cne.n rronyLJaBaHe Ha ITI1CMeHa 3aSIBKa, BKJIIOLJI1TeJIHO 113npareHa no cpaKc, en. noma 111111 .npyr, 113p11LJHO
.uorosopeH c aHeKc KbM .norosopa HaLJI1H Me)l<.ny CTpaHI1Te - 3a peryn.SipH11 3a.SIBKI1. ITpH )l<enamre or cTpaHa Ha Bb3JIO)I<HTeJI.SI peryn.SipHine
.uocTaBKI1 me M3BbprnsaMe no yrosopeH rpacp11K.
He norJelie om 2 '-WCa LJaca cne.n norryLJaBaHe Ha 3a.SIBKa or Bb 3JIOJKIITEJHI, ompaseHa BKJIIOLJI1TeJIHO no cpaKc, en. now,a HJII1 .npyr,
H3pHLJHO .norosopeH c aHeKc KbM .norosopa HaLJI1H Me)l(.ny CTpaHHTe, a npH Heo6xo,nHMOCT - 11 no rerrecpoH- 3a cneiiiHH 3a.SIBKH
}J;ocTaBKHTe ,UO onpe.uerreHOTO OT Bb3JIO>KI1TeJl.SI cppaHKO M.SICTO 3a J(OCTaBKa, lll,e H3BbpiiiBaMe B pa60THH .llHI1, OT 08.00 J(O 16.00 qaca. B cnyqaif LJe cpoKbT 3a .nocrasKa H3TI1Lia B Hepa6oreH ,neH, }l.ocrasKara crre}l.Ba .na ce H3IIbJIHI1 HaM-KbCHo s rrbpB11.SI pa6oreH }l.eH,
crre.nsaw, .ueH.SI, B KOHTO H3TI1'IaT cpoKosere.
ITpH 113pHIIHO yKa3aHHe or crpaHa Ha Bb3JIO)I<HTeJISI w,e .nocraBHM 3a.SIBeHHTe npH cneiiiHH 3a.SI.BKI1 KOJIHLJecrsa H3BbH yKa3aHI1.SI no
rope qacosH ,nMarra30H.
CbrJiaCHM CMe .na .nocraB.SIMe JieKapcrseHHTe rrpo.nyKTI1, rrpe,nMeT Ha II03HU11.SI.Ta!Hre, 3a KOHTO ~acrsaMe, Cbo6pa3HO npe.nsapHrenHo
yrosopeH rpacpHK, rrp11 )l(eJiaHHe or crpaHa Ha Bb3JIO)I(HTeJI.SI.
2.MHCTO ua U3UbJIHeHHe: <l>paHKO M.SICTOTO Ha }l.OCTaBKa IIO HaCTO.SIW,aTa IIOpbLIKa, B qacTTa H /o6oco6eHMTe II03MUHH/, 3a KO.SITO yqacTBaMe, UJ,e
6b}l.e:"Crreu;HMH3HpaHa 6oJIHHUa 3a aKTHBHO neqeHHe Ha OHKOJIOf"I1LJHH 3a6oJI.SIBaHH.SI - Co<pH.SI o6nacr" EOO.[(, rp.CocpH.SI 1123, 6yn.
,Croneros" NQ 67, ArrreKa
3.TexuuqecKuTe xapaKTepncTUKH Ha rrpe}l.JiaraHHTe or Hac neKapcrseHH rrpo.nyKnl rro 06oco6eHa II03HUH.SI NQ 206 ca no.npo6Ho
onHcaHH B ra6rr11LJeH BH.U B H3rOTBeHoTo rro o6pa3eua Ha ITpHJIO)I(eHHe NQ 2.1. 206 "CrreuHcpHKaUH.SI no 06oco6eHa no3HU11.SI NQ_ 206", Hepa3}l.eJIHa LJaCT OT HaCTO.Silli,OTO TeXHHqecKO npe,UJIO)I(eHHe.
4. KaqecTBO u cpoK ua rOAHOCT .[(eKJiapHpaMe, qe npe}l.JiaraHI1Te or Hac rreKapcrseHH rrpo.nyKTH:
• ca perHcTpHpaHI1 3a ynorpe6a B crpaHara H rrpHTe)l(aBaT pa3peiiiHTeJIHH 3a ynorpe6a, cuJiacHo 3fliTXM, npHTe)l(aBaT cepTHcpHKaTH, Y.UOCTOBep.SIBamH KaLieCTBOTO Ha IIpO.UYKTHTe, JIHnCBaT OcpHQHMHH Cb06meHHSI HJIH OrpaHHI.JHTeJIHH MepKH 3a ynorpe6a Ha JieKapCTBeHHTe rrpO.UYKTH;
• OTfOBap.S!T Ha HOpMaTHBHO ycTaHOBeHHTe H3HCKBaHI1.SI 3a KaqeCTBO H eBponeHCKH CTaH,napTH.
• OTfOBap.S!T Ha CbOTBeTHHTe ,neHCTBaW,H HOpMaTHBHH 113HCKBaH11.SI 3a IIpO}l.a:>K6a - BaJIHJ(HM pa3perneHH.SI 3a yiiOTpe6a H QeHa, ' cpopMHpaHa s CbOTBeTCTBHe c H3MCKBaHH.SITa Ha Hape.n6ara 3a ycnoBH.SITa, rrpasHnara H pe.na 3a perynHpaHe H
perHcTpHpaHe Ha ueHHTe Ha JieKapcrsemne rrpo,nyKTH. j ~ ¢ ~~
l(~ pH.BENI .:
,.,o ~~~-/ > _b-JtW\-Id ~
~~~
LJ:eKn3pH:p3Me, qe npH .nocT3BK3T3 H3 neK3pCTBeHHTe npo.nyKTH:, me ce cno6paJHBaMe c H3H:CKBaHHHT3 H3 H3pe;::J:63 N2 39 oT 13 cerrTeMBpH: 2007 f. 33 npHHl(HriHTe H H3HCKB3HH:HTa 33 ,LJ,06p3T3 )J,H:CTpH6yropcKa npaKTHK3.
rapaHTHp3Me ,LJ,OCT3BKH C OCTaThl.!eH CpOK Ha fO)J,HOCT KbM ,LJ,aTaTa H3 ,UOCT3BK3 He ITO-MaJlbK OT 60% OT CpOK3 H3 fO,LJ,HOCT, YKa33H Bnpxy
OrraKOBK3Ta H3 CbOTBeTHHH npo,n;yKT.
5. OnaKOBKa u MapKupoBKa ITpe.unaraHHTe or Hac MeJJ:I.fUHHCKH H3,n;enH.si C3 s cnoTBeTcTBHe c H3HCKB3HJUIT3 H3 Bn3nm£mren.si H npH .uocT3BK3T3 me orrosapHT H3
H3HCKB3HHHT3 II me 6n,U3T:
~) • OIT3KOB3HH B OpHfHH3JTH3 Ori3KOBK3 H3 rrpOH3BO)J,HTeJIH, CbC C'bOTBeTH3Ta M3pKH:pOBK3 33 npOH3BO,UHTeJI H napTH)J,HH
HOMep3, C H3HeCeH3 "CE" M3pKH:pOBK3, H3HeCeH H,LJ,eHTIIQJHK31J,HOHeH HOMep H3 HOTH<}>HUHp3HHH opr3H, KOf3TO T3KbB Ce
H3HCKB3 OT ,UeHCTB3mOTO 33KOHO)J,3TenCTBO, K3TO C riOCTaBeH3 M3pKHpOBK3T3 me e nOCT3BeH3 H3 BCeKH K3WOH, CbOTBeTHO - H3
BCHK3 OIT3KOBK3.
• OIT3KOB3HH B OpHrHH3JTH3T3 Ori3KOBK3 H3 npOH3BO,UMTen51, C HeH3pyweH3 l(51JTOCT, 6e3 )),3 C3 MOKpH.
• Ori3KOB3HH riO H3lfHH, KOHTO fH 33IT33Ba OT BC51K3KBH riOBpe,UH, )J,bfl)!(3mH Ce H3 3TMOC<}>epmt YCJIOBHH H Tp3HCITOpT.
UJ,e H3nnnHHM npe.nMeT3 H3 .norosop3 B nonHo CbOTBeTCTBMe c H3HCKB3HH51T3 Ha Bn3RO)!(H:Ten51, nocol.JeHH B TexHH:l.JeCKHTe
CITeUHCjmK3UHH H )J,OKyMeHT3l(H51T3 33 Y1.!3CTHe.
KhM uacTOHW.OTO TexuuqecKo npe.r.no:JKeuue npunaraMe: 1. ITpHnO)!(eHHe N2 2.1. 206"Cneu;H<}>HK3UH.si no 06oco6eH3 no3MUHH N2 206"
llOllUHC
UElJAT
Kp3CHMH:p H / fhnHOMom
rn'!Uk¥Ll~a
tld'l~-bOHJiiKC <l>apM3" EOO)]/
3
IIpHno:>KeHHe NQ 2.1. KbM OpHJIO)Kemt:e NQ 2 "TexHHqecKo rrpe.LJ.JIO)KeHHe"
Cnenulj>nK3QHH no o6oco6eu3 noJHQHH .N!! 206 OT npone.r.yp3 33 Bb3Jiar3ue ua o6m.ecTBena nopbqK3 c npe,llMeT: ")J,ocTaBK3 ua neK3pCTBenu npo)J.yKTH 33 uy~~muTe ua
~nenuaJJnlnpaua 6oJJunna Ja aKTnouo JJe~euue ua oni<oJJorn'IHH Ja6oJJHBann•- CotjJHH oiiJJaCT" EOO,l{ no 50 oiiocoiieuu noJuQnn"
NiHa o6oco6 eHaTa no3ML\M
R
1
206
flBK8pcTBBH8 npeAilaraHa cpopMa PecpepeHTHa " nporH03HO pa31f;>acoeKa,
AHaToMo- lnOCO'feHaTa CToMHOCT38 KOmNeCTBO KonM-.eCTBO
TepaneBnNBH Me>lfAyttSpc>AHO HehSTeHTHO OT ODD/ /cornaCHo TbproecKo HaMMeHoeaHMe I MIMnM6polli a npoM3BOAMTen/n
H811MeHoeaHMe /INN/ B'b3nOlKMTBnR TepaneeTMYBH~ Cnet.\MtPHKSL\111 onaKOBKaTa pMTe>KaTen PY KOA /ATC-KOAf a Kypc 'stTa Ha 111 npeAilaraHa
cne4MtPMKa4111 8"b3110lKMTBnR/ neKapcTBeHa SITa/ o't . lf;>opMa
2 3 4 5 6 7 8 9
B05CB01 HaTpl<lee XllOpl<l,o, 0,9% 1000 napeHTepanHa
2,36 1000 Natrium choratum sol. 0,9% 1000 ml B.Braun
Mll , nn.6aHKa Q:>opMa
3a6eJJe)f(Ka: CHBaTa LJaCT OT Ta6nwuaTa ce nonbJJBa OT cneuHqmKaumna Ha Bb3JJO)f(HTeJJSI - npHJJO)f(eHwe KbM JJ.OKy MeHTaUHHTa - KOJJOHH A- G. B JlSICHaTa/)f(bJJTa 4aCT ce
nonbJJBaT JJ.aHHHTe 3a npeJJ.JJaraHHSI OT yLJaCTHHKa npOJJ.YKT.
20.05.2016 r. llOllllHC
flEqAT
KpacHMHp HHKonaes HH /lhnHOMO~HHK Ha" <DbQ
0TopM3al.l IIIR:AA/
HE
10
AA
~
~) )..1,0 "C.6AJI03- CO<bllll OI>JIACT" EOO)l,
rp.COfJmsr, 6yJI. "CToJieTOB" .N'!! 67
TEXHlfqECKO TIPEJJ:JI OJKEHIIE
TIPMJIOJKEHIIE .N! 2 06pme11
~ 3a yqacrHe B OTKpHTa npou.eLJ.ypa 3a Bb3JiaraHe Ha o6ruecrseHa nopo'lKa c npeLJ.MeT:
")l,OCT3BK3 Ha JieKapCTBCHH npOLJ.YKTH 33 HY~JJ:HTC Ha "Cneu;H3JIH3Hp3H3 fiOJIHHU.3 33 3KTHBHO JIClJCHHC H3 OHKOJIOfH'IHH 3a60JISIB3HJIH
- Cocj>uH o6JI3CT" EOO)l, no o6oco6euu no3uu;uu" 06oco6eu3 no3HU.HH .N'!! 207 Puurep 500 MJI, DJI. 63HK3 n3peuTepaJIH3 dwpMa [ uJnucaa ce HOM epa u HGUMenoaaJ-tuemo Ha o6oco6e11ama n03UlfWl].
,<!>bOHHKC <!>apMa" EOO.[( c EHK: 203283623, per11crpar.uur no .IUJ:C: , cbc ceLJ,aJIHll.le H a)J,pec Ha ynpasneHHe rp. Co<}JHH 1700, paH:oH p-H
CryLJ,eHTCKH, yn. "OKonospbCTeH noT" N:! 199A,ren. :02/96581 OO,<}laKc:02/9658172, e-mail: [email protected], I1HrepHeT crparm11a: http: //www.phoenixphanna.bg ,a.LJ.pec 3a KopecrrOHLJ,eHUH.H: rp. Co<}JH5I 1700, o6nacT Co<}JIUI, o6ruHHa CTOJTH<JHa, p-H Cry)J,eHTCKH, yn. "OKoJTospocreH nor" N2 199a
Tene<}JoH 3a KOHTaKTH : 02 I 965 81 09; <l>aKc: 02 /965 88 28; e -mail: kr.nikolae•@ulwenixpharma.bg, I1HTepHeT aLJ.pec:
http://www.phoenixphanna.bg/ ,6aHKOBa CMeTKa: BG91 UNCR96601030899522, npeLJ,crasrumaHo or KpacHMHp HHKonaes HHKOJTaes, EfH 7712023968, Ha LJ.Jib)KHOCT ,[(HpeKrop I>oJTHH'leH rrroap 11 ,[(aHMeJTa ITerposa HHKonosa, ErH 7106114033 Ha LJ.JTb)KHOCT MarHcop <l>apMau.esr
EonHH<JeH nroap, B KaYeCTBOTO HH Ha nbJTHOMOll.lHHUH Ha ynpaBHTemne Ha "<!>bOHHKC <l>apMa" EOO.[(
YBAJKAEMA rOCllOJKO YTIP ABIITEJI,
CJTeLJ. 3ano3HaBaHe c LJ.OKyMeHTaUH51Ta 3a yqacrHe B orKpHra npoueLJ.ypa 3a Bb3JTaraHe Ha o6mecTseHa rropb'!Ka c npeLJ,Mer: ".IJ:ocT3BKa ua
JieKapcTseuJt npoJJ;yKTH 1a uy~JJ:HTe ua "Cneu;uaJIH3Hp3H3 6oJiuuu;a 33 aKTHBHO JielJeuue ua OHKOJIOfH'IHH 3a6oJIHBauuH - Co,JmH
o6JiacT" EOO.IJ: no o6oco6euu noJuu.uu", cMe cornacHM c nocmseHHTe or Bac ycnoBH.H H nr rrpHeMaMe 6e3 Bb3pa)KeHH51.
C HaCT051ll.lOTO BH npe.LJ.CTaBRMe Hawero npeLJ.JIO)I{eHHe 3a H3ITbJIHeHHe Ha rropb4KaTa no 06oco6eua no3uu;usr .N'!! 207 Puurep 500 MJI,
nJI. 63HK3n3peuTepaJiua dJopM3 uJnucaa ce HOMepa u HGWvteHoaaHuemo ua o6oco6e1-1ama nOJU~JWl], npH cJTeLJ,HHTe ycJTOBH.H:
1. CpoKoBe no o6mecTBCH3T3 nopbiJK3:
1 . 1 . CpoK 3a I13TibJTHeHHe Ha nopb'lKaTa- 12 (.LJ.BaHaLJ,ecer) Meceua, cq~onaHo or LJ,arara Ha CKJTIO'lBaHe
M3TH'laHe/rrpeKpaT51BaHe Ha npe)J,XOLJ,HO CKJIIO'leHH51 LJ,OfOBOp CbC CbiUH5I rrpeLJ,MeT, KOeTO OT Cb6HTI15ITa H3CTbTIH ITO-KbCHO.
~) 1 . 2 . CbrnacHH CMe )J,a )J,OCTaB.srMe neKapcTBeHHTe npo.rzyKTH, npeJJ.MeT Ha rro3H~HHTe, 3a KOHTO yqacTBaMe, B cpoK )J,O:
He noeetJe om 48 tJaca qaca cne)J, nonyqasaHe Ha nHcMeHa 3a.SIBKa, BKniOlJHTenuo H3npaTeHa no cpaKc, en. noma HJ1H JJ.pyr, H3pHquo
)J,orosopeH c aHeKc KbM )J,orosopa Hal.[HH Me)I(JJ.Y cTpaHHTe - 3a peryn.srpHH 3a.SIBKH. ITpH )l(enaHHe OT cTpaHa Ha Bb3JJO)l{I1Ten51 peryn51pHHTe
JJ.OCTaBKH rue H3BbprnsaMe no yrosopeH rpacpHK.
He noeetJe om 2 tJaca qaca cne)J, rronyqasaHe Ha 3a.SIBKa OT Bb3JIOJKHTEJUI, oTrrpaseHa BKmO'-IHTeJIHO no cpaKc, en. noma HnH JJ.pyr,
H3pH'IHO )J,OfOBOpeH C aHeKC KbM )J,OfOBOpa Hal.[HH Me)I()J,y CTpamne, a npH He06XO)J,HMOCT - H ITO TeJie<pOH- 3a CTleWHH 3a.SIBKH
)J,OCTaBKHTe )1,0 orrpe)J,eJieHOTO OT Bb3JI0)l{J1TeJI.SI <J:>paHKO M.SICTO 3a )J,OCTaBKa, rue 113BbpWBaMe B pa60THH )J,HH, OT 08.00 )1,0 16.00 qaca. B cnyqaii qe cpOKbT 3a )J,OCTasKa H3TH4a s uepa6oTeH )J.eH, )J,OCTaBKaTa crre)J,Ba )J,a ce H3nbJIHH HaH-KbCHO s nbpBH.SI pa6oTeH )J,eH ,
cne)J,sam )J,eH.SI, s KOHTO H3TH'-IaT cpoKoseTe.
npH H3pH4HO yKa3aHH.e OT CTpaHa Ha Bb3JIO)l{HTeJI.SI lll,e )J,OCTaBHM 3a.SIBeHHTe rrpH CIIeWHH 3aJIBKH KOJIH'leCTBa H3BbH yKa3aHH.SI flO
rope qacosH )J,Harra30H.
CbrnacHH CMe )J,a JJ.OCTaB.SIMe neKapcTBeHHTe rrpoJJ.yKTH, npeJJ.MeT Ha no3Hl.lH.SITa!HTe, 3a KOHTO yqacTBaMe, cbo6pa3HO npeJJ.B~pHTen -
yrosopeH r pacpHK, rrpH )l{eJiaHHe OT CTpaua Ha Bb3JIO)I(HTen.SI.
2.MHCTO Ha H30bJ1HeHUe:
<l>paHKO M.SICTOTO ua JJ.OCTaBKa no HacTo.SiruaTa rropb4Ka, s qacrra H. /o6oco6emne no3Hl.lHHI, 3a KO.SITO yqacTsaMe, me
6b)J.e:"CneuHanH3HpaHa 6onHHI.la 3a aKTHBHO neqeHHe Ha OHKonomqHH 3a6on.SIB3HH.SI - CocpH.SI o6n3cT" EOO;:J:, rp.Co<J:>H.SI 1123, 6yrr.
,CToneTos" NQ 67, ArrTeKa
3.TexuuqecKnTe xapaKTepucTHKH H3 npe)J,n3r3HHTe OT Hac neK3pCTBeHH npoJJ.yKTH no 06oco6eua no3HUH.SI NQ 207 C3 rro)J,po6Ho
orrHC3HH s T36JmqeH BHJJ. s H3fOTBeHoTo no o6pa3eua Ha TipHno)l{eHHe NQ 2.1. 207 "CneuHcpHKa~H.sr no 06oco6eHa no3Hl.liUI NQ 207", Hep33)J,eJIHa 'laCT OT HaCTO.SIIl.lOTO TeXHHl.[eCKO npe)J,JIO)f(eHHe.
4. Ka'leCTBO u cpoK ua roJJ.HOCT
;:J:eKn3pHp3Me, qe npe)J,naraHHTe oT Hac neK3pCTBeHH npoJJ.yKTH:
• C3 perHcTpHpaHH 33 ynoTpe63 B cTp3HaTa H npHTe)l{aBaT pa3peunnenHH 3a yrroTpe63, CbrnacHo 3JITIXM, npHTe)I(3BaT
cepTHcpHKaTH, YJJ.OCTosep.SisaruH Ka'leCTBOTO Ha npoJJ.yKTHTe, nHrrcsaT o<J:>HUHaJIHH cbo6meHH.SI HJIH orpaHHl.[HTenHH MepKH 3a
ynoTpe6a Ha neKapCTBeHHTe npOJJ.YKTH;
• OTrosap.SIT H3 HOpMaTHBHO YCT3HOBeHHTe H3HCKBaHH.SI 33 KaqeCTBO H esponeHCKH CTaH)J,3pTH.
• OTrOB3p.SIT Ha CbOTBeTHHTe )J,ei1cTB3IlJ,H HOpM3THBHH H3HCKBaHH.SI 33 npo)J,a)l<63 - B3JIH)J.HH pa3perneHH.SI 33 yrroTpe6a H UeHa,
cpopMHpaHa B CbOTBeTCTBHe c H3HCKB3HH.SITa H3 HapeJJ.6aTa 33 ycnosmiTa, npasHnaT3 H pe)J,a 3a perynH~iA
perHCTpHpaHe H3 uemiTe Ha JieKapCTBeHHTe npOJJ.YKTH. ./~~f, o/' '~\ O,x \rJ ;
pt\~ ... I
):leKJiapnpaMe, qe npH nocTaBK~pCTBCHHTe nponyKTH, ll1C ce c.a6p!13HBaMe c H3HCKBaRHHTa Ha Hapen6a N• 39 OT 13 cenTeMBpH 2007 r. 3a IIpHHI.{HIIHTe H H3HCKBaHH51Ta 3a .U06para )lHCTpH6yropcKa npaKTHKa.
fapaHTHpaMe )lOCTaBKH C OCTaThLJeH CpOK Ha fO.[IHOCT KbM )laTaTa Ha )lOCTaBKa He IIO-MaJlbK OT 60% OT CpOKa Ha fO)lHOCT, YKa3aH BbpXy
OIIaKOBKaTa Ha CbOTBeTHH51 IIpO.L\YKT.
5. OnaKOBKa u MapKupoBKa ITpe.unaraHHTe or Hac Me.UHIJ:HHCKH H3.UeJimi ca B CbOTBeTCTBHe c H3HCKBamuna Ha Bb3JIO)!(JfTeJI51 11 npH .uocrasKara me orrosapHT Ha
H3HCKBaHH51Ta 11 me 6b)laT:
• OIIaKOBaHH B OpHrHHaJIHa OIIaKOBKa Ha IIpOH3BO.[\HTeJI51, CbC CbOTBeTHaTa MapKHpOBKa 3a IIpOH3BO)lHTeJI M rrapTH.UHH
HOMepa, C HaHeCeHa "C£" MapKHpOBKa, HaHeCeH H.[leHTI1cl>HKal.{HOHeH HOMep Ha HOTHcl>HU:HpaHH51 OpraH, KOfaTO TaKbB Ce
H3HCKBa OT )leHCTBamOTO 3aKOHO)laTeJICTBO, KaTO C IIOCTaBeHa MapKHpOBKaTa me e IIOCTaBeHa Ha BCeKH KaiiJOH, CbOTBeTHO - Ha
BC51Ka OIIaKOBKa.
• OIIaKOBaHI1 B Op11rHHaJIHaTa OIIaKOBKa Ha IIpOH3BO,UHTeJ15I, C HeHapyrneHa l{51JIOCT, 6e3 .[Ia Ca MOKpH.
• OIIaKOBaHH IIO HaLJHH, KOHTO fH 3aiia3Ba OT BC51KaKBii IIOBpe.UH, )lbJI)l(all.{H Ce Ha aTMOCcl>epHH ycJIOBH51 M TpaHCIIOpT.
~e H3IIbJIHHM rrpe.uMeTa Ha .uorosopa B IIbJIHO CbOTBeTCTBHe c H3HCKBaHH51Ta Ha Bb3JIO)l(HTemi, rroco'ieHH B TexHH'ieCKHTe
cneu:mlHl:Kal{HH H .UOKyMeHTal{H51Ta 3a YLJaCTHe .
KLM uacroHJ..QOTO rexuuqecKo npeJJ.JIOil\euue npuJiaraMe: 1. IIpHilO)[(eJ-me .N2 2.1. 207"Crreu:Hcl>HKaU,H51 no 06oco6eHa no3HU.H51 N2 207''
~ P/t7 DOllllliC
IIEqAT
3
N!!Ha o6oco6 eHara
no3MI..II1 .R
1
207
KbM flpHJIO)I(eHJ-ie
~)Kauus no o6oco6eua no3HUHB No 207
IlpHJIO)I(eHHe N2 2. 1. N2 2 "TexHHqecKo npe)J,JIO)I(eHHe"
OT npoue)J.ypa 33 B'b3JI3r3ue H3 o6meCTseua nopb'IKa c npe)J.MeT: ",LI,ocT3BK3 H3 JieK3pcTseuu npo)J.yKTH 33 uy~uTe ua "Cneuu3JIH3npaH3 6oJIHHU3 33 3KTHBHO Jie'leuue H3 ouKoJioruquu 3360JIHB3HUH- Co«J>uu o6JI3CT" EOO,LI, no 50 o6oco6euu no1uuuu"
JleKapcraeHa npeAJ"'araHa cpopMa ~ecpepeHTHa nporH03HO pa3cf>acoeKa,
AHaroMo- /noco~:~eHara CTOr;1HOCT 39 KQ11~4ecTBO Kom11.1ecTeo
repaneanNeH Me~KAyHaPQAHO HenareHTHO OT ~~; ODD/ h:br119CHO TbproecKo Ha~MeHoeaHMe I 111/HilH 6pOM B npm13BO,QIIITen/n
HSI1M6H0BSHI1e /INN/ TepaneeTHYeH ~
pMre>Karen PY KOA /ATC-KoAI
Bb3110>KIIITenSJ cn~Ltlii4>HK8l.l11 onaKOBKara B KYPC s:na Ha H npeAJ"'araHa
cnel!l1cf>111Kall~ Bbano>t<lllren.R/ neKapcreeHa .RTa/ ,, cpopMa
2 3 4 5 6 7 8 9
8058801 P~~tHrep 500 Mn, nn. 6aHKa napeHrepanHa
1,68 1500 Ringer sol. 500 ml B.8raun
WOPMS -
3a6ene>KKa: C1-1BaTa Yacr OT ra6mtuaTa ce nonbllBa OT cneuw<j>HKauw~Ta Ha Bb3no>KI!Ten~ - npHno>Kemte KbM noKyMeHTaUHHTa - KO!lOHH A - G. B n~cHaTafJKbJlTa .. mer ce nonbnsaT naHHHTe Ja npennaraHH~ or Y'I3CTHHKa nponyKT.
20.05 .2016 r. llOliiiHC
fiEqAT
KpacHMHp HHKonaes HHKonaes
/ IloJIHOMOI.I..(HHK Ha" <l>bOHHK~tti'
~~
0TOPM3a...-III.R: IJ,A I
HE
10
AA
1.1
~ )1;0 "CEAJI03- CO<I>IDI OEJIACT" EOO):( rp.CocJ!uH, 6yJI. "CroJieToB" .N'!! 67
TEXHHqECKO ITPE):(JI OlKEHHE
3a yqacn1e B OTKpHTa npoue.ZJ.ypa 3a Bo3naraHe Ha o6mecTBeHa rropoqKa c rrpe.ZJ.MeT:
llPMJIOlKEHHE X2 2 06pme4
")J;OCT3BK3 H3 JieK3pCTBeHH npOJJ.YKTH 33 uy~HTe H3 "CneQH3J1H3Hp3H3 60JIHHQ3 33 3KTHBHO Jieqeuue H3 OHKOJIOfUquu 3360JIHB3HHH - CocJ!uH o6JI3CT" EOO,L( no o6oco6euu no3uu;uu"
06oco6eu3 no3HU:HH .N'! 208 X3pTM3H 500 MJI., nJI. 63HK3 n3peuTep3JIH3 d!opM3 [ UJnucea ce NOM epa u HGUMeHoemmemo Ha o6oco6eHama nOJUl,fU5l]. ,<DbOHllKC <DapMa" EOO,[( c EllK: 203283623, pen1cTparuu1 no ,ll:.Zl,C: , cbc ce)J.anmu:e H a)l,pec Ha yrrpaBneuHe rp. Co<tJH.sr 1700, pai1oH p-H CTy.ZJ.eHTCKM, yn. "OKonoBpbcTeH ribT" N2 199A,Ten.:02/9658 1 OO,<t>aKc:02/9658172, e-mail: [email protected], l1HTepHeT CTpamm:a: http://www.phoenixphanna.bg ,a)l,pec 3a KOpecrrOH)l,eHrrH.sr: rp. Co<PHSI 1700, o6nacT CoqmSI, o6mHHa CTOmlqHa, p-H CTy)l,eHTCKH, yJl. "OKonoBpocTeH TibT" N2 199a Tene¢oH 3a KOHTaKTM: 02 I 965 81 09; <l>aKc: 02 /965 88 28; e - mail: [email protected], llHTepHeT a.ZJ.pec: http://www.phoenixpharma.bg/ ,6aHKOBa cMeTKa: BG91 UNCR96601 030899522, rrpe.ZJ.CTaBrr.srsaHo OT KpacnMHp HHKonaes HHKonaes, EfH 7712023968, Ha .ZJ.Jib)KHOCT ,[(upeKTop oonHwieH na3ap H ,[(aHHena IleTpoBa HHKOJIOBa, EfH 7106114033 Ha )l,JT'b)KHOCT Mamcop <DapMauesT ooJJHH'IeH nroap, B Ka'IeCTBOTO HH Ha TI'hJlHOMOIIIHHQH Ha ynpaBMTeJTHTe Ha "<l>bOHI1KC <l>apMa" EOO,U
YBAlKAEMA rOCllOlKO YllPABliTEJI,
Cne)l, 3arro3HaBaHe c .ZJ.OKyMeHTauH.srTa 3a yqacTae B OTKpHTa npoue.ZJ.ypa 3a Bb3JTaraHe Ha o6mecTBeHa rropbiiKa c rrpe)l,MeT: "):(ocT3BKa ua
JieK3pCTBeuu npOJJ.YKTH 33 uy~uTe H3 "Cneu;uaJIH3Hp3H3 6oJIHHU:3 33 3KTHBHO Jielfeuue H3 OHKOJIOrHlfHH 3360JIHB3HHH - CocJ!un
o6JI3CT 11 EOO):( no o6oco6euu no3uu;uu", cMe cbrJJaCHH c nocTaBeHaTe OT Bac ycnoBHSI H m rrpHeMaMe 6e3 Bo3pa)KeHH51.
C HaCT05llllOTO BH npe)l,cTaBSIMe HarneTo rrpe)l,JlO)I{eHHe 3a H3TIJ:..:meHHe Ha nopb'IKaTa no 06oco6ena noJuu;un .N'! 208 XapTM3H 500
MJI., nJI. 63HK3n3peuTepaJIH3 d>OpMa U3nucea ce HOMepa u HawweNoemtuemo 1-w o6oco6e1-1Gma noJUl,fU5l], rrpH cne)l,HHTe ycnoBHSI:
1. CpoKose no o6m:ecTBeH3Ta nopb'IKa:
1. 1. CpoK 3a H3l1bJ1HeHHe Ha IlOpbqKaTa- 12 ()l,BaHa)J.eCeT) Meceu:a, C'IHTaHO OT )J.aTaTa Ha CKJIIOqBaHe Ha
H3TH'IaHe/rrpeKpaDIBaHe Ha rrpe)J.XO)J.HO CKJUO'IeHH51: )J.OfOBOp CbC CblllH5l npe)J.MeT, KOeTO OT Co6HTHS!Ta HaCTbTIH IlO-KbCHO.
1 • 2 • ComaCHR CMC na nocms.MC flCKap~l npOI1)'KTR, npe){M<T Ha il03RURHTC, 3a KOHTO }"laCTBaMe, B CpOK )10:
He noeelle om 48 llaca qaca cne.u nonyqasaHe Ha nHcMeHa 3a51BKa, BKJllOLJHTeJIHO H3npareHa no Q:>aKc, en. now,a HnH .upyr, H3pHLJHO
.uorosopeH c aHeKc KbM .uorosopa Ha'mH Me)!(.uy crpaHHTe - 3a perymlpHH 3a51BKH. llpH )!(enaHHe or crpaHa Ha Bb3nO)!(HTen51 peryn51pHine
.uocTaBKH w,e H3BbprnsaMe no yrosopeH rpaci>HK.
He noee'le om 2 ~Jaca qaca cne.u nonyqasaHe Ha 3a51BKa OT Bb3JIOJKM.TEJHI, ornpaseHa BKniOLJHTenHo no Q:>aKc, en. rroma HnH .upyr,
H3pHLJHO .uorosopeH c aHeKc KbM .uorosopa HaLJHH Me)!(.uy cTpaHine, a rrpH Heo6xo.nH:MOCT- H no rene<PoH- 3a cnernmi 3a51BKH
,[(OCTaBKHTe .UO orrpe.neneHOTO OT Bb3J10)!(HTen51 cppaHKO M51CTO 3a )J,OCTaBKa, me H3BbpU1BaMe B pa60THH )J,HH, OT 08.00 )),0 16.00
qaca. B cnyqai1: "'!e cpOK'hT 3a .uocTaBKa H3THLia B Hepa6oTeH .neH, .uocTaBKara cne.usa .ua ce H3n'hJIHH HaH-KbCHO B nbpBH51 pa6oTeH .neH,
cne.usam .ueH51, B KOHTO H3THLiaT cpoKosere.
flpH I13pH:LJHO YKa3aHHe OT CTpaHa Ha Bb3nO)!(lfTeJI51 rue )J,OCTRBHM 3a51BeHHTe IIpH cneiiiHH 3a51BKH KOJIHL!eCTBa H3BbH yKa3aHH51 no
rope qacoBH .UHana3oH.
CnmacHH CMe .ua .uocraB51Me neKapcTBeHHTe npo.uyKTH, npe.nMeT Ha n03H~H51Ta!HTe, 3a KOHTO yqacTBaMe, cno6pa3HO npe,llsapHTeJIHO
yrosopeH rpaci>HK, np11: )!(eJJaHHe OT crpaHa Ha Bb3nO)!(HTeJI51.
2.MHCTO ua 113II'hJIHeuue: <l>paHKO M51CTOTO Ha .uocrasKa no Hacroamara nopbLIKa, B qacrra it /o6oco6eHHTe no3Rrum/ , 3a K051TO yqacTBaMe, me
6n.ue:"Cne~HaJIH3H:paHa 6onHH~a 3a aKTHBHO JJeqeHHe Ha OHKOJJOfliLIHH 3a6omlBaHM51 - Coclm51 o6JJacT" EOO~, rp.CocpH51 1123, 6yn.
,CToneToB" N2 67, AnTeKa
3.TexuuqecKnTe xapaKTepncTHKH Ha rrpe.nnaraHMTe OT Hac JJeKapcrseHH npo.nyKTH no 06oco6eHa no3H~H51 N2 208 ca no.upo6Ho
onHcaHH B Ta6JmqeH BH.U B H3rOTBeHoTo no o6pa3e~a Ha llpHnO)!(eHHe N2 2.1. 208 "Crre~HcpHKa~H51 no 06oco6eHa no3H~H51 N2 208 ",
Hepa3.nenHa 9aCT OT HaCT051mOTO TeXHH:qecKO rrpe.nnmKeHHe.
4. KaqecTBO u cpoK ua ro).J,HOCT ,[(eKJJapHpaMe, qe npe.nJJaraHHTe or Hac JJeKapcTsemf npo.uyKTH:
• ca pemcrpHpaHH 3a ynorpe6a B cTpaHaTa H rrpHTe)l(aBaT pa3pernHTeJIHH 3a yrroTpe6a, cnrnacHo 3fliTXM, rrpHTe)!(aBaT
cepntcpHKaTH, y.uocrosep.Hsarn:H Ka'!eCTBOTO Ha rrpo.nyKTHTe, mmcsaT ocpH~H:aJIHH cno6meHH51 HnH: orpaHuqurenHH: MepKH: 3a
yrrorpe6a Ha neKapcrsemne npO.UYKTH:;
• 0TfOBap51T Ha HOpMaTHBHO ycTaHOBeHHTe I13HCKBaHH51 3a Kal!eCTBO H: esponeHCKH CTaH,llapTH.
• OTfOBap51T Ha CbOTBeTHHTe )leHCTBaiUH: HOpMaTHBHH Ii3HCKBaHH51 3a npo,lla)!(6a - BaJJH:)J,HH pa3perneHH51 3a ynoTpe6a H ~eHa
cpopMupaHa B CbOTBeTCTBHe c H3H:CKBaHH51Ta Ha Hape.u6aTa 3a ycJJOBH5rTa, npasunara u pe.ua Ja
perHCTp!ipaHe Ha ~eHHTe Ha JieKapCTBeHHTe rrpO.UYKTH.
~ )J,eKnapupaMe, qe np11 .nocTasKaTa Ha neKapcTBeHHTe npo,nyKTH, me ce coo6pa351BaMe c H3HCKBaHH51Ta Ha Hape.n6a NQ 39 OT 13 ceriTeMBpH 2007 r. 3a npHHUHni1Te 11 113HCKBaHH51Ta 3a _no6paTa ,[{11CTpY16yTOpCKa npaKTHKa.
rapaHTHpaMe JJ:OCTaBKH C OCTaTh'IeH CpOK Ha fOJJ:HOCT KbM ,[{aTaTa Ha ):(OCTaBKa He TIO-MaJ1bK OT 60% OT CpOKa Ha rO,UHOCT, YKa3aH Bopxy
onaKOBKaTa Ha CbOTBeTHH51 npO):(YKT.
5. OnaKOBKa u MapKupoBKa f1pe,nJJaraHHTe OT HaC Me,[{HUHHCKH 113,UeJIH51 Ca B CbOTBeTCTBHe C 11311CKBaHH51Ta Ha Bb3JI0)£{11TeJI51 H npH ):(OCTaBKaTa me OTrOBapHT Ha
H311CKBaHH51Ta 11 me 6bL{aT:
• OITaKOBaHI1 B OpHn-JHaJIHa OllaKOBKa Ha npOH3BO,[{HTeJJ51, CbC CbOTBeTHaTa MapK11pOBKa 3a llp0113BO,[{HTeJJ 11 napTHJJ:HH
HOMepa, C HaHeCeHa "CE" MapKHpOBKa, HaHeCeH HL{eHTHqJHKai.J,HOHeH HOMep Ha HOTHQJHUHpaHH51 OpraH, KOfaTO TaKbB Ce
11311CKBa OT ,[{eHCTBall{OTO 3aKOHO,[{aTeJICTBO, KaTO C ITOCTaBeHa MapKHpOBKaTa me e llOCTaBeHa Ha BCeKH KaUJOH, CbOTBeTHO - Ha
BC51Ka OITaKOBKa.
• OllaKOBaHM B OpHTMHaJIHara OTiaKOBKa Ha np0113BO,[{HTeJ151 , C HeHapyrneHa U51J10CT, 6e3 ,Ua ca MOKpH.
• onaKoBaHM no Ha'IHH, Koiho rH 3ana3Ba or BCHKaKBH rrospe,nH, ,nbmKamu ce Ha arMoccpepHH ycnoBH51 11 rpaHcnopr.
lll,e H3IToJIHHM npe,nMera Ha .uorosopa B nonHo cborsercrsHe c H3YICKBaHH51Ta Ha Bo3JIO:>Imren.H, noco'!eHH B TexHH'IeCKHTe
cnei.J,HcpHKaUHM M ):(OKyMeHTa[(H51Ta 3a yqaCTHe.
KbM uacTOHI.QOTO TCXHH"JecKo npeJJ,Jlomeuue npHJiaraMe:
1. f1pMJ10)£{eHHe NQ 2.1. 208"Crreuu$HKaUH51 no 06oco6eHa TI03HUH51 NQ 208"
llOlliUIC
flEqAT
h~
3
NeHa o6oco6 eHaTa
no31414M Jl
1
208
~ llpHJIO)l(em:~e NQ 2.1.
KbM IlpHJIO)l(eHHe NQ 2 "TexHHqecKo rrpe)J,JIO)l(eHHe"
Cneu.ucJmKaQUH no ooocooeua D03HQHB .N'!! 208 OT npou.eAypa Ja B'bJJiaraue ua OOII.J.eCTBena nopb'IKa c npe)lMeT: ".l1:ocTaBKa ua JieKapcTBenu npo)lyKTH Ja nyiKJJ;nTe ua
"Cneu.uaJin3npaua ooJinnu.a Ja aKTHBHo Jie'lenue ua onKOJiorn'IHH JaooJIHBanuB- CoclmH ooJiacT" EOO,n: no 50 ooocooeuu nOJnuuu"
fleKapcTBetta npeAJlaraHa QwpMa . N PeQ:>epeHTHa nporH03HO pa3ct>acoaKa,
AHaTOMo- /nOCO'feHaTa 't CTOMHOCT 38 KOnMI.feCTBO KonM'4eCTBO
TepaneaTMI.f&H Me)I(AyH8J)OAHO He08TBHTHO OT DOD/ /cbrnacHo TaproacKo HaMMeHoaaHMe I MIMnM 6pol4 a npoM3BOAMTenln
KOA /ATC-Ko/:J/ H8MM8HOUHM8 /INN/ Bb3nO>KJIITens:~ TepaneaTMI.feH cne~Mct>14Ka14M onaKoaKaTa pMTelKaTen PY
B ,~, K)'pc ~Ta 1-18'1 M npeAJlaraHa & cne!4Mct>MKa~ Bb3no>J<MTens:tl neKapcTaeHa
SIT a/ • ct>opMa 2 3 4 5 6 7 8 9
8058801 XapTMaH 500 Mil ., nn . 6aHKa napeHTepanHa 2 1500 Hartmannn sol. 500 ml
B.Braun
·-· cj:lopMa
3a6ene)f(Ka: CHsaTa 43CT OT TII6nHuaTa ce nonbnsa OT cneuHQlHKatU1HTa Ha Bb3JlO)I(HTenH - npHllO)I{eHHe KbM .aoKyMeHTaUHHTa - KOJlOHH A- G. B .llHCHaTa/)f(bJlTa 43CT ce
nonbll83T .ll3HHHTe 33 npe.anaraHH.SI OT Y43CTHHK3 npO.llYKT.
20.05.2016 r. llOliiiUC
llEl.JAT ~
0TOpM38L4 M.R: AA I
HE
10
M - ----
t
~ ,l(O "C1iAJI03- CO«<>IDI OEJIACT" EOO)]; rp.Cofj>us, 6yJI. "CroJieTOB" .N!! 67
TEXHHqECKO IIPE,l(JIO)KEHHE
3a y•-mcnte B OTKpHTa npoue.nypa 3a Bn3naraue Ha o6mecTBeHa nopn'IKa c npe.uMeT:
llPHJIO)I{EHHE .N2 2 06pa3elJ
",lJ,OCTaBKa Ha JieKapCTBeHH npo}J.yKTH 3a uy~nTe Ha "CneuuaJIH3HpaHa 60JIHHl{a Ja aKTHBHO JIC'IeHUe Ha OHKOJIOfHqHU 3a60JIHBaHIIH
- Cofj>uH o6JiaCT" EOO)J; no o6oco6euu no3nuuu" 06oco6eua noJHUHH .N'!! 210 Hydroxyethylstarch 6% 500 ml, nJI. 6anKa napeuTepaJiua d!OpMa [wnucea ce fiOMepa u uaUMeNoeaHuemo 11.a o6oco6enama n03WfUR]. , <l>bOHI1KC <I>apMa" EOO)J; c EHK: 203283623, perHCTpa~HH no .IJ.[(C: , cbc ce.rr.a.nH~e 11 a.rr.pec Ha ynpasneHHe rp. Co<j)HH 1700, pai1oH p-H CTy.rr.eHTCKH, yn. "OKonospbcTeH nbT" NQ 199A,Ten.:02/9658100,<j)aKc:02/9658172, e-mail: [email protected], HHTepHeT cTpaHH~a:
http://www.phoenixpharma.bg ,a.rr.pec 3a KOpecnOH.D,eHL\1151: rp. Co<j)HH 1700, o6nacT Co<j)HH, o61l.(HHa CTOJJH'-IHa, p-H CTy)l,eHTCKH, yJJ. "OKOJlOBpbCTeH llbT" J{Q 199a Tene<j)oH Ja KOHTaKTH: 02 I 965 81 09; <l>aKc: 02 /965 88 28; e - mail: [email protected], J..1HTepHeT a.rr.pec : http://www.phoenixpharma.bg/ ,6aHKOBa cMeTKa: BG91UNCR96601030899522, npe.Jl.CTaBJJSJBaHo OT KpacHMHp HHKonaes HHKonaes, ErH 7712023968, Ha .Jl.Ilb)KHOCT )J;HpeKTop 6oJ1HH4eH na3ap 11 ,ll.aHHena fleTposa HHKOJJosa, ErH 7106114033 Ha .LJ.Jlb)KHOCT Mamcbp <l>apMauesT E>onHH4eH na3ap, s KaYeCTBOTo HH Ha nbJlHOMOil.(HHL\H Ha ynpaBHTeJIHTe Ha "<l>bOHHKC <I>apMa" EOO,LJ:
YBA)KAEMA rOCIIOJKO YllP ABIITEJI,
Cne.rr. JanoJHaBaHe c .ll.OKyMeHTal\HHTa 3a yqacTMe B OTKpHTa npo~e.rr.ypa Ja Bb3JiaraHe Ha o61l.(eCTBeHa nopb'IKa c npe.rr.MeT: ",LJ:ocTaBKa ua
JieKapcTseuu npoiJ.yKnt Ja ny)K)J,nTe ua "Cneuuannlnpaua 6onuuua Ja aKTHBHO Jieqeuue ua OHKOJIOrH'IHH Ja6oJIHBaHHH- Co«JluSI o6JiacT" EOO)], no
o6oco6euu noJnun•t", cMe CbrJiaCHH c nocTaBeHHTe OT Bac ycnoBHH 11 m npHeMaMe 6e3 Bb3p3)KeHHH.
C HacTOHil.(OTO 811 npe.ll.CTaBSJMe HaweTo npe)l,JimKeHHe Ja HJnbJIHem-te Ha nopb4KaTa no 06oco6ena noJHf!HSI .N'!! 210 Hydroxyethylstarch 6% 500 ml, nJI. 6anKa napenTepanna «bopMa [u3nucea ce NOAtepa u f/au.MeNoeaHuemo ua o6oco6e1-1ama no3UlfUR], npH cne.LJ.HHTe ycnoBHH:
1. Cpoteose no o6tQecTsenaTa nopb'IKa:
~ 1. 1. CpoK 3a H3llbJ1HeHHe Ha nopb4KaTa- 12 (.rr.saHa.rr.eceT) Meceua, C4HTaHo oT .rr.aTaTa Ha CKJII04BaHe Ha )l,orosopa 1111
~a npe.LJ.XO.LJ.HO CKJ1104eHHSI )l,OrOBOp CbC Cbll.(H51 npe.LJ.MeT, KOeTO OT Cb6HTHSJTa HaCTbllH llO-KbCHO. ~
~ 1 . 2 . C.rnaCHH cMe Aa AOCTilBHMe neKapcTBCHHTe npoAyKTH, npeAMCT Ha n03HUHHTe, 3a KOHTO y•acTBaMe, • ,o'\ ~o': ,
1
ne noee.e om 48 •aca qaca CJlen no~Ha nHcMeHa 3a>lBKa, BKJliD"HTeJ!HO H3nparewa no Q>aKc, en. noma""" npyr, H3P"""o norosopeH c
aHeKC KbM ,UOfOBOpa Ha411H Me)J(_uy CTpaHI1Te - 3a peryn51pHH 3a51BKI1. np11 )KeJlaHHe OT CTpaHa Ha Bb3J10)J(HTeJl51 perymlpHHTe ,UOCTaBKH W.e
H3BbpwsaMe no yrosopeH rpa<j:>HK.
He noeette om 2 ttaca Yaca cne.n nonyYaBaHe Ha 3aSJBKa OT B'b3JIOJKHTEJUI, oTnpaseHa BKJli04HTenHo no <j:>aKc, en . now.a 111111 .npyr, H3pH4HO
.norosopeH c aHeKc KbM )l.Orosopa Ha4HH Me)J(_uy CTpaHI1Te, a np11 Heo6xo,nHMOCT- 11 no Tene<j:>oH- 3a cneWH11 3aSJBKH
)l;ocTaBKI1Te ,UO Onpe,UeJleHOTO OT Bb3J10)1(HTeJ151 <j:>paHKO MSICTO 3a ,UOCTaBKa, me 113BbpWBaMe B pa60THH ,UHI1, OT 08.00 ,UO 16.00 4aCa. B CJly4aH 4e CpOKbT 3a ,UOCTaBKa 113TH4a B Hepa6oTeH ,UeH, ,UOCTaBKaTa CJle,UBa ,Ua Ce 113nbJ1HH HaH-KbCHO B nbpB1151 pa6oTeH ,UeH, CJle,D,BaiU ,UeHSJ, B
KOHTO 113TI14aT cpoKoBeTe.
flp11 113p114HO yKa3aHI1e OT CTpaHa Ha Bb3J10)J(HTeJ1SJ w,e ,UOCTaBI1M 3aSJBeHHTe npH cnell1HI1 3aSIBKH KOJ1H4eCTBa H3BbH YKa3aHI151 no-rope
4acos11 ,UI1ana30H.
CbrnaCHI1 CMe .ua ,ll,OCTaBSJMe neKapcTBeHI1Te npo,nyKTH, npe,D,MeT Ha no3HU11SJTai HTe, 3a KOHTO y4aCTBaMe, Cbo6pa3HO npe,UsapHTenHo yrosopeH
rpa<j:>HK, npH )J(eJlaHHe OT CTpaHa Ha 8b3Jl0)J(HTeJ151 .
2.MHCTO ua HlU"hJIHeiiHe:
<l>paHKO MSICTOTO Ha ,ll,OCTaBKa no HaCTOSill1,3Ta nopb4Ka, B 4aCTTa H /o6oco6eHHTe n03HUHH/, 3a KOSITO y4aCTBaMe, w,e 6b,Ue:"CneUHaJ1113HpaHa
6onHHUa 3a aKTHBHO ne4eHHe Ha OHKonorH4 HH 3a6omJBaHHSJ - Co<j:>HSJ o6nacT" EOO)l;, rp.Co<j:>HSJ 1123, 6yn. ,CToneTos" N2 67, AnTeKa
/
3.TexunlfeCKHTe xapaKTepncTHKH Ha npe)l.naraHHTe OT Hac neKapcTBeHH npo,nyKTH no 06oco6eHa no3HUHSJ N2 210 ca no.npo6Ho onHcaHH B
Ta6J1H4eH Bl1,ll, B H3rOTBeHOTO no o6pa3ell,a Ha npHJlO)J(eHHe N"!! 2.1. ... "CneuH<j:>HKaUHSI no 06oco6eHa n03HUI151 .NQ 210", Hepa3)leJlHa 4aCT OT
HaCTOSiill,OTO TeXHH4eCKO npe,D,JlO)J(eHHe.
4.KalfeCTBO H CpOK 11a rO~IIOCT
,[{eKnapHpaMe, Ye npe,UnaraHHTe OT Hac neKapcTBeHH npo,UyKTH:
• ca pemcTpHpaHH 3a ynoTpe6a B CTpaHaTa 11 npHTe)J(aBaT pa3pewHTenHH 3a ynoTpe6a, CbrnacHo 3JlnXM, npHTe)J(aBaT cepTH<}lHKant,
y.uocTosepSJBaw,H Ka4eCTBOTO Ha npo,UyKTHTe, nHncsaT o<j:>HLJ,HanHH Cbo6w.eHHSJ 111111 orpaHH4HTenHH MepKH 3a ynoTpe6a Ha neKapcTBemne
npo,UyKTH;
• OTfOBapSIT Ha HOpMaHIBHO ycTaHOBeHHTe H3HCKBaHH51 3a Ka4eCTBO 11 eBponeHCKH CTaH)lapTH.
• OTfOBapSIT Ha CbOTBeTHHTe ,UeHCTBaJ.J.J.H HOpMaTHBHH H3HCKBaHI1SI 3a npo,Ua)J(6a- BaJlH,ll,HH pa3peilleHHSI 3a ynoTpe6a 11 ll,eHa, <j:>opM11paHa
B CbOTBeTCTBHe c H3HCKBaHHSJTa Ha Hape.n6aTa 3a ycnoBI1SJTa, npasHnaTa 11 pe,Ua 3a perynHpaHe 11 pemcTpHpaHe Ha ueHHTe Ha
JleKapCTBeHHTe npO,UYKTH .
,[{eKnapHpaMe, 'le np11 .uocTaBKaTa Ha neKapcTBeHHTe npo,nyKTH, me ce Cbo6pa3SJBaMe c H3HCKBaHHSJTa Ha Hape.n6a ]'{Q 39 OT 13 cenTeMBpH 2007 r. 3a npHHli,HnHTe 11 H3HCKBaHH51Ta 3a ,U06paTa ,ll,HCTpH6yTOpCKa npaKTHKa.
rapaHTHpaMe ,ll,OCTaBKH C OCTaTb4eH CpOK Ha fO,ll,HOCT KbM )laTaTa Ha ,ll,OCTaBKa He nO-MaJlbK OT 60% OT cp
CbOTBeTHI151 npo,UyKT.
2
S.OnaKOBKa u MapKuposKa npe.ll,JlaraHHTe OT HaC Me)J.HUHHCKH H3.ll,eJll-1$1 Ca B CbOTBeTCTBHe C H3HCKBaHH$1Ta Ha Bb3J10)1(11Teml 11 npH )J.OCTaBKaTa w.e OTfOBapHT Ha 113HCKBaHH.sJTa
11 w.e 6b.LJ.aT:
• OnaKOBaHI1 B OpHrHHaJlHa onaKOBKa Ha np0113B0)1.11TeJl$1, CbC CbOTBeTHaTa MapKHpOBKa 3a np0113BO)J.HTeJl H napT11)1.HH HOMepa, C
HaHeCeHa "CE" MapK11pOBKa, HaHeCeH 11)1.eHTHcjmKaUHOHeH HOMep Ha HOT11cpHUHpaHH$1 OpraH, KOfaTO TaKbB Ce H311CKBa OT )J.eHCTBawOTO
3aKOHO)J.aTeJ1CTBO, KaTO C nOCTaBeHa MapKHpOBKaTa J.Ue e nOCTaBeHa Ha BCeKH KaWOH, CbOTBeTHO - Ha BCHKa onaKOBKa.
• onaKOBaHI1 B OpHntHaJlHaTa onaKOBKa Ha np0113BO)J.HTeJlH, C HeHapyweHa U$1JlOCT, 6e3 )J.a Ca MOKpH.
• onaKOBaHI1 no Ha4HH, KOl:fTO rH 3ana3Ba OT BC$1KaKBI1 nospe.LJ.H, J],bJl)l(aJ.UH Ce Ha aTMOCcpepH11 ycJlOBHH 11 TpaHCnOpT.
Il.J,e H3nbJlHI1M npe.LJ.MeTa Ha .LJ.Orosopa s nbJlHO CbOTBeTCTBI1e c H311CKBaHI1HTa Ha 8b3JlO)I(HTeJJH, nocoLieHH s TexHH4eCKHTe cneu11cp11KaUHH 11
.ll,OKyMeHTaU11$1Ta 3a yLJaCTI1e .
KbM uacTOHLQOTO Texuu .. ecKo npe,nJiomeuue npuJJaraMe: 1. npHJlO)J(eHHe }{Q 2.1. ... "CneuHcp11KaUH~ no 06oco6eHa no311UI1$1 NQ 210 Hydroxyethylstarch 6% SOO,ml, q,.n. 6auKa napeuTepaJJua IJlopMa"
~)
llOliiiliC
llK'-IAT
.1J:aHI1eJla nerposa HHKOJlOBa
lnbJlHOMOUJ.HHK Ha "<l>bOHJ!IKC <l>
3
N9Ha o6oc o6eH ara
0031'14 MSI
1
210
flpHJJO)I(eHI-Je N2 2.1. KbM f1pHJJO)l(emre N2 2 "TexHHY.ecKo npe.LJ.JlO)l(eHHe"
Cneu,Hij)HK3U,HH no o6oco6eu3 no3uu,uH .N'!! 210 OT npou,e.LJ.yp3 33 B'h3JI3r3ue ua o6mecTseua nopbqK3 c npe.LJ.MeT: ",ll,ocTaBKa H3 JJeKapcTseuu npo.LJ.yKTH 3a uyiK.LJ.HTe ua
"Cneu,naJIH3Hp3ua 6oJJHHIJ,3 33 aKTHBHO JJe""leuue H3 OHKOJJoruqnu 3360JJHBannH- CocjluH o6JI3CT" EOO.LJ: no o6oco6euu no3nu,uu"
PecpepeHTHa npp11;fQ3HO npeAJ1araHa
AHBTOMo- fleKapCTBeHa CTOMHOCT 38
KOII1'14ecTBO pa3cpacoaKa,
repaneent MeJKAyttapoAHO ttenarettTtto <J>opMa DOD/ /cbrnaCHo TbproscKo Konw-tecrso M/Mmt npor.t3BOAMTen/npMTe
l.f9H KOA ti8MM8HOB8ttMe /INN/ /noc~eHara or TepaneBTI'II.f cnellr.t<PHKS4 HSMMeHosaHMe I 6potll a onaKOBKaTa >Karen PY
/ATC-'KO/J/ Bb3.nO>KHT91lSI B eH KYpc
~~ra Ha H npeAJ1araHa cne4111cpMK841'1RTa/ 8'b¥!O>KMTen neKapcreeHa
Sl/ ct>opMa 2 3 4 5 6 7 8 9
B05AA07 Hydroxyethylstarch 6% 500 ml, napettrepanHa 15,46 50 Voluven sol. 6%500 ml
Fresenius Kabi nn. 6aHKa <tJopMa
3a6ene)I(Ka: C1-maTa •meT OT Ta6mtuaTa ce nonbnsa OT cneUJ,HjmKaUJ-HITa Ha Bb3JlO)J<I1Temi - npHllO)I(emte KbM .uoKyMeHTaUH»Ta - KOJlOHH A- G. B n»cHaTal)l(bJlTa YacT ce nOnbJlBaT .llaHHHTe 3a npe,D,JlaraHHH OT y4aCTHHKa npO.llyKT.
20.05.2016 r.
~
IIOlliiHC
IIEqAT
KpacHMHp HMKO
C <l>apMa" EOO,Z:I/
,J
OropM3a'-' HSI: AA I
HE
10
M
~