РОСЗДРАВНАДЗОР Информационное письмо № 16И-959/13 от 20.08.2013


ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ В СФЕРЕ ЗДРАВООХРАНЕНИЯ (РОСЗДРАВНАДЗОР)

109012, Москва, Славянская пл. 4, стр. 1, Телефон: 8(495)698-45-38; 8(495)698-15-74 https://roszdravnadzor.gov.ru

Информационное письмо № 16И-959/13 от 20.08.2013

Решение по результатам экспертизы качества лекарственных средств

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or 27.12.2012

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IIPE" (8 KBapriul, 4.10, nnrep A. 40ur 50ur.. yr. rrr. rcoHr. (
l),
nou.09l, r.Xapa6ann,
naqKH KapToHHbte
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04h-t304/12 Anrequoe yqpexAeHue
or 27.12.2012
Vl[l V6ueraxresofi h.T.
(yn.llovroe as, I. 10. Inrep
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c.

flpon:no4urert
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3xcneprHar opraHH3auHt

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ropoAa Pocroea-Ha-Aony)

raolerrn u.5r
OAO
l0uLr., yn. flq. roHr. (2), nar{Kn

J

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of6y

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030912

($Hrran

ropoAa Pocrosa-Ha-AoHy)

Xoureyroao,

Xapa6annucxr.rfi p-H,
AcrpaxaHcrcaq

o6racrr)

04h-1304n2 3OO "Onprva AKCOH"
or 27.12.2012
iyn. B r.r norpa xtas, 1.49, r.Co.rl,t,
.llb

(pacHoaapcxrfi xpafi)

bHcaKoAHr

ra6l. norprrrue

KHrx.-pacrB. o6o,roqroft

3AO "Euorotr"

Poccnr

5ur

or 27.12.2012

l0ur., yr. rq. roHr. (3). na.r.

-r\b

OOO "tDrpnra AKCOH"
(yr.BNuorp a1*as, a.49. r.CoqH.

ynaKoBKH 6e:rr.{eft xosrte

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KOHrypHbre

SapruauenrrqecKat
Qa6pura"

FrHKorlHoBat rcHclora ra6l.

OAO "MocxNnr$apna-

04H-1304il2 OOO

ot 27.12.2012

"
AKCOH"

(yr. Br uorp a1*ar. a.49, r.Coqu,

KplcHoaapcxrft rpafi)
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or 27.12.2012
(yn. Br.rHorp aAHafl , a.49. r.Coqr.r.
Kpacuo4apcnlfi rpaft)
J\b 04H- 1304/12 OOO "Oupnra AKCOH"
ot 27.12.2012 (yn. Bnuorp aAHafl , a.49, r.CoqH.
Kpa*roaapcrufi rpafi)
Ns 04H-1304112 OOO "Onpr',ra AKCOH"
or 27.12.2012
(yr. Br.r uorp aAHafl , a.49. r.Coq r.r.
KpacHo4apcxnfi rpafi)
Ns 04H-1304/12 C)OO "@rpua AKCOH"
or 27.12.2012
(yl.BuHorpaAHac, A.49. r.Co.rH.
Kpacsoaapcrcrfi rpafi)

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50r,ar

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l0ur.. yn. q.{. roHr. (5),

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l,rnl.H.A.CetrauLro

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260412

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foPoaa Pocrosa-Ha-/Iouy)

PoccHr

Poccnr

of6y

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5909t2

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naq Kanr *
reBHr Apaxe J\e l00. 6aHrn

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Poc:4paaHaa:opa ($unaa.l
ropoAa Pocrosa-Ha-Aony)

6e:tgqefi xoBble KoHTVnHhle
Poccnr

of6y

"vt

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Poc:4pasuaA3opa ($ nn Nan
ropoAa Pocroea-Ha-/loHy)

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ofBy "l4MU3yAOCMll"

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ropoAa Pocrona-Ha-Aony)

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ofBy "HMU3yAOCMll"

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lOrur.. )'naKoBKH
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[')yAOCM t l"

ropoAa Pocrosa-Ha-Aony)

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HapyxHoro IlpHMeHeHHfl

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Poc:4paaHaA3opa (Snnr-rar

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fopoAa Pocrosa-Ha-AoHy)

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o6racru)
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or 27.12.2012

54 (DMEA
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or 27.12.2012

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cx. MocxoscKaq

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or 27.12.2012

Ns 04H-1304112

or 27.12.2012

MV3 "Co,rueqHoropcKafl UE"
(uxp.Pernurlo,
r.ColHeq soropcK, MocroscxaR
o6racru)
MV3 "ColHeqHoropcKafl UE"
(urcp.PexnHqo,

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o6lacrr)
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or 27.12.2012
(uxp.Pexuuqo,
r.ColseqHoropcK. Mocroscrcas
o6racrs)
Ns 04H-1304112

OKY3 "Mt{C MBn PO no pK"
or 27.12.2012
(yr. K. HlnuxilHoea, A.28,
r.?lucra, Pecny6,rura
KalusrrHr
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ot 27.12.2012
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r.?rncra. Pecny6lHra

bre

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OAO "BopucoacxHfi

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KoHrypHble

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| 0rur., ynaKoBKu Rqeft roeHe
t(oHrypHble ( l), na.r. xapr.

ooo

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r6806t2

(Srr uar

ropoAa Pocrosa-Ha-AoHy)

qernlcal uqHJroBafl KHcJtora
ra6rerrn 500rur I 0urr.,
A

3aBOA

Pecny6rnra

ofBy "HMU3yAOCMll"

Eerapycs

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3660712

ropoAa Pocrosa-Ha-AoHy)

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orEy "hMu3yAocMn"

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ropoAa Pocrosa-Ha-Aony)

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ropoAa Pocrosa-Ha-AoHy)

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rrr. KoHr. (6), nav. rapr.
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ofBy "HMU3yAOCMn"

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Han

ropoAa Pocrosa-Ha-AoHy)

naq. KapT.

04H-1304il2 Anreqsas opraHH3auufl
or 27.12.2012
OOO "Bnra-Eaft+" (y,r.Ce4osa,
.r!b

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or 27.12.2012
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Ne 04H-1304112

or 27.12.2012

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or 27.12.2012
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ropoAa Pocrosa-Ha-AoHy)

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or 27.12.2012

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lAn-re.rHas opt.ar{H:}arrHrl
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ropo4a Pocrosa-Ha-AoHy)

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flpuroxeHr4e:Ha 4 r.s I arcs.

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AHOBJIEH] btM TpeooBaHHRM HalrMeHosaHHe opraHU3auHH.
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PoccHs ofBy "HMU?yAOCMft" t40812 l), Poc:4panuaA3opa ($ur uar nou.09l, r.Xapa6ann, naqKH KapToHHbte ropoAa Pocroea-Ha-Aony) AcrpaxaHcrcas o6lacru) .Nb 04h-t304/12 Anrequoe yqpexAeHue J reBoMHqeTuH raolerrn u.5r OAO "6roxutllx PoccHq of6y "HMU3yAOCMn"
or 27.12.2012 Vl[l V6ueraxresofi h.T. l0uLr., yn. flq. roHr. (2), nar{Kn 030912 Poc14pas uaA3opa ($Hrran (yn.llovroe as, I. 10. Inrep KapToHHbte ropoAa Pocrosa-Ha-AoHy) rolr.]l1b4, c. Xoureyroao, Xapa6annucxr.rfi p-H, AcrpaxaHcrcaq o6racrr) .llb 04h-1304n2 3OO "Onprva AKCOH" bHcaKoAHr ra6l. norprrrue 3AO "Euorotr"
or 27.12.2012 iyn. B r.r norpa xtas, 1.49, r.Co.rl,t, Poccnr ofBy "HMU3yAOCMll" 0t60412 KHrx.-pacrB. o6o,roqroft 5ur (pacHoaapcxrfi xpafi) Poct4panuaA3opa (Sunuar l0ur., yr. rq. roHr. (3). na.r.
ropoAa Pocrona-Ha-Aony) Kapr.
Ns 04H-1304/t2 OOO "tDrpnra AKCOH" AHoa3oJt raOrerK[ 20ur lOurr.. 3AO "MocxoBcKat PoccHq DfEy "[4MU?yAOCMft"
or 27.12.2012 (yr.BNuorp a1*as, a.49. r.CoqH. ynaKoBKH 6e:rr.{eft xosrte 0606t2 SapruauenrrqecKat )ocr4paauaA3opa (r[unnar KpacHo4apcru.rfi rpafi) KOHrypHbre Qa6pura" 'opoAa Pocroea-Ha-AoHy) -r\b 04H-1304il2 OOO "or 27.12.2012 (yn. Br.rHorp aAHafl , a.49. r.Coqr.r.
PoccHr of6y "l4MuSyAOCMfl" 5909t2 25rur., yn. rq. roHr. (2). raqKH Kpacuo4apcnlfi rpaft) Poc:ApaeHaAtopa (SnnNar KapToHHbte J\b 04H- 1304/12 OOO "Oupnra AKCOH" /FlHirJtbt llH 't'aOJteTKH )uuMr (-)A0 "'l'roueHcrnfi lPoaa Pocrosa-ua-Aosy) ot 27.12.2012 (yn. Bnuorp aAHafl , a.49, r.CoqH. l0utr., ynaKoBKH Poccnr of6y "HMU?yAOCMfl" 2902t3 x03" Poc:4paaHaa:opa ($unaa.l Kpa*roaapcrufi rpafi) 6e:tgqefi xoBble KoHTVnHhle Ns 04H-1304112 ropoAa Pocrosa-Ha-Aony) OOO "Onpr',ra AKCOH" TaoIeTKfi | utxT..
^uililPKaM OOO "Oapnranol- Poccnr of6y "vt Mt(SyAocMll"
or 27.12.2012 (yr. Br.r uorp aAHafl , a.49. r.Coq r.r. ynaKoBKH r.{efiKosule 52t2t2 Borra" Poc:4pasuaA3opa ($ nn Nan KpacHo4apcxnfi rpafi) KoHryDHble (5)- naq Kanr * Ns 04H-1304/12 ropoAa Pocroea-Ha-/loHy) C)OO "@rpua AKCOH" reBHr Apaxe J\e l00. 6aHrn OAO "Map6uorfapu" Poccl.rs ofBy "HMII?yAOCMft"
or 27.12.2012 (yl.BuHorpaAHac, A.49. r.Co.rH. noruuepHsle* 250213 Poc:ApasHar3opa ($uman Kpacsoaapcrcrfi rpafi) ropoAa Pocrosa-sa-l[oHy) ii)cl ;orpn'r,q rci'r jrr OvparorrAoH ra6ler.xH 50u r OAO "liopuc0ecrHii or 27.12.20t2 (yn.BuuorpaAHar. a.49. r.Coqn.
Pecnv6.rrnrca ol'tiy "14M I [')yAOCM t l" 2102t3 lOrur.. )'naKoBKH 3aBOA Eenapl-cu Poc:r4pas na/l3opa ({r nn uan KpacHo4apcrcr.rfi rpafi) 6erbs.{efi roBbte KoHrypH bte rve4npenaparoe" ropoAa Pocrosa-Ha-Aony) Ne 04H-1304112 3AO "fleHrxpoQr Oapua" MeHosa:HH pacrBop Anq OAO "HsaHoBcKat Poccun ofEy "t4Mtl?yAOCMn"
or 27.12.2012 (yr.l{egrpa.nuHas, a.40. OflX 050t l3 HapyxHoro IlpHMeHeHHfl SapruauesrHqecKafl Poc:4paaHaA3opa (Snnr-rar "Epuo,tH Ho". r.n.HKuta.
[cnnpronofi ] 40nr. $raxoHsl Sa6pnra" fopoAa Pocrosa-Ha-AoHy) /{uurpoacrcuft p-H. Mocroacxaq o6racru) -r\lb 04H- t304il2 of5y3 MCr{ .t\tb | 54 (DMEA A ttt oxc u UHl,,t l.t H ra6,'terxt4 OAO'Err-r"rrC or 27.12.2012 PoccHl.r (r',rrp.Ceaepnulfi . l. I a, PoccHc ofBy "l4MUSyAOCMfl" 6n012 500rvrr I Orur., yraKoBKH Pocr4panHaA3opa (Sunnan r. KpacHoapuefi cx. MocxoscKaq rqefi rogrre rourypnsle (2), ropoAa Pocroaa-Ha-/IoHy) o6lacru) rlaq. KapT.
Ns 04H-1304/12 MV3 "ColueqHoropcKar I_lE" AualsrllH ra6lerxu 500r,ar OAO "Map6noSapnr" Poccnr ofBy "hMu?yAocMt-t" r6806t2 or 27.12.2012 (rurp.PerrHqo, l0urr.. ylaKoBKt4 r.ColseqHoropct(, Mocroscrcaq Poc14paaHa4ropa (Srr uar 6e:rs.{efi roBble KoHrypH bre ropoAa Pocrosa-Ha-AoHy) o6racrs) -l\le 041,1-1304/12 MV3 "Co,rueqHoropcKafl UE" A qernlcal uqHJroBafl KHcJtora OAO "BopucoacxHfi Pecny6rnra ofBy "HMU3yAOCMll"
or 27.12.2012 (uxp.Pernurlo, 3660712 ra6rerrn 500rur I 0urr., 3aBOA Eerapycs Poc14pasHaA3opa (QHn uan r.ColHeq soropcK, MocroscxaR ynaKoBKh 6esrn.{efi rossre ve4npenapaton" ropoAa Pocrosa-Ha-AoHy) o6racru) KoHrypHble Ns 04H-1304112 MV3 "ColHeqHoropcKafl UE" L eHaAeKcHH rablerrcn 70ur ooo Vrpanua orEy "hMu3yAocMn" 80612 or 27.12.2012 (urcp.PexnHqo, | 0rur., ynaKoBKu Rqeft roeHe "OapN.taqesrHqecKat Poc:4paaHaA3opa ($nn aan r.ColseqsoropcK, Mocroscrcaq t(oHrypHble ( l), na.r. xapr. KoMnaHHg "34opoBbe" ropoAa Pocrosa-Ha-Aony) o6lacrr) Ns 04H-1304112 MV3 "ColseqHoropcKar qE"
PHOoKcHH 'ra6n. n/nnlo 200ur OAO "EtocHHTe3"
or 27.12.2012 (uxp.Pexuuqo, Poccrr ofBy "HMU3yAOCMII" r004r I l0ur., yn. rq. rcoHr. (5), naqKlt Poc:4pasHaA3opa ($Hn aar r.ColseqHoropcK. Mocroscrcas KapToHHbte ropoAa Pocrosa-Ha-AoHy) o6racrs) Ns 04H-1304112 OKY3 "Mt{C MBn PO no pK" l laHKpearnH ra6,rerrn OAO "Hp6urcrcufi or 27.12.2012 (yr. K. HlnuxilHoea, A.28, Pocct,rs ofBy "HMU3yAOCMn" 910612 noKpblTbte KHrx.-pacTB. xo3" Poc14paeHaA3opa ($ur rar r.?lucra, Pecny6,rura o6oroqxofi 25EA l0ur., yn. ropoAa Pocroga-Ha-AoHy) KalusrrHr rrr. KoHr. (6), nav. rapr.
Ns 04H-1304112 OKY3 "Mt{C MBA pO no pK"
AHanbrnH ra0nerKu 500n,tr OAO "Map6uo$apr'a ot 27.12.2012 (yr.K.HnrcuxHHosa, A.28.
PoccHq ofBy "hMu?yAOCM[I" 50il2 lOur., y[aKoBKH Pocr4pasHaA3opa ($nlaa,'r r.?rncra. Pecny6lHra 6e:rq,{efi rcoBbre KoHrypH bte ropoAa Pocroga-Ha-AoHy) Ka,ruulxur Ib 04H- 1304il2 OKY3 "MtlC'MBll PO rro PK" Acxop6u HoBar KHcJtora rpaxe OAO "Map6uodrapu" I)occuH ol-By "l4M I [')yAOCMII" 8308 r 2 or 27.12.2012 (y,r. K. I,l,rroruxu Hosa, r.2 8. 50rnrr 200urr.. 6aHxu PclcrlpaaHa1'x)pa ( tpu:l r.ran r.?rncra. Pecny6rura nonHMepHbre ropoAa Pocloaa-Ha-/[oHy) Kaluurur Jr 04H-1304il2 OOO ".r!b 04H-1304il2 Anreqsas opraHH3auufl Acxop6raHoBar KucJrora Apaxe OAO "Map6norpaptr" ofBy "14MufyAOCMfl"
PoccHq t0r03t3 or 27.12.2012 OOO "Bnra-Eaft+" (y,r.Ce4osa, 50ur 200ur.,6aHru Poc gApas Har'l3 Poccl.rs t303t2 or 27.12.2012 OOO "Bnra_Eafi*" (yn.CeAoaa, 5Ornlr l0rur., yn. rv. ronr. (5), npenapa.rst" Poc:gpanHa4:opa ($unnar a. | 0. r.TaraHpor, Pocroacxat naqKH KapToHHbre Hu.H.A.Cervauro ropoAa Pocroea-Ha-/loHy) o6racrr) .rlb 04H-t 304/12 Anre.{Has opraHn3auufl Hn$e4nnr.rH ra6rerru nlntlo OOO "O:oH" of6y "l4Mu?yAocMn"
Poccnr 09 t0l2 or 27.12.2012 OOO "Bura-Eafi +" (yn.Ce4ona. l0nr 50rur., ynaKoBKH Poc:gpaeuaA3opa ($urnan a. | 0, r.Taraupor, PocroacxaR qqeftxonule rcoHrypHsre ( l), ropoAa Pocrona-ua-Aosy) o6racrr) fiaq. Kapr.
J\e 04H-1304112 Anrequaq opraHH3aUUs Pesur Apaxe -llb 100, 6asru OAO "Map6no$apr'1" ofBy "14Mu?yAocMfl"
Poccur r70il3 or 27.12.2012 OOC) "Bura-Eafi+" (yn.Celona, norNuepHsre* Poc14paauaA3opa ($aruan a. | 0. r.TaraHpor, Pocroncran ropoAa Pocroea-ua-Aony) o6racrs) Nq 04H-1304112 Anre.tHac opraHn3auHfl PesNr Apaxe Ne | 00. 6auxu OAO "Map6uo$apnr" ofBy "HMII?yAOCMn"
Poccl.rc t48t2l2 or 27.12.2012 OOO "Bnra-Bafi*" (yl.Ce4oaa, nolunaepHste* PoclApaeHaA3opa (tf u,ruar l. I 0. r.Taraupor. Pocroacxar ropoAa Pocrosa-na-AoHy) o6nacrs) Itr 041,1- | 3041 12 Yrols aKrHBHpoBaHxsrfi -yBO lAn-re.rHas opt.ar{H:}arrHrl OAO "Ypa,r6ro$apu Pocct.rs ol'6y "HM[I]yAOCMII"
or 27.12.2012 20il3 IOOO "Bnra-Fafi*" (yr.Ce4oea. ra6rerru 250urt\,lql0. Pocr4panHaA.lopa ($Hn r.rar pocroscrcas la. 10. r.TaraHpor. ynaKoBKH 6e:rs.left rosHe ropo4a Pocrosa-Ha-AoHy) lo6nacru) r(oHrypHHe
* - no nposepeHHblM noKa3arersM

Министерство здравоохранения Российской Федерации
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ Г. |

В СФЕРЕ ЗДРАВООХРАНЕНИЯ (РОСЗДРАВНАДЗОР) Руководителям организаций- Славянская пл. 4, стр. |. Москва, 109074 производителей лекарственных Телефон: (495) 698 45 38; 698 15 74 средств
fF D0; Аи - POO fy: .

LO Cd L015 № Е G2 ILLS Руководителям организаций-
На № от импортеров лекарственных средств
=

Субъектам обращения лекарственных средств
Решение по результатам жспертизы качества лекарственных средств
Федеральная служба по надзору в сфере здравоохранения информирует, что по результатам экспертизы качества лекарственных средств принято решение о соответствии установленным требованиям качества лекарственных средств, перечисленных в приложении.

Приложение: на 4 л.в | экз.

Врио руководителя р | | _ M.A. Мурашко
Г.В. Ганночка 84995780187

Скачать документ: Письмо 16И-959/13 от 20.08.2013

Информационные письма Росздравнадзора по контролю качества: Лекарственные средства

Информационные письма Росздравнадзора по контролю качества: Медицинские изделия

   

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