РОСЗДРАВНАДЗОР Информационное письмо № 16И-640/13 от 13.06.2013


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-640/13 от 13.06.2013

Решение по результатам экспертизы качества лекарственных средств

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n 27.12.2012

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27.12.2012

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27.12.2012

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r 27.12.2012

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r 27.12.2012

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04u-1304/12 Anrexa Hfl lllesrrosa M.B.
27.12.2012
(np.Orrr6pscroft Petolrcqnn,
0414-1304/12

27.12.2012

Pocctls

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Crauponolscr
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t090912

Poc:4pasualsopa
(Craeponolscxr.rfi tlr.rruar)

o6oroqxofi 25E.{ l0rur., yn.
tr{. KoHr. (6), nau. rapr.
noKpbrTbre KHrrr.-pacTB.

orEy "t4Mu3yAOCMtI'

I,l.ngut

ofEy 'HMII3yAOCMII'
Pocs4panHa4sopa

(Cranpononscrcuft Sunnaa)

8202577

t04vt-1304/t2
'27.12.2012

t04V-1304/12
.27.12.2012

MEY3 "feoprneecrcar I{PE"
(yl.@nnaroea,9.3,
r.feoprnencr, Cranponor ucrcufi
rpaft)

facra:r@ ra6lerrn 6urr..

fhuna Kpaxon,

ynaKoBKH qqefirossre
KoHTypHbre (10), nav. xapr.

@apuaqeurn.recrnfi
saeoa A.O.

MEY3 "feoBrueecxar I{PB"
(yl.Oularosa, 4.3,
r. feoprnencr, Cranpono.nscrcnfi
rpafi)

Maa.noxc@ ra6lemn
xeBareJrbHbre I 0mr., y[aKoBKr.t

CaHoSn-AeeHrHc
C.n.A.

* - no npoBepeHHbtM noKa3areJrrM

rqefixonue roHrypHrre (2),
naq. KapT.

floruua

ofBy "HMu3yAocMf["

l4r438l I

Pocrgpaauag:opa

(Craepononscrufi Qnluar)
Vl^ratus,

orEy "HMuSyAocMfI"
Poc34paeHa4sopa

(Craeponolscxnft Qulr.ral)

Al

15

Mnnrcrepcrao 3apaBooxprnefl trf, pocctf,crof, Oeacpaqxr

OEAEPAJIbIIAfl CJTY]KBA IIO HA.iI3OPY B C@EPE 3PABOO)(PAHEIdd,Tn go$.ryABHAA3OP) Pyxono4ureJrrM opraHLrc arlufi - lpor,r3BoAr4TeJreft JreKapcTBerrHhrx Crassgcxar w., A.4, crp. l, MocKBa, 109074 cpeAcrB rer.: (495) 698 46 28.698 46 tl
PyronogureJrrM opraHr43arlnfi - /3 06 P0/3 Nn _16, r4MrropTepoB JreKapcTBeHHhrx cpeAcTB
HaJtlb Cy6rerranr o6parqenu.r T I JreKapcTBeHHhrx cpeAcTB Peruenr,re no pe3yJrbraraM sKcleprr,r3hr KaqecTBa JreKapcTBeHHbD( cpeAcTB

@e4epanrHar cJryx6a no HaA3opy B coepe 3ApaBooxp a*e*krs, uHoopMnpyer, qro no pe3ynbraraM sKcrleprl{3br KaqecrBa JreKapcrBeHHbrx cpeAcrB npr{HflTo pelueHr.re o coorBercrBuu ycraHoBJIeHHbIM rpe6onalruxu KaqecrBa JreKapcrBeHHhrx cpeAcrB, [epeq[creHHBrx B npr,rJrox e$uv.

flpunoxeHue:Ha 5 n.n 1 srs.

Bpzo pyKoBoAlrreJur M.A. Myparuro

f.B. fanHo.rra 84995780187 flpnroxeHne K nucbMy pocs4panua4 Cnegenrr o neKapcrBennbrx cpeAcrBax!
rro De3yJrbTaTAM gKcnepr[3br Kaqe sopa or /J 06Jo/J m /€a _ 64 [T: ::::::T::*O"BHaA3opoM rrpn'nro peure'rre o coorBercrBrrn rx rc,rrenrDo Hanil.reHosaHue opraH H sa\t4vr, Houep saAaHHfl npeAcraBnBrueft o6pasqrr JlerapcrneHHoe cpelcrBo neKapcTBeHHbrx cpeAcTB flpousro4urelr CrpaHa np-ea SrcneprHaa opraHu3aqn, Jft04U-1304/12 Anrerca HfI Anronosof Cepwu I.A. reBur AprDrce }lslOO, 6aHrn OAO "Map6noSap?, or 27.12.20t2 (yn.farapr.rua, A.66, Poccur 1r,r Dy "l4Mq3yAOcMII"
nonlrMepHbre t27tr12 r.HeeuuHoMsrccr, Pocs4paaHa4sopa Crasponomcrnfi rpafi) (Cranpo nonscru ft {r.rnr,ran) Ns 04kI-1304/12 Anrera ryII CK "UpA.hlb63, uerpoHn,qa3o.n ra6lerrn n 27.12.2012 (yn.Bocrovnay. A.63/2, OAO "@apucraH.qapr- Poccnr lr,r Dy "l,lMq3yAOCMn, 250ur 20ur., ynaKoBKH JIercpe4crna" 6809t2 c.Kovy6eeacroe, Kovy6eeacrcHfi sqefixorue PocsApanHaA3opa ronrypnsre (I), p-H, Craupononrcrnfi rpafi) (Cranpononrcrufi rlaq. KapT. {aazal) Vs04U-1304/tZ An'rerca ryn CK "UpA "Nb63" AHarrbrr.rH raOlerrn 500nrr n27.12.2012 OOO "AcQapua"
[yr. Bocrovu ax, g.63 /2, lOnm., ynaKoBKH Poccur rgr Dy "l4Mt_{3yAocMn,, :.Kovy6eercroe, Kouy6eescrnft 40n12 6errqefi roB bre KoHrypHbre Pocs4paaHa4sopa r-n, Cranponoarcrcuft rpafi) (Cranpononrcrnft tso4v-t3o4lrz Qunaan) fen@
r 27.12.2012 (Vr.BocrorrHar, A.63/2, r aHHTUAHH raOlerrz n/ nn/ o OOO "OgoH" Pocq.rc \rrr rr y "t1Mt_tgyAOCMn, f c.Kovy6eencroe, Kovy6eescraft lSOrrar lOurr., yn. f,q. rour. (2), t45ttt2 I naq. KapT. Pocs4paeuagsopa CraBponorrrcruft rpafi) :
tg 04V-1304/tZ lp-H, (Cranpononrcrufi Slunan) Anrera ryII CK "UpA Nr63" rr,rooKcuH Ta6rsrKu n/ nt/ o r 27.12.2012 (yn. Boc'rov uan, g.63 /2, )OO "Orou"
2 00nrr 25tnr., y[aKoBKr.t Poccns q,r by "t4Mq3yAocMII"
610912 c.Kovy6eencroe, Kovy6eescrafi qqefircosue PocsApasHaA:opa xonrypHue (2), p-u, Cranpononscrurfi rpafi) nar{. KapT. iCraeponolrcrcufi Sr.rnnan) ,- 04V-1304/12 Anrexa ryfl CK "qpA Nr63, qrypaqnrnH ra6t.
r 27.12.2012 (yn.Bocrov ua4 p,.63 /2, l/npwror. p- OAO "Hp6r.rtc*"f pa Mfl MecTHOro n HapyxHoro Poccnr \r/r Dy zlMt_l3yAocMn, c.Kovy6eeocroe, Kovy6eescx[ft x(D3, 2951212 npr.rMeHeHr s 20ur J{b I 0 (yn. Pocs4paana4:opa p-s, Craopononrcrr.rfi rcpafi) (Crarpononrcrnfi 6esrrq. xout.) 04u-t304/12 Anrera fvn Cf ,flfa:li[J;- uMe[pa3on Kancynbr KHrrI._
Quanaa) 27.12.2012 (yn.Bocrovua4 p.63/2, OOO "flpous"oacrg;
pacrB. 2Orrar l0urr., yn.,q. Pocczr (DfBy "I4MI{3Va-gyn, c.Kovy6eencxoe, Kovy6eescrHft MegnraMeHtonrt 600912 rorn. (3), nar{. Kapr. Pocs4panHa4sopa p-H, Crasponolscrctfi rpafi) (Cranpononrcruft r\ 04kr-t304/12 Sulual) flu rrKa r yu uK "qPA J\!63" flepexncr roaopogu pacrBop o 27.12.2012 (yn. Bocrov uan, g.63 /2, L'UIJ ''I,IOAHbIC Poccnq u,r by "t{Mt_l3yAocMn,, c.Ko.ry6eeacnoe, Kovy6eescxufi AJrff MecTHOro H HapyxHoro TCXHOJIOTI,IH II t04tn2 npHMeHeHHn,40ut 3% Npl Pocsgpaauagropa p-n, Cranpononrcrufi rpafi) Mapretuurtt (QnaroHsr reMHoro crercna) (Craeponolrcrcaft Snlr.ran) o4vt-t304/ l2 lAnrexa rv@ flaurcpearnu ra6lerra \-rA\-, npoHTcKHI4 27.12.2012 (Vr.Bocrov uat, s.6312, noKpbrTbre K[Ur.-pacTB.
Poccnr ofEy "HMqSyAocMrI; t32t2t2 f x(D3" Pocs4paeua4sopa c. Kovy6eencroe, Kovy6eescrnfi oboloqrcoft 25E{ l0rur., yn.
I (Crauponolrcrnfi Sunual) lp-n, Craeponolscrnfi rpaft) rq. KoHr. (6), nav. rcapr.
Ns04V-1304/12 Anrera ryII CK "UpA.l\b63" (Dypasonn4os ra6le'mn 50ur >r 27.12.2012 UAU "t4pourcrufi PoccHq onEy "l4MU3yAocMn"
(ya.Bocrovwa4 g.63/2, (ynarcoexn 6egrsqefi rossle l2t0t2 x(D3" Poce4paaua4:opa c.Kovy6eercroe, Kovy6eescKrrfi rourypHrre) Jlbl0 p-H, Crarpononrcrcufi rcpaft) (Cranpono-irscrcnfi r[nnr.raa) Ys04kI-1304/12 Anrera ryn CK "IIPA Ns63" Hr.rQe4nnraH .upaxe I 0rr,r n27.12.2012 (yr. Bocrov wan, g.63 /2, banKaHeapMa- Eolrapur p-u, Cranponolrcrnft rcpaft) (C'nanpononscrnfi Qranr,rar) $04v-1304/12 Anrera ryfl CK "tIpA.lt!63" H HKoTI4HoBa' KI,IcJIoTa OAO "Hp6arcrcufi Poccl,rt (DfBy "I4Mq3yAocMIIt n 27.12.2012 (yn.Bocrov nan, a.63 /2, ra6aerrn 50nar lOurr., yrr.,q. 30712 xo3" Poc:gpanuagsopa c.Kovy6eencrcoe, Kovy6eescrcnft tcour. (5), raq. Kapr.
p-u, Craepononscrcr,rft rpafi) (Cranpononrcrnfi Qznnaa) $04v-1304/r2 Anrera ryII CK ,IIPA Ne63" AcropyrlrH ra6rerrcH ,r 27.12.2012 JUU ''U3OH'' PoccHc ofBy "I4MII3yAocM[;;
(yr. Bocrov uae, g.63 / 2, 50urF50ur 25un,yn. rq. 42t012 c.Kovy6eercrcoe, Kovy6eescrnfi rour. (2), raq. Poc:4paana4sopa Kapr.
p-u, Crarpononscrrafi rcpafi) (Craeponolrcruft Qunuan) te04H-1304/12 Anrera ryn CK "tIpA Ns63" Keropon@ ra6n. n/n-n/o l0rvrr r 27.12.2012 (yn.Bocrov nan, g.63 / 2, [-p Pea4u'c llw4ut ofBy "HMII3yAOCMII" 8202742 l0rur., yn. rq. roHr. (2), naqrn Jla6oparopr,lc JIr4 c.Kouy6eeocroe, Kovy6eencrnfi Pocsgpaaua4sopa KapToHH6re p-n, Cranpononrcxraft rcpaft) (Cranpononrcxnfi Sunual) e 04U-1304/12 Anrera ryII CK "UpA.llb63" Cenagexcnn ra6rerx[ 70Mr r 27.12.2012 (yn.Bocrovual a.63/2, ooo Vrpanua @fEy ,HMIISyAoCMII'
I Orur., ynaKoBKH sqefirossre 150812 "tDapuaqerrr.rqecKat Pocs4paaHa4sopa c.Ko.ry6eencroe, Kovy6eescKrrfi KoHTypHbre (2), nav. rapr. KoMnaHUt "34opotbert (Cranpononrcrufi Qr.rnnan) p-n, Cranpononrcrr,lfi rpaft) p 04H-1304/12 An'rera ryII CK "IIPA.l!b63"- uarr4Aor ra6rerrr,r r 27.12.2012 (yn.Bocrov uan, g.63 /2, oAo Poccl.ls oI.By "HMqSyAocMn"
noAbr3brrtHsre 60ur l0un., yn. "TarxnuSapMnpena- 246trt2 c.Kouy6eeacrcoe, Kovy6eescrnft Pocrgpaeuagsopa KOHT. parbtt'
p-H, Craeponolscruft rcpaft) 'I{. (Craspononrcrnfi S nnr.ral) 04u-r304/t2 An'rera ryII CK "UPA Ns63" Balt4ol c rlrcro:ofi, ra6lerrcr.r UAU "QapMcTaHAapr_
27.r2.20r2 (yr.Bocrovua4 g.63/2, [oAbr3brqHue 60ur l0urr..
Poccn.r ofBy "HMIISyAOCMn'; 40312 IIercpe4crna"
c.Kovy6eencKoe, Koqy6eeBcKr4 fi ynaKoBKH Pocr4paenagsopa s.{efirosHe p-u, Craopononrcrnfi rpafi) (Cranponoarcxufi Surr.ra.n) KOHTypHbre 04vr-r304n2 Anrer
"-04V-1304/12 Anrera fYn CK "UPA.llb63" EorpurnHnra uacroft xa, 25 rrrl OOO "funnoKpar" Poccur @f6y "HMIISyAOCMII" 080820 l 2 r 27.12.2012 (yr.Bocro.r na4 a.63 12, Ne l, $raron-KaneJrbHr,rqbt Pocr4panua4sopa c.Kouy6eencroe, Kouy6eescrHft TeMHOTO CTeKJIa, naq. KapT. (Craaponolucrnfi $ranr.ran) p-u, Cranponolrcrnfi rpaft) t04V-1304/12 Anrera Hfl Jlaescrofi E.fl. AcroQeH-fI'ra6lerrn I 0ulr., OAO "(DapMcraHAapr. Poccnr ofEy "pIMLI3yAOCMII" 2t6lrt2 r 27.12.2012 (np.Kynaroea, 9.49/5, ynaKoBKH rqefrrosHe JIencpe4craa" PocsgpanHagsopa r.C'raoponolr, Cranpononrcrcufi KOHTypHbre (Craapononscrcnft Suluaa) Kpafi) l 0414-1304/12 Anrera I4fI Jlaeecrcofi E.fl. @ypaqnnnn ra6n. y/npwror. p- OAO "Hp6r,lrcrcuft Poccur ofEy 'HMIISyAOCMII" 256ttt2 27.12.2012 (np.Kynaroea, p.49/5, Pa Arq MecTHoFo H Hap)DKHOTO xo3" Pocs4paruag:opa r.Craeponols, Cranponolrcrnfi npr.rMeHeHr{ s 20ur Ne I 0 (yn. (Cranponolucrnft Qnnuan) Kpaft) 6egrrq. roHr.) 04vr-r304/12 Anrera Hfl Jlaescrofi E.fI. AHalrruH'ra6lerrn 500rrar OOO "AcQapua" PoccHc ofBy "HMIISyAOCMII' 261012 27.12.2012 (np.Kynaxo ea, p,.49 I 5, l0rnr., ynaKoBKr,r Pocs4panHa4sopa r.Cranponolr, Cranponolrcrcnfi 6esrsqeilrcoBbre KoHrypHbre (C'ranpononscrcnft Qnlnan) rpaft) u04V-1304/12 Anrena I4fI Jlaencrofi E.il. Auunarou ra6lerrn n/o 250rrar OAO "OpraHnKa" Poccnr ofFy "I4MIISyAOCMII" 3004r2 r 27.12.2012 (np.Kyrarcosa, 9.4915, l00urr., $laroHu'r/cr. (l), Pocs4paoHaAsopa r.Crarponols, Craeponolrcrnfi naqKH KapToHHHe (Cranponolscrufi Qunnan) npafi) o4u-1304/12 Anrera HfI Jlaescroft E.tI. Acxop6nuoBar KxcJrora Apar(e OAO "Map6noQapu" Poccnq ofEy "HMuSyAocMn" t36t0t2 27.r2.20r2 (np.Kynarova, 9.49/5, 5Our 200rur.,6aHKr.r Poc14paeHa4:opa r.Cranponolt, Cranponolrcrnft noJrHMepHbre (Cranponolscruft $r.lnuan) rpafi) tO4V-1304/12 Anrera Hfl Jlaencrcoft E.n. Keropon@ ra6l. n/nn/o l0rvrr .{-p PegAr,r'c VuAuc ofBy "pIMuSyAocM[, 8202s77 r 27.12.2012 (np.Kyraroea, 9.49/5, l0nr., yn. flrr. roHr. (2), raqKr.r Jla6oparopnc JIIA Pocs4panuag:opa r.Craeponols, Cranponolrcrufi KapToHHSre (CraepononrcrcNfi Sralnan) KpaR) 04v-1304/12 I.BY3 "HeQreryrucrar I{PE" Ouenpasol KancyJrbr Kr,ru.- OOO "flpon3BoAcrBo PoccHq ofBy "I,IMII3yAOCMII" 7rttt2 27.12.2012 (yr.Tpauc n opruaq 9.22, pacrB. 2Orvrn l0rur., yn. rq. ueAt,tKaueHToB" Pocs4paaua4sopa r.HeQreryrr,rcr, Craaponolrcrnfi roHr. (3), naq. Kapr. (Cranponor rcrcuft Sunr.ra:r) xpaft) t04Lt-1304n2 fBV3 "HeSrerynacrar I{PE" flaHrpearnu ra6lerra OAO "Hp6r.rrcrcuft Poccur orEy "t4Mu3yAOCMtI' t090912 | 27.12.20t2 (yr.Tpancno prua4 p,.22, noKpbrTbre Kntlr.-pacTB. xo3" Poc:4pasualsopa r. HeQrercyrucr, Craaponolscrufi o6oroqrofi 25EA l0rur., yn.
(Craeponolscxr.rfi tlr.rruar) rpafi) tq. KoHr. (6), na,r. rapr.
s 04kI-1304/12 MEY3 "feopraencrar I{PE" flaHrpearnu ra6lerru OAO "Hp6nrcrufi Pocclrs ofBy "HMIISyAOCMII" 750512 r 27.12.2012 (yn.@nlaroBa, g.3, noKpbrTbre Kr.tu.-pacTB. xo3" Pocsgpanua4ropa r.feoprneacrc, Cranponolscruft o6oroqxofi 25E.{ l0rur., yn. (Craeponon rcrcufi Snnr.la.rr) rpaft) tr{. KoHr. (6), nau. rapr.
t04V-1304/12 MBY3 "feopnnencrcan I{PE" flauxpearnu ra6lerrcu OAO "Hp6nrcrufi Poccnr ofEy "HMIISyAOCMII' 610912 r 27.12.2012 (yr.OnnaroBa, A.3, noKpbrTbre KHrrr.-pacTB. xo3" Pocs4parHa4sopa r.feoprnencrc, Craeponolrcrcnfi o6oroqrcofi 25EA l0rur., yn. (Crarponorucrnft Qnnuan) rpafi) rq. KoHr. (6), nav. rapr.
04v-r304/r2 Anrera l,[fl lUesrrosa M.B. Acnaprau ra6rerxn Ns50 OAO "Jlynaucrtft YrcpanHa ofBy 'HMII3yAOCMII. r880812 27.12.2012 (np.Orrr6prcroft Penomoqun, (ynaroarn rqeftrossre xo3" Pocs4paeHagropa A.7/2, r.CraBponoJrb, roHrypHue)* (Cranpononscrnfi Qnlraan) Cranponolrcrnfi xpafi) r04V-1304/12 Anrera HfI [IeerKosa M.B. Aualrrnu ra6lerxu 500rr,rr OAO "TpueHcrufi Pocctls oI-Ey "HMIISyAOCMII' 166lt12 r 27.12.2012 (np.Orrr6prcrofi Peaoruoqnu, l0ur., yrraKoBKH xo3" Pocs4panna4sopa 9.7 /2, r .CraBporroJrl, 6esrsqefi roBbre KoHTypHbre (Cranpononrcrcnfi Qnnr.lzur) Craeponolscrnft rpafi) t 0414-1304/12 Anrerca l4fl lllesrKosa M.B. Xoresgulr ra6lerrcn n/o l0rur.. PyII Pecny6lnxa ofEy "I,IMIISyAOCMII" 600s12 :27.12.2O12 (np.Orrr6prcrofi Peeolrcqnn, ynaKoBKI,t rqefircogrre "Eemrre4npenaparbl" Eenapycr Pocsgpanuagsopa A.712, r.CraBponoJrb, KoHTypHbre (5), nav. rcapr. (Cranponolrcrnfi Qnlnan) Cranponolrcrufi rcpafi) t 0414-1304/12 Anrera HfI lllenqroea M.B. AcroQeH-fI radlerrcn I 0rur., .27.12.2012 OAO "Oaprr,rcraHAapr. Pocq,rg ofBy "I4MIISyAOCMII" t440812 (np.Orrr6pscrofi Penolrcqun, y[aKoBKI,t r.{efirosste JIexcpe4c'rna" Pocs4paena4sopa g.7/2, r.CraBpononb, KoHTypHbre (Cranponolscrafi Sunual) Crarponolrcrcraft rpafi) J 0414-1304/12Anrera I4fl lllesqrcosa M.B. flnrorcaH ra6lerrn 0.25ur OAO "fe4eoH Benrpnr ofBy 'HMu3yAOCMil" 531 l T2 c 27.12.2012 (np.Ornr6pscroil Pesolrcqun, 50urt., Q.naroHu nJracr[KoBbre, Puxtep" Pocs4panuagsopa *7/2, r.CraBponoJrb, nar{. KapT. (Cranpononrcrnft Qanazur) Cranponolscrr,lft rpail) l 04u-1304/12 Anrexa Hfl lllesrrosa M.B. Keropon@ ra6l. n/nr/o l0l,r ,{-p PegAH'c I,l.ngut ofEy 'HMII3yAOCMII' 8202577 0 27.12.2012 (np.Orrr6pscroft Petolrcqnn, lOrur., yn. rq. roH'r. (2), naqKn Jla6oparopnc JIIA Pocs4panHa4sopa 9.712, r.CraBpononb, KapToHHbte (Cranpononscrcuft Sunnaa) Crauponolscr
* - no npoBepeHHbtM noKa3areJrrM

Министерство здравоохранения Российской Федерации
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ В СФЕРЕ ЗДРАВООХРАНЕНИЯ (РОСЗДРАВНАДЗОР)
Славянская пл., д. 4, стр. 1, Москва, 109074 тел.: (495) 698 46 28, 698 46 11
BOE. РО № Б-Р
На №
Г |

Решение по результатам экспертизы качества лекарственных средств
перечисленных в приложении.

Приложение: на 5 л.в | экз.

Врио руководителя
Г.В. Ганночка 84995780187
Руководителям организаций- производителей лекарственных средств
Руководителям организаций- импортеров лекарственных средств
Субъектам обращения лекарственных средств
М.А. Мурашко

Скачать документ: Письмо 16И-640/13 от 13.06.2013

Информационные письма Росздравнадзора по контролю качества: Лекарственные средства

Информационные письма Росздравнадзора по контролю качества: Медицинские изделия

   

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