РОСЗДРАВНАДЗОР Информационное письмо № 16И-571/13 от 04.06.2013


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-571/13 от 04.06.2013

Решение по результатам экспертизы качества лекарственных средств

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(yn.feHepar a fltueza, g.17,
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or 27.12.2012
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or 27.12.2012

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Ns04V-1304/12
or 27.12.2012

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or 27.12.2012

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Ns 0414-1304/12 Anrexa HfI fa4raoa a V.B.
(yr.feuepar a flnneta, p.17,
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r.Bla4nraara:, Pecny6lnra
Cenepnar Ocerur-Alanur)
Ns04V-1304/12

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(fy4eprr,reccrcr.l ft Sniruan)

5208t2

Mrnucrepcrao 34paBooxpanelrrr Poccufrcxoil Oe4epauun

OEAEPAJIbHAfl CJTy)KBA TIO HAI3OPY B COEPE 3IFABOO)GAHEHr{fl (POC3FABT{AA3OP) Pyroao4ureJrf,M opraHr,r3arlnfi - rrpoH3BoAr4Teneft neKapcTBeHHbrX Crascacrar nn., a.4, crp. l, Mocrn4 1090]-4 cpe.qcTB rcr.: (495) 698 46 28, 698 46 tl

f: 06./O/3N, /6a -,r/fr Pyxono4zreJrrM opraHr{3arlr4fi - r{MnopTepoB JreKapcTBeHHbrX CpeACrB
Ha Ns Cy6rerrarra o6paqexur t- neKapcrBeHHhx cpeAcTB Peruenne rro peyJrbraraM 3Kc[eprr{3bl KaqecTBa neKapcTBeHHbrX CpeACTB

(De4epanrHaf, cJlyx6a uo HaA3opy n csepe 3ApaBooxpatenufl unQoprrarapyer, qro rlo p$ynbraraM SKCleprI{3bI KaqecrBa neKapcrBeHHhrx cpeAcrB npr4Hrro peureHr{e o cooTBeTcTBLIII yCTaHOBneHHbIM rpe6onaHuxna KaqecTBa neKapcTBeHHhrx cpeAcTB, uepeqHcileHHbrx B rrptrJrox eIJuLr.

flpunoxeHrre:Ha 5 n.s 1 sxs.

Bprao pyKoBoArrreJrt M.A. Myparuxo

f.B. faHHoqxa 8499s780r87 flpHroxeuue K nrcbMy Pocs4panHa4zopa org/. 1Fi@M f4a Cnegenun o JrexapcrBerrHbrx cpeAcrBax, rro p$yJlbraraM sKcneprlr3bl KaqecrBa -44 Koropblx PocrgpannaA3opoM nprrrrflTo pe[reHrre o coorBercrBnrr ax KaqecrBa HbIM M HaH [aeHosaHne opraH lt sar\un, Horr,rep saliaqnfl. npeAcraBuBuleft o6pasqrr JlercapcrneuHoe cpeAcrBo flponsno4nrels CrpaHa np-aa 3rcnepruar opraH H3aqr,tt JreKapcTBeHHbrx cpeAcTB Cepr.ru Ns04H-1304/12 Anreqnoe yqper(AeHne Asalrrnu ra6lerrcn 500rur OOO "AcQapMa" Poccnq ofBy "HMUSyAOCMII"
or 27.122012 14[I Axuelonahngmpa l0urr., ynaKoBKH 351 t2 Poc:gpaoHaAsopa VclraHosHa (c.Honolarcroe, 6e:rqqefi xoBbre KoHTypHbre (fy4eprraeccxnft Sr.rnr.ra.n) Hosoraxcrnfi p-u, Pecny6nurca AarecraH) Ns 04H-1304/12 fEY PA "HosoraKcKat Merpon ngatol-JlerT ra6aerru OAO "TrcrrleHcrnft or 27.12.2012 paftouuar 6olruuqa Nol "
Poccr.rc ofBy "HMIISyAOCMII" 030612 250rvrr | Ourr., yrraKoBKH xo3" Pocr4panua4ropa (c.Hoeonarcroe, Hooolrarcrnft p. 6esrrqeft rcoBrre KoHTypHbre (fy4eprvrecc rra fi Snlr.ran) u, Pecny6lura,{arecran) Ns04V-1304/12 MEY3 P,{ "fopogcxar 6olrunqa BalnAol ra6lerrn oAo Poccnr (DfBy "I4MII9yAOCMII" 264tlt2 or 27.12.2012 J\pl r.Maxa.{Karbr" noAbr3HqHrre 60ur l0ur., yn. "TarxuuQapMnpera- Poe4panua4sopa (yl.Jlanrr.rena, 4.5 5a, flI{. KOHT. parbltt (fygepMeccrcr.lfi Snnr.ra.n) r.Maxaqrcala, Pecny6laxa ,{arecraH) Np04V-1304112 MEY3 P.{ "fopo4crar 6olrHuqa Merponu4asol ra6aerru OAO "Hp6nrcxnfi Pocclll (DfFy "HMUSyAOCMfI"
or 27.12.2012 J\bl r.MaxaqKarbr" 15lIll 250rr,rr I 0rur., ynaKoBKr.r xo3' Pocsgpaena4ropa (yn.Jlanrnena, g.55a, 6egrrqefi xoBbre KoHTypHbre (fy4eprvreccrcnft Qrarnan) r. Maxaqrala, Pecny6lnra
,{anecran) Ns04V-1304/12 MEY3 P! "fopo4crar 6olsuuqa (Dypasolr.r4os ra6nemn 50nar OAO ",{a.nrxnruQaprra Poccr,rx (DfEy "nMIISyAOCMII"
w 27.12.2012 Jtl r.MaxaqKarbr" (ynaronru 6egrrqeft KosHe 221210 Pocrgparuagsopa (yn.Jlanrr.re na, p,.5 5 a, roHrypuue) J'{!10 (fygeprvreccxzft Qnnnan) r. Maxaqrcala, Pecrry6ln ra ,{arecran) Ns04V-1304/12 MEY3 P,{ "fopogcrar 6o.nruuqa JlnAorcanu pacrBop AJrt oAo PoccHq orBy "IIMLISyAOCMII" 47ttt2 or 27.12.2012 llbl r.MaxaqKarbt" uurexqufi 20ur/ut2ul ''Hosocu6xuuSapu"
Pocrgparua4sopa (yn.Jlanrraena, 4.5 5a, aMnynbr (10), naurr.r (fygeplreccrufi Qunraaa) r.Maxa.{rara, Pecny6lnra KapToHHbre [arecran) Jft04Ll-r304/t2 MEY3 P{ "fopo4crcar 6olsHuqa Eucaxo4ul ra6lerru 0O0 "Ogos Pocct,tq @fBy "HMU3yAOCMII"
or 27.12.2012 J\bl n.Maxa.rKarbr" noKpbrTbre KHIlr.-pacrB.
060711 Poc:4pasua4sopa (yn.Jlanrnena, g.55a, o6oloqrcofi 5ur 30ur., yn. rq.
(fygepNreccrcnfi S anr.ral) r.Maxa.{rara, Pecny6lnra roHr. (l), naq. Kapr.
[arecrax) Ng04H-1304/12 OOO "Berrop Oapu" Encaro4ul-Arpr.l@ ra6lerrcn OAO "XOK PoccHq (DI-Ey "HMII3yAOCMTI'
or 27.12.2012 (y-rr.MaHraur eya, g.l 3 4, rroKpbtTbre Kr,IU.-pacTB. 3805 l2 "AKpnxI,IH" Pocsgpanua4:opa r.Maxa.txana, Pecny6lara o6oloqrcoft 5ur l0ur., yr. rq.
(fygeprr,r ecc rcnfi ,{arecran) rcour. (3), naq. Kapr. QHn r.ra.n)
tft04kt-1304/12 OOO "Berrop Oapu" AHoHKoptu raorerKn 250ur OOO "flnrc-Saprna Poccug ofEy "HMqSyAOCMII"
or 27.12.2012 (yn.MaHraru eea, g.7 3 4, No60 (ynarosnn rqeftxosHe 50812 IIPO'' PocsgpanHagsopa r.Maxaqrala" Pecny6lnna rourypHue) (fy4eprvreccrra fi .{arecraH) Sun r.ran) Np04V-1304/12 OOO "Berrop @apna" {nrorcnu ra6lerrn 0.25 rur OAO "@apnacraHAapr- Poccl,rc DI-Ey "I4MII3yAOCMII'
or 27.12.2012 (yn.MaHrarueaa, g. I 34, I Ourr., ynaKoBKrd rqefirosrle t4l0t2 TonrcrcxauSapu" Pocs4panua4ropa r. Maxaqrar4 Pecny6lnxa KoHrypHbre (3), nau. xapr. 'fy.qepueccrnfi ,{arec'rau) Qul r.ran) Ns04VI-1304/12 OOO "Bex'rop (Dapru" @ypasonu4ou ra6lerrcu 50ur OAO "Hp6arcrcnfi Poccur ofEy "HMII3yAOCMII"
or 27.12.2012 (yn.MaHraur esa, p. | 3 4, (ynaronrr.r 6esrsqefi rosHe r7ttt2 xo3" Pocsgpanuagropa r.Maxaqrala, Pecrqr6lnra KoHrypHbre) Ilel0 (fyaepueccrcr.rfi $nnaan) .{arecraH) Np 04LI-1304/12 I.BY PA "Hogoraxcras Pu6orcns-JlerT ra6lerrcpr n/o OA0 "TrorvreHcrcufi Poccsr ofBy "I4MLI3yAOCMfI"
or 27.12.2012 paftounar 6olrunqa .l\bl " 200nrr I Orur., yrraKoBKH 290712 xo3" Pocs4paruagsopa (c.Honolaxcroe, Hotolarcxuft p. rqefircosue rcoHrypnue (5), (fy4epueccrr.rfi t[nlnan) u, Pecnyblnna,{arecmu) naq. KapT.
llb 04H-1304/12 Anrexa HfI Ayrueea 3.A. HoeoranH pacrBop AJrt OAO t'Enox[MHK" Poccnr ofEy "l,lMqSyAocMfI"
or 27.12.2012 (yr.T.Ayureea, g.4, c.Cypxaxn, aurerqufi 5ur/ul 5rrll, 2251012 Pocr4panHa4sopa Haspanoacx ufr p-y, Pecny6lr,rra aMnynbr (10), nav. rapr.
(fygepueccxu fi Sralr.ran) Hurylerur) Ns 0414-1304112 Anrera I,IfI Ayrlena 3.A. Asalrrus ra6lerrn 500rr,r OAO "Trouescrufi or 27.12.2012 (yr.T.Ayrue sa, p,.4, c.Cypxaxn, PoccHq ofEy "HMIISyAocMfI, 162rt12 lOur., ynaKoBKr,t xo3" Pocs4panua4sopa HaspaHoncrnfi p-u, Pecny6nnxa 6esrsqefi roBHe KoHTypHbre (fy4epnaeccrcnfi Qunnan) llHryruernr) Np0414-1304112 Anrera HfI Ayruena 3.A. Acrop6nuoBar KucJrora ApiDKe m 27.12.2012 (yr.T.Ayrue na, g.4, c.Cypxaxu, UAO "Map6no$ap*r Poccur @fEy ,I4MLI3yAOCMII" l5lll12 50rvrr 200urr., 6auru PocsgpaeuaAsopa Haspauoncx uil p -n, Pecny6lurca rroJIHMepHble (fy4epnaeccru fi Qnlnan) HHryulerr.la) Ng04H-1304/12 Anrexa I4II Ayurena 3.A. Kalrqur rurroKoHar rablerrcu OAO "Trouescrcufi or 27.12.2012 (yr.T.Ayrue Ba, g.4, c.Cypxaxu, Poccns ofBy "HMIISyAOCMII" 891212 5O0rrar J\b I 0, ynaroexn x(D3" Pocsgpanuagsopa Haspauoncruft p-H, Pecny6rnrca 6egrcqeft roBbre KoHTypHbre (fy4eprraeccrnfi Qunna:r) HHryruernr) Np0414-1304112 Anrera Illl Anflara.tresa M.B. (DypaqunnH ra6n. p/npwror. p- OAO "l4p6urcrufi Pocq,rs (DfEy "l,IMuSyAOCMn'
or 27.12.2012 (yn.Ocrano za, 6l u, c.3Kaxeto, 2841212 Pa rur MeCTHOTO n HapyxHoro x(D3" Pocs4paeHa4:opa Ha:pauoec rc uit p-u, Pec ny6lnra npprMeHeHnr 2Orrar J\ol0 (yn.
(fy4eprvrecc rn ft Qr,lnrazur) HHryruernr) 6esrrq. roHr.) Ns04V-1304/12 Anrerca HfI An6araqileea M.B. Vrols aKrnBnpoBaunuft-YB@ 0AO "Ypa.n6uoQaprr,r Poccur @fEy "HMUSyAOCMn"
or 27.12.2012 (yr.Ocnauo ea, 6/ u, c.Sraxeno, 2200912 ra6rerrn 250rvrr Nsl0, Poe4panHa4sopa Haspauoncrnfi p-u, Pecny6lnra ynaKoBKr,r 6esrsqefi rcossre (fygeprvrecc rn fi Sralr.ra:l) I4Hryruenar) KOHTypHbre Ng04V-1304/12 AtI OOO "BnKropufl" AHa.nrrnu ra6-lerrn 500rvrr OAO "TroueHcrnft Poccltq @fBy "tIMUSyAOCMft' r59ttt2 or 27.12.2012 (yr.fleprou aficrcax, A.44a, l0urr., ynaKoBKrt xo3" Pocr4panna4sopa r.Blagurarrar, Pecny6luxa 6egrqqeft roBbre KoHTypH bre (fygepMeccrcaft Snnnan) Cenepuar Ocernr-Alauna) Ns04V-1304112 An OOO "Br,rKropufl" AqetnlcalnllHJloBar KlrcJrora OAO "Eopncoscruft or 27.12.2012 (ya.flepoou aftcra4 p.44a, Pecny6nnra ofEy "I4MqSyAocM[, 5300912 ra6rerxu 500rr,rr I Orur., 3aBO,tl Eelapycr Pocr4panHa4sopa r.Bla4nranrar, Pecny6lnra ynaKoBKr.t 6estrqefi rossle nae4npenaparor" (fy4epureccxuft Snnuan) Cenepuar Ocerur-Alaunr) KoHTypH6re Ng04V-1304/12 HV3 "Vsronar 6olrHuqa Ha Barugol ra6le'mn OAO "Map6r.ro{apl,r or 27.12.2012 cr.Bla4nxasra3 OAO "PXA"
Poccur ofBy "IIMIISyAOCMII" r80812 noA6fl36tqHue 60nar lOrur..
Poc:4pasHa4sopa (yn.9xalona, 9.16, ynaKoBKH .rqefirosHe (fygeprvrecc rr.r ft S nnnal) r.Ba44nraoras, Pecny6lnxa KOHTypHbre Ceaepuaa Ocerur-Alauur) Ns04V-1304112 HV3 "Vsrosar 6olruHqa Ha I{nanoro6anaMrdH pacrBop nnr OA0 "Eopaconcrcnft Pecny6nura ofBy "HMLI3yAOCMII"
or 27.12.2012 cr.Bla4nrasxa3 OAO "PXAU 1040812 uHrexqufi 0,5ur/ul lun 3aBOA Eenapycr Pocsgpanua4sopa (yr.9ranora, 9.16, aMnynbr (10), navrra uegnpenaparon" (fygepna eccnr.r fi Q nnr.ral) r.Bl44uraeras, Pecny6lnna KapToHHbre CenepHaa Ocernr-Alaunr) Ns04Id-1304/12 HV3 "Vglorar 6o.nruuqa Ha 3pr.rnrar ra6-nerrn lOur lOrur.. OOO "@apuanol- Poccvs ofBy "HMIISyAOCMII.
or 27.12.2012 cr.Bla4urcasra3 OAO TTPXJT'' 160812 ynaKoBKn rqefiKosHe Borra" PocagpanHa4sopa (yn.tlxanooa, p.16, KoHTypHbte (5), nau. rapr.
(fyleprraeccxr.r ft Qunnan) r.Bla4nranras, Pecny6luxa CenepHar Ocerur-AnaHnr) Ns 04U-1304/12 HV3 "Vsroear 6olsuuqa ua MerpoHn4arol ra6lerrcn UAU "QapMcraHAapr Poccus @f6y "l4Mq3yAocMfl"
o"r 27.12.2012 cr.Bla4nrcasrca3 OAO "pXA" 25Orrar 20urr., y[aKoBKH 470712 JIerccpe4crna" Pocs4panna4:opa (yl.tIralooa, p,.16, sqefiroerre rconrypnue (l), (fygeprraeccrcnfi r.Bra4nxanra:, Pecny6luna naq. KapT. $aluan) Cenepuar Ocerrar-AnaHr,rr) Ns04V-1304/12 HV3 "Vsrosar 6oruHr,rua Ha hloBoKanH pacrBop Anfl OAO "Buoxr,rMHK" Pocq.r.s al sy "HMII3yAOCMn, or 27.12.2012 cr. Bla4nrcanrcas OAO "pXA" nurercqnfi 5ur/ul 5rrln, 2281012 (yr.9rcanona, 4.16, Poca4panua4ropa aMnyJrbr (10), nau. rapr.
r.Blagnnaercas, Pecny6lnra (fy4ep nr eccna ft Q alr.ra.n) CenepHar Ocernr-Alaunr) Ns 04kl-1304/12 Anrera HfI faasaosa V.B. AeBHr KarrcyJrbr lOrur., OOO "Jlrcnan" Poccuq a|by "l4Mu3yAocMf["
or 27.12.2012 (yn.fenepana flluera, 4. I 7, ynaKoBKx lqefirosHe 2st0r2 r.Blagnrcanras, Pecny6luna Pocsgpanna4sopa KOHrypHbre (fygepuecc rcr,l fi S ranr.ran) CenepHar Ocernr-Alaunr) Np04V-1304/12 Anrera Hfl faagaon a V.B. 3pnuur ra6rgrKr.r l0rur lOrur.. OOO "Oapruanol- or 27.12.2012 (yr.feHepar a fltneaa, g.17, ynaKoBKr,r rqefiKosrre PoccHq ol'by "HMu3yAocMf[" 0904t2 Borfat' PocsgpaeHa4sopa r.Bra4nraaras, Pecny6nnra KoHrypHbre (5), nav. rapr.
(fygepueccru ft Sr.rnr.ral) Ceuepuaa Ocerrar-Alaunr) Ns04V-1304/12 Anrexa Hfl faasaos a Ll-B. Hosorar.rn pacrBop Ant UAO "llaruxr.rrvr$apnr Poccas (DfBy "HMUSyAocMfI"
or 27.12.2012 (yn.feHepar a fltueza, g.17, uHserqnfi Sur/ua 5ul, 1t0t2 PocsgpanHagsopa r.Bla4nrannas, Pecnybnnra aMrynbr (10), nav. rapr.
Cenepnar Ocerur-Anauur) (fyaepueccrufi Qr.rruaa) Jft04n-t304/r2 HV3 "Ysrooar 6olrHzqa ua AHarsrnH pacrBop glr uly u UUU Vxpanna ofEy "I,IMU3yAocMrIt or 27.12.2012 cr.Bla4urasra3 OAO "pXA" n/u rne4eHnr 500ur/ul 2un. 301012 "{Dapuaqearr,rqecKat PocsgpaaHagsopa (yn.tka.nona, A.16, aMnyrrbr (10), navrcn KoMnaHl,tt "34opoBle"
r.Bl4guxarxas, Pecny6lura ifyaeprnreccrcuft Snnral) KapToHHbre Cenepuan Ocernr-AnaHnr) Np04Id-1304112 HV3 "Vgrosar 6omnr,rqa Ha Auunarc pacrBop Anfl OAO "KeuepoBcKat PoccHq ofBy "I4MIISyAocMn';
or 27.12.2012 cr.Bla4nrarrag OAO "PX,q" Hapy)KHofo npuMeHeHHr r.{ 261012 QapnrSa6pr,rrca" Poc:4paeua4sopa (yr.9ranona, A.16, nHrarrquft, 40ut l0%o.
(fygep rvrecc rr.rfi Sr,rnnan) r.Bnagnranrcas, Pecny6nnra Qraronsr Ceaepuar Ocerux-Alaunr) Ns04V-1304/12 Anrera HfI faasaoe a V.B. Analrrnu pacrBop pn s/s u UOO VrpauHa (DfEy "I,tMUSyAocMfI"
or 27.12.2012 (yr.feHepar a fTnueza, g.l 7, n/u nnegeuns 50Orvrr/nrn 2un. ''@apruaqenuqecKat I 003 l2 Pocs4panua4sopa r.BnaAHKaBra:, Pecny6lurca aMnyJrbr (10), naurcn KoMnaHI,rr "34opoBle" (fygeprraeccruft Qunnan) CenepHar Ocerna-Alanur) KapToHHbre Ns04V-1304/12 Anrerca Hfl faasaosa V.B. AHarrrnH ra6lerrn 500elr OAO "Map6uoQaprr,r" Pocq.r.fl @f6y "I,IMIISyAOCMII" 2160912 or 27.12.2012 (yr.fenepan a flnneua, 9.17, lOrur., ynaKoBKH Poc:gpaaua.q:opa r.Bragnranxas, Pecny6lnrca Oesrgqeft roBbre KoHTypH bte (fygeprraeccrrafi Qnnuan) Ceeepuar Oce'rnr-Al auut) Ns04V-1304/12 Anrexa Hfl faagaosa V.B. AcxopyruH ra6lerrcpr OAO "Map6r,ro$aprr,r" Poccns ofBy "HMIISyAOCMn" 470512 or27.l2.2ol2 (yr. feuepan a fltueza, g. | 7, 50rr,rr+50rr,r r I 0rur., ynaKoBKH Pocr4paana4:opa r.Bla4nranrcas, Pecny6lnna rqefi rosrre rcoHrypuue (5), (fyaeprnr eccxnfi Sulr.ra.n) CerepHar Ocernr-AnaHr{r) naqK[ KapToHHHe Ns 0414-1304/12 Anrexa HfI fa4raoa a V.B. MerpoH uga:ol ra6lerrr.r OAO "(DapucraHAapr. Poccl,rs ofEy "HMIISyAOCMfI" 5208t2 or27.12.2012 (yr.feuepar a flnneta, p.17, 250rur 20ur.,ynaKoBKH Jlexcpe4craa" Pocs4panna4ropa r.Bla4nraara:, Pecny6lnra rqefirosHe ronrypnue (l), (fy4eprr,reccrcr.l ft Sniruan) Cenepnar Ocerur-Alanur) [aq. KapT.

Министерство здравоохранения Российской Федерации
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ Г 1
В СФЕРЕ ЗДРАВООХРАНЕНИЯ Руководителям организаций- (РОСЗДРАВНАДЗОР) .
производителей лекарственных средств
Славянская пл., д. 4, стр. 1, Москва, 109074 тел.: (495) 698 46 28, 698 46 11
Р уководителям организаций-
L4¢ РО 93 ИР -277//8 — импортеров лекарственных средств
На № Субъектам обращения Г 7 лекарственных средств
Решение по результатам экспертизы 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 5 л.в 1 экз.

Врио руководителя М.А. Мурашко
Г.В. Ганночка 84995780187

Скачать документ: Письмо 16И-571/13 от 04.06.2013

Информационные письма Росздравнадзора по контролю качества: Лекарственные средства

Информационные письма Росздравнадзора по контролю качества: Медицинские изделия

   

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