KHTOBe - government.bg...2018/10/01  · Ha 1, T. 29a OT 3MM, 13bB Bp'b3Ka C 1 , T.4 OT AP Ha...

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OBPA3EL( TEXHIPIECK0 IIPEAIIO)KEHHE no o6mecmeena noirbinca c npedmem: ,Ifocma6Ka Ha AtedummcKu u3denuR,.nut1uu npedna3Hu cpedcmea u Kolicymamueu 3a Hydicdume Ha Ilpoepama „flodo6pReane ycmotiqu6ocinma Ha HaquoHanuama npozpama no myeepKyno3a" U docmatma Ha duaenocmuKymu u Koucymamu6u 3a muxpocKoncKu u Kyizmypeiniu U3C.11e66(1111411 3a my6epigno3a npe3 2018 2. 6116 eirb3Ka c 113111,1111eHUeM0 Ha „Haquona.rmama npozpama 3a npeeem4uR u Konmpon Ha my6epKyno3ama" 6 Peny6.7uKa EbizzapuR 3a nepuoda 2017-2020 2., muogreama 40 o6oco6eHu no3uouu. IlpervioxceimeTo e HO o6oco6elia 1103HHHS1 N2 33 c ripeameT KHTOBe 3a moneKyasipHa JAHaTHOCTHICa HacTosnueTo TexHwiecKo npeanowanie e no,qa,rteHo OT: EI3JITAP1451" E00,/ H no,nynicaHo OT: BeHMICJIaB KOCTaAHHOB KapaM4)11J10B B KalleCTBOTO My Ha: ynpaBHTen 3a6e.nealcKa: Ha ocnoeanue to. 47, WI. 9 om 17173011, Koeamo piacmnux nodaea ogr)epma 3a noeette om edua o6oco6ena n03uqu51, 3a ecRica o6oco6ena no3uqusi ce npedcmaesi omdeilno mexnutiecKo npedilamenue, oKomn.neKmoeano CbC cbomeemnume npagodicenusi , 3a KORMO ce omnacNm. Obabp)Kamie: 1. goKymeHT 3a yrrbnHomoutaBaHe, KOFaTO JIHHeTO, KOeTO Hoi:taBa oitiepTaTa, He e 3aK0HHH5IT npeacTaBnTen Ha riacTmma; 2. lipeo rtnoweHHe 3a 1431TbJIHeHHe Ha nopv-maTa B C'bOTBeTCTBHe C TexHwieciarre cneuncimixaumll H 143HCKBaHH5ITa Ha B13JI0>KHTe.1151. 3. Kbm TexturiecKoTo npealloweline ce lipllaaraT: 3.1. Ho o6oco6cmi 1103111HIH N2N2 25, 29, 30,31, 33, 38 H 40: 3.1.1. AeKaapaullm OT riacmnxa, ge Me,{1111tHHCKHTe H3 0 11eJIHA ca BK1110IleHH B CIIHCBKa no WI. 1, T. 1, 6yKBa "6" OT Hape,E16aTa 3a yCJI0BHATa H peAa 3a CbCTaBAHe Ha CIIHCbK Ha Me,L1HUHHCKHTe H3,T1eJIH51 no Lui. 30a OT 3a1cOHa 3a Me,L1111114HCIGITe 143,ELeJIHA /3M14/ H 3a onpe,Etemsnie Ha cToilHocrra, KOATO Te ce 3armawaT, C npwrioweHo u3B.nemeHlle OT CHHC'bKa no Lim 1, T. 1, 6yKBa "6" OT Flape,T16aTa 3a ycnoBllsura H peAa 3a C'bCTaB51He Ha CIIHC'bK Ha Me):11IAHHCKHTe H3,£1e111131 no Lui.30 OT 3M14 H 3a onpegefunie Ha CTOrlHOCTTa, KOATO Te ce 3annainaT, OT KOeTO H3B.aemeHne e BH,L(Ha npo,rtaxcHaTa ueHa no CMHC'bJI a Ha §1, T. 29a OT 3MM, 13bB Bp'b3Ka C § 1 , T.4 OT AP Ha Hape,a6aTa, 3a BCAKa no3unill51/HomeHmaTypa, 3a KOATO ymaCTHHKBT 110)3(aBa 04)epTa. 3.1.2. 3aBepeHo Konlle Ha ocimullarieH o ttoxymeHT, 1434ta,LteH OT HAJI, OT KOIITO ,Ra e BH,E111-10, Lie 3a CbOTBeTHOTO Me,L1141.114HCK0 H3Ae.rnie, 3a KOeTO ce ytiacTBa Hmma perllcrrpnpaHll ,L1aHHH B HAJI H/I4J114 EUDAMED 3a HH1114,LICHT14/110TeHHHaJIHH HHIIHAeHTH npe3 nocne,amfre ,E(Be roman'', KaKTO H 6J10K14paHH HJIH 143TerneHH napTHAH OT CbIIIOTO me,alluitHcKo 143,rtenlle npe3 nocneaHHTe 2 FO,L1HHH. flpezicTaBeHnsi AoKymeHT OT HAJI cne,rma ;la 61.4e H3,aa.aeH npean He noBege OT e,rtnH meceu OT no,rtaBaHe Ha o(1)epTa OT riacTfflwa. 3.1.3. ilexnapaulm, B KOATO nocogeHo Me,E1HHHHCKOTO H3,rte.rme, 3a KOCTO ce yqacTBa H KOHKpeTHHAT o6LuecTBeH 4oH,rt Ha C'bOTBeTHaTa abp)KaBa, no Kano ce 3anJ1ama. 3.1.4. 3aBepeHo Konue Ha geKnapaunsi 3a CbOTBeTCTBHe C ,anpeKTHBa 98/79/EC, 113 i a OT npoH3BoxiTerm. 3.2. Ho o6oco6eint 1103111111H N2 N2 25 H 39:

Transcript of KHTOBe - government.bg...2018/10/01  · Ha 1, T. 29a OT 3MM, 13bB Bp'b3Ka C 1 , T.4 OT AP Ha...

Page 1: KHTOBe - government.bg...2018/10/01  · Ha 1, T. 29a OT 3MM, 13bB Bp'b3Ka C 1 , T.4 OT AP Ha Hape,a6aTa, 3a BCAKa no3unill51/HomeHmaTypa, 3a KOATO ymaCTHHKBT 110)3(aBa 04)epTa. 3.1.2.

OBPA3EL(

TEXHIPIECK0 IIPEAIIO)KEHHEno o6mecmeena noirbinca c npedmem:

,Ifocma6Ka Ha AtedummcKu u3denuR,.nut1uu npedna3Hu cpedcmea u Kolicymamueu 3a HydicdumeHa Ilpoepama „flodo6pReane ycmotiqu6ocinma Ha HaquoHanuama npozpama no myeepKyno3a"U docmatma Ha duaenocmuKymu u Koucymamu6u 3a muxpocKoncKu u Kyizmypeiniu U3C.11e66(11114113a my6epigno3a npe3 2018 2. 6116 eirb3Ka c 113111,1111eHUeM0 Ha „Haquona.rmama npozpama 3anpeeem4uR u Konmpon Ha my6epKyno3ama" 6 Peny6.7uKa EbizzapuR 3a nepuoda 2017-2020 2.,

muogreama 40 o6oco6eHu no3uouu.IlpervioxceimeTo e HO o6oco6elia 1103HHHS1 N2 33 c ripeameT KHTOBe 3a moneKyasipHa

JAHaTHOCTHICa

HacTosnueTo TexHwiecKo npeanowanie e no,qa,rteHo OT: EI3JITAP1451" E00,/H no,nynicaHo OT: BeHMICJIaB KOCTaAHHOB KapaM4)11J10B

B KalleCTBOTO My Ha: ynpaBHTen

3a6e.nealcKa: Ha ocnoeanue to. 47, WI. 9 om 17173011, Koeamo piacmnux nodaea ogr)epma 3a noeette

• om edua o6oco6ena n03uqu51, 3a ecRica o6oco6ena no3uqusi ce npedcmaesi omdeilno mexnutiecKonpedilamenue, oKomn.neKmoeano CbC cbomeemnume npagodicenusi , 3a KORMO ce omnacNm.

Obabp)Kamie:

1. goKymeHT 3a yrrbnHomoutaBaHe, KOFaTO JIHHeTO, KOeTO Hoi:taBa oitiepTaTa, He e 3aK0HHH5IT

npeacTaBnTen Ha riacTmma;

2. lipeortnoweHHe 3a 1431TbJIHeHHe Ha nopv-maTa B C'bOTBeTCTBHe C TexHwieciarre cneuncimixaumll H

143HCKBaHH5ITa Ha B13JI0>KHTe.1151.

3. Kbm TexturiecKoTo npealloweline ce lipllaaraT:3.1. Ho o6oco6cmi 1103111HIH N2N2 25, 29, 30, 31, 33, 38 H 40: 3.1.1. AeKaapaullm OT riacmnxa, ge Me,{1111tHHCKHTe H3011eJIHA ca BK1110IleHH B CIIHCBKa no WI. 1, T. 1,

6yKBa "6" OT Hape,E16aTa 3a yCJI0BHATa H peAa 3a CbCTaBAHe Ha CIIHCbK Ha Me,L1HUHHCKHTe H3,T1eJIH51 no

Lui. 30a OT 3a1cOHa 3a Me,L1111114HCIGITe 143,ELeJIHA /3M14/ H 3a onpe,Etemsnie Ha cToilHocrra, KOATO Te ce

3armawaT, C npwrioweHo u3B.nemeHlle OT CHHC'bKa no Lim 1, T. 1, 6yKBa "6" OT Flape,T16aTa 3a ycnoBllsura

H peAa 3a C'bCTaB51He Ha CIIHC'bK Ha Me):11IAHHCKHTe H3,£1e111131 no Lui.30 OT 3M14 H 3a onpegefunie Ha

CTOrlHOCTTa, KOATO Te ce 3annainaT, OT KOeTO H3B.aemeHne e BH,L(Ha npo,rtaxcHaTa ueHa no CMHC'bJI

• a

Ha §1, T. 29a OT 3MM, 13bB Bp'b3Ka C § 1 , T.4 OT AP Ha Hape,a6aTa, 3a BCAKa no3unill51/HomeHmaTypa, 3aKOATO ymaCTHHKBT 110)3(aBa 04)epTa.

3.1.2. 3aBepeHo Konlle Ha ocimullarieH ottoxymeHT, 1434ta,LteH OT HAJI, OT KOIITO ,Ra e BH,E111-10, Lie 3a

CbOTBeTHOTO Me,L1141.114HCK0 H3Ae.rnie, 3a KOeTO ce ytiacTBa Hmma perllcrrpnpaHll ,L1aHHH B HAJI H/I4J114

EUDAMED 3a HH1114,LICHT14/110TeHHHaJIHH HHIIHAeHTH npe3 nocne,amfre ,E(Be roman'', KaKTO H

6J10K14paHH HJIH 143TerneHH napTHAH OT CbIIIOTO me,alluitHcKo 143,rtenlle npe3 nocneaHHTe 2 FO,L1HHH.

flpezicTaBeHnsi AoKymeHT OT HAJI cne,rma ;la 61.4e H3,aa.aeH npean He noBege OT e,rtnH meceu OT

no,rtaBaHe Ha o(1)epTa OT riacTfflwa.

3.1.3. ilexnapaulm, B KOATO nocogeHo Me,E1HHHHCKOTO H3,rte.rme, 3a KOCTO ce yqacTBa H

KOHKpeTHHAT o6LuecTBeH 4oH,rt Ha C'bOTBeTHaTa abp)KaBa, no Kano ce 3anJ1ama.

3.1.4. 3aBepeHo Konue Ha geKnapaunsi 3a CbOTBeTCTBHe C ,anpeKTHBa 98/79/EC, 113 i a OT

npoH3BoxiTerm.

3.2. Ho o6oco6eint 1103111111H N2 N2 25 H 39:

Page 2: KHTOBe - government.bg...2018/10/01  · Ha 1, T. 29a OT 3MM, 13bB Bp'b3Ka C 1 , T.4 OT AP Ha Hape,a6aTa, 3a BCAKa no3unill51/HomeHmaTypa, 3a KOATO ymaCTHHKBT 110)3(aBa 04)epTa. 3.1.2.

3aBepeHo Konme Ha Ae 3a C'bOTBeTCTBIle C AmpeKTHBa 93/42/E1'IO, 143,EmaeHa OTIlp0H3B0a1TeIDI.3.3. Ho o6oco6eHn HOMIXHIll N2 .N2 26, 27 H 28: 3aBepeHo KonHe Ha geKnapauHA 3a CbOTBeTCTBI4e C AtipeKTHBa 89/686/EHO HRH AHpeKTHBa93/42/EHO, H3ga,rieHa OT Ilp0143BOXITeJIA.*AKo npou36odumenl1m e KnacuOuqupan u3de.auRma Kamo meauguncKu u 3a MAX e npeacmaaeuo Konue

na ,aelatapaquA 3a cbomeemcmeue c ,aupeKmuea 93/42/EHO, mo piacmiluK-bm cneoea aa npedcmaeudoKymeumume no m. 3.1.3.4. no BCIIIIICH o6oco6eHH no3Huimi, C Hnc.rHotirernie Ha o6oco6eHH 1103141.11111 N.q.N2 13, 38, 39 H 40: 3aBepeHo Korme Ha cepTH4mKaT BAC EN ISO 9001 HIM eKBHBaJleHTeH cepTH(I)HKaT KaKTO H ApyruAoKa3aTencTBa 3a eKBI4BaneFITHI4 mepKH 3a ocHrypsmaHe Ha KamecTBoTo, C o6xBaT cbrnacHo npe,ameTaHa o6oco6eHaTa II03HUH513a KOATO ce riacTBa, H3,LtageH Ha HmeTo Ha Hp0143BO,L114TeJI51;3.5. Ho o6oco6eHa 1103HIANSI N2 23: AeKnapallust OT rtacTHHKa, me ce 3a,Erb.TI)KaBaT 3a co6cTBeHa cmema ,rta noaabp)KaT HankmaTaanapaTypa 3a awromaTH3HpaHa allaTHOCTHKa Ha Ty6epKyno3a BACTEC MGIT 14/11.TH4 ripHHeo6xo1U1mocT 6e313'133Me34(HO npegocTaBAT H noarrhp)KaT CBOA TaxaBa C KanauHTeT 3a mHHHmym 500npo6H e,ll,HoBpemeHHo B rpa,noBeTe Co4misi — 2 anapaTa, HnoBAHB — 1 anapaT H HneBeH - 1 anapaT, 3aIlepHO,L(a OT cKmotmaHe Ha AoroBopa LO H3tieprmaHe HajIITLIHOCTTa Ha AocTaBeHHTe MeallIAHHCKH143,4e.TI11.51 HJII4 JO 143THIlaHe cpoKa HM Ha I-0,EIHOCT. (cao6oaert meKcm)

• 3.6. no o6oco6eHa H03111X1151 N2 23: AeKnapaum, qe H3,L(eJIHATa ute BKJIKYIBaT H BC14,4KH Heo6xo,aHmH KOHCyMaTHBI4 H peaKTHBH 3aH3pa6oTKa Ha aHTH6H0rpamIrre (a cao6odeu meKcm u a cJlytIaü, e e npunaNcumo)..3.7. Ho o6oco6eHa 11031111(1151 N2 33: ,E1eKJIapaH1151 OT ymacTHHKa, Lie ce 3a,LIBJI>KaBaT 3a c06cTBeHa CMCTK ja noxybp)KaT Hanw-maTaanapaTypa 3a JIHHer1H0-XH6pHAH3aHHOHHH aHaJIH3H C TwinCubatur 14/HJIH npu Heo6xo,mmocT6e3B133Me3,E(HO otta npeAocTaBscr H noarubp)KaT CB051 TaKarta B rpa,/loBeTe C04)1431— 2 anapaTa, FLTIOBAHB —1 anapaT, H HneBeH - 1 anapaT, 3a nepHo,Lta OT cKniomBaHe Ha goroBopa ingepnBaHe HanHmHocTra HaAocTaBeHHTe Me4114I.H4HCKH H3,LIeJII451 HJIH JO H3THmaHe Cp0Ka MM Ha roAHocT. (cao6oaeu meKcm)3.9. Ho o6oco6eHa HO3lIIutSl .N2 29: AeKnapauktm OT riacTHHKa, qe npeanoweHHeTo HM BKJI10,4Ba He06X0,L(1MH51 3a inpa6oTBaHeTo HaTecToBeTe 6poil enpyBeTKH 3a B3HmaHe Ha Kp'bB C JIHTHeB xenapHH. (cao600eu meKcm)3.10. no o6oco6eHa 110311111111 N2 30: AeKnapaum OT riacTHHKa, Lie ripeano)KeHHeTo 14M BKJI104Ba He06X0A1MHTe 3a H3pa6oTBaHeTo HaTecToBeTe KOJI1414eCTBa OT CJIe,EIHHTe KOHyMaTHBH H peaK-THBH: PeareHT 3a HamansmaHe ITHCBCTBHeTOHa rpaHynouHTH B oT,Lkenemi nepH(PepHH Kp'bBHH moHoHyKneapHH KMCTKH, XpaHHTenHa cpeAa 3aKynTHBHpaHe Ha nmmtiouHTH, Cnati,aorie 3a 6143030 KJIeTb4H0 npe6posmaHe, EnpyBeTKH 3a rpaAHeHTHo

• cenapHpaHe Ha moHoHyKneapHH KIIeTKH, BaKyymHa enpyBeTKH 3a B3HmaHe Ha KpBB C JJHTMB xenapHH.(cao6odeu meKcm)3.11. Ho o6oco6eHa 11031111111H .N2 40: AeKnapaum OT riacTHHKa, Lie Me,LIHHHHCKI4Te 143ACJIHSIca C'bC cpoK Ha FOAHOCT He no- Ma.TIKO OT 1 F. OTAaTaTa Ha Hp0H3BOACTBO. B ,Lketcriapaullsrra riacTHHukfre nocotma H Hp0H3BOACTBeH1451cpoK Ha ro,mocTHa npeaaaraHoTo OT TAX H3,rtenHe. (cao6odeu meKcm)

4. AeKnapauHA 3a cBrnacHe c Knay3HTe Ha npHnoweHHA npoeKT Ha goroBop;5. AeKnapauHm 3a cpoKa Ha BaTIKEIHOCT Ha ockepTaTa;

AATA: 16.05.2018 r. nognmc H

Page 3: KHTOBe - government.bg...2018/10/01  · Ha 1, T. 29a OT 3MM, 13bB Bp'b3Ka C 1 , T.4 OT AP Ha Hape,a6aTa, 3a BCAKa no3unill51/HomeHmaTypa, 3a KOATO ymaCTHHKBT 110)3(aBa 04)epTa. 3.1.2.

JJIONCEHHE 3A H3HIJIHEHHE HA HOPIIIKATA

jocmaexa Ha meduquucuu u3deaug,./iuquu npedna3nu cpedcmea u Koncymamueu 3aupicdume Ha Hpozpama „HodoopReaHe ycmoiiqueocmma Ha Hatfuonanuama npozpama no

my6epKy.rio3a" u docmaexa Ha duaznocmutrymu u Koncymamueu 3a mukpocKoncKu uKy.nmypennu u3c.qedeallus1 3a myoepxy.no3a npe3 2018 2 6b6 epwica c u3n-bsmenuemo Ha„Haquouaimama npozpama 3a npeeenuuR u Konmpo.3 Ha my6epig,w3ama" 6 Peny6.7uKa

Eb.nzapust 3a nepuoda 2017-2020 z., eicuotreau4a 40 000couenu no3uquu.

OT: BILIFAPI451" E00,Lk

YBANCAEMH JAMH H FOCHOJA,C HacTosiwoTo, BH npeAcTaBsime HaweTo TexmviecKo npe,anoweHHe 3a H31Th.nHeHHe Ha

o65n3eHaTa OT Bac npoueTtypa 3a 13b3.naraHe Ha o6wecTseHa noinoixa c npeameT: jocmaaKa nameOuuuncKu u3denuR, autinu npeOna3nu cpeocmea u Koncymamuou 3a nymoume Ira Hpozpama„Hodo6pReane ycmotiqueocmma na Haquona.rinama npozpama no my6epKyno3a" u OocmaeKa iiaOuaznocmukymu U KOUCyMaMU6U 3a AtUKpOCKOUCKU u Kyirmypeiniu u3citedeanuR 3a my6epKy.ao3a npe32018 4 61,6 ep-b3Ka c u3n1,imenuemo na „Hauuonainfama npoepama 3a npeeenouR u Konmpon iiamyeeptcpw3ama" 6 PenyarmKa Eb.azapuR 3a nepuo0a 2017-2020 6Kmogaama 40 o6oco6enuno3uuuu.

Hpea.no•AcenneTo e no o6oco6ena 1103HUHS1 .N2 33 c upegmeT KHTOBe 3amoneKyanpna anarnocTinca

1. Aex.napHpame, iie cme 3ano3HaTH, cporbT Ha AoroBopbT e 1 (eaHa) roamia, CLIHTBHO OTitaTaTa Ha no,anHcBaHeTo My.'

2. AeKnapHpame, cme 3ano3HaTH, tie Cp0KbT Ha H3n-bs1Hemie Ha OT,aeJIHHTe ,LIOCTBBKH 110o6oco6eHH 110314aHH OT N2 1 AO N2 37 e ao 30 KanaLaaptipt AHH OT AaTaTa Ha 3aRBKaTa.

geKnapHpame, tie cme 3ano3HaTH, CpOK'bT Ha H3nbnHeHHe Ha OTACJIHI4Te AOCTaBlat noo6oco6eHH 1103111.1,H11 OT N2 38 to N2 40 e He HO-KbCHO OT 14 Ka.rieH,EtapHH ,L1HH OT AaTaTa Ha 3asn3KaTa.

3. rapaHTHpame, tie CM B bcTosnille H3C11311HHM Kw-lee-mem) nopv-HcaTa B rrb.nHo

CbOTBeTCTBHe C H314CKBaHH5ITa Ha BI3J10>ICHTeJ131.4. 3a 113n1,nHeHHe Ha nornAKaTa npeanarame:

143HCKBBHHR Ha B1.3JIOACHTeJ151 IlpeJVIOACCHHe na riacTHHKa

.1Y2Ilatimenonanne Ha o6oco6etiaTa

HO3HHHH

Msiptc

a

KOJIIH

veer

BO

JO

011HCBHHe Ha npexuarattoTo ttlitenne, B KoeTo

3Bal..TINCHTC.TMO cc nocogna

11p0H3BOAHTCJI, HanmetionaHHe Ha H3,11P-J1HeTO,

KaTa.rimKeH Homep, onaKonKa H Lip.HHAtintutyamt3Hpauta HIHIPOpMBHHH H np-b3Ka

(link) ICI.M 04)HHHBAHHS1 Hwreptter catiT Ha

Hp0H3BOAHTeJ1H/HTe c ity6.rinKynaitrae

TexiimiecKH JABHHH Ha ChOTBeTHOTO

meatiunticKo H3Thentie, JIH4HO npeanauto

cpeacTno HUH KoHcymaTtin, B cayman tie HMa

TaKlina.

33.1

KHT 3a moneKynApHa AHarHocTHKaHa MHHHMyM 6 BH,aa B M

tuberculosis complex, BKJ1. BCG, OTKynTypa (HKnioHHaul: ,41-1K

0.1114rOl3yKJ1e0TH2114 3a nonHmepa3HaHepH)KHa peaKuHA, Taq nonHmepa3a

14 mem6paHH c reu cneumcillpiHHAHK coHAu 3a Hoene/wawa

6poriTedT

192

GenoType Mycobacterium MTBCKaT .N2 30196

Irlp0H3BOAHTe.11: FIAIN-Lifescience

KHT 3a moneKynApHa AHarHocTHKa HaJ1041111HHTeJ1H14 6 BHAB Ty6epKyno3HH

mHKo6aKTepHH, BKJ1. BCG ulam (BKJHOLIBBLIA: AFIK

13a o6oco6euti no3uuuu MAI, 38 u 40, cpoxbm 3a u3nuatietitte ue cnedea Oa cmaptimpa no-pailo om 21.06.2018 2.

Page 4: KHTOBe - government.bg...2018/10/01  · Ha 1, T. 29a OT 3MM, 13bB Bp'b3Ka C 1 , T.4 OT AP Ha Hape,a6aTa, 3a BCAKa no3unill51/HomeHmaTypa, 3a KOATO ymaCTHHKBT 110)3(aBa 04)epTa. 3.1.2.

O

xH6pHAH3aulls1 B 1 Ha6op) OJIIWOHyKJIHOTH)114 3a no.rwmepa3Ha BepHwHapeaKuHB Tag noaHmepa3a H mem6paHH c reHcneuHciwum AFIK COHAN 3a nocsiezBaula

xH6pH4H3aLum B 1 Ha6op).https://www.hain-

lifescience.de/en/products/microbiology/mycobacteria/tuberculosis/genotype-mtbc.html

33.2

KHT 3a mariewsipHa aHarHocniKaHa AOHIJIHHTellHH mHHHmym 16BH,Ba aTHHHLIHH mllK06airreptm

(BKJIIONBaill: AFIKonHroHyx.rieoTHAH 3a narmmepa3HaBepH)KHa peaKuHA, Tag narnimepa3aH mem6paHH c reH cnewist•HquillAHK coH,BH 3a noc.ne,BBaniaxH6pH1maums1 B 1 Ha6op)

6port-rect.

192

GenoType Mycobacterium ASKa-r .PC2 29896

flpoH3Bonwren: HAIN-Lifescience

KHT 3a monexy.rimpHa ,aHarHocum Ha,a0H1AHHTCJIHH 16 BH,Ba aTHEIHHHH mHK06awrepHH

(BK.rllogBaul: Am( OJINFOHyKJIHOTHAN 3ano.rwmepa3Ha BepH)KHa peaKHHA Tag narifimepa3a H

mem6paHH c reH cnemict•HqHH /INK coH,BH 3anoc.nezeama xH6p1&B13aHHA B 1 Ha6op).

https://www.hain-lifescience.de/en/products/microbiology/mycobacte

ria/ntm/genotype-mycobacterium-as.html

GenoType Mycobacterium CMKa-r N2 29996

FIpoH3BoAHTen: HAIN-Lifescience

KHT 3a moneKy.risipHa AHarHoc-rHica Ha 13 BH,ziaBTHEHILIHN mHKo6atcrepHH, (BK.ruotiBaut: RHK01114r0HyKJ1HOTHAH 3a no.ruimepa3Ha BepH)KHapeaKHHA Tag nonHmepa3a N mem6paHH c reHcneuH4)HLIHH AHK coHim 3a nocneilBaula

xH6pHitH3aHH1 B 1 Ha6op).https://www.hain-

lifescience.de/en/products/microbiology/mycobacteria/ntm/genotype-mycobacterium-cm.html

33.3

KHT 3a mo.neKynmpHa ,aHarHomixaHa mHHHmym 13 BH,rla Hari- gecTocpeataHH KIIHHHNHO 31-IBLIHMHaTI4HWIHH mHKo6arrepHH OTKy.riTypa (BK.rnoimaut: AHK

ofiHroHym AeoTHH 3a narwmepamaBepH)KHa peaKumm, Tag nonHmepa3aH mem6paHH c reH cnew4w-uni,LIFIK coH,BH 3a noc.rie,BBatuaxH6pHAH3auHsi B 1 Ha6op)

6poilTeCT

288

33.4

KHT 3a marieKy.rulpHaJIHarliOCTHKBHa M. tuberculosis complex OT

6e.lo,apo6eu KJ114/1W-Iet1 ma-repHan HKy.riTypa c onpe,ge.runie

eimoripemeHno Ha pe3HcTeHTH0cTICbM Rifampicin H Isoniazid

(BKJI/O'IBBLIA: AHK011HrotiymeoTHArt 3a naimmepa3HaBepH)KHa peaKuHm,Tag narnimepa3aH mem6paHH c reH cnewisimiumAHK comp' 3a nocne,aBaulaxH6pHAH3aHHA B 1 Ha6op)

6portTeCT

960

GenoType Mycobacterium MTBDRplusKa-r .N2 30496A

FIpoH3Bo.aHTen: HAIN-Lifescience

KHT 3a moneKynsipHa AHarHocTHKa Ha M.tuberculosis Komn.rieKc OT 6e.no,apo6eH KJIHIIIILICHmaTepHan N Ky.Trypa c onpe,Befunie eAllovemeHnoHa pe3HCTeHTHOCT ICbM Rifampicin H lsoniazid

(BicruoqBaui: ,EIHK OJIHr011yK11e0THAN 3anar1Hmepa3Ha BepH)ffla peaKHHB,Tag no.r1Hmepa3a H

mem6paHH c reH cneuH4mgilH JIIHK coH,BH 3anoc.ne,BBaula xH6pH.aH3auHsi B 1 Ha6op)

https://www.hain-lifescience.de/en/products/microbiology/mycobacte

ria/tuberculosis/genotype-mtbdrplus.htmlGenoType Mycobacterium MTBDRsIver 2.0

Ka-r N2 31796A

flp0113110AHTCJI:IIAIN-Lifescience

KHT 3a monetcy.ruipHa ,aHarHocTnka Ha Mtuberculosis Komn.neKc OT 6eno,Bpo6eH KIIHHINCH

ma-repHan H Ky.riTypa c onpeAcrisnie Hape3HCTeHTHOCT KIM (i)J1y0p0XH110110FIN H/HJIH

AMHH0IJINKO3HAH/LINKJIH'INH nenTHAH(BKJIIONBBILI: AFIK wiHroHyKrieoTHAH 3a

nomimepa3Ha BempicHa peaKuHR,Taq narnimepa3a 14mem6paHH c reH cneu4H,-Hm AHK coHAH 3a

33.5

KHT 3a marieKynApHa AtiartiocniKaHa M. tuberculosis Komn.nexc OT

6e.rioApo6eH KJIHIllitleH maTepHan HKynTypa c onpe,aensme Ha

pe3HCTCHTHOCT ICbMOnyopoxH11011011H H/HJIH

AMH110r1INKO3H,EIH/LINKJIHNHI4nenTH,BH (B}uuotiBauu AFIK

omirollyKrieoTHAH 3a nomimepa3HaBeinpicHa peaKuHR,Tag no.ruimepa3aH mem6paHH c reH enam4:qv-1mi)LIFIK coKBH 3a noc.ne,BBaulaxH6pHA13auusis 1 Ha6op)

6portTeCT

192

Page 5: KHTOBe - government.bg...2018/10/01  · Ha 1, T. 29a OT 3MM, 13bB Bp'b3Ka C 1 , T.4 OT AP Ha Hape,a6aTa, 3a BCAKa no3unill51/HomeHmaTypa, 3a KOATO ymaCTHHKBT 110)3(aBa 04)epTa. 3.1.2.

/

noc.newmula xH6pH4H3auHR B 1 Ha6op)https://www.hain-

I i fescience.de/en/products/microbiology/mycobacteria/tuberculosis/genotype-mtbdrsl.html

33.6

KHT 3a mageKy.risipHa zmarHocTHKaHa M. avium complex, M abscessuscomplex H M chelonae OT KyyrrypaH onpe.ae.rimHe Ha pe3HCTeHTHOCT

ICEM maxpoRKBH Hat mHHOTJIHKO3Hail (BKJ1101Balli:

AHK OJIHrOHyK.TleOTHAH 3anomimepa3Ha Bepmfaia peaKum,

Tag narnimepa3a H mem6paHH c remcneutulmimmi ,E(FIK COHJIH 3a

nocne,aBaula xH6pHAH3auHRB 1Ha6op)

6poriTeCT

192

GenoType NTM-DR

KaT .1,C229796

11p0H3BOAHTell: HAIN-Lifescience

KHT 3a monexy.rimpHa ArtarnoutiKa Ha M. aviumcomplex, M abscessus complex H M chelonae OTKyirrypa H onpe.riensuie Ha pe3HCTeHTHOCT KIM

maxponH,BH H aMHHOTJIHKO3HAH (BKJ110413aLU: AFIKomiroHymeoTH4tH 3a no.rmimepama BepH)mapeaKuHm, Tag no.ruimepa3a H mem6paHH c rencneumcimimHH MAK coH,BH 3a noc.ne.aBaula

XH6pH2iH3a1.11131131 Ha6op)https://www.hain-

lifescience.de/en/products/microbiology/mycobacteria/ntm/genotype-ntm-dr.html

5. geKnapHpame, tie ce 3ano3HaTH, me meAHHHHcKHTe 113,11eRH5, 111411HHTe npe,ana3HH cpe,acTsa H

KOHCyMaTHBHTe clle,aBa oaa HmaT mHHHmaneH cpoK Ha rO,E1HOCT He no-masrbK OT 75% OT 06ABeHHA OT

npoH3Boa,HTe.rm KIM ,aaTaTa Ha BCAKa „ROCTaBKa.

6. geKnapHpame, B CAriar1 Ha dr_tocTainca Ha H3,L1eJ11,1A C 110-KpaTIK OT ,aoroaopeHHA cpoK Ha

rO,L1HOCT ce Lt1JDKH HeycTorma, KaKTO c.nea,Ba:

OT 74,99% ,ao 65,00% cpoK Ha roamocr — HeycToriKa 10% abpxy cToilHocTTa Ha ,aocTariKaTa;

OT 64,99% ,ao 50,00% cpoK Ha ro,aHocT — HeycTortKa 15% abpxy CTOAHOCTTa Ha AocTasKaTa;

7. AemapHpame, tie AocTaBKaTa Ha me,aHHHHcKHTe H34e.r11451, J1H4HHTe npe,ana3HH cpe,acTsa H

KOHCyMaTHBliTe C OCTaTILICH Cp0K Ha ro,a,Hocr no-masnA OT 50% ce H3B143111Ba camo c nHcmeHo cl.r.nacHe

OT BI3JIMICHTeJI5I, KaTO ce )11,J1)KH HeycTorma B pa3mep Ha 25% Bbpxy CTOrlHOCTra Ha ,aocTaBKaTa.

8. geKnapHpame, tie npe.a.riaraHHTe H3AellH5l ate npirrewasaT KIM momeuTa Ha LtocTasKa

cepTHitinKaT 3a KatleCTBO OT 11p0H3B0,E1HTeJ151, H3,aa,aeH 3a BCAKa oTitenHa napTH,aa HJ1H ,apyr aoKymeHT

yaocTosepsiBaui ,aaTaTa Ha 11p0H3BOACTBO

flptuunicemisc

• 041lluitamin ,E10KyMeHTH, 011HCaHHA H/11J1H 0430HUHal1HH KaTa110314 Ha npon3BoAnTerim/HTeHa Me,E1141.1HHCK0T0/HTe H3,11eJ1HA.Ytracmiruuume c.nedea da Mooam da doxaorcam cbomeemcmeuemo tra npednaeauume om

MRX CMOKU C U3UCK6OHURMCI Ha 67,3110.2lCUMeR5l.

• no o6oco6eHH 1103HUHH N2N2 1, 2, 3, 4, 5, 6, 7, 8, 25, 26, 27, 28 H 40 - mocTpa/H Hanpea.naraHHTe H3,Lten1451.

IloactrenuR:

17pedcmaaelfama mocmpa, ure 6bde non:walla 3a npoceptca Ha cbomaemcmauemo Ira otkepupwromo u3denire, c

U3UCK6OHU51Ma ira 6b3.11031CUMell9 HOCOLleHU a mexinmecKama cnetfircpwcatrug. Mocmpama mpa6aa da e o6o3trayetra

no 'faqir'', om KaiM0 da e audiro 3a KOR o6oco6etra no3uguR ce nodaaa, 'cam° u om KOU yqacmuux e npedcmaaeua.

Ilpu ouelixa Ira cbomaemcmaue Ira u3denuemo c U3UCK6OHURMa Ira Bb3.110MUMe.11R, Mbp006CKUR MK) HaMocmpama

lye 6bde napyureir.

RATA: 16.05.2018 r. HME, riogrivic