Ministerial Decree No. 839 validating the Regulation “On state registration of genetically modified organisms destined for release into environment, and also produce obtained from or containing such organisms

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ITpo,n;yKIJ;M51 110,IJ;Jie)KMT rocy,n;apCTBeHHOH perMCTpau;MM TOJibKO IIOCJie rocy,n;apCTBeHHOM per11crpau;1111 MO,IJ;M~MIJ;HpOBaHHbIX opraHM3MOB, C 11p11MeHeH11eM KOTOpbIX OHa 11011y1IeHa 11 (111111) KOTOpoie OHa co,n;ep)K11T, M MO)KeT MCIIOJib30BaTbC51 TOJibKO B Tex u;e1151X, ,IJ;JI51 KOTOpbIX 3aper11crp11poBaHbI 3Tl1 MO,IJ;M~MIJ;HpOBaHHble opraHM3Mbl. 19. )];1151 rocy,n;apCTBeHHOH per11crpau;1111 11po,n;yKIJ;MM IOpH,IJ;MIIeCKOe JIMIJ;O, ocyru;ecTBJI51IOIIJ;ee M3rOTOBJieHMe (IIOCTaBKy) 11po,z:i;yKIJ;MM (,n;anee B HaCT051IIJ;eM pa3,n;erre - 3a51BMTeJib ), 11pe,n;cTaBJI51eT B perMcTpHpYIQru;Mtt opraH Ha 6yMa)KHOM HOCMTerre MJIM B ~OpMe 3JieKTpOHHOro ,[(OKyMeHTa, 110,IJ;IIMCaHHOro ycMJieHHOH KBaJIM~MIJ;HpoBaHHOM 311eKTpOHHOM 110,IJ;IIMCbIO, B TOM 1IMC11e C MCIIOJib30BaHMeM ~e,n;epanoHOH rocy,n;apCTBeHHOM MH~OpMaIJ;MOHHOH CMCTeMbI "E,n;MHbIM IIOpTan rocy,n;apCTBeHHbIX M MYHMIJ;MllaJibHbIX ycrryr ( ~YHKIJ;Htt)": a) 3a51BJieHMe O rocy,n;apCTBeHHOH perMCTpau;MM 11po,n;yKIJ;MM, KOTopoe O~OpMmieTC51 Ha pyccKOM 513bIKe M co,n;ep)KHT crre,z:i;y10ru;11e CBe,[(eHM51: IIOJIHOe HaMMeHOBaHMe M MeCTOHaXO)K,IJ;eHMe 3a51BMTeJI5I; perMCTpau;MOHHbIM HOMep CBM,IJ;eTeJibCTBa O rocy,n;apcTBeHHOH perMCTpau;1111 M0,[(11~11IJ;HpoBaHHOro opraHM3Ma ( opraHl13MOB ), C 11p11MeHeHMeM KOTOporo IIOJiyqeHa perMCTpHpyeMa51 11po,n;yKIJ;M51 MJIM KOTOpbIM OHa co,n;ep)KHT; KOMIIOHeHTHbIM COCTaB 11po,n;yKIJ;Ml1, BKJII01Ia51 MH~OpMau;1110 0 KOJIMIIeCTBe MO,IJ;M~Mu;MpoBaHHOro opraHM3Ma ( opraHM3MOB ), 11p11cyTCTBy10ru;ero B 11po,n;yKIJ;MM; CBe,z:i;eHM51 0 perMCTpau;MM 11po,z:i;yKIJ;MM 3a py6e)KOM (11p11 HaJIM"tJHH); 6) 3aKJII0"4:eHMe o pe3yrroTaTax MOJieKyrr51pHo-reHeTMIIecKoro MCCJie,IJ;OBaHM51, 11pe,z:i;ycMOTpeHHOe a63au;eM BTOpbIM 110.IJ:IIYHKTa "6" IIYHKTa 12 HaCT051IIJ;HX ITpaBM11, B IIaCTM IIO,[(TBep)K,[(eHM51 11p11cyTCTBM51 B per11crp11pyeMOH 11po,n:yKIJ;l1M 3a51B11eHHOro M0,[(11~MIJ;11pOBaHHOro opraHH3Ma ( opraHM3MOB ). 2156612.doc 8 20. Pen1cTp11pyIOmJ1ii opraH: a) B cpoK, He ITpeBhlll]aIOII];J1H 30 ,nHeii co .I1:H51 ITOJiyqeHl151 yKa3aHHhIX B ITYHKTe 19 HaCT05IID;l1X IIpaB11JI ,noKyMeHTOB: ITpOBO.Il:11T ITpOBepKy co,nep)KaID;l1XC51 B Hl1X CBe,neH11ii; ITp11H11MaeT peruett11e o rocy,napcTBeHHoii per11cTpau;1111 ITpo,nyKu;1111 11 11HcpopM11pyeT 3a51Bl1TeJI51 o ITp11H51T1111 TaKoro perueH115I; ITp11H11MaeT peruett11e 06 OTKa3e B rocy,napcTBeHHOH per11cTpau;1111 ITpo,nyKU:1111 11 HaITpaBJI51eT 3a51Bl1TeJIIO MOTl1B11pOBaHHhIH OTKa3 B rocy,napcTBeHHOH per11crpau;1111 ITpo,nyKu;1111; 6) B TeLJeH11e 15 ,nHeii co .I1:H51 ITPl1H51Tl151 perueHl151 0 rocy,napCTBeHHOH per11cTpau;1111 ITpo,nyKu;1111: BHOCl1T l1Hq:>OpMau;11IO O ITpo,nyKU:1111 B CBO.Il:HhIH peecTp C ITp11CBOeHl1eM per11cTpau;110Httoro HOMepa; Bhl,naeT 3a51Bl1TeJIIO CB11,neTeJihCTBO O rocy,napcTBeHHOH per11crpau;1111 ITpo,nyKu;1111, co,nep)Kaiu;ee per11cTpau;110HHhIH HOMep 11 cITeu;11anoH0Ie ycnoB1151 11CITOJih30BaH1151 (ITp11 HaJil1LJ1111), Ha 6yMa)KHOM HOCl1TeJie 11Jil1 B cpopMe 3JieKTpOHHOro ,noKyMeHTa ITO Bo16opy 3a51Bl1TeJI51. 21. B rocy,napcTBeHHOH per11cTpau;1111 ITPO.Il:YKU:1111 MO)KeT 6o1Tb OTKa3aHO B cJiyqae Heco6JIIO,neHl151 Tpe6oBaHl1H, YKa3aHHhIX B ITYHKTe 19 HaCT051ID;l1X I1paB11JI. IV. Be,neH11e cBo,nHoro peecTpa 22. CBo,nHoIH peecTp Be,neTc51 M11tt11cTepcTBOM 3,npaBooxpatteH1151 Pocc11iicKoii <I>e,nepau:1111 B 3JieKrpOHHOM B11,ne c co6nIO,nett11eM Tpe60Batt11ii, ycTaHOBJieHHblX 3aKOHo,naTeJioCTBOM Pocc11HCKOH <I>e,nepau:1111 06 l1Hq:>OpMau;1111, l1Hq:>OpMau;110HHhIX TeXHOJIOrl151X 11 0 3aID;l1Te l1Hq:>OpMau;1111. CooTBeTCTBYIOID;a51 l1Hq:>OpMau;1151 BHOCl1TC51 B CBO.Il:HhIH peecTp per11cTp11pyIOID;l1Ml1 opraHaMl1 B ITOp51,nKe, OITpe,neJI51eMOM M11Hl1CTepCTBOM 3,npaBooxpaHeHirn Pocc11iicKoii <I>e,n:epaIJ;i,111 ITO cornacoBaHMIO c M11tt11cTepcTBOM CB51311 11 MaccoBoIX KOMMYHMKau;11ii Pocc11iicKoii <I>e,nepau:1111, M11H11cTepcTBOM o6pa30BaH1151 11 HayK11 Pocc11iicKoii <I>e,nepau;1111, M11tt11cTepcTBOM cenocKoro X0351HCTBa Pocc11iicKoii <I>e,nepau:1111 11 <I>e,nepanoHoii cny)K6oii ITO Ha,n3opy B ccpepe 3aiu;11ThI ITpaB ITorpe611Teneii 11 6naroITonyq1151 qenoBeKa. 23. CBo,nHoIH peecrp BKJIIOLJaeT: peecTp MO,n11cp11u;11poBaHHhIX opraHl13MOB; peecrp ITpo,nyKu;1111. 2156612.doc 9 24. PeecTp MO,n;Hqrn:IJJipoBaHHblX opraHH3M0B co,n;ep)l{HT CJie,n;yIOru;yIO HH<pOpMal(HIO: a) perHCTpal(HOHHbIH H0Mep M HaHMeH0BaHHe MO,D;H<pHI(HpOBaHHOro opraHH3Ma C yKa3aHHeM ero TaKC0H0MHqecKoro CTaTyca M CBe,n;eHHH 0 TpaHC<pOpMal(HOHHOM co6hITHH (xapaKTepHCTHKH reHen1qecKOH MO,D;H<pHKal(HH) B BH,n;e K0,n;a, ccpopMHpOBaHHOro corJiaCH0 O6ru:epoccHHCKOMy KJiaCCH<pHKaTopy TpaHccpopMal(HOHHblX co6bITHH; 6) II0JIH0e HaHMeH0BaHHe M MeCT0HaX0)l{,D;eHHe 3a5IBHTem1, YKa3aHH0ro B pa3,n;eJie II HaCT05Iill;HX IlpaBHJI, M H3r0T0BHTeJI51 MO,D;H<pHI(HpOBaHHOro opraHH3Ma; B) CBe,n;eHH:51 0 BH,n;e (BH,n;ax) l(eJieBoro HCII0Jib30BaHH51 MO,D;H<pHI(HpOBaHHOro opraHH3Ma M ycTaH0BJieHHblX crrel(HaJibHbIX ycJI0BHXX HCII0Jib30BaHHX (rrpH HaJI0:q0:11); r) CBe,n;eHH51 0 rrpoBe,n;eHHbIX 3KCIIepTH3aX (11ccJie,n;oBaHH5IX), a TaK)l{e 06 ycTaH0BJieHHblX crrel(HaJibHbIX ycJI0BH5IX HCII0Jib30BaHH51 (rrpH HaJI11q0:0:); ,n;) CBe,n;eHH51 06 opraHH3al(H5IX (HCilbITaTeJibHbIX Jia6opaTop0:xx), rrp0B0,D;HBillHX 3KCIIepTH3bl ( HCCJie,n;oBaHH51 ); e) CBe,n;eHH:51 06 aHHYJIHp0BaHHH CBH,n;eTeJibCTBa 0 rocy,n;apcTBeHHOH perHCTpal(HH MO,D;H<pHI(HpoBaHHOro opraHH3Ma. 25. PeecTp rrpo,n;yKI(HH co,n;ep)l{HT CJie,n;yIOru:yIO HH<pOpMal(HIO: a) perHCTpal(HOHHblH H0Mep M HaHMeH0BaHHe rrpo,n;yKI(HH; 6) per11crpal(HOHHblH H0Mep MO,D;H<pHI(HpOBaHHOro opraHH3Ma ( opraHH3MOB), C rrpHMeHeHHeM K0T0poro II0JiyqeHa M (HJIH) KOTOpbIH co,n;ep)l{HT rrpo,n;yKu11x; B) II0JIH0e HaHMeH0BaHHe M MeCT0HaX0)l{,D;eHHe 3a5IBHTeJI51, YKa3aHH0r0 B pa3,n;ene III HacToxru:11:x IlpaBHJI; r) CBe,n;eHH51 06 ycTaH0BJieHHblX CIIel(HaJibHblX ycJI0BH5IX HCII0Jib30BaHH51 (rrpH HaJIHqHH); ,n;) CBe,n;eHH51 06 aHHYJIHp0BaHHH CBH,D;eTeJibCTBa 0 rocy,n;apCTBeHHOH perHCTpal(HH rrpo,n;yKI(HH. 26. I1H<pOpMal(H51, co,n;ep)l{aru:axcx B CB0,D;H0M peecTpe, 5IBJI5IeTCX OTKpbITOH M 06ru:e,n;ocTyIIHOH ,D;JI51 03HaK0MJieHH51 C Hett <pH3HqecKHX M IOp11,n;11qecKHX JIHI( M pa3Meru:aeTCX Ha O<pHI(HaJibHOM cattTe MHHHCTepCTBa 3,n;paBooxpaHeHH51 PocCHHCKOH <l>e,n;epal(HH B HH<pOpMal(HOHHO­ TeJieKOMMYHHKal(HOHHOH ceTH "I1HTepHeT". 27. PerHCTpHpyIOru:He opraHbl pa3Meru:aIOT Ha CB0HX O<pHI(HaJibHblX cattTax B HH<pOpMal(HOHHO-TeJieKOMMYHHKal(HOHHOH ceTH "HHTepHeT"' a TaK)l{e 21566 I 2.doc 10 B cpe,n:epanbHOH rocy,n:apcTBeHHOH HH<popMaU:HOHHOH cHcTeMe "E,n:HHbIH rropTaJI rocy ,n:apCTBeHHbIX If MYHHU:lfIIaJibHbIX ycnyr ( cpyHKU:lfH)": a) HH<popMau:mo 0 3aperHCTpHp0BaHHbIX HMM MO,D:lf<pHU:HpoBaHHblX opraHH3Max, co,n:ep)Kamy10c51 B peecTpe MO,n:H<pHU:HpoBaHHhIX opraHH3MOB (HaHMeHOBaHHe MO,D:lf<pHU:HpOBaHHOro opraHH3Ma If ero TpattccpopMaU:HOHHOe co6bITHe, Blf,D:bl u:eneBoro lfCIIOJib30BaHH51 MO,D:H<plfU:HpOBaHHoro opraHH3Ma, CBe,n:eHH51 0 crreu;HaJibHbIX ycJIOBlf5IX lfCIIOJib30BaHH51, 06 aHHYJIHpOBaHJflf CBH,n:eTeJibCTBa 0 rocy,n:apCTBeHHOH perHCTpaU:HH MO,D:lf<pHU:HPOBaHHOro opraHH3Ma ); 6) lfH<pOpMaU:HIO O 3aperHCTpHpOBaHHOM HMM npo,n:yKU:lflf, co,n:ep)KaIIJ;yIOCR B peecTpe npo,n:yKU:HH ( ttaHMeHoBaHHe npo,n:yKU:HH, MO,D:H<pHU:HpOBaHHbIH opraHH3M ( opraHH3MbI), C npHMeHeHHeM K0Toporo rrony1IeHa npo,n:yKU:lf51 If (HJIH) KOTOpbIH co,n:ep)KHT npo,n:yKU:H51, perHCTpaU:HOHHbIH H0Mep TaKoro MO,D:lf<pHU:HpOBaHHOro opraHH3Ma ( opraHH3MOB ), CBe,n:eHH51 0 cneu;HaJibHblX ycJIOBH51X lfCilOJib30BaHH51, 06 aHHYJIHp0BaHHlf CBH,n:eTeJibCTBa 0 rocy,n:apCTBeHHOH perHCTpau;HH npo,n:yKu:1,rn); B) nepe1IHH opraHH3aU:HH (HCilbITaTeJibHbIX na6opaTOpHtt), npOBO,D:5IIIJ;lfX C00TBeTCTBYIOIIJ;He 3KCnepTH3bl ( lfCCJie,n:oBaHH51 ), HX MeCT0HaX0)K,D:eHHe If TeJie<pOHbI; r) MeTO,D:lfKlf ( lfCCJie,n:oBaHHH ); rrp0H3B0,D:CTBa C00TBeTCTBYIOIUHX 3KCIIepTH3 ,n:) nopR,n:0K ocymecTBJieHH51 M0HHT0pHHra B03,D:eHCTBH51 Ha 1.JenoBeKa If 0Kpy)KaIOrn;y10 cpe,n:y reHHO-lfH)KeHepHO-MO,D:lf<pHU:HpOBaHHbIX opraHH3M0B If rrpo,n:yKU:lflf, nony1IeHHOH C npHMeHeHHeM TaKHX opraHH3M0B HJIH co,n:ep)Karn;ett TaKHe opraHH3Mbl. 2156612.doc