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V4ACB=VABL 4>:C<5=BV2, I> =5 ?5@5410G5=V 70:>=>402AB2>< 4;O CG0A=8:V2 - N@848G=8E, DV78G=8E >AV1, C B><C G8A;V DV78G=8E >AV1 - ?V4?@8T<FV2, C A:;04V B5=45@=>W ?@>?>78FVW =5 <>65 1CB8 ?V4AB02>N 4;O WW 2V4E8;5==O 70<>2=8:><. 5.#G0A=8:8 B>@3V2 =5@57845=B8 4;O 28:>=0==O 28<>3 I>4> ?>40==O 4>:C<5=BV2, ?5@5410G5=8E >40B:>< 1 4> B5=45@=>W 4>:C<5=B0FVW, ?>40NBL C A:;04V A2>TW ?@>?>78FVW, 4>:C<5=B8, ?5@5410G5=V 70:>=>402AB2>< :@0W=, 45 2>=8 70@5TAB@>20=V. 6./:I> 4>:C<5=B, I> 28<030TBLAO 70<>2=8:><, <VAB8BL V=D>@<0FVN, O:0 T ?C1;VG=>N, I> >?@8;N4=5=0 C D>@<V 2V4:@8B8E 40=8E 73V4=> V7  HYPERLINK "https://zakon.rada.gov.ua/laws/show/2939-17" \h 0:>=>< #:@0W=8 "@> 4>ABC? 4> ?C1;VG=>W V=D>@<0FVW" B0/01> <VAB8BLAO C 2V4:@8B8E T48=8E 45@602=8E @5TAB@0E, 4>ABC? 4> O:8E T 2V;L=8<, CG0A=8: =040T ;8AB-@>7 OA=5==O, 2 O:><C 707=0G0T, 45 <VAB8BLAO B0:0 V=D>@<0FVO. 7. $0:B ?>40==O B5=45@=>W ?@>?>78FVW CG0A=8:>< - DV78G=>N >A>1>N G8 DV78G=>N >A>1>N-?V4?@8T<F5<, O:0 T AC1 T:B>< ?5@A>=0;L=8E 40=8E, 22060TBLAO 157C<>2=>N 73>4>N AC1 T:B0 ?5@A>=0;L=8E 40=8E I>4> >1@>1:8 WW ?5@A>=0;L=8E 40=8E C 72 O7:C 7 CG0ABN 2 ?@>F54C@V 70:C?V2;V, 2V4?>2V4=> 4> 0170FC 4 AB0BBV 2 0:>=C #:@0W=8 @> 70E8AB ?5@A>=0;L=8E 40=8E 2V4 01.06.2010 ! 2297-VI. 8./:I> 28<>30 2 B5=45@=V9 4>:C<5=B0FVW 2AB0=>2;5=0 45:V;L:0 @07V2, CG0A=8:/?5@5<>65FL <>65 ?>40B8 =5>1EV4=89 4>:C<5=B 01> V=D>@<0FVN >48= @07. 9.$0:B>< ?>40==O B5=45@=>W ?@>?>78FVW CG0A=8: ?V4B25@46CT, I> C ?>?5@54=VE 2V4=>A8=0E <V6 #G0A=8:>< B0 0<>2=8:>< B0:C >?5@0B82=>-3>A?>40@AL:C/V A0=:FVN/W, ?5@5410G5=C/V ?C=:B>< 4 G0AB8=8 1 AB0BBV 236 #, O: 2V4<>20 2V4 2AB0=>2;5==O 3>A?>40@AL:8E 2V4=>A8= =0 <091CB=T, =5 1C;> 70AB>A>20=>*. @8<VB:0: *# @07V 70AB>AC20==O 707=0G5=>W A0=:FVW 0<>2=8: ?@89<0T @VH5==O ?@> 2V4<>2C CG0A=8:C 2 CG0ABV C ?@>F54C@V 70:C?V2;V B0 2V4E8;OT CG0A=8:0 O: B0:>3>, I> =5 2V4?>2V40T 2AB0=>2;5=8< HYPERLINK "https://zakon.rada.gov.ua/laws/show/922-19" \l "n1422" \h 0170F>< ?5@H8<G0AB8=8 B@5BL>W AB0BBV 22 0:>=C #:@0W=8 @> ?C1;VG=V 70:C?V2;V 28<>30< 4> CG0A=8:0 2V4?>2V4=> 4> 70:>=>402AB20. 10. "5=45@=0 ?@>?>78FVO CG0A=8:0 <>65 <VAB8B8 4>:C<5=B8 7 2>4O=8<8 7=0:0<8. 11. #G0A=8:8 ?@8 ?>40==V B5=45@=>W ?@>?>78FVW ?>28==V 2@0E>2C20B8 =>@<8 (2@0EC20==O< 22060TBLAO D0:B ?>40==O B5=45@=>W ?@>?>78FVW, I> CG0A=8: >7=09><;5=89 7 40=8< =>@<0<8 V WE =5 ?>@CHCT, 6>4=V >:@5<V ?V4B25@465==O =5 ?>B@V1=> ?>4020B8):  ?>AB0=>28 01V=5BC V=VAB@V2 #:@0W=8 @> 70157?5G5==O 70E8ABC =0FV>=0;L=8E V=B5@5AV2 70 <091CB=V<8 ?>7>20<8 45@6028 #:@0W=0 C 72 O7:C 7 2V9AL:>2>N 03@5AVTN >AV9AL:>W $545@0FVW 2V4 03.03.2022 ! 187, >A:V;L:8 70<>2=8: =5 <>65 28:>=C20B8 7>1>2 O70==O, :@548B>@0<8 70 O:8<8 T >AV9AL:0 $545@0FVO 01> >A>18, ?>2 O70=V 7 :@0W=>N-03@5A>@><, I> 287=0G5=V ?V4?C=:B>< 1 ?C=:BC 1 FVTW >AB0=>28;  ?>AB0=>28 01V=5BC V=VAB@V2 #:@0W=8 @> 70AB>AC20==O 701>@>=8 22575==O B>20@V2 7 >AV9AL:>W $545@0FVW 2V4 09.04.2022 ! 426, >A:V;L:8 FVTN ?>AB0=>2>N 701>@>=5=> 22575==O =0 <8B=C B5@8B>@VN #:@0W=8 2 <8B=><C @568<V V<?>@BC B>20@V2 7 >AV9AL:>W $545@0FVW;  0:>=C #:@0W=8 @> 70157?5G5==O ?@02 V A2>1>4 3@><04O= B0 ?@02>289 @568< =0 B8<G0A>2> >:C?>20=V9 B5@8B>@VW #:@0W=8 2V4 15.04.2014 ! 1207-VII..  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https://minre.gov.ua/" \t "_blank" https://minre.gov.ua/ 73V4=> 5@5;V:C. # @07V O:I> V=D>@<0FVO I>4> <VAF57=0E>465==O (<VAF5 ?@>6820==O) 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perfringensC?*0,5 :31!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 7 :>=B@>;5< 2V4:@8BBO; #?0:>2:0 - ?;0AB8:>289 :>=B59=5@ ?> 500 3; V4?>2V4=VABL AB0=40@B0< ISO, GMP B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV. =AB@C:FVO 45@602=>N <>2>N. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!.30@ !01C@> 7 3;N:>7>NC?*0,5 :31!CE89 ?@5?0@0B C 283;O4V 3@0=C;. @83V=0;L=0 702>4AL:0 C?0:>2:0 7 :>=B@>;5< 2V4:@8BBO; @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 500 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro 01> 4VNG0 45@602=0 @5TAB@0FVO 2 #:@0W=V. 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"5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!.>682=89 1C;L9>=C?*0,5 :318:>@8AB>2CTBLAO 4;O :C;LB82C20==O H8@>:>3> :>;0 <V:@>>@30=V7<V2. !CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 7 :>=B@>;5< 2V4:@8BBO; #?0:>2:0 - ?;0AB8:>289 :>=B59=5@ ?> 500 3; V4?>2V4=VABL AB0=40@B0< ISO, GMP B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV. VNG0 @5TAB@0FVO 2 #:@0W=V 01> 2V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro. =AB@C:FVO 45@602=>N <>2>N. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. V4:5 BV>3;V:>;525 A5@54>28I5C?*0,5 :31!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 500 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. 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VNG0 @5TAB@0FVO 2 #:@0W=V 01> 2V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro . =AB@C:FVO 45@602=>N <>2>N. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!!5@54>28I5 ;V3;5@0C?*0,5 :31!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 7 :>=B@>;5< 2V4:@8BBO; #?0:>2:0 - ?;0AB8:>289 :>=B59=5@ ?> 500 3; V4?>2V4=VABL AB0=40@B0< ISO, GMP B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV. VNG0 @5TAB@0FVO 2 #:@0W=V 01> 2V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro. =AB@C:FVO 45@602=>N <>2>N. 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"5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!&8B@0B=89 030@ @VAB5=A5=0C?*0,5 :31!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 7 :>=B@>;5< 2V4:@8BBO; #?0:>2:0 - ?;0AB8:>289 :>=B59=5@ ?> 500 3; V4?>2V4=VABL AB0=40@B0< ISO, GMP B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV. VNG0 @5TAB@0FVO 2 #:@0W=V 01> 2V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro. =AB@C:FVO 45@602=>N <>2>N. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!&8B@0B=89 030@ !V<<>=A0C?*0,5 :31!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 7 :>=B@>;5< 2V4:@8BBO; @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 500 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. 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VNG0 @5TAB@0FVO 2 #:@0W=V 01> 2V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro; =AB@C:FVO 45@602=>N <>2>N; "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2; 5@52V@5=89 B5AB-:C;LBC@0<8 "!!!5@54>28I5 0??0?>@B0-0A8;V04VA0, <>48DV:>20=89 C?*0,5 :31!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 500 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro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in vitro. =AB@C:FVO 45@602=>N <>2>N. "5@<V= 715@V30==O =5 <5=H5 12 <VAOFV2. "5<?5@0BC@0 715@V30==O: 2V4?>2V4=> 4> V=AB@C:FVW ?> 70AB>AC20==N. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!.01CD5@5=0 ?5?B>==0 2>40C?*0,5 :3101CD5@5=0 ?5?B>==0 2>40 A;C68BL A5@54>28I5< ?5@28==>3> 71030G5==O, O:5 28:>@8AB>2CNBL 4;O ?V428I5==O 28AV20T<>ABV ?>H:>465=8E A0;L<>=5; 7 E0@G>28E ?@>4C:BV2 (?5@54 A5;5:B82=8< 71030G5==O< V 284V;5==O<). 5:><5=4>20=0 <V6=0@>4=8< :><VB5B>< (ISO 6579: 1993). !CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C; #?0:>2:0 - ?;0AB8:>289 :>=B59=5@ ?> 500 3; @83V=0;L=0 702>4AL:0 C?0:>2:0 7 :>=B@>;5< 2V4:@8BBO; V4?>2V4=VABL AB0=40@B0< ISO, GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV; 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N; >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV. VNG0 @5TAB@0FVO 2 #:@0W=V 01> 2V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro; =AB@C:FVO 45@602=>N <>2>N; "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2; 5@52V@5=89 B5AB-:C;LBC@0<8 "!!;30@ 4;O V45=B8DV:0FVW ;VAB5@V9 (PALCAM)C?*0,5 :318:>@8AB>2CNBL 4;O A5;5:B82=>3> 284V;5==O B0 V45=B8DV:0FVW 284V2 Listeria. !CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C; @83V=0;L=0 702>4AL:0 C?0:>2:0 7 :>=B@>;5< 2V4:@8BBO; #?0:>2:0 - ?;0AB8:>289 :>=B59=5@ ?> 500 3; V4?>2V4=VABL AB0=40@B0< ISO, GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV; 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N; >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04><; VNG0 @5TAB@0FVO 2 #:@0W=V 01> 2V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro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in vitro; =AB@C:FVO 45@602=>N <>2>N; 5@52V@5=89 B5AB-:C;LBC@0<8 "!!;A=>20 :AD>@4AL:>3> A5@54>28I0 4;O ;VAB5@V9 C?*0,5 :31!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 7 :>=B@>;5< 2V4:@8BBO; #?0:>2:0 - ?;0AB8:>289 :>=B59=5@ ?> 500 3; V4?>2V4=VABL AB0=40@B0< ISO, GMP B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV. VNG0 @5TAB@0FVO 2 #:@0W=V 01> 2V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro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in vitro; =AB@C:FVO 45@602=>N <>2>N; 5@52V@5=89 B5AB-:C;LBC@0<8 "!!;A=>20 1C;L9>=C $@5975@0 C?*0,5 :31 5:><5=4CTBLAO :><VB5B>< ISO 4;O ?5@28==>3> V ?>2B>@=>3> 71030G5==O, 284V;5==O V ?V4@0EC=:C Listeria monocytogenes2 E0@G>28E ?@>4C:B0E V :>@<0E 4;O B20@8=. !CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C; @83V=0;L=0 702>4AL:0 C?0:>2:0; #?0:>2:0 - ?;0AB8:>289 :>=B59=5@ ?> 500 3; V4?>2V4=VABL AB0=40@B0< ISO, GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV;; 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N; >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV. VNG0 @5TAB@0FVO 2 #:@0W=V 01> 2V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro; =AB@C:FVO 45@602=>N <>2>N; "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2; 5@52V@5=89 B5AB-:C;LBC@0<8 "!!!5;5:B82=0 4>102:0 $@5975@0D;0:.10!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C G5@2>=C20B>-:>@8G=52>3> :>;L>@C; @83V=0;L=0 702>4AL:0 C?0:>2:0; #?0:>2:0 - ?> 5 D;; VAB8BL 22,5<3 AC<VHV 0=B81V>B8:V2 C D;0:>=V: :@8D;02V= 3V4@>E;>@84 - 12,500<3 0;V48:A>20 :8A;>B0 - 10,0 <3 V4?>2V4=VABL AB0=40@B0< ISO, GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV; 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N; >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV. VNG0 @5TAB@0FVO 2 #:@0W=V 01> 2V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro; =AB@C:FVO 45@602=>N <>2>N; 5@52V@5=89 B5AB-:C;LBC@0<8 "!!; =AB@C:FVO 45@602=>N <>2>N; 5@52V@5=89 B5AB-:C;LBC@0<8 "!!;>102:0 $@5975@0D;0:.10 5:><5=4CTBLAO <V6=0@>4=8< :><VB5B>< ISO 4;O A5;5:B82=>3> 284V;5==O V ?V4@0EC=:C Listeria monocytogenes 7 E0@G>28E ?@>4C:BV2, :>@<V2 4;O B20@8= V V=H>3> <0B5@V0;C. !CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C 75;5=>3> :>;L>@C. 0:C20==O - ?> 10 D;. 1 D;./250 <3 F8B@0B0 70;V70. V4?>2V4=VABL AB0=40@B0< ISO, GMP B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N, 7@07>: 5B8:5B:8. !5@B8DV:0B8 0=0;V7C B0 O:>ABV (>@83V=0; B0 ?5@5:;04); VNG0 @5TAB@0FVO 2 #:@0W=V 01> 2V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro. =AB@C:FVO 45@602=>N <>2>N. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 30@-030@, 10:B5@V>;>3VG=89C?*0,5 :32!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C;. #?0:>2:0 - ?;0AB8:>289 :>=B59=5@ ?> 5003; @83V=0;L=0 702>4AL:0 C?0:>2:0, =5?5@5D0A>20=89; V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N, 7@07>: 5B8:5B:8. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro 01> 4VNG0 45@602=0 @5TAB@0FVO 2 #:@0W=V.@V646>289 5:AB@0:B, ACE89C?*0,5 :31!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 500 3 7 :>=B@>;5< 2V4:@8BBO. "5@<V= ?@840B=>ABV  =5 <5=H5 4 @>:V2 7 40B8 283>B>2;5==O. V4?>2V4=VABL AB0=40@B0< ISO, GMP 01> WHO GMP, B0 C:@0W=AL:8< AB0=40@B0< O:>ABV. 5@52V@5=89 B5AB-:C;LBC@0<8 "!!. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 45@602=>N <>2>N. >?VO A5@B8DV:0BC 0=0;V7C B0 O:>ABV 7 ?5@5:;04>< 45@602=>N <>2>N. =AB@C:FVO 45@602=>N <>2>N. V4?>2V4=VABL "5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro 01> 4VNG0 45@602=0 @5TAB@0FVO 2 #:@0W=V.A=>20 :>;C<1V9A:>3> :@>2'O=>3> 030@CC?*0,5 :33!CE89 ?@5?0@0B C 283;O4V 3><>35==>3> A8?CG>3> ?>@>H:C. @83V=0;L=0 702>4AL:0 C?0:>2:0 7 :>=B@>;5< 2V4:@8BBO; @83V=0;L=0 702>4AL:0 C?0:>2:0 ?;0AB8:>289 :>=B59=5@ ?> 500 3 7 :>=B@>;5< 2V4:@8BBO. 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