kosmetik_4mac
TRANSCRIPT
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KAWALAN KOSMETIK DIKAWALAN KOSMETIK DI
MALAYSIAMALAYSIA
ZURAIDA BT ABDULLAHZURAIDA BT ABDULLAHPusat Pasca Pendaftaran ProduPusat Pasca Pendaftaran Produ
B!ro Pen"a#a$an %ar&aseut!a$ Ke'an"saanB!ro Pen"a#a$an %ar&aseut!a$ Ke'an"saan
Ke&enter!an Kes!(atan Ma$a)s!aKe&enter!an Kes!(atan Ma$a)s!a
Pro"ra& Pen!n"atan Kua$!t! Produ Her'a %RIM * Me+DPro"ra& Pen!n"atan Kua$!t! Produ Her'a %RIM * Me+D
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Kandun"anKandun"an
De,n!s! - .en"e$asan os&et!De,n!s! - .en"e$asan os&et! Pr!ns!. dan e.er$uan a#a$an os&et!Pr!ns!. dan e.er$uan a#a$an os&et! %aeda(%aeda( Prosedur Not!,as!Prosedur Not!,as!
Tan""un"/a#a' s)ar!atTan""un"/a#a' s)ar!at Peranan .!(a re"u$ator!Peranan .!(a re"u$ator! Pro"ra& .e&antauan .rodu d! .asaran 0PMS1Pro"ra& .e&antauan .rodu d! .asaran 0PMS1 S!ste& (ar&on!sas! os&et!S!ste& (ar&on!sas! os&et! Ba(an*'a(an d! da$a& for&u$as! os&et!Ba(an*'a(an d! da$a& for&u$as! os&et!
Ke.er$uan .e$a'e$an - conto( $a'e$Ke.er$uan .e$a'e$an - conto( $a'e$ Tuntutan os&et!Tuntutan os&et! Ke.er$uan A&a$an Per!$an"an Ba! 0APB1Ke.er$uan A&a$an Per!$an"an Ba! 0APB1 +a'aran*ca'aran .rosedur not!,as!+a'aran*ca'aran .rosedur not!,as!
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De,n!s! * KOSMETIKDe,n!s! * KOSMETIK
Produ os&et! 'er&asudProdu os&et! 'er&asud22
3 A.a*a.aA.a*a.a 'a(an atau .ersed!aan )an" d!cadan"'a(an atau .ersed!aan )an" d!cadan"untu d!"unaan atau d!ataan se'a"a! 'o$e(untu d!"unaan atau d!ataan se'a"a! 'o$e(
d!"unaan e atasd!"unaan e atas 'e'era.a 'a(a"!an $uaran'e'era.a 'a(a"!an $uarantu'u( 'adan &anus!atu'u( 'adan &anus!a00e.!der&!s4 s!ste&e.!der&!s4 s!ste&ra&'ut4 uu4 '!'!r4 or"an "en!ta$ $uaranra&'ut4 uu4 '!'!r4 or"an "en!ta$ $uarand$$1d$$1atau e atasatau e atas"!"!"!"! dandan&e&'ran &uosa d! da$a&&e&'ran &uosa d! da$a&ron""a &u$utron""a &u$ut4 'a"! &e&'ers!(4 &e#an"!44 'a"! &e&'ers!(4 &e#an"!4
&e&.er'a!!5 &en"u'a( atau &encant!an&e&.er'a!!5 &en"u'a( atau &encant!anu$!t &ua dan 5atau &en"(!$an"an 'au 'adan4u$!t &ua dan 5atau &en"(!$an"an 'au 'adan4dan 5atau &en"(!ndar atau &en/a"a da$a&dan 5atau &en"(!ndar atau &en/a"a da$a&eadaan )an" 'a!6eadaan )an" 'a!6
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De,n!s!De,n!s!
Untu d!"una .ada 'a(a"!an $uar 'adanUntu d!"una .ada 'a(a"!an $uar 'adanse.ert!7se.ert!7
** e.!der&!s 0u$!t1e.!der&!s 0u$!t1
* ra&'ut* ra&'ut* uu* uu
* '!'!r* '!'!r
* or"an "en!ta$ $uaran* or"an "en!ta$ $uaran* "!"!* "!"!
* d! da$a& ron""a &u$ut* d! da$a& ron""a &u$ut
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%un"s!%un"s! Me#an"!Me#an"! 00to perfumeto perfume11
Me&.er'a!!5Me&.er'a!!5&en"u'a( atau&en"u'a( atau&encant!an&encant!an 00 totochange thechange theappearanceappearance11
Me&'ers!(Me&'ers!( 00to cleanto clean11
Men"(!ndarMen"(!ndar 00to protectto protect11
Men"(!$an"an 'auMen"(!$an"an 'au'adan'adan 00to correct bodyto correct bodyodoursodours11
Men/a"a da$a&Men/a"a da$a&eadaan 'a!eadaan 'a! 00to keepto keepin good conditionin good condition11
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Pen"e$asan ProduPen"e$asan Produ
Kos&et!Kos&et! Kate"or! IKate"or! I
3 Produ 'er.otens! untu d!te$an atau &eresa.Produ 'er.otens! untu d!te$an atau &eresa.
&asu e da$a& s!ste& dara( &e$a$u! u$!t&asu e da$a& s!ste& dara( &e$a$u! u$!tatau &e&'ran &uosa6atau &e&'ran &uosa6
Produ untu &ata 0ecua$! untu e"unaanProdu untu &ata 0ecua$! untu e"unaanen!n"1en!n"1
Produ untu '!'!rProdu untu '!'!r
Produ untu ron""a &u$utProdu untu ron""a &u$ut
Pe#arna ra&'utPe#arna ra&'ut
Sun tanningSun tanning55 sun-blocksun-block
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Pen"e$asan Produ Kos&et!Pen"e$asan Produ Kos&et!
Kate"or! IIKate"or! II
3 Produ*.rodu )an" t!da terta$u d!Produ*.rodu )an" t!da terta$u d!
'a#a( ate"or! I'a#a( ate"or! I
M!sa$n)a 2M!sa$n)a 2
3 Kr!& .e$e&'a'4 ceca!r 5 $os)en .encuc! &ua d$$6Kr!& .e$e&'a'4 ceca!r 5 $os)en .encuc! &ua d$$6
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ProduProdu External Personal CareExternal Personal Care0EP+10EP+1
Produ*.roduProdu*.rodu External Personal CareExternal Personal Care0EP+10EP+1
D!e$asan se'a"a! .rodu os&et!D!e$asan se'a"a! .rodu os&et!
*se$aras den"an ne"ara*ne"ara ASEAN $a!n*se$aras den"an ne"ara*ne"ara ASEAN $a!n
e"7 Ant!dandru9e"7 Ant!dandru9
Ant!acneAnt!acne
Ant!'acter!a$Ant!'acter!a$
Ant!*.$a:ue5ant!*ca;!t) d$$Ant!*.$a:ue5ant!*ca;!t) d$$
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Pr!ns!.Pr!ns!.
P!(aP!(a Industr!Industr!ada$a(ada$a( 'ertan""un"/a#a''ertan""un"/a#a'e atase atasese$a&atan ua$!t! danese$a&atan ua$!t! danperformanceperformanceatau e,as!atau e,as!Produ Kos&et!6Produ Kos&et!6
A"ens! era/aanA"ens! era/aand!'er! &andat dan uasa untud!'er! &andat dan uasa untu&enda.atan &a$u&at dar! .e&o(on dan&enda.atan &a$u&at dar! .e&o(on dan&en/a$anan .e&er!saan &en"!ut A&a$an&en/a$anan .e&er!saan &en"!ut A&a$anPer!$an"an Ba! d! .re&!s .en"!$an" dan d!'er!Per!$an"an Ba! d! .re&!s .en"!$an" dan d!'er!&andat untu &e&antau Produ Kos&et! d!&andat untu &e&antau Produ Kos&et! d!
.asaran6
.asaran6
Pen""unaPen""una.er$u d!'er!an &a$u&at )an" cuu. dan.er$u d!'er!an &a$u&at )an" cuu. dan$en"a. untu &e&'uat .!$!(an )an" '!/a 0$en"a. untu &e&'uat .!$!(an )an" '!/a 0 informedinformedchoicechoice1 serta cara .en""unaan )an" 'etu$61 serta cara .en""unaan )an" 'etu$6
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Kena.a .er$un)a a#a$anKena.a .er$un)a a#a$an
os&et!
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%aeda( e.ada !ndustr!%aeda( e.ada !ndustr!
Me&.erce.atan .roses .e$ancaranMe&.erce.atan .roses .e$ancaransesuatu .rodu6sesuatu .rodu6
Prosedur .en"a#a$an )an" &uda(6Prosedur .en"a#a$an )an" &uda(6
Men"(adan 'er$e$uasan)a .rodu*.roduMen"(adan 'er$e$uasan)a .rodu*.rodu)an" uran" 'erua$!t! d! .asaran6)an" uran" 'erua$!t! d! .asaran6
Mera.atan (u'un"an den"anMera.atan (u'un"an den"an Regulator.Regulator.
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%aeda( e.ada .!(a%aeda( e.ada .!(a
re"u$ator!re"u$ator! Mean!s&e .en"a#a$an )an" &encuu.!Mean!s&e .en"a#a$an )an" &encuu.!
dan 'eresan untu e.ent!n"an .en""una6dan 'eresan untu e.ent!n"an .en""una6
Infor&as! )an" d!.er$uan untuInfor&as! )an" d!.er$uan untu&en/a$anan at!;!t! sur;e!$ans )an"&en/a$anan at!;!t! sur;e!$ans )an"
'eresan6'eresan6
Mera.atan (u'un"an den"an .!(aMera.atan (u'un"an den"an .!(a
!ndustr!6!ndustr!6
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%aeda( e.ada .en""una%aeda( e.ada .en""una
Me&ast!an .rodu os&et! ada$a(Me&ast!an .rodu os&et! ada$a(
se$a&at6se$a&at6
Me&.ero$e(! &a$u&at secara ce.atMe&.ero$e(! &a$u&at secara ce.atter(ada. .rodu 3.rodu 'aru dan !no;at!f6ter(ada. .rodu 3.rodu 'aru dan !no;at!f6
Me&ast!an .en""una da.at &e&'uatMe&ast!an .en""una da.at &e&'uat
.!$!(an '!/a.!$!(an '!/a00informed choiceinformed choice1 se&asa1 se&asa
&enentuan os&et! )an" sesua! untu&enentuan os&et! )an" sesua! untu
&erea6&erea6
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Kese$a&atan Produ Kos&et!Kese$a&atan Produ Kos&et! Asas*asas ese$a&atan2Asas*asas ese$a&atan2
3 T!da &en"a!'atan e&udaratan e.ada es!(atanT!da &en"a!'atan e&udaratan e.ada es!(atana.a'!$a d!"unaan secara 'etu$6a.a'!$a d!"unaan secara 'etu$6
3 Pen"!$an" .er$u &en"u&.u$an &a$u&at ten!a$Pen"!$an" .er$u &en"u&.u$an &a$u&at ten!a$
'era!tan .rodu )an" d! !$an"6'era!tan .rodu )an" d! !$an"6
3 Ko&.onen 'a(an &enta( dan .rodu s!a. .er$u d!n!$a!Ko&.onen 'a(an &enta( dan .rodu s!a. .er$u d!n!$a!dar! as.e ese$a&atan6dar! as.e ese$a&atan6
3 Produ d!(as!$an &e&atu(! e.er$uan APB6Produ d!(as!$an &e&atu(! e.er$uan APB6
3 Data*data ese$a&atan .er$u d!sed!aan6Data*data ese$a&atan .er$u d!sed!aan6
3 Me&atu(! e.er$uan .e$a'e$an6Me&atu(! e.er$uan .e$a'e$an6
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Per$asanaan Peraturan*.eraturanPer$asanaan Peraturan*.eraturan
Ka#a$an Dada( Dan Kos&et! =>?@Ka#a$an Dada( Dan Kos&et! =>?@
FasaFasa Jenis ProdukJenis Produk KuatkuasaKuatkuasa PelesenanPelesenan
%asa =%asa = Pendaftaran .rodu )" &en"andun"!Pendaftaran .rodu )" &en"andun"!Racun Ber/adua$Racun Ber/adua$
= No;e&'er= No;e&'er=>?=>?
= Me! =>?= Me! =>?
%asa C%asa C Pendaftaran Produ Buan RacunPendaftaran Produ Buan Racun = O"os =>??= O"os =>?? = anuar! =>>C= anuar! =>>C
%asa %asa Pendaftaran Produ Trad!s!ona$Pendaftaran Produ Trad!s!ona$ = anuar! =>>C= anuar! =>>C = anuar! =>>>= anuar! =>>>
%asa @%asa @ Pendaftaran Produ Kos&et!Pendaftaran Produ Kos&et!
0te$a( d!$asanaan secara0te$a( d!$asanaan secara'er.er!n"at 1'er.er!n"at 1
!6 Pe#arna ra&'ut!6 Pe#arna ra&'ut
0P(en)$ened!a&!ne50P(en)$ened!a&!ne5
To$uened!a&!ne1To$uened!a&!ne1
!!6 Produ .e&ut!( "!"!!!6 Produ .e&ut!( "!"!
= %e'ruar! CFFC= %e'ruar! CFFC
= un =>>== un =>>=
= %e'ruar! =>>G= %e'ruar! =>>G
= anuar! CFF@= anuar! CFF@
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Prosedur PendaftaranProsedur Pendaftaran
Se(!n""a = D!se&'er CFFSe(!n""a = D!se&'er CFF
3PendaftaranPendaftaran 0 = %e'ruar! CFFC10 = %e'ruar! CFFC1
3 Pe$esenan 0= anuar! CFF@1Pe$esenan 0= anuar! CFF@1
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Prosedur Not!,as!Prosedur Not!,as!
Mu$a! = anuar! CFF?Mu$a! = anuar! CFF?3 Se$aras den"an .ersetu/uan )an" d!ca.a! o$e(Se$aras den"an .ersetu/uan )an" d!ca.a! o$e(
se&ua an""ota ne"ara ASEAN 'a"!se&ua an""ota ne"ara ASEAN 'a"!
.e$asanaan S!& Har&on!sas! Kos&et!.e$asanaan S!& Har&on!sas! Kos&et!
ASEAN !a!tu .e&atu(an e.adaASEAN !a!tu .e&atu(an e.adaASEAASEACosmetic !irecti"es #AC!$%Cosmetic !irecti"es #AC!$%
Prosedur Pendaftaran 0CFFC*CFF1Prosedur Pendaftaran 0CFFC*CFF1
Prosedur Not!,as! 0&u$a! CFF?1Prosedur Not!,as! 0&u$a! CFF?1
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S!a.a )an" .er$u &e&'uatS!a.a )an" .er$u &e&'uat
Not!,as!Not!,as! S)ar!at )an" 'ertan""un"/a#a'S)ar!at )an" 'ertan""un"/a#a'
&e&asaran .rodu .er$u &e&'uat&e&asaran .rodu .er$u &e&'uat
not!,as! e.ada Pen"ara(not!,as! e.ada Pen"ara(
Per(!d&atan %ar&as! 0Per(!d&atan %ar&as! 0!irector of!irector ofPharmaceutical Ser"ices% !PSPharmaceutical Ser"ices% !PS11
se'e$u& .rodu terse'ut 'o$e(se'e$u& .rodu terse'ut 'o$e(
d!.asarand!.asaran
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PROSES NOTI%IKASIPROSES NOTI%IKASI
PEMOHON
BPFK
NOTANOTIFIKASI
PRODUK IMPORT No&'or Not!,as!
Ke'enaranMen"!&.ort
- Me&'oron"
PRODUK TEMPATAN No&'or Not!,as!
Ke'enaran Men"!$an" -Me&'oron"
.er&o(onan secara on$!ne * s!ste& uestC
D!e$uaran o$e( BP%K da$a& te&.o( =* (ar!
Pe&.rosesan 'a)aran
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Proses Not!,as!Proses Not!,as!
Per&o(onan secaraPer&o(onan secara online& 'uest(online& 'uest(
-- Boran" Not!,as! 0ASEAN te&.$ate1Boran" Not!,as! 0ASEAN te&.$ate1
)ebsite &)ebsite & ***.bpfk.go".my***.bpfk.go".my
Kate"or! I - IIKate"or! I - II
Yuran 7 RM F6FF 5 set!a. .roduYuran 7 RM F6FF 5 set!a. .rodu
http://www.bpfk.gov.my/http://www.bpfk.gov.my/http://www.bpfk.gov.my/http://www.bpfk.gov.my/ -
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Ma$u&at )an" .er$uMa$u&at )an" .er$u
d!e&uaand!e&uaan Ma$u&at .rodu 3 na&a 4 /ena&a d$$Ma$u&at .rodu 3 na&a 4 /ena&a d$$ Na&a - a$a&at .en"!$an"Na&a - a$a&at .en"!$an"
Ma$u&at s)ar!at )an" 'ertan""un"/a#a'Ma$u&at s)ar!at )an" 'ertan""un"/a#a'
&e&asaran .rodu&e&asaran .rodu Ma$u&at !nd!;!du )an" &e#a!$! s)ar!atMa$u&at !nd!;!du )an" &e#a!$! s)ar!at
untu &en"e&uaan not!,as!untu &en"e&uaan not!,as!
Na&a - a$a&at .en"!&.ort 0.rodu !&.ort1Na&a - a$a&at .en"!&.ort 0.rodu !&.ort1
Senara! 'a(an d! da$a& for&u$as!Senara! 'a(an d! da$a& for&u$as!
Surat uasa dar!.ada .e&!$! .roduSurat uasa dar!.ada .e&!$! .rodu
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Ma$u&at )an" .er$uMa$u&at )an" .er$u
d!e&uaand!e&uaan Pen"auan dan .en"esa(an 7Pen"auan dan .en"esa(an 7
3 Produ terse'ut &e&atu(!Produ terse'ut &e&atu(!ASEA CosmeticASEA Cosmetic
!irecti"e!irecti"e
3 P!(a s)ar!at aan 'ertan""un"/a#a' untuP!(a s)ar!at aan 'ertan""un"/a#a' untu Me&ast!an PI% tersed!aMe&ast!an PI% tersed!a
Men)!&.an &a$u&at5$a.oran at!;!t! .an""!$'a$!Men)!&.an &a$u&at5$a.oran at!;!t! .an""!$'a$!
Me$a.oran esan ad;ersMe$a.oran esan ad;ers
Me$a.oran .!ndaan )an" d!'uat .ada &a$u&atMe$a.oran .!ndaan )an" d!'uat .ada &a$u&at.rodu 'ernot!,as!.rodu 'ernot!,as!
Ma$u&at )an" d!e&uaan ada$a( 'enarMa$u&at )an" d!e&uaan ada$a( 'enar
La!n*$a!nLa!n*$a!n
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Tan""un"/a#a' .!(aTan""un"/a#a' .!(a
S)ar!atS)ar!at Me&ast!an ese$a&atan 4 ua$!t! danMe&ast!an ese$a&atan 4 ua$!t! dan
e'eresanan .rodu )an" d!.asarane'eresanan .rodu )an" d!.asaran
Men)!&.an se&ua &a$u&at .roduMen)!&.an se&ua &a$u&at .rodu*%a!$ Ma$u&at Produ 5*%a!$ Ma$u&at Produ 5Product +nformationProduct +nformation
,ile,ile#P+,$#P+,$
Me&ast!an .e&atu(an e.adaMe&ast!an .e&atu(an e.ada
ar!s.anduan A&a$an Per!$an"an Ba! 0APB1ar!s.anduan A&a$an Per!$an"an Ba! 0APB1
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Tan""un"/a#a' .!(aTan""un"/a#a' .!(a
S)ar!atS)ar!at Me&ast!an 'a(a#a .en!$a!anMe&ast!an 'a(a#a .en!$a!an
ese$a&atan .rodu te$a(ese$a&atan .rodu te$a(
d!$asanaand!$asanaan
Me&antau .rodu da$a& .asaranMe&antau .rodu da$a& .asaran
dan &e$a.oran esan ad;ers .rodudan &e$a.oran esan ad;ers .rodu
0se!ran)a ada1 e.ada .!(a0se!ran)a ada1 e.ada .!(a
'eruasa'eruasa
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Tan""un"/a#a' .!(aTan""un"/a#a' .!(a
S)ar!atS)ar!at Me&.un)a! .en"eta(uan ten!a$Me&.un)a! .en"eta(uan ten!a$
serta .en"a$a&an )an" secuu.n)aserta .en"a$a&an )an" secuu.n)a
da$a& se&ua e.er$uan undan"*da$a& se&ua e.er$uan undan"*
undan" )an" d!teta.an 'a"! .roduundan" )an" d!teta.an 'a"! .roduos&et!os&et!
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Peranan P!(a Re"u$ator!Peranan P!(a Re"u$ator!
Pe&antauan .rodu d! .asaran secaraPe&antauan .rodu d! .asaran secara'erterusan 0'erterusan 0Post-market sur"eillancePost-market sur"eillance
programmeprogramme1 'a"! &e$!ndun"! .en""una1 'a"! &e$!ndun"! .en""una
&e$a$u!7&e$a$u!7
Men/a$anan .roses .en)ar!n"anMen/a$anan .roses .en)ar!n"an
for&u$a ter(ada. se&ua os&et!for&u$a ter(ada. se&ua os&et!
'ernot!,as!'ernot!,as!
Men/a$anan aud!t .e&atu(an e atasMen/a$anan aud!t .e&atu(an e atas%a!$ Ma$u&at Produ 0%a!$ Ma$u&at Produ 0ProductProduct
+nformation ,ile+nformation ,ile#P+,$#P+,$11
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Peranan P!(a Re"u$ator!Peranan P!(a Re"u$ator!
Men/a$anan aud!t .e&atu(an eMen/a$anan aud!t .e&atu(an eatas .re&!s .en"!$an" * A&a$anatas .re&!s .en"!$an" * A&a$an
Per!$an"an Ba! 0APB1Per!$an"an Ba! 0APB1
Pensa&.e$an dan .en"u/!an .roduPensa&.e$an dan .en"u/!an .rodu
)an" ada d! .asaran)an" ada d! .asaran
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Peranan P!(a Re"u$ator!Peranan P!(a Re"u$ator!
Pen)!asatan e atas aduan dar!Pen)!asatan e atas aduan dar!
.en""una5oran" ra&a!.en""una5oran" ra&a!
S!ste& a&aran dan .ertuaranS!ste& a&aran dan .ertuaran
&a$u&at d! a$an"an ne"ara*ne"ara&a$u&at d! a$an"an ne"ara*ne"ara
ASEANASEAN
Pe&on!toran esan ad;ersPe&on!toran esan ad;ers
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P P t P d K t! d!P P t P d K t! d!
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Pro"ra& Pe&antauan Produ Kos&et! d!Pro"ra& Pe&antauan Produ Kos&et! d!
.asaran.asaran
00Post arket Sur"eillancePost arket Sur"eillance11
O'/et!f7
Me&ast!an .rodu os&et! ada$a( ter/a&!n dar!as.e ese$a&atan dan ua$!t! serta &e&atu(!
e.er$uan .erundan"an
Men"ena$.ast! dan &en)!asat aduan*aduandar!.ada .en""una6
Me&ast!an tuntutan .rodu os&et! 'ernot!,as!ada$a( se$aras den"an so. tuntutan os&et!
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At!;!t!*at!;!t! PMSAt!;!t!*at!;!t! PMS
Proses .en)ar!n"an andun"anProses .en)ar!n"an andun"an
'a(an .rodu 'ernot!,as!'a(an .rodu 'ernot!,as!
Aud!t PI%Aud!t PI%
Pen"(antaran5.en"a&'!$an sa&.e$Pen"(antaran5.en"a&'!$an sa&.e$
.rodu.rodu
U/!an ter(ada. sa&.e$ .roduU/!an ter(ada. sa&.e$ .rodu Pen)e&aan $a'e$ dan tuntutanPen)e&aan $a'e$ dan tuntutan
.rodu.rodu
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Status .rodu d!.asaranStatus .rodu d!.asaran
Produ os&et! )an" te$a( 'erdaftarProdu os&et! )an" te$a( 'erdaftar
se'e$u& = anuar! CFF?se'e$u& =anuar! CFF?d!e$asand!e$asan
se'a"a! .roduse'a"a! .rodu sed!a ada 0sed!a ada 0 existingexisting11
3 MAL=C@G?KMAL=C@G?K
Per&o(onan &e$a$u! .rosedur not!,as!Per&o(onan &e$a$u! .rosedur not!,as!
.ada atau.ada atau se$e.as = anuar! CFF?se$e.as = anuar! CFF?
d!e$asan se'a"a!d!e$asan se'a"a! .rodu 'aru.rodu 'aru3 NOT=C@G?KNOT=C@G?K
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Produ sed!a ada d! .asaranProdu sed!a ada d! .asaran
Ba"! &en)era"a&an aeda(Ba"! &en)era"a&an aeda(
.en"a#a$an4 no&'or .endaftaran.en"a#a$an4 no&'or .endaftaran
.rodu sed!a ada te$a( d!tuar.rodu sed!a ada te$a( d!tuar
e.ada no&'or not!,as!e.ada no&'or not!,as! +t(7+t(7
MAL=C@G?KMAL=C@G?KNOT=C@G?KENOT=C@G?KE
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%a!$ Ma$u&at Produ 5%a!$ Ma$u&at Produ 5ProductProduct
+nformation ,ile+nformation ,ile 0 PI%10 PI%1 D!s!&.an d! .re&!s s)ar!at )an"D!s!&.an d! .re&!s s)ar!at )an"
'ertan""un"/a#a' &e&asaran .rodu'ertan""un"/a#a' &e&asaran .rodu
Ba(asa* BM or BIBa(asa* BM or BI
Bo$e( d!e&uaan '!$a*'!$a &asa a.a'!$aBo$e( d!e&uaan '!$a*'!$a &asa a.a'!$ad!&!ntad!&!nta
Men)!&.an se&ua &a$u&at ter!n! 'erenaanMen)!&.an se&ua &a$u&at ter!n! 'erenaan.rodu.rodu
% !$ M $ P d 5% !$ M $ t P d 5P dP d t
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%a!$ Ma$u&at Produ 5%a!$ Ma$u&at Produ 5ProductProduct
+nformation ,ile+nformation ,ile 0 PI%10 PI%1
Ma$u&at*&a$u&atMa$u&at*&a$u&at 77* Kandun"an 'a(an* Kandun"an 'a(an
* S.es!,as! 'a(an &enta( dan .rodu s!a. - S!/!$ ana$!sa* S.es!,as! 'a(an &enta( dan .rodu s!a. - S!/!$ ana$!sa
* La'e$ .rodu* La'e$ .rodu
* Proses .en"!$an"an* Proses .en"!$an"an
** Safety assessment for human health-Safety assessment for human health- 'a(an4 ta(a.'a(an4 ta(a.
.endeda(an d$$.endeda(an d$$
* Data soon"an ter(ada. tuntutan .rodu 0c$a!&s1* Data soon"an ter(ada. tuntutan .rodu 0c$a!&s1
* Data e,as! dan ese$a&atan .rodu* Data e,as! dan ese$a&atan .rodu* Kesan &udarat )an" &un"!n ter/ad!* Kesan &udarat )an" &un"!n ter/ad!
* Kaeda( .en"u/!an .rodu s!a. d$$* Kaeda( .en"u/!an .rodu s!a. d$$
Sa&'8
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%a!$ Ma$u&at Produ 5%a!$ Ma$u&at Produ 5ProductProduct
+nformation ,ile+nformation ,ile 0 PI%10 PI%1
Part + & Administrati"e !ocuments Product Summary
Part ++ & 'uality data of ra* material
Part +++ & 'uality data of ,inishedProduct
Part +/ & Safety and E0cacy data
0Ma$u&at $an/ut 7 ru/u ar!s.anduan PI% .ada 1uidelines for Controlof Cosmetic product in alaysia$
Sa&'8
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Per$asanaan ProsedurPer$asanaan Prosedur
Not!,as! d! ne"ara ASEANNot!,as! d! ne"ara ASEANNe"ara*ne"ara )an" te$a(Ne"ara*ne"ara )an" te$a(
&e$asanaan Prosedur Not!,as!7&e$asanaan Prosedur Not!,as!7 Ma$a)s!a4 P(!$!..!ne4 S!n"a.oreMa$a)s!a4 P(!$!..!ne4 S!n"a.ore
3 Tar!( .er$asanaan 7 = an CFF?6Tar!( .er$asanaan 7 = an CFF?6
J!et Na& 7 =F Mac CFF?6J!et Na& 7 =F Mac CFF?6
T(a!$and 7 = Mac CFF?T(a!$and 7 = Mac CFF?
Brune! Darussa$a& 7 un CFF?Brune! Darussa$a& 7 un CFF? Lao PDR 7 a(!r CFF?Lao PDR 7 a(!r CFF?
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Per$asanaan ProsedurPer$asanaan Prosedur
Not!,as! d! ne"ara ASEANNot!,as! d! ne"ara ASEANNe"ara*ne"ara )an" te$a(&e&'er!an o&!t&en untu&e$asanaan Prosedur Not!,as!7
+a&'od!a 7 = Mac CFF>+a&'od!a 7 = Mac CFF>
M)an&ar 7 a(!r an CFF>M)an&ar 7 a(!r an CFF>
Sa&'8
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Per$asanaan ProsedurNot!,as! d! ne"ara ASEANNe"ara )an" t!da &e&'er!ano&!t&en 'a"! .er$asanaanProsedur Not!,as!
Indones!a
Sa&'8
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ASEAN Cosmetic DirectiveAktiviti Seelu!
PerlaksanaanNoti"kasi
Sele#as PerlaksanaanNoti"kasi
Pre-market
appro"al
Se&ua .rodu
d!daftaran se'e$u&
d!.asaran 0.re*&aret
a..ro;a$1
Notifikasi produk (no pre-Notifikasi produk (no pre-
market approval) dan disusulimarket approval) dan disusuli
dengan pemantauan produkdengan pemantauan produk
dipasaran (PMS)dipasaran (PMS)
Pen!$a!an
ese$a&ata
n .rodu
Dou&en soon"an
ese$a&atan dan e,as!
.rodu d!e&uaan
a.a'!$a d!&!nta
Per$u ada dan tersed!a
Ma$u&at
$en"a.
.rodu
Dou&en d!e&uaan
e.ada BP%K
Per$u ada dan tersed!a
a.a'!$a d!&!nta 0d!s!&.an
d! .re&!s s)ar!at )an"
'ertan""un"/a#a'
&e&asaran .rodu1
ASEAN C ti Di ti
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At!;!t! Se'e$u& Per$asanaanNot!,as!
Se$e.as Per$asanaanNot!,as!
Kaeda(
.en"u/!an
.rodu
* Mest! tersed!a a.a'!$a
d!&!nta o$e( .!(a
re"u$atorSenara!
'a(an
* Pro(!'!ted $!st 0@=1
* Restr!cted $!st 0GG1
* co$orants ;e $!st 0=@?1
*Preser;at!;es ;e $!st
0G1
*UJ ,$ters ;e $!st 0C1
* Pro(!'!ted $!st 0=C@1
* Restr!cted $!st 0=F=1
* +o$orants ;e $!st 0=>1
* Preser;at!;es ;e $!st
01
* UJ %!$ters ;e $!st 0F1
0sa&'661
ASEAN Cosmetic Directive
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At!;!t! Se'e$u& Per$asanaanNot!,as!
Se$e.as Per$asanaanNot!,as!
KeperluanPelabelan
ASEAN technicaldocuments
A!
Pengilangan "esen Pengilang Pematuhan kepadaASEAN Cosmetic GMPRequirements
Post MarketSurveillance
Minima Aktif dan sistematik
ASEAN Cosmetic Directive0sa&'61
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Ba(an*'a(an d! da$a& ProduBa(an*'a(an d! da$a& Produ
Kos&et! 0Kos&et! 0+ngredients+ngredients11
Senara! ne"at!fSenara! ne"at!f
3 Ba(an*'a(an )an"Ba(an*'a(an )an"TERLARANTERLARAN0Anne0Anne
II 3 Part I1II 3 Part I1
3 Ba(an*'a(an d!"unaan secara ter(adBa(an*'a(an d!"unaan secara ter(addan s)arat tertentu 0Anne III 3 Part I1dan s)arat tertentu 0Anne III 3 Part I1
Senara! .os!t!fSenara! .os!t!f
A"en .e#arna 0Anne IJ 3 Part I1A"en .e#arna 0Anne IJ 3 Part I1 Pen"a#et 0Anne JI 3 Part I1Pen"a#et 0Anne JI 3 Part I1
Pena.!s sur!a 5Pena.!s sur!a 5 2/ ,ilters2/ ,ilters0Anne JII10Anne JII1
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Ba(an*'a(an d! da$a& ProduBa(an*'a(an d! da$a& Produ
Kos&et! 0Kos&et! 0+ngredients+ngredients11 Kos&et! &est!$a( 'e'as dar! 'a(an )an"
terandun" da$a& senara! racun 'er/adua$
+t(7 H)dro:u!none
Tret!no!n T(eo.()$$!ne
Ae$a!c Ac!d
0Senara! racun 'er/adua$7###6.(ar&ac)6"o;6&)1
0sa&'661
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Pe$a'e$anPe$a'e$an
O'/et!fO'/et!f
3 Untu &e&ast!an .en""una da.at &e&'uatUntu &e&ast!an .en""una da.at &e&'uat
.!$!(an )an" '!/a 0.!$!(an )an" '!/a 0informed choiceinformed choice1 se&asa1 se&asa
&enentuan os&et! )an" sesua! untu&enentuan os&et! )an" sesua! untu&erea&erea
DANDAN
3 Untu &e&'antu .!(a 'eruasaUntu &e&'antu .!(a 'eruasa&en/a$anan at!;!t! sur;e!$ans den"an $e'!(&en/a$anan at!;!t! sur;e!$ans den"an $e'!(
'eresan6'eresan6
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Pe$a'e$anPe$a'e$an
La'e$La'e$
3 Ma$u&at2Ma$u&at2
Bertu$!s4 'erceta atau "ra, )an"Bertu$!s4 'erceta atau "ra, )an"
d!.ero$e(! dar! .rodu atau ota $uard!.ero$e(! dar! .rodu atau ota $uar
atau .ada s!s!. 'un"usanatau .ada s!s!. 'un"usan66
0sa&'81
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Ke.er$uan Pe$a'e$anKe.er$uan Pe$a'e$an
Na&a Produ dan fun"s!n)aNa&a Produ dan fun"s!n)a
+ara .en""unaan 3+ara .en""unaan 3/!a t!da /e$as dar! desr!.s! .rodu/!a t!da /e$as dar! desr!.s! .rodu
Senara! 'a(an*Senara! 'a(an* descending order of percentagedescending order of percentage
Ne"ara .en"e$uar5.en"!$an"Ne"ara .en"e$uar5.en"!$an"
E" 7E" 7 ade in alaysiaade in alaysia
Manufactured in USAManufactured in USA
Country of origin !"ailandCountry of origin !"ailand
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Ke.er$uan Pe$a'e$anKe.er$uan Pe$a'e$an
Na&a dan a$a&at s)ar!at )an"Na&a dan a$a&at s)ar!at )an"'ertan""un"/a#a' &e&asaran .rodu'ertan""un"/a#a' &e&asaran .rodu
Kandun"an 0&" atau &$1Kandun"an 0&" atau &$1
No6 Ke$o&.o 0No6 Ke$o&.o 03atch o.3atch o.11
Tar!( d!!$an"an atau tar!( $u.utTar!( d!!$an"an atau tar!( $u.ut
0Tar!( $u.ut 7te&.o( (a)at F 'u$an10Tar!( $u.ut 7te&.o( (a)at F 'u$an1
0sa&'81
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Ke.er$uan Pe$a'e$anKe.er$uan Pe$a'e$an
Ma$u&at ta&'a(anMa$u&at ta&'a(an
Pern)ataan su&'er 'a(an sa&a adaPern)ataan su&'er 'a(an sa&a ada
dar!.adadar!.ada 3o"ine3o"ineatauatau PorcinePorcineEg !"is #roduct contains ingredientEg !"is #roduct contains ingredient
of #ork origin $ %eef origin&of #ork origin $ %eef origin&
Amaran#$arningAmaran#$arning
0sa&'81
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Pe&'un"usan 'ersa! ec!$Pe&'un"usan 'ersa! ec!$
Ke.er$uan &!n!&a 'a"! $a'e$ terdeatKe.er$uan &!n!&a 'a"! $a'e$ terdeat Na&a .roduNa&a .rodu
No&'or e$o&.o 0No&'or e$o&.o 03atch o.3atch o.11
Ma$u&at $a!nMa$u&at $a!n D!.a&eran da$a& s!s!. 'un"usan 0R!sa$a(D!.a&eran da$a& s!s!. 'un"usan 0R!sa$a(
dandan hang tagshang tagsd$$1d$$1
Ra 0Ra 0display paneldisplay panel11
0Ma$u&at $an/ut 7 ru/u ar!s.anduan Pe$a'e$an .ada 1uidelines for Control ofCosmetic product in alaysia$
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La'e$ terdeat
La'e$Luar
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Tuntutan 0Tuntutan 0ClaimsClaims11
Tuntutan .eru'atan 0Tuntutan .eru'atan 0edicinal claimsedicinal claims11
3 ProduProdu t!dat!dad!ato"er!an se'a"a!d!ato"er!an se'a"a!
os&et!6os&et!6
Tuntutan )an" t!da d!'enaran 'a"!Tuntutan )an" t!da d!'enaran 'a"!
Produ Kos&et!Produ Kos&et!
0Ma$u&at $an/ut 7 ru/u ar!s.anduan Tuntutan .ada 1uidelines forControl of Cosmetic product in alaysia$
Tuntutan )an" t!da d!'enaran 'a"! ProduTuntutan
)an" t!da d!'enaran 'a"! Produ
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Kos&et!Kos&et!
Tuntutan D!'enaranTuntutan D!'enaran Tuntutan )" t!daTuntutan )" t!da
d!'enarand!'enaran
Membersihkan kepingan kelumumurMembersihkan kepingan kelumumurdari rambutdari rambut
Men"(a.usan e$u&u&ur2Men"(a.usan e$u&u&ur2
Me$a&'atan tanda*tanda a!'atMe$a&'atan tanda*tanda a!'at.enuaan.enuaan
Men"(a$an" .enuaanMen"(a$an" .enuaanMen"(a$an" .roses .enuaanMen"(a$an" .roses .enuaan
Pe&'ers!( e.ada u$!t )an"Pe&'ers!( e.ada u$!t )an"&uda( 'er/era#at&uda( 'er/era#at
Me$!ndun"! ane4 /era#at4 /era"atMe$!ndun"! ane4 /era#at4 /era"atdan '!nt! (!ta&dan '!nt! (!ta&
Men"(a$an" /era#atMen"(a$an" /era#at
Me&'er(ent!an '!nt! (!ta&Me&'er(ent!an '!nt! (!ta&
Me&'antu &en"uran"anMe&'antu &en"uran"an.ena&.!$an u$!t oren atau se$u$!t.ena&.!$an u$!t oren atau se$u$!t
dan &e&.er'a!! e$e&a(an u$!tdan &e&.er'a!! e$e&a(an u$!t
Meru/u e.ada2Meru/u e.ada2
* &en"uran"an 'erat 'adan* &en"uran"an 'erat 'adan
* &en"(a.usan se$u$!t* &en"(a.usan se$u$!t
* &en"(!$an"an $e&a* &en"(!$an"an $e&a
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Tuntutan 0Tuntutan 0ClaimsClaims1 3 sa&'61 3 sa&'6
Ter'ut! 'o$e( &en"uran"an 5 &en"(a.usanTer'ut! 'o$e( &en"uran"an 5 &en"(a.usan
se$u$!t da$a& &asa &!n!t6se$u$!t da$a& &asa &!n!t6
Kuran" C !nc! da$a& te&.o( &!n""u6Kuran" C !nc! da$a& te&.o( &!n""u6
Men"(!$an"an $e&a an""aran C !nc! dar!Men"(!$an"an $e&a an""aran C !nc! dar!
set!a. 'a(a"!an .a(a da$a& te&.o( set!a. 'a(a"!an .a(a da$a& te&.o(
&!n""u6&!n""u6
0Ma$u&at $an/ut 7 ru/u e.er$uan tuntutan .ada 1uidelines for Control of Cosmeticproduct in alaysia$
A $ P !$ B !A $ P !$ B !
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A&a$an Per!$an"an Ba!A&a$an Per!$an"an Ba!0APB5MP10APB5MP1
Penentuan ua$!t! .roduPenentuan ua$!t! .rodu
Produ da.at d!e$uaran secaraProdu da.at d!e$uaran secara
sera"a& untu &e&enu(! .!a#a!ansera"a& untu &e&enu(! .!a#a!an
ua$!t! )an" d!tentuan6ua$!t! )an" d!tentuan6
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E$e&en*e$e&en uta&a APBE$e&en*e$e&en uta&a APB
Ka!tan"anKa!tan"an Pre&!s 0'an"unan !$an"1Pre&!s 0'an"unan !$an"1 Pera$atanPera$atan Ke'ers!(an - san!tas!Ke'ers!(an - san!tas!
Pen"!$an"anPen"!$an"an Ka#a$an &utuKa#a$an &utu Aud!t da$a&an 3 $a.oran .e&er!saan da$a&anAud!t da$a&an 3 $a.oran .e&er!saan da$a&an Pen)!&.ananPen)!&.anan Pen"!$an" ontra dan ana$!s!sPen"!$an" ontra dan ana$!s!s AduanAduan Prosedur Pan""!$*Ba$!Prosedur Pan""!$*Ba$! Dou&enDou&en
+a'aran )an" .er$u+a'aran )an" .er$u
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+a'aran )an" .er$u+a'aran )an" .er$u
d!.ert!&'an"and!.ert!&'an"an Per$asanaan ASEAN +os&et!cPer$asanaan ASEAN +os&et!c !irecti"es!irecti"es
0CFF?10CFF?1
Produ*.rodu os&et! 'e'as d!.asaranProdu*.rodu os&et! 'e'as d!.asaran
P!(a 'eruasa .er$uP!(a 'eruasa .er$u competentcompetent dandan
'eru.a)a untu &en/a$anan at!;!t!'eru.a)a untu &en/a$anan at!;!t!
Sur;e!$$ance den"an $e'!( at!f danSur;e!$$ance den"an $e'!( at!f dans!ste&at!s!ste&at!
+a'aran )an" .er$u+a'aran )an" .er$u
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+a'aran )an" .er$u+a'aran )an" .er$u
d!.ert!&'an"and!.ert!&'an"an Prosedur not!,as!Prosedur not!,as!
T!ada $a"! .roses .endaftaran 3T!ada $a"! .roses .endaftaran 3 nonopremarket appro"alpremarket appro"al
Pen""una aan terdeda( e.ada .rodu*Pen""una aan terdeda( e.ada .rodu*.rodu os&et! )an" t!da se$a&at.rodu os&et! )an" t!da se$a&at
Produ )an" t!da &e&atu(! e.er$uanProdu )an" t!da &e&atu(! e.er$uan
(an)a da.at d!ena$.ast! se&asa .roses(an)a da.at d!ena$.ast! se&asa .rosesPost arket Sur"eillancePost arket Sur"eillance
0sa&'81
+ ' $+ ' $
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+a'aran )an" .er$u+a'aran )an" .er$u
d!.ert!&'an"and!.ert!&'an"an Ke.er$uanKe.er$uanProduct +nformation ,ile#P+,$Product +nformation ,ile#P+,$
P!(a !ndustr! &as!( 'e$u& 'ersed!aP!(a !ndustr! &as!( 'e$u& 'ersed!a
se.enu(n)a untu &en)ed!aanse.enu(n)a untu &en)ed!aan
e.er$uan .ada PI%e.er$uan .ada PI% Ke.er$uanKe.er$uanABPABP
Ne"ara ASEAN $a!n &un"!n t!daNe"ara ASEAN $a!n &un"!n t!da
&e$asanaan e.er$uan APB se.ert!&e$asanaan e.er$uan APB se.ert!)an" d!"ar!san da$a&)an" d!"ar!san da$a& directi"esdirecti"es
0sa&'81
+a'aran )an" .er$u+a'aran )an" .er$u
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+a'aran )an" .er$u+a'aran )an" .er$u
d!.ert!&'an"and!.ert!&'an"an
Pen"uatuasaanPen"uatuasaan Ker/asa&a antara .!(a .en"uatuasaKer/asa&a antara .!(a .en"uatuasa
dan .!(a re"u$ator! a&at .ent!n"dan .!(a re"u$ator! a&at .ent!n"
'a"! &erea$!sas!an s!& (ar&on!sas!'a"! &erea$!sas!an s!& (ar&on!sas!os&et! d! set!a. ne"ara ASEANos&et! d! set!a. ne"ara ASEAN
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