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BOYTE
CUCQUÅNLYDUqc
流‥牢う/QD-QLD
DecIap・Tudo
CONGHOAXAHOICHUNGHiAVI帥NAM
Hanh ph血c
崩n鉦ngの,巧碗ng子枇22015
QUY台TDINHVeviecrnts6dmg埴lmh加thudcrakh6idanhmucCicthu6t
_1°_(,《 _壬ノ {/ ○○_
duqcc和S6d負ngkytai VietNam
CUCTRUONGCUCQUANLYDUOc
C祖cdLuatD同Cngay14thang6n血2005;
Cえnc掴ghidinhs663nO12伸一CPngay31/8nO12chacI血pmquy
dinhch血ang・nhiemv明uyenhanvacocaht6cmcc缶BeY
血C丘Quy担nhs63861/QD-BYTngay30解013cbaBOtrudngBoY
te’quydinhchlicnmg・血iemvu・quyenhanvaccrcmt6ch軸ac甘CQuanM
Car=Cti「Ⅱ16ngtus644m14什BYTngay25/1脚4cdaBeYtequy
dinhviecdmgkythu6C;
C祖cdthOngtin,muyehc60C缶CoquanquanyDmcmetsdnudctren
thggidil冷ketluancdaHeiD6ngTuvahc姉dangkythu6訂吋tevev*c
thu6ch血hoatchuBiphenyldimethyldicarboxylathoacBifendatvathudc
ChtiahoatchatCefetametchtJadap血gd雌hieuquatheoquydinhhienharh;
XetdenghichaⅢhgphdngDangkythu61TtuhgphengQuanly
Ch釦utmgdlm6C-CucQuanlyDuqc,
QUl塙TDINH,
Dieul・Rdtsddangkychcacthudcch血hoatchatBiphenyldimethyl
dicarboxylatmu6cch血hoatchatCefetametrakhbiDanhmuccacthu6cdLm
C和S6{泊ngkylmh址taiVigNam(C6Danhmuckemmeo).
Dieu2・Dinhchilmhhhtremto血qu6cvathuh6itoanbOcacthu6c
chtfahoatchatBiphenyldimethyldicarboxylat,mu6cchtiahoatchaCefI弛met
Dieu3・GiaocOngtydangkyph釦坤V6inhasanxualnhanhapkhau,
nhaphanph6ithu6bthuchjenthuh6ivamytoanbOthu6bch血hoatchat
Biphenyldimethyldicarboxylat・thu6cchdahoatchaCefetametvabaocaoket
quaveCucQuanlyDuqctheod血gquydinh寅ThOngtus609nOlOrTT_BYT
ngay28m010ChBQYtghudngdanviecquanlychatluqngthu6t.
SdYtgcactfnh・thanhph6匹Cthuocmngumgc6tr紺nhiemchidao
glamSatViecthucmencOngtacthuh6ivamycacthu6cneutren.
Dieu4・Quy担nhnaycdhieu匝kきぬngaykybanh池.
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Dieu5.Giamd6cSdYtecacdnh,thaIhph6叫CthuecmnguOng・
Giまmd6ccacdcnvikinhdoanhthu6C・Giamd6ccosddmgkiv輝Cnhasan
xuatcacthu6cneutaiDieulchiutrachnhiemthihadhQuyetdinhnay・
CUCTRUO
XNKDtJqCPh血l; muecBOYte; �&ユdネ��
・遊 -rtJOngQu6CCtJdng ・Tdngcucmiquan-BOT濃chinh・Baol
-VYmaPChe,(hcQuるnlyY・Duqccd
chBabenh,manh請=30Yte・VienKN
m.HCM;
Ndnhln:_NhuDieu5;
巧tI血gNguyenThiKhnTien(deblc);-αcD6ngchiTh血tru8ng(debh);
-CucQuanY・BeQu6cpheng・CucYte一
_CucYleGiaothOngvantai-BOGiaotn
Tdng∽ngtyDLJqCVietNam・儲cCbngty
儀。Be.hvien&Vienc6giumgb帥trUC_ _ - h l ′■÷ -Ll
しみC f)Clu- ▼〇㌧′〇〇〇・〇“▼●÷●●‾‾ p‾‾ ‾‾ ●ノ ‘
websiiecやCQLD,T雑)chiDLJqC&Myp血1-CucQLD;
LtmVT,C各cmengthuocCucQLD・DKT(12)・
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睦㊥‾YT臆
C胆Q岬AN虹音曲噂C
1.1.Nha san xuat:
(卑滝蘭㊦A※A轍⑳賄斑tiJRr髄払V醜聞N蝕但
齢掴約回軸的‥隠紳輔胱6
妙AN肥前倒UCCAC町斑U6cRUTS6秒姻GIK宵
(BanharhkemeheoQuy彊nhs6年23伸一QLDngaycz9thangチnam2015)
…旺宛¢摘む0加c血腫匝emy臓me鋤的a抽0Xylaな
置賜擬霧勤務器溺磐gocThien御痢樽3・批駒ki-Do,Korea
BoramPharm・C高Ltd・ak:471MbAmae-DongDanwon-guAns。n_Si,
Tenthu6c Hoatchか Dangbaoch6 S6d如g呼
BiphenylDimethyl
Dicarboxylate25mgViennen VN-10013-10
2・C6ngty肪ngky:HanbuIPharm・Co・,Ltd・伽:#40TaBa′ye-RLWbngokAnseuTtg-Si
Gl′eOnggi-Do,Kbrea).
2.1.Nha
ne履n-gu �ク��ィ�H�H���x��x�x�x���h�x�ネ�tァ(�ネ�h�xx��H8テ�ネ菠�H�H�X�hx�x�トィ��・X�X�4、ネ耳�ァX�ネ�誘eX�X��ナUX��ィ��V蔔郵圏(+�dト夫�x�t��ニ蘿メ��Ⅲ誚6��vニヨク�ニV�、カ�V��「�
STT 彦V蹤⑳d2�Hoatch気 認�誚&����Sbdぬg呼
2 �7FW&��BiphenylDimethyl Dicarboxylate25mg 蒜坊跏V����メ�VN-11822-11
Ltd(微を・16017月bi“k
3・Cengtydangky:DaewonPharmaceu‘icalCo・・Ltd・(祝:467-24,RtLfyd-dbng,Kwangiin-gu,
Seolil,Korea).
1⊥・〇、maSanXuat:JJaeWOnJ’llarmaCeuticalCo・,Ltd・伸C:903-1・Sdngshin-′・i,めmgmm-my Hwaseong-kun,Rimggi-doKorea).
STT 彦V�WSc��Hoatch釦 認�誚&����S6d如g呼
3 犯庸Vカ�BiphenylDimethyl Dicarboxylate25mg 蒜坊跏V����メ�VN-13107.11
4・CengtydangkJ:DongKwangPharmaceuticalCo・,Ltd・(秋:Co均。Lゆり0陶kTbwer,
25T5,1-Kd,Chungmuro,Chungrg均Seoul,Kbrea).
4・1・Nhasanxu鉦DongKwangPharmaceuticaICo・・Ltd・伽:439-1,MbgokdbngPy。ICgtaek
Cl切bIungki-くれKbrea).
STT 彦V蹤Ⅲ&2�Hoatchat 認�諍:6���S6d如8時
4 彦�ヌ����&ニWB�BiphenylDimemyl Dic孤boxylate 25mg 蒜坊跏V�VN-11018-10
5・C6mgty舶ngky:HanaPharm・Coe,批d・¢沈:301Ba7めB仏946-18,Doguk-Dong,
Ka′qgmm-KiL,SeouLKorea).
5・l・Nhasanxuat:DaeHanNewPhamCo・・鵬・(dk:#904-3,Sdngshi肌的砂angnam一砂un,
H訪asung-S RJ伍〝ggi-Do,KoI・ea).
1/7
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ungbuk STT 噺��VV��ィ�B���FV蹤Ⅲ�2�Hoatch鉦 禰フvv(*��2�S8d弧gky
6 噺��Vト6��7VニR�BiphenylDimethyl Dicarboxylate 7,5mg 蒜坊跏�誚8ネニr�VN-15918-12
7 蒜坊跏V蓙��問�BiphenylDimethyl Dicarboxylate 25mg 蒜坊跏V�VN-12488-11
6.Cengtyd如gky:IIHwaCo・,Ltd中線:437SutaekL’ねngGuri-Shi,Ryonggi-do・Korea)・
6工Nhasanxuat:Huons.Co.,Ltd互沈:907-6・Sdngshin-ri,砂angnam-myunJHwaseong-kun,
理nggi-ゐKorea・
STT 8 鳴���FV蹤Ⅲ&2�Hoatch気 祢$�v(*�ッ�S6寄れgky
Huparantab・ ���逍トF蒙Vラ鳴�F��&&�免�FR�#Vヨr�Viennen 錨�テ�Cs�8�テ�"�
6.2.Nh2日sanXuat:KyungDongPharm・Co・,Ltd・¢沈:535-3・Dae,′ang-li・‰nggam-nVmn,
諒asung-eiuRyunggi-db,Korea)・
STT 彦V蹤⑳d2�Hoatch如 認�誚&�����S6dねg呼
9 磐�7F�vV薈�(�2�BiphenylDimethyl Dicarboxylate 25mg 蒜坊跏V�VN_10304-10
6.3.Nhashxu紙EtexPharmInc.(dk:#649-1,Chqfi-Dong,Danwon-Gu,AnsanSi・匂′eOnggi-
oKorea.
STT 彦V蹤⑳d2�H。atC血気 認�諍o柳6��S6d犯gky
10 這V6��F�(�B�BiphenylDimethyl Dicarboxylate 25mg 蒜坊跏V�VN-11905-11
11 噺�ヨ�カ萌F�(�B�BiphenylDimethyl Dicarboxylate 25mg 蒜坊跏V�VN-11907-11
7.Cengtyd軸gkg:KolonINetworldCorporation(紡:533-2GasanTdbngGeumcheon-gu・
Seo訪Korea),
7.1.融As缶xu鉦SaH珪nPharmCo・,Ltd・作紡:904-2,Sangsin-1子Lb)angmm一myun・I7品aSung-
め)ungki-do,KoT.ea)・
〈STT 彦V踪.�V�2�亜oate正金t �i)9z��.�8唏饕�
217
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Peaceiil′・a
ト ノ鳥・卑五歳 e融引
数ca璃CX)庖te
25mg
Vi奮Irl宛
8-C垂訓対疏堕吋か臨噂e馳揃馳a蹴Co。,姐御:513-2,協b一品gBunわg-gu,Seongnam-CiDIq,eO17ggi-D‘7,1わrea).
8・1・隅会議m測紙班鵬鵬音こ0醐剛胆rm雑e繭aECo。出藍解
7均)en・HwaSungShi,Rj)eng窮Do,Kbrea).
STT 彦V顏7X�ヨ2�Ⅲoaft血気 倬6ヨy*ヨ���S錆施mg時
13 噺V�ニ����BiphenylDimethyl Dicarboxylate 7,5mg 蒜坊跏�誚8ヘニヨr�VN-11928_11
552-2王もu77gC巌unRi
9・Cengtydangky:KyongboPharmaceuticalCo・,Ltd・伽:345-6Silok-Do移Asal萄
Chungcheongnam-db336-02aKoT・ea).
9・1・Nhasanxuat:TheragenEtexCo・Ltd“伽:#649-1,Chqii-DongDanwon也Ansan茸
q)eOnggi-Do,Kbrea).
STT 彦V蹤⑳f2�Hoatch丸 認�誚&����S6d祖gky
14 陪W��6棉匁6��7VニR�BiphenyIDimethyl Dicarboxylate 7,5mg 蒜坊跏�誚8ネニr� VN-12540_11
10・Cengtydangky:PhaImixCorporation偽:1304,GarakH)Tbwer,99-7GarakLdbng,
Sbngz)a-gu,StoulKorea),
10・1・Nhasanxuat:TheragenEtexCo・Ltd・仰:#649-1・C/毎ii-DongDanwon-Gu.Ansan萌
GJ)eOnggi-Do,Kbrea).
STT 彦V蹤⑳d2�Hoatch鉦 認�誚&���イ�S6d祖gky
15 杷�也F�%F�(�B�BiphenylDimethyl Dicarboxylate 25mg 蒜坊跏V�VN-13305-11
10・2・NhasanxumKyungDongPhamCo・・Ltd・伽:535-3′Da。′angJ口脇Lggam一mn,
Hwasung-Ci切Ryunggi-do,Korea).
STT 彦V蹤⑳f2�Hoatch鉦 認�誚&����、言ニー
16 陪V&萌�BiphenylDimethyl Dicarboxylate 25mg 蒜坊跏V�VN-11244-10
10・3・NIlainxuat:SkyNewPharm・Co・,Ltd・¢t:1234-3°hongwang-dong,Siheung-Si,
匂′eOnggi-do.Korea).
STT 彦V蹤Ⅴ�ヨ2�H鋪tC血気 認�諄シV����S∂d嘘gky
17 牌�F免�B�BiphenylDimeth)′1 Dicarboxylate 25nlg 蒜坊跏V�VN-15571-12
3/7
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刷1品症言霊言霊掠高言誼融点親臨言申言高宮′信雄a妙飾,最か荊梢高砂言ノ朽u-
Gangw STT 柳�リ�7g&V��ィ�R���FV蹤⑳f2�Hoa蘭 上郷車軸を 儡5牒盃ngky
18 �芳�ニ��BiphenylDimetllyl Dic紋boxylate 25mg 蒜坊跏V�VNJ3825-日
11.Cengtydangky:PhilInternationalC0°,Ltd・儲:629-4Y訪am-DongKalmam-RiL・
Seoul,Korea).
Nha san xuat:Samchundang PharmaceuticalCo・・Ltd・作的:904-1Sangshin-Ri,
eoni-DoKorea yangnam STT 利�2�FV蹤⑳d2�H。atchか 認�誚&��>ツ�S6d如gky
19 ��ニカ�觀ヨ�F�"�BiphenylDimethyl Dicarboxylate 25mg 蒜坊跏V����メ�VN-13835-11
12.Cengtydangky:SchnellKoreaPharmaCo・・Ltd・伽:4FIねesungBleZg#747-2YeokS.am-
dong,Kangnam-kLLSeouLKorea)・
12.1.Nhasanxu紅SkyNewPharm・Co・,Ltd・(紡:418-21Daqu-dbngSiheung-Si,Gyeonggi-
Korea, STT 噺�V��ィ�B���FV蹤Ⅲ&2�H。atCh鉦 認�誚(*����S6滴ngky
20 �カ�F��BiphenylDimethyl Dicarboxylate 25mg 蒜坊跏V�VN-10567-10
13.Cengtydangky:C6mgtycSphhdtrqcDanapha伺t:253mngS調anhKhe・TPDd
N訪れ
13.1.Nhasanxuat:C6mgtycbph五mduqcDanapha佃k:253DHngSrmanhRm,TPBは
N宿 匁x�ィ�B�5EB�Tenthubc 陪�F6��Dangbかchを �.蓬�vキ�
21 陪W⊥ヌF�"�BiphenylDimethyl Dicarboxylate 25mg 蒜坊跏V�VD-15331-11
14.CengtydaT堰ky:C6mgtyCSphhDuvcph五mBosTonVietNam(dk:S643,Duengs68,
KCNViet賄m-Sing申Ore,muGnAn,BinhDwng,鵬tNanか
Nhasanxuat:C∂ngtyCbphanD叫Cph紅BosTonVi”NamGk:S543・DzzGngs68,
cN醗tNam-SingqporeThuanAn,BわhDlmg・V肇tNam)・
STT 彦V蹤Ⅱ62�Hoatchか 認�誚(*�ッ�Sbd盃ngky
22 彦蒙昧W��F��Biphenyldimethyl dicarboxylat25mg 蒜坊跏V����メ�VD-14259-11
15.Cbngtydangky:C6ngtJrTN轍HUSPhamaUSAG有L∂B1-10,dz元高gD2,KCN的Bac
C,iChLTPHうChl脇th)・
4/7
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嵩擢晋誤読中古品告高雄/Ljノー鳥目売高亮 一小一言:∴∵Vふら∴
16・C細gty軸g時C∂嘩恥か担ゐ皿砂噂融弧弛雌g軸g働点6S67‘紛gs62,KCNTdnTt70,P・Tt3nTt70A,Q・BinhTGn,TPHich血筋Zh).
1帥・Nhas缶別紙C6mgtyc∂ph組恥吋叩h細陣地mg眺ng働∴・L∂sd7
nJqO,r・LanLqOA,Q・BinhLt的LP・H∂ChiMinh).
STT 彦V蹤⑳f2�Hoatchれ 認�誚)D�6��Sa露mgky
24 波VヨWF∮#Vヨr�Biphenyldimethyl dicarboxylat25mg 蒜坊跏V襷������メ�VD-11671-10
d訪dngs62,
17・Cengtydangky:C6ngtyc6phandtrgcphamV珊PMc偽証777dz来訪gMeLinh-
P・KhaiQuang-7P・VmhYan-Tmh脇hPhdcl
17・l・NhAsanxuat:C6mgtycbphhndtrgcphamV珊Phhc伺k:S6777di売高gMeLinh-P.肋ai
Quang-TP・Vmhnn-n諒hV紡hPhZk).
STT 彦V蹈棉Sd2�Hoatch釦 認�誚&���b�S6慮れg呼
25 �没�觚�Biphenyldimethyl dicarboxylat25mg 蒜坊跏V����メ�VD-15665-11
18・Cengty肱ngky:C6ngtyc6phansanxua1-thtmgmaiDuvcphamD∂ngNam停船:L6
2A,Dut毎S61A・KCNTあThQB脇坊TPHechtMnh).
18・l・Nhasanxu計;C6mgtyc6phAns祖Xual一‘huungmaiDtrgcp肩mD∂ngNam偽:L6
2AD庇en 行AKCNT〈T QB、hT人 TPH,Z:Ju’OngSOJA,KCJV・LanL的Q・Binhr勧TP・H∂ChlMinh).
STT 彦V蹤⑳d2�Hoatch釦 認�誚(*��2�S6d祖g呼
26 認���&盲x�3Vヨr�BiphenylDimemyl Dicarboxylat7,5 mg 蒜坊跏�誚8ネニr�VD-19123-13
19・COngtydangky:C6mgtyDtrgcTrungmrng3伺k:115-N軸GiaTtr-Da焔ng).
191Nh、’∴∴へ’t c人’・l・Nhasanxuat:C6ngty皿gcTrungmmg3脅t:115-入官∂GiaTLr-DdA樗ng)
STT 彦V蹤⑳d2�Hoatc血気 認�誚&���イ�S d磁ngky
27 �WFV6���FV2�BiphenylDimethyl Dicarboxylat7,5 mg 蒜坊跏�誚8ネニr�VD-12593-10
20・Cengtyd細g母C6mgtyTNHHdtrgcphamDatViPhh(批:L∂M7A-CNDu・dngD17
KCNん砂Phu・6C,thhBinhDlOng).
20・1・N愉sanxuat:C6gtyTNHHdu・9・cph五m坤ViPhd伺t:LbM7A-CNDuengD17
KCN砂Ph〝63,tinhBinhDuorZg).
STT 彦V顏9%�2�駐韓tぬ釦 �X�ヨxシS��亊ク+2�S6離職g時
5/7
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l I28 亦�W78-3��現車規/草 dicarbCX
29 磐��V�Bipheny dicarbox
㍑高畠串
ylat25mg
i旭25mg
V誇nnen諒iしJ
phim
Viennenda.ibao
phim
VD一日630工0
VD-14586-11
21.Cengtydangky:C6ngtyTN開脚EnterPharma伺t:S625,Dudngs68,KJ最CNV擁
賄m-SingやOre,ThuenAn,BinhD脱〃好手
21.1.Nhasanxu鉦CangtyTNHHPhilInterPharma(枕:S625,DudlgS68,KhuCNV埼t
B“hD〝On g STT ��8�2���FV蹤⑳f2�H。atch鉦 祢$�v(*��イ�Sるd祖gky
30 ��ニ6Vニツ�Biphenyldimethyl dicarboxylat3mg 蒜坊跏�誚ヨVメ�VD-19216-13
22.Cengtydangky;C6ngtyTNHHsanxuhthumgmaidugcphamNIC(NICPharma)
伽:L611DduengCKhuc6ngnghiaTm的quGnBinh筋やHbch棚nh)・
22.1,Nh講nxu舘C6ngtyTNHHsanxuatthuOngmaiduqcphまmNIC(NICPharm津的:
11Ddzzi涜gCKhucengnghiepTt5nTtzo,qu紡Binhmn・妙HeChiMinh)・
STT �「��ニV蹤⑳f2�Hoatch釦 認�誚&���2�S6慮れgky
31 杷��W�Biphenyldimethyl dicarboxylate 25mg 蒜坊跏V�VD-12671-10
23.Cengtydangkg:C6ngtycbphまnc6ngnghesinhhocd叫CEhamICA伺k:L610,DzEdng
s65,KCNVietNam-Sing‘POre,muanAn,tinhB励Ducmg)・
23.1.Nhasanxuat:C6mg諦phhc∂ngnghesinhhocduvcphhICA御:LeIaDwGmgs6
KCNl働Nam-Singqpore,mu細An,(inhBinD厄の9・
STT 彦V蹤⑳d2�Hoatch鉦 認�誚$��コ�S∂d祖gky
32 杷�V2�Biphenyldimethyl dicarboxylat25mg 蒜坊跏V�VD-15314-11
II.Thu6cch血hoatChatCefetamet:
.C∂ngtydangky:AlembicLtd・qt:AlembieRoadVdebddra390003,G20aratState,助a lNh、・nxu錆AlembicLtd・伺t:AlembicRoadThdbdara390003,GzdaratState,脇a)・
a STT ����ニV蹤⑳d2�Hoatch気 禰コ没&�����Sbd血gky
33 �ヌF�ヨWC#S��Ce缶tametPivoxil Hydrochloride250mg 蒜坊跏V����メ�VN_151191-12
25.C6ngty統ngky:C6ngtyTNHHNhanSinh(紡:DB29BiiuC蛮P・14・Q・TanBinh・TP
磐盤盈Ⅹ諒。。ng.y.NHH。SPh。.m。USAGk:teB1-10,d・諭ngD2,KCNTtかBdcChiTPHbchlMnh).
STT 彦T⑦⑳S2�Ho隼tC鹿t 禰咢v(.ヲ6���S6露ngky
34 �&W�ニW�Ce危tametPiヽ′OXil Hydrochloride500mg 蒜坊跏V����メ�VD-15733-11
5/7
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