BOY TE CONG HOA XA HOI CHU NGHIA VIfT NAM
CUC QUAN LY DUQC ‘Doc lip - Ty do - Hanh phic
sé: 90 /QB-QLD
Ha Noi, ngay OD thaing )2sxcim 2015
N CHINE
QUYET DINE
Vé vige ban hanh danh muc 02 thudc sin xuit trong née
(thude didn tri ung thu ding ky in @du- s6 ding ky c6 higu luc 02 nim)
duge cp s6 dang ky Iwu hanb tai Vigt Nam- Dgt 149
CUC TRUONG CYC QUAN LY DUgC
Cén cit Luat Duge ngay 14 thang 6 ném 2005;
Can cit Nghj dinh s6 63/2012/ND-CP ngiy 31/8/2012 ota Chinh phil quy
inh chite nang, nhigm ve, quyén han vaco cdu tS chitcclaBO Yt,
© Cin eft Quyét dinh s6 3861/QD-BYT neay 30/9/2013 cia BO tring BS Y
18 vé viée quy dinh chic ning, nhi¢m vu, quyén han va co cau t6 chite ctia Cue
Quan ly Duge thuge BG Y 18;
Can cit Théng tr s6 44/2014/TT-BYT ngiy 25/11/2014 cha BO ¥ 18 qui
dinh vige dang kf thude,
Cin cit ¥ kién cha Hoi dng tu vin cp s6 ding ky Iu hanh thudc BEY té;
Xét a8 nghi cha Truéng phong Ding ky thudc - Cuc Quan ly Duge;
QuYET DINH:
pigu 1: Ban hanh kém theo Quyét djnh nay danh muc 02 thude san xuét
trong nuéc (thude diéu tr] ung thu ding ky jan du — s6 dang ky higu lye 02 nim)
duge cép s6 dang ky Iuu hanh tai Viet Nam - Dot 149.
pidu 2: Céng ty sin xudt va cong ty ding ky cé thuéc hu hanh phai in s6
ding ky duge BG Y té cp 1én nha thude va phai chép ting odp-quy ché cd
lign quan dén sin xuit va lu hanh thude. Sé ding Af,
gif tr) 02 nm ké tir ngay ky Quyét dinh. f.
Diéu 3: Trong qué trinh luu hanh thuéc,
. co sé digu tr} 48 thc hign theo dling cdc quy dink gh@ARAnRNYS
theo dai higu lye, d6 an toan, the dung monk yer xo
Vigt Nam. Céng ty ding ky 06 trich nhiém téng hop
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