UBND TlNH KON TUM S(JYTE CONG HOA xA HOI can NGIDA VIJj:T NAM DQc I~p - Tl}' do - Hanh phiic 86: J65C/8YT-NVD VIv tri~n khai thirc hien IT s6 06/20171 TT-BYT va IT s6 07/20 17/IT-BYT v~DM thuoc dQCva nguyen lieu dQc hun thuoc va DM thuoc khong ke dan Kon Tum, ngay 16 thong 6 ndm 2017 Kinh giri: - Cac dan vi tnrc thuoc Sa Y t€; - Cac co sa san xu§.t,kinh doanh thuoc. Ngay 03/5/2017, BQ Y t€ ban hanh Thong nr s6 06/2017/TT-BYT vS viec ban hanh Danh muc thuoc dQc va nguyen lieu dQc lam thuoc va Thong tu s6 07/20 17/TT-BYT ban hanh Danh muc thuoc khong ke dan. Hai Thong tu nay co hieu luc thi hanh k~ ill ngay 01/7/2017; Sa Y t€ dS nghi cac dan vi tnrc thuoc Sa Y t€ va cac co sa san xu§.t, kinh doanh thuoc tren dia ban tinh (cdc doanh nghiep kinh doanh thuoc, nha thuoc, quay thuoc va cac co sa y hoc c6 truyen) c~p nhat nghien ctru, qulin triet va trien khai thuc hien hai Thong tu s6 06/2017/TT-BYT ban hanh Danh m\lc thu6c dQc va nguyen li~u dQc lam thu6c va Thong tu s6 07/20 17ITT-BYT ngay 03/5/2017 cua BQY t€ ban hanh Danh m\lCthu6c khong ke dan t;;tidan vi, ca sa minh (file hai Thong tu va Danh m¥c thu6c arc va nguyen li?u arc lam thu6c ainh kem thea C6ng van nay tren h¢ th6ng eOffice va Trang thong tin ai?n tu cua Sa Y ti). Trong qua trinh th\lC hi~n, n€u co kho khan, vuong mic dS nghi cac dan vi ca sa bao cao vS Sa Y t€ d~tang hgp, dSxu§.tBQY t€./. Nu;nh~n: - Nhutren; - Uinh d~o So y t~; - PhOngY t~ cac huy~n, thfmh phd; - Cong ty CP Dugc - VTYT Kon Tum; - Cong ty TNHH Dugc phfun Alpha; - Cong ty TNIrn Thai Hoa; - Cac phOng thuQc So Y t€; - Trang Thong tin di~n tli So Y t~; - Luu: VT, NVD. ~ KT.GIMtDOC ~~G\_' lAMDOC
12
Embed
lam sa Sasyt.kontum.gov.vn/Uploads/files/Thông tin thuốc/Năm... · 2017-06-28 · Danh muc thuoc doc va nguyen 1i~udQc lam thuoc duoc ban hanh kern theo Thong nrnay. Di~u 4.Mt}c
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
UBND TlNH KON TUMS(JYTE
CONG HOA xA HOI canNGIDA VIJj:T NAMDQc I~p - Tl}' do - Hanh phiic
86: J65C/8YT-NVDVIv tri~n khai thirc hien IT s6 06/20171TT-BYT va IT s6 07/20 17/IT-BYTv~ DM thuoc dQCva nguyen lieu dQchun thuoc va DM thuoc khong ke dan
Kon Tum, ngay 16 thong 6 ndm 2017
Kinh giri:- Cac dan vi tnrc thuoc Sa Y t€;- Cac co sa san xu§.t,kinh doanh thuoc.
Ngay 03/5/2017, BQY t€ ban hanh Thong nr s6 06/2017/TT-BYT vS viecban hanh Danh muc thuoc dQc va nguyen lieu dQc lam thuoc va Thong tu s607/20 17/TT-BYT ban hanh Danh muc thuoc khong ke dan. Hai Thong tu nay cohieu luc thi hanh k~ illngay 01/7/2017;
Sa Y t€ dS nghi cac dan vi tnrc thuoc Sa Y t€ va cac co sa san xu§.t,kinhdoanh thuoc tren dia ban tinh (cdc doanh nghiep kinh doanh thuoc, nha thuoc,quay thuoc va cac co sa y hoc c6 truyen) c~p nhat nghien ctru, qulin triet va trienkhai thuc hien hai Thong tu s6 06/2017/TT-BYT ban hanh Danh m\lc thu6c dQcva nguyen li~u dQc lam thu6c va Thong tu s6 07/20 17ITT-BYT ngay 03/5/2017cua BQY t€ ban hanh Danh m\lCthu6c khong ke dan t;;tidan vi, ca sa minh (filehai Thong tu va Danh m¥c thu6c arc va nguyen li?u arc lam thu6c ainh kemthea C6ng van nay tren h¢ th6ng eOffice va Trang thong tin ai?n tu cua Sa Y ti).
Trong qua trinh th\lC hi~n, n€u co kho khan, vuong mic dS nghi cac dan vica sa bao cao vS Sa Y t€ d~ tang hgp, dS xu§.tBQY t€./.
Nu;nh~n:- Nhutren;- Uinh d~o So y t~;- PhOngY t~ cac huy~n, thfmh phd;- Cong ty CP Dugc - VTYT Kon Tum;- Cong ty TNHH Dugc phfun Alpha;- Cong ty TNIrn Thai Hoa;- Cac phOng thuQc So Y t€;- Trang Thong tin di~n tli So Y t~;- Luu: VT, NVD. ~
KT.GIMtDOC~~G\_' lAMDOC
BOYTE
I
CQNGHOA xA HQI cnu NGHiA vrsr JMDoc lap - Ttl do - Hanh phuc !
Y. •• IHa N9i, ngiry0.3 thang onam 2017S6: 06 12017fIT-BYT
;(jY TE TiNH KON TUM THONG TV"
DEN!!~;,:~D&:1.an hanh Danh muc thuAc dQc vii nguyen li~u dqc lam thuac I
Chinh phil quy dinh chuc nlmg nhiem vtl, quyen han va co edt.( 16 chtrc efaR(j Y tP; ;
Thea eM nghi eua Cue truong Cue Qulin If;Duae,
86 truong B9 Y td ban hanh "Th6ng tu ban hanh Danh mile thuoc tJ()'c anguyen li¢u tJ9c lam thu6c".
if)i~u 1. Pham vi di~u chlnh I
., r tThong nr nay quy dinh nguyen Hie xay dung, tieu chi lua chon thuoc dQc,
nguyen lieu doc lam thuoc; Danh muc thu<3cdQc, nguyen li~u dQc him thu6c:ladiroc chat, thuoc h6a duoc; muc dich ban hanh va trach nhi~m thl,lChi~n, I
I)'A 2 N .. ~ .. d ,... h' I h h J. .. Jjlleu • guyen tac xay l}'Dg va heu C I y-a C QDt uoc, nguyen ~ulam thuAc vao Danh myc thuac d(lc, nguyen li~u d(lc Ilim thuBc I
1.Nguyen t~e xay dl,l"ngDanh IDI,lCthu6c d(>c,nguyen Ji~u dQc hlm thu6F:a) Bao dam an toan eho ngum su dl,lng;
b) Bao dam vi~c ti~p c~n thu6c lqp thai cho nguai dan;c) Phil hqp v6i thvc t~ su dvug? cung u-ng thu6c eua Vi~t Nam;
d) Hoa hqp v6i cac nguyen t~c; quy djnh trong pharr lOl;\i thu6c dq>c,nguyen 1i~u dQc lam thu6c clla cac nuae trong khu Y\IC va tren thS giai; 1
d) Can CLr VaG to hLT<Jngd~n 811 d\lng thu6c eta dagc phe duy~t, Dugc thuQU6c gia, co so dfr li~u v~ thu6c tren th~ gi6i, cae bai bao dugc dang tai tren ~act(;1P<:hikhoa hvc va clk tai Ii~u khac co lien quan. I
I2. Tieu chi lI,ra chQn thu6c, nguyen li~u him thu6c VaG Danh m\lc thq6c
d<)c,nguye~ li~u doc lam thu6c: , . j
~ T?uQc, ng;lyc?A li~l~ la~ thuo~ dUQc xem ,xet de l\1'a,chQ,n vao ~anh ~~cthuoe d9c, nguyen IH~udQc lam thuoe trong truang hgp co nguy co gay ra IfQthay nhieu khci nang sau day 6 tren nguo-i:
a) Kha nang gay ung thtr (Carcinogenicity);
• Chlmg (hu: BQ Y l~~I '. a N!p\Y,ky: 16106/"0 1~ 16:59:02""., ~ H, lhong VOlliee Be;>Y Te
,,Q Y'"
•
;~ Chlmg lhu: BQ Y le~ IJ Ngay ky: 21106/2017 II :o! :42~:..... H~ lh6ng VOffice BQ Y Te
2
,b) Kha nang ga~ di t~t bao thai hoac tre so sinh (Teratogenicity) boac dQttinh doi voi S1! phat trien (Developmental toxicity);
c) Boc tinh dbi voi S\l sinh san (Reproductive toxicity);d) Doc tinh bo phan co the nguoi 0 li~u thap (Organ toxicity at low
doses);d) Kha nang gay dot bien gen (Genotoxicity).
Ban hanh Danh muc thu6c dQc, nguyen li~u dQc lam thuoc la co sa d~ coquan quan ly nha mroc co tham quyen thuc hien quy dinh v~ quan ly d6i voithu6c doc, nguyen lieu dt)c lam thuoc trong kinh doanh, ghi nhan, ke don, c~pphat, pha ch~, bao quan, sir dung, thanh tra, kl~m tra, xu ly vi pharn va cac hoatdong khac co lien quan.
Di~u 5. Hi~u I,!c thi himhThong tu nay c6 hi~u llle thi hanh k~ tu ngay 01 thimg 7 nam 2017.
D o). 6 DO,).. k'h ~ h A oJ.leu' .. leu ,oan c uyen tlep1. D6i vai cac thu6c, nguyen li~u lam thu6c dft dtr<;rc ec1pgi~y dang ky luu
hanh ho~c dUQe c~p giay phep Dh~p khAu truoc ngay Thong tu nay co hl¢u ItJc,cae co so dUng ten tren gidy dang ky luu hanh, co so nh~p khAu thu6c, nguyenli~u him thu6c phai ph€m IOlil1, c~p nh~t, b6 sung cac thong tin li~n quan d~n ~i~cphan lo~ thu6c, nguyen li~u lam thu6e thea quy dinh clla Thong tu nay trennhftn va to huoog d~n sti dl,lng thu6c theo 19 trinh quy dinh t~i Thong tu quydinh v~ ghi nhan thu6c, nguyen li~u lam thu6c do BQ tru6ng Bt) Y t~ ban hanhtruac khi dua thu6c, nguyen li~u lam thu6c ra luu thong tren thi truOng.
2. £>5i vai thu6c, duQ'c chdt co h6 so dang ky t~i Vi~t Nam ho~c ha S0
nh~p khAu thu6c chua co gi§y dang ky luu hanh t;;ti Vi~t Nam da nop t?i Cl,lCQulm ly DuQ'c truac ngay Thong tu mlY co hi~u it!C nhung chua duQ'c c~p gi~ydang ky lUll hanh ho~c c~p gidy phep nh~p kh§u thl phili th\fc hi9n phun [o'i\itheo quy dinh t~i Thong tu nay.
thu6c trong Danh ITII,lC quy dinh t?i Di€u 3 eua Thong tu nay theo Thong tu quy
3
dinh chi ti~t ~Qt sa DiSu cua Lu~t diroc vS thu6c phai ki~m soat d~c bi~t do ~Qtnrong BQ Y te ban hanh; !
b) f)~ xuat sua d6i, be, sung Danh muc thu6c dQc, nguyen lieu dQc lainthu6c cho phu hop tlnh hlnh thuc te, bao dam dap irng kip thoi thu6c phuc t·cho cong tac phong benh, chua benh.
2. Trach nhiern cua CI,lC Quan 19 Duoc: '
a) Chu tri, phoi hop voi cac co quan chirc nang thuc hicn Thong ill nay; ,
b) Ra soat Danh rnuc thu6c doc, n&Uyen Ii~u dQc lam thuac va bao caotnrong BQY t~ tren co so d8 xu!t sua doi, b6 sung cua cac don vi quy dinhKhoan 1 f)i~u nay hoac k~t luan cua HQi dang tu van cAp gidy dang Icy hruthuoc, nguyen li~u lam thuoc.
Trong qua trinh thuc hi~n n~u 00 vAnd~ virong m~c, de ngh] cae ccrt6 chfrc, ca nhan kip thai phlm anh v8 C\lC Quan ly DuQ'c (BQ Y t8) d8 xemgiai quy~t./.i/v
Nui nhpn:- Van phong Chinh phu (Cong bao, COngThong tin di~ntiI CP);- BQ tnr<'mgNguy~n Thi Kim Ti~n;- Cae Thlt tnt6'ng Bo Y t~;- BQ Tll phap (CI,lCKiBm tra vfln ban QPPL);- Cae BQ: Bo Cong an (C!,Ie Y th B9 Qu6c pMng (e!,lcQulin y); Bo Giao thong v~ t-Ai (C\lC Y ta);- Sa Y tS cac tinh, thAnh ph6 lIVc thuQc TW;- Cac vv, Cvc, T6ng C\lC, van phOns BQ, Thanh tra S9 -BoY t~;. HiQPhOi Doanh nghi~p duqc ViQtNam;- T6ng Ccng ty DIIQ'C Vi~t NarnC~ Th' . d·• • B' Y ,- ong oog t.1n I~nttr Q te;
- LlTu:VT, QLD.~
BQyrt CQNGBoA xA HQI cau NGHiA vrsr NAMDQc lip - TV' do - H~nh phuc
DANHM1)CThuBc dQc va nguyen li~u dQc lam tbuBc
(Ban hanh kem theo Thong tus&: 06 12017nT-BYT ngaya3thimg rnam 2017c-ua BQ trutmg BQ Y t~)
109 Vinorelbine Tiem: cac dang110 Zidovudine U cac dang
III Ziprasidone Uong: cac dang
* Danh muc nay bao g6m cd cac mu6i cua cae chdt ghi trong Bang nay, /chi pacmU6i d6 co thi hinh Ihiinh va t6nr;;w {t
~ /. -KT. BO TRU ...xr ..-;;>~Rr DM" tr~L/~ 'j'
"'~'T'.'"Z Q J. C '~~.-u-Ull; UOC U'ong
BOYTE CQNG HOA xA HQI CHU NGHlA V"q:T~AMf>9c lip - TV do - H,nb phue
HiJN(>i,ngay 03 thangSniim 2017 IS6: or 12017m-BYT
Chuy in, .e .wuh6 so s6: Cdll.cll LUQf duoc ngay 06 thdng 4 nam 2016;
Can cu Nghi dinh s6 63/2012/ND-CP ngay 31 thang 8 ndm 2012 c 'aChinh phI; quy dinh chuc nang nhiem ~J quy~n han va co cJu t6 chtec c 'a86 Y ti;
Theo dJ nghi cua C1,Ic trutmg C1,IC Quan iyDuac,B9 truong Bf> Y Ii ban hanh' "Thong ttr ban hanh Danh muc thu6c kho g
Ire don ".
'(HONGTUBan hanh Danb muc thuac kbong ke don
sCS Y TE rlNHKON TUM,t so: 51Oj ·DENNgay:JJ1611011.
,
Di~u 1. Pham vi di~u ehinh
Thong ill nay quy dinh nguyen ~c xay dung, tieu chi lira chon th ~ckhong ke dan; Danh rnuc thucc khong ke dan; muc dich ban hanh va tra hnhiern thuc hien.
Di~u 2. Nguyen t~c xay d\fog va ti~u chi 1'/8 chen tbu6c vao Da hmuc thu&c kbong ke doon
I. Nguyen tAcxay dl,ffigDanh m\lC thu6c khong ke dan:a) Bao dam an toan cho nguOi sa d\lflg;b) BilO diun vi~ tiq, '*' thu&ckjp thOi cho nguoi dan; Ic) Ph~hqp v~ ~h~ctBsu ~111O:,cung ~g thU6~cua :i~t~am; .. "Id) Hoa hqp VO'l cac nguyen tac~quy dInh phan lo~uthuoc khong ke d
clla cac nuac trong khu Vl,J'C va tren th~ gim.
2. Tieu chi Iva chQndua thu6c vao Danh ml:lC thu6c khong ke don
Thu6c dugc xem xet l\la chQnvao Danh m1,lcthu&ckhong ke don khiUng cae tieu chi sau day:
a) Thu6c co dQc tinh th§p, trong qua trinh bao qUM va khi vao trong (Jth8 nguai khong t{to ra cac san phfun phan buy co dQc tinh, khong cO nh- gphan Un? co,h~i n~jem ~Qng.da ~~QC bi8th~~C du,Q'cT6 ,~h(rcy}a ~8 g~m,F,(Jquan quan ly~co ~hamquyen eua Vi¥t Nam ho~c nuac ngoaJ khuyen cao co Plfntmg co h~i dan den mQttrong nhUng h~u qua sau day: I
~ ,\..' ~Ij
t,8' ~ Chung lim: BOY L~\! !Nl?ily,ky: 16/06/201~ 16:5f:57~' • .- H9 lhong VOfficc B(l Y Tc •Chung thu: BOY l~~ b Ngay IcY: 2)/06/2017 I) :01:42
~ ..~, Hq th6ng VOfficc BOY Ta
,.''. 2
- Ttf vong;- De doa tinh mang;_ BUQcngiroi benh phai nh~p vi~n d~ di~u tri ho~c keo dai thai gian n~~
vien cua nguoi benh;- D~ lai di chirng nang n~ ho~c vinh vi~n cho ngiroi benh;
- Gay di t~t bAm sinh a thai nhi;_Bfit ky phan irng co hai khac gay h~u qua nghiem trong v~ m~t lam sang
cho nguoi benh do nguoi hanh ngh~ kham benh, chua benh danh gia, nhan dinh.
b) Thu3c co pham vi li8u dung ['Qng, an toan cho cac nhom tu6i, it co anhhuang d~n vi~c chAn doan va dieu tri cac benh can thee doi lam sang;
e) Tbu6c diroc chi dinh trong di.~utr] cac benh khong phai la benh nghiemtrong va nguoi benh co th~ tv diBu tri, khong nh§t thiet phai co SlJ ke dan vathee doi cua nguaj hilOh ngb~ kham b~nh, chua ~nh;
~) 8uemg dun~, d~g th116c dan giW:l ma nguaj sa ,dl,mgco th~ t\1'dung(cbu yeu hi duang uong. dung ngoru. da) vai ham IUQ'Ilg, nong dQ thich hgp chovi~c tv diSu tri;
d) Thu3c it tU'ang tac vm cae thu6c kha.c va thuc an, d6 u6ng thong d\.mg;
e) Thu6c it co kha nang gay tinh tr~g I~ thuQc;
g) Thu6c it co nguy ca bi l~m d\illg, sa dl:}ngsat m\lc dich him limh huangd~n slJ an toan eua nguai Slr dl:}ng;
h) Thu6c cia co thai gian luu hanh t~ Vi¢t Nam t6i thi~u tir 05 nam tr6len.
Di~u 3. Danh m\tc thu&c khong ke dO'lJThu6c khong ke dan quy dinh t~ Danh m\1c ban hanh kern thee Thong tlI
nay.
I>i~u 4. M\lc dich ban himh Danb m\lc tbu8c khong ke dO'n
1. Danh m\lc thu6c khang ke don la co s6 d~ phan lo~i thu6c khong kedan va thu6c ke dan. Cae thu6c khong thuQc Danh m\lc thu6c khong ke danduqc phan lo~i lil thu6c ke dan.
2. Danh m\lc thu6c khang ke dan 1ftCCI sj d~, co quan quan Iy nha nuocxay d\ffig va ban hmh cac quy dinh, huang dan doi voi thuoc khang ke dantrong dang ky thubc. san xu~t, xuAt kh§u, nh~p khgu, luu thong ph an ph6i th~6c,thong tin quang cao thu6c, thanh tra, ki~m tra, xu Iy vi ph~m va cae ho~t dbngkhac co lien quan.
I>i~u 5. Hi~u l\l'c thi hanh1. Thong tu nay co hi~u l\1'c·thihfmh k~ tir ngay 01 thang 7 nam 2017.
0\,
3 I2. Thong nr s6 23/2014nT.;BYT ngay 30 thing 6 nam 2014 cua Bk>
twang BQ Y t@ ban hanh Danh rnuc thu6c khong ke dan h~t hieu IlJc thi hanh ~enr ngay Thong tu nay co hi~u hrc. i!
!
Di~u 6. Di~u khoan cblJy~n ti~p I. ,j
1. Ke nr ngay Thong nr filly co hi~u 11,c, cac thuoc trong Danh muc thUGCkhong ke d.an ,ban hanh k~m thea Thong tu nay duoc phep C~P.Phat, him Ie va ~irdung khong can dan thuoc, tnr tnreng hop thuoc dang duoc phan loai 1a thu~cke dan tren nhan (bao g6m =.tb huong dful su dung thu6c) thl pha.i cap ph,t,ban 1e va su dung thea don thuoc. i
2. 86i voi cac thu6c aa ougc cAp gi&y dang ky hill hanh t~i Vi~t Naknhoac duoc dip gi~y phep nh~p khAu tru6'c ngay Thong tu nay co hi~u 1\re th~chi~n nhLfsaL!: I!
a) D6i vai cae thu6c thuQc Danh mve thu6c khong ke don thea quy diJmt~i Thong tu s6 23/20 14/TT-BYT nhung khong thuQc Danh m\lC thuf>c khong ~edan ban ~anh kern theo Th?ng tU,nay, cae eo so dUng ten tren ~i~y dang kY l~ruh~mh thuoc, co sa nh~P khau thuoc phai pharr lo~i, c~p nh~t, b6 sung cac thobgtin lien quan d&n vi~c phan lo~i thu6c thea quy d.jnh cua Thong tu miy !ren nhlinva to huong d~n su d\lng thu6c theo lQ trinh quy dinb ~ Thong tu quy dinh ~~ghi nhin thu6c, nguyen li~u lam thu6c do BQ tWCmg'BQ Y tS ban himh tru6c lthidua thu6c ra 1Uti thong tren thi truemg. I
" , ib) Dei v6i cae thuoc k.hong thuQc Danh m\lc thuoc khong ke don th.eo ~uy
dinh t~i Thong tu s6 23/20 14ITT-BYT nh~ng thuQc Daub ro\le thu8c khongjkedan ban himh kern theo Thong. til nay, ke ttl ngay Thong tU' nay co hi~u. ~~c,khul~n khich co sa dUng ten .tren gi~y dang.kY lUll hanh thu6c" CCI sa nh~p ~Authuoc phan lo~i" c~p n.h~t; bo sung cae thong tin lien quan den vi~c phan lp~i
, ~ l!
thuoc thel;) quy diJ~heua Thong tu nay tren nha:n va to huemg dan Str dvng th~octnrfc kh~ dua ;_thu~c1'a Iyu t~on~ tren. thi. !rUemg; h~~c cn: co ~adUyc P?ep t~nxuat, nlwp khau cae thuoe co thong tm lIen quan den phan lo~u thuoc tren n~anv~ to h~6'ng dan Slr dvng nhu ad duqc phe duy~t 08 luu han.h d.Snh~.t.h~ d~ngcua thuoc. I
3. D6i v6i he, so dang ky thu6c t?i Vi~t Nam va h6 so nh~p kh§.u thb6cchua co gifiy dang ky h.m h::inhtl;li Vi~t Nam o§ nQP t~}evc, Qulm ly Dugc t;focng~y Thong tu n~y c~ hi~u, l\tc ~un.¥ chua d~?c cap giay dang ky luu hi· .ho?c chua duqc cap glay phep nh~p khau thvc hlyn nhu sau:
I' • Ia) D6i vai ca.c thuoc thuQc Danh m\lc thuoc khong ke don thea quy ~nh
t~i Thong tLr s6 2312014/TI-BYT nhtmg khong thuQc Danh m\lc thufi~khon$ kedan ban h,inh kern theo Thong tu nay thi phai thvc hi~n phan to?1 thuoc theo quydinh t~i Thong tu nay; I
b) D6i vai cac thu6c khong thuQc Danh m\lc thu6c khong ke don thea buy, 1 ~dinh t~i Thong tu so 23/2014/TT-BYT nhl1ng thuQc Danh m'llc thuoc khon. ke
dan ban hanh kem thea Thong tu nay, co sa duqc ti~p tvc thvc hi~n phan llo~i
\~,
4 ..thuoc theo h3 so da n9P hoac thuc hi~n phan loai thu6e theo quy dinh cua Thongnr nay.
f)i~u 7. Trach nbi~m thi hanh1. Trach nhiern cua co sa ducc, co sa kham benh, chua benh:
a) Tlurc hi~n cac quy dinh tai Thong nr nay;b) D~ xudt sua d6i, be, sung Danh muc thu6e khong ke don cho phu hop
tinh hlnh thuc tS, bao dam dap irng kip thai thuoc phuc VI,) cho cong tac phongbenh, chira benh,
2. Trach nhiem cua C\1e Quan ly DUQc:
a) Chu tri, phoi hop voi cac co' quan chirc nang thirc hien Thong tu nay;b) Ra soat Danh muc thu6c khong kc don, tru thuoc e6 truy~n khong ke
don va bao cao B9 tnrong BQY t~ tren co so d~ xudt sua d6i, b6 sung cua cacdon vi quy dinh tai Khoan 1 Di8u Ray ho~e k~t lu;fm cua HQi d6ng illv~n C§.pgi§y dapg ky hru ha,nh thube, nguyen Ii~u lam lhu6c.
3. Trach nhi~m eua Cl,1eQuart ly Y, DuQ'c e6 truy~n:a) Ph6i hQ'P vo; CI,1CQuim ly DuQ'Cva cae co quon chuc nang thve hi~n
Thong tu nay;b) Ra soat Danh tnl,)C thu6c e6 truyBn k.h6ng ke don va bao cao Bi? truemg
BQ Y t<% tl'en co s6 dB xud,t sua d6i, b6 sung cua cac don vi quy djnh t~i Khoim 1DiSu mlY ho~c k~t lu~n eua HQi d8ng tu vdn edp gi§y dang ky luu hanh thubc,nguyen li~u lam thubc.
Ndi ""~JI:• VAn phong, Chinh phll (Cong bilo, Cbng Thong tin di~n111CP);- B¢ tl'U'Crng Nguytn Thi Kim Ti~n:• Cae Thu tnItmg BQ Y t~;• HI>Tlr phap (eve Ki~m tra van ban QPPL);_Cac BQ: B(l Cong un (C\lC Y t8), B(>Qu6c phaug (C!,ICQuail y); Bo Giao thong v~n rai (C!,IC Y ta);_So y t~ cile linh, thanh ph5 tr~rcthuQc TW;_ Cae Y\I, (\Ie.T6ng C\lC,Van phong BQ. Thanh tra B(> -B(>Y t~._Hi~p hoi Dnanh nghi~p dlJ'Q'cVi~t Nam;• T6ng Cong ly DuQ'c Vi~t Nam_C6ng Thong tin di~n tlr B(>Y ta;- LlJ'u: VT. OLD. YDCT'.~