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

Ch~n: r;n c" L udt duac "gay 06 thdng 4 "am2016.. ILw h6sd 16:..· ·..~n cit Nghi dinh s6 63/2012/ND-CP ngay 31 thong 8 ruim 2012 cTta

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);

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;~ 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).

Di~u 3. Danh muc thuac dQc, nguyen n~u dQc lam thuAcDanh muc thuoc doc va nguyen 1i~u dQc lam thuoc duoc ban hanh kern

theo Thong nr nay.

Di~u 4. Mt}c dich ban hanh Danh muc tbu8c dQc, nguyen Ji~u dQc lamthuAc

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.

Di~u 7. Tnlch nhi~m thi hanh1. Trach nhi~m clla co sa dl1Q'C,co so khrun b~nh, chua b~nh:a) Th\lc hi~n cae quy dinh v€ quiln ly thu6e d9c, nguyen li~u dQc lam

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~)

ITNguyen Ii~u d9Cl Duong dung, dang bao ch~ c?a

Thu8c chea nguyen Ii~u dQc thu8c dQc1 Abirateron Uong: cac dang2 Acid valproic Uong: cac dang; Tiem: cac dang

3 Anastrozol Uong: cac dang

4 Arsenic trioxid Tiern: cac dang

5 Atracurium besylat Tiem: cac dang6 Atropin sui fat Tiern: cac dang

7 Azacitidin Tiem: cac dang

8 Bicalutamid Uong: cac dangI

9 Bleomycin Tiem: cac dang I

10 Bortezomib Tiem: cac dang-

11 Botulinum toxin Tiem: cac dang

12 Bupivacain Tiern: cac dang

13 Capecitabin Uong: cac dang,I

14 Carbamazepin Uong: cac dang I

15 Carboplatin Tiem: cac dang

16 Cannustin Tiem: cac dang

17 Cetrorelix Tiern: cac dang

18 Chlorambucil Uong: cac dang I

19 Choriogonadotropin alfa Tiem: cac dang :

20 Cisplatin Tiem: cac dang _ .....-21 Colistin Tiern: cac d"mg

22 Conjugated Oestrogens Uong: cac d?Ilg

23 Cyclophosphamid Uong: cac d?ng; Tiem: cac d~rg

24 Cyclosporin Uong: cac d<,lOg

25 Cytarabin Tiem: cac d?ng

'2

Nguyen li~u c1Qcl Dtr<rng du:ng, d,ng baC) chi cr aTT

Th uac chira nguyen li~u (fOe tbu&c dQc26 Dacarbazine Tiem: cac dang

27 Daetinomycin Tiem: cac dang

28 Daunorubicin Tiem: cac dang

29 Degarelix Tiem: cac dang-

30 Desflurane Khi hoa long

31 Dexmedetomidin Tiem: cac dang

32 Docetaxel Tiem: cac dang

33 Doxorubicin Tiem: cac dang

34 Entecavir Uong: cac dang

35 Epirubicin Tiern: cac dang

36 Erlotinib Uong: cac dang

37 Estradiol Tiem: cac dang I38 Etoposide Uong: cac dang; Tiem: cac dai g39 Everolimus Uong: cac dang

40 Exemestane Uong: cac dang41 Fludarabine Tiern: cac dang42 Fluorouracil (5-FU) Tiem: cac dang

43 Flutamide Uong: cac dang

44 Fulvestrant Tiern: cac dang

45 Ganciclovir Tiem: cac dang46 Ganirelix Tiem: cac dang

47 Gefitinib Uong: cac dang

48 Gerncitabine Tiern: cac dang

49 Goserelin Tiern: cac dangI

...

50 Halothan Khi hoa long51 Hydroxyurea Uong: cac dang

52 Ifosfamide Tiem: cac dang

53 Imatinib Uong: cae d~ng

54 Irinoteea.n Tiem: cac d\lng

55 lsotlllran Khi hoa long

56 Lenalidomide Uong: Clic d~g

57 Letrozole Uong: eae d~g

3

ITNguyen Ii~u dQcl Dtrirng dung, dang bao ch~ cua

TbuAc chira nguyen Ii~u d,Qc tbuac dQc

58 Leuprorelin (Leuprolide) Tiem: cac dang

59 Levobupivacain Tiern: cac dang

60 Medroxy progesterone acetate Tiern: cac dang1

61 Menotropin Tiern: cac dang I62 Mepivacain Tiern: cac dang

""\

I63 Mercaptopurine Uong: cac dang j64 Methotrexate Uang: cac dang; Tiem: cac dang

65 Methyltestosteron Uong: cac dang

66 .Mitomycin C Tiern: cac dang

67 Mitoxantrone Tiern: cac dangI

68 Myeophenolate Uong: cac dang I

69 Neostigrnin metylsulfat Tiern: cac dang

70 Nilotinib Uong: cac dang

71 Octreotide Tiern: cac dang I

72 Oxaliplatin Tiern: cac dang I73 Oxcarbazepine Hong: cac dang I

74 Oxytocin Tiem: cac dang_I-

75 Paelitaxel Tiern: cac dang I76 Pamidronat disodium Uong: cac dang; Tiern: cac dang

77 Pancuroniurn bromid Tiern: cac dang II

78 Pazopanib Uong: elk dang I

79 Pemetrexed Tiern: cac dang I

80 Pipecuronium bromid Tiem: cac dang II

81 Procain hydroclorid Tiem: cae d~ng I._.

82 Progesterone Tiem: cae d~ng I

83 Propofo} Tiem: cac d~g

84 Pyridostigmin bromid Tiem: cae d~ng

85 Ribavirin U6ng: cac d~g; Tiem: cac d!;l,ngI

86 RocuroniUlTI bromide Tiem: cac d~ng

87 Ropivacaine Tiem: cae d~ng I

88 Sevofluran Khi hoa long I

89 Sirolimus Uong: cae d~,mg __j

,r •

~

4

Nguyen Ii~u dQcf DU'Cmgdung, d,ng bao c~laTT

ThuAc chira nguyen li~u dqc thu8c dQc

90 Sorafenib Uong: cac dang

91 Sunitinib fbng: cac dang

92 Suxarnethonium clorid Tiem: cac dang

93 Tacrolimus uang: oac dang; Tiem: cac dan g

94 Talniflumat Uong: cac dang

95 Tamoxifen Uong: cac dang,

96 Temozolornide Uong: cac dang

97 Testosterone Uong: cac dang; Tiem: cac dang

98 Thalidomide Uoni cac dang

99 Thiopental Tiem: cac dang

100 Thiotepa Tiem: cac dang

101 Thymosin alpha I Tiern: cac dang

102 Topotecan Uong: cac dang; Tiem: cac dar g

103 Triptorelin Tiern: cac dang

104 Tritenoin (All-Trans Retinoic Acid) fbng: cac dang105 Valganciclovir Uong: cac dang106 Vecuronium bromide Tiem: cac dang

107 Vinblastine Tiern: cac dang

108 Vincristin Tiem: cac dang

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'.~