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<~ 1~~,;'~: -i--rofNQ-cp phien i19P thuong ky Chinh phu than,g 02 nam 2017, Theo do, Chtnp"~I.i; ~,~I phu thong nhft ch~)Ph"e~,ti~p tuc thV',Ghi~,~ ~ ~~~~ ~~fig ~,j v~i ~u~t,I (J) '" L>i_t/ ,:? I diroc 2016 den khi Nghi dinh quy dinh chi ttetmQt so GleU va bI~n phap thi hanp___I _,_'~=~~~53J Lu~t duqc Ham 2016 (sau day gQi t~tta Nghi dinh) c6 hi~:ul~rcthi hAnh. j

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2. Tbll t\IC, dip phep nh~p khau thubc thanh pharo, \TaC xin, sinh pham y ~echua co s6 dang ky luu himh t~iVi~tNarng6il): !

a) Thu6c tbanh ph~m co chiradll\1c chdlchua C686 dallg ky h{}?cdugc c}1~teta co s6 dang ky nhung chua dap lIng <iii rthu cAtt diSutri, sinh ph§tn yt~dtmg 4~h' b"nh h'" b" 'h Ipong ((' , c ua ((n ; I

b) Thu6c hiSm, thu6c cho nhu cAudi~u tri cua b~nh vi~n trongtrllOng hqpd0Cbi~t d~cung c5p cho cO's& kham b~nh, ch¥a b~nh; ',.' I

c) VAc xin~ sinh phfrm y tS theo nhu d.lI d:i~u tri d~c bi~t d~ C(lllg cap c~oco sa di~u trl, co sa tiem ph6ng va cu sa xet tlghi~m; i

d) Thu6c dap tin!?nhu cAlldlpbachcho phong1 ch6ngdjch b~nb,khijc phdch~u qua tbietl. tai, thcimhQa; "', I

d) ThuAc ph~.JC V\l eho cac chuang trinhm\lc tiSuy t8 QU5c:.gia; Ie) Thu6c vi~ntrQ', Yi~n trq nh~nd~o; , i

,~ g).:hu~c d~~gcho .~~c ~~cht~ulam s.~ng1}am.~~u ~an~~ ~aPh~cj\lVl((C nghlen cUU,kiem nghl~ll1l klem a!M, n&fiJencuu slrihkba dl,lng/tl1QngdlI01)gsinh hQc;

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h) Thu6c d~ tham gia tnmg bay) trien HimhQi cho va cac tnrong hop tarnnhap, tai xu~t thu6c khac;

i) Thuoc chua benh eho ngtroi thea duong nhap khftu phi m~u dich., .....j" . 't.. _'.' f.:. or", "

3. Thu tuc dip phep nhap khdu diroe chat de san xuatthuoc xuat khau, saoxu§t thu6c phuc vu yell du quoc phong, an ninh, phong dieh, nghien ciru sanXUfrtthudc, k.iSm nghiem, nghien ciru. .

4. Th1.1tuc c~p phep nhap khAula diroc, y6 pang, .chdt.ch\l~, gao bi ti6pXlIC true tiep voi thuoc.

5. Thu tuc c~p phep nh~p khdu song song thuAc bi~t ducc g6c..6. Thu tuc kiem dinh v~c xin, sinh phAroy t~ nh~p kh~u.7. Th(1 tuc thong quan xuftt khau, nh~p khaq thu5c, nguyenli~u lam thu6~.8. Thil tt,lc e~p phep nh~p kh§.u.xu~t khau th.u6c giiy pghi~n,thu6c hti6ng

tam than, tiSn eh~t dung lam thu5c, nguyeJJJi~u. gay nghi~n"hU&:lg:tam th!n, ti@nch~t, thu6c thimh phfun d?ng ph6i hQ'p c6 chua ho;;tt chat gay n.ghi~n,·d?ngph6i

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hqp co chua ho?t chat huang tfun than, d?ng phoj hgp co chua den Ghatdun~lftmthu6c.

9: Thu tlJC cap giAy phep muattoqg nl,l"qc thl,l6cgay hgl1i~l1'tim.be h!iOng.tam th§n, tiSn chat dung lam thu6c, nguyenli~u. gay nghi~n,.l'lli6ngtam tb,§p, ti~nch~.t.

10. ThCI tvc cho phep nh?p khftu,xu§.t kh~uthuac,gaynghi~n, thu6c huortgtam th§n, ti&n eh~t dung lam thu6c theo duang Pili m~u dich. . .

11. Tht}We ti8p ijh~n b& sa (tangky tho~g tin thlJ6p; tiSp nh~tt h§ sa d~ngky h9i thao gi6i thi~u thu6c cho.cEm qQyt~; c~pthechongmYLgi6ithf~uthuBc co·trinh d9 chuyen mon du(,lc S1 d~i hQc vadugc sitruilg c~p;

J 2. Tht) tlfc xac nh~n nQi dung quang cao thu6c.13. Thu tve ke khai, ke khai ll;ligia.thu6c.14. Thu tvc thu h&i thu5c, phan.lQ~i muc tlQ t,hij bah .",(t 1:2thti.6c bLthuba~,

plwm vi thu h6i thu6c. . ..15. Tfit) tvc dp, cap Ilfi, gia h?I1;.b6 sung ph~m vi kinh doanh irong Gigy

ehung nh~n du di@uki~n kinh doanh thu6c d6i v&i cO'.s6 sanxudUhu6c, ba.n buonthu6c, ban Ie thu6c, thu thu6c tren lam sang.

J 6. 111.utvc eftpJ;;ti Chqpg chLl:l~Mpihedggc. v(u.HU'o1\g d~nvi~cti~p l'lb~n,x-fr.lY tlui t"'~b~~h chiqh, quy~(li~vA chuy~n

ti~p d5i voi nlQt sf, tru'O'l1g'h<tP:1. 86i v6i chung chi harth ngh~ .d!Jo/Q:a) TruOng hqp nguOi c6 ch(mg chi hltnh rtgh~ht~th;;tnsau ngay 31 thfing 12

nam 2016 nhtmg eta nQP h6 sa dS nghj Q~pl?i chUng chi hfm.J;i~ghStruocngay Ngh!dinh co hi~u l\Ic thi himh: Trong thai gian.chCtxete~pchimg chi hanh ngh~moi~duQ'cti8p ll,lc Slr d\lng chung chi hanh ngh~iia p§p as hanh nghS dugc c110den khi co

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quan tiep nhan h6 so' co thong bao; ,b) Truong hop nguoi co clurng chi hanh nghS h~t han sau ngay.31 thing l~

nam 2016 nhung khong nQP h6 sa de nghi c&plai chimg chi hanh ngh8 tnroc ngayNgh] dinh co hi~u lire thi hanh thl khong aU'Q'c phep sir dung chimg chi hanhngh~¥h8t han a8 hanh ngh€ diroc; .. !

c) cap Chung chi hanh ngh~ ducc: HB SO'., trinh tu, thu tuc cap Chungchlhanhnghe duoc diroc thuc hi~n thea quy dinh cua Lll~t duoc 20J6.

2. D6i voi GiAyclnmg nh~n au di&uki~h kinh doanh.thuoc: Ia) Truong hop ca sa kinh doanh ducc co Gidy clnrng rih?Il du di~u ki~~

kinh doanh thuoc hSt hieu lire thi hanh sau ngay 3J thang 12 nMl2016 nhung 4anop h6 So' d~ nghi gia h~ Giay ch(mg nh~:du di@uki~tl kinh.doanh thubc tnr4engay Nghi dinh co hi~u Ivc thi hanh; TtOJlg thoi gian cho xet gia h~, dll'Q'cti~p t\~CSlr d\,lngGiAy chung nh~ndll di~u ki~nkinhdoanhthu&c de kirih doanh duQ'c th~o

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dCIngph~m vi kinh doanh trong Giay chimg nh~n oil dien ki~n kinh doahh thuqcda duQ'c CAR cho dSn,kbi co qllan ti~pnh~nh6 5(1qOtboqg bao; :

b) Ttuang hqp Co' sa kinh doanh dugc C'Q Oiiy chWig :rili~Il·dli<tj~uki~Iikinh doanh thu6c hathi~u h,rc thi hanh saungay31 thang12nam2016nhungkhortg

.. : _~. __- . , . _". . _ _. _ . "' . tI1<)P h6 sa de"nghi gia h~ Giay chUng nh~ du dieu ki~n kinh doanh thuoc tnrqcngay Nghi dinh co hi~u h,rcthihanh thikhongatrqcphep ti§ptl:lcsud\lngGiAychurignh~n du diSu ki¢n kinh dQanh thu6c, oa h8t hf;ln08 kioh doarih duQ'c. .

3. D6i Val dang k9 thu6c:a) TruOng hqp thu6c h~t hi~u 19c s6 dapgky luu hanh saullgay 31 thang

I 2 nam 2016 nhung co so eta nQp van ban cam k~t thu8q ougc ~an:.xu§t;:1U1lhar}hthea dung h6 So' dang ky dk}phe duy~tvaluut~i B9 Yt~ (e1}e Quanly .DUQ'd~,dUQ'e tiSp 1\1e duy tri hi~u ll,tc s6 aangky·tuu hanhcho <1Snkhi cohu6ngd§nmqi;

b) Truong hQ'Pthu6e h8t hi~ul\lc s6 dang ky lu:uhfm}1:S2lU ngay 31 t]:ul~g12 nam 2016 nhung co sa kh6ng nQp v.an b~n ¢atn k,St ·theo,quY djnht\li diSm:a.khofm nay thi kllong 1Ugc ti~Pt ...\).cdUy.·.·.·tri hi~ul\(e s6 dang.lcYlgu,.hWl. h" ,I

4. Co' sa co Giay phep ho~t oQugclla doanh ,nghi~p auoc Ilg()ai vS thu6c vanguyen li~u lam thu6c ~i Vi~tNam, Gi§y phep ho~t dQng ella doanh nghi~p nlI~cngoai vS v~c xin, sinh phAm y t6 va nguyen 1i~usanx~t vfic xin va §inh ph~ti1YtS~iVi~l Nam IHhhi~u h.resau ngay 31 thaog 12 nam 2016(t11Q'cti~pWe .$U dl)ngca~>gi~yphepDayd€ th~rchi¢nthu t\,lCthong qUail xu&tkh&ll'nh~p kh~u thubc, nguyep li~u lAmthu6e ello dShkhi Nghi dinh c6hi~u lJ..Ic thihfuili. !

5. D6i Val cae Co' s&dang san xu~t; xtl.dt kha'u, nh~pJ(h§.u.,b~n buon" l:>~n~~,cung {mg, Slr d\lng thu6C gay nghi'~nj~h~r6chv&ng tam.thdn, ti€ll ch~t dlll1g:}~Uthu6c, nguyen li~ll gay nghi~n, huangtmn thAn, tiSn ch§t, thu6c thanb phfund~gp~6ih9P co chUaho~t chfrt gay nghl~n,d~g ph5Lhc;rp co ch~ hQ~tch~t hU'Qng~n~. ,

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dang phoi hop eo chira ti@nch~t dung lam thuoc tiSp tuc thuc hien theo Ngh] dinh102/201 6/ND-CP ngay 01 thang 7 nam 2016 cua Chinh phil quy dinh di8.uki~hkinh doanh thu6c va cac van ban guy pham phap Ju~t co lien quan dSnthOi di&mNghi dinh eo hieu luc thi hanh,

III. Ngirng' ti~p nh~n va gHiiqQy~tdBi vOicae thu t\lC hanh chinb'khongdu'Q'churmg din-t~i Cong van nay cho 4~ttkhi Ngbi (ljn:h ~6 hi~u IlfC thi hanh,

Trong qua tri nh tri~n khai thuc hi~n, n8u.co' kho khan, vuong )Jl!c:48 nghigiri y kien bang van ban vS BQ Y tS (Cue Quan ly.ducc) d~,kWthgigiili qUYSt.

BQ Y te thong bao dS cac don v,jbiBtva thuc hi~n.l.

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Nai nlz~,,:- Nhtr tren;- BQ tru<'rng (d~ b/e);- LIIU: VT, PC,.QLD (2b);-•

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UBND TINE LAo CAlSOYTE

S<3: OjISYT-SL

SAO Ll)CLew Cai, ngay 18 thang 4 ndm 2017

NO'; nhQIl: ,- Phong Y te: Tp. Lao Cai, Rio Yen, Van Ban,B~e Ha, Muong Khuong;- Van phong HDND va VBND cac huyen BaoThang, Sa Pa, Bat xa. Simaeai;- Cac doanh nghiep kinh doanh thuoc tren dia ban;- Thanh tra SaY t~;- Van phong Sa Y t~;-LUU:VT,~ Ph~mHAng Thanh