Thông tư 08 - 2022 TT-BYT Quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc

Thông tư 08 - 2022 TT-BYT Quy định việc đăng ký lưu hành thuốc, nguyên liệu làm thuốc

1. .CT
BOYTE CONGHOAXAHOICHiTNGHiAvrsrNAM
DqcI~p-T"do-H~nhplnic
S6: 12022/TT-BYT HaN{H,ngay thangndm2022
THONGTU
Quydjnhvi~cdangkyhruhanhthuoc,nguyenli~ulamthuBc
CanctrLudtDU(Jcs6105120161QH13 ngay06thangAndm2016;
CancuNghidinhs65412017IND-CP ngay08thang5ndm2017cuaChinh
philquydinhchitiitmots6di~uvabienphapthihanhLudtDU(Jc;
CanctrNghidinhs675120171ND-CP ngay20thang6ndm2017cuaChinh
philquydinhchtrcnang, nhiem v¥,quyenhanvaco'cdut6chuccuaB(JYtd;
CancuNghidtnhs615512018IND-CP ngay12thang11ndm2018cuaChinh
philsuad6i,b6sungmots6quydinhlienquandindi~ukienddutukinhdoanhthuoc
phamviquanIf;nhamarccuaB(JYtd;
Theod~nghicuaCuetruongCueQuanIf;DU(Jc.
B(JtruongB(JYtdbanhanhThong tuquydinh.viecdangkyluuhanhthuoc,
nguyen lieulamthu6c.
ChuangI
QUYDJNHCHUNG
Di~u1.Ph~mvidi~uchinh
1.ThongtunayquydinhchitiSt:
a)H6sa,thut\lCc~p,giah~n,thayd6i,b6sung,thuh6igi~ydangkYluu
hanhthu6choaduQ'c,v~cxin,sinhphfim,thu6cduQ'cli~uvanguyen li~ulam
thu6c(duQ'cch~t,banthanhphfimduQ'cli~u,taduQ'c, vonang)dungchonguai
t~iVi~tNam;
b)Yeuc§.uvSdfrli~ulamsangdSbaodamantoan,hi~uquatrongh6sa
dangkythu6c;
c)TieuchidSxacdinhtruanghQ'PmiSnthu,miSnmQts6giaido~nthu
thu6ctrenlamsangt~iVi~tNam,thu6cphaiyeuc§.uthuHimsanggiaido~n4;
d)Nguyent~ct6chuc,ho~tdQngcuachuyengiathfimdinhh6sadSnghi
c~p,giah~n,thayd6i,b6sunggi~ydangkyluuhanhthu6c, nguyen li~ulam
thu6c;
d)Nguyent~ct6chuc,ho~tdQngcuachuyen giathfimdinhh6sadSnghi
c~pphepnh~pkhfiuthu6cchuacogi~ydangkyluuhanhd6ivaicactruanghQ'P
quydinht~idiSmakhoan 43DiSu5Nghidinhs6155/20181ND-CP ngay12thangV
\
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

2. 2
11nam2018cuaChinhphusuad6i,b6sungmots6quydinhlienquandSndiSu
kiendfiutirkinhdoanhthuocphamviquanlynhamroccuaBQYtS(saudaygoi
t~tlaNghidinhs6155/2018!ND-CP);
e)Nguyent~ct6chirc, hoatdongcuaHQid6ngtuvancfipgifiydangkyhru
hanhthuoc,nguyenlieulamthuoc(saudaygoit~tlaHQid6ng);
g)Trinhtvthamdinhh6sadSnghicfip,giahan,thayd6i,b6sunggifiy
dangkyhruhanhthuoc,nguyenlieulamthuoc; trinhtvthamdinhh6sanhap
khfiuthuocchuacogifiydangkyhruhanh.
2.Thongnrnaykhongb~tbuocapdungchocactnronghopquydinhtai
diema,bkhoan2DiSu54LuatDuocvabanthanhphamduoclieudochinhco
sasanxufitdSsanxufitthu6cthanhphfimquydinht~idiSmekhoan1DiSu93
Nghidinhs654/2017/ND-CPngay08thang5nam2017cuaChinhphuquydinh
chitiStmQts6diSuvahi~nphapthihanhLu~tDuQ'c(saudaygQit~tlaNghidinh
s654/2017!ND-CP),tmtruemghgpcO'sadangkytvnguy~napd\lng.
Di~u2.Giaithichtirngfr
TrongThongtunay,cactungudu6idayduQ'chiSunhusau:
1.H6sakYthuc;itchungASEAN (ACTD)labQtaili~uhuangd~nh6sa
dangkythu6cdapungcacyeucfiukythu~tchungcuaHi~phQicacnu6cDong
NamA(ASEAN)duQ'cquydinht~iPh\ll\lcIbanhanhkerntheaThongtunay.
2.H6sakYthuc;itchungICH-CTDlam~uh6sachungcuaHQinghiqu6c
tSvShaihoacacthut\lCdangkYduQ'cphfimsud\lngchonguai.
3.Thayd6iIanlanhUngthayd6icoanhhuangrar~t,tflJCtiSpdSnchfit
lUQ'llg, antoanvahi~uquacuathu6c, duQ'cquydinht~iPh\ll\lcIIbanhanhkern
theaThongtunay.
4.Thayd6inh6lanhungthayd6ikhonganhhuangho~canhhuangdtit
dSnhi~uqua,chfitIUQ'llgvaantoancuathu6c,duQ'cquydinht~iPh\ll\lcIIban
hanhkerntheaThongtunay.
5.CO'sadangkYthu6c, nguyen li¢ulamthu6clacO'sadUngtennQpdan
dSnghicfip,giah~n,thayd6i,b6sunggifiydangkylUllhanhthu6c,nguyenli~u
lamthu6c.
6.CO'sascmxucitthu6clacO'sathvchi~nmQt,mQts6congdo~nho~ctoan
bQquatrinhsanxufitJ1o~cthvchi~nvi~cxufitxuang10thu6c.
7.CO'sascmxucitnguyenli¢ulamthu6clacO'sasanxufitranguyenli~udS
sanxufitthu6cthanhphfimho~ccO'sathvchi~nvi~cxufitxuang10nguyenli~u
lamthu6c. .
8.GiciychUngnhc;inscmphdmdU(Jcphdm(CPP)lagifiychUngnh~nduQ'c
cfiptheaH~th6ngc~nI~gnh~n?chfitluQ'llpc~csanphfimduQ'cphfimlUllh.any
trongthuangm~iquoctecuaTochucYtethegi6i(WHO). ff
~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

3. 3
9.CoquanquemIfDU(1cphdmChduAu(EMA)vaCoquanqu~nIfduac
chatche(SRA-StringentRegulatoryAuthorities)lacaccoquanbaogom.
a)CoquanquanlyDU<)'QphamChauAu(EMA);
b)Coquanquanlyduocchatche(SRA-StringentRegulatoryAuthorities):
lacaccoquanquanlydirocduocT6chircYtSthSgioi(WHO)phan10(;1ithuoc
danhsachSRA,baogem:
-ThanhvienICHtnroc23thang10nam2015,baogom:CoquanQuanly
DuocvathucphamMy(US-FDA),Coquanquanlyduoccuacacmrocthuoc
LienminhChauAu(EuropeanUnion),Coquanquanlythuocvacacsanphamy
tScuaVuongquocAnh(MHRA),CoquanquanlyduocvatrangthiStbiytS
Nh~tBan(PMDA);
-ThanhvienquansatcuaICHtnrocngay23thang10nam2015baog6m:
CoquanquanlyDuocthuocHiephoithuongmainrdoChauAu(EFTA­
EuropeanFreeTradeAssociation)voidaidienCoquanquanlyDirocThVYSy
(Swissmedic)vaBQYtSCanada(HealthCanada);
-ThanhviencohiepdinhlienkSt,congnh~nl~nnhauvaiThanhvienICH
truacngay23thang10nam2015baog6m:Dc,Aixolen,LiechtensteinvaNa
Uy.
10.Chitsahfrugidyphepluuhimhthu6c(Productlicenseholder!
Marketingauthorizationholder)lacosasahfrugi~ypheplUllhanhthu6cdu<),c
ghitrenGi~ychUngnh~nsanph~mdu<),cph~m(CPP)theam~ucuaWHOban
hanh.
11.BimthimhphdmdU(1cli¢ulanguyenli~udSsanxu~tthu6ccongu6n
g6cdu<),cli~uduaid(;1ngcao,c6m,bQt,dichchiSt,tinhd~u,nha,gom,th(;1ch.
Di~u3.Traehnhi~mellacO'sO'dangkythuBe,nguyenli~ulamthuBe
1.Chiutrachnhi~mtoandi~ntruacphaplu~tvStinhchinhxac,hqpphap,
trungthccuat~tcacactaili~utrongh6sodangkY.Ph6ihqpvaicosasanxu~t,
coquancoth~mquySntrongnuac,nuacngoaitrongvi~ctralaicacvanbancua
CvcQuanlyDu<)'cdSnghikiSmtratinhxacthccuacacgi~ytaphaplycolien
quantrongh6sodangkythu6c.
2.Thchi~ndangkythayd6i,b6sungtheaquydinht(;1ikhoan4DiSu27,
khoan3DiSu30,khoan3DiSu32vaDiSu38Thongtunaytrongthaigiangi~y
dangkylUllhanhthu6c,nguyenli~ulamthu6cconhi~uh,rc.
3.Chiutrachnhi~mvSvi~cthayd6i,b6sungnQidungnhful,huangd~nsu
dVngthu6ctheadungnQidungtrongvanbanyeuc~uc~pnh~tcuaCvcQuanly
Du<)'ctrongthaigiangi~ydangkylUllhanhthu6cconhi~ulcrnakhongphai
nQPh6sodangkythayd6i,b6sung.
4.B~odamch~tluqng,antoan,hi~uquacuathu6c,nguyenli~ulamthu6c;, ~
dungvaihosodangkY. ~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

4. 4
5.ThongbaobangvanbanchoCueQuanlyDuoctrongthaihan30ngay
kSnrngaycoquyetdinhthuh6igi§.ydangkyluuhanhtaib§.tkymrocnaotren
thSgioid6ivoithuoc,nguyenlieulamthuocdffdirocc§.pgiaydangkyhruhanh
taiVietNamconhieulirevaneur6lydobithuh6i.
6.Ph6ihopchatchevoicosasanxu§.tthuocthuchiennghienciruhoac
cungc§.pthemthongtinlienquandSnthu6cdangkykhicothongtinhoacbang
chimglienquandSntinhantoanvahieuquacuathuoctrongquatrinhhruhanh
theoyeuc~ucuacoquanquanlycothamquyen,
7.Ph6ihopvoicosasanxuat,nhapkhau,phanphcithuocthuchienviec
theodoi,giamsat,thuth~p,t6nghqp,danhgiavaguibaocaodSnTrungtam
Qu6cgiavSThongtinthu6cvaTheod6iphanUngcoh~icuathu6c(Trungtam
Dr&ADRQu6cgia)thongtincactruanghqpphanungsautiemchung,phan
Ungcoh~icuathu6ctheoquydinht~ikhoan5DiSu77Lu~tDuQ'c,cachuang
d~nqu6cgiavScanhgiacduQ'cdoB9YtSbanhanhvacacquydinhcolienquan.
8.BaodamduytridiSuki~nho~td9ngkinhdoanhduQ'ccuacO'sadangky
trongthaih~nhi~ulvccuagi§.ydangkylUllhanhthu6c,nguyenli~ulamthu6c.
TrongtruanghqpkhongcondapUngdudiSuki~nho~td9ng,cO'sadangkyphai
cotrachnhi~mthvchi~nthayd6icO'sadangkytheoquydinht~icuakhoan4
DiSu27,khoan3DiSu30,khoan3DiSu32vaDiSu38Thongtunaytrongthai
h~n30ngaykStungaycO'sadangkYkhongcondudiSuki~nho~td9ng.
9.Chiutrachnhi~mvScacv§.ndSlienquandSnquYSnsahfrutritu~d6i
vaithu6c, nguyenli~ulamthu6cdocO'sadangkyluuhanht~iVi~tNam.
10.Ph6ihqpcO'sasanxu§.tc~pnh~ttieuchu~nch§.tluqngthu6c,nguyen
li~ulamthu6ctheoquydinht~iThongtus61112018/TT-BYT ngay04thang5
nam2018cuaB9truangB9YtSquydinhvSch§.tluqngthu6c,nguyenli~ulam
thu6c(saudayviStt~tlaThong tus611120l8/TT-BYT) vaThongtus6
38/2021/TT-BYTngay31thang12nam2021cuaB9truangB9YtSquydinhvS
ch§.tluqngduQ'cli~u,vithu6cc6truySn,thu6cc6truySn(saudayg<)it~tlaThong
tus638/20211TT-BYT).
11.Thvchi~nkSho~chquanlynguycO'dffduQ'cpheduy~ttrongh6sO'dS
nghic§.p,giah~ngi§.ydangkYlUllhanhd6ivaiv~cxin.
12.Chiutrachnhi~mtheoquydinht~ikhoan2DiSu57Lu~tDuQ'Cvacac
quydinht~iDiSunayd6ivaithu6c, nguyenli~ulamthu6cdocO'sadangkykS
tungayC\1CQuanlyDuQ'ckycongvanchophepthayd6icO'sadangky,bao
g6mcacacthu6c,nguyenli~ulamthu6cdffduQ'cduaralUllhanhtruacthaidiSm
C\1CQuanlyDuQ'ccocongvanchophepchuySnd6icO'sadangkY·
13.Ph6ihqpvaicO'sasanxu§.tcungc§.pm9ttrongcacgi§.yta,taili~uquy
dinht~ikh?an11DiSu22ThongtunaychocO'quanquanlycoth~mquySnkhi./
duQ'cyeucau. W
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

5. 5 >
14.ChiutrachnhiemtheaquydinhtaiThongtunayvacacquydinhcua
phapluatkhaccolienquan.
f)i~u4.Trachnhiemc~a,~<rsirsanxufttthuoc,nguyenli~ulamthudc
1.Phaisanxuatthuoc,nguyenli~ulamthuoctaidungcosacogifiyphep
sanxufitlgifiychirngnhandudieukienkinhdoanhdiroccophamvisanxufit
thuoc,nguyenlieulamthuocdocoquanquanlycothamquyencap,
2.ChiutrachnhiemtoandientnrocphapluatvStinhchinhxac,hopphap,
trungthirccuatfitcacactailieulienquandSnthuoc,nguyenlieulamthuocdoco
sasanxufitthuoc,nguyenlieulamthuoccungcfipchocosadangkythuocdS
dangkyhruhanhtaiVietNam.
3.Ph6ihopvoicosadangkythuoc, nguyenlieulamthuoc:
a)Thuchienquydinhtaikhoan2,3va4DiSu3Thongtunay;
b)Thirchi~ncacyeuc~uvSkiSmtra,danhgiacosasanxufitkhicoyeu
c~ucuacoquanquanlycoth~mquySn.
4.DSnghithuh6igifiydangkyluuhanhthu6c, nguyenli~ulamthu6cdo
cosasanxufittrongtruOnghgpthu6c,nguyenli~ulamthu6ccovfindSvSchfit
lugng,antoanvahi~uquaanhhuangdSnsuckhoecuanguaisud\mgtheaMfiu
1ITTbanhanhkerntheaThongtunay.
5.BaodamcacdiSuki~nhOC;ltd(>ngcuacosasanxufittrongthaihC;lnhi~u
h,rccuagifiydangkyluuhanhthu6c,nguyenli~ulamthu6c.
6.Truanghgpcosadangkythu6c,nguyenli~ulamthu6ckhongdudiSu
ki~nhOC;ltd(>ngtheothongbaocuacoquanquanlycoth~mquySn,cosasanxufit
duQ'cthvchi~nvi~cthayd6icosadangkycuathu6c,nguyenli~ulamthu6ctrong
thaihC;ln30ngaykStilngaycovanbanthongbao.
7.Thvchi~nc~pnh~ttieuchu~nchfitlugngthu6c, nguyenli~ulamthu6c
theaquydinhtC;liThongtus611/2018/TT-BYT vaThongtus638/20211TT-BYT.
8.Chiutnichnhi~mdanhgiavabaodamcosasanxufitnguyenli~ulam
thu6cdapungthvchanht6tsanxufitnguyenli~ulamthu6c,luutruvacungcfip
m(>ttrongcacgifiyta,taili~uquydinht;likhoan11DiSu22Thongtunaychoco
quanquanlycoth~mquySnkhiduQ'cyeuc~u.
f)i~u5.Quydinhv~baocaotheodoi,danhgiaantoan,hi~uqua
1.CosakinhdoanhduQ'c,cosakhamb~nh,chuab~nhphaithvchi~nvi~c
thead6i,giamsat,thuth~p,t6nghgp,danhgiavabaocaocoquancoth~mquySn
thongtincactruOnghgpphanli'ngsautiemchung,phanlingcohC;licuathu6c
theaquydinhtC;liDiSu77,DiSu78Lu~tDuQ'c,cachuangdfinqu6cgiavScanh
giacduQ'cdoB(>YtSbanhanhvacacquydinhcolienquan.
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

6. 6
2.Cosadangkythuocphaibaocaotheadoi,danhgiaantoan,hieuqua
cuathu6cquydinhtaikhoan2DiSu8ThongtunaytheaM~u2A1TT(d6ivoi
thuoc)hoacM~u2B/TT(d6ivoivacxin):
a)Dinhky06thangmotl~ntrongthaihangi§.ydangkyhruhanhconhieu
hrcguivSTrungtamDr&ADRQuocgia;
b)KhinQPh6sadangkygiahangi§.ydangkyhruhanhtaiC\lCQuanly
Duoc.
3.Cosakhambenh,chuabenhcosirdungthu6cbaocaotinhhinhsirdung
thu6ctheaM~u2C/TT banhanhkerntheaThongtirnaydinhky06thangmot
l~ntrongthaihangi§.ydangkyhruhanhconhieuhrcd6ivoithuoc-quydinhtai
khoan2DiSu8ThongtirnayvaguivSTrungtamDr&ADRQuocgia.
4.Dinhky06thangmotl~n,TrungtamDr&ADRQuocgiacotrachnhiem
t6nghqp,danhgiavaguibaocaovSC\lCQuanlyDuQ'c.
Di~u6.Ngooogfr,hlohthrrchBsO',salU'Q'oghBsO',titili~u.
1.Ngonngusud\lngtrongh6sadangky
H6sadangkythu6c,nguyen li~ulamthu6cphaiduQ'cviStb~ngtiSngVi~t
ho~ctiSngAnh.Riengtahuangd~nsudVngthu6cvatomt~td~ctinhsanph~m
phaiduQ'cviStb~ngtiSngVi~t.
2.H6sadangkythu6c,nguyen li~ulamthu6cphaiduQ'cchu~nbitrenkh6
gi§.yA4,dongch~cch~n.H6saphaicotrangbia(M~u3/TT)duQ'cs~pxSpthea
dungtrinhtvcuam\lcl\lc(M~u4/TT),cophancachgiuacacph~n.Cacph~n
phancachphaiduQ'cdanhs6thlit\Tvacod§.uxacnh~ncuacasadangkyho~c
casasanxu§.tthu6c,nguyenli~ulamthu6catrangd~utiencuam6iph~ntrong
toanbQh6sa(ch§.pnh~nd§.ucuavanphongd~idi~nd6ivaithu6cnuacngoai).
Quydinhnaykhongapd\lngd6ivaih6sanQptrvctuySn.
Cactaili~usauphaidongthanhcacph~nriengvakern01dandangky:
a)Taili~unghiencUutuangduangsinhh9C;
b)Taili~utiSnlamsang,lamsang;
c)Taili~udanhgiavi~cdaplingGMPtheaquydinht~iDiSu95,98Nghi
dinhs654/2017/ND-CPvakhoan 53DiSu4,khoan51DiSu5Nghidinh
155/2018/ND-CPd6ivaicasasanxu§.tthu6c,nguyenli~ulamthu6cnuacngoaikhi
dangkylUllhanht~iVi~tNam.
3.Cacthu6ccothSdangkytrongcungmQth6sakhicochungcacySut6
sau:tenthu6c;d~ngbaochS;duangdung; tieuchu~nch§.tluqngthu6c;tenvadia
chinhasanxu§.t;cungcongthlicbaochS,trongdo:cocunghamluqngduQ'cch§.t
tinhtheadanvichialiSud6ivaicacthu6cd~ngr~ncochialiSu;cocungn6ng
dQho~chiunlugngdugcchiltd6ivaicacthubcd(lIlgrilnkhongchialibu,d:]
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

7. 7
longhoacbanr~n;coclingnongdQhoachamhrongdirocchatvachatlieubao
bitiSpxuctruetiSpvoithuocd6ivoicacthuocdangtiem,tiemtruyen,
4.SohrongcactailieuphainQPtrongh6sadSnghic~p,giahangi~ydang
kyhruhanh,cuthSnhusau:
a)01(mot)bQcod~yduh6satheoquydinhtaikhoan1,2,3,5DiSu27
Thongtirnayd6ivoithuochoaduoc,v~cxin,sinhphamvah6saquydinhtai
khoan1,2DiSu30,khoan1,2DiSu32Thongtunayd6ivoithu6cduoclieu,
nguyenlieulamthuoc;
b)01(mot)bansaod~yduh6sad6ivoiv~cxin;02(hai)bansaocactailieu
g6mdandangky,tieuchuanch~throngvaphuongphapkiSmnghiemthuoc,
nguyenlieulamthu6cd6ivaicactruOnghqpconl~i;
c)02(hai)bQm~unhanthu6c,nguyenli~ulamthu6cvato'huangd~nsu
d\lngthu6cd\IkiSnluuhanhcod~uxacnh?ncuacasadangky(ch~pnh?nd~u
cuavanphongd~idi~nd6ivaithu6cnuacngoai)ho~ccasasanxu~t.Cacnhan
thu6c,nguyenli~ulamthu6cduqcg~n,thiStkStrenkh6gi~yphlihqpnhung
khongnhohankh6A4.TruOnghqpnQPh6satr\IctuySn,casachinQp01bQ
m~unhanthu6c,nguyenli~ulamthu6cvato'huangd~nsud\lngthu6c.
5.S6lUQ'llgcactaili~uphainQPtrongh6sadangkythayd6i,b6sunggi~y
dangkyluuhanh:
a)01(mQt)bQcod~yducactaili~utheoquydinht~ikhoan4DiSu27
Thongtunayd6ivaithu6choaduqc,v~cxin,sinhph~mvakhoan3DiSu30,
khoan3DiSu32Thongtunayd6ivaithu6cduqcli~u,nguyenli~ulamthu6c;
b)02(hai)bQm~unhanthu6c,nguyenli~ulamthu6cvato'huangd~nsu
d\lngthu6cdSnghithayd6id6ivaitru0'nghqpthayd6inhan,huangd~nsud\lng,
cod~uxacnh?ncuacasadangky(ch~pnh?nd~ucuavanphongd~idi~nd6ivai
thu6cnuacngoai)ho~ccasasanxu~t.Cacnhanthu6c,nguyenli~ulamthu6c
duqcg~,thiStkStrenkh6gi~yphlihqpnhungkhongnhohankh6A4.TruOng
hqpnQPh6satr\IctuySn,casachinQP01bQm~unhanthu6c,nguyenli~ulam
thu6cvato'huangd~nsud\lngthu6c.
6.QuydinhvSvi~capd\lngh6satr\IctuySn:
a)S6luqng,thanhph~nh6sa:01(mQt)bQh6sad~ydutheoquydinht~i
Thongtunay(trutrangbia);D6ivaicacph~nh6sac~nbaom?tdfrli~u,casa
nQptr\IctiSpt~iC\lCQuanlyDuqctheoquydinht~iThongtus605/201O/TT­
BYTngay01thang3nam2010cuaBQtruangBQYtShuangd~nbaom?tdfr
li~uthunghi~mtrongdangkythu6c(saudaygQit~tlaThongtus605/2010/TT­
BYT);
b)LQtrinhnQPh6satr\IctuySnth\Ichi~ntheocongb6cuaBQYtS.KStu
ngayquydinhapd\lngnQPh6satr\IctuySntoanbQ,casadangkynQPh6satr\Ic
tuySntheodungquydinht~idiSmakhoannay.Tru0'nghqpcoyeuc~ucungc~pV
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

8. 8
bangiayh6sadangkydSxemxet,d6ichieu,C\lCQuanlyDuoccovanbanthong
bao.
Di~u7.Phidangkythudc,nguyenli~uHamthuBc
Cosadangkythuoc,nguyen lieulamthu6cphainQPphilienquandSn
dangkythuoc,nguyenlieulamthuoctheaquydinhcuaphapluathienhanhvSphi
val~phi.
Di~u8.Hi~ull!c,kyhi~uciiagiiydangkyhruhanhthudc,nguyenli~u
lamthuBcvathoihannqph6SO'dangkygiahan;sBIUQ'nggiiydangkyIU'u
hanhchocacthuBccocimgdUQ'cchitho~cthanhphindUQ'cli~u,dangbao
ch~,dmrngdung,hamIUQ'ngho~cn6ngdqtrongmqtdonviphanli~u
1.Thaihanhieuluccuagi~ydangkyhruhanhthuoc,nguyenlieulam
thu6cla05(narn)namkStirngayc~phoacgiah:;m,tmtruanghgpquydinht~i
khoan2DiSunay.
2.Thaih~nhi~ulvccuagi~ydangkylUllhanhla03(ba)namkStungay
c~pd6ivaica.cthu6csau:
a)Thu6cmai,v~cxinl~nd~uc~pgi~ydangkylUllhanh,sinhph~mtham
chiSu,sinhph~mtuangtvl~nd~uc~pgi~ydangkYlUllhanht~iVi~tNam;
b)Thu6cclingduQ'cch~t,n6ngdQ,hamlugng, d~ngbaochSvaithu6cmai
rnathu6cmaidochuaduQ'cc~pgi~ydangkylUllhanhvaithaih~n05(nam)
nam;
c)CactruanghgptiSpt\lCthead5iantoan,hi~uquatheaykiSntuv~n
cuaH9id6ng;
d)Thu6cthuQctwanghgpquydinht~idiSma,bvackhoannaynhungt~i
thaidiSmnQPh6sagiah~ngi~ydangkylUllhanhrnachuacobaocaoantoan,
hi~uquavilydochualUllhanhho~ccobaocaoantoan,hi~uquanhungs6lugng
thu6csud\lng,s61ugngb~nhnhan, thaigiansud\lngcanh~nchStheaykiSncua
HQid6ngho~ccokhuySnnghicuacasakhamchuab~nhvSvi~cc~ntiSpt\lc
thead5iantoan,hi~uqua.
3.M6ithu6c, nguyenli~ulamthu6cduQ'cc~pgi~ydangkylUllhanhseco
mQts6dangkytheac~utrucquydinht~iPh\ll\lcVIbanhanhkerntheaThong
tunay.
4.Thaih~nnQph6sadangkygiah~n:Trongyang12thangtruackhigi~y
dangkyluuhanhhSthi~uIvc,casadangkyphainQph6sagiah~ngi~ydangkY
lUllhanh.
5.Truanghgpcothayd6ih6sahanhchinhtrongh6sagiah~n,sau12
thangkStungaybanhanhQu,YStdinhgiah~ngi~ydangk11uuhanh, casaphai/
thvchi~ncacnQidungthaydoidaduQ'cpheduy~ttronghosagiah~n.vi
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

9. 9
6.S6hronggi§.ydangkyluuhanhd6ivoithuoccuaclingcosasanxu§.t
coclingduocchathoacthanhphanduoclieu;dangbaoche;duongdung;ham
hronghoacnongd9trongmotdanviphanlieu:01giaydangkyluuhanhvoiten
thuongmaiva01gi§.ydangkyluuhanhvoitenchungquoctS.Quydinhnay
khongapdungvoithu6csanxuatgiacongvathu6csanxu§.tvoirnucdichchidS
xu§.tkhau,
Di~u9.Tieuchiphanloaivacactruonghgpcongb8bi~tdU'gcg8c,
sinhphimthamchi~u
1.Tieuchiphan10C;libietduocg6c,sinhphamthamchiSu
a)Thu6cduocc§.pgi§.ydangkyluuhanhtaiVietNamduocphan10C;lila
bietduocg6c,sinhphamthamchienkhidapimgd6ngthaicactieuchisau:
-Cod~ydudfrli~ulamsangvSantoan,hi~uquatheaquydinhtC;liDiSu
13Thongtunay;
Riengsinhph~mthamchiSu,phaicod~yduh6sO',dfrli~uvSch§.tlUQ1lg,
tiSnlamsang, lamsangtheahuangphittriSnm9tsanph~msinhh9Ctud~u,
khongphaiphittriSntheahuangtuangtvsinhh9C;
-DuQ'cc§.pphepluuhanhbaim9ttrongcaccO'quanquanlyquydinhtC;li
khoan9DiSu2Thongtunay,truthu6cmaisanxu§.ttC;liVi~tNam.
b)D6ivaithu6cda:duQ'cB9YtScongb6bi~tduQ'cg6c,sinhph~mtham
chiSusaudod~tgiacongho~cchuySngiaocongngh~sanxu§.tm9t,m9ts6
ho~ctoanb9caccongdOC;lntC;licO'sasanxu§.tthu6ctC;liVi~tNamphaibaodam
thu6cda:congb6bi~tduQ'cg6c,sinhph~mthamchiSuvathu6cgiacongho~c
chuySngiaocongngh~sanxu§.ttC;liVi~tNamdapUngd6ngthaicactieuchisau:
-ClingcongthucbaochS;
-Clingquytrinhsanxu§.t;
-Clingtieuchu~nch§.tlUQ1lgnguyenli~u;
-Clingtieuchu~nch§.tlUQ1lgthu6cthanhph~m;
TruOnghqpcothayd6im9ttrongcactieuchitC;lidiSmnayho~ccacthay
d6ikhaclienquandSnch§.tlUQ1lgcuathu6c,cacthayd6inayphaiduQ'cphe
duy~tbaicO'quanquanlyduQ'cnuacsanxu§.tho~ccO'quanquanlyquydinhtC;li
khoan9DiSu2Thongtunayda:c§.pphepluuhanhthu6cdoho~ccO'sadangky
phaicungc§.pdfrli~uchungminhthu6csanxu§.ttC;liVi~tNamtuangduangvS
ch§.tlUQ1lgsovaibi~tduQ'cg6c,sinhph~mthamchiSutruackhigiacongho~c
chuySngiaocongngh~.
c)Thu6cda:duQ'ccongb6labi~tduQ'cg6c,sinhph~mthamchiSucothay
d6icO'sasanxu§.tthithu6cdUQ'cc§.pgi§.ydangkyluuhanhmaicuacO'sasan
xu§.tthayd6iclingduQ'cphan10C;lilabi~tduQ'cg6c,sinhph~mthamchiSutrencO'
sacodSnghib~ngvanbancuacO'sadangkynSudapUngd6ngthaicactieuchi
sauday: V
~
(p;c,~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

10. 10
-Thu6cduoccfipphephruhanhboim9ttrongcaccoquanquanlyquy
dinhtaikhoan9DiSu2Thongtirnay;
-Thuocdapirngd6ngthaicactieuchiquydinhtaidiembkhoan1DiSu
nay.
Truonghopcothayd6imottrongcactieuchitaidiSmbkhoan1DiSu
nayhoaccacthayd6ikhaclienquandenchfithrongcuathuoc,cacthayd6inay
phaiduocpheduyetboicoquanquanlydirocmrocsanxuathoaccoquanquan
lyquydinhtaikhoan9DiSu2Thong tirnaydacfipphephruhanhthuocdohoac
cosadangkyphaicungcapdtrlieuclnrngminhthu6csanxufittaicosamoi
nrongduongvSchfithrongsovoibietduocg6c,sinhphamthamchientnrockhi
thayd6icosasanxufit.
2.Cactnronghopthu6cduQ'cphanlo:;tilabi~tduQ'cg6c,sinhph~mtham
chiSu:
a)Thu6cdaduQ'cB9YtScongb6labi~tduQ'cg6c,sinhph~mthamchiSu
duQ'csanxufittoanb9t:;tinuaccocoquanquanlyquydinht:;tikhoan9DiSu2
ThongtunayduQ'ctiSpt\lCphanlo:;tilabi~tduQ'cg6c,sinhph~mthamchiSunSu
thu9Cm9ttrongcactruanghqpsauday:
-Thu6ccogifiydangkyluuhanhconhi~uh.rcho?cduQ'cgiah:;tnho?c
duQ'cthayd6i,b6sungkhongthu9Cquydinht:;tidiSmbkhoan2DiSu55Lu~t
DuQ'c.Cosadangkykhongphain9Ph6sodSnghiphanlo:;tibi~tduQ'cg6c,sinh
ph~m thamchiSu;
-Thu6cduQ'ccfipgifiydangkylUllhanhmaitheohinhthlicdangkyl:;ti
quydinht:;tiThongtus64412014/TT-BYT ngay25thang11nam2014cuaB9
truangB9YtSquydinhvi~cdangkythu6c(saudayg<)it~tlaThongtus6
44/2014/TT-BYT) rnacoclingcongthlicbaochS,quytrinhsanxufit,tieuchu~n
chfitluqngnguyenli~u,tieuchu~nchfitluqngthu6cthanhph~msovaibi~tduQ'c
g6c,sinhph~mthamchiSudaduQ'ccongb6ho?ccothayd6ilienquandSnn9i
dungtrendaduQ'cC\lCQuanlyDuQ'cho?cnuacsat:;tipheduy~t.CosadangkY
n9Ph6soc~pnh~tphanlo:;tibi~tduQ'cg6c,sinhph~mthamchiSutheoquydinh
t:;tiPh\ll\lcIIbanhanhkerntheoThongtunay;
-Thu6cthayd6icosasanxufitvaduQ'CcfipgifiydangkylUllhanhmai
daplingquydinht:;tidiSmckhoan1DiSunay.CosadangkYn9Ph6soc~pnh~t
phanlo:;tibi~tduQ'cg6c,sinhph~mthamchiSutheoquydinht:;tiPh\ll\lcIIban
hanhkerntheoThongtunay.
b)Thu6csanxufitt:;tinuacngoaidaduQ'cB9YtScongb6labi~tduQ'cg6c,
sinhph~mthamchiSukhongduQ'csanxufittoanb9t~inuaccocoquanquanly
quydinht:;tikhoan9DiSu2ThongtunaynhungduQ'ccfippheplUllhanht:;tinuac
c~coquanquanlythu9Cdanhs~chquydin?t:;tikhoan~Di~u2ThongtunaydUQ'CJ
tieptvcphanlo:;tilabi~tduQ'cgoc,sinhphamthamchieuneuthu9cm9ttrongcac
truanghqpsauday:
j~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

11. 11
-Thu6ccogiaydangkyhruhanhconhieuhrchoacduocgiahanhoac
duocthayd6i,b6sungkhongthuocquydinhtaidiembkhoan2DiSu55Luat
Duoc;
-Thu6cduocc§.pgi§.ydangkyhruhanhmoitheahinhthircdangkylai
quydinhtaiThongtus644/2014/TT-BYTrnacoclingcongthircbaochS,quy
trinhsanxuat,tieuchuftnch§.tIUQ'ngnguyenlieu,tieuchuanch§.throngthuoc
thanhphamsovoibietdirocg6c,sinhphamthamchiSudffdiroccongb6hoacco
thayd6ilienquandSnnoidungtrendffduoccoquanquanlyVietNamhoacmroc
sataipheduyet;
-Thuocthayd6icosasanxu§.tvaduocc§.pgi§.ydangkyhruhanhmoirna
dapirngquydinhtaidiemckhoan1DiSunay;
CosadangkynQPh6sac~pnh~tphanlo~ibi~tduQ'cg6c,sinhphftmtham
chiSud6ivai03truOnghqptrentheaquydinht~iPh\ll\lcIIbanhanhkernthea
Thongtunay.
c)Thu6cdffduQ'cBQYtScongb6labi~tduQ'cg6c,sinhphftmthamchiSu
sanxu§.ttoclnbQcaccongdo~nt~iVi~tNamho~csanxu§.tmQt,mQts6congdo~
t~iVi~tNamvacaccongdo~nsanxu§.tconl~iduQ'cth\Ichi~ntoanb<)t~inuac
cocaquanquanlyquydinht~ikhoan9DiSu2ThongtumiyduQ'ctiSpt\lCphan
lo~ilabi~tduQ'cg6c,sinhphftmthamchiSunSuthu<)cm<)ttrongcactruOnghqp
sauday:
-Thu6ccogi§.ydangkyluuhanhconhi~ul\Icho~cduQ'cgiah~nho~c
duQ'cthayd6i,b6sungkhongthu<)cquydinht~idiSmbkhoan2DiSu55Lu~t
DuQ'c.Casadangkykhongphain<)ph6sadSnghiphanlo~ibi~tduQ'cg6c,sinh
phftmthamchiSu;
-Thu6cduQ'cc§.pgi§.ydangkylUllhanhmaitheahinhthucdangkyl~i
quydinht~iThongtus644/2014/TT-BYTrnacoclingcongthucbaochS,quy
trinhsanxu§.t,tieuchuftnch~tIUQ'llgnguyenli~u,tieuchuftnch§.tIUQ'llgthu6c
thanhphftmsovaibi~tduQ'cg6c,sinhphftmthamchiSudffduQ'ccongb6ho~cco
thayd6ilienquandSnnQidungtrendffduQ'ccaquanquanlyVi~tNamho~cnuac
sat~ipheduy~t.Casadangkyn<)ph6sac~pnh~tphanlo~ibi~tduQ'cg6c,sinh
phftmthamchiSutheaquydinht~iPh\ll\lcIIbanhanhkerntheaThongtunay;
-Thu6cthayd6icasasanxu~tvadUQ'Cc~pgi~ydangkylUllhanhmairna
dapUngquydinht~idiSmckhoan1DiSunay.CasadangkYn<)ph6sac~pnh~t
phanlo~ibi~tduQ'cg6c,sinhphftmthamchiSutheaquydinht~iPh\ll\lcIIban
hanhkerntheaThongtunay.
d)Thu6cdffdUQ'cB<)YtScongb6labi~tduQ'cg6c,sinhph~mthamchiSu
sanxu§.tm<)t,m<)ts6congdo~nt~iVi~tNamvacaccongdo~nsanxu~tconl~i
khongdUQ'cth\Ichi~ntoanb<)t~inuaccocaquanquanlyquydinht~ikhoan9
DiSu2ThongtunaynhungduQ'cc§.ppheplUllhanht~inuaccocaquanquanly~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

12. 12
quydinhtaikhoan9DiSu2Thong tunayduoctiSptucphanloailabietdirocg6c,
sinhphamthamchieunSuthuocmottrongcactnronghQ'Psauday:
-Thu6ccogi~ydangkyhruhanhconhieuluchoacduocgiahanhoacdiroc
thayd6i,b6sungkhongthuoctnronghQ'Pquydinhtaidiembkhoan2DiSu55Ludt
Duoc;
-Thu6cduocc~pgi~ydangkyhruhanhmoitheahinhtlnrcdangkylai
quydinhtaiThongtirs644/2014/TT-BYT rnacoclingcongthircbaoche,quy
trinhsanxu~t,tieuchuanch~throngnguyenlieu,tieuchu~nchatluongthu6c
thanhphamsovoibietduocg6c,sinhphamthamchiendiiduoccongb6hoacco
thayd6ilienquandSnnoidungtrendiiduoccoquanquan1yVietNamhoacnuac
sat~ipheduy~t;
-Thu6cthayd6icO'sasanxu~tvaduQ'Cc~pgi~ydangkylUllhanhmairna
dapungquydinht~idiSmckhoan1DiSunay;
CO'sadangkyn(>ph6sO'C?Pnh?tphan10~ibi~tduQ'cg6c,sinhph~mtham
chiSud6ivai03truOnghQ'Ptrentheaquydinht~iPh\ll\lcIIbanhanhkernthea
Thongtunay.
d)Thu6cdiiduQ'cB(>YtScongb61abi~tduQ'cg6c,sinhph~mthamchiSu
sanxu~ttoanb(>t~inuaccocO'quanquan1yquydinht~ikhoan9DiSu2Thong
tunay,duQ'cgiacongho~cchuySngiaocongngh~sanxu~tt~iVi~tNamthithu6c
duQ'cgiacongho~cchuySngiaocongngh~sanxu~tm(>t,m(>ts6ho~ctoanb(>cac
congdo~nsanxu~tt~iVi~tNamvac~pgi~ydangkylUllhanhmaiduQ'ctiSpWc
phan10~i1abi~tduQ'cg6c,sinhph~mthamchiSunSudapungquydinht~idiSm
bkhoan1DiSunay.CO'sadangkythu6cd~tgiacongho~cchuySngiaocong
ngh~sanxu~tt~iVi~tNamn(>ph6sO'C?Pnh?tphan10~ibi~tduQ'cg6c,sinhph~m
thamchiSutheaquydinht~iPh\ll\lcIIbanhanhkerntheaThongtunay;
e)Thu6cdiiduQ'cB(>YtScongb61abi~tduQ'cg6c,sinhph~mthamchiSu
khongduQ'csanxu~ttoanb(>t~inuaccocO'quanquan1yquydinht~ikhoan9
DiSu2ThongtunaynhungduQ'cc~ppheplUllhanht~inuaccocO'quanquan1y
quydinht~ikhoan9DiSu2Thongtunay,duQ'cgiacongho~cchuySngiaocong
ngh~sanxu~tt~iVi~tNamthithu6cduQ'cgiacongho~cchuySngiaocongngh~
sanxu~tm(>t,m(>ts6ho~ctoanb(>caccongdo~nsanxu~tt~iVi~tNamvac~p
gi~ydangkylUllhanhmaiduQ'ctiSpt\lCphan10~i1abi~tduQ'cg6c,sinhph~m
thamchiSunSudapUngquydinht~idiSmbkhoan1DiSunay.CO'sadangky
thu6cgiacongho~cchuySngiaocongngh~sanxu~tt~iVi~tNamn(>ph6sO'C?P
nh?tphan10~ibi~tduQ'cg6c,sinhph~mthamchiSutheaquydinht~iPh\ll\lcII
banhanhkerntheaThongtunay;
g)Thu6cchuaduQ'cB(>YtScongb6bi~tduQ'cg6c,sinhph~mthamchiSu
n~udapung,quydinht~i,diSmakhoan1DiSunaythiduQ'cphan10~i1abi~tduQ'c/
goc,sinhphamthamchieu.CO'sadangkyn(>phosO'C?Pnh?tphan10~ibi~tduQ'c0/
,
l
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

13. 13
g6c,sinhphamtharnchieutheoquydinhtaiPhulucIIbanhanhkerntheoThong
tunay.
I)i~u10.Tieuchiphanloaithu8ccochungminhturmgdurmgsinhhoc
Thu6cdiroccftpgiaydangkyhruhanhtaiVietNamduocphanloaila
thuoccoclnrngrninhtuongduongsinhh9Ckhicobaocaotuongduongsinhh9C
dapirngquydinhcuaB9Yt@vSthuocphaithirtuongdirongsinhh9Cvacacyeu
d.ud6ivoih6sabaocaos6lieunghiencirutuongduongsinhh9Ctrongdangky
hruhanhthuoctaiVietNarn.
I)i~u11.YeucAubaom~tdfrli~ud8ivoih8so'dangkythu8c
CO'sadangkythuocconhuc~ubaomatdirlieud6ivoih6sadangky
thu6cthirchientheoquydinhtaiThongtuOS12010/TT-BYTvaphaineuradS
nghitrongdandangkytheoMfiuS/TTbanhanhkernThongtunay.
I)i~u12.Qu·ydinhv~xacminhtinhxacthl}'ccuagi~yto'phapIy
1.Truackhicftpgiftydangkyluuhanh,C\lCQuanIyDuQ'cthchi~nxac
rninhcacgiftytaphapIydan9Ptrongh6sadangkYthu6ctrongcactruanghgp
C\lthSnhUsau:
a)B6ivaiCPP:
-CPPcodftuhi~ut~yxoa,suachuathongtin;
-CPPtrongh6sadangkythu6ccuacaccO'sasanxuftt,cO'sadangkyda
bicO'quancoth~rnquySncuaVi~tNarnxuphliltviphlilrnhanhchinhvShanhvi
cungcftpthongtinlienquand@nh6sakythu~tkhongdatrencO'sanghiencUu
ho~csanxufttthct@cuacO'sasanxufttthu9Cdanhrn\lcduQ'ccongb6trenTrang
thongtindi~ntucuaC\lCQuanIyDuQ'c.Thaihlilnapd\lngvi~cxacthcCPPla
02narnkStilngayk@tthucthaihlilntlilrnngilngnh~nh6sacftp,giahlilngiftydang
kyluuhanh;
-CPPcuathu6csanxufttbaicO'saI~nd~ucothu6cdangkyluuhanhtlili
Vi~tNarn,triltruanghgpthu6cconhiSucO'satharngiasanxuftttrongdoitnhftt
rn9tcO'sadacothu6cduQ'ccftpgiftydangkyluuhanhtliliVi~tNarn;
-CPPlabandi~ntuduQ'ccungcftpb~nghinhthucttraCUutiltrangthong
tindi~ntuho~ccO'saduli~uti@ngAnhcuacO'quancftpho~ccO'quancoth~rn
quySncacnuacrnakhongtracUutrctuy@nduQ'cb~ngduangdfintrangthong
tindi~nturnacO'sacungcftptrongh6sa;
-CPPkhongcodftuxacnh~ncuacO'quancoth~rnquySncuanuaccftp;
-CactruanghgpdoH9id6ngyeuc~uthchi~nvi~cxacthc.
b)86ivaicacgiftytaphapIylienquand@ncO'sadangky,cO'sasanxuftt:
Vi~cxacrninhtinhxacthcduQ'capd\lngd6ivaigiftytaphapIycuacO'sadang
ky,cO'sasanxufttI~nd~ucothu6cdangkytliliVi~tNarn. ~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

14. 14
2.D6ivoithuocdadirocc~pgi~ydangkyhruhanh,C\lCQuanlyDiroc
thuchienxacminhtinhxacthuccuacacgi~ytophaplykhitiSpnhanthongtin
banghinhthircvanban,thirdi~ntilcongvu,thongtinquaphuongtienthongtin
daichungphananhlienquandSntinhtrangc~pphep,hruhanhthuocamrocsa
taic~nxacminh,lamr5hoacthongtinvSvieckhongdapimgdieukienhoatdong
cuacosasanxu~tthuoc,cosadangkymrocngoai,
3.ViecxacminhtinhxacthuccuaCPPvagi~ytophaplyn(>ptrongh6so
dangkythuocduocthuchienbanghinhthircvanbanhoacthirdientilcongvu
theaeachthircsauday:
a)Xacminhtinhxacthucgi~ytophaplylienquandSnhQ'Pphaphoalanh
sv:C\lCQWlnlyDuQ'cph6ihQ'PvaiC\lCLanhsv-B(>Ngo~igiaoho~ccacco
quanngo~igiaocochucnanghQ'PphaphoalanhsvcuaVi~tNamt~inuacngoai
dSxacminhth~mquySn,thongtinlienquandSnhQ'P.phaphoalanhsvgi~yta
phaplynuacngoaidSsild\lngt~iVi~tNamd6ivaicactruanghQ'Pquydinht~i
tiSt2,3diSmavadiSmbkhoan1DiSunay;
b)Xacminhtinhxacthvccuan(>idunggi~ytaphaply:C\lCQuimlyDuQ'c
ph6ihQ'PvaiCoquanc~p/banhanhcacgi~ytaphaplydSxacminhcacthongtin
daneutrongcacgi~ytaneutrend6ivaicactruanghQ'Pquydinht~itiSt1,4,5,
6diSmakhO<ln1DiSunay.
4.Vi~cxacminhtinhxacthvcgi~ytaphaplyquydinht~ikhoan1DiSu
nayduQ'cthvchi~nd6ngthaivaithuwcth~mdinhh6sodangkythu6cvatrong
thaih~nquydinht~ikhoan5DiSu56Lu~tDuQ'c.Thu6cchiduQ'cxemxetc~p
gi~ydangkylUllhanhnSucokStquaxacminhd~tyeuc~ucuacaccoquanco
th~mquySnneut~ikhoan3DiSunay.
VanbandSnghixacthvcgi~ytaphaplyduQ'cgilid6ngthaichocosa
dangkythu6c.Trongthaih~n06thangkStungayC\lCQuanlyDuQ'cthvchi~n
xacminhrnakhongnh~nduQ'ckStquaxacthvccuacoquancoth~mquySn,C\lC
QuanlyDuQ'cbaocaoH(>id6ngvStinhtr~ngxacthvcgi~ytaphaplyvadSxu~t
chuac~pgi~ydangkylUllhanh.
ChuO'ngII
YEUcAuVEDULI:¢ULAMSANGDEBAoDAMANToAN,
HI:¢UQuAvATIEUCHiticDINHTRUONGH<}PMIENTHU,
MIENMOTSOGIAIDOi).NTHUTHUOCTRENLAMSANG,
THuncPMITHULAMSANGGIAIDOi).N4Ti).IVI:¢TNAM
Di~u13.QuydinbV~dfrIi~uHimsangtronghBsO'dangkyluuhanh
d8iVOlthu8choadU'q'c,v~cxin,sinhphAm
1.Yel!c~uvSdfrli~l!lamsang?Sbaodamantoan,hi~uquacuathu6choa/
duQ'cmai,vacxin,sinhphamtronghosodangkylUllhanh. \Jj
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

15. 15
a)CacnghienciruHimsangcuathuoc,cacdfrlieutrongh6salamsang
phaiphuhopvoihuangd~ncuaICH,BQYtSVietNamhoachuangd~ncuacac
t6chirckhacrnaVietNamcongnhan(bao.gom: huangd~ncuat6clnrcquoctS
rnaVietNamlathanhvien,huongd~ncuacoquanquanlyquydinhtaikhoan9
DiSu2Thongtunay),tnrtnronghopquydinhtaikhoan3DiSunay;
b)Dirlieulamsang(tnrsinhphamtuongtvvoisinhphamthamchienda
duocc~pgi~ydangkyluuhanhtaiVietNam)phaicoduthongtindSphantich,
biengiaiduocvSanhhuangcuaySut6chungtQcnguoichauAlienquandSnan
toan,hieuquacuathu6cnhamngoaisuydfrlieulamsangtrenchungtQcnguoi
chauAtheacachuangd~nquydinhtC;lidiSmakhoannayho~cphaicodfrli~u
nghienClmb~cc~utheahuangd~ncuaICH-E5nh&mngoC;lisuydfrli~ulamsang
trenchungtQcnguaichauA;
c)V~cxindilduQ'cc~pphepluuhanhdapUngquydinhtC;lidiSmdkhoan
4DiSu22Thongtunayvacod~ydudfrli~ulamsangvSantoan,hi~uquathea
quydinhtC;lidiSma,bkhoannaynhungchuaduQ'csanxu~ttoanbQcaccongdOC;ln
trendaychuySncuacacnuaclathanhvienquydinhtC;likhoan9DiSu2Thongtu
naythiphaicodfrli~ulamsanglienquandSndanhgiatinhantoanvatinhsinh
miSndichtrenqu~nthSdichtC;liVi~tNamtruackhiduQ'cc~pphepluuhanh;
d)V~cxincod~ydudfrli~ulamsangdanhgiatinhantoan,hi~uquaquy
dinhtC;lidiSma,bkhoannaynhungchuadapungquydinhtC;lidiSmdkhoan4
DiSu22Thongtunaythiphaicodfrli~ulamsanglienquandSndanhgiatinhan
toanvatinhsinhmiSndichtrenqu~nthSdichtC;liVi~tNamtruackhiduQ'cc~p
phepluuhanh.
2.Thu6choaduQ'ccohamluqngho~cn6ngdQ,duemgdung,cachdung,
liSudung,chidinh,d6ituqngb~nhnhanho~cdC;lngbaochSanhhuangdSnsinh
duQ'ChQccuathu6ckhacvaibi~tduQ'cg6cdaduQ'cc~pphepluuhanhtC;liVi~t
Namho~ckhacvaithu6cduQ'cc~pphepluuhanhboimQttrongcaccaquanquan
lyquydinhtC;likhoan9DiSu2Thongtunayrnabi~tduQ'cg6cchuaduQ'cc~p
phepluuhanhtC;liVi~tNamphaicodfrli~ulamsangtheaquydinhtC;lidiSma,b
khoan1vakhoan3DiSunaytruackhiduQ'cc~pphepluuhanh.
3.TrongtruemghqpnghienClmduQ'cthvchi~ntruacthaidiSmcoquy
dinh,huangd~nvSnghienClmphattriSnthu6cquydinhtC;lidiSmakhoan1DiSu
naythiduQ'cxemxetch~pnh~ndfrli~ucuanghienClmdSth~mdinh.
Di~u14.Yeuc~uv~dfrli~uHimsangd~baodamantoan,hi~uqua
tronghBsO'dangkyIU'uhanhdBiv&ithuBccoSk~thgpm&iCllacacdU'gc
ch~t,sinhphAmtU'O'ngt
1.Thu6ccoS\IkSthqpmaicuacacduQ'cch~tphaicod~ydudfrli~ulam
sangtheahuangd~ncuaUSFDA, EMAho~cWHOvSphMtriSnlamsangthu6c~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

16. 16
phoihopc6dinhliSuthirchientheaquydinhtaiPhulucIVbanhanhkernthea
Thongnrnay.
2.Sinhphamnrongnrphaicod~ydudfrli~ulamsangtheahuangd~nvS
phattriensinhphamnrongtudoBQYtSVietNambanhanhhoachuangd~ncua
WHO.Chapnhanhuangd~ncuaUSFDA,EMAvacachuangd~nduocxay
dungtrencosacachuangd~nnay.Cachuangd~ncuaWHO,USFDA,EMA
theaPhulucIVbanhanhkerntheaThongtirnay.
f)i~u15.YeucAuv~dfrli~uHimsangd~baodamantoan,hi~uqua
tronghBsodangkyhruhanhdBivOithuBchoadUQ'cmtrikhdngphailabi~t
A
dUQ'cgoc
1.D6ivoithuocduocc~pphephruhanhamrocsatailathu6ckedan(tnr
tnronghopthuocsanxu~ttaiVietNam)vadffcoitnhatmQtthu6ctuangt\1'(cung
du(),cch~t,n6ngdQ,hamluqng,d:;tngbaochS,duangdung)du(),cc~pphepluu
hanhbaimQttrongcaccoquanquanlyquydinht:;tikhoan9DiSu2Thongtunay
phaicodfrli~ulamsangdapUngmQttrongtruanghqpsau:
a)Codfrli~ulamsangcuachinhthu6ctuangt\1'dodu()'cchusahfrucho
phepsud\lng.Dfrli~ulamsangcuathu6ctuangt\1'phaidapUngquydinht:;ti
DiSu13Thongtunay;
b)Codfrli~ulamsangt~phqptll'caccongtrinhnghienClmcongb6trong
yvanvadfrli~uvSnghienClmtuangduongsinhhQc(tmtruanghqpthu6ckhong
coyeuc~uphaithutuangduangsinhhQctheaquydinhcuacoquanquanlynuac
sat:;ti).
2.D6ivaithu6ckhongkedontheaquydinhcuanuacsat:;ti(trirtruang
hqpthu6csanxu~tt:;tiVi~tNamvatruanghqpquydinht:;tikhoan3DiSunay)va
dffcoitnh~tmQtthu6ctuangt\1'(cungdu(),cch~t,n6ngdQ,hamluqng,d:;tngbao
chS,duangdung)du()'cc~pphepluuhanhbaiitnh~tmQtnuactrenthSgiaiphai
codfrli~ulamsangdap(:engmQttrongtruanghqpsau:
a)Codfrli~ulamsangcuachinhthu6ctuangt\1'dodu()'cchusahfrucho
phepsud\lng.Dfrli~ulamsangcuathu6ctuangt\1'phaidapUngquydinht:;ti
DiSu13cuaThongtunay;
b)Codfrli~ulamsangt~phqptilcaccongtrinhnghienClmcongb6trong
yvanvadfrli~uvSnghienClmtuang duangsinhhQc(triltruanghqpthu6ckhong
coyeuc~uphaithutuangduangsinhhQctheaquydinhcuacoquanquanlynuac
sat:;ti).
3.D6ivaithu6cdu(),cc~pphepluuhanhvaphanlo:;tilathu6ckhongke
donbaiitnh~tmQttrongcaccoquanquanlyquydinht:;tikhoan9DiSu2Thong
tunaythiphaicotaili~uthuyStminhvab~ngchUngchUngminhvi~csud\lng
c~cdu()'cch~ttrongthanhph~ncuathu6c(vSchidir;h, liSudung,duangdun~/
doituqngsud\lng)dffdu()'cghir5trongDu()'cthuQuocgiaVi~tNam, Du()'cdie t
1t4-
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

17. 17
VietNam,Duocthirhoaccactailieuduocchapnhanboimottrongcaccoquan
quanlyquydinhtaikhoan9DiSu2Thongtirnay.
Di~u16.YeucAuv~dft,lieulamsangdaiv&ithuacdiidU'gccApgiAy
dangkyhruhanht~iVi~tNamnhungcothayd8i,b8sunglien,quand~ndft
li~ulamsangsovrrihBso'dangkythuacdiidU'gcpheduy~t.'-
Thu6choadiroc, vacxin,sinhpham, thuocduoclieudiiduocc~pgi~ydang
kyhruhanhtaiVietNamcothayd6i,b6sunglienquand8ndfrlieulamsangso
voih6sodangkYthuocdiiduocpheduyet, cosadangkyphaib6sungdfrlieu
lamsangtheaquydinhtaiPhulucIIbanhanhkerntheaThongtirnay.
Di~u17.TieuchiX3Cdinhmi~nmQt,mQtsagiaido~nthirthuachoa
dU'gcm&i,v~cxin,sinhphAmtrenlamsangtrU'&ckhicAppheplU'uhanh
Thu6cchuadapungquydinht~iDiSu13ThongtunayduQ'cB(>truang
B(>Yt8xemxetquy8tdinhmiSnm(>t,m(>ts6giaido~nthuthu6ctrenHimsang
(baog6mcamiSngifundfrli~uHimsang)trencosayki8ntuv~ncuaH(>id6ng
khithu(>cm(>ttrongcactruemghqpsau:
1.Thu6cdapungnhuc§.uc~pbachchoqu6cphong,anninh,phong,ch6ng
dichb~nh,kh~cph\lch~uquathientai,thamhQarnatrenthitruemgchuacosful
cacthu6ckhaccokhanangthaythS.
2.Thu6cdiiduQ'cc~ppheplUllhanhbaiitnh~tm(>ttrongs6caccoquan
quanlyquydinht~ikhoan9DiSu2Thongtunaydvatrenh6solamsangmiSn
giamtheaquydinhcuacaccoquannay.
3.Thu6cdungdSdiSutricacb~nhhi8mg~p;b~nhhiSmngheo.
4.V~cxin,sinhph~mduQ'csanxu~tt~iVi~tNamtheahinhthucchuySn
giaocongngh~m(>t,m(>ts6ho~ctoanb(>caccongdo~ncuaquytrinhsanxu~t
thanhph~mrnav~cxin,sinhph~m truacchuySn giaocongngh~codfrli~ulam
sangdapungquydinht~ikhoan1DiSu13,DiSu14Thongtunay.
Di~u18.YeucAuv~dftli~ulamsangtronghBsO'dangkylU'uhanhdai
v&ithuacdU'gcli~u
1.Yeuc§.uvSdfrli~ulamsangdSbaodamantoan,hi~uquatrongh6so
dangkylUllhanhd6ivaithu6cduQ'cli~umai
a)CacnghienellUlamsangcuathu6c, cacdfrli~utrongh6solamsang
phaiphuhqpvaiHuangd~nnghiencUutiSnlamsangvalamsangthu6cduQ'c
li~ucuaB(>Yt8ho~ccuat6chuckhacrnaVi~tNamcongnh~n,baog6m:Huang
d~nnghiencuudanhgiaantoanvahi~uquacuathu6cduQ'cli~ucua(Research
guidelinesforevaluatingthesafetyandefficacyofherbalmedicines)ho~cco
quanquanlyquydinht~ikhoan9DiSu2Thongtunay.Trongtrucmghqpnghien
cuuduQ'cthvchi~ntruacthaidiSmcoquydinh,huangd~nneutrenvSnghien
cuuphattriSnthu6cthiduQ'cxemxetch~pnh~ndfrli~ucuanghiencUudSth~mv
dinh·.,
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

18. 18
b)Thu6cduoclieucodfrlieutrichd~ntilcactailieusauduocchapnhan
ladfrlieuHimsangdexemxettinhantoan,hieuquacuathu6c:
-CacchuyenluanlienquandSntinhantoan,hieuquacuathuocduocdS
c~ptrongcacduocdien,duocthircuaVi~tNamhoaccuacacmroctrenthSgioi;
-CacbaibaodanhgiavStinhantoan,hieuquacuathuocdirocdangtai
trencactapchithuocdanhmucSCI(ScienceCitationIndex)-Chis6trichd~n
khoahocvacacdfrlieulamsangt~phoptilcaccongtrinhnghienCUucongb6
trongyvankhac;
-Baocaodanhgiatinhantoan,hieuquacuadStaikhoahocvacongnghe
c~pquocgia,cApbQhoaccAptinhda:duocnghiemthu.
2.Thu6cdu<),cli~ukhongyeuc~uphainQpdfrli~ulamsangtheoquydinh
t?ikhoan1DiSunaynSudaptmgmQttrongcacdiSuki~nsau:
a)Thu6cdu<),cli~ucocungthanhph§.n,kh6ilu<),ngdu<),cli~u,chidinh,
dUOngdung,d?ngbaochSv6imQtthu6cdu<),cli~ukhacda:du<),ccApgiAydang
kyluuhanh(baog6mcatruOnghqpgiAydangkyluuhanhda:hSthi~uh,rc)tril
cacthu6cda:du<),cxacdinhlathu6cc6truySnvakhongcochidinhd6iv6icac
b~nhthuQcDanhm\lcb~nhdoBQtruangBQYtSbanhanhtheoquydinht?idiem
bkhoan1DiSu89Lu~tDu<)'c;
b)TruOnghqpthu6cdu<)'cli~ucocungthanhph§.n,kh6iluqngdu<),cli~u,
chidinh,dUOngdung,d?ngbaochSv6imQtthu6cdu<)'cli~um6idu<)'ccApphep
luuhanht?iVi~tNamtrencO'socod§.ydudfrli~ulamsangtheoquydinht?i
khoan 1DiSunayvakhongcothemchidinhd6iv6icacb~nhthuQcDanhm\lc
b~nhdoBQtruangBQYtSbanhanhtheoquydinht?idiembkhoan1DiSu89
Lu~tDu<)'cthidu<)'cxemxetcApphepluuhanhkhithu6cdu<)'cli~ukhacdoda:
du<)'ccApphepluuhanh,giah?llv6ihi~uhIcgiAydangkyluuhanh05nam.
J)i~u19.TieuchixacdjnhtrmrnghQ'pdU'Q'cmi~nmQt,mQts8giaido~n
thi'rthu8cdU'Q'cli~utrenlamsangtrU'O'ckhicippheplU'uhanh
Thu6cdu<)'cli~uchuadapungquydinht?iDiSu18Thongtunaydu<)'cBQ
truangBQYtSxemxetquyStdinhvi~cmiSnmQt,mQts6giaido?nthuthu6ctren
lamsang(baog6mcamiSngiamdfrli~ulamsang)trencO'soykiSntuvAncua
HQid6ngkhithuQcmQttrongcactruOnghqpsau:
1.Thu6cdapungnhuc§.ucApbachchoqu6cphong,anninh,phong,ch6ng
dichb~nh,kh~cph\lch~uquathientai,thamhQarnatrenthitruongchuacos~n
cacthu6ckhaccokhanangthaythS.
2.Thu6cda:du<)'ccApphepluuhanhbaiitnh~tmQttrongs6caccO'quan
quanlythamchiSuquydinht?ikhoan9DiSu2Thongtunaydl,l'atrenh6salam
sangmiSngiamtheoquydinhcuacaccO'quannay.
3.Thu6ccochidinhd6iv6icacb~nhthuQcDanhm\lcb~nhdoBQtruangJ
BQYtSbanhanhtheoquydinht?idiembkhoan1DiSu89Lu~tDuQ'cnhung
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

19. 19
khongthuoctnronghopdirocmiSnth~lamsangquydinhtaikhoan3DiSu20
Thongtunay.
4.Thu6ccosirphoihopmoicuacacduoclieudatirngsirdunglamthu6c
taiVi~tNamvakhongcochidinhd6ivoicacbenhthuocDanhmucbenhdoBQ
tnrongBQYtSbanhanhquydinhtaidiSmbkhoan1Dieu89LuatDuoc,
Di~u20.Tieuchixacdjnhtrmmghopdugcmi~nthu'Himsangt~iVi~t
Namtrurrckhic~pphephruhanh
1.Thu6cgenericcocungduocchat,hamhrong,nongdQ,dirongdung,each
dung,liSudung,chidinh,d6itirongbenhnhan,dangbaochSvoimotthuockhac
dadirocc~pgiaydangkyluuhanh.
2.Thu6cmoi(tnrv~cxin)daduocc~pphepluuhanht(;liitnh~tmQtnuac
trenthSgiaivacod~ydudfrli~ulamsangvSantoan,hi~uquatheaquydinht(;li
DiSu13,DiSu18Thongtunay.
3.Thu6cduQ'cli~udaduQ'cc~pgi~ydangkyluuhanhtruacngayLu~t
DuQ'c2016cohi~ul\l'cvakhongcochidinhd6ivaicacb~nhthuQcDanhm\lc
b~nhdoBQtru6ngBQYtSbanhanh.
4.V~cxindap(engquydinht(;lidiSmdkhoan4DiSu22Thongtunay,
duQ'csanxu~ttoanbQcaccongdO(;lnanuaccocoquanquanlyquydinht(;li
khoan9DiSu2Thongtunayvacod~ydudfrli~ulamsangvSantoan,hi~uqua
theaquydinht(;liDiSu13Thongtunay.
Di~u21.Tieuchid~xacdinhtru(rnghgpphaithfrHimsanggiaido~n
IVt~iVi~tNam
Thu6cdaduQ'cc~pgi~ydangkyluuhanhnhungc~ndanhgiathemvSan
toan,hi~uquatrencosaykiSntuv~ncuaHQid6ng.
ChuO'ngIII
HOsoDANGKYTHU6c,NGUYENLltULAMTHU6c
Ml}C1
QUYDINHCHUNGVEHOsoDENGHIcAp,GIA~N,
THAYDOl,BOSUNGGIAyDANGKYLUlJHANHTHU6c,
NGUYENLltULAMTHU6c
Di~u22.Quydinhd8iv6'icactaili~utronghBsO'd~nghic~p,giah~n,
thaydBi,bBsunggi~ydangkyluuhanhthu8c,nguyenli~ulamthu8c
1.Gi~ytodocoquancoth§.mquySnnu6cngoaic~pphaiduQ'chgpphap
hoalanhS\l't~eoquydinhcuaphaplu~tvShgpphaphoalanhS\l',tmcactruemg~
hgpduQ'cmientheaquydinhcuaphaplu~t.
-------- ----
------
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

20. 20
2.Gi~yphep,gi~yclnrngnhan,gi~yxacnhan,gi~ydangky(goichunghi
giaytaphaply)trongh6saphaiconhieuhrctaithaidiemtiSpnhanghitren
PhiSutiSpnhanddivoigi~ytophapIycoghithaihanhieulire.TruonghopCPP
~ongghithaihanhieuhrcthithaihanhieulireduoctinhla24thangkStirngay
dip.
3.Gi~ytophaply:
a)Banchinhphaicod~yduchirky,tennguoikyvad~uxacnhancuaco
quancothamquyencuamroccaphoacbansaococlnrngthucphaidocoquan,
t6chirccothamquyencuaVietNamclnrngthuctheaquydinhcuaphapluatVi~t
NamvSchirngthircbansaotirbanchinh.Trongtnronghopc~nthietphaixu~t
trinhbanchinhdSddichiSu;
b)TruanghQ'pgi~ytaphapIyduQ'cc~plabandi~ntil(ch~pnh~nban
khongcoduchfrky,tennguaikyho~cd~uxacnh~ncuacaquancoth~mquySn
cuanuacc~pgi~ytaphapIy),casadangkyphain9Pm9ttrongcacgi~ytasau
day:
-Banchinhho~cbansaochUngthlJccuagi~ytaphapIyduQ'ccaquanco
th~mquySnnuacngoaichUngnh~nvaduQ'ChqpphaphoaHinhSlJtheaquydinh;
-KStquatlJtraClrugi~ytaphapIytutrangthongtindi~ntilho~ccasadfr
li~utiSngAnhcuacaquanc~pgi~ytaphapIyho~ccaquancoth~mquySncac
nuaccodongd~uxacnh~ncuacasakerntheavanbancungc~pthongtinvS
duangdfintraClrudSnCvcQuanIyDuQ'c.Casadangkyphaichiutrachnhi~m
toandi~ntruacphaplu~tvStinhhqpphap,tinhchinhxaccuacacgi~yta,thong
tinnayvakStquatlJtraClrucuacasa.
4.QuydinhddivaiCPP:
a)CPPphaiduQ'cc~pbaicaquancoth~mquySnvacodun9idungthea
mfiucuaWHOduQ'ccongbdtrentrangthongtindi~ntilcuaWHO
(https://www.who.int).
b)CPPphaicochfrky,tennguaiky,ngayc~pvad~ucuacaquanc~pCPP.
TruanghqpCPPkhongcod~uxacnh~ncuacaquancoth~mquySncuanuac
c~p,casadangkycungc~ptaili~uchungminhCPPkhongyeuc~ud~utheaquy
dinhanuacsat?i.
c)Ddivaithudcgeneric,thudc duQ'cli~u,sinhph~mprobiotics,thudcgia
h?n,thayd6i,b6sunggi~ydangkylUllhanh:
Phaico01CPPduQ'ccftpbaicaquancoth~mquySncuanuacsanxufttxac
nh~nthudcduQ'ccftpphepvalUllhanhthlJctSt?inuacdo.
TruanghqpCPPxacnh~nthudckhongduQ'ccftppheplUllhanhanuacsan
xufttho~ccftpphepnhungkhonglUllhanhthlJctSanuacsanxu~t,casadangkY
phaicungc~Pthem01giftytaphapIyduQ'c,cftpbaic,aquanquanlyquydinht?~./
khoan9Dieu2Thongtunayxacnh~nthuocduQ'CcapphepvaluuhanhthlJCtetV
~~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

21. 21
taimrocdovoicacn9idungt6ithiSusau:tenthuoc,dirocch~t,nongd9hoacham
hrongdirocchat,dangbaoche,tenvadiachicosasanxuat.
d)D6ivoithuochoaduocmoi,v~cxin,sinhpharnnhapkhau,tnrsinh
phamprobiotics:
Phaico01CPPduocc~pboicoquancothamquyencuamrocsanxu~t,
xacnhanthuocduocc~pphepvahruhanhthirctStaimrocdo.
TruonghQ'Pcoquancoth~mquyenmrocsanxu~tc~pCPPthuocdanhsach
quydinhtaikhoan9DiSu2Thongtirnaythichiphain9P01CPP.
TruonghQ'Pcoquancothamquyenmrocsanxu~tc~pCPPkhongthuoc
danhsachquydinhtaikhoan9DiSu2Thongtirnaythiphaicothemgi~yto'phap
lyduocc~pboicoquanquanlyquydinhtaikhoan9DiSu2Thongtirnayxac
nhanthuocduQ'cc~pphepvaluuhanhth\IctSt~inuacdovaicacn9idungt6i
thiSusau:tenthu6c,duQ'cch~t,n6ngd9ho~chamIUQ'llgduQ'cch~t,d~ngbaochS,
tenvadiachicosasanxu~tho~ctaili~uchungminhthu6cthu9Cdanhm\lcthu6c
tiSnth~mdinhcuaWHO.
d)D6ivaithu6cdSnghiduQ'cphfmlo~ibi~tduQ'cg6c,sinhph~mtham
chiSu:
Phaico01CPPduQ'cc~pbaicoquancoth~mquySncuanuacsanxu~t,
xacnh?nthu6cduQ'cc~pphepvaluuhanhth\ICtSt~inuacdo.
TruOnghQ'Pcoquancoth~mquySnnuacsanxu~tc~pCPPthu9cdanhsach
quydinht~ikhoan9DiSu2Thongtunaythichiphain9P01CPP.
TruOnghQ'Pcoquancoth~mquySnnuacsanxu~tc~pCPPkhongthu9C
danhsachquydinht~ikhoan9DiSu2Thongtunaythiphaicothemgi~yto'phap
lyduQ'cc~pbaicoquanquanlyquydinht~ikhoan9DiSu2Thongtunayxac
nh?nthu6cduQ'cc~pphepvaluuhanhth\IctSt~inuacdovaicacn9idungt6i
thiSusau:tenthu6c,duQ'cch~t,n6ngd9ho~chamIUQ'llgduQ'cch~t,d~ngbaochS,
tenvadiachicosasanxu~t.
e)D6ivaithu6c,v~cxin,sinhph~mnh?Pkh~ukhongcungc~pduQ'cCPP
dapUngquydinht~idiSmc,dkhoannay,B9truangB9YtSxemxetquyStdinh
trencosaykiSntuv~ncuaH9id6ngkhithu6cduQ'cc~pphepluuhanhbaiit
nh~tm9tcoquancoth~mquySntrenthSgiaivathu9Cm9ttrongcactruOnghQ'P
sauday:
-Thu6c,v~cxin,sinhph~mdSdapUngnhuc~uchoqu6cphong,anninh;
phong,ch6ngdich,b~nh,kh~cph\lch?uquathientai,thamhQa,thu6cph\lcV\l
chochuangtrinhytScuanhanuac;
-V~cxindungchochuangtrinhtiemchungrnar9ngqu6cgiarnatrenthi
trU0'ngkhongs~ncov~cxinkhaccokhanangthaythSvSm~ts6IUQ'llg,ch~t
IUQ'llg,antoan,hi~uquaho~cchiphisud\lngv~cxin; V
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

22. 22
-Cactnronghopd~cbietkhaccovanbanthoathuan,congnhanl~nnhau
giiracaccoquancoth~mquyenv~di~ukiensanxuat,hruhanhthuoc,vilcxin,
sinhpham,
g)CacthongtinthShientrenCPPphaithongnh§.tvoicacthongtincolien
quantrongh6sodangkythuoc.TruonghopthongtinthShientrenCPPchua
thongnhatvoitailieuhanhchinhtrongh6sodangkythuoc, cosadangkyco
vanbangiaitrinhkerntheatailieuchtrngminh.
5.Dandangkyvah6so,tailieukhactrongphanh6sohanhchinhcolien
quanphaiduockyvadongd§.u,khongsirdungchirkyd§.u.Cosadangky,san
xu~tcothSsirdungchirkys6dSkycactaili~ulienquancuacosadangky,san
xu§.t.Viecdangkyvasirdungchfrkys6duqcth\Ichi~ntheaquydinht~iNghi
dinhs6130/2018/ND-CPngay27thang9nam2018cuaChinhphuquydinhchi
tiStthihanhlu?tgiaodichdi~ntuv~chfrkYs6vadichV\lchUngth\ICchfrkYs6.
Cactaili~utrenphaiduqckYbaimQttrongchucdanhsau:
a)ChutichHQid6ngthanhvien,hQid6ngquantri;t&nggiamd6c;giam
d6cdi~uhanh;giamd6ccosadangky,si'mxu§.t;
b)Nguaiduqcphancongtheaquydinht~idi~ul~congty,vanbanphan
congcongvi~cho~ctaili~ukhacchungminhv~th~mquy~nkycuanguaiky;
c)Nguaiduqcnhfrngnguaiquydinht~idiSmaho~cdiSmbkhoi'mnayuy
quy~ntr\ICtiSpkY·
6.Quydinhd6ivaithuuyquy~n:
a)-Oyquy~nduqcdUngtencosadangkyphaicocacnQidungsau:
-Tenvadiachichusahfrugi§.yphepluuhanhho~ccosasanxu§.tuy
,
quyen;
-Tenvadiachicosadangkyduqcuyquy~n;
-Tenthu6c;n6ngdQhamluqngduqcch~t;d~ngbaochS;
-NQidunguyquy~n.
TrongtruOnghqpuyquy~nnhi~uthu6c, thuuyquy~nphaicodanhmvc
thu6ccod~yducacnQidungneutren.
Thuuyquy~ndungtencosadangkyd6ivaithu6cnuacngoaiphaiduqc
hqpphaphoaHinhS\Itheaquydinh.Thuuyquy~nphailabanchinhho~cbansao
cochUngthlJc.
b)-Oyquy~nkYtentrenh6sodangkyphaicocacnQidungsau:
-Tenvadiachicosadangky;
-Tenvachucdanhnguaiuyquy~nvanguaiduqcuyquy~n;
-Tenthu6c;n6ngdQ,hamluqngduqcch§.t;d~ngbaochS;
-NQidunguyquy~n;
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

23. 23
-Hieuhrccuathiruyquyen,
Trongtnronghopuyquyennhieuthuoc,thiruyquyenphaicodanhmuc
thuoccod§.yducacn9idungneutren.
Truonghopnguoiduocuyquyenkytentrenh6sokhongphaitwangvan
phongdaidien,trengiayuyquyenphaicod&uvachirkyxacnhancuatnrong
vanphongdaidientaiVi~tNam.
Thuuyquyenphailabanchinhhoacbansaocod&uxacnhancuavan
phongdaidien(tnronghoplacosadangkynuocngoai)hoacd&uxacnhancua
cosadangkytrongmroc.
c)S6hrongthiruyquyentrongh6so:
-Truonghopcosadangkykhaccosasanxuat,m6ih6sophain9Pkern
motthuuyquyendUngtencosadangky;
-TruOnghgpchucdanhcuanguaikytentrenh6sokhongthu9Cm9ttrong
cacchucdanhquydinht~idi@ma,bkhoan5Di~unay,m6ih6sophain9Pkern
m9tthuuyquy~nkytentrenh6sodangkY.
7.Gi&ychungnh~ndudiSuki~nkinhdoanhdugcv6im9ttrongcachinh
thuckinhdoanh:sanxu&t,banbuon,xu&tkh:1u,nh~pkh:1uthu6c,nguyenIi~ulam
thu6c(d6iv6icosadangkycuaVi~tNam).
8.Gi&yphepthanhI~pVanphongd~idi~nt~iVi~tNam.
TruOnghgpten,diachicuacosadangkytrenGi&yphepthanhI~pVan
phongd~idi~nt~iVi~tNamkhacv6iten,diachitrenGi&yto'phapIycuacosa
dangkydocoquanquanIycoth:1mquy~nnu6cngoaic&pthiphaicungc&ptai
Ii~uchUngminh.
9.Gi&yto'phapIydocoquanquanIycoth:1mquy~nnu6cngoaic&pcho
phepthl,Ichi~nitnh&tm9ttrongcachinhthuckinhdoanhsau:sanxu&t,banbuon,
xu&tkh:1u,nh~pkh:1uthu6c,nguyenIi~ulamthu6c(d6iv6icosadangkycua
nu6cngoai).
TruOnghgpcosadangkythu6cd6ngthaiIacosasanxu&tthu6cghitren
Cppthikhongyeuc§.uphain9PGi&yto'phapIytheoquydinht~ikhoannay.
TruOnghgpcacnu6ckhongc&pgi&yphepsanxu&t,banbuon,xu&tkh:1u,
nh~pkh:1uthu6c,nguyenli~ulamthu6cthiphaicogi&yphepthanhI~pho~cdang
kykinhdoanhcoph~mvikinhdoanhlaitnh&tm9ttrongcachinhthucsau:san
xu&t,banbuon, xu&tkh:1u,nh~pkh:1uthu6c,nguyenli~ulamthu6ckerntheogi&y
chUngnh~ncuacoquancoth:1mquySnchungnh~ncosadapungdi~uki~nva
dangho~td9ngvSdugcho~cm9ttrongcacgi&ychUngnh~nthl,Ichanht6tsan
xu&tthu6c,thl,Ichanht6tphanph6ithu6c,thl,Ichanht6tcungc&pthu6c,thl,Ic
hanht6tbaoquanthu6c.
---------
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

24. 24
D6ivoicoSo'dangkynguyenlieuhimthuoc,tnronghopmrocsotaikhong
c§.pgi~yphepkinhdoanhduocchocaccoSo'kinhdoanhnguyenlieuhimthuoc,
ch~pnhancacgiaypheptheoquydinhcuamrocSo'taitrongdocon9idungxac
dinhpharnvikinhdoanhcuacoSo'himottrongcachinhthirc:sanxuat,banbucn,
xu~tkhau,nhapkhftunguyenlieulamthu6c.
10.TruonghopcoSo'dangkydffcotentrongdanhsachcoSo'dangky
thuoc, nguyenli~ulamthu6cdiroccongb6trentrangthongtindiennrcuaCue
QuanlyDuocthikhongphain9Pgi~ytoquydinhtaikhoan7,8,9DiSunay.
11.TailieuchirngminhcoSo'sanxuatduocchat,taduoc,vonang,ban
thanhphamdirocli~uvaduoclieu(d@sanxu~tthu6cdiroclieu)dapirngthirc
hanht6tsanxu~tnguyenlieulamthuoc(GMP)coth@'lamottrongcacIO<;ligi~y
tosau:
a)Gi~ychUngnh~nGMP;
b)Gi~yphepsanxu~tcoxacnh~nn9idungcoSo'sanxu~tdapungGMP;
c)CPPd6ivaidUQ'cch~tcon9idungdapungGMP;
d)ChUngnh~nphilhqpchuyenlu~nDuQ'cdi@nCh§.uAu(CEP);
d)D6ivaitaduQ'ctrongh6sodangkythu6cthanhphftm, nguyenli~ulam
thu6clabanthanhphftm:
TruOnghqpkhongcungc~pduQ'cgi~ytoquydinht<;lim9ttrongcacdi@rn
a,b,dkhoannay,coSo'sanxu~tthu6cthanhphftm, banthanhphftmthvchi~ntv
danhgiavi~cdapungthvchanht6tsanxu~tcuacoSo'sanxu~ttaduQ'ctheoquy
dinht<;lidi@mdkhoan1DiSu3,di@mbkhoan3DiSu3vadi@mdkhoan5DiSu
20Thongtus635/2018/TT-BYT ngay22thang11nam2018cuaB9truangB9
YtSquydinhvSthvchanht61sanxu~tthu6c,nguyenli~ulamthu6c(duQ'csua
d6i,b6sungt<;lidi@ma,bvadkhoan6DiSu1Thongtus629/2020/TT-BYT ngay
31112/2020 cuaB9YtSsuad6i,b6sungvabffibom9ts6vanbanquyph<;lmphap
lu~tdoB9truangB9YtSbanhanhanh, lientichbanhanh)vatvcongb6trong
h6sodangkythu6cvSnguyent~c,tieuchuftnthvchanht6tsanxu~trnacoSo'
sanxu~ttadUQ'cdapungvacamkStchiutrachnhi~mtruacphaplu~tvScongb6
naytheoM~u10/TTbanhanhkerntheoThongtunay;
e)D6ivaiduQ'cli~utrongh6sodangkythu6c:
TruOnghqpkhongcungc~pduQ'cgi~ytoquydinht<;lidi@ma,bkhoannay,
coSo'cungc~pgi~ychungnh~ndapungthvchanht6tnuoitr6ngthuhaiduQ'c
li~u(GACP);
g)Cacgi~ytophaplykhacduQ'cc~pbaicoquancothftmquySncocacn9i
dungt6ithi@ubaog6m:tenvadiachinhasanxu~t,xacnh~ncoSo'sanxu~tdap
ungGMPvatencuaduQ'cch~tltaduQ'c/vo nang/banthanhphftmduQ'cli~u/duQ'c /
li~u. U/
\J
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

25. 25
12.Mftunhanthuoc,nguyenlieulamthuocvatohuongdftnsirdungthuoc
hruhanhthuctStainuocsanxuathoacmrocc~pCPPcodauxacnhancuavan
phongdaidienhoaccosadangkyhoaccosasanxuat(chapnhanbaninmau
theodungmftunhandanghruhanhanuocsatai),Truonghoptohuongdftnsir
dungthuocthuctStaimrocsataikhongphaibangtiengAnhyeuc~unopban
dichsangtiengAnhhoactiengVi~tcod~uxacnhancuavanphongdaidienhoac
cosadangkyhoaccosasanxuat.
13.Mftunhanthuoc,nguyenlieulamthuocvatohirongdftnsudungthuoc
dukienhruhanhtaiVietNamthuchientheoquydinhcuaBQtnrongBQYtS
quydinhghinhanthubc,nguyenli~ulamthubcvacacyeuc~ucvthSsau:
a)Mftunhan,tohuangdftnsudVngdkiSnluuhanhphaicod~uxacnh~n
cuavanphongd~idi~nho~ccosadangkyho~ccosasanxu~t;
b)Nhanbaobingoaicuathu6c,nguyenli~ulamthubcphaidu<)'cinrna
v~ch(Barcode)ho~crnaQR(Quickresponse)ho~crnaDataMatrixCode(DMC)
theolQtrinhquydinht~idiSmIkhoan1UiSu48Thongtunay.
14.TruOnghqpcosasanxu~tthubc,nguyenli~ulamthubccotentrong
danhmvccosasanxu~tdu<)'ccongbbtrentrangthongtindi~ntucuaCvcQuan
1yDu<)'cvSvi~cdadu<),cdanhgiadaplingGMPthikhongyeuc~uphainQPh6
sodanhgiavi~cdaplingthchanhtbtsanxu~ttrongh6sodangkythu6c,nguyen
1i~ulamthubc.
15.Tieuchufinch~tIU<,Yllg,phuongphapkiSmnghi~m,phiSukiSmnghi~m
vah6songhienClrudQ6ndinh(apdVngdbivaicaph~nh6sodu<)'cch~tvathu6c
thanhph~m)phailabanchinhcod~uxacnh~ncuacosasanxu~t,truOnghqpco
nhiSucosasanxu~tthamgiaquatrinhsanxu~tthanhph~m,ch~pnh~nd~ucua
cosachiutrachnhi~mvSkiSmtrach~t1u<),ngthubcho~cxu~txuang10;truOng
hqpnQPbansaothiphaicod~uxacnh~ncuacosadangky(ch~pnh~nd~ucua
vanphongd~idi~ndbivaithubcnuacngoai).
TruOnghqph6sodu<),cch~tkhongcod~uxacnh~ncuacosasanxu~t
du<)'cch~t,cosasanxu~tthu6cthanhph~mphaithchi~ndongd~uxacnh~nva
chiutrachnhi~mtruacphaplu~tvStinhchinhxac,hqpphap,trungthccuatai
1i~unay.
PhiSukiSmnghi~mphaibaog6mcacthongtinsau:thongtinhanhchinh
(ten,diachicosasanxu~t,sbphiSukiSmnghi~m,tenvachfrkycuanguoidu<),c
giaotrachnhi~m,ngayphathanhphiSukiSmnghi~m)vathongtinvSmftuthu6c,
nguyenli~ulamthu6c(tensanph~m,s610,h~ndung,tieuchu~nch~tlU<,Yllgap
dVng,chitieuch~tlU<,Yllg,yeuc~uch~t1u<,Yllg,kStquakiSmnghi~m,kSt1u~nvS
ch~t1U<,Yllg10sanphftm).
16.Quydinhdbi?vaiphiSuki~mnghi~m,kStquath~mdinhtieuchu~nch~~ ~
lU<,Yllg,phuongphapkiemnghi~mbangthcnghi~mt~iVi~tNam: r
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

26. 26
PhiSukiemnghiem,kStquathamdinhtieuchuftnchftthrong,phuongphap
kiemnghiembangthucnghiemd6ivoicoSo'sanxufttchuadapirngGMPthea
1(>trinhcuaB(>YtShoacnhtrngtnronghopduocC\lCQuanlyDirocthongbao
theaquydinhtaiPhulucIIIbanhanhkerntheaThongtunaycoxacnhancuaco
So'kiSmnghiemthuoccuanhamrocdapirngGLPhoaccoSo'kinhdoanhdichvu
kiSmnghiernthuoc,nguyenlieulamthu6cdaduoccftpgiftyclnrngnhandudiSu
kienkinhdoanhphuhopvoiphamvihoatdongphailabanchinhhoacbansao
coclnrngthirc.
17.Giftychirngnhannguyenlieulamthuocduocphepsanxuftthoachru
hanhamrocsanxuat,baog6mcacthongtinb~tbuocsau:tennguyenlieu;tenva
diachicaSo'sanxuftt;nuacsanxuftt;chuky,dftuvahQtencuanguoikygiftyxac
nh~n.
Ili~u23.Quydinhchungv~taili~uhanhchinhtrongh8SO'd~nghicfip,
giah~n,thayd8i,b8sunggifiydangkyhruhanhthu8c,nguyenli~ulamthu8c
1.Taili~uhanhchinhcuah6sadSnghicftpgiftydangkyluuhanhthu6c
hoaduQ'cmai,v~cxin,sinhphftmbaog6m:
a)DandangkytheaM~u5/TTbanhanhkerntheaThongtunay;
b)GiftyuyquySndungtencaSo'dangky(nSuco);
c)GiftyuyquySnkytentrenh6sadangky(nSuco);
d)M~unhanthu6c, nguyenli~ulamthu6cvatohuangd~nsud\lngthu6c
dlJkiSnluuhanh;
d)Giftychungnh~ndudiSuki~nkinhdoanhduQ'cd6ivaicaSo'dangky
cuaVi~tNam;
e)Giftytophaply,giftyphepthanhl~pvanphongd~idi~nt~iVi~tNam
d6ivaicaSo'dangkynuacngoai;
g)Tomt~td~ctinhsanphftmd6ivaithu6choaduQ'cmai,v~cxin,sinh
phftmtheoM~u6/TTbanhanhkerntheaThongtunay;
h)GiftytophaplycuacaSo'sanxufttduQ'cchftt,taduQ'c,vonang,banthanh
phftmduQ'cli~u,duQ'cli~u;
i)Giftych(mgnh~ncuacaSo'kiSmnghi~md6ivaitruCmghqpquydinht~i
khoan16DiSu22Thongtunay;
k)KSho~chquanlynguyca(d6ivaiv~cxin)theaM~u7ITTbanhanhkern
theaThongtunay;
1)M~unhanthu6cvatohuangd~nsud\lngthu6cluuhanhthlJctSt~inuac
sanxufttho~~nuaccftpCPPd6iv~ih6sa,dangkythu6cn~acngoai; ./
m)Giaychungnh~nCPPdoivaihosadangkythuocnuacngoai;tV
l~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

27. 27
n)TailieudanhgiaviecdapimgGMPd6ivoicactnronghopquydinhtai
DiSu95Nghidinhs654/2017/ND-CPd6ivoicosasanxulitthuoc,nguyenlieulam
thuocmrocngoaikhidangkyluuhanhtaiVietNamd6ivoih6sadangkythuoc
mrocngoai(trirtnronghopcosad§:duoccongb6thongtindapirngGMPtren
trangthongtindientucuaC\lCQuanlyDuochoaccosad§:n9Ph6sadSnghi
C\lCQuanlyDuocdanhgiadapirngGMP).
2.Tailieuhanhchinhh6sadSnghiclipgiliydangkyluuhanhthuocgeneric,
thu6cdiroclieu,nguyenlieulamthuoctheaquydinhtaidiema,b,c,d,d,e,h,i,
I,m,nkhoan1DiSunayvagiliyclnrngnhannguyenli~ulamthu6cduocphep
sanxulithoacluuhanhanuacsanxulitd6ivaih6sadangkynguyenli~ulam
thu6csanxulitt(:linuacngoai.
3.Taili~uhanhchinhh6sadSnghigiah(:lngiliydangkYluuhanhthu6c
hoaduQ'c,v~cxin,sinhph~m, thu6cduQ'cli~u,nguyenli~ulamthu6ctheaquy
dinht(:lidiSma,c,d,e,m,nkhoan1DiSunayvacactaili~usau:
a)GiliyuyquySnd(mgtencasadangkyd6ivaitruOnghgpthayd6icasa
dangkyt(:lithaidiSmn9Ph6sagiah(:ln;
b)Baocaoluuhanhthu6c, nguyenli~ulamthu6ctheaM~u8/TTbanhanh
kerntheaThongtunay;
c)Bansaogiliydangkyluuhanhthu6c,nguyenli~ulamthu6ct(:liVi~tNam;
d)Baocaothead5i,danhgiaantoan,hi~uqua;tinhhinhsud\lngthu6cthea
M~u2/TTbanhanhkerntheaThongtunayd6ivaih6sagiah(:lnthu6choaduQ'c,
v~cxin,sinhph~m,thu6cduQ'cli~ucoyeuceluphaibaocaothead5i,danhgiaan
toan,hi~uquatheaquydinht(:likhoan2Di~u5Thongtunay;
d)Giliychungnh~nnguyenli~ulamthu6cduQ'cphepsanxulitho~cluuhanh
6nuacsanxulitd6ivaih6sagiah(:lnnguyenli~ulamthu6csanxulitt(:linuac
ngoai.
4.Taili~uhanhchinhh6sadSnghithayd6i,b6sunggiliydangkyluuhanh
thu6choaduQ'c, v~cxin,sinhph~m,thu6cduQ'cli~u,nguyenli~ulamthu6cthea
quydinht(:lidiSma,ckhoan1DiSunay.
5.Taili~uhanhchinhh6sadSnghiclipgiliydangkYluuhanhthu6cthea
quytrinhth~mdinhrutg<;>ntheaquydinht(:lidiSma,b,c,d,d,e,h,i,I,mkhoan
1DiSunay.
M1}c2
HOSODENGHIcAp,GIAH~N,THAYDOl,BOSUNGGIAyDANG
KYLUUHANHTHUOCHOADU'<}C,VAcXIN,SINHPHAM
Di~u24.TiliIi~uchfithrgngtrongh8so'd~nghicfip,thayd6i,b6sung
gifiydangkyIU'uhilnhthuachoadU'gc,vicxin,sinhphim
,Taili~uchlitIUQ'ngth\Ichi~ntheahuangd~nt(:liPhelnII-ACTDho~cHgp~
phan3-ICH-CTDvacacquydinhsau:
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

28. 28
1.D6ivoiv~cxin,huyetthanhcochuakhangthe,d~nxu~tcuamauva
huyettuongngiroi:
a)Gi~yclnrngnhanxu~txirong10duocc~pboicoquancothAmquyen
mrocc~pCPPtheaquydinhhoacmottrongcaccoquanquanlyquydinhtai
khoan9Di~u2Thongurnay;
b)PhiSukiSmnghiem,tieuchuAnch~throngvaphuongphapkiemnghiem
coxacnhanboiVienKiSmdinhquocgiav~cxinvasinhpharnytS.
2.D6ivoithu6chiem,thu6cdSdaptrngnhuc§.uchoquocphong,anninh;
phong,chongdich,benh,kh~cphuchauquathientai,thamhoavathuocchonhu
c§.udi~utridacbiet:
a)Thu6chiSmdSdi~utribenhhiSmg~p:dfrlieunghiencirud(>6ndinh
s~ncotheahuangd~ncuaASEANho~ccuaICH;
b)Thu6cdSdapilngnhuc§.uchoqu6cphong,anninh;phong,chfmgdich,
b~nh,kh~cphvch~uquathientai,thamh<;>a:
Ch~pnh~ndfrli~unghienCUud(>6ndinhs~ncot<;lithaidiSmn(>ph6sO'
dangkydSxemxeth<;lndungcuathu6ctrencO'saykiSncuaH(>id6ngtrong
truanghQ'Pkhoangthaigiancuadfrli~unghiencUud(>6ndinhcuathu6cchua
dapilngduquydinhv~thaigiannghienCUut6ithiSutheahuangd~ncua
ASEAN.
SaukhiduQ'cc~pgi~ydangkyluuhanh,cO'saphaitiSptvcn(>ph6sO'
nghienCUud(>6ndinhthanhphAmchodSnkhikhoangthaigiannghiencuud(>
6ndinht6ithiSuthctSdapilngtheahuangd~ncuaASEANv~CvcQuanly
DuQ'ctheahinhthucthayd6i,b6sungquydinht<;liPhvlvcIIThongtunaydS
duQ'cxemxetvac~pnh~th<;lndungtheaquydinh.
TruanghQ'Pthu6ckhongd<;ltkStquanghiencuud(>6ndinhthead~cuO'ng
trongh6sO'dangky,cO'saphaibaocaongayv~CvcQuanlyDuQ'cdStrinhH(>i
d6ngxemxetv~h<;lndungcuathu6c.
TrencO'saykiSntuv~ncuaH(>id6ng,CvcQuanlyDuQ'cxemxet,quySt
dinhv~h<;lndungcuathu6cbaog6mcacac10thu6cdffsanxu~tcancutrendfr
li~unghiencUud(>6ndinhthctS.
c)Thu6cchonhuc§.udi~utrid~cbi~t:dfrli~unghiencUud(>6ndinhs~n
cotheahuangd~ncuaASEANho~ccuaICHduQ'cB(>truangB(>YtSquyStdinh
trencO'saykiSncuaH(>id6ngtrongtruanghQ'PcO'sadangkychungminhthu6c
khongthSbaoquanadi~uki~nkhih~uvungIVbtheahuangd~ncuaASEAN.
,3.TruanghQ'PcO'sasanxu~tsudVngnguyenli~ulamthu6cdffduQ'cc~p/
gHiydangky1uuhanht<;liVi~tNam: V
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

29. 29
a)KhongyeudlUphainoptaili~uchatlUQ11glienquandSnnguyenlieuva
tailieuquydinhtaidiemhkhoan1DiSu23Thongtunaytrongh6sadangky
thuocthanhpham;
b)Cosadangkyphainop:
-01phieukiernnghiemnguyenlieulamthu6cdocosasanxu~tthu6c
thanhphamkiernnghiemphaicod~yducacchitieuch~tIUQ11gvoimirechat
lUQ11gnrongduonghoacchatchehanrmrcchatlUQ11gtrongtieuchuancuacosa
sanxu~tnguyenlieu.Truonghopcosasanxu~tthuocthanhphamkhongdunang
hrckiSmtrat~tcacacchitieuch~tlUQ11g, cosaphaicungc~pphieuphantich
cacchitieuconthiSudoCoquankiemnghiemnhamrochoaccosakinhdoanh
dichvukiSmnghiemthuoc, nguyenlieulamthu6cdadUQ'cc~pgi~ychUngnh~
dudiSuki~nkinhdoanhduQ'cthchi~n;
-01phiSukiSmnghi~mnguyenli~ulamthu6cdocasasanxu~tnguyen
li~ukiSmnghi~m.
4.D6ivaithu6cdSnghithchi~ntheoquytrinhth~mdinhrutg~m
a)Ph~nh6saduQ'cch~t:
-TenduQ'cch~t(ghitheotenchungqu6ctS);
-Tenvadiachicasasanxu~tduQ'cch~t,banthanhph~mchuaduQ'cch~t;
-Tieuchu~nch~tIUQ11gvaphuangphapkiSmnghi~mduQ'cch~t,banthanh
ph~mchuaduQ'cch~t.TruOnghqpthu6cdangkytheotieuchu~nDuQ'cdiSnVi~t
Namho~ctieuchu~nduQ'cdiSnthamchiSutheoquydinhcuaB{iYtSthichighi
tenduQ'cdiSn,phienbanduQ'cdiSnapd\mgho~cghiduQ'cdiSnhi~nhanh;
-01PhiSukiSmnghi~mduQ'cch~t,banthanhph~mcuacasasanxu~tduQ'c
ch~t,banthanhph~mva01PhiSukiSmnghi~mduQ'cch~t,banthanhph~mcua
casasanxu~tthu6cthanhph~m;
-D6ivaiduQ'cch~tad~ngbanthanhph~mthiphaicothemcongthucbao
chSvaquytrinhsanxu~tbanthanhph~mchuaduQ'cch~tcuacasasanxu~tban
thanhph~m.
b)Ph~nh6sathanhph~m:
-Motavathanhph~ntheohuangdftnt~iPh~nP.1-ACTD;
-Tieuchu~nch~tlUQ11gvaphuangphapkiSmnghi~mthu6cthanhph~m.
TruOnghQ'PdangkYtheotieuchu~nDuQ'cdiSnVi~tNamho~ctieuchu~ndUQ'c
diSnthamchiSutheoquydinhcuaB{iYtSthighitenduQ'cdiSn,phienbanduQ'c
diSnho~cghiduQ'cdiSnhi~nhanh;
-Sanxu~tthanhph~m,baog6m:congthuc10sanxu~t;quytrinhsanxu~t
vakiSmsoa~quy?trinh;kiSmsoatcac~uacquantn,mgvacacsanph~mtrunggian.~
-Phieukiemnghi~mthanhpham; .;
~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

30. 30
-Baobidonggoisacap:Motahinhthirc,chfitli~uvatieuchuanchfit
hrongbaobidonggoisacfip;
-BaocaonghienCUudQ6ndinhcuathuocthanhpham,
c)Cactailieuconlaicuaphanh6sachfithrongthuchientheahuangdan
taiPhfinII-ACTDhoacHopphan3-ICH-CTDluutaicosadangkyvacosa
,
sanxuat,
5.TailieuquydinhtaiDiSunayphaithirchientheacacquydinhsau:
a)ApdungtheacacquydinhtaiPhulucIbanhanhkerntheaThongtu
nay,baogom:
-H6sakythuatchungASEAN(ACTD);
-HuangdannghiencirudQ6ndinh;
-Huangdanthamdinhquytrinhsanxuat;
-Huangdanthamdinhphirongphapphantich;
-HuangdannghienCUusinhkhadungvatuongduongsinhh9C;
b)D6ivoih6sathuocdffchu~nbitheamauICH-CTDvahuangdanky
thuattuongirngcuaICHthikhongyeucfiuchuySnd6ih6satheaquydinht~i
diSmakhoannay;
c)TruOnghqpnguyenli~ucogifiychungnh~ntuanthuduqcdiSnchauAu
(CEP):H6saduqcchfitt~idiSma,bkhoannaycothSduqcthaythSb&ngvi~c
nQpbQtaili~usau:
-Gifiych(mgnh~ntuanthuduqcdiSnchauAu(CEP)d6ivaiduqcchfit
kerntheatfitcacacphvIvcduqcbanhanhbaiHQid6ngchauAuvSchfitlugng
thu6c(EDQM);
-S6li~uphantich10duqcchfit;
-NSuthaih~nphaikiSmtral~ichfitluqngduqcchfitkhongneutrongCEP,
nQps6li~unghienCUudQ6ndinhcuaduqcchfit.
Di~u25.Taili~uti~nHimsangtrongh&sO'd~ngh!c~p,thaydBi,bB
sunggi~ydangkylU'uhanhthu8choaduQ'c,v~cxin,sinhphim
Taili~utiSnlamsangthchi~ntheohuangdant~iPhfinIII-ACTDho~c
Hqpphfin4-ICH-CTD.
D6ivaisinhph~mprobioticscongu6ng6c,chungvikhu~n,n6ngdQ,ham
luqng,chidinh,liSudungtuO'ngtsinhph~mduqccfipphepboimQttrongcac
cO'quanqwinlyquydinht~ikhoan9DiSu2ThongtunaythikhongphainQPtai
li~utiSnlamsang. . /
Di~u26.Taili~uHimsangtrongh&sO'd~ngh!c~p,thaydBi,bBsungu/
gi~ydangkylU'uhanhthu8choadU'Q'c,v~cxin,sinhphAm
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

31. 31
Taili~ulamsangthuchientheohuangd~ntaiPh~nIV-ACTDhoacHQ'P
phan5-ICH-CTD.
D6ivoisinhphamprobioticsconguongoc,chungvikhuan,n6ngdQ,ham
IUQ'l1g,chidinh,liSudungtuongtvsinhphamduocc~pphepboimottrongcac
coquanquanlyquydinhtaikhoan9Dieu2Thongtirnaythikhongyeuc~utai
lieulamsang.
Di~u27.H8so'd~ngh]c§p,giahan,thayd8i,b8sunggi§ydangkyhru
hanhthudchoadune,v~cxin,sinhphsm
1.H6sadSnghicapgi~ydangkyhruhanhthuochoadirocmoi,v~cxin,
sinhpham,baogorn:
a)Cactailieuhanhchinhtheaquydinhtaikhoan1Di@u23Thongtirnay.
b)TailieuchathrongquydinhtaiDi@u24Thongtirnay;
c)Tailieuti@nlamsangquydinhtaiDi@u25Thongtunay;
d)Tailieulamsangquydinht(:liDi@u26Thongtunay;
d)TruOnghQ'PcaSo'dangkYcod@nghiphanIO(:libi~tduQ'cg6c,sinhph~m
tharnchiSukhinQph6sad@nghic~pgi~ydangkyluuhanhthu6cthithvchi~n
theaquydinht(:lidiSma,b,c,dkhoan1Di@unayvatiSt2diSrnakhoan1Di@u
9Thongtunay.
2.H6sad@nghic~pgi~ydangkyluuhanhthu6cgeneric,baog6m:
a)Cactaili~uhanhchinhtheaquydinht(:likhoan2Di@u23Thongtunay;
b)Taili~uch~tIUQ'l1gquydinht(:liDi@u24Thongtunay.
3.H6sad@nghigiah(:lngi~ydangkyluuhanhthu6c:
a)Cactaili~uhanhchinhtheaquydinht(:likhoan3Di@u23Thongtunay~
b)Cactaili~ulienquantheaquydinht(:liPh\ll\lcIIbanhanhkernThong
tunayd6ivaicactruanghQ'Pthu6ccothayd6iv@h6sahanhchinh(khongbao
g6rnthayd6irnftunhanthu6cvato'huangdftnsud\lngthu6c).
TruOnghQ'PcaSo'dangkydanQpthayd6iv@h6sahanhchinhtruacthai
diSmnQph6sagiah(:lnnhungchuaduQ'cpheduy~tthikhongphainQPl(:liphk
h6sanaytrongh6sagiah(:lngi~ydangkylUllhanh.
4.H6sad@nghithayd6i,b6sunggi~ydangkylUllhanhthu6c,baog6m:
a)Taili~uhanhchinhtheaquydinht(:likhoan4Di@u23Thongtunay~
b)Cactaili~utuang(mgv6icacnQidungthayd6ilan,thayd6inh6quy
dinht(:liPh\ll\lcIIbanhanhkernThongtunay.D6ivaiv~cxincuacungmQtca
So'sanxu~tho~cchuSo'hfrugi~ypheplUllhanhthu6cch~pnh~nthayd6idia
diSrncaSo'sanxu~tacungqu6cgiaho~cngoaiqu6cgiadaduQ'cc~pgi~ydangV
kylUllhanh.
~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

32. 32
5.H6sad@nghicfipgifiydangkyhruhanhthuoctheaquytrinhthamdinh
rutgon,baog6m:
a)Cactailieuhanhchinhtheaquydinhtaikhoan5:E>i@u23Thongnrnay;
b)TailieuchfitlUQ11gthuchientheaquydinhtaidi@ma,bkhoan4:E>i@u
24Thongnrnay.
My.c3
HOsaDENGHJcAp,GIAH~N,THAYDOl,BOSUNG
GIAYDANGKYLUUHANHTHU6cDUQCLI:¢U
Di~u28.Taili~uch~tIU'gngtrongh&SO'd~ngh]c~p,thayd8i,b8sung
gi~ydangkyIU'uhanhthu8cdurrcli~u
1.Nguyenlieu
a)Quytrinhsanxufit(chiapdungd6ivoinguyenlieuduoclieu):Mota
chiti@t,d~yduquatrinhsache,[email protected]@unguyenlieu
labanthanhphamdiroclieu,caoduoclieuphairnotachiti@tquytrinhsanxufit
banthanhphamduoclieu,caoduoclieutirnguyenlieuduoclieu(tnrtnronghop
banthanhphamdirocli~u,caoduQ'cli~udaduQ'ccfipgifiydangkyluuhanh);
b)Tieuchu~nchfitlUQ11gvaphuangphapki@mnghi~m
-:E>6iv6iduQ'cli~ukhongphaid~ngbanthanhph~mduQ'cli~u:thchi~n
theaquydinht~iThongtus638/20211TT-BYT;
-:E>6iv6ibanthanhph~mduQ'cli~uapdVngtuangtquydinhv@tieu
chu~n chfitlUQ11gvaphuangphapki@mnghi~md6iv6iduQ'cli~ukhongphaid~ng
banthanhph~mduQ'cli~uquydinht~iThongtus638/20211TT-BYT.
c)Phi@uki@mnghi~mnguyen li~u
-01Phi@uki@mnghi~mduQ'cli~ucuacasosanxufitthu6cthanhph~m.
Truemghqpcasosanxufitthu6cthanhph~mkhongdunanglcki@mtratfitca
cacchitieuchfitlUQ11g,casophaicungcfipphiSuphantichcacchitieuconthi@u
doCaquanki@mnghi~mnhanu6cho~ccasokinhdoanhdichvvki@mnghi~m
thu6c,nguyenli~ulamthu6cdaduQ'ccfipgifiychUngnh~ndudi@uki~nkinh
doanhduQ'cki@mnghi~mthchi~n;
-01PhiSuki@mnghi~mbanthanhph~mduQ'cli~u,caoduQ'cli~ucuacaso
sanxufitbanthanhph~mduQ'cli~u,caoduQ'cli~uva01Phi@uki@mnghi~mban
thanhph~mduQ'cli~u,caoduqcli~ucuacasosanxufitthu6cthanhph~m.
2.Thanhph~m
a)Quytrinhsanxufit
-Congthucchodanvidonggoinh6nhfit:ten,hamlUQ11g,n6ngdQ,kh6i/
lUQ11g, tieuchu~n~pdVngcuatUngthan?ph~ncotrong~ongthucchomQtdan\V
vidonggoinh6nhat.TruemghqpsanxuattubanthanhphamduQ'cli~u,caoduQ'c
J~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

33. 33
lieuphaighir6kh6ihrongduoclieutuongirngvoibanthanhphamduoclieu,
caoduoclieuhoactyl~caoduoclieu,banthanhphamdiroclieusovoiduoclieu
bandfiuhoackerntheohamhrong(0/0)cuaduocchat,nhomhopchatdffdinh
hrongduoctheotirngdiroclieu;
_Congthircchomot10sanxuatthuocthanhpham:ghir6ten,kh6ihrong,
thStichcuatirngthanhphantrongcongthirc10thuoc;
-Sad6quytrinhsanxuatthuoc:thShiendfiyducacgiaidoantrongqua
trinhsanxu~tthuocbaog6mduongdicuanguyenlieuvaphilhopvoimotaquy
trinhsanxu~t;
-Motaquytrinhsanxuatthuoc:motad§.ydu,chitiStcacbuocthuchien
trongtirnggiaidoancuaquytrinhsanxu~tbaog6md§.yducacthongs6kythu~t
cuatUnggiaidO(;ln;
-Danhm\lctrangthiStbi:tenthiStbi,thongs6,m\lcdichsud\lng;
-KiSmsoattrongquatrinhsanxu~t:Motadfiydu,chitiStcacchitieukiSm
tra,kiSmsoatd6ivaim6igiaidO(;lng6mtenchitieu,tieuchu~nch~pnh~n,
phuangphapkiSmsoat,tfinsu~tkiSmsoat,s6IUQ'ngmftul~ydSkiSmsoat;
b)Tieuchu~nch~tIUQ'ngvaphuangphapkiSmnghi~m
-Congthucchodanvidonggoinh6nh~t:ten,hamIUQ'llg,n6ngdQ,kh6i
IUQ'llg,tieuchu~napd\lngcuatUngthanhphfincotrongcongthucchomQtdan
vidonggoinh6nh~t.TruOnghqpsanxu~ttubanthanhph~mduQ'cli~u,caoduQ'c
li~uphaighir6kh6ilUQ'ngduQ'cli~utuang(mgvaibanthanhph~mduQ'cli~u,
caoduQ'cli~uho~ctyl~caoduQ'cli~u,banthanhph~mduQ'cli~usovaiduQ'cli~u
bandfiuho~ckerntheohamlUQ'llg(%)cuaduQ'cch~t,nhomhqpch~tdffdinh
IUQ'llgduQ'ctheotUngduQ'cli~u;
-Tieuchu~nthanhph~m:th\1'chi~ntheoquydinht(;liThongtus6
1112018/TT-BYT;
c)PhiSukiSmnghi~mthanhph~m;
d)Tieuchu~ncuabaobidonggoi:Motadfiydu,chitiStch~tli~ubaobi,
chitieuch~tlUQ'llg,mucch~tlUQ'llgvaphuangphapkiSmnghi~m;
d)BaocaonghienCUudQ6ndinhtheohuangdftnnghiencUudQ6ndinh
quydinht(;liPh\ll\lCIbanhanhkerntheoThongtunay.
Di~u29.Taili~uantoan,hi~uquatrongh8SO'd~nghicfip,giah~n,
thayd6i,b6sunggifiydangkyluuhanhthuc3cdUQ'cli~u
1.Taili~uantoan,hi~uquad6ivaithu6cdUQ'cli~uth\1'chi~ntheoquydinh
cuaPh\ll\lcVbanhanhkerntheoThongtunayho~ctheoquydinhcuaASEAN
(ACTD),ICH-CTD.
2.Cactaili~uquydinht(;lidiSmbkhoan1DiSu18Thongtunay(nSuco).~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

34. 34
Di~u30.HBsod~ngh]cfip,giahan,thaydBi,bBsunggifiydangkyhru
hanhthuBcdUQ'cli~u
1.H6sadSnghic~pgi~ydangkyhruhanhthu6cdiroclieu,baag6rn:
a)Cactailieuhanhchinhtheaquydinhtaikhoan2DiSu23Thongtirnay;
b)Tailieuch~throngquydinhtaiDiSu28Thongtirnay;
c)Tailieuantoan,hieuquaquydinhtaiDiSu29Thongtirnay;
2.H6sadSnghigiahangi~ydangkyhruhanhthuocduoclieu:
a)Cactailieuhanhchinhtheaquydinhtaikhoan3DiSu23Thongtunay;
b)CactailieulienquantheaquydinhtaiMucDPhulucIIbanhanhkern
Thongtirnayd6ivoicactnronghopthu6ccothayd6ivSh6sahanhchinhtai
thaidiemgiahangi~ydangkyhruhanh(khongbaag6mthayd6im~unhanthu6c
vatahuangdansud\lngthu6c).
TruOnghqpcasadangkydan<)pthayd6ivSh6sahanhchinhtruacthai
diSrnn<)ph6sagiah1;lnnhungchuaduqcpheduy~tthikhongphain<)p11;liph~n
h6sanaytrangh6sagiah1;lngi~ydangkylUllhanh.
3.H6sadSnghithayd6i,b6sunggi~ydangkyluuhanhthu6cduqcli~u,
baag6m:
a)Taili~uhanhchinhtheaquydinht1;likhaan4DiSu23Thongtunay;
b)Taili~utuangungvaicacn<)idungthayd6ilan,thayd6inhoquydinh
t1;liM\lcDPh\ll\lcIIbanhanhkerntheaThongtunay.
M\lc4
HOsaDANGKYNGUYENLI:¢ULAMTHUOC
Di~u31.Taili~uchitIUQ'ngtronghBsO'd~nghicfip,thayd8i,b8sung
gifiydangkyluuhimhnguyenli~ulamthuBc
1.D6ivainguyenli~uduqcch~t:ThllChi~ntheah6saACTDph~nduqc
ch~t.TruOnghqpduqcch~tdangkych~tluqngtheatieuchu§.nnhasanxu~t,phai
n<)pkerntheah6sat6ngthSduqcch~t(DrugMasterFile).
2.D6ivainguyenli~uad1;lngbanthanhph~rnchuaduqcch~t:ThllChi~n
theah6saACTDnhudangkythu6cthanhph~rn, trangdoph~nh6savSthanh
ph~rnduqcthayb~ngh6sabanthanh ph~rndangkY;caccongthuccharn<)tdan
viliSu,danvidonggoinhonh~tthayb~ngcongthuc10sanxu~t.
3.D6ivainguyenli~ubanthanhph~rnduqcli~u,taduqc, vonang:
a)Congthucbaach@d6ivaibanthanhph~mduqcli~u,taduqcad1;lng
tr<)ns~n,yonang:thanhph~n, kh6iluqng, thStich,tieuchu~nch~tluqn&cua!UngJ
thanhphantrongcongthuc.TruOnghqpsud\lllgnguyenli~uconguongoctu
d<)ngv~tphaicungc~pthongtinvScacch~tng~unhien(cacs6li~uantaanvi
rut); ~~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

35. 35
b)Quytrinhsanxuftt
_Sad6quytrinhsanxuat: thShiend~yducacgiaidoantrongquatrinhsan
xuatbaog6mduongdicuanguyen lieuvaphuhopvoimotaquytrinhsanxuat;
-Motaquytrinhsanxuat:motad~ydu,chitiStcacbuocthirchientrong
tunggiaideancuaquytrinhsanxufttbaog6md~yducacthongs6kythuatcua
tunggiaidoan;
-DanhmuctrangthiStbi:tenthiStbi,thongs6,mucdichsirdung;
_KiSmsoattrongquatrinhsanxuat:Motad~ydu,chitiStcacchitieukiSm
tra,kiemsoatd6ivoim6igiaidoang6mtenchitieu,tieuchuAnchapnhan,
phuongphapkiSmsoat,t~nsuatkiemsoat,s6hrongm~ul~ydSkiemsoat,
c)TieuchuanchftthrongvaphuangphapkiSmnghi~m
-D6ivaibanthanhphAmduQ'cli~uapd\lngtuangt\1'quydinhv@tieu
chuAnchfttluqngvaphuangphapkiSmnghi~md6ivaiduQ'cli~ukhongphaid~ng
banthanhphAmduQ'cli~uquydinht~iThongtus638/20211TT-BYT;
-D6ivaitaduQ'c,VOnang:th\1'chi~ntheoquydinht~iThongtus6
1112018/TT-BYT.
d)PhiSukiSmnghi~m;
d)TieuchuAncuabaobidonggoi:Motad~ydu,chitiStch~tli~ubaobi,
chitieuchfttluqng,mucchfttluqngvaphuangphapkiSmnghi~m;
e)Baocaonghiencuud96ndinh,baog6md@cuangnghienCUud96n
dinh;s6li~unghienCUud96ndinh;kStquavabanlu~n.
f)i~u32.HBSO'd~nghicip,giah~n,thaydBi,bBsunggiiydangkylU'u
hanhnguyenli~ulamthuBc
1.H6sad@nghicftpgiftydangkYluuhanhnguyenli~ulamthu6c, baog6m:
a)Taili~uhanhchinhtheoquydinht~ikhoan2Di@u23Thongtunay;
b)Taili~uchfttluqngquydinht~iDi@u31Thongtunay.
2.H6sad@nghigiah~ngiftydangkyluuhanhnguyenli~ulamthu6c:
a)Cactaili~uhanhchinhtheoquydinht~ikhoan3Di@u23Thongtunay;
b)Cactaili~ulienquantheoquydinht~iM\lcBPh\ll\lcIIbanhanhkern
Thongtunayd6ivaicactruOnghqpnguyenli~ulamthu6ccothayd6iv@h6sa
hanhchinht~ithaidiSmgiah~ngiftydangkyluuhanh(khongbaog6mthayd6i
m~unhannguyenli~ulamthu6c).
TruOnghqpcasadangkydan9Pthayd6iv@h6sahanhchinhtruacthai
diSmn9Ph6sagiah~nnhungchuaduQ'cpheduy~tthikhongphain9Pl~iph~n
h6sanaytrongh6sagiah~giftydangkYluuhanh.
3.H6sad@nghithayd6i,b6sunggi~ydangkyluuhanhnguyenli~ulam~
thu6c, baog6m:
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

36. 36
a)Tailieuhanhchinhtheaquydinhtaikhoan4DiSu23Thongnrnay;
b)Tailieutuongirngvoicacne)idungthayd6i100,thayd6inhotheaquy
dinhtaiPhftnBPhulucIIbanhanhkerntheaThongnrnay.
ChU'O'DgIV
TmJTl)CcAp,GIA~N,THAYDOl,BOSUNGGIAyDANGKYLUU
HANHTHUOC,NGUYENLr¢ULAMTHUOC;TRiNH11/THAMDJNH
HOsaNII4PKHAuTHUOCCHUACOGIAyDANGKYLUUHANH
Di~u33.CactruonghopdU'gcthchi~ntheoquytrinhthAmdjnh
nhanh,thamdjnhrutgQn
1.Cactnronghopduocthirchientheaquytrinhth~mdinhnhanh
H6sadangkythuccdirocthamdinhtheaquytrinhthamdinhnhanhkhi
dapirngmottrongcacdiSukiensauday:
a)Thuc3cthuocDanhmucthuc3chiSmdoBe)tnrongBe)YtSbanhanh;
b)Thuc3cdapirngnhucftuc~pbachchoquocphong, anninh,quc3cphong,
chongdichbenh,kh~cphuch~uquathientai,thamhoa;
c)Thuc3ctrongmrocsanxu~ttrennhtrngdaychuyenmoidattieuchu~nGMP
hoactrendaychuyennangc~pd~ttieuchukGMP-EU, GMP-PIC/S vatuongduong
trongthaih~nkhongqua18thangkStungayduqcc~pgi~ychUngnh~nGMP;
d)v~cxindffduqcWHOtiSndanhgiad~tyeucftu,v~cxindungtrongchuong
trinhtiemchUngrnare)ngquc3Cgia;
d)Thuc3cchuyenkhoad~ctQ,thuc3ccod~ngbao~hSd~cbi~tchicokhongqua
02(hai)thuc3ctuangt(cungduqc ch~t,cungd~ngbaochS,cunghamluqng,
n6ngde))cogi~ydangkyluuhanhthuc3ct~iVi~tNamconhi~ulct~ithaidiSm
ne)ph6sO',baog6m:
-Thuc3cdiSutriungthu;
-Thuc3cdiSutrikhangvirutthSh~mm;
-KhangsinhthSh~mai;
-Thuc3cdungtrongdiSutrisc3txu~thuySt, lao,sc3tret;
-Thuc3cleCchSmi@ndichdungtrongghept~ng.
e)Thuc3csanxu~ttrongnuac,baog6m:
-Thuc3cduqcsanxu~tgiacongho~cchuySngiaocongngh~sanxu~tt~iVi~t
Namdc3ivaithu6cdiSutriungthu,v~cxin,sinhph~m,thu6cdiSutrikhangvi
rutthSh~mai,khangsinhthSh~mai,thu6cleCchSmi@ndichdungtrongghep
t~ng;
-Thuc3cduqcli~ucodStaikhoah<)cvacongngh~c~pquc3cgia,c~pbe)ho~c
c~ptinhdffduqcnghi~mthud~tyeucftu,thu6cduqcsanxu~ttoanb¢tungu6n/
duqcli~utrongnuacd~tGACP; VI
~~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

37. 37
-Thuocmoisanxu~ttrongnuocdffhoanthanhthuchienthirnghiemlam
sangtaiVietNam;
g)Thu6cmoi(dieutriungthu,khangvirutthSh~moi,khangsinhthSh~
moi),sinhphamthamchieu;
h)Bietduocg6cduocsanxu~tgiaconghoacchuyengiaocongnghesan
xu~ttaiVi~tNam;
i)Thu6cthayd6icosasanxu~td~ndSnphaic~pgi~ydangkyhruhanhmoi
theaquydinhtaidiSmbkhoan2DiSu55LuatDuoc.
2.CactnronghQ'Pdirocthamdinhtheaquytrinhrutgon
H6sadangkythuocduocthamdinhtheaquytrinhthamdinhrutgonkhi
dapirngd6ngthaicacdieukiensau:
a)Thu6cduocsanxu~ttaicasaduocC\lCQuanIyDuocdinhkydanhgia
viecdapirngthuchanht6tsanxu~tthu6c;
b)Thu6cthu<)cDanhm\lcthu6ckhongkedan;
c)Thu6ckhongphaid~ngbaochSgiaiphongbiSnd6i;
d)Thu6ckhongdungtrl,l'ctiSptrenm~t.
Di~u34.Th§mquy~ne§p,giah~n,thaydBi,bBsunggi§ydangkyluu
himhthuBe,nguyenli~ulamthuBe
1.C\lCQuanIyDuQ'cvacacdanvidoB<)truangB<)YtSquyStdinh(sau
daygQit~tladanvithfimdinh)t6chucthfimdinhh6sac~p,giah~n,thayd6ib6
sunggi~ydangkYlUllhanhthu6c,nguyenli~ulamthu6c,trutruanghQ'Pquydinh
t~idiSmbkhoan2DiSunay.
2.C\lCQuanIyDuQ'c:
a)C~p,giah~n,pheduy~tthayd6i,b6sunggi~ydangkyIuuhanhthu6c,
congb6bi~tduQ'cg6c,sinhphfimthamchiSu,thu6ccobaocaonghienClrutuang
duangsinhhQctrencasaykiSntuv~ncuaH<)id6ngd6ivaitUngtruanghQ'PC\l
thSho?cchutruangchungcuaH<)id6ngapd\lngchotUnglo~ihinhthayd6i,b6
sung,trutwanghQ'Pquydinht~idiSmbkhoannay;
b)Congb6trentrangthongtindi~ntucuaC\lCQminIyDuQ'cn<)idungthay
d6i,b6sunggi~ydangkylUllhanhthu6c,nguyenli~ulamthu6cd6ivaithayd6i
nh6chiyeuc~uthongbao(Notification).
Di~u35.Quydjnhchungv~trinhtve§p,giah~n,thaydBi,bBsunggi§y
dangkyluuhanhthuBe,nguyenli~ulamthuBe
1.H6saduQ'cn<)ptn,rctuySn,n<)ptrl,l'ctiSpho?cguiquaduangbUlldi~n
dSnC\lCQuanIyDuQ'c.
2.Saukhinh~nduQ'cd~ydlih6sa,C\lCQuanIyDuQ'ctrachocasadangky
PhiSutiSpnh~nh6satheaM~u9/TTbanhanhkerntheaThongtunay. ~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

38. 38
C\lCQuanlyDuoctiSpnhanh6sarnakhongb~tbuocphainopCPPd5ivoi
tnronghQ'PquydinhtaidiSmekhoan4DiSu22Thongtunayvatailieuquydinh
taidiSmbkhoan1DiSu24Thongtunaytaithaidiemnoph6sa.
3.D5ivoih6sanhapkhauthuocchuacogi~ydangkyluuhanh,viectiSp
nhanh6sathuchientheoquydinhtaidiSmbkhoan1DiSu77Nghidinhs5
54/2017/ND-CP.
4.T6chircthamdinhh6sadSnghicap,giahan,thayd6i,b6sunggi~ydang
kyluuhanhthuoc,nguyenlieulamthuocvah6sanhapkh~uthuocchuacogi~y
dangkyluuhanh:
a)C\lCQuanIyDuocchuyenh6sachocacchuyengiahoaccacdanvidiroc
B<)YtSgiaonhiemvudSt6clnrcth~mdinhtrencosadanhsachchuyengiado
C\lCQuanlyDuQ'cho?ccacdanvith~mdinhthanhl~p,pheduy~t;
b)Trencasat6nghQ'PykiSnth~mdinhcuacacchuyengiaho?ccacdanvi
th~mdinhvaxemxetcacthongtinlienquan,C\lCQuanlyDuQ'cchiutnichnhi~m
dSxu~tvi~cc~p,giahc;tn,thayd6i,b6sungho?cchuac~p,giahc;tn,thayd6i,b6
sungho?ckhongc~p,giahc;tn,thayd6i,b6sunggi~ydangkyluuhanhthu5c,
nguyenli~ulamthu5c;c~p,chuac~pho?ckhongc~pgi~yphepnh~pkh~uthu5c
chuacogi~ydangkyluuhanh.YkiSndSxu~tcuaC\lCQuanlyDuQ'cduQ'cthS
hi~ntrenbienbanth~mdinh;
c)C\lCQuanlyDuQ'ctrinhH<)id6ngxemxet,tuv~nvScacykiSndSxu~t
cuaC\lCQuanlyDuQ'cquydinhtc;tidiSmbkhoannayd5iv6icactruanghQ'Psau:
-C~p,khongc~p;giahc;tn,khonggiahc;tn;pheduy~t,khongpheduy~tthay
d6i,b6sunggi~ydangkyluuhanhthu5c,nguyenli~ulamthu5ctrutruanghQ'P
quydinhtc;tikhoan5DiSunay;
-Congb5,khongcongb5bi~tduQ'cg5c,sinhph~mthamchiSutrutruang
hQ'Pcasadangkythu5ckhongphain<)ph6sadSnghiphanloc;tibi~tduQ'cg5c,
sinhph~mthamchiSuquydinhDiSu9Thongtunay;
-C~p,khongc~pgi~yphepnh~pkh~uthu5cchuacogi~ydangkyluuhanh;
-CactruanghQ'PkhacdoC\lCQuanlyDuQ'cdSxu~tdSdapUngnhuc~uc~p
thiSttrongphongb~nh,chuab~nh.
5.D5ivOicach6sadSnghic~p,giahc;tn,thayd6i,b6sunggi~ydangkYluu
hanhthu5c,nguyenli~ulamthu5c, casachiduQ'Cphepsuad6i,b6sungkhongqua
03l~n.NSuquas5lksuad6i,b6sungneutrenrnah6sasuad6i,b6sungchua
dc;tt,C\lCQminlyDuQ'ccocongvanthongbaokhongdi>ngyc~p,giahc;tngi~y
dangkyluuhanh,khongdi>ngypheduy~thi>sathayd6i,b6sung.Hi>sadfln<)p
khongcongiatrio . "
\I
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

39. 39
Di~u36.Thiituccipgiiydangkyhruhanhthudc,trinhtt}.'thAmdjnhh8
sonh~pkhAuthudcchuacogiiydangkyhruhanh
1.Trongthaihant6ida12thangk@tirngaynhanduh6sad6ivoih6sadS
nghicftpgiftydangkyhruhanhthuoc(tnrtnrongh<JPquydinhtaiDiSu39Thong
tirnay),CueQuanlyDuoccapgiftydangkyhruhanhthuoc.Truongh<JPkhong
cftphoacchuacftp,CueQuanlyDuoccovanbantraIoivaneurolydo.Thai
giangiaiquyetcacbuocduocquydinh,cuth@nhirsau:
a)Trongthaihan02thangk@tirngaytiSpnhanh6sa,CueQuanlyDuoc
tienhanhrasoat,phanlo~ivaguih6sachocacchuyen giathAmdinhho~ccac
danvithAm dinh. Trongthaih:~m06thangk@tungaynh~nduQ'ch6satueVc
QuanlyDuQ'c, cacchuyen giathAmdinhho~ccacdanvithAmdinhphaihoan
thanhbienbanthAmdinhvaguievcQminlyDuQ'ct6ngh<JP,dSxufttykiSntren
bienbanthAmdinhtheoquydinht~ikhoim 4DiSu35Thongtunay;
b)Trongthaih~n02thangk@tungaynh~nduQ'cbienbanthAm dinh'evc
Quan lyDuQ'ccovanbantralaid6ivaih6sathAmdinhchuad~tvaneurolydo.
D6ivaih6saduQ'ceVcQuanlyDuQ'cdSxufttcftp,khongcftpho~cdSxufttc~n
xinykiSnxemxet,tuvftncuaH9id6ng,eVcQuan lyDuQ'cchuy@nVanphong
H9id6ngd@t6chilch<;>pH9id6ng;
c)Trongthaih~n01thangk@tungaynh~nduQ'ctaili~utueVcQuanly
DuQ'c,VanphongH9id6ngt6chilch<;>pH9id6ngvaguibienbanh<;>pH9id6ng
vSevcQuanlyDuQ'c;
d)Trongthaih~n01thangk@tungaynh~nduQ'cbienbanh<;>pH9id6ng,
evcQuanlyDuQ'cbanhanhquyStdinhcftpgiftydangkyluuhanhd6ivaih6sa
d~tyeuc~u;evcQuanlyDuQ'ccovanbantralaitheokStlu~ncuaH9id6ngd6i
vaih6sathAmdinhchuad~t,khongd~tvaneurolydo.
2.Trongthaih~n36thangd6ivaitruOngh<JPcoyeuc~ub6sungtaili~u
tiSnlamsangvalamsang, taili~utuangduongsinhh<;>c,taili~unghienClrud9
6ndinhho~ctrongthaih~n12thangd6ivaicactruOngh<JPb6sungtaili~ukhac,
k@tungayeVcQuanlyDuQ'ccovanbanthongbao,coSo'dangkyphain9Ptai
li~ub6sungtheoyeuc~u.Sauthaih~nnay,caSo'dangkykhongn9Ptaili~ub6
sungthih6sadan9Pkhongcongiatrio
eaSo'dangkyduQ'cphepthongbaoc~pnh~tb~ngvanbanvSevcQuanly
DuQ'cvSh6sadangkydan9PvadangtrongthaigianthAmdinhd6ivaicac
truangh<JPc~pnh~tthongtinlienquandSnantoan,hi~uquacuathu6cho~cgifty
to'phaplycuacaSo'dangkY,caSo'sanxufttthu6c, nguyenli~ulamthu6csovai
h6sadan9P.
Thaigiank@tukhicovanbanthongbaocuaeVcQuanlyDuQ'cdSnkhi
caSo'dangkyn9Ptaili~ub6sungkhongduQ'ctinhvaothaih~nquydinht~i
khoan5DiSu56Lu~tDuQ'c. ~
vI~
----------- --_.
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

40. 40
3.Trongthaihan06thangkStil'ngaynhandutailieub6sung,CueQuan1y
Duocbanhanhquyetdinhc~pgi~ydangky1uuhanhd6ivoih6sadatyeuc~u
hoaccovanbantraloid6ivoih6sath~mdinhkhongdattheokStluancuaH9i
d6nghoaccovanbantraloid6ivoih6sath~mdinhchuadatvaneur51ydo.
Thaigiangiaiquyetcacbuocdirocquydinh,cuthSnhusau:
a)Trongthaihan01thangkStil'ngaytiSpnhanh6sa,CueQuan1yDiroc
tienhanhreisoat,phan10~ivaguih6sachocacchuyengiathamdinhhoaccac
danvith~mdinh.Trongthaihan02thangkStil'ngaynhandiroch6satil'Cue
Quan1yDiroc,cacchuyengiath~m dinhho~ccacdanvith~mdinhphaihoan
thanhbienbanth~mdinhvaguiCvcQuan1yDugct6nghgp,dSxu~tykiSntren
bienbanth~mdinhtheoquydinht~ikhmin4DiSu35Thongtunay;
b)Trongthaih~n01thangkStil'ngaynh~ndugcbienbanth~mdinh,Cvc
Quan1yDugccovanbantra1aid6ivaih6sath~mdinhchuad~tvaneur51ydo.
D6ivaih6sadugcCvcQuan1yDugcdSxu~tc~p,khongc~pho~cdSxu~tc~n
xinykiSnxemxet,tuv~ncuaH9id6ng,CvcQuan1yDugcchuySnVanphong
H9id6ngdShQpt6chucH9id6ng;
c)Trongthaih~n01thangkStil'ngaynh~ndugctaili~util'CvcQuan1y
Dugc,VanphongH9id6ngt6chuchQpH9id6ngvaguibienbanhQPH9id6ng
vSCvcQuanlyDugc;
d)Trongthaih~n01thangkStil'ngaykStil'ngaynh~ndugcbienbanhQP
H9id6ng,CvcQuanlyDugcbanhanhquyStdinhc~pgi~ydangkY1uuhanhd6i
vaih6sad~tyeuc~u;CvcQuanlyDugccovanbantra1aitheokStlu~ncuaH9i
d6ngd6ivaih6sath~mdinhchuad~t,khongd~tvaneur5lydo.
4.Trinhtvth~mdinhh6sanh~pkh~uthu6cchuacogi~ydangky1uuhanh:
a)Trongthaih~05ngaylamvi~ckStirngaynh~duh6sa,C\lCQuan1yDugc
tiSnhanhchuySnh6sachocacchuyengiathfundinhho~ccacdanvithfundinh.
Thaigianth~mdinh1akhongqua30ngayd6ivaicach6sakhongyeud.u
dfr1i~ulamsang,tai1i~uchungminhtuangtvsovaisinhph~mthamchiSu,ho~c
khongqua60ngayd6ivaid6ivaicach6sayeuc~udfr1i~ulamsangho~ctai
1i~uchUngminhtuangtvsovaisinhph~mthamchiSukStil'ngayCvcQuan1y
DugcchuySnh6sachochuyengiath~mdinhho~cdanvith~mdinh;
b)Trongthaih~n20ngaykStil'ngaynh~ndugcbienbanth~mdinh:
-CvcQuan1yDugct6nghgpykiSnth~mdinhcuacacchuyengiath~m
dinhho~ccacdanvith~mdinhvaxemxetcacthongtinlienquandSdSxu~tvi~c
c~p,chuac~pho~ckhongc~pgi~yphepnh~pkh~uthu6cchuacogi~ydangkY
1uuhanh.
-D6ivaih6sac~nphaitrinhH9id6ngtheoquydinht~idiSmckhoan4
Di~u35Thongtunay,CvcQuan1yDugctrinhH9id6ngtrongphienhQpg~nJ
nhat·
, 1~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

41. 41
_D6ivoih6sathamdinhchuadat,CueQuanlyDuoccovanbantraIoiva
neuralydo.
c)Trongthaihan05ngaylamvieckStirngaynhanduocbienbanh9PHQi
d6ng,CueQuanlyDuocc~PGi~yphepnhapkhaud6ivoih6sadatyeudm;
hoaccovanbantraloitheak@tluancuaHQid6ngd6ivoih6sathamdinhchua
dathoackhongdatyeucfiuvaneuralydo;
d)Saukhinhandiroch6sasuad6i,b6sungcuacosanhapkhau,CueQuan
lyDuocthuchientheaquydinhtaidiema,bvackhoannay.
D6ivoih6saHQid6ngcoyeucfiusuad6i,b6sungvakhongyeucfiuphai
trinhlaiHQid6nglfinsau,CueQuanlyDuQ'cthongbaochocO'sasuad6i,b6
sung;truOnghgph6sasuad6i,b6sungth~mdinhd~tyeucfiu,evcQmlnlyDuQ'c
thvchi~nvi~cc~ppheprnakhongphaitrinhl~iHQid6ng.
Di~u37.Thotl]cgiah~ngiiydangkyIU1lhimhthuBc,nguyenli~ulamthuBc
1.Trongthaih~n03thangkStungaynh~nduh6sO',eVcQuanlyDuQ'cgia
h~ngi~ydangkylUllhanhlUllhanhthu6c,nguyenli~ulamthu6c.TruOnghgp
khonggiah~nho~cchuagiah~n,eVcQuanlyDuQ'ccovanbantralaivaneura
lydo.ThaigiancacbuacduQ'cquydinh,cvthSnhusau:
a)Trongthaih~n08ngaylamvi~ckStungayti@pnh~nh6sO',evcQuanly
DuQ'cti@nhanhrasoat,phanlo~ivaguih6sachocacchuyengiath~mdinhho~c
cacdanvith~mdinh.Trongthaih~n01thangkStungaynh~nduQ'Ch6satueVc
QmlnlyDuQ'c,cacchuyengiath~mdinhho~ccacdanvith~mdinhphaihoan
thanhbienbanth~mdinhvaguievcQuanlyDuQ'ct6nghgp,k@tlu~nbienban
th~mdinhtheaquydinht~ikhoan4DiSu35Thongtunay;
b)Trongthaih~n12ngaylamvi~ckStungaynh~nduQ'cbienbanth~m
dinh,evcQuanlyDuQ'ccovanbantralaid6ivaih6sath~mdinhchuad~tva
neuralydo.D6ivaih6sadUQ'ceVcQuanlyDuQ'cdSxu~tgiah~n,khonggia
h~nho~cdSxu~tcfinxinyki@nth~mdinh,tuv~ncuaHQid6ng,evcQuanly
DuQ'cchuySnVanphongHQid6ngdSt6chuch9PHQid6ng;
c)Trongthaih~n06ngaylamvi~ckStungaynh~nduQ'ctaili~utuevcQuan
lyDuQ'c,VanphongHQid6ngt6chuch9PHQid6ngvaguibienbanh9PHQi
d6ngvSevcQuanlyDuQ'c;
d)Trongthaih~n18ngaylamvi~ckStungaynh~nduQ'cbienbanh9PHQi
d6ng,evcQuanlyDuQ'cbanhanhquy@tdinhgiah~ngi~ydangkylUllhanhd6i
vaih6sad~tyeucfiu;evcQuanlyDuQ'ccovanbantralaitheak@tlu~ncuaHQi
d6ngd6ivaih6sath~mdinhchuad~t,khongd~tvaneuralydo.
2.Trangthaih~n12thangd6ivaicactruOnghgpb6sungtaili~u,kStungay
eVcQuanlyDuQ'ccovanb~mthongbao,cO'sadangkyphainQPtaili~ub6sung
theayeucfiu.Sauthaih~nnay,cO'sadangkykhongnQPtaili~ub6sungthih6
sadanQPkhongcongiatrio
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

42. 42
CosadangkydirocphepthongbaocapnhatbangvanbanvSCueQuanly
DirocvSh6sadffnopvadangtrong thaigianth~mdinhd6ivoicactnronghop
c~pnhatthongtinlienquandSnantoan,hieuquacuathu6choacgiftytaphaply
cuacosadangky,cosasanxufttthuoc,nguyenlieulamthuocsovoih6sadffnop,
ThaigiankStirkhicovanbanthongbaocuaCueQuanlyDuocdSnkhi
cosadangkyn<)ptailieub6sungkhongduoctinhvaothaihanquydinhtai
khoan5DiSu56LuatDuoc.
3.Trongthaihan03thangkStirngaynhandutailieub6sung,CueQuan
IyDirocbanhanhquyetdinhgiahangil1ydangkyhruhanhd6ivoih6sadC:ltyeu
cfiu;evcQuanlyDugccovanbantralaitheokStlu~ncuaH<)id6ngd6ivaih6
sath~mdinhchuadC:lt,khongdC:ltvaneur5lydo.
Trinhtv,thaigianxemxettaili~ub6sungdugcthvchi~ntheoquydinh
tC:likhoan1DiSunay.
Di~u38.Thot1}cthayd8i,b8sunggi§ydangkyIll'llhimhthuBc,nguyen
li~ulamthuBctrongthOigiangi§ydangkyIll'llhanhthuBc,nguyenli~ulam
thuBcconhi~ulc
1.Thayd6i,b6sunggil1ydangkylUllhanhthu6c,nguyenli~ulamthu6c, tru
truanghgpquydinhtC:likhoan2DiSunay
TrongthaihC:ln03thangkStungaynh~nduh6sa,eVcQuanlyDugcphe
duy~tn<)idungthayd6i,b6sung. Truanghgpkhongpheduy~tho~cchuaphe
duy~t, eVcQuanlyDugccovanbantralaivaneur5lydo.Thaigiancacbuac
dugcquydinh,cvthSnhusau:
a)TrongthaihC:ln08ngayElmvi~ckStungaynh~nduh6sa,eVcQuanly
DugctiSnhanhrasoat,phan10C:livaguih6sachocacchuyengiaho~ccacdan
vith~mdinh.TrongthaihC:lll01thangkStungaynh~ndugch6satueVcQuan
lyDugc,chuyengiavacacdanvith~mdinhphaihoanthanhbienbanth~mdinh
vaguievcQuanlyDugct6nghgp,kStlu~nbienbanth~mdinhtheoquydinhtC:li
khoan4DiSu35Thongtunay;
b)TrongthaihC:ln12ngaylamvi~ckStungaynh~ndugcbienbanth~m
dinhcuacacchuyengiath~mdinhho~ccacdanvith~mdinh,evcQuanlyDugc
covanbantralaid6ivaih6sath~mdinhchuadC:ltho~ckhongdC:ltvaneur5ly
do.D6ivaih6sath~mdinhdC:ltyeucfiuho~cnhungtruanghgpkhaccfinxiny
kiSnth~mdinh,tuvl1ncuaH<)id6ng, evcQuanlyDugcchuySnVanphongHQi
d6ngdSt6chilch9PH<)id6ng;
c)TrongthaihC:ln06ngaylamvi~ckStungaynh~ndugctaili~utuevc
QuanlyDugc, VanphongH<)id6ngt6chilch9PH<)id6ngvacobienbanh9P
H<)id6ngguievcQuanlyDugc;
d)TrongthaihC:ln18ngaylamvi~ckStungaynh~ndugcbienbanh9PHQi
d6ng, evcQuanlyDugccongb6bi~tdugcg6c,sinhph~mthamchiSu,thu6cco
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

43. 43
baocaonghienCUunrongduongsinhhoc,pheduyetnoidungthayd6i,b6sung
hoaccovanbantraIoitheak~tluancuaH9idi)ngd6ivoihi)sathamdinhchua
dat,khongdatvaneurolydo.
2.Thayd6i,b6sunggi~ydangkyluuhanhthuoc,nguyenlieulamthuoc
d6ivoinoidungthayd6inhochiyeuc~uthongbao(Notification):
Trongthaihan15ngaylamvieckStilngaytiepnhanduhi)so,CueQuanly
Duocthuchienphanloaivacongb6noidungthayd6inhochiyeuc~uthongbao
trenTrangthongtindientircuaCueQuanlyDiroc.Truonghopn9idungthay
d6i,b6sungkhongphilhopvoiphanloaithayd6inhochiyeuc~uthongbao,
CueQuanlyDuoccovanbanthongbao.
CO'saduocthchi~nvachiuhoantoantrachnhi~md6ivain9idungthay
d6i,b6sungkStilngayti~pnh~nghitrenphi~uti~pnh~nhi)sa.CO'sadangky
thu6c,cO'sasanxu~tchiutrachnhi~mtruacphaplu~tvStinhchinhxac,trung
thccuathongtinthayd6ib6sungchiyeuc~uthongbao,thchi~nluutrfrhi)
sO',taili~udScO'quancoth~mquySnkiSmtrah~um~i.
3.Trongthaih~n36thangd6ivaitruanghqpcoyeuc~ub6sungtaili~u
tiSnlamsangvalamsang,taili~utuO'ngduangsinhh<;>c,taili~unghiencUud9
6ndinhho~ctrongthaih~n12thangd6ivaicactruanghqpb6sungtaili~ukhac,
kStilngayCvcQuanlyDuqccovanbanthongbao,cO'sadangkyphain9Ptai
li~ub6sungtheayeuc~u.Sauthaih~nnay,cO'sadangkykhongn9Ptaili~ub6
sungthihi)sadffn9Pkhongcongiatrio
CO'sadangkYduqcphepthongbaoc~pnh~tb~ngvanbanvSCvcQuanly
DuqcvShi)sadangkydffn9Pvadangtrongthaigianth~mdinhd6ivaicac
truanghqpc~pnh~tthongtinlienquand~nantoan,hi~uquacuathu6cho~cgi~y
to'phaplycuacO'sadangkY,cO'sasanxu~tthu6c,nguyenli~ulamthu6csovai
hi)sadffn9P.
ThaigiankStilkhicovanbanthongbaocuaCvcQuanlyDuqcd~nkhi
cO'sadangkyn9Ptaili~ub6sungkhongduqctinhvaothaih~nquydinht~i
kho<in5DiSu56Lu~tDuqc.
4.Trongthaih~n02thangkStilngaynh~ndutaili~ub6sungd6ivaihi)
saquydinht~ikho~m1DiSunay,CvcQuanlyDuqcpheduy~tthayd6i,b6sung
gi~ydangkyluuhanhd6ivaihi)sad~tyeuc~u;covanbantralaid6ivaihi)sa
th~mdinhchuad~t,khongd~tvaneur6lydo.Thaigiancacbuacduqcquydinh,
cvthSnhusau:
a)Trongthaih~n05ngaylamvi~ckStilngaynh~nduhi)sO',CvcQuanly
Duqcti~nhanhrasoat,phanlo~ivaguihi)sachocacchuyengiath~mdinhho~c
cacdanvith~mdinh.Trongthaih~n08ngaylamvi~ckStilngaynh~nduqchi)
satilCvcQuilllyDuqc,cacchuyengiath~mdinhho~ccacdanvith~mdinh
phaihoant~anhbienbanth~mdinhvaguiCvc9uanlyDuqct6nghqp,k~tlu~n~
bienb~mthamdinhtheaquydinht~ikhoan4Dieu35Thongtunay;
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

44. 44
b)Trongthaihan07ngaylamvieckSnrngaynhanduocbienbantham
dinhcuacacchuyengiathamdinhhoaccacdonvith~mdinh,C\lCQuanlyDuoc
covanbantraloid6ivoih6sathamdinhchuadathoackhongdatvaneuraly
do.D6ivoih6sathamdinhdatyeucauhoacnhirngtnronghopkhaccanxiny
kienth~mdinh,nrv§.ncuaHQid6ng,C\lCQuanlyDuocchuyenVanphongHQi
dongdSt6chirchopHQid6ng;
c)Trongthaihan06ngaylamvieckStirngaynhandiroctailieutilCue
QuanlyDtroc, VanphongHQid6ngt6clnrchopHQid6ngvagiribienbanhop
HQid6ngvSC\lCQuanlyDuoc;
d)Trongthaihan18ngaylamvieckStungaynh?ndugcbienbanh<)pHQi
d6ng,C\lCQuanlyDugccongb6bi~tdugcg6c,sinhph~mthamchiSu,thu6cco
baocaonghienClrutuongduangsinhh<)c;pheduy~tnQidungthayd6i,b6sung
thu6cd6iv6ih6sad~tyeucau.C\lCQuanlyDugccovanbantralaitheokSt
lu?ncuaHQid6ngd6iv6ih6sath~mdinhchuad~t,khongd~tvaneuralydo.
5.Thaih~nphaith\}'chi~nd6iv6icacnQidungthayd6i,b6sunggi§.ydangkY
lUllhanhthu6c, nguyenli~ulamthu6c:khongqua12thangkSillngayC\lCQuanly
DugckYbanhanhcongvanpheduy~td6iv6icactfUanghgpthayd6i,b6sung.
6.MQts6truanghgpthayd6i,b6sung,casodangkythu6c, casosanxu§.t
thu6cchiutrachnhi~mt\}'C?Pnh?ttrennhan,huangdfinsud\lngthu6cvakhong
yeucauphainQph6saho~cthongbaochoC\lCQuanlyDugc,baog6mcac
truanghgpsauday:
a)Th\}'chi~nvi~cghinhanthu6c, nguyenli~ulamthu6c,huangdfinsu
d\lngthu6ctheoquydinht~ikhoan2DiSu35Thongtuo112018/TT-BYT ngay
18thang01nam2018cuaBQtruangBQYtSquydinhghinhanthu6c,nguyen
li~ulamthu6cvatahuangdfinsud\lngthu6c;
b)Thgchi~nvi~cthayd6i,b6sungnQidungnhan,huangdfinsud\lng
thu6ctheocongvancuaC\lCQuanlydugchuangdfinchutruongcuaHQid6ng;
c)NgoainhungtruanghgpphainQpl~imfiunhan, huangdfinsudVng
thu6ckhicothayd6i,b6sungtheoquydinht~iPh\ll\lcIIbanhanhkerntheo
Thongtunay,cacthayd6ikhaclienquandSncacthongtintrennhan,huangdfin
sud\lngthu6c, casodangkY,casosanxu§.tphait\}'C?Pnh?tkhidadugcC\lC
QuanlyDugcpheduy~td6iv6icacthayd6i,b6sungnay.
d)CacnQidungkhac:
-Thayd6ivitri,thongtincasonh?Pkh~uthu<3c,nguyenli~ulamthu&c
ghitrennhanho~ctahuangdfinsud\lngthu6c;
-Sua16ichinhtatrennhan,tahuangdfinsud\lngthu6c;
-Thayd6ib6C\lCtrinhbaycacmvctrongtahuangdfinsud\lngthu6c/
nhungkhongthayd6inQidungtahuangdfinsud\lngthu6cdadugcpheduy~ttV
theodungquydinhd6iv6itahu6ngdfinsud\lngthu6c;
\foIb·
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

45. 45
-B6sungthongtinvStieuchu~nch~tlUQ11gtrennhan,huangd~nsirdung
thuoctheoh6sadaduocCueQuanlyDuocpheduyet;
-B6cacthongtinkhongJ~~t buoctrennhan,huangd~nsirdungthu6c.
Di~u39.Trinhtl]'c§pgi§ydangkYluuhanhthuBcthuchi~ntheoquytrinh
thimdinhnhanh,thimdjnhrutg<}nvac§pgi§ydangkyhruhanhnguyenli~u
lamthuBc
1.Trongthaihan06thangkStirngaynhanduh6sa,CueQuanlyDuocc~p
gi~ydangkyhruhanhthuoc, nguyenlieulamthuoc.TruonghQ'Pkhongc~phoac
chuac~p,CueQuanlyDuoccovanbantraloivaneur5lydo.Thaigiangiai
quyetcacbuocduocquydinh,cuthSnhusau:
a)Trongthaihan16ngaylamvieckStungaynh~nduh6sa,eVcQuanly
DuQ'cphanlo~ivaguih6sachochuyengiaho~ccacdanvith~mdjnh.Trong
thaih~n03thangkStungaynh~ndUQ'ch6satueVcQuanlyDuQ'c, chuyengia
vacacdanvithcimdinhphaihoanthanhbienbanthcimdinhvaguievcQuanly
DuQ'ct6nghQ'P,kStlu~nbienbanthcimdinhtheoquydinht~ikhoan4UiSu35
Thongtunay;
b)Trongthaih~n18ngaylamvi~ckStungaynh~nduQ'cbienbanthcim
dinh,evcQuanlyDuQ'ccovanbantralaid6ivaih6sathcimdinhchuad~tva
neur6lydo.U6ivaih6sathcimdinhd~tyeuc~u,khongd~tyeuc~uho~cnhUng
truanghQ'Pkhacc~nxinykiSnth~mdinh,tuv~ncuaHQid6ngtuv~nc~pgi~y
dangkyluuhanhthu6c,nguyenli~ulamthu6c, evcQuanlyDuQ'cchuySnVan
phongHQid6ngdSh<;>pt6chuch<;>pHQid6ng;
c)Trongthaih~n10ngaylamvi~ckStungaynh~nduQ'ctaili~utuevc
QmlnIyDuQ'c,VanphongHQid6ngt6chuch<;>pHQid6ngvaguibienbanh<;>p
HQid6ngvSevcQuanIyDuQ'c;
d)Trongthaih~n01thangkStungaynh~nduQ'cbienbanh<;>pHQid6ng,
CvcQuanlyDuQ'cbanhanhquyStdinhc~pgi~ydangkyluuhanhd6ivaih6sa
d~tyeuc~u;evcQuanlyDuQ'ccovanbantralaitheokStlu~ncuaHQid6ngd6i
vaih6sathcimdinhchuad~t,khongd~tvaneur5lydo.
2.Trongthaih~n36thangd6ivaitruanghQ'Pcoyeuc~ub6sungtaili~u
tiSnlamsangvaHimsang,taili~utuangduangsinhh<;>c,taili~unghienClrudQ
6ndinhho~ctrongthaih~n12thangd6ivaicactruOnghQ'Pb6sungtaili~ukhac,
kStungayevcQuanIyDuQ'ccovanbanthongbao,casadangkyphainQPtai
li~ub6sungtheoyeuc~u.Sauthaih~nnay,casadangkykhOngnQptaili~ub6
sungthih6sadanQPkhongcongiatrio
CasadangkYduQ'cphepthongbaoc~pnh~tb~ngvanbanvSevcQuanly
DuQ'cvSh6sadangkydanQPvadangtrongthaigianthcimdinhd6ivaicac
truanghQ'Pc~pnh~tthongtinlienquandSnantoan,hi~uquacuathu6cho~cgi~y
t~phapIycuacasadangkY,casasanxu~tthu6c, nguyenli~ulamthu6csovai~
hosadanQP.
/~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

46. 46
Thaigiank@tirkhicovanbanthongbaocuaCueQuanIfDuocdSnkhi
cosadangkynQPUtilieub6sungkhongduoctinhvaothaihanquydinhtai
khoan5Dieu56LuatDuoc,
3.Trongthaihan03thangk@tirngaynhandutailieub6sung,CueQuan
IfDuocbanhanhquyetdinhe~pgi~ydangkyhruhanhd6ivoih6sodatyeucau;
eveQuanIfDuoccovanbantraloitheakStluancuaHQid6ngd6ivoih6so
thamdinhchuadat,khongdatvaneuroIfdo.Thaigiangiaiquyetcacbuocduoc
quydinh,cuth@nhusau:
a)Trongthaihan10ngaylamvieck@tirngaytiepnhanh6so,eveQuanIf
Duoctienhanhrasoat,phanloaivagirih6soehocaeehuyengiathAmdinhho~e
caedanvithAmdinh.Trongthaih(;ln16ngaylamvi~ek@tungaynh~nduqeh6
sO'tueveQuanIfDuqe, caeehuyen giathAmdinhho~ecaedanvithAmdinh
phaihoanthanhbienbanthAmdinhvaguieveQuanIfDuqet6nghqp,dSxu~t
fkiSntrenbienbanthAmdinhtheaquydinht(;likhoan4DiSu35Thongtunay;
b)Trongthaih(;ln08ngaylamvi~ek@tungaynh~nduqebienbanthAm
dinh,eveQuanIfDuqecovanbantralaid6ivaih6sO'thAmdinhchuad(;ltva
neuroIfdo.D6ivaih6sO'duqeeveQuanIfDuqedSxu~te~p,khonge~pho~e
dSxu~te~nxinfkiSnxemxet,tuv~neuaHQid6ng,eveQuanIfDuqeehuy@n
VanphongHQid6ngd@h<;>pt6ehueh<;>pHQid6ng;
c)Trongthaih(;ln10ngaylamvi~ek@tungaynh~nduqetaili~utueve
QuanIfDuqe,VanphongHQid6ngt6ehueh<;>pHQid6ngvaguibienbanh<;>p
HQid6ngvSeveQuanIfDuqe;
d)Trongthaih(;ln01thangkStungaynh~nduqebienbanh<;>pHQid6ng,
eveQuanIfDuqebanhanhquyStdinhe~pgi~ydangkflUllhoohd6ivaih6sO'
d(;ltyeue~u;eveQuanIfDuqecovanbantralaitheakStlu~neuaHQid6ngd6i
vaih6sO'thAmdinhchuad(;lt,khongd(;ltvaneuroIfdo.
ChuO'ngV
THUHenGIAyDANGKYLUlJHA.NH,NGUNGNH~NHOsacAp,
GIAH~NGIAYDANGKYLUlJHA.NH
Di~u40.Th~mquy~n,thnt\lcthuhBigiiydangkyluuhanhthuBc,
nguyenli~ulamthu8c
1.ThAmquySnthuh6ivatraehnhi~mthongbaothuh6igi~ydangkYlUllhanh:
a)eVeQuanIfDuqethuh6igi~ydangkfluuhanhthu6e,nguyenli~ulam
thu6ethuQecaetruanghqpquydinht(;likhoan1DiSu58Lu~tDuqe;
b),SaYtScaetinh,thanhph6tlVeth?QeTrungu?TIg, :-tScaenganhthong/
baoquyetdinheuaeVeQmlnIfDuqevevi~ethuhoigiaydangkflUllhanlV/
thu6e,nguyenli~ulamthu6ethuQediabanquanIf.
j~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

47. 47
2.Thutucthuh6igiftydangkyhruhanhthuoc,nguyenli~ulamthuocquy
dinhtaidiema,bkhoan1DiSu58LuatDuoc:
Trongthaihankhongt}_ua30ngaykStirngaycoquyetdinhthuh6ithuoc
cuacoquanquanlycothamquyen,C\lCQuanlyDuocraquyetdinhthuh6igifty
dangkyhruhanhthuoc,nguyenlieulamthuoc,
3.Thutucthuh6igiaydangkyhruhanhthuoc,nguyenlieulamthuocquy
dinhtaidiSmd,dkhoan1DiSu58LuatDuoc
Trongthaihankhongqua30ngaykStirngaycokStluanbangvanbancua
coquanquanlycothftmquyenvSviech6socuathuocdiidiroccftpgiftydangky
luuhanhlah6sogiamaohoacthuoc,nguyenlieulamthuocduocsanxufttkhong
dungdiachitheoh6sodangky,C\lCQuanlyDuQ'craquYStdinhthuh6igifty
dangkylUllhanhthu6c,nguyenli~ulamthu6c.
4.Thut\lCthuh6igiftydangkylUllhanhthu6c,nguyenli~ulamthu6cquy
dinht:;tidiSmcvaekhoan1DiSu58Lu~tDuQ'c
Trongthaih:;tnkhongqua10ngaykStungaycoquanquanlycothftmquYSn
cuaVi~tNamho~ckStungaynh~nduQ'cthongbaocuaWHOho~ccuanuacxuftt
xukhuySncaothu6ckhongantoan,hi~uquachongumsud\lngho~ccoquanco
thftmquySncuanuacngoaithuh6igiftychUngnh~nsanphftm,C\lCQuanlyDuQ'c
raquyStdinhthuh6igiftydangkylUllhanhthu6c,nguyenli~ulamthu6c.
5.Thut\lCthuh6igiftydangkylUllhanhthu6c,nguyenli~ulamthu6cquy
dinht:;tidiSmgkhoan1DiSu58Lu~tDuQ'c:
a)Cosan9PdandSnghithuh6igiftydangkYlUllhanhthu6c,nguyenli~u
lamthu6ct:;tiVi~tNamcuacosasanxufttho~ccosadangkythu6c,nguyenli~u
lamthu6ctheaMfiu1ITTbanhanhkerntheaThongtunay;
b)Trongthaih:;tnkhongqua20ngaykStungaynh~nduQ'cdandSnghithu
h6i,C\lCQuanlyDuQ'craquyStdinhthuh6igiftydangkylUllhanhthu6c,nguyen
li~ulamthu6c.
Di~u41.Quydinhv~vi~engirngnh~nhBSO'e~p,giah~ngi~ydangky
hfUhanhthuBe,nguyenIi~ulamthuBe
1.Vi~cnglingnh~nh6socftp,giah:;tngiftydangkYlUllhanhthu6c,nguyen
li~ulamthu6cth\!chi~ntheaquydinht:;ticackhoan2,3va4DiSu100cuaNghi
dinhs654/2017/ND-CP.
2.C\lCQuanly,DuQ'cthongbaovi~ct;glingnh~nh6socftp,giah:;tngiftyV
dangkylUllhanhthuoc, nguyenli~ulamthuoc.
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

48. 48
ChuongVI
NGUYENTAcTOCHUC,HO~TDONGCVAHOIDONGTUVAN
cApGIAyDANGKYLUUHANHrtruoc,NGUYENLIEULAM
'rnuoc,DONVITHAMDINH,CHUYENGIATHAMnINH.. .
Di~u42.TBchirc,hoatdQngciiaHQidang
1.B<)tnrongB<)YtSthanhl~pHoid6ngtuv~nc~pgiaydangIcyhruhanh
thuoc, nguyen lieulamthu6c.ThanhvienHoid6nglacacchuyengiacotrinhd<)
chuyen monvakinhnghiemphilhopbaodamkhanangth~m dinhh6so,phan
bienykiencuachuyengiathamdinh,ykiSndSxu~tcuaCueQuanlyDuocva
nrvanchoB<)tnrongB<)YtScacv~ndSlienquandSnphapchSduoc,h6sovS
ch~throng, antoan,hieuquacuathuoc,nguyenlieulamthu6c.
2.Hdid6ngcotrachnhiemtirv~nchoB<)tnrongB<)YtStrongvieccap,
giahan,thayd6i,b6sunggi~ydangkyluuhanhthuoc, nguyenlieulamthuoc;
c~pphepnh~pkh~uthu6cchuacogi~ydangkylUllhanht~iVi~tNamtrencosa
kStquath~mdinhcuachuyengia,ykiSndSxu~tcuaCvcQuanlyDu<)'cvacac
v~ndSlienquandoB<)truemgB<)YtSyeuc~u.H<)id6ngchiutrachnhi~mtruoc
B<)truemgB<)YtSvScacykiSntuv~n.
3.Nguyent~cho~td<)ngcuaH<)id6ng:
a)H<)id6ngho~td<)ngtheanguyent~cd6ngthu~n,t~ptrungdanchu,khach
quan, congkhai,minhb~ch.YkiSncuaH<)id6ngphaibaodamcosaphaply,co
sakhoah9C,xemxetkStquath~mdinhh6socuacacchuyengiath~mdinh,can
cuthvctiSnlamsang,dSxu~tcuaCvcQuanlyDu<)'c;
b)H<)id6ngh9Pkhicotil2/3thanhvienH<)id6ngdudiSuki~n(theoQuy
chSt6chucho~td<)ngcuaH<)id6ngdoB<)YtSbanhanh)thamdv,truOnghqp
thanhvienH<)id6ngkhongthamdvbu6ih9PnhungcoguiykiSnb&ngvanban
thidu<)'cxemlathamdvh9P;
ChutichH<)id6ngho~cnguai du<),cChutichH<)id6nguyquySnchutrih9P
H<)id6ngkStlu~ntrencosacoitnh~t2/3YkiSncuacacthanhvienthamdvh9P
d6ngthu~n.CacykiSnchuad6ngthu~voikStlu~ncuaH<)id6ngdu<),cbaolUll.
YkiSncuacacthanhvienH<)id6ngvakStlu~CllaH<)id6ngphaidu<)'cthShi~n
trongbienbanh9PH<)id6ng,kScaykiSnchuad6ngthu~vOikStlu~cuaH<)id6ng.
c)TruOnghqpkhongt6chuch9PH<)id6ng, ChutichH<)id6ngthvchi~n
vi~cl~yykiSnb&ngvanbandSncacthanhvienH<)id6ng;
TruOnghqpdffquathaih~nguixinykiSn,ChutichH<)id6ngho~cnguai
du<)'cuyquYSnduarakStlu~ncuaH<)id6ngkhicoitnh~t2/3s6thanhviendff
guiykiSnguivSThuangtflJcH<)id6ngdSt6nghqp.
YkiSnkStlu~ncua,H<)id6~gdVatrencosayk~Snd6ngthu~ncuaitnh~t/
2/3thanhviendffcoykienguiveThuOngtrvcH<)idongvatrencosabaocao
tbnghqpvadbxuiitcuae\lcQuanlyDu'!c; ~~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

49. '. 49
YkienkStluancuaHQid6ngdirocthShienbangPhieutrinhghiykiSnkSt
luancuaChutichHQid6nghoaccuanguoidirocChutichHQid6nguyquyen.
d)Trangtnronghopc~thi@t,thanhvienhQid6ngcoquyenxemxet,tham
dinhh6sa,ChutichHQid6ngcoquyenthamvc1nthemykientircacchuyengiadQc
l~pngoaicacthanhvientrangHQid6ngtnrockhidirarakStluancudicling.Cac
chuyengianaycothStruetiSpthamduphienh9PHQid6nghoacchoykiSnbang
vanban,cotrachnhiemvaquyenIoinhucacthanhvienchinhtlurccuaHQid6ng;
d)Khongviphamcacnguyent~cvSxungdQtloiich.
4.CueQuanlyDuocthamrmrutrinhBQtnrongBQYtSbanhanhquychS
vSt6chuc,ho~tdQngcuaHQid6ng,cachSph6ihqpgiuaHQid6ngvachuyen
giath~mdinhtrongquatrinhc~p,giah~n,thayd6i,b6sunggi~ydangkyluu
hanhthu6c,nguyenli~ulamthu6c,gi~yphepnh~pkh~uthu6cchuacogi~ydang
kyluuhanht~iVi~tNam.
5.Kinhphiho~tdQngcuaHQid6ngduQ'cthvchi~ntheaquydiMcuaphaplu~t.
6.ThuangtrvcHQid6ngd~tt~iCvcQwinlyDuQ'c.
I>i~u43.TBehue,ho~tdQngellado'nvith~mdinh,ehuyengiath~m
dinhh&SO'd~nghie§p,giah~n,thaydBi,bBsungthuBe,nguyenli~ulam
thuBe,th~mdinhh&SO'd~nghie§pgi§yphepnh~pkh~uthuBeehU'acogi§y
dangkylU'uhanh
1.CvcQuanlyDuQ'c,danvith~mdinhcotrachnhi~mthanhl~pcactiSu
banchuyengiath~mdinh:phapchS;tieuchu~nch~tluqng;duQ'cly;lamsang;bao
chS,dQ6ndiM;tuangduangsinhh9CvadanhsachchuyengiatrongcactiSuban
th~mdinhh6sadSnghic~p,giah~n,thayd6i,b6sungthu6c, nguyenli~ulam
thu6c,th~mdinhh6sadSnghic~pgi~yphepnh~pkh~uthu6cchuacogi~ydang
kyluuhanh.Cac~ucactiSubanchuyengiath~mdinhphaiphlihqpvaiphanlo~i
sanph~mdangkYvahinhthucdangkyho~csanph~mdSnghic~pphepnh~pkh~u
vahinhthucdSnghic~pphepnh~pkh~u.
2.Chuyengiath~mdinhho~tdQngtheanguyent~c:cacykiSnth~mdinh
phaibaodamcancuphaply,casakhoah9CvaphaiduQ'CthShi~ntrongbienban
th~mdinhh6sadSnghic~p,giah~n,thayd6i,b6sungthu6c,nguyenli~ulam
thu6cho~cbienbanth~mdinhh6sadSnghic~pphepnh~pkh~uthu6cchuaco
gi~ydangkyluuhanh.Chuyengiath~mdinhchiutrachnhi~mtruacCvctruOng
CvcQuanlyDuQ'cvatruacdanvith~mdinhvScacnQidungth~mdinh,ykiSn
dSxu~tlienquandSncongtacth~mdinhh6sadSnghic~p,giah~n,thayd6i,b6
sungthu6c,nguyenli~ulamthu6c, th~mdinhh6sanh~pkh~uthu6cchuacogi~y
dangkyluuhanh.
3.CvcQuanlyDuQ'ccancuchucnang, nhi~mV\lduQ'cgiaoxaydvngva
banhanhquychSt6chucvaho~tdQngcuacacnhomchuyengiath~mdinh(bao
g6mcachuyengiacuadanvith~mdinh)h6sadSnghic~p,giah~n,thayd6i,V
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

50. 50
sungthuoc, nguyenlieulamthuoc, h6sanhapkhAuthuocchuacogiaydangky
luuhanh;kyhopd6ngvoichuyengiathamdinhhoacdanvithamdinhh6sa;
C\lCQuanlyDuoc,danvithAmdinht6chirccackhoat~phuan, daotao
chochuyengiathamdinh;tiSnhanhdanhgiananglirechuyenmoncuachuyen
giathAmdinhdodanvithanhl~pvasirtuanthucacquydinhdScodiSuchinh, b6
sungchuyengiathamdinhphilhop,
4.Kinhphit6chircthbdinhh6sadirocthuchientheaquydinhcuaphapluat.
ChUO'DgVII
DIEUKHoANTHIHA.NH
Di~u44.Hi~ull}'cthihanh
1.ThongtunaycohieuhrcthihanhkStirngaythangnam .
2.Baibecacquydinhsau:
a)Thongtus632/2018/TT-BYT ngay12thang11nam2018cuaBotnrong
B9YtSquydinhvi~cdangkythu6c;
b)Khoan3DiSu1Thongtus623/2021/TT-BYT ngay09thang12nam
2021cuaB9tru6ngB9YtSsuad6i,b6sungm9ts6vanbanquyph~mphaplu~t
doB9tru6ngB9YtSbanhanh;
c)Khoan5DiSu1Thongtus62912020/TT-BYT ngay31thang12nam
2020cuaB9tru6ngB9YtSsuad6i,b6sungvabaibem9ts6vanbanquyph~m
phaplu~tdoB9tru6ngB9YtSbanhanh,lientichbanhanh;
d)DiSmhkhoan3DiSu14Thongtus60112018/TT-BYTngay18thang
01nam2018cuaB9truemgB9YtSquydinhghinhanthu6c, nguyenli~ulam
thu6cvatahuangd~nsud\lngthu6c.
Di~u45.Di~ukho3Dchuy~nti~p
1.Cach6sadan9PtruacthaidiSmThongtunaycohi~ulvcthihanhduQ'c
tiSp1\lcthvchi~ntheaquydinht~ithaidiSmn9Ph6sa,trUtruanghqpcasadangkY
tvnguy~nthvchi~ntheaquydinhkStUngaykYbanhanhThongtunay.
2.Cach6sadan9PchocaquantiSpnh~h6satruacngayThongtunay
cohi~ulvcnhungdangtrongquatrinhgiaiquyStduQ'capd\lngtheaquydinhco
lienquant~iThongtunayho~ccacquydinhtruacngayThongtunaycohi~u
lvctheahuangthu~nti~nchodoanhnghi~p,t6chilc,canhfm.
3.Thu6cduQ'cn9Ph6sadangkYtheacacquydinhtruacngayThongtus6
32/2018m-BYTcohi~uIvcvadUQ'ccfipgifiydangkYluuhanhho~cgiah~gifiydang
kyluuhanh,casachiduQ'csanxufitthu6cthanhphbtUnguyenli~ulamthu6csanxufitj
bOicaccasasanxufitdapilngthvchanht6tsanxufitvaiph~viphilhQ'PtheadUngquy
dinh~DiSu141Nghidinhs654/2017/Nl)-CP.CasasanxufitvacasadangkYphai
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

51. ·. 51
luutrfrtaili~uchimgminhtheaquydinhtaikhoan11DiSu22Thongtunayvaxu:ittrinh
chocaccoquancothfunquyenlienquankhicoyeuc~u.
4.ViecdangkyhruhartlivKcxinphongCovid-19trongtnronghopclip
bachthuchientheaquydinhtaiThongtirs611/2021/TT-BYT ngay19thangS
nam2021cuaBQtnrongBQYtShuongdftndangkyhruhanhv~cxinphong
Covid-19trongtnronghopclipbach.
5.TruonghopWHOcongb6mftuCPPcapnhat,trongthaihan12thang
kStirngaymftuCPPc~pnhatduoccongb6trentrangthongtindiennrcuaWHO,
cosadangkyphainQpCPPcodunQidungtheamftuCPPcapnhattrongh6sa
dangkythu6c.Chapnhand6ivoiCPPchuac~pnhat(mftucfi)nSuCPPconhieu
hrctaithaidiemtiSpnhanh6sadangkythuoc.
6.NQidunglienquandencoquanquanlynuacthamchiSuquydinht~i
khoan9DiSu2Thongtus632/201S/TT-BYTduqcdftnchiSut~ivanbanquy
ph~mphaplu~tkhacduqctiSpt\lCthlJchi~ndSnkhivanbanquyph~mphaplu~t
doduqcsuad6i,b6sung, thaythSho(lcbaiboo
7.Truanghqpthu6cdaduqcBQYtScongb6bi~tduqcg6ctruacthai
diSmThongtunaycohi~ullJc,giaoC\lCQwinlyDuqcthlJchi~ndiSuchinh, c~p
nh~tthayd6i,b6sungthongtindacongb6bi~tduqcg6ctheadSnghicuacasa
dangkythu6c.
S.TruOnghqpPh\ll\lcI,III,IVbanhanhkerntheaThongtunayc~pnh~t
theanhfrngyeuc~ukythu~tchungAsean,trongthaih~n06thangkStungaycac
taili~uc~pnh~tduqccongb6trenC6ngthongtindi~ntucuaAsean
(https:llasean.org/our-communities/economic-community/standard-and­
comformancelkey-documents-publications/), C\lCQuanlyDuqct6chucdichva
congb6nQidungc~pnh~ttrenC6ngthongtindi~ntucuaBQYtSvaTrangthong
tindi~ntucuaC\lCQuanlyDuqc.
Trongthaih~n06thangkStungayC\lCQuanlyDuqccongb6nQidung
c~pnh~ttrenC6ngthongtindi~ntucuaBQYtSvaTrangthongtindi~ntucua
C\lCQuanlyDuqc, casadangky,casasanxu:itphaic~pnh~ttrongh6sadang
kythu6c.
9.Thu6cdangkysanxu:itt~iVi~tNamtheahinhthucchuySngiaocong
ngh~,thu6cthlJchi~ndonggoithucliptiSpt\lCthlJchi~ntheoquydinht~iThong
tu32/201S/TT-BYT dSnkhiThongtuquydinhvi~cdangkyluuhanhd6ivai
thu6cgiacong,thu6cchuySn giaocongngh~t~iVi~tNamcuaBQYtSduqcban
hanhvacohi~ullJcthihanh.
Di~u46.LQtrinhtht}'chi~n
1.KSillngayThongtunaycohi~ullJcthihaM,casasanxu:itconhiSuhan
02thu6ccocungduqcch:itho(lcthanhph~nduqcli~u,d~ngbaochS,dUOngdung,
hamluqngho(lcn6~gdQtrongmQtdanviphanliSudaduqcclipgi:iydangki~
lUllhanh,khinQphosadenghigiah~ngiaydangkylUllhanh, casasanxuat
J~
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

52. 52 .'
phcihopvoicosadangkythuochrachonvadSnghigiahangiftydangkyhru
hanhcho2thuoctheaquydinhtaikhoan6DiSu8Thongtunay,cacthuocdff
diroccftpgiftydangkyluuhanhconlaiseduocgiahanhieuhrcgiftydangkyluu
hanhdSnhStngay31112/2025.
2.D6ivoithuoc,nguyenlieulamthu6csanxuftttrongmrocdffduoccftp
giftydangkyluuhanhtnrocngayThongtunaycohieuhrcthihanhvacosaco
nhuc~unhapkh~unguyenlieulamthu6clatadiroc,vonangvSVietNam:Tnroc
khinhapkhaul~nd~uvSVietNam,cosadangkyc~pnhattoanb<)thongtinvS
nguyenlieulamthuoclataduoc,vonangtrongh6sadffduocpheduyetlenh~
thongdichvucongtfCtuySnCllaC\lCQuanlyDuQ'c.Trongthaigian05ngay
lamvi~ckStungaycasac~pnh~tthongtinlenh~th6ng,C\lCQuanlyDuQ'cphai
hoanthanhvi~ccongb6.Casadangkychiutrachnhi~mvStinhchinhxacClla
thongtinc~pnh~tsovaithongtintrongh6sadangkYdffduQ'cpheduy~tva
khongb~tbu<)cphaic~pnh~tl~ithongtinal~nnh~pkh~utiSptheo.
3.Vi~capd\lllgs6dangkYtheacftutrUcquydiM~iPh\ll\lcVIbanhanhkern
theaThongtunaykhicftpmm,giah~giftydangkYluuhanhthChi~nkSillngay01
thang01nam2023.D6ivmthu6cdffduQ'ccftps6dangkYtruacngay01thang01nam
2023duQ'cgiah~giftydangkyluuhanhthiduQ'ctiSpt\}c·sud\lllgs6dangkYillcftp
truackhigiah~trongthaih~t6ida12thangkSillngayduQ'ccftps6dangkYthea
cftutrUcquydiM~iPh\ll\lcVIbanhanhkerntheaThongtunay.
Di~u47.Di~ukho3nthamchi~u
Trongtruanghgpcacvanbanquyph~mphaplu~tvacacquydinhduQ'c
vi~nd~ntrongThongtunaycoSsuad6i,b6sungho~cduQ'cthaythSthiapd\lng
theavanbanquyph~mphaplu~tmaio
Di~u48.Trachnhi~mthihanh
1.C\lCQuanlyDuQ'ccancuchucnang,nhi~mV\lduQ'cgiaova1<)trinhhoa
hgpASEANtrongdangkythu6c,cotrachnhi~m: .
a)T6chuchuangd~nvathChi~ncacquydinhCllaThongtunay;
b)C~pnh~tdanhm\lccacthu6c,nguyenli~ulamthu6cduQ'ccftp,giah~n
giftydangkyluuhanhtrongthaih~n05ngaykStungaycftp,giah~ngiftydang
kyluuhanhvacacthongtindangkythu6c,nguyenli~ulamthu6ckhactrentrang
thongtindi~ntucllaC\lCQuanlyDuQ'c;
c)Congb6,c~pnh~tdanhm\lccacthu6ccochUngminhtuangduangsinh
h9C,thu6cduQ'ccongb6bi~tduQ'cg6c,sinhph~mthamchiSutrongthaih~n05ngay
kStungaycftpgiftydangkYluuhanhvacacthongtinthayd6i,b6sungcllathu6c
cochUngminhtuangduangsinhh9C,thu6cduQ'ccongb6bi~tduQ'cg6c,sinhph~m
thamchiSutron9thaih~n07ngaykStungaypheduy~tthayd6i,b6sunggiftydan7'
kYluuhanhthuoctrentrangthongtindi~ntuCllaC\lCQuanlyDuQ'c; W
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

53. 53
d)Xemxet,illsoarthuoccochungminhwangduongsinhhoc,thuocetadiroc
congb6bietdirocg6c,sinhphamthamchieukhongcondapirngcactieuchitheaquy
dinh:.,
d)Xaydung,banhanht6chirctrienkhaithuchiencacquytrinhchuan
(SOPs)trongdangkythuocvas6tayhuangd~ndangkythuoc(QM);
e)Ph6ihopvoiC\lCQuanIyY,Dirocc6truyentrongviecgiahan,thay
d6i,b6sunggi~ydangkyhruhanhthu6cc6truyen,duoclieudffduocc~pgi~y
dangkYhruhanhtheaquydinhtaiThongtus644/2014/TT-BYT ngay25thang
11nam2014cuaBQtnrongBQYtSquydinhviecdangkythuoc;
g)Truonghopcosadangkythuoccohanhvigiamaohoactvysuachua
h6sa,tailieu,gi~ytophapIycuacaccoquanchucnangcuaVi~tNamhoi[tccua
nuacngoai;sud\lngcond~ugiahoi[tcgiam~ochukyhoi[tcd~ucuacasadang
ky,casasanxu~tvacaccasalienquantrongh6sadangkythu6cthiC\lCQuan
IyDuQ'csecocongvancanhbaocasavangimgnh~nh6sac~p,giah~ngi~y
dangkylUllhanhthu6c,nguyenli~ulamthu6ctheaquydinht~ikhoan2,3va4
DiSu100Nghidinh54/2017IND-CPngay08thang5nam2017cuaChinhphuquy
dinhchitiStmQts6diSuvabi~nphapthihanhLu~tDuQ'c.
Ngoaicachinhthuctren,C\lCQuanIyDuQ'ccongkhainQidungviph~m
cuacasatrentrangthongtindi~ntucuaC\lCQuanlyDuQ'c,d6ngthaithongbao
taicaquanThanhtravacaccaquanchucnangcothAmquySndSxemxet,xuly
theaquydinhcuaphaplu~t;
h)Truanghgpcasasanxu~tthu6ccohanhvigiam~ohoi[tctvysuachua
h6sa,taili~u,gi~ytaphaplycuacaccaquanchucnangcuaVi~tNamhoi[tccua
nuacngoai;cungc~ph6sachocasadangkythu6cdSdangkylUllhanht~iVi~t
Namkhongdvatrennghiencuu,sanxu~tthvctSthiC\lCQuanlyDuQ'cseco
congvancanhbaocasavangimgnh~nh6sac~p,giah~ngi~ydangkyluuhanh
thu6c,nguyenli~ulamthu6ctheaquydinht~ikhoan2,3va4DiSu100Nghi
dinh54/2017/ND-CPngay08thang5nam2017cuaChinhphuquydinhchitiStmQt
s6diSuvabi~nphapthihanhLu~tDuQ'c.
Ngoaicachinhthuctren,C\lCQuanlyDuQ'ccongkhainQidungviph~m
cuacasatrentrangthongtindi~ntucuaC\lCQuanlyDuQ'c,d6ngthaithongbao
taicaquanThanhtravacaccaquanchucnangcothAmquySndSxemxet,xuly
theaquydinhcuaphaplu~t;
i)Trongtruanghgpc~nthiSt,C\lCQuanIyDuQ'ct6chuccUQchQpvaica
sadangky,casasanxu~t,chuyengiathAmdinhnh~mlamracacvu6ngm~c
lienquandSnvi~cthAmdinhh6sadangkythu6c,nguyenli~ulamthu6c;
k)Congb6trentrangthongtindi~ntucuaC\lCQuanlyDuQ'cdanhm\lc
caccasadang~y,casasanxu~tthu6c, nguyenli~ulamthu6ctheaquydinhy
khoan10,14Dieu22Thongtunay;
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10

54. 54
I)Xaydungquydinhviecapdungrnavach(Barcode),rnaQR,rnaDataMatrix
Code(DMC)trenbaobingoaicuathuoc,nguyenli~ulamthuoccuacaccosasanxu~t
nh~mquanly,nhandien,truyxuatnguong6cthuoc,nguyenlieulamthuochruhanh
trenthitnrongvaIQtrinhthuchientheaquydinhcuaBQtnrongBQYtS;
m)Trongthaihan30ngaykStirngayc~p,giahangi~ydangkyhruhanh
thuoc,nguyenlieulamthuoc,CueQuanIyDiroctranhan,huangd~nsudung
thu6cchocosadangky;
n)Trongthaihan15ngaykStilngaycap,giahangiaydangkyhruhanh
thuoc,nguyenlieulamthuoc,07ngaykSnrngaypheduyetthayd6i,b6sunggi~y
dangkyhruhanhthuoc,nguyenli~ulamthuoc,CueQuanIyDuoccongb6nguon
nguyenlieulamthu6cd6iv6icacthu6csanxu~tt~iVi~tNamtrentrangthong
tindi~ntucuaCvcQuanIyDuQ'c.
2.SaYtScactinh,thanhph6tr\IcthuQcTrunguangchiutrachnhi~mkiSm
tra,thanhtravi~cth\Ichi~nThongtunayd6iv6icacdonvisanxu~t,kinhdoanh
duQ'cph~mtrongph~mviquanIY.
3.Cacdanvitf1JcthUQCBQYtS,T6ngCongtyDuQ'cVi~tNam-CTCP,cacco
sakinhdoanhthu6ccotrachnhi~mth\Ichi~nThongtunay.
Trongquatrinhth\Ichi~nnSucokhokhan,vuangm~c,caccoquan,t6J
chuc, canhanphananhv@BQYtS(CvcQuanIyDuQ'c)dSxemxetgiaiquySt.!...tf~,--
NO'inh{in:
-UybanxahQicuaQu6chQi;
-VanphOngChinhphu(PhongCongbao,
C6ngthongtindi~nChillhphO;VvKGVX);
-Q.B9trucmgB9Yt~(d~b/c);
-CacThutrucmgB9Yt~;
-B9Tuphap(Cvcki~mtravanbanQPPL);
-B9KhoahQCvaCongngM;
-B9CongThuO'ng;
-B0Qu6cphOng(C\ICQuanY);
-B9Congan(CvcYtS);
-B9Giaothongv?ntai(CvcYt~GTVT);
-B9Taichinh(T6ngCvcHaiquan);
-CacVv,Cvc,ThanhtraB9Yt~;
-So'Yt~cactinh,thanhph6tnJcthu9CTV';
-H9id6ngtuv~ndpGDKLHthu6c, nguyen li~ulamthu6c;
-T6ngcongtyDUQ'c Vi~tNam-CTCP;
-Hi~ph9iDoanhnghi~pdUQ'cVi~tNam;
-H9iDuqchQcVi~tNam;
-T6ngcvcHaiquan;
-C6ngthongtindi~ntliBYT, WebsiteCvcQLD;
-CacDNSX,KDthu6ctrongnu6cvanu6cngoai;
-Vi~nki~mnghi~mthu6cTW;Vi~nki~mnghi~mthu6cTP.
HCM; Vi~nKi~mdinhQu6cgiav~cxinvasinhphAmyt~;
-Luu:VT,PC,QLD(5).
KT.~<)TR~ONG .fI~
THUTRUONG ~-
DBXuanTuyen
syt_binhphuoc_vt_Van thu SYT Binh Phuoc_06/09/2022 08:44:10