Pho Bien TT 44

Thng t s 44/2014/TT-BYT
ngy 25/11/2014 ca B Y t quy nh vic

NG K THUC
ThS. Nguyn Huy Hng

Ph trng phng KT
THNG T S 44/2014/TT-BYT
06 chng, 40 iu, 05 ph lc v cc biu mu, quy

nh vic ng k thuc bao gm thuc thnh phm,
nguyn liu lm thuc, vc xin, sinh phm y t, tr thc
phm chc nng.
Thng t c hiu lc: 15/01/2015.
Ph lc II - Cc thay i ln, thay i nh, thay i

khc i vi thuc c cp SK hiu lc k t
ngy 01/4/2015.
NHNG NI DUNG C TH CA
THNG T 44/2014/TT-BYT
Chng I. Nhng quy nh chung (12 iu)
iu 1. Phm vi iu chnh
Quy nh vic KT dng cho ngi lu hnh ti Vit Nam.
iu 2. Gii thch t ng
Thng t 44: 11 khi nim
Cc kha nim khc: Lut Dc, cc Lut c lin quan
- C s sn xut l c s thc hin t nht mt cng on sn
xut hoc thc hin vic kim tra cht lng xut xng l
thuc (TT 22: v/hoc xut xng thnh phm).
- Thuc mi l thuc cha dc cht mi, thuc c s kt hp
mi ca cc dc cht lu hnh (Lut Dc: ln u tin
ng k lu hnh ti VN).
iu 3. Yu cu, quyn v trch nhim i vi c s KT

1. C s KT phi p ng yu cu sau y
a) C s KD thuc ca Vit Nam.
C GCN KKDT ti Vit Nam.
b) C s KD thuc ca nc ngoi
C Giy php SX, KD thuc do CQQLNN c thm quyn
nc ngoi cp V Giy php thnh lp VPD ti Vit Nam
C Giy php ng k hot ng trong lnh vc thuc, nguyn
liu lm thuc ti Vit Nam (cp trc ngy 15/1/2015 v cn
hiu lc)
Trng hp khng c Giy php thnh lp VPD ti Vit Nam,
c s KD thuc ca nc ngoi phi y quyn cho c s KD
thuc ca Vit Nam KT.
2. C s KT c cc quyn sau y
a) c hng dn v KT, c bit cc thng tin lin quan n
thuc do c s ng tn ng k;
b) c ngh rt SK ca thuc do c s ng tn ng k;
c) c khiu ni cc quyt nh hnh chnh ca CQQLNN c
thm quyn lin quan n vic cp SK lu hnh thuc theo
quy nh ca php lut v khiu ni.
3. Trch nhim ca c s KT
a) Bo m CL, AT, HQ ca thuc v bo m thuc lu hnh
ng vi HS ng k;
b) Cung cp y v chnh xc tt c cc d liu, bo co v

thng tin lin quan n thuc khi np HS ng k, trong qu
trnh ng k cng nh qu trnh lu hnh thuc hoc khi c
yu cu ca CQQLNN;
c) Cp nht cc thng tin lin quan n CL, AT, HQ ca thuc
trong trng hp cc thng tin ny cha c trong HS np
hoc ang trong qu trnh thm nh HS; cc thng tin, thay i
ca thuc lu hnh so vi HS ng k trong thi gian SK lu
hnh cn hiu lc, k c cc thay i khng thuc cc mc
thay i phi ng k quy nh ti Ph lc II;
d) Trong thi hn ti a 07 ngy lm vic, phi thng bo cho
Cc QLD hoc V TTBYT (i vi SPC in vitro) v cc
CQQLNN c lin quan trong trng hp thuc c SK lu
hnh ti Vit Nam cn hiu lc b thu hi giy php lu hnh ti
bt k nc no trn th gii, nu r l do b thu hi giy php
lu hnh;
) Phi hp vi c s NK, c s SX thu hi trn th trng cc
thuc khng bo m cht lng, an ton, hiu qu theo yu
cu ca CQQLNN hoc do chnh c s ng k, c s SX pht
hin; bo co kt qu thu hi v xut phng n x l;
e) Bo co bng vn bn vo ngy 15 thng 12 hng nm cho

Cc QLD hoc V TTBYT (i vi SPC in vitro) mt hng
thuc ng k c lu hnh; gii trnh l do cc trng hp
thuc ng k nhng khng c SX (i vi thuc TN)
hoc khng c NK (i vi thuc NN)
g) Lu tr HS v cung cp HS cho CQQLNN c thm quyn
khi c yu cu;
h) Hp tc v to iu kin cho vic thc hin kim tra, nh gi

c s SX khi c thng bo ca Cc QLD hoc V TTBYT (i
vi SPC in vitro);
3. Trch nhim ca C s KT
i) Phi thay i c s ng k i vi cc thuc do c s ng
tn ng k theo quy nh ti Ph lc s II trong thi hn
ti a 01 thng, k t ngy c s ng k ngng hot ng
hoc b CQQLNN c thm quyn chm dt hot ng.
k) Phi hp vi nh SX tin hnh cc nghin cu hoc

cung cp thm cc thng tin lin quan i vi thuc ng
k khi c nghi ng hoc bng chng lin quan n an ton
ca thuc trong qu trnh lu hnh theo yu cu ca
CQQLNN.
iu 4. Yu cu, quyn v trch nhim i vi c s SX thuc.
1. C s SX thuc phi p ng cc yu cu sau y:
a) C s SX thuc TN phi c GCN KKDT v GCN GMP theo l
trnh p dng GMP ca B Y t hoc GCN KKDT i vi
trng hp c s SX phi thm nh iu kin SX khi cp GCN
KKDT quy nh ti Khon 8 iu 1 N 89/2012/N-CP
b) C s SX thuc NN phi t GMP tng ng hoc cao hn
GMP-WHO. Trng hp GMP hoc CPP khng ghi r c s SX
t GMP-WHO, c s ng k phi cung cp bng chng chng
minh GMP m c s SX t khng thp hn GMP-WHO. i
vi SPC in vitro, c s SX phi t GMP hoc ISO hoc cc
GCN khc tng ng. Trong trng hp nghi ng v iu kin
SX hoc cht lng thuc, Cc QLD hoc V TTBYT (i vi
SPC in vitro) s tin hnh nh gi kim tra c s SX trc
hoc sau khi cp SK lu hnh.

1. C s SX thuc phi p ng cc yu cu sau y:
c) Thuc phi c SX ti ng c s c giy php SX do CQNN c
thm quyn cp, khng c SX thuc ti cc c s khc theo hnh
thc mn giy php sn xut (Loan Licence).
2. C s SX thuc c cc quyn sau y:
a) c hng dn v KT v c bit cc thng tin lin quan n
thuc do c s SX c ng k ti Vit Nam;
b) c ngh rt SK ca thuc do c s SX trong trng hp
thuc c vn v CL, AT, HQ nh hng n sc kho ca
ngi s dng m khng nht thit phi c kin ng ca c
s ng k thuc theo Mu s 01/TT;
c) c khiu ni cc quyt nh hnh chnh ca CQNN c thm
quyn lin quan n vic cp SK lu hnh thuc theo quy nh
ca php lut v khiu ni;
d) c ngh thay i c s ng k khc i vi cc thuc ca
chnh c s SX trong trng hp c s ng k khng thc
hin quy nh ti im i khon 3 iu 3 Thng t ny.
iu 4. Yu cu, quyn v trch nhim i vi c s SX thuc
3. C s SX thuc c cc trch nhim sau y:
a) Bo m thuc t TCCL, AT, HQ ng vi HS ng k c
BYT xt duyt;
b) Phi hp vi c s NK, c s KT thu hi trn th trng cc
thuc khng bo m CL, AT, HQ theo yu cu ca CQQLNN c
thm quyn hoc do chnh c s ng k, c s SX pht hin; bo
co kt qu thu hi v xut phng n x l;
c) Phi hp vi c s KT thc hin cc ni dung quy nh ti im
, h v k khon 3 iu 3 Thng t ny.
d) Chun b y phng tin, iu kin lm vic phc v cho vic
kim tra, nh gi c s sn xut khi c yu cu ca Cc QLD
hoc V TTBYT (i vi SPC in vitro);
iu 5. Yu cu i vi CSNQ v nhn NQ SX thuc, thuc SX

theo hnh thc GC
1. i vi thuc ha dc, vc xin, huyt thanh cha khng th,
SPYT: CSNQ v nhn NQ SX phi t GMP-WHO tr ln; i
vi SPC in vitro: phi t GMP, ISO hoc cc TC khc tng
ng.
2. i vi thuc ng y, thuc t dc liu, nguyn liu lm thuc:
a) CSNQ NN phi t GMP - WHO tr ln. CSNQ TN thc hin
theo l trnh trin khai p dng GMP ca BYT;
b) C s nhn NQ thc hin theo l trnh GMP ca BYT.
3. i vi thuc SX theo hnh thc GC, thc hin theo quy nh ti
Thng t s 23/2013/TT-BYT.
iu 6. Yu cu v phiu kim nghim thuc trong HS ng k

1. i vi thuc ho dc, SPYT, thuc ng y, thuc t dc liu
a) C s SX thuc t GMP t thm nh tiu chun, kim nghim
v np PKN ca chnh c s SX np HS ng k;
b) Trng hp c s SX thuc trong nc cha t GMP, c s
KT phi tin hnh thm nh tiu chun v np PKN ca mt
trong s cc c s kim nghim thuc ca Nh nc Trung
ng hoc doanh nghip lm dch v kim nghim thuc c cp
GCN KKDT.
iu 6. Yu cu v phiu kim nghim thuc trong HS ng k

2. i vi vc xin, huyt thanh cha khng th, SPC in vitro
a) C s ng k vc xin, huyt thanh cha khng th phi tin hnh
thm nh tiu chun v np PKN ca Vin KVX & SPYT;
b) C s ng k SPC in vitro c s dng PKN ca chnh c s
SX np HS ng k lu hnh nu c s SX t GMP hoc
cc tiu chun khc tng ng. Trng hp c s SX cha t
GMP hoc ISO hoc cc tiu chun khc tng ng, c s ng
k phi tin hnh thm nh tiu chun v np PKN ca Vin
KVX & SPYT.
3. Trong qu trnh thm nh HS KT, c s KT phi thm nh li
tiu chun v phng php kim nghim ti cc c s kim
nghim do BYT ch nh i vi cc trng hp quy nh ti Ph
lc s III.
iu 7. Yu cu v AT, HQ ca thuc
1. Thuc mi khi ng k lu hnh ti Vit Nam phi thc hin th
nghim lm sng theo quy nh ti Thng t s 03/2012/TT-BYT.
2. Thuc c cp SK ln u nhng c yu cu theo di, nh
gi AT, HQ trong qu trnh lu hnh, c s ng k v c s
KCB c s dng thuc phi thc hin bo co AT, HQ ca
thuc khi np HS ng k li theo quy nh:
a) C s K phi hp vi c s SX (t/h c s ng k khng phi
l c s SX) c trch nhim bo co AT, HQ ca thuc theo
Mu s 03A/TT v gi v BYT v thc hin vic lu tr HS,
ti liu.
b) C s KCB s dng thuc c yu cu theo di, nh gi AT,
HQ c trch nhim bo co tnh hnh s dng thuc theo Mu
s 03B/TT v gi v B Y t; thc hin vic lu tr HS, ti liu.
iu 8. Yu cu v sinh kh dng v tng ng sinh hc

ca thuc
Theo quy nh v np bo co s liu nghin cu sinh kh
dng, tng ng sinh hc quy nh ti Thng t s
08/2010/TT-BYT ngy 26/4/2010 ca B trng B Y t
hng dn bo co s liu nghin cu sinh kh dng, tng
ng sinh hc trong ng k thuc.
iu 9. Cc hnh thc KT
1. ng k ln u p dng i vi thuc thuc mt trong cc
trng hp sau y:
a) Thuc cha c cp SK lu hnh ti Vit Nam;
b) Thuc c cp SK ti Vit Nam v trong thi hn SK cn
hiu lc nhng c thay i khc theo quy nh ti Ph lc s II
hoc khi SK ht hiu lc phi yu cu ng k ln u;
c) Thuc c cp SK ti Vit Nam nhng khng np HS theo
ng thi hn np HS ng k li hoc ng k gia hn theo quy
nh ti khon 2 iu 12 Thng t ny khi SK ht hiu lc.
2. ng k li p dng i vi thuc c cp SK nhng
SK ht hiu lc v khng p ng iu kin ng k gia
hn quy nh ti khon 3 iu ny.
3. ng k gia hn p dng i vi thuc c cp SK ln u
hoc thuc c cp SK li nhng ht hiu lc v p ng cc
yu cu:
a) Thuc ha dc, thuc ng y, thuc t DL v nguyn liu lm
thuc:
c cp SK c hiu lc 5 nm khi ng k ln u hoc ng
k li v c lu hnh trn th trng sau khi c cp SK
HS ng k ln u, ng k li thc hin theo mu ACTD v
ACTR i vi thuc ha dc hoc theo quy nh ti Thng t s
22/2009/TT-BYT
Khng thuc mt trong cc trng hp quy nh ti iu 32, iu
33 Thng t ny.
Khng c bt k khuyn co no ca WHO hoc ca CQQL dc
VN hoc NN v hiu qu iu tr trong thi gian ng k gia hn
Khng c bt k thay i, b sung no ti thi im np h s ng
k gia hn v trong qu trnh thm nh HS ng k gia hn.
b) Vc xin, SPYT, huyt thanh cha khng th, SPC in vitro:

c cp SK c hiu lc 5 nm khi ng k ln u hoc
ng k li v c lu hnh trn th trng sau khi c cp SK;
H s ng k ln u hoc ng k li thc hin theo quy
nh ti Thng t s 22/2009/TT-BYT);
Khng thuc mt trong cc t/h quy nh ti 32, 33 TT ny;
Khng c bt k khuyn co no ca WHO hoc ca CQQL dc

Vit Nam hoc nc ngoi v hiu qu iu tr hoc s dng
trong thi gian ng k gia hn;
Khng c bt k T, BS no ti thi im np HS ng k gia
hn v trong qu trnh thm nh HS ng k gia hn.
c) Mt thuc c th c xem xt gia hn nhiu ln nu p ng y
cc yu cu quy nh ti im a hoc b khon ny.
iu 9. Cc hnh thc KT
4. ng k thay i, b sung p dng i vi mt thuc c SK
nhng c thay i, b sung trong thi gian SK cn hiu lc theo
quy nh ti Ph lc s II.
Khi c cc ni dung thay i hoc b sung theo yu cu ca

Hi ng t vn cp SK, c s ng k phi hp vi c s
SX thc hin cp nht, b sung theo ng hng dn ca
CQQLNN c thm quyn v chu trch nhim v ni dung
thay i m khng phi np HS ng k thay i.
iu 10. t tn thuc
Tn thng mi phi m bo tun th cc nguyn tc sau:
a) Khng ghi qu tc dng iu tr ca thuc;
b) Khng ghi sai tc dng iu tr v tc dng dc l ca thuc;
c) Khng vi phm thun phong, m tc, truyn thng ca Vit Nam;
d) Khng gy xung t vi cc i tng SHTT ca c nhn, t chc
khc ang c bo h;
) Khng trng hoc tng t vi tn thuc c cp SK ca c
s khc.
e) Khng c t tn thuc ging nhau nu thuc c thnh phn hot
cht khc nhau.
g) Khng c t tn thuc khc nhau trong trng hp thuc
c cng cng thc bo ch, cng QTSX ca cng mt NSX
iu 11. Ngn ng, hnh thc HS, mu thuc v l ph
1. Ngn ng s dng trong HS ng k:
a) HS ng k thuc SX TN: Ting Vit;
b) HS ng k thuc NN: Ting Vit hoc ting Anh. Trng hp
vit bng ting Anh, cc thng tin trong HDSD thuc v TTT
phi c dch ra ting Vit.
2. HS ng k thuc phi c chun b trn kh giy A4, ng

chc chn. HS phi c sp xp theo ng trnh t ca mc lc,
c phn cch gia cc phn. Cc phn phn cch phi c nh
s th t d tham kho v c xc nhn ca c s ng k hoc
c s SX thuc trang u tin ca mi phn trong ton b
HS.

3. Mi thuc phi c HS ng k ring, tr trng hp thuc c
chung tt c cc yu t sau c th ng k trong cng mt HS:
a) Tn thuc;
b) Dng bo ch;
c) Cng thc cho mt n v liu (i vi dng thuc n liu) hoc
cng nng hm lng (i vi thuc a liu);
d) Nh sn xut.

4. Yu cu chung i vi ti liu phi np trong HS ng k ln
u, ng k li, ng k gia hn, ng k thay i khc nh
sau:
a) 01 bn gc c y HS.
b) 02 bn sao cc ti liu gm n ng k thuc v TCTP.
i vi vc xin, huyt thanh cha khng th, SPYT (tr SPC in
vitro), b sung thm 01bn sao y h s gc.
c) Nhn thuc: 02 b mu nhn thit k.
ng k li khng yu cu np li nhn nu khng c thay i so
vi ng k ln u;

4. Yu cu chung i vi ti liu phi np trong HS ng k ln
u, ng k li, ng k gia hn, ng k thay i khc nh
sau:
d) Thng tin sn phm: T HDSD ph hp vi tng loi thuc theo
quy nh ti Thng t s 04/2008/TT-BYT.
ng k li khng yu cu np li thng tin sn phm nu khng c
thay i so vi ng k ln u;
) Mu thuc, nguyn liu lm thuc:
- 01 (mt) n v ng gi cho mt quy cch ng k lu hnh;
- Khi lng cho 03 ln kim nghim i vi nguyn liu;
- i vi vc xin, huyt thanh cha khng th, c s ng k gi mu
lu ti Vin Kim nh quc gia vc xin v sinh phm y t.

5. i vi h s ng k thay i, b sung:
Yu cu np 01 bn gc c y cc ti liu ty ni dung ng k
thay i ln, thay i nh theo quy nh ti khon 5, khon 6 iu
16 Thng t ny i vi thuc ha dc, vc xin, huyt thanh cha
khng th, sinh phm y t, khon 3 v 5 iu 21 Thng t ny i
vi sinh phm chn on in vitro v khon 3, khon 4 iu 25
Thng t ny i vi thuc ng y, thuc t dc liu, nguyn liu
lm thuc.

6. Quy nh i vi h s php l:
a) GCN CPP, Giy php SX, KD thuc do CQQLNN c thm quyn
nc ngoi cp, GMP, giy php thnh lp VPD ti Vit Nam
hoc cc GCN t tiu chun tng ng i vi SPC in vitro
b) GCN, vn bng bo h, H chuyn giao quyn s hu i tng s
hu cng nghip c lin quan trong h s KT (nu c) do cc c
quan c thm quyn v s hu cng nghip cp hoc xc nhn
phi l bn sao c chng thc hoc bn sao c ng du ca c
KT

7. Cc h s hnh chnh khc:
a) n ng k
b) Giy y quyn thc hin theo mu
- y quyn c ng tn c s ng k
- y quyn k tn vo HS KT khi c s KT y quyn cho VPD

ca c s KT ti Vit Nam
- y quyn s dng tn thuc ng k nhn hiu hng ho khi ch
s hu NHHH khng phi l c s KT
c) Bn sao c chng thc H nhng quyn i vi thuc sn xut
theo hnh thc nhng quyn

8. Nhn thuc v thng tin sn phm: Ni dung nhn thuc v
thng tin sn phm thc hin theo quy nh ti Thng t s
04/2008/TT-BYT.
9. Ph ng k thuc:
C s KT phi np ph lin quan n ng k v lu hnh thuc,
kim tra, gim st GMP c s SX thuc theo quy nh ca php
lut hin hnh v ph v l ph.
iu 12. Hiu lc ca SK thuc v thi hn np HS ng k

li, HS ng k gia hn
1. Thi hn hiu lc ca SK lu hnh thuc ti a l 05 nm
Trng hp HTV cp SK yu cu tip tc nh gi v AT,
HQ ca thuc, thi hn hiu lc ca SK ti a l 03 nm.
2. Thi hn np HS ng k li, HS ng k gia hn:
a) Trong thi hn 06 thng trc khi SK lu hnh ht hiu lc, c
s ng k c th np HS ng k gia hn.
b) Trong thi hn 12 thng trc v 06 thng sau khi SK lu hnh
ht hiu lc, c s c th np HS ng k li. Trng hp c s
np HS ng k li th khng c php np HS ng k gia
hn.
Chng II. S HU TR TU
I VI THUC NG K (03 iu)
iu 13. Nguyn tc chung

1. C s KT chu trch nhim v SHTT i vi thuc ng k.
2. Cc c s KT xc lp quyn v SHTT hoc tin hnh tra cu
cc i tng SHTT c lin quan trc khi ng k lu hnh
thuc ti Vit Nam.
3. Trng hp c tranh chp v SHTT trong khi xem xt cp
SK, bn phn i vic cp SK cho thuc c tranh chp v
SHTT phi cung cp kt lun ca CQQLNN v SHTT hoc c
quan c chc nng thc thi quyn SHTT v hnh vi xm phm
quyn SHTT. B Y t khng cp SK cho thuc nu c
c s khng nh thuc khi c cp SK s xm phm
quyn SHTT ang c bo h ca c nhn, t chc khc.
Chng II
S HU TR TU I VI THUC NG K
iu 13. Nguyn tc chung

4. Trng hp c tranh chp v SHTT sau khi cp SK lu
hnh, trn c s xem xt ngh ca ch th quyn SHTT hoc
bn th ba c li ch lin quan v cn c vo phn quyt ca Ta
n hoc kt lun cui cng ca CQQLNN v SHTT hoc c
quan chc nng thc thi quyn s hu tr tu v hnh vi xm
phm quyn SHTT, B Y t s quyt nh rt SK hoc nh ch
lu hnh theo quy nh ti khon 6 iu 32 hoc khon 2 iu
33 Thng t ny.
Chng II
S HU TR TU I VI THUC NG K
iu 14. Sng ch lin quan n thuc ng k

1. Thuc cha hot cht cn ang trong giai on bo h SHTT, c s
ng k c th cung cp cc ti liu php l lin quan n tnh trng
bo h v quyn SHTT (vn bng c quyn sng ch) i vi
thuc ng k (nu c).
2. Trong thi hn 02 nm trc khi mt thuc ht thi hn bo h sng
ch, c s KT c th tin hnh np HS ng k lu hnh thuc
generic km cc ti liu chng minh thuc bo h sp ht hn hiu
lc.
iu 15. Bo mt d liu i vi HS ng k: Thc hin theo quy

nh ti Thng t s 05/2010/TT-BYT.
Chng III
H S NG K THUC (13 iu)
Mc I. HS KT ha dc mi, vc xin, huyt thanh cha
khng th, SPYT.
iu 16. Cc HS phi np:

1. H s ng k ln u i vi thuc ho dc mi, vc xin,
huyt thanh cha khng th, SPYT:
Phn I : H s hnh chnh v thng tin sn phm
Phn II : H s cht lng
Phn III: H s tin lm sng
Phn IV: H s lm sng
2. H s ng k ln u i vi thuc generic (ch p dng i
vi thuc ha dc):
Phn I. H s hnh chnh v thng tin sn phm;
Phn II. H s cht lng;

Chng III
H S NG K THUC
3. H s ng k li, bao gm:

a) Phn I. H s hnh chnh v thng tin sn phm;
b) Phn II. H s cht lng: Trng hp h s ng k ln u
chun b theo ACTD hoc theo mu ICH- CTD v p ng cc yu
cu k thut chung ca ASEAN, khi ng k li ch yu cu np
tiu chun v phng php kim nghim thnh phm;
Chng III
H S NG K THUC

4. H s ng k gia hn bao gm:
b) Phn II. H s khc bao gm:
Cng vn ca Cc QLD hoc V TTBYT cho php T/BS trong
qu trnh lu hnh, h s, ti liu thc hin thay i, b sung
theo hnh thc ch yu cu thng bo (bn sao)
TC v PPKN thnh phm i vi cc thuc khng theo TCD (bn
sao);
H s, ti liu chng minh thuc nhp khu vo Vit Nam i
vi thuc NN. H s, ti liu chng minh thuc SX v phn phi
ti Vit Nam i vi thuc TN.
Chng III
H S NG K THUC
5. H s ng k cc thay i ln
Phn IV. H s lm sng;
Cc ni dung thay i ln v cc h s tng ng phi np thc

hin theo hng dn ti Ph lc II
6. H s ng k cc thay i nh
Cc ni dung thay i nh v cc h s tng ng phi np thc

hin theo hng dn ti Ph lc II
Chng III
H S NG K THUC
7. HS ng k cc thay i khc: Theo quy nh ti khon 1 iu
ny (# ng k ln u).
8. Cc HS quy nh ti cc khon 1, 2, 3, 4 v khon 5 iu ny phi
thc hin theo cc quy nh sau:
a) p dng theo cc quy nh ti Ph lc I , bao gm:
H s k thut chung ASEAN (ACTD);
Hng dn nghin cu n nh;
Hng dn thm nh quy trnh sn xut;
Hng dn thm nh phng php phn tch;
Hng dn nghin cu sinh kh dng v tng ng sinh hc;
b) B cc theo mu ca ACTD hoc ICH- CTD.

9. i vi thuc SX gia cng: thc hin theo quy nh Thng t
23/2013/TT-BYT.
Chng III
H S NG K THUC
iu 17. H s hnh chnh v thng tin sn phm (19 mc)

C bn tng t TT 22
Mt s thay i/b sung:
- B FSC
- Ch chp nhn CPP (v b sung GMP nu CPP
khng c xc nhn c s SX t GMP)
- Nhn thuc ch yu cu np bn sao khi K gia hn
- Thng tin sn phm: ch yu cu T HDSD (chung
cho thuc k n, khng k n, thuc generic);
np bn sao khi K gia hn; b t Thng tin cho
bnh nhn i vi thuc khng k n.
- B sung giy GMP/Giy CN tng ng i vi c
s sn xut bao b tip xc trc tip vi thuc
Chng III
H S NG K THUC
iu 18. H s cht lng

- Tng t TT 22
- B sung khon 2: Quy nh h s K thuc SX
nhng quyn
iu 19. H s tin lm sng (Tng t TT 22)

iu 20. H s lm sng (Tng t TT 22)
Chi tit cc quy nh v cc phn h s s c trnh by

v hng dn chi tit trong cc bi trnh by sau.
Chng III. H S NG K THUC
Mc 2. HS ng k SPC Invitro (iu 21, 22, 23, 24)
iu 21. Cc HS phi np
1. HS ng k ln u i vi SPC in vitro, k c bn thnh phm:
a) Phn I. H s hnh chnh;
b) Phn II. H s cht lng;
c) Phn III. H s hiu qu chn on, khng p dng quy nh ny
i vi bn thnh phm;
b) Phn II. H s cht lng.
3. H s ng k cc thay i bao gm:
a) n ng k (theo mu);
b) Cc phn HS lin quan n thay i: np cc phn HS tng ng
theo quy nh ti Mc A- Ph lc IV
Chng III
H S NG K THUC
iu 21. Cc HS phi np
4. HS ng k gia hn bao gm:
Bn sao cc cng vn ca Cc QLD/V TTBYT cho php thay
i, b sung trong qu trnh lu hnh
Bn sao phn HS cht lng theo quy nh ti Mc A Ph lc IV
HS, ti liu chng minh SPC in vitro nhp khu vo Vit

Nam i vi thuc NN. HS, ti liu chng minh SPC in vitro
SX v phn phi ti Vit Nam i vi thuc trong nc.
Chng III
H S NG K THUC
iu 21. Cc HS phi np
5. H s ng k cc thay i khc phi np li h s nh

ng k ln u thc hin theo hng dn ti Mc B -
Ph lc IV ban hnh km theo Thng t ny.
Chng III
H S NG K THUC
iu 22. HS hnh chnh v TTSP: Trnh by chi tit phn sau
iu 23. H s cht lng:
1. Mc lc;
2. Thnh phn hot cht;
3. Thnh phm;
4. n nh.
Yu cu ca HS thc hin theo quy nh ti Mc A- Ph lc IV
iu 24. H s nh gi hiu qu SPC:
1. Mc lc.
2. Cc bo co nghin cu.
Yu cu ca HS thc hin theo quy nh ti Mc A- Ph lc IV
Chng III
H S NG K THUC
Mc 3. HS ng k thuc t dc liu, thuc ng y v nguyn

liu lm thuc (iu 25, 26, 27,28)
iu 25. Cc h s phi np
1. H s ng k ln u, bao gm:
a) H s hnh chnh v thng tin sn phm (xem iu 17).
b) H s cht lng (xem iu 27).
c) H s an ton v hiu qu ch p dng i vi thuc mi, nguyn
liu lm thuc mi (xem iu 28).
Chng III
H S NG K THUC
a) H s hnh chnh v thng tin sn phm;
b) H s cht lng;
3. H s ng k cc thay i ln: cc ni dung thay i ln v cc
h s tng ng phi np thc hin theo hng dn ti phn I -
Mc C - Ph lc s II.
4. H s ng k cc thay i nh: cc ni dung thay i nh v cc
h s tng ng phi np thc hin theo hng dn ti phn II -
Mc C - Ph lc s II.
5. H s ng k gia hn, bao gm:
- Bn sao cc cng vn ca Cc QLD cho php T/BS trong qu
trnh lu hnh, bn sao h s, ti liu thc hin T/BS theo
hnh thc ch yu cu thng bo;
- Bn sao TC & PPKN TP i vi cc thuc khng theo TCD;
- H s, ti liu chng minh thuc NK vo Vit Nam i vi
thuc nc ngoi. H s, ti liu chng minh thuc SX v
phn phi ti Vit Nam i vi thuc trong nc.
6. H s ng k cc thay i khc: H s phi np theo quy
nh ti khon 1 iu ny (ng k ln u).
iu 26. H s hnh chnh v thng tin sn phm: thc hin theo

quy nh ti iu 17 Thng t ny.
iu 27. H s cht lng

1. Quy trnh sn xut
2. Tiu chun cht lng v phng php kim nghim
iu 28. H s an ton, hiu qu: thc hin theo quy nh v th

nghim lm sng ca B Y t, bao gm:
1. Cc bo co v c tnh hc.
2. Cc bo co v nghin cu lm sng, khng p dng quy nh
ny i vi ng k nguyn liu.
Chng IV. TRNH T, TH TC KT V THM
QUYN CP, TM NGNG, RT SK (6 iu)
1. Cc QLD c trch nhim
a) Tip nhn cc HS KT c np trc tip hoc gi qua ng
bu in i vi cc trng hp sau y:
HS KT ng k ln u, ng k li, ng k gia hn, tr HS
ng k SPC in vitro v HS KT dng ngoi SX trong nc.
HS KT thay i ln, thay i nh, thay i khc i vi cc thuc
c SK, tr HS ng k SPC in vitro.
b) T chc thm nh, trnh HDDTV cp SK i vi cc HS ng k
ln u v ng k li hoc trnh B trng BYT ph duyt danh
mc thuc gia hn SK i vi cc HS ng k gia hn.
c) T chc thm nh v tr li bng vn bn cc HS ng k thay i
ln, thay i nh, thay i khc i vi cc thuc c cp s
ng k cn hiu lc.
QUYN CP, TM NGNG, RT SK
2. V Trang thit b v Cng trnh y t c trch nhim

a) Tip nhn cc h s ng k SPC in vitro c np trc tip hoc
gi qua ng bu in i vi cc h s ng k sinh phm chn
on in vitro ng k ln u, ng k li, ng k gia hn v h s
ng k thay i ln, thay i nh, thay i khc;
b) T chc thm nh v trnh HTV cp SK thuc B Y t i vi
cc HS ng k SPC in vitro ng k ln u, ng k li;
c) T chc thm nh v trnh B trng ph duyt danh mc
SPC in vitro ng k gia hn;
d) T chc thm nh v tr li bng vn bn cc HS ng k thay i
ln, thay i nh, thay i khc i vi cc SPC in vitro
3. S Y t cc tnh, thnh ph trc thuc trung ng ni c c s

sn xut c trch nhim
a) Tip nhn h s ng k ln u, ng k li, ng k gia hn c
np trc tip hoc gi qua ng bu in i vi cc thuc dng
ngoi sn xut trong nc quy nh ti Ph lc s V ban hnh km
theo Thng t ny;
b) T chc thm nh cc HS c tip nhn theo quy nh ti im a
khon ny v gi cng vn km theo danh mc thuc thm nh
t yu cu v Cc QLD cp SK.
iu 30. Thm quyn cp s ng k

1. B trng BYT y quyn cho Cc trng Cc QLD k Q ban
hnh danh mc thuc c cp SK trong cc trng hp:
a) HS KT do Cc QLD tip nhn, t chc thm nh theo quy nh
ti im b khon 1 iu 29 Thng t ny;
b) HS KT do S Y t tip nhn, t chc thm nh theo quy nh ti
khon 3 iu 29 Thng t ny.
2. B trng BYT y quyn cho V trng V TTBYT k Quyt

nh ban hnh danh mc SPC in vitro c cp SK i vi cc
HS ng k SPC in vitro theo quy nh ti Khon 2 iu 29
Thng t ny.
iu 31. Thi hn cp SK hoc tr li i vi cc HS ng k

thay i ln, thay i nh, thay i khc
1. Cc QLD/V TTBYT xem xt cp SK i vi cc HS ng k ln
u, HS ng k li trong thi hn ti a 06 thng v HS ng k
gia hn trong thi hn ti a 03 thng k t ngy nhn h s
hp l. Trng hp cc HS ng k cha hoc khng p ng quy
nh c cp s ng k hoc gia hn s ng k, B Y t c
vn bn tr li v nu r l do.
2. Trong thi hn 03 thng k t ngy nhn c h s hp l, S Y
t c trch nhim t chc thm nh v gi v Cc QLD cng vn
km theo danh mc thuc ngh cp SK i vi cc thuc do S
Y t tip nhn h s Cc QLD xem xt, cp SK
3. K t ngy nhn h s hp l, Cc QL/V TTBYT xem xt tr
li i vi cc HS ng k thay i ln, thay i nh trong thi
hn ti a nh sau:
a) 90 ngy i vi ng k thay i ln hoc ng k thay i nh cn
ph duyt trc khi thc hin c t 02 ni dung ngh thay i
tr ln v 60 ngy i vi cc HS thay i nh cn ph duyt trc
khi thc hin c 01 ni dung thay i.
b) 20 ngy i vi cc HS thay i nh ch yu cu thng bo, nu
khng c kin ca CQQLNN th c php thc hin.
4. i vi cc ngh thay i khc, HS thc hin theo quy nh
nh i vi HS ng k ln u v thi gian tr li thc hin theo
quy nh ti khon 1 v 2 iu ny.
5. Cc QLD/V TTBYT xem xt cp s ng k hoc tr li bng vn
bn trc thi hn quy nh ti khon 1 v 3 iu ny khi c
ngh ca c s ng k nu trong n ng k quy nh theo Mu
s 06/TT i vi cc trng hp sau y:
a) Thuc p ng nhu cu iu tr c bit thuc DM thuc him;
b) Thuc p ng nhu cu iu tr trong cc trng hp khn cp,
thin tai, dch bnh;
c) Thuc trong nc SX trn nhng dy chuyn mi t GMP trong
thi hn khng qu 18 thng, k t ngy c cp GMP.
d) Vc xin c WHO tin nh gi t yu cu v c xem
xt cp SK theo quy trnh rt gn do Cc QLD xy dng, ban
hnh.
iu 32. Cc trng hp rt SK thuc

1. Thuc c sn xut khng ng vi HS ng k lu hnh c
B Y t xt duyt.
2. Thuc c 02 l sn xut khng t TCCL hoc thuc vi phm
TCCL 01 ln nhng nghim trng do CQQLNN v cht lng
thuc kt lun.
3. C s sn xut hoc c s ng k ngh rt s ng k lu hnh
ti Vit Nam.
iu 32. Cc trng hp rt SK thuc

4. Thuc b rt SK lu hnh nc s ti.
5. Thuc c cha hot cht c WHO hoc c quan chc nng c
thm quyn ca Vit Nam hoc nc ngoi khuyn co l khng an
ton cho ngi s dng.
6. Thuc b cc c quan c thm quyn kt lun l xm phm quyn
SHTT.
7. Thuc khng thc hin vic thay i c s ng k quy nh ti
im i khon 3 iu 3 hoc im d khon 2 iu 4 Thng t
ny sau thi hn 02 thng, k t ngy c s ng k ngng
hot ng hoc b CQQLNN c thm quyn chm dt hot
ng.
iu 33. Cc trng hp tm ngng tip nhn mi HS KT v

ngng cp SK lu hnh thuc cho cc HS np
1. C s ng k, c s SX thuc c t 02 thuc tr ln khng t
TCCL trc khi lu hnh hoc b nh ch lu hnh trong vng
01 nm.
2. C s ng k, c s SX c thuc b rt SK quy nh ti khon
1 iu 32 Thng t ny; hoc thuc mt trong cc trng hp quy
nh ti khon 4, khon 5 hoc khon 6 iu 32 Thng t ny
nhng khng thng bo cho BYT

3. C s K, c s SX thuc thc hin hnh vi gi mo, t sa

cha HS ti liu, giy t php l ca cc CQNN c thm quyn hoc
s dng con du gi, gi mo ch k, du ca cc c s ng k, c
s SX v cc c s c lin quan khc trong HS ng k

4. C s K, c s SX thuc cung cp HS, d liu, thng tin lin quan
n HS k thut bao gm HS TCCL, PPSX, m khng da
trn c s NC, thc nghim, SX thc t ca c s SX hoc c s
ng k thuc
5. C s K, c s SX thuc cung cp cc HS, d liu, thng tin v
tc dng, AT, HQ ca thuc m khng c cc ti liu, bng chng
khoa hc chng minh
6. C s K, c s SX thuc np mu thuc ng k khng phi do
chnh c s NC hoc SX
7. C s K khng thc hin cp nht thng tin thuc theo yu
cu ca Cc QLD quy nh ti khon 4 iu 9 Thng t ny.
iu 34. Thm quyn ra quyt nh, trch nhim thng bo v

thi hn rt SK lu hnh, tm ngng nhn HS, tm ngng cp
SK lu hnh thuc
1. B trng B Y t u quyn cho Cc trng Cc QLD ra quyt
nh rt SK lu hnh, tm ngng nhn HS, tm ngng cp SK
thuc v V trng V TTBYT ra quyt nh rt SK lu hnh,
tm ngng nhn HS, tm ngng cp SK SPC in vitro.
2. S Y t cc tnh, tp trc thuc Trung ng, Y t cc ngnh thng
bo quyt nh ca B Y t rt SK hoc tm ngng nhn HS, tm
ngng cp SK trn phm vi, a bn qun l.
iu 34. Thm quyn ra Q, trch nhim thng bo v thi hn

rt SK, tm ngng nhn HS, tm ngng cp SK
3. Thi hn tm ngng nhn mi HS KT v tm ngng cp SK cho
cc h s np ti a l 02 nm i vi cc trng hp quy nh
ti khon 1, khon 2 v khon 3 iu 33, hoc nh ch lu hnh
thuc th 02 hoc c quyt nh x l ca CQQLNN c thm
quyn i vi c s thc hin hnh vi khon 3 iu 33.
4. Thi hn tm ngng tip nhn mi HS KT v tm ngng cp SK
cho cc HS np i vi cc trng hp quy nh ti im khon
4, khon 5 v khon 6 iu 33 ti a l 01 nm
5. Thi hn tm ngng tip nhn mi HS KT v tm ngng cp SK
cho cc HS np i vi cc trng hp quy nh ti khon 7
iu 33 ti a l 06 thng
Chng V. T CHC, HOT NG CA CHUYN GIA
THM NH V H TV CP SK (2 iu)
iu 35. T chc, hot ng ca HTV cp SK
1. B Y t thnh lp HTV cp SK.
2. HTV c nhim v t vn cho B trng trong vic cp SK cho
thuc lu hnh ti Vit Nam; cc ch trng v ha hp quy ch
KT vi cc nc trong khu vc v trn TG; chnh sch v SX,
NK v lu hnh thuc ti Vit Nam bao gm vic s dng thuc
trn ngi Vit Nam nh gi tnh AT, HQ ca thuc.
3. HTV hot ng theo nguyn tc: kin t vn ca HTV phi
bo m cn c php l, c s khoa hc v phi c th hin trong
Bin bn cuc hp Hi ng. HTV chu trch nhim trc B
trng BYT v cc kin tham mu, t vn lin quan n KT.
4. Cc QLD/V TTBYT tham mu cho B trng trong vic ban hnh
quy nh v t chc v hot ng ca HTV, c ch phi hp gia
HTV v cc nhm CGT trong qu trnh cp SK.
Chng V. T CHC, HOT NG CA CHUYN GIA
THM NH V H TV CP SK
iu 36. T chc, hot ng ca CG v cc nhm CGT HS KT

1. B Y t giao Cc QLD/V TTBYT cn c chc nng, nhim v
c giao c trch nhim thnh lp cc nhm CGT h s KT
2. Nhm CGT c nhim v t vn cho Cc QLD trong vic thm
nh HS KT v xut vic cp, b sung hoc khng cp SK.
3. Nhm CGT hot ng theo nguyn tc: Cc kin gp hoc
xut ca CGT phi bo m cn c php l, c s khoa hc v
phi c th hin trong Bin bn thm nh HS KT. Chuyn gia
thm nh chu trch nhim trc Cc trng Cc QLD/V
trng V TTBYT v cc ni dung, kin t vn v xut.
4. Cc QLD/V TTBYT xy dng v ban hnh cc quy nh v tiu
ch la chn, t chc v hot ng ca cc nhm CGT HS KT;
t chc thm nh, tng hp kt qu thm nh trnh HTV.
Chng VI. T CHC THC HIN (4 iu)
iu 37. Hiu lc thi hnh
1. Thng t ny c hiu lc thi hnh k t ngy 15/01/2015.

2. Cc thay i ln, thay i nh, thay i khc p dng i vi thuc
c cp SK lu hnh quy nh ti Ph lc II c p dng
thc hin k t ngy 01/4/2015.
3. Bi b Thng t s 22/2009/TT-BYT v mt s ni dung tng ng
trong cc Thng t khc c lin quan
Chng VI. T CHC THC HIN
iu 38. iu khon chuyn tip
1. Cc h s ng k np trc ngy Thng t ny c hiu lc thi

hnh c thm nh v cp SK theo quy nh ti Thng t s
22/2009/TT-BYT.
2. Cc c s ng k thuc nc ngoi c Giy php ng k hot

ng trong lnh vc thuc, nguyn liu lm thuc ti Vit Nam
c cp trc ngy Thng t ny c hiu lc c s dng
ng k thuc cho ht thi hn hiu lc ghi trn Giy php.
Chng VI. T CHC THC HIN
iu 39. iu khon tham chiu

Trong trng hp cc VB QPPL v cc quy nh c vin dn
trong Thng t ny c s thay i, b sung hoc c thay th th
p dng theo VB QPPL mi.
iu 40. Trch nhim thi hnh

Cc QLD/V TTB&CTYT: Hng dn thc hin Thng t; cp
nht, bin tp, ban hnh ACTD/ACTR; cng b trn website cc
thuc c cp SK; xy dng SOP, STK thuc.
SYT: thanh tra, kim tra vic thc hin Thng t.
Cc n v c lin quan: thc hin theo Thng t.

THNG T S 44/2014/TT-BYT
Ph lc I. B h s k thut chung ASEAN (ACTD) v cc

hng dn k thut.
Ph lc II. Cc thay i ln, thay i nh, thay i khc p dng
i vi cc thuc c cp s ng k lu hnh.
Ph lc III. Cc trng hp yu cu thm nh li tiu chun v
phng php kim nghim.
Ph lc IV. Quy nh v h s i vi sinh phm chn on In
vitro (bao gm bn thnh phm).
Ph lc V. Danh mc thuc sn xut trong nc np h s ng
k ti s y t a phng.
Xin trn trng cm n!

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Thng t s 44/2014/TT-BYT

ngy 25/11/2014 ca B Y t quy nh vic

ThS. Nguyn Huy Hng

06 chng, 40 iu, 05 ph lc v cc biu mu, quy

Thng t c hiu lc: 15/01/2015.

Ph lc II - Cc thay i ln, thay i nh, thay i

iu 3. Yu cu, quyn v trch nhim i vi c s KT

iu 3. Yu cu, quyn v trch nhim i vi c s KT

iu 3. Yu cu, quyn v trch nhim i vi c s KT

b) Cung cp y v chnh xc tt c cc d liu, bo co v

iu 3. Yu cu, quyn v trch nhim i vi c s KT

e) Bo co bng vn bn vo ngy 15 thng 12 hng nm cho

iu 3. Yu cu, quyn v trch nhim i vi c s KT

h) Hp tc v to iu kin cho vic thc hin kim tra, nh gi

iu 3. Yu cu, quyn v trch nhim i vi c s KT

k) Phi hp vi nh SX tin hnh cc nghin cu hoc

iu 4. Yu cu, quyn v trch nhim i vi c s SX thuc.

iu 5. Yu cu i vi CSNQ v nhn NQ SX thuc, thuc SX

iu 6. Yu cu v phiu kim nghim thuc trong HS ng k

iu 6. Yu cu v phiu kim nghim thuc trong HS ng k

iu 8. Yu cu v sinh kh dng v tng ng sinh hc

b) Vc xin, SPYT, huyt thanh cha khng th, SPC in vitro:

Khng c bt k khuyn co no ca WHO hoc ca CQQL dc

Khi c cc ni dung thay i hoc b sung theo yu cu ca

2. HS ng k thuc phi c chun b trn kh giy A4, ng

iu 11. Ngn ng, hnh thc HS, mu thuc v l ph

iu 11. Ngn ng, hnh thc HS, mu thuc v l ph

iu 11. Ngn ng, hnh thc HS, mu thuc v l ph

iu 11. Ngn ng, hnh thc HS, mu thuc v l ph

iu 11. Ngn ng, hnh thc HS, mu thuc v l ph

iu 11. Ngn ng, hnh thc HS, mu thuc v l ph

- y quyn k tn vo HS KT khi c s KT y quyn cho VPD

iu 11. Ngn ng, hnh thc HS, mu thuc v l ph

iu 12. Hiu lc ca SK thuc v thi hn np HS ng k

iu 13. Nguyn tc chung

iu 13. Nguyn tc chung

iu 14. Sng ch lin quan n thuc ng k

iu 15. Bo mt d liu i vi HS ng k: Thc hin theo quy

iu 16. Cc HS phi np:

Phn II. H s cht lng;

iu 16. Cc HS phi np:

3. H s ng k li, bao gm:

iu 16. Cc HS phi np:

Phn II. H s cht lng;

Phn IV. H s lm sng;

Cc ni dung thay i ln v cc h s tng ng phi np thc

Phn II. H s cht lng;

Cc ni dung thay i nh v cc h s tng ng phi np thc

Hng dn nghin cu n nh;

Hng dn thm nh quy trnh sn xut;

Hng dn thm nh phng php phn tch;

Hng dn nghin cu sinh kh dng v tng ng sinh hc;

b) B cc theo mu ca ACTD hoc ICH- CTD.

iu 17. H s hnh chnh v thng tin sn phm (19 mc)

iu 18. H s cht lng

iu 19. H s tin lm sng (Tng t TT 22)

Chi tit cc quy nh v cc phn h s s c trnh by

HS, ti liu chng minh SPC in vitro nhp khu vo Vit

5. H s ng k cc thay i khc phi np li h s nh

Mc 3. HS ng k thuc t dc liu, thuc ng y v nguyn

iu 26. H s hnh chnh v thng tin sn phm: thc hin theo

iu 27. H s cht lng

iu 28. H s an ton, hiu qu: thc hin theo quy nh v th