B Y T

CNG HA X HI CH NGHA VIT NAM

c lp - T do - Hnh phc

S: 14/2012/TT-BYT

H Ni, ngy 31 thng 8 nm 2012

THNG T
Quy nh cc nguyn tc, tiu chun Thc hnh tt sn xut
bao b dc phm v hng dn trin khai, p dng
Cn c Lut Dc s 34/2005/QH11 ngy 14/6/2005;
Cn c Ngh nh s 188/2007/N-CP ngy 27/12/2007 ca Chnh ph
quy nh chc nng, nhim v, quyn hn v c cu t chc ca B Y t;
Cn c Quyt nh s 43/2007/Q-TTg ngy 29/3/2007 ca Th tng
Chnh ph v vic ph duyt n Pht trin cng nghip Dc v xy dng
m hnh h thng cung ng thuc ca Vit Nam giai on 2007 - 2015 v tm
nhn n nm 2020;
Xt ngh ca Cc trng Cc Qun l dc,
B Y t ban hnh Thng t quy nh cc nguyn tc, tiu chun Thc
hnh tt sn xut bao b dc phm v hng dn vic trin khai, p dng nh
sau:
Mc I
QUY NH CHUNG

iu 1. Phm vi iu chnh
Thng t ny quy nh cc nguyn tc, tiu chun Thc hnh tt sn xut
bao b dc phm v hng dn vic trin khai, p dng cc nguyn tc, tiu
chun Thc hnh tt sn xut bao b dc phm trong lnh vc sn xut bao b
tip xc trc tip vi thuc.
iu 2. i tng p dng
Thng t ny quy nh p dng i vi cc c s sn xut, kinh doanh bao
b tip xc trc tip vi thuc v cc c s sn xut thuc lu thng trn th
trng Vit Nam.
Mc II
NGUYN TC TIU CHUN THC HNH TT SN XUT BAO B DC
PHM V HNG DN TRIN KHAI P DNG

iu 3. Nguyn tc tiu chun Thc hnh tt bao b dc phm

Cc nguyn tc, tiu chun Thc hnh tt sn xut bao b dc phm
c quy nh ti Ph lc 1 v Ph lc 2 nh km Thng t ny.
iu 4. T chc thc hin

1. Cc Qun l dc ch tr, phi hp vi cc n v lin quan t chc ph

bin cc nguyn tc, tiu chun Thc hnh tt sn xut bao b dc phm (sau
y gi tt l GMP bao b dc phm), danh mc kim tra GMP bao b dc
phm v hng dn trin khai, p dng GMP bao b dc phm cho S Y t cc
tnh, thnh ph trc thuc Trung ng, Y t cc ngnh v cc c s sn xut bao
b tip xc trc tip vi thuc.
2. Cc c s sn xut bao b tip xc trc tip vi thuc c nhu cu ng k
kim tra cp Giy chng nhn GMP bao b dc phm:
a) Nghin cu v hun luyn cc nguyn tc, tiu chun GMP bao b dc
phm v danh mc kim tra GMP bao b dc phm v cc quy nh c lin
quan cho cn b, nhn vin trong c s.
b) Cn c cc nguyn tc, tiu chun GMP bao b dc phm, quy m,
ngun lc v nh hng pht trin p dng ph hp vi thc t trin khai ti
c s.
c) Da trn danh mc kim tra GMP bao b dc phm (Ph lc 3) xy
dng danh mc t kim tra ca c s mnh v tin hnh t kim tra pht hin
cc khim khuyt v khc phc cc tn ti.
iu 5. ng k kim tra
Cc c s sn xut bao b c nhu cu ng k kim tra cp Giy chng
nhn GMP bao b dc phm sau khi t kim tra, nh gi t GMP bao b dc
phm, np trc tip hoc gi theo ng bu in 01 b h s ng k kim tra
n Cc Qun l dc - B Y t.
Thnh phn h s ng k kim tra:
1. Trng hp ng k kim tra ln u:
a) Bn ng k kim tra GMP bao b dc phm (Ph lc 4 - Mu 1);
b) Bn sao Quyt nh thnh lp c s hoc Giy chng nhn ng k kinh
doanh hoc Giy chng nhn u t c xc nhn ca c s;
c) S t chc nhn s (bao gm h, tn, trnh chuyn mn ca cc
cn b ch cht);
d) S nh xng v cc khu vc kim tra cht lng, bo qun (bao
gm s tng th nh my; s ng i ca nhn vin, nguyn liu ban
u, bn thnh phm; s cp sch phng sn xut, phng kim nghim; s
b tr my mc, thit b,);
) Chng trnh, ti liu v bo co tm tt v hun luyn, o to GMP
bao b dc phm ti c s;
e) Danh mc thit b (sn xut, kim nghim v bo qun) hin c v sn
phm d kin sn xut;
g) Bo co t thanh tra ca c s t gn nht (trong vng 03 thng).
2. Trng hp ng k ti kim tra:

Trc 02 thng tnh n ngy Giy chng nhn t nguyn tc, tiu chun
GMP bao b dc phm ht hn, c s tin hnh np h s ng k ti kim tra.
C s sau khi np h s ng k ti kim tra vn c php sn xut theo
phm vi quy nh trong Giy chng nhn.
Thnh phn h s ng k ti kim tra:
a) Bn ng k ti kim tra GMP bao b dc phm (Ph lc 4 - Mu 2);
b) Bo co khc phc cc tn ti trong kim tra ln trc;
c) Bo co tm tt hot ng ca c s trong 03 nm qua;
d) Bo co nhng thay i ca c s trong 03 nm trin khai GMP bao b
dc phm (nu c).
) Bo co t thanh tra ca c s t gn nht (trong vng 03 thng).
3. C s c nhu cu b sung dy chuyn mi np h s ng k nh ng
k kim tra ln u (theo quy nh ti khon 1, iu 5). Trng hp giy chng
nhn GMP cha ht hn nhng c s c nhu cu ti kim tra cng vi ng k
kim tra b sung dy chuyn mi th c th np h s ng k ti kim tra (theo
quy nh ti khon 2, iu 5) ng thi vi ng k kim tra b sung dy
chuyn mi.
iu 6. Thm quyn, trnh t, th tc tip nhn, thm nh h s, kim
tra, v cp Giy chng nhn t nguyn tc, tiu chun GMP bao b dc
phm
1. Thm quyn
Cc Qun l dc chu trch nhim tip nhn v thm nh h s ng k
kim tra, thnh lp on v t chc kim tra thc t, x l kt qu sau kim tra
v cp Giy chng nhn t nguyn tc, tiu chun GMP bao b dc phm cho
c s sn xut bao b.
2. Trnh t, th tc gii quyt
a) Sau khi nhn h s ng k kim tra ca c s theo quy nh ti iu
5, Cc Qun l dc tin hnh thm nh h s.
b) Trong vng 05 ngy lm vic k t khi nhn c h s v ph thm
nh theo quy nh hin hnh, Cc Qun l dc phi thng bo bng vn bn
cho c s bit v k hoch kim tra hoc tnh trng h s cha t yu cu.
c) Trong vng 20 ngy lm vic k t khi thng bo k hoch kim tra, Cc
Qun l dc phi ra quyt nh thnh lp on, tin hnh kim tra thc t.
iu 7. Kim tra, x l kt qu kim tra v cp Giy chng nhn t
nguyn tc, tiu chun GMP bao b dc phm
1. Thnh phn on kim tra
on kim tra bao gm Trng on, Th k on (Cc Qun l dc) v
cc thnh vin (i din ca Vin Kim nghim thuc Trung ng hoc Vin
Kim thuc thnh ph H Ch Minh, i din S Y t tnh, thnh ph trc thuc

Trung ng ni c a im c s sn xut ng k kim tra GMP bao b dc

phm v c th c thm i din ca Cc Qun l dc).
2. Tiu chun cn b kim tra
a) Cn b kim tra phi c trnh i hc tr ln; c kin thc, kinh
nghim v kim tra GMP, nm vng cc nguyn tc, tiu chun GMP, c
o to hun luyn v GMP v thanh tra, kim tra GMP.
b) C phng php thanh tra, kim tra khoa hc, cng quyt, c kh nng
pht hin nhanh cc sai st ca c s ng thi phi a ra c cc bin php
c tnh thuyt phc gip c s khc phc thiu st.
c) Trung thc, khch quan v nghim chnh chp hnh cc quy ch, quy
nh php lut trong qu trnh kim tra.
d) C sc khe, khng ang mc cc bnh truyn nhim.
3. Kim tra
a) on kim tra c trch nhim kim tra ton b cc hot ng ca c s
bao b tip xc trc tip vi thuc theo cc nguyn tc, tiu chun GMP bao b
dc phm v cc qui nh chuyn mn hin hnh:
- Bc 1: Thng bo Quyt nh thnh lp on kim tra.
- Bc 2: C s sn xut trnh by qu trnh trin khai GMP bao b dc
phm; kt qu t thanh tra; bo co tnh hnh hot ng, nhng thay i ca c
s sau 03 nm trin khai v kt qu khc phc nhng tn ti ca ln kim tra
trc (trong trng hp ng k ti kim tra); gii thch, lm r cc vn theo
yu cu ca on kim tra.
- Bc 3: on kim tra tin hnh nh gi thc t (nh xng, khu vc
kim tra cht lng, bo qun, cc tin ch ph tr) v kim tra cc h s, ti
liu c lin quan.
- Bc 4: Tho lun, thng nht thng qua bin bn kim tra.
b) Bin bn kim tra phi ch r cc tn ti trong vic trin khai p dng
GMP bao b dc phm, kt lun v mc p ng nguyn tc, tiu chun
GMP bao b dc phm. Trong trng hp c s sn xut khng nht tr vi
kin ca on kim tra, bin bn phi ghi r tt c cc kin bo lu ca c s.
Bin bn c ph trch c s cng trng on v th k on kim tra k xc
nhn; lm thnh 03 bn, 01 bn lu ti c s, 02 bn lu ti Cc Qun l dc.
4. X l kt qu sau kim tra v cp Giy chng nhn.
a) Nu c s c kim tra p ng cc nguyn tc, tiu chun GMP bao b
dc phm, Cc Qun l dc phi cp Giy chng nhn cho c s trong vng
05 ngy lm vic k t khi kt thc vic kim tra.
Giy chng nhn t nguyn tc, tiu chun GMP bao b dc phm c gi
tr 03 nm k t ngy k.

b) Nu c s c kim tra v c bn p ng cc nguyn tc, tiu chun

GMP bao b dc phm v cn mt s tn ti nhng khng nh hng n cht
lng sn phm, c th khc phc c trong thi gian ngn, on kim tra yu
cu c s phi khc phc, sa cha v bo co kt qu khc phc nhng tn ti
m on kim tra nu ra trong bin bn gi v Cc Qun l dc trong vng
2 thng k t khi kt thc vic kim tra.
Trong vng 05 ngy lm vic k t khi nhn c bo co khc phc, Cc
Qun l dc phi cp Giy chng nhn t nguyn tc, tiu chun GMP bao b
dc phm cho c s nu bo co khc phc t yu cu hoc phi thng bo
bng vn bn cho c s bit v tnh trng bo co khng t yu cu.
Qu hai thng k t khi kt thc vic kim tra, nu c s khng gi bo co
khc phc hp l th phi tin hnh ng k kim tra nh ng k kim tra ln
u v np l ph theo quy nh.
c) Nu c s c kim tra cha p ng cc nguyn tc, tiu chun GMP,
c s phi khc phc sa cha cc tn ti c nu ra trong bin bn kim tra.
Sau khi t nh gi t yu cu, c s tin hnh ng k kim tra nh ng k
kim tra ln u v np l ph theo quy nh.
iu 8. Thanh tra, kim tra v x l vi phm
1. Hot ng thanh tra, kim tra nh gi vic tun th cc nguyn tc, tiu
chun GMP bao b dc phm c tin hnh nh k mi 03 nm hoc thanh,
kim tra t xut theo ngh ca c s hoc theo yu cu ca c quan chc
nng do B Y t (Cc Qun l dc) tin hnh.
2. Trong qu trnh kim tra, nu pht hin c s c vi phm nh hng
nghim trng n cht lng sn phm, trng on kim tra yu cu c s tm
dng vic sn xut, lp bin bn, bo co ngi c thm quyn ra quyt nh x
l chnh thc.
iu 9. K hoch trin khai
1. Cc c s sn xut bao b tip xc trc tip vi thuc nghin cu, p
dng nguyn tc, tiu chun GMP bao b dc phm. B Y t ban hnh cc
chnh sch c th v nhng quy nh ph hp nhm thc y vic trin khai, p
dng nguyn tc, tiu chun GMP bao b dc phm.
2. B Y t yu cu cc c s sn xut thuc phi s dng bao b t tiu
chun cht lng, kim sot c cht liu cu thnh v m bo v sinh.
3. Hi ng Dc in Vit Nam ch tr, phi hp vi Vin Kim nghim
thuc Trung ng, Vin Kim nghim thuc thnh ph H Ch Minh, Vin Kim
nh Quc gia v vc xin v sinh phm y t xy dng v trnh cp c thm
quyn ban hnh tiu chun cht lng ca cc loi bao b tip xc trc tip vi
thuc cc c s sn xut, kinh doanh thuc v cc c s sn xut, kinh doanh
bao b tip xc trc tip vi thuc c cn c thc hin.
4. Cc Qun l dc ch tr, phi hp vi cc n v lin quan tng cng
cng tc hu kim, nng cao hiu qu hot ng tin kim, m bo s dng bao

b ng gi dc phm t cht lng, ph hp vi dng bo ch v c tnh

ha, l, vi sinh ca thuc; c bit ch trng n nhng loi bao b tc ng
nhiu n cht lng thuc nh bao b khng lm sch c trc khi s dng,
bao b ng gi cc thuc v trng nh thuc tim, tim truyn, thuc nh mt,
nh mi, bao b ng gi thuc cha cc hot cht km bn vng, thuc dng
ng ung, bao b kh kim tra cht lng cu thnh nh bao b lm bng thy
tinh, cht do.
5. L trnh thc hin
a) K t ngy 01/4/2013, cc c s sn xut thuc lu thng trn th trng
ch s dng cc loi bao b cp 1 l loi khng lm sch c trc khi dng
nh bao b ng gi dng cun (mng nhm, mng PVC), u ng xt ca c s
t nguyn tc, tiu chun GMP bao b dc phm. Cc l bao b s dng phi
c phiu kim nghim, tem nhn gc ca nh sn xut km theo.
b) K t ngy 01/01/2014, cc c s sn xut thuc lu thng trn th
trng ch s dng cc loi bao b ng gi cp 1 i vi cc loi bao b ng
gi khc ca c s t nguyn tc, tiu chun GMP bao b dc phm. Cc l
bao b s dng phi c phiu kim nghim, tem nhn gc ca nh sn xut km
theo.
c) Trc cc thi im nu trn, B Y t khuyn khch c s sn xut thuc
lu thng trn th trng s dng sn phm ca nhng c s t nguyn tc, tiu
chun GMP bao b dc phm.
iu 10. iu khon thi hnh
1. Thng t ny c hiu lc thi hnh k t ngy 15 thng 10 nm 2012.
2. Cc ng/b Chnh Vn phng, Cc trng Cc Qun l dc, Th
trng cc n v thuc B Y t, Gim c S Y t cc tnh, thnh ph trc
thuc Trung ng, Th trng y t cc ngnh v cc t chc, c nhn c lin
quan chu trch nhim thi hnh Thng t ny.
3. Trong qu trnh thc hin nu c kh khn, vng mc hoc pht sinh
lin quan, ngh cc t chc, c nhn c bo co gi v B Y t (Cc Qun l
dc) kp thi xem xt, gii quyt./.
KT. B TRNG
TH TRNG
( k)

Cao Minh Quang