B Y T

--------

CNG HA X HI CH NGHA VIT NAM

c lp - T do - Hnh phc
------------------------------------H Ni, ngy 25 thng 01 nm 2011

S: 06/2011/TT-BYT

THNG T
Quy nh v qun l m phm
Cn c Ngh nh s 188/2007/N-CP ngy 27 thng 12 nm 2007 ca Chnh ph quy
nh chc nng, nhim v, quyn hn v c cu t chc ca B Y t;
Cn c Ngh nh s 132/2008/N-CP ngy 31 thng 12 nm 2008 ca Chnh ph quy
nh chi tit thi hnh mt s iu ca Lut Cht lng sn phm, hng ho;
Cn c Ngh nh s 24/2003/N-CP ngy 13 thng 3 nm 2003 ca Chnh ph quy
nh chi tit thi hnh Php lnh Qung co;
Cn c Ngh nh s 89/2006/N-CP ngy 30 thng 8 nm 2006 ca Chnh ph quy
nh v ghi nhn hng ho;
Cn c Ngh nh s 12/2006/N-CP ngy 23 thng 01 nm 2006 ca Chnh ph Quy
nh chi tit thi hnh Lut Thng mi v hot ng mua bn hng ho quc t v cc hot
ng i l mua, bn, gia cng v qu cnh hng ho vi nc ngoi;
Cn c Quyt nh s 10/2010/Q-TTg ngy 10 thng 02 nm 2010 ca Th tng
Chnh ph quy nh Giy chng nhn lu hnh t do i vi sn phm, hng ho xut khu
v nhp khu;
trin khai Hip nh ha hp trong qun l m phm c cc nc thnh vin
Hip hi cc nc ng Nam k ngy 02 thng 9 nm 2003 (gi tt l Hip nh m phm
ASEAN), B Y t quy nh v qun l m phm nh sau:
Chng I
QUY NH CHUNG
iu 1. Phm vi iu chnh v i tng p dng
1. Thng t ny quy nh vic qun l cc sn phm m phm sn xut trong nc,
m phm nhp khu lu thng trong phm vi lnh th Vit Nam, bao gm: cng b sn
phm m phm; h s thng tin sn phm; yu cu v an ton sn phm; ghi nhn m phm;
qung co m phm; xut khu, nhp khu m phm; ly mu m phm kim tra cht
lng; kim tra, thanh tra v x l vi phm; trch nhim ca t chc, c nhn sn xut, bun
bn, nhp khu m phm v quyn ca ngi tiu dng.
2. Thng t ny p dng i vi cc c quan qun l nh nc v m phm, cc t
chc, c nhn tin hnh cc hot ng lin quan n cng b sn phm m phm, thng tin,
qung co, xut khu, nhp khu, sn xut, bun bn sn phm m phm ti Vit Nam.
iu 2. Gii thch thut ng

Trong Thng t ny cc t ng di y c hiu nh sau:

1. Sn phm m phm l mt cht hay ch phm c s dng tip xc vi nhng
b phn bn ngoi c th con ngi (da, h thng lng tc, mng tay, mng chn, mi v c
quan sinh dc ngoi) hoc rng v nim mc ming vi mc ch chnh l lm sch, lm
thm, thay i din mo, hnh thc, iu chnh mi c th, bo v c th hoc gi c th
trong iu kin tt.
2. Tn m phm l tn c t cho mt sn phm m phm, c th l tn mi t t
cng vi thng hiu hoc tn ca nh sn xut. Cc k t cu thnh tn sn phm phi l cc
k t c gc ch ci Latin.
3. T chc, c nhn chu trch nhim a sn phm ra th trng l t chc, c nhn
ng tn trn h s cng b sn phm m phm v chu trch nhim v sn phm m phm
trn th trng.
4. S tip nhn Phiu cng b sn phm m phm l s do c quan qun l nh nc
c thm quyn cp khi tip nhn h s cng b sn phm m phm. S tip nhn Phiu cng
b c gi tr chng nhn sn phm m phm c t chc, c nhn chu trch nhim a
sn phm ra th trng khai bo vi c quan qun l nh nc c thm quyn v vic m
phm s c lu thng trn th trng m khng c gi tr chng nhn sn phm m bo
tnh an ton, hiu qu, p ng tt c cc yu cu ca Hip nh m phm ASEAN v cc ph
lc (Annexes) km theo.
5. Ch s hu sn phm m phm l t chc, c nhn s hu cng thc, quy trnh sn
xut, tiu chun cht lng sn phm.
6. n nh ca sn phm l kh nng n nh ca sn phm khi c bo qun
trong iu kin thch hp vn duy tr c nhng tnh nng ban u ca n, c bit l vn
phi m bo c cc yu cu v tnh an ton.
7. nh lng ca hng ho l lng m phm c th hin bng khi lng tnh
hoc th tch thc theo h mt hoc c h mt v h o lng Anh.
8. Nhn m phm l bn vit, bn in, bn v, bn chp ca ch, hnh v, hnh nh c
dn, in, nh, c, chm, khc trc tip trn hng ho, bao b thng phm ca hng ho hoc
trn cc cht liu khc c gn trn hng ho, bao b thng phm ca hng ha.
9. Ghi nhn m phm l th hin ni dung c bn, cn thit v m phm ln nhn
ngi dng nhn bit, lm cn c la chn v s dng ng; nh sn xut, kinh doanh
qung b cho hng ho ca mnh v lm cn c cc c quan chc nng thc hin vic kim
tra, kim sot.
10. Nhn gc l nhn th hin ln u c gn trn bao b thng phm ca m
phm.
11. Nhn ph l nhn th hin nhng ni dung bt buc c dch t nhn gc ca m
phm bng ting nc ngoi ra ting Vit v b sung nhng ni dung bt buc bng ting
Vit theo quy nh ca Thng t ny m nhn gc ca m phm cn thiu.

12. Bao b thng phm ca m phm l bao b cha ng m phm v lu thng

cng vi m phm. Bao b thng phm ca m phm gm hai loi: Bao b trc tip v bao b
ngoi.
a) Bao b trc tip l bao b cha ng hng ho, tip xc trc tip vi hng ho, to ra
hnh khi hoc bc kn theo hnh khi ca hng ha.
b) Bao b ngoi l bao b dng bao gi mt hoc mt s n v hng ho c bao b
trc tip.
13. Lu thng m phm l hot ng trng by, vn chuyn, lu gi hng ho trong
qu trnh mua bn hng ha, tr trng hp vn chuyn hng ha ca t chc, c nhn nhp
khu hng ha t ca khu v kho lu gi.
14. S l sn xut m phm l k hiu bng s hoc bng ch, hoc kt hp c s v
ch nhm nhn bit l sn phm v cho php truy xt ton b lai lch ca mt l sn phm
bao gm tt c cc cng on ca qu trnh sn xut, kim tra cht lng v phn phi l sn
phm .
15. Ngy sn xut m phm l mc thi gian hon thnh sn xut, ch bin, ng gi
hoc cc hnh thc khc hon thin cng on cui cng ca l sn phm.
16. Hn dng ca m phm (hn s dng) l mc thi gian c n nh cho mt l
m phm m sau thi hn ny m phm khng c php lu thng, s dng.
17. S dng tt nht trc ngy l mc thi gian m nh sn xut khuyn dng khi
cht lng sn phm ang t mc ti u.
18. Xut x hng ho ca m phm l nc hoc vng lnh th ni sn xut ra ton b
m phm hoc ni thc hin cng on ch bin c bn cui cng i vi m phm trong
trng hp c nhiu nc hoc vng lnh th tham gia vo qu trnh sn xut m phm .
19. Giy chng nhn lu hnh t do (CFS - Certificate of Free Sale) l giy chng
nhn do c quan c thm quyn ca nc xut khu cp cho thng nhn xut khu m phm
ghi trong CFS chng nhn rng m phm c sn xut v c php lu hnh t do
ti nc xut khu.
20. Hng dn s dng l nhng thng tin cn thit hng dn cho ngi s dng
m phm an ton, hp l. Hng dn s dng c th in trn bao b trc tip hoc theo dng ti
liu i km theo bao b thng phm ca m phm trong ghi hng dn s dng v nhng
ni dung khc theo quy nh.
21. Qung co m phm l cc hot ng gii thiu, qung b m phm nhm thc
y qu trnh sn xut, bn, s dng m phm.
22. Hi tho, s kin gii thiu m phm l hi ngh gii thiu hoc tho lun
chuyn vi ngi tiu dng v cc vn chuyn su lin quan n m phm.
23. Ngi qung co l t chc, c nhn c nhu cu qung co v m phm do mnh
sn xut, phn phi.

24. Ngi pht hnh qung co l t chc, c nhn a sn phm qung co m phm
n ngi tiu dng, bao gm c quan bo ch, truyn thanh, truyn hnh, nh xut bn, t
chc qun l mng thng tin my tnh, ngi t chc chng trnh vn ho, th thao, hi ch,
trin lm v t chc, c nhn s dng phng tin qung co khc.
25. Hi ng m phm ASEAN l c quan i din cho cc nc thnh vin ASEAN
theo di, quyt nh v gii quyt cc tranh chp lin quan n vic thc hin Hip nh
m phm ASEAN.
Chng II
CNG B SN PHM M PHM
iu 3. Quy nh v vic cng b sn phm m phm
1. Cc t chc, c nhn chu trch nhim a sn phm m phm ra th trng ch
c php a m phm ra lu thng khi c c quan qun l nh nc c thm quyn
cp s tip nhn Phiu cng b sn phm m phm v phi hon ton chu trch nhim v tnh
an ton, hiu qu v cht lng sn phm. C quan nh nc c thm quyn s tin hnh
kim tra hu mi khi sn phm lu thng trn th trng.
2. L ph cng b sn phm m phm c thc hin theo quy nh hin hnh.
3. T chc, c nhn chu trch nhim a sn phm ra lu thng trn th trng phi
c chc nng kinh doanh m phm ti Vit Nam.
4. Vic cng b tnh nng ca sn phm m phm (mc ch s dng ca sn phm)
phi p ng hng dn ca ASEAN v cng b tnh nng sn phm m phm (Ph lc s
03-MP).
iu 4. H s cng b sn phm m phm
H s cng b sn phm m phm bao gm cc ti liu sau:
1. Phiu cng b sn phm m phm (02 bn) km theo d liu cng b (bn mm ca
Phiu cng b);
2. Bn sao Giy chng nhn ng k kinh doanh ca t chc, c nhn chu trch
nhim a sn phm ra th trng (c ch k v ng du ca doanh nghip). Trng hp m
phm sn xut trong nc m t chc, c nhn chu trch nhim a sn phm ra th trng
khng phi l nh sn xut th phi c bn sao Giy chng nhn ng k kinh doanh ca nh
sn xut (c chng thc hp l);
3. Bn chnh hoc bn sao c chng thc hp l Giy y quyn ca nh sn xut hoc
ch s hu sn phm y quyn cho t chc, c nhn chu trch nhim a sn phm ra th
trng c phn phi sn phm m phm ti Vit Nam (p dng i vi m phm nhp
khu v m phm sn xut trong nc m t chc, c nhn chu trch nhim a sn phm ra
th trng khng phi l nh sn xut). i vi sn phm nhp khu th Giy u quyn phi l
bn c chng thc ch k v c hp php ho lnh s theo quy nh ca php lut, tr

trng hp c min hp php ho lnh s theo cc iu c quc t m Vit Nam l thnh

vin. Giy u quyn phi p ng cc yu cu quy nh ti iu 6 Thng t ny.
4. Giy chng nhn lu hnh t do (CFS): Ch p dng i vi trng hp cng b
sn phm m phm nhp khu v p ng cc yu cu sau:
a) CFS do nc s ti cp l bn chnh hoc bn sao c chng thc hp l, cn hn.
Trng hp CFS khng nu thi hn th phi l bn c cp trong vng 24 thng k t ngy
cp.
b) CFS phi c hp php ho lnh s theo quy nh ca php lut, tr trng hp
c min hp php ho lnh s theo cc iu c quc t m Vit Nam l thnh vin.
iu 5. Cch lp Phiu cng b sn phm m phm v d liu cng b
1. Phiu cng b sn phm m phm:
a) Phiu cng b sn phm m phm c lp theo mu Ph lc s 01-MP. Phiu
cng b phi c ngi i din theo php lut k, c ng du gip lai ca t chc, c nhn
chu trch nhim a sn phm ra th trng. Cch ghi cc ni dung trong Phiu cng b sn
phm m phm theo hng dn ti Ph lc s 02-MP.
b) Mi sn phm m phm c cng b trong mt Phiu cng b.
Sn phm m phm c sn xut hon chnh ti mi cng ty sn xut khc nhau th
cng b ring. Trng hp c trn mt cng ty tham gia cc cng on sn xut sn xut
ra mt sn phm hon chnh th lp chung trong mt Phiu cng b v phi nu r tn v a
ch y ca tng cng ty.
Cc sn phm cng mt ch s hu sn phm thuc mt trong cc trng hp sau y
c php cng b trong mt Phiu cng b:
- Cc sn phm c ng di tn chung v c bn di dng mt b sn phm.
- Cc sn phm cng tn, cng dng sn phm c cng thc tng t nhau nhng c
mu sc hoc mi khc nhau. i vi sn phm nhum tc, nc hoa cng b ring cho tng
mu, mi.
- Cc dng khc s c Cc Qun l dc - B Y t quyt nh da vo quyt nh
ca Hi ng m phm ASEAN.
c) Cch ghi thnh phn cng thc c trong sn phm m phm:
- Thnh phn c trong cng thc sn phm phi c ghi y theo th t hm
lng gim dn. Cc thnh phn nc hoa, cht to hng v cc nguyn liu ca chng c
th vit di dng hng liu (perfume, fragrance, flavour, aroma). Nhng thnh phn vi
hm lng nh hn 1% c th lit k theo bt k th t no sau cc thnh phn c hm lng
ln hn 1%. Cc cht mu c th c ghi theo bt c th t no sau cc thnh phn khc
theo ch dn mu (CI) hoc theo tn nh trong Ph lc IV (Annex IV) ca Hip nh m
phm ASEAN. Nhng sn phm m phm dng trang im, di dng cc mu khc nhau
c th lit k tt c cc cht mu trong mc c th cha hoc +/-.

- Nu y t l phn trm ca cc thnh phn c quy nh v gii hn nng , hm

lng ti cc Ph lc (Annexes) ca Hip nh m phm ASEAN. Gia hng n v v hng
thp phn c nh du bng du phy (,).
- Tn thnh phn phi c ghi bng danh php quc t (International Nomenclature
of Cosmetic Ingredients - INCI) quy nh trong cc n phm mi nht: T in thnh phn
m phm quc t (International Cosmetic Ingredient Dictionary), Dc in Anh (British
Pharmacopoeia), Dc in M (United States Pharmacopoeia), D liu tm tt v ho hc
(Chemical Abstract Services), Tiu chun Nht Bn v thnh phn nguyn liu m phm
(Japanese Standard Cosmetic Ingredient), n phm ca Nht Bn v thnh phn nguyn liu
m phm (Japanese Cosmetic Ingredients Codex). Tn thc vt v dch chit t thc vt phi
c vit bng tn khoa hc bao gm chi, loi thc vt (tn chi thc vt c th rt ngn). Cc
thnh phn c ngun gc t ng vt cn nu chnh xc tn khoa hc ca loi ng vt .
Nhng cht sau y khng c coi l thnh phn ca m phm:
- Tp cht trong nguyn liu c s dng.
- Cc nguyn liu ph c s dng v mc ch k thut nhng khng c mt trong
sn phm thnh phm.
- Nguyn liu c s dng vi s lng cn thit nh dung mi hoc cht mang ca
cc thnh phn to mi.
d) Ngn ng trnh by trong Phiu cng b l ting Vit hoc ting Anh. Cc ni dung
ghi ti mc 3 (Mc ch s dng), mc 7 (Thng tin v t chc, c nhn chu trch nhim a
sn phm ra th trng), mc 8 (Thng tin v ngi i din theo php lut ca Cng ty), mc
9 (Thng tin v Cng ty nhp khu) trong Phiu cng b phi ghi bng ting Vit hoc ting
Vit v ting Anh.
2. D liu cng b (bn mm ca Phiu cng b): Cc t chc, c nhn c th np d
liu cng b quy nh ti khon 1 iu 4 ca Thng t ny theo mt trong hai cch thc sau:
a) Khai bo trc tip: T chc, c nhn ng tn cng b sn phm m phm gi vn
bn v Cc Qun l dc - B Y t c cp ti khon truy cp vo c s d liu v qun
l m phm, khai bo trc tip trn c s d liu. Phiu cng b np cho c quan qun l nh
nc c thm quyn phi c in ra t c s d liu .
b) Truy cp vo trang thng tin in t ca Cc Qun l dc, ti c s d liu ca
Phiu cng b sn phm m phm (Ph lc s 01-MP), in y thng tin theo quy nh
vo c s d liu, sao lu vo phng tin lu gi in t (USB, CD-ROM, ...). Phiu cng
b np cho c quan qun l nh nc c thm quyn phi c in ra t c s d liu .
T chc, c nhn ng tn cng b sn phm phi chu hon ton trch nhim v tnh
ph hp cc ni dung ca Phiu cng b sn phm m phm (bn c k tn, ng du) vi d
liu cng b (bn mm) khai bo hoc np cho c quan qun l.
iu 6. Quy nh v Giy y quyn
1. Ngn ng trnh by l ting Vit, ting Anh hoc song ng ting Vit v ting Anh.

2. Giy u quyn phi c y cc ni dung sau:

a) Tn, a ch ca nh sn xut; trng hp bn u quyn l ch s hu sn phm th
cn nu r tn, a ch ca ch s hu sn phm v tn, a ch ca nh sn xut;
b) Tn, a ch ca t chc, c nhn c y quyn;
c) Phm vi y quyn (ng tn cng b v phn phi sn phm m phm ti Vit
Nam);
d) Nhn hng hoc tn sn phm c y quyn;
) Thi hn y quyn;
e) Cam kt ca nh sn xut hoc ch s hu sn phm cung cp y H s thng
tin sn phm (PIF) cho t chc, c nhn chu trch nhim a sn phm ra th trng ti Vit
Nam;
g) Tn, chc danh, ch k ca ngi i din cho bn u quyn.
iu 7. Th tc tip nhn v gii quyt h s cng b sn phm m phm
1. H s cng b sn phm m phm c lm thnh 01 b, np trc tip hoc gi
qua ng bu in ti c quan qun l nh nc c thm quyn sau:
a) i vi m phm nhp khu: T chc, c nhn chu trch nhim a sn phm ra
th trng np h s cng b sn phm m phm ti Cc Qun l dc - B Y t.
b) i vi m phm sn xut trong nc: T chc, c nhn chu trch nhim a sn
phm ra th trng np h s cng b sn phm m phm ti S Y t ni t nh my sn
xut. Sn phm m phm c sn xut, ng gi t bn thnh phm nhp khu c coi nh
sn phm sn xut trong nc.
c) i vi m phm kinh doanh trong phm vi Khu thng mi cng nghip thuc
Khu kinh t ca khu Mc Bi, tnh Ty Ninh thc hin cng b ti Ban Qun l Khu kinh t
ca khu Mc Bi; m phm kinh doanh trong phm vi Khu kinh t - thng mi c bit
Lao Bo, tnh Qung Tr thc hin cng b ti Ban Qun l Khu kinh t tnh Qung Tr.
Vic a m phm t Khu thng mi cng nghip thuc Khu kinh t ca khu Mc
Bi, tnh Ty Ninh vo cc khu chc nng khc trong Khu kinh t ca khu Mc Bi, tnh
Ty Ninh hoc a vo th trng ni a kinh doanh; a m phm t Khu Kinh t Thng mi c bit Lao Bo, tnh Qung Tr vo th trng ni a kinh doanh phi thc
hin cng b ti Cc Qun l dc - B Y t theo quy nh ca Thng t ny (t chc, c
nhn ng tn cng b sn phm m phm phi c chc nng kinh doanh m phm ti Vit
Nam v nm ngoi 2 khu ny).
2. Gii quyt h s cng b sn phm m phm:
a) Trong vng 03 ngy lm vic k t ngy nhn c h s cng b hp l v l ph
cng b theo quy nh, c quan qun l nh nc c thm quyn c trch nhim ban hnh s
tip nhn Phiu cng b sn phm m phm.

b) Trng hp h s cng b cha p ng theo quy nh ca Thng t ny th trong

vng 05 ngy lm vic k t ngy nhn c h s, c quan tip nhn h s thng bo bng
vn bn cho t chc, c nhn cng b bit cc ni dung cha p ng sa i, b sung h
s (nu c th cc ni dung cha p ng).
H s b sung ca n v gm:
- Vn bn gii trnh v vic sa i, b sung ca t chc, c nhn ng tn cng b;
- Phiu cng b sn phm m phm km theo d liu cng b (bn mm ca Phiu
cng b) hoc ti liu khc c sa i, b sung;
Trong vng 05 ngy lm vic k t ngy nhn c h s b sung p ng theo quy
nh ca Thng t ny, c quan qun l nh nc c thm quyn c trch nhim ban hnh s
tip nhn Phiu cng b sn phm m phm.
Trng hp h s sa i, b sung khng p ng theo quy nh ca Thng t ny th
trong vng 05 ngy lm vic k t ngy nhn c h s b sung, c quan tip nhn h s
thng bo bng vn bn khng cp s tip nhn Phiu cng b sn phm m phm cho sn
phm ny.
c) Trong thi gian 03 thng k t ngy ban hnh vn bn thng bo theo quy nh ti
im b khon ny, nu c quan qun l nh nc c thm quyn khng nhn c h s b
sung ca t chc, c nhn ng tn cng b th h s cng b khng cn gi tr. Trong trng
hp ny, nu t chc, c nhn mun tip tc cng b th phi np h s mi v np l ph mi
theo quy nh.
iu 8. Quy nh v cch ghi s tip nhn Phiu cng b sn phm m phm
S tip nhn phiu cng b sn phm m phm c quy nh nh sau: s th t c
cp + gch cho + nm cp (hai ch s cui) + gch cho + CBMP + gch ngang + k hiu
vit tt tn tnh, thnh ph, Ban Qun l Khu kinh t hoc Cc Qun l dc (QLD) theo Ph
lc s 04-MP.
V d: 135/11/CBMP-HN c ngha l s tip nhn Phiu cng b m phm l 135 do
S Y t H Ni cp nm 2011.
iu 9. Thay i cc ni dung cng b
i vi cc sn phm m phm cng b v c cp s tip nhn Phiu cng b
sn phm m phm, khi c thay i cc ni dung quy nh ti Ph lc s 05-MP, t chc, c
nhn chu trch nhim a sn phm ra th trng phi c vn bn ngh b sung (i vi
cc ni dung khng phi cng b mi) km theo ti liu c lin quan n ni dung b sung v
phi c s chp thun bng vn bn ca c quan nh nc c thm quyn hoc thc hin
cng b mi theo quy nh (i vi cc ni dung phi cng b mi).
iu 10. Hiu lc ca s tip nhn Phiu cng b sn phm m phm
S tip nhn Phiu cng b sn phm m phm c gi tr 05 nm k t ngy cp. Ht
thi hn 05 nm, t chc, c nhn mun tip tc a sn phm m phm ra lu thng trn th

trng th phi cng b li trc khi s tip nhn Phiu cng b sn phm m phm ht hn
v phi np l ph theo quy nh.
Chng III
H S THNG TIN SN PHM M PHM
iu 11. Quy nh chung v H s thng tin sn phm m phm
Mi sn phm m phm khi a ra lu thng trn th trng phi c H s thng tin
sn phm (PIF - Product Information File) theo hng dn ca ASEAN lu gi ti a ch ca
t chc, c nhn chu trch nhim a sn phm ra th trng.
iu 12. Ni dung ca H s thng tin sn phm m phm
1. H s Thng tin sn phm m phm gm c 4 phn nh sau:
a) Phn 1: Ti liu hnh chnh v tm tt v sn phm;
b) Phn 2: Cht lng ca nguyn liu;
c) Phn 3: Cht lng ca thnh phm;
d) Phn 4: An ton v hiu qu.
Ni dung chi tit ca H s Thng tin sn phm m phm quy nh ti Ph lc s 07MP.
2. Phn 1 ca H s thng tin sn phm phi c xut trnh ngay cho c quan kim
tra, thanh tra khi c yu cu; cc phn khc nu cha y th xut trnh trong vng 1560 ngy k t ngy kim tra theo yu cu ca c quan chc nng.
Chng IV
YU CU V AN TON SN PHM M PHM
iu 13. Yu cu v an ton sn phm m phm
Cc t chc, c nhn chu trch nhim a sn phm m phm ra th trng phi m
bo cc sn phm ca mnh khng c hi i vi sc kho con ngi khi c dng trong
nhng iu kin bnh thng hoc nhng iu kin thch hp c hng dn, ph hp vi
dng bo ch, thng tin ghi trn nhn, hng dn s dng, thn trng c bit, cng nh cc
thng tin khc cung cp bi nh sn xut hoc ch s hu sn phm.
Nh sn xut, ch s hu sn phm phi nh gi tnh an ton trn mi sn phm m
phm theo Hng dn nh gi tnh an ton m phm ca ASEAN. Gii hn kim loi nng v
vi sinh vt trong m phm phi p ng yu cu ca ASEAN quy nh ti Ph lc s 06-MP.
Thnh phn cng thc m phm phi p ng theo cc Ph lc (Annexes) - bn mi nht ca
Hip nh m phm ASEAN (a ch truy cp: www.dav.gov.vn hoc www.aseansec.org).
iu 14. Cc thnh phn cht cm, cc thnh phn c quy nh v gii hn nng
, hm lng v iu kin s dng trong cng thc sn phm m phm

Cc t chc, c nhn khng c a ra th trng nhng sn phm m phm c

cha:
1. Cc cht cm s dng trong m phm vi iu kin i km c lit k trong Ph
lc II (Annex II).
2. Cc thnh phn c lit k trong phn th nht ca Ph lc III (Annex III), vi
nng , hm lng vt qu gii hn hoc nm ngoi iu kin cho php.
3. Cc cht mu khc vi cc cht c lit k trong Ph lc IV (Annex IV), phn 1,
tr trng hp cc m phm cha cc cht mu vi mc ch duy nht nhum tc.
4. Cc cht mu c lit k trong Ph lc IV (Annex IV), phn 1 c s dng ngoi
iu kin nu.
5. Cc cht bo qun nm ngoi danh mc trong Ph lc VI (Annex VI), phn 1.
6. Cc cht bo qun c lit k trong Ph lc VI (Annex VI), phn 1, vi hm lng
vt qu gii hn hoc nm ngoi iu kin cho php, tr trng hp cc cht ny c s
dng vi mc ch c bit, khng lin quan n cng dng l cht bo qun.
7. Cc cht lc tia t ngoi nm ngoi danh mc trong Ph lc VII (Annex VII), phn
1.
8. Cc cht lc tia t ngoi nm trong Ph lc VII (Annex VII), phn 1 nhng c hm
lng vt qu gii hn hoc iu kin cho php.
S c mt ca cc cht c lit k trong Ph lc II (Annex II) vi hm lng vt vn
c chp nhn nu v l do k thut khng th trnh c trong Thc hnh tt sn xut m
phm v vn m bo yu cu v an ton ca m phm nh quy nh ti iu 13 ca
Thng t ny.
iu 15. Nhng sn phm m phm cha cc thnh phn sau y th vn c
php lu thng trn th trng
1. Cc thnh phn hoc nguyn liu c lit k trong Ph lc III (Annex III), phn 2,
trong gii hn v theo nhng iu kin nu, cho n ngy c quy nh trong ct (g) ca
Ph lc ny.
2. Cc cht mu c lit k trong Ph lc IV, phn 2, trong gii hn cho php v
trong iu kin c chp nhn, cho n ngy c quy nh trong ph lc ny.
3. Cc cht bo qun c lit k trong Ph lc VI, phn 2, trong gii hn cho php v
trong iu kin c chp nhn, cho n ngy c cp n trong ct (f) ca Ph lc ny.
Tuy nhin, mt vi thnh phn trong s ny c th c s dng nhng hm lng khc vi
mc ch c th, c th hin r rng trong dng trnh by ca sn phm.
4. Cc cht lc tia t ngoi c quy nh trong phn 2 ca Ph lc VII (Annex VII),
trong gii hn cho php v trong iu kin quy nh, cho n ngy c cp n trong
ct (f) ca Ph lc ny.

10

Quy nh v vic s dng cc cht nm trong cc Ph lc (Annexes) nu trn c th

thay i theo quyt nh ca Hi ng m phm ASEAN. Cc quy nh ny s t ng c
cp nht v c gi tr ti Vit Nam.
Chng V
GHI NHN M PHM
iu 16. V tr nhn m phm
1. Nhn m phm phi c gn trn hng ha, bao b thng phm ca hng ha v
tr khi quan st c th nhn bit c d dng, y cc ni dung quy nh ca nhn m
khng phi tho ri cc chi tit, cc phn ca hng ha.
2. Trng hp khng c hoc khng th m bao b ngoi th trn bao b ngoi phi
c nhn v nhn phi trnh by y cc ni dung bt buc.
iu 17. Kch thc, hnh thc v ni dung ca nhn
1. T chc, c nhn chu trch nhim a sn phm m phm ra th trng t xc nh
kch thc ca nhn hng ho m phm nhng phi bo m thng tin ghi trn nhn phi d
c bng mt thng. Ni dung ca nhn v nhn ph (nu c) phi trung thc, r rng, chnh
xc v phn nh ng tnh nng ca sn phm.
2. Mu sc ca ch, ch s, hnh v, hnh nh, du hiu, k hiu trnh by trn nhn
m phm phi r rng. Mu sc ca ch v s phi tng phn vi nn ca nhn.
iu 18. Ni dung bt buc phi ghi trn nhn
1. Nhn sn phm m phm phi ph hp vi yu cu ghi nhn m phm ca
ASEAN. Nhng thng tin sau phi c th hin trn nhn sn phm:
a) Tn ca sn phm v chc nng ca n, tr khi dng trnh by sn phm th hin
r rng chc nng ca sn phm;
b) Hng dn s dng, tr khi dng trnh by th hin r rng cch s dng ca sn
phm;
c) Thnh phn cng thc y : Phi ghi r cc thnh phn theo danh php quc t
quy nh trong cc n phm mi nht nu ti im c khon 1 iu 5 ca Thng t ny (khng
phi ghi t l phn trm ca cc thnh phn);
d) Tn nc sn xut;
) Tn v a ch ca t chc, c nhn chu trch nhim a sn phm ra th trng
(ghi y bng ting Vit theo Giy chng nhn ng k kinh doanh hoc Giy php u
t);
e) nh lng th hin bng khi lng tnh hoc th tch, theo h mt hoc c h mt
v h o lng Anh;
g) S l sn xut;

11

h) Ngy sn xut hoc hn dng phi c th hin mt cch r rng (v d:

ngy/thng/nm). Cch ghi ngy phi th hin r rng gm thng, nm hoc ngy, thng, nm
theo ng th t. C th dng t ngy ht hn hoc s dng tt nht trc ngy, nu cn
thit c th b sung thm iu kin ch nh cn tun th m bo s n nh ca sn
phm.
Vi nhng sn phm c n nh di 30 thng, bt buc phi ghi ngy ht hn;
i) Lu v an ton khi s dng, c bit theo nhng lu nm trong ct "iu kin
s dng v nhng cnh bo bt buc phi in trn nhn sn phm" c cp trong cc ph
lc ca Hip nh m phm ASEAN, nhng thn trng ny bt buc phi th hin trn nhn
sn phm.
2. Trong trng hp kch thc, dng hoc cht liu bao gi khng th in c y
cc thng tin quy nh ti khon 1 iu ny trn nhn gc, nhng ni dung bt buc ny phi
c ghi trn nhn ph nh km theo sn phm m phm v trn nhn m phm phi ch ra
ni ghi cc ni dung .
Cc thng tin sau y bt buc phi c ghi trn nhn gc ca bao b trc tip ca
sn phm:
a) Tn sn phm;
b) S l sn xut.
iu 19. Ngn ng trnh by trn nhn m phm
Nhng ni dung quy nh ti iu 18 ca Thng t ny phi c trnh by bng ting
Anh hoc ting Vit; ring cc thng tin ti im b, , i khon 1 iu 18 phi ghi bng ting
Vit.
iu 20. Cc ni dung khc th hin trn nhn m phm
T chc, c nhn c php ghi trn nhn m phm nhng ni dung khc. Nhng ni
dung ghi thm khng c tri vi quy nh ca php lut v phi m bo trung thc, chnh
xc, phn nh ng bn cht ca hng ho, khng che khut, khng lm sai lch nhng ni
dung bt buc ghi trn nhn m phm.
Chng VI
QUNG CO M PHM
iu 21. Quy nh v qung co m phm
1. Qung co m phm c thc hin trn cc phng tin thng tin i chng nh
truyn hnh, truyn thanh, trang thng tin in t (Internet, Website), sch, bo, tp ch, t ri,
pano, p phch, vt th trn khng, vt th di nc hoc cc phng tin qung co khc do
n v kinh doanh m phm thc hin hoc ti tr, u quyn cho n v khc thc hin v cc
hot ng t chc hi tho, thng tin, gii thiu sn phm m phm.

12

2. Cc n v ch c php qung co, t chc hi tho, s kin gii thiu cc sn

phm m phm khi c Phiu tip nhn h s ng k qung co, t chc hi tho, s kin
gii thiu m phm theo quy nh ca php lut.
3. Ni dung qung co m phm phi ph hp vi cc ti liu chng minh tnh an ton
v hiu qu ca m phm v phi tun th theo hng dn v cng b tnh nng sn phm m
phm ca ASEAN.
iu 22. Ni dung qung co m phm, hi tho, s kin gii thiu m phm
Ni dung qung co m phm, hi tho, s kin gii thiu m phm phi c cc
thng tin sau:
1. Tn m phm;
2. Tnh nng, cng dng (nu cc tnh nng, cng dng ch yu ca m phm nu
cha th hin trn tn ca sn phm);
3. Tn v a ch ca t chc, c nhn chu trch nhim a sn phm m phm ra th
trng;
4. Lu khi s dng (nu c).
iu 23. Qung co m phm trn phng tin truyn hnh, truyn thanh
Qung co m phm trn phng tin truyn hnh, truyn thanh th cc khon 1, 3, 4
iu 22 phi c c to, r rng. Trng hp hin th bng ch trn mn hnh cc ni dung
trn th tc hin th phi ph hp v c ch qung co ln bo m r rng, d c.
iu 24. Qung co trn bo ch, t ri
Qung co trn bo ch, t ri th cui trang u tin ca ti liu qung co m phm
phi in: (a) S Phiu tip nhn h s ng k qung co ca S Y t; b) ngy ... thng ...
nm ... nhn h s hp l ghi trn Phiu tip nhn.
iu 25. H s ng k qung co m phm, t chc hi tho, s kin gii thiu
m phm
1. H s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm
bao gm cc ti liu sau:
a) Phiu ng k qung co m phm, t chc hi tho, s kin gii thiu m phm
(Ph lc s 10-MP);
b) Bn sao Phiu cng b sn phm m phm c cp (c ng du ca t chc,
c nhn ng k qung co);
c) Bn sao Giy chng nhn ng k kinh doanh ca t chc, c nhn ng k qung
co (c ng du ca t chc, c nhn ng k qung co);
d) Th u quyn ca t chc, c nhn cng b m phm cho t chc, c nhn ng k
qung co, t chc hi tho, s kin gii thiu m phm (trng hp t chc, c nhn ng

13

k qung co, t chc hi tho, s kin gii thiu m phm khng phi l t chc, c nhn
cng b sn phm m phm);
) Ti liu thuyt minh cho cc tnh nng, cng dng ca sn phm trong trng hp
ni dung qung co, ni dung trnh by ti hi tho, s kin gii thiu m phm nu tnh
nng, cng dng ca sn phm nm ngoi ni dung nu trong Phiu cng b sn phm m
phm;
e) 02 kch bn qung co (kch bn phi m t r phn hnh nh, phn li, phn nhc
d nh s qung co) hoc 02 mu qung co d nh s pht hnh (p dng i vi h s
ng k qung co m phm) hoc ti liu d nh trng by, pht hnh ti hi tho, s kin
gii thiu m phm (p dng i vi h s ng k t chc hi tho, s kin gii thiu m
phm). H s phi c du gip lai ca t chc, c nhn ng k qung co, t chc hi tho,
s kin gii thiu m phm.
2. Cch lp h s ng k qung co m phm, t chc hi tho, s kin gii thiu m
phm:
a) H s ng k qung co m phm c th c lp cho mt hoc nhiu sn phm,
c qung co trn mt hoc nhiu phng tin thng tin i chng khc nhau.
Mu qung co, kch bn qung co m phm c th c lp cho mt hoc nhiu sn
phm khc nhau.
b) H s ng k t chc hi tho, s kin gii thiu m phm c th c lp cho
mt hoc nhiu sn phm c t chc ti mt hoc nhiu a im trn a bn tnh, thnh
ph.
iu 26. Thm quyn tip nhn, gii quyt h s ng k qung co m phm, t
chc hi tho, s kin gii thiu m phm
1. T chc, c nhn trc khi qung co m phm phi gi 01 b h s ng k qung
co m phm theo quy nh hin hnh v S Y t ni t tr s chnh ca t chc, c nhn
cng b sn phm m phm. Phong b ng h s ghi r "H s ng k qung co m
phm".
2. T chc, c nhn trc khi t chc hi tho, s kin gii thiu m phm phi gi 01
b h s theo quy nh hin hnh v S Y t a phng ni t chc hi tho, s kin gii
thiu m phm. Phong b ng h s ghi r "H s ng k t chc hi tho, s kin gii
thiu m phm".
3. S Y t cc tnh, thnh ph trc thuc Trung ng (tr cc hnh thc qung co
thc hin theo Thng t lin tch s 06/2007/TTLT/BVHTT-BYT-BNN-BXD ngy
28/02/2007 ca lin B Vn ho Thng tin, B Y t, B Nng nghip v Pht trin nng thn,
B Xy dng v vic hng dn th tc cp giy php thc hin qung co mt ca lin
thng) tip nhn v gii quyt h s ng k qung co m phm, t chc hi tho, s kin
gii thiu m phm.
iu 27. Trnh t, th tc cp Phiu tip nhn h s ng k qung co, t chc
hi tho, s kin gii thiu m phm

14

1. Sau khi nhn c h s ng k qung co m phm, t chc hi tho, s kin

gii thiu m phm hp l theo ng quy nh ca Thng t ny v l ph theo quy nh hin
hnh, S Y t gi cho n v np h s ng k mt Phiu tip nhn h s ng k qung
co, t chc hi tho, s kin gii thiu m phm (Ph lc s 11-MP) km theo mu hoc
kch bn qung co t yu cu (p dng vi h s ng k qung co m phm). Ngy ghi
trn Phiu tip nhn h s l ngy S Y t nhn h s hp l. Sau 10 ngy lm vic, k t
ngy nhn c h s, nu S Y t khng c vn bn yu cu sa i, b sung th n v
c quyn qung co, t chc hi tho, s kin gii thiu m phm theo ng ni dung
ng k.
2. Trng hp h s cha hp l theo quy nh ca Thng t ny th S Y t c vn
bn thng bo cho n v b sung, hon chnh h s.
a) Trong vn bn phi nu c th, chi tit nhng ti liu v ni dung cn sa i, b
sung.
b) n v phi sa i, b sung theo ng nhng ni dung c nu trong vn bn
yu cu sa i, b sung v gi v S Y t. Khi n v b sung h s th S Y t gi mt
Phiu tip nhn h s, ngy ghi trn Phiu tip nhn h s l ngy S Y t nhn c h s
b sung hp l theo yu cu. Sau 10 ngy lm vic, k t ngy nhn c ni dung qung co
sa i, b sung nu S Y t khng c vn bn yu cu sa i, b sung th n v c
qung co, t chc hi tho, s kin gii thiu m phm nh ni dung sa i.
c) Trng hp h s b sung khng p ng theo ng nhng ni dung c nu
trong vn bn yu cu sa i, b sung th S Y t s thng bo cho n v khng c qung
co, t chc hi tho, s kin gii thiu m phm theo ni dung ng k. Trong trng
hp ny, nu n v mun tip tc qung co, t chc hi tho, s kin gii thiu m phm
phi np h s; trnh t ng k v thm nh h s c thc hin li t u v phi np l
ph theo quy nh.
d) Trong thi gian 02 thng, k t ngy S Y t c vn bn gi n v np h s
nhng ni dung cn b sung, nu S Y t khng nhn c vn bn km h s b sung th h
s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm np khng
cn gi tr.
iu 28. Ph thm nh ni dung thng tin, qung co
1. Ph thm nh ni dung qung co m phm cho mt h s thc hin theo quy nh
hin hnh c tnh theo sn phm tng ng vi 01 Phiu cng b sn phm m phm
c cp s tip nhn (khng ph thuc vo cc phng tin thng tin i chng s dng
qung co).
2. Ph thm nh h s t chc hi tho, s kin gii thiu m phm (Ph thm nh
ni dung thng tin, qung co) thc hin theo quy nh hin hnh c tnh theo sn phm
tng ng vi 01 Phiu cng b sn phm m phm c cp s tip nhn (khng ph
thuc s ln t chc v a im t chc hi tho, s kin gii thiu m phm).
iu 29. Qung co m phm ti a phng khc

15

Sau khi nhn c Phiu tip nhn h s ng k qung co m phm, n v mun

qung co trn cc phng tin qung co thuc a phng khc ni gi h s ng k
qung co th phi gi thng bo bng vn bn km theo bn sao c chng thc hp l Phiu
tip nhn h s ng k qung co m phm v ton b ni dung qung co c lin quan
ng k (kch bn hoc mu qung co) cho S Y t a phng ni d nh tin hnh qung
co trc khi tin hnh qung co t nht 03 ngy lm vic.
iu 30. Thay i, b sung ni dung qung co, t chc hi tho, s kin gii
thiu m phm
1. n v ng k qung co, t chc hi tho, s kin gii thiu m phm phi np
h s ng k b sung ti S Y t ni cp Phiu tip nhn h s khi c thay i mt trong cc
ni dung sau:
a) Tn, a ch ca t chc, c nhn chu trch nhim a sn phm ra th trng m
khng thay i s Giy chng nhn ng k kinh doanh hoc s Giy chng nhn u t;
b) Tn, a ch ca n v ng k qung co, t chc hi tho, s kin gii thiu m
phm m khng thay i s Giy chng nhn ng k kinh doanh hoc s Giy chng nhn
u t;
c) a im, thi gian chnh thc t chc hi tho, s kin gii thiu m phm so vi
d kin ng k.
2. H s b sung bao gm: Vn bn ngh thay i, b sung v ti liu c lin quan
n ni dung thay i, b sung.
3. Nhng thay i, b sung khc ngoi cc ni dung nu ti khon 1 iu ny, n v
ng k qung co, t chc hi tho, s kin gii thiu m phm phi tin hnh ng k mi
theo quy nh.
4. S Y t c trch nhim gii quyt h s b sung trong vng 10 ngy lm vic k t
ngy nhn h s hp l.
iu 31. Cc trng hp ht hiu lc ca ni dung qung co m phm, t chc
hi tho, s kin gii thiu m phm
1. Ni dung qung co m phm, t chc hi tho, s kin gii thiu m phm ht gi
tr trong cc trng hp sau:
a) M phm c s ng k lu hnh, s Phiu tip nhn bn cng b tiu chun cht
lng m phm, s tip nhn Phiu cng b sn phm m phm ht gi tr.
b) M phm b c quan qun l nh nc c thm quyn khuyn co ngng s dng
hoc b thu hi sn phm.
c) C nhng thay i v thng tin nh hng n tnh an ton v cht lng ca m
phm.
2. n v c ni dung qung co m phm, t chc hi tho, s kin gii thiu m
phm ht gi tr c trch nhim thng bo cho cc c quan c lin quan, ngi pht hnh
qung co ngng ngay vic pht hnh thng tin, qung co m phm .

16

Chng VII
XUT KHU, NHP KHU M PHM
iu 32. Xut khu m phm
Vic xut khu m phm thc hin ti c quan Hi quan theo quy nh php lut hin
hnh v cc yu cu ca nc nhp khu.
iu 33. H s, th tc cp Giy chng nhn lu hnh t do (CFS) i vi m
phm sn xut trong nc xut khu
1. H s ngh cp CFS bao gm:
a) n ngh cp CFS (Ph lc IV ca Quyt nh s 10/2010/Q-TTg ngy
10/02/2010 ca Th tng Chnh ph quy nh Giy chng nhn lu hnh t do i vi sn
phm, hng ho xut khu v nhp khu) c k khai hon chnh v hp l;
b) Bn sao Phiu cng b sn phm m phm c c quan c thm quyn cp s
tip nhn (bn sao c ng du ca thng nhn ngh cp CFS).
2. Vic cp Giy chng nhn lu hnh t do (CFS) i vi m phm sn xut trong
nc xut khu thc hin theo quy nh ti Chng II Quyt nh s 10/2010/Q-TTg
ngy 10/02/2010 ca Th tng Chnh ph quy nh Giy chng nhn lu hnh t do i vi
sn phm, hng ha xut khu v nhp khu, ngoi ra:
a) M phm sn xut trong nc xut khu c cp CFS khi sn phm c c
quan qun l nh nc c thm quyn cp s tip nhn Phiu cng b sn phm m phm.
b) Thng nhn xut khu phi ng k h s thng nhn ti S Y t ni t c s
sn xut m phm v lm th tc cp CFS i vi hng ha m phm xut khu.
c) Mi CFS c cp cho 01 hoc nhiu sn phm (mu CFS theo Ph lc s 12-MP)
v c gi tr hiu lc trong vng 02 nm k t ngy cp.
3. Ph, l ph cp CFS thc hin theo quy nh hin hnh (Ph, l ph cp CFS tnh theo
sn phm ng vi 01 Phiu cng b sn phm m phm c cp s tip nhn).
4. S Y t cc tnh, thnh ph trc thuc Trung ng l c quan c thm quyn cp v
qun l CFS i vi m phm xut khu c sn xut trn a bn (ni t c s sn xut
m phm).
iu 34. H s, th tc cp Giy chng nhn c s p ng cc nguyn tc, tiu
chun "Thc hnh tt sn xut m phm" ca Hip hi cc nc ng Nam (CGMPASEAN) phc v cho nhu cu xut khu
1. n v sn xut c nhu cu cp Giy chng nhn c s p ng cc nguyn tc, tiu
chun Thc hnh tt sn xut m phm ca Hip hi cc nc ng Nam (CGMPASEAN) phc v cho xut khu gi h s ng k kim tra v Cc Qun l dc - B Y
t. H s bao gm:
a) Phiu ng k kim tra Thc hnh tt sn xut m phm (Ph lc s 13-MP);

17

b) Bn sao Giy ng k kinh doanh hoc Giy php u t;

c) S t chc v nhn s ca c s (s t chc phi th hin r tn, chc danh,
trnh chuyn mn k thut ca cc cn b ph trch cc b phn), qu trnh cng tc v
kinh nghim trong lnh vc c phn cng ca cc cn b ph trch cc b phn (sn xut,
kim tra cht lng, m bo cht lng, nh kho);
d) Chng trnh tp hun, nh gi kt qu tp hun Thc hnh tt sn xut m
phm ti n v;
) S v tr v thit k ca nh my (bao gm: s mt bng tng th; s
ng i ca cng nhn; s ng i ca nguyn liu, bao b, bn thnh phm, thnh
phm; s h thng x l cht thi);
e) Danh mc thit b hin c ca nh my (bao gm thit b sn xut v thit b kim
tra cht lng m phm) phi th hin c tn thit b, nm sn xut, nc sn xut v tnh
trng ca thit b;
g) Danh mc cc mt hng ang sn xut hoc d kin sn xut (ghi r dng sn
phm);
h) Bin bn t thanh tra Thc hnh tt sn xut m phm (Bin bn t thanh tra phi
th hin r thi gian thanh tra, thnh phn on t thanh tra, mc tiu t thanh tra, kt qu t
thanh tra v cc xut thi gian v bin php khc phc cc tn ti).
2. Thm quyn tip nhn v gii quyt h s:
Cc Qun l dc - B Y t c trch nhim xem xt h s, ln k hoch v ra quyt
nh thnh lp on kim tra, thng bo cho c s t nht 10 ngy trc khi tin hnh kim
tra.
3. Giy chng nhn c s p ng cc nguyn tc, tiu chun "Thc hnh tt sn xut
m phm" c gi tr 03 nm k t ngy cp.
4. n v sn xut (gi tt l c s ng k GMP) phi np ph thm nh tiu chun
v iu kin sn xut m phm theo quy nh hin hnh.
iu 35. Nhp khu m phm
1. Cc sn phm m phm c Cc Qun l dc - B Y t cp s tip nhn
Phiu cng b sn phm m phm cn hiu lc c php nhp khu vo Vit Nam. Th tc
nhp khu thc hin ti c quan Hi quan theo quy nh hin hnh. Khi lm th tc nhp
khu, doanh nghip xut trnh vi c quan Hi quan Phiu cng b sn phm m phm
c Cc Qun l dc - B Y t cp s tip nhn.
2. Nhp khu m phm trong mt s trng hp c bit (khng bt buc phi thc
hin cng b sn phm m phm theo quy nh ca Thng t ny):
a) T chc, c nhn nhp khu m phm nghin cu, kim nghim phi gi n
hng nhp khu m phm dng cho nghin cu, kim nghim ti Cc Qun l dc - B Y t
(Ph lc s 14-MP). S lng ti a cho mi sn phm l 10 mu.

18

n hng nhp khu m phm dng cho nghin cu, kim nghim c lm thnh 03
bn. Sau khi c ph duyt, 02 bn c lu ti Cc Qun l dc, 01 bn gi n v. Bn
gi n v c ng du Bn gi doanh nghip trnh c quan Hi quan khi lm th tc
thng quan.
Cc sn phm m phm nhp khu nghin cu, kim nghim phi c s dng
ng mc ch, khng c php a ra lu thng trn th trng.
b) T chc, c nhn nhn m phm l qu biu, qu tng lm th tc nhp khu ti c
quan Hi quan theo quy nh. Tng tr gi mi ln nhn khng vt qu nh mc hng ha
c min thu theo quy nh hin hnh.
Cc mu m phm nhp khu l qu biu, qu tng khng c php a ra lu thng
trn th trng.
c) T chc, c nhn nhp khu m phm trng by ti hi ch, trin lm v cc
trng hp tm nhp ti xut khc phi lm th tc xin cp giy php tm nhp ti xut ca
B Cng Thng theo quy nh hin hnh.
Chng VIII
LY MU M PHM KIM TRA CHT LNG
iu 36. Nguyn tc ly mu
1. Ly mu m phm kim tra hoc gim st cht lng theo nguyn tc ly mu
ngu nhin v phi ly mu nhng v tr khc nhau ca l hng.
2. Lng mu cn ly phn tch v lu cn c vo yu cu kim tra, tiu chun
cht lng, phng php th nhng t nht phi cho ba ln phn tch hoc phi thc
hin php th m bo thu c kt qu chnh xc v tin cy.
3. Cc mu phn tch v mu lu phi c cho vo ng, hn kn v dn nhn.
Nhn ca ng mu phi ghi r tn sn phm, tn t chc, c nhn chu trch nhim a
sn phm ra th trng, s l sn xut, hn dng, ni ly mu, ngy ly mu.
4. Lp bin bn ly mu m phm theo mu Ph lc s 09-MP: Bin bn ly mu m
phm phi ghi r tn sn phm, s l sn xut, ngy ly mu, a im ly mu, ghi chp v
nhng bt thng ca qu trnh ly mu, tn v ch k ca ngi ly mu, i din c s
c ly mu, ngi chng kin (khi cn thit). Bin bn c lm thnh 03 bn: mt bn lu
ti c s c ly mu, mt bn lu ti c quan kim nghim, mt bn lu ti c quan qun l
kim tra cht lng m phm.
iu 37. Quyn hn v trch nhim ca ngi ly mu
1. Xut trnh th thanh tra vin hoc kim sot vin cht lng hoc giy gii thiu
hoc quyt nh thnh lp on kim tra do th trng c quan kim tra cht lng m phm
k khi thi hnh nhim v.

19

2. Yu cu c s c mu xut trnh cc h s, ti liu, lin quan n ngun gc, s

lng, cht lng ca l m phm c ly mu, a ra phng n ly mu, s lng mu
phn tch v mu lu c ly ca l m phm trong qu trnh ly mu.
3. Kim tra, ly mu bt k bao gi no trong l m phm khi c nghi ng v cht
lng, tnh an ton ca sn phm.
4. Chu trch nhim trc php lut v cc thao tc k thut, th tc php l trong qu
trnh ly mu, vn chuyn v bn giao mu cho c quan kim nghim.
iu 38. Vn chuyn v bn giao mu
1. Sau khi hon tt vic ly mu, ngi ly mu phi chuyn cc mu ly km bin
bn ly mu m phm v bn giao ngay cho c quan kim nghim. Trng hp c bit, mu
c th gi n c quan kim nghim qua ng bu in.
2. Mu m phm ly phi c ng gi trong bao gi ph hp v vn chuyn
bng phng tin thch hp m bo mu c bo qun theo ng quy nh, trnh h
hng, v trong qu trnh vn chuyn.
iu 39. Kt lun kt qu kim tra cht lng cc mu m phm
1. Cc mu m phm do cc c quan nh nc c thm quyn v kim tra cht lng
ly mu m bo tnh i din cho c l m phm v c tin hnh phn tch ti cc phng
th nghim c cng nhn th kt lun kt qu kim tra cht lng c gi tr php l i vi
c l m phm.
2. Cc mu m phm do t chc, c nhn gi ti c quan kim tra cht lng ca nh
nc xc nh cht lng th kt lun kt qu kim tra cht lng ch c gi tr php l i
vi mu gi ti.
iu 40. Kinh ph ly mu m phm v kim nghim xc nh cht lng m
phm
1. Kinh ph ly mu v kinh ph kim nghim mu m phm kim tra cht lng
trong sn xut, pha ch v lu thng trn th trng do c quan kim tra cht lng quyt
nh vic ly mu v kim nghim mu chi tr theo quy nh ti Thng t lin tch s
28/2010/TTLT-BTC-BKHCN ngy 03/3/2010 ca lin b Ti chnh v Khoa hc v Cng
ngh hng dn qun l v s dng kinh ph i vi hot ng kim tra nh nc v cht
lng sn phm, hng ha.
2. Trong trng hp mu m phm kim nghim c c quan kim tra cht lng
m phm kt lun khng t tiu chun cht lng, t chc, c nhn chu trch nhim a sn
phm ra th trng phi hon tr ton b kinh ph ly mu v kinh ph kim nghim mu m
phm cho c quan kim tra cht lng theo quy nh ti cc iu 10, iu 12, iu 14, iu
16 v iu 41 ca Lut Cht lng sn phm, hng ha nm 2007, Thng t lin tch s
28/2010/TTLT-BTC-BKHCN ngy 03/3/2010 ca lin b Ti chnh v Khoa hc v Cng
ngh hng dn qun l v s dng kinh ph i vi hot ng kim tra nh nc v cht
lng sn phm, hng ha v cc vn bn quy phm php lut c lin quan.

20

3. Trng hp m phm b khiu ni, t co v cht lng m c quan kim tra kt

lun vic khiu ni, t co v cht lng m phm khng ng th ngi khiu ni, t co
phi thanh ton hon tr chi ph ly mu v chi ph phn tch, kim nghim mu m phm cho
c quan kim tra quy nh ti khon 1 iu ny.
4. Kinh ph ly mu m phm kim tra cht lng, kinh ph kim nghim mu m
phm c b tr trong d ton kinh ph hot ng ca c quan kim tra cht lng nh nc
v m phm theo quy nh ti Thng t lin tch s 28/2010/TTLT-BTC-BKHCN ngy
03/3/2010 ca lin b Ti chnh v Khoa hc v Cng ngh hng dn qun l v s dng
kinh ph i vi hot ng kim tra nh nc v cht lng sn phm, hng ha.
Chng IX
KIM TRA, THANH TRA V X L VI PHM
iu 41. Kim tra nh nc v cht lng m phm
1. C quan kim tra cht lng m phm:
a) C quan kim tra cht lng m phm Trung ng l Cc Qun l dc - B Y
t. Cc Qun l dc ch o h thng kim nghim trn phm vi ton quc. Trong hot ng
kim tra nh nc v cht lng m phm, Cc Qun l dc phi hp vi Thanh tra B Y
t, Vin Kim nghim thuc Trung ng, Vin Kim nghim thuc thnh ph H Ch Minh,
S Y t cc tnh, thnh ph trc thuc Trung ng trin khai v gim st cc hot ng v hu
mi i vi cc sn phm m phm.
Trn c s kt qu kim nghim m phm ca cc c quan kim nghim nh nc,
Cc Qun l dc - B Y t l c quan kt lun cht lng m phm trn phm vi ton quc.
b) C quan kim tra cht lng m phm a phng l S Y t tnh, thnh ph trc
thuc Trung ng. S Y t cc tnh, thnh ph Trung ng t chc trin khai cc hot ng
v hu mi i vi m phm sn xut trong nc, m phm nhp khu lu thng trn a bn
v x l cc vn v cht lng m phm theo quy nh ca php lut. Theo di, thng k
tnh hnh qun l cht lng m phm ti a phng.
Kt lun cht lng m phm trn c s kt qu kim nghim m phm ca c s
kim nghim nh nc v m phm ti a phng.
2. H thng kim nghim ca nh nc v m phm bao gm:
a) Trung ng: Vin Kim nghim thuc Trung ng, Vin Kim nghim thuc
thnh ph H Ch Minh;
b) a phng: Trung tm kim nghim thuc v m phm cc tnh, thnh ph trc
thuc Trung ng.
3. Th trng cc c quan kim nghim cht lng m phm chu trch nhim v kt
lun kt qu kim tra cht lng m phm trc php lut.
iu 42. Hnh thc kim tra, thanh tra

21

1. Kim tra, thanh tra nh k: Kim tra, thanh tra nh k s c c quan c thm
quyn thng bo trc cho n v c kim tra n v chun b v vic thanh tra trc
khi tin hnh hot ng kim tra, thanh tra.
2. Kim tra, thanh tra t xut: Kim tra, thanh tra t xut khi pht hin nhng sn
phm khng t cht lng, khng tun th quy nh lu thng trn th trng hoc do cc
khiu ni ca khch hng. Trong trng hp khn cp, c quan c thm quyn c quyn kim
tra, thanh tra khng cn bo trc.
iu 43. Ni dung kim tra, thanh tra
1. Kim tra, thanh tra vic chp hnh php lut v sn xut, bun bn m phm:
a) Vic tun th cc nguyn tc, tiu chun "Thc hnh tt sn xut m phm" ca
Hip hi cc nc ng Nam (CGMP-ASEAN) hoc tng ng c Hi ng m
phm ASEAN tha nhn;
b) Ghi nhn m phm;
c) H s thng tin sn phm (PIF) theo quy nh ca ASEAN;
d) Qung co m phm.
2. Kim tra, thanh tra vic gii quyt tranh chp, khiu ni, t co v cht lng v cc
ni dung khc lin quan n m phm (nu c).
3. Kim tra, thanh tra vic thc hin thng bo thu hi m phm theo quy nh (nu
c).
iu 44. Th t u tin trong kim tra gim st hu mi
Vic kim tra, thanh tra gim st hu mi m phm cn tp trung ti cc n v nhp
khu, phn phi, sn xut. Th t u tin trong vic kim tra gim st hu mi m phm da
vo loi sn phm, ngun gc xut x, nhn hng, thng hiu cng ty, thnh phn cng thc
sn phm theo hng dn ca ASEAN v kim tra gim st hu mi (Ph lc s 08-MP).
iu 45. nh ch lu hnh v thu hi m phm
1. M phm b nh ch lu hnh v thu hi khi xy ra mt trong cc trng hp sau:
a) M phm lu thng khi cha c c quan qun l nh nc c thm quyn cp s
tip nhn Phiu cng b sn phm m phm;
b) M phm khng t cht lng, khng an ton cho ngi s dng;
c) M phm lu thng c cng thc khng ng nh h s cng b;
d) M phm lu thng c cha thnh phn cht cm s dng trong m phm, cc cht
c nng , hm lng vt qu gii hn cho php;
) M phm lu thng c nhn ghi cng dng khng ph hp vi h s cng b hoc
khng p ng quy nh v ghi nhn sn phm ca Thng t ny, ty mc vi phm c th
b nh ch lu hnh v thu hi;
e) M phm lu thng c sn xut ti c s khng p ng nguyn tc, tiu chun
"Thc hnh tt sn xut m phm" ca Hip hi cc nc ng Nam (CGMP-ASEAN)

22

hoc tng ng c Hi ng m phm ASEAN tha nhn, tu mc vi phm c th b

nh ch lu hnh v thu hi;
g) M phm ht hn s dng hoc qu thi hn theo khuyn co ca nh sn xut;
h) M phm gi, nhp lu, khng r ngun gc, xut x, m phm khng cn nguyn
vn bao b;
i) M phm do t chc, c nhn chu trch nhim a sn phm ra th trng c vn
bn thu hi t nguyn.
2. Thm quyn ra quyt nh thu hi m phm vi phm:
a) Cc Qun l dc - B Y t ra quyt nh thu hi m phm vi phm trong phm vi
ton quc.
b) S Y t tnh, thnh ph trc thuc Trung ng, Ban Qun l Khu kinh t ca khu
Mc Bi (tnh Ty Ninh), Ban Qun l Khu kinh t tnh Qung Tr thc hin thng bo ca
Cc Qun l dc - B Y t v thu hi m phm vi phm theo quy nh ca php lut trn a
bn v bo co v Cc Qun l dc.
iu 46. Thu hi s tip nhn Phiu cng b sn phm m phm
1. S tip nhn Phiu cng b sn phm m phm b thu hi khi xy ra mt trong cc
trng hp sau:
a) M phm lu thng c 2 l khng t cht lng do c quan qun l nh nc v
cht lng m phm kt lun;
b) M phm lu thng c cng thc khng ng nh h s cng b;
c) M phm lu thng c nhn ghi sai lch ngun gc, xut x;
d) M phm lu thng c nhn ghi sai lch bn cht tnh nng vn c ca sn phm;
) M phm khng an ton cho ngi s dng;
e) M phm lu thng c cha thnh phn cht cm s dng trong m phm, cc cht
c nng , hm lng vt qu gii hn cho php;
g) M phm b cc c quan nh nc c thm quyn kt lun l vi phm quyn s hu
tr tu hoc mo nhn ca sn phm khc c php lu hnh;
h) M phm b cm lu hnh nc s ti;
i) T chc, c nhn a sn phm ra th trng c vn bn ngh thu hi s tip nhn
Phiu cng b sn phm m phm;
k) Khng c H s thng tin sn phm (PIF) xut trnh cho c quan c thm quyn
theo quy nh ti iu 12 ca Thng t ny;
l) Gi mo ti liu, s dng con du gi hoc gi mo ch k, du ca c quan chc
nng Vit Nam hoc nc ngoi, ca nh sn xut hoc ch s hu sn phm;
m) K khai khng trung thc cc ni dung trong Phiu cng b sn phm m phm.
2. Thm quyn ra quyt nh thu hi s tip nhn Phiu cng b sn phm m phm:

23

a) Cc Qun l dc - B Y t ra quyt nh thu hi s tip nhn Phiu cng b sn

phm sn xut trong nc do Cc Qun l dc cp s tip nhn trc ngy 25/4/2009, m
phm nhp khu trong phm vi ton quc.
b) S Y t tnh, thnh ph trc thuc Trung ng ra quyt nh thu hi s tip nhn
Phiu cng b sn phm m phm sn xut ti a phng do n v mnh cp.
c) Ban Qun l Khu kinh t ca khu Mc Bi (tnh Ty Ninh), Ban Qun l Khu kinh
t tnh Qung Tr ra quyt nh thu hi s tip nhn Phiu cng b sn phm m phm do n
v mnh cp.
iu 47. Cc trng hp tm ngng tip nhn h s cng b sn phm m phm,
h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm
1. C quan qun l nh nc c thm quyn s tm ngng xem xt v tip nhn h s
cng b sn phm m phm 06 thng i vi cc t chc, c nhn c mt trong cc hnh vi
sau:
a) Kinh doanh m phm nhp lu, m phm gi, khng r ngun gc, xut x;
b) Kinh doanh m phm cha c c quan qun l nh nc c thm quyn cp s
tip nhn Phiu cng b sn phm m phm;
c) Khng thc hin thu hi m phm vi phm theo thng bo ca c quan nh nc c
thm quyn;
d) Sn xut, kinh doanh m phm ti c s khng tun th cc nguyn tc, tiu chun
"Thc hnh tt sn xut m phm" ca Hip hi cc nc ng Nam (CGMP-ASEAN)
hoc tng ng c Hi ng m phm ASEAN tha nhn;
) Sn xut, kinh doanh m phm c thnh phn cht cm s dng trong m phm
hoc vt qu gii hn cho php i vi cc cht c quy nh gii hn nng , hm lng s
dng theo quy nh hin hnh ca php lut;
e) S dng nguyn liu sn xut m phm b nc sn xut cng b cm lu thng
trn th trng;
g) Nhp khu, kinh doanh m phm hoc nguyn liu sn xut m phm b nc
sn xut cng b cm lu thng trn th trng;
h) Sn xut, kinh doanh m phm c cng thc khng ng nh h s cng b;
i) Gi mo ti liu, s dng con du gi hoc gi mo ch k, du ca c quan chc
nng Vit Nam hoc nc ngoi, ca nh sn xut hoc ch s hu sn phm;
k) K khai khng trung thc cc ni dung trong Phiu cng b sn phm m phm;
l) Khng c H s thng tin sn phm (PIF) lu ti doanh nghip theo quy nh.
2. C quan qun l nh nc c thm quyn s tm ngng xem xt v tip nhn h s
ng k qung co m phm, t chc hi tho, s kin gii thiu m phm 06 thng i vi
t chc, c nhn c mt trong cc hnh vi sau:

24

a) Qung co m phm, t chc hi tho, s kin gii thiu m phm khi cha c
Phiu tip nhn h s ng k qung co m phm, t chc hi tho, s kin gii thiu m
phm do c quan qun l nh nc c thm quyn cp theo quy nh ca php lut;
b) Qung co m phm hoc t chc hi tho, s kin gii thiu m phm i vi cc
sn phm m phm cha c cp s tip nhn Phiu cng b sn phm m phm;
c) Qung co m phm c th lm cho ngi tiu dng hiu nhm sn phm l
thuc; qung co m phm c s dng danh ngha, biu tng, hnh nh, th tn ca t chc
y, dc, ca cn b y t; qung co m phm nu tnh nng cng dng cha c s khoa
hc.
3. C quan qun l nh nc c thm quyn s xem xt tm ngng tip nhn h s
cng b sn phm m phm, h s ng k qung co m phm, t chc hi tho, s kin
gii thiu m phm i vi t chc, c nhn khng np bo co kt qu hot ng sn xut
kinh doanh hng nm theo quy nh.
Ht thi hn tm ngng xem xt, tip nhn h s, sau khi n v khc phc y
cc vi phm v c bo co, c quan qun l nh nc c thm quyn s tip tc xem xt, tip
nhn h s cng b sn phm m phm, h s ng k qung co m phm, t chc hi tho,
s kin gii thiu sn phm m phm ca n v.
Chng X
TRCH NHIM CA T CHC, C NHN SN XUT, BUN BN, NHP KHU
M PHM V QUYN CA NGI TIU DNG
iu 48. Trch nhim ca t chc, c nhn sn xut, bun bn, nhp khu m
phm lu thng trn th trng Vit Nam
1. T chc, c nhn chu trch nhim a sn phm m phm ra th trng phi chu
hon ton trch nhim v cc ni dung k khai trong Phiu cng b sn phm m phm, chu
hon ton trch nhim v tnh an ton, hiu qu v cht lng sn phm, m bo rng sn
phm a ra lu thng p ng tt c cc yu cu ca Hip nh m phm ASEAN v cc
Ph lc km theo.
2. T chc, c nhn a sn phm m phm lu hnh trn th trng c trch nhim
theo di, pht hin v thu hi ngay m phm khng t tiu chun cht lng, thc hin thng
bo thu hi ca c quan qun l nh nc c thm quyn, bo co v vic thu hi m phm
gi c quan nh nc c thm quyn; gii quyt kp thi khiu ni ca khch hng v cht
lng m phm, bi thng thit hi cho khch hng theo quy nh ca php lut. ng thi,
phi hon tr li tin cho ngi mua hng v cc chi ph pht sinh trong qu trnh bo qun,
vn chuyn, lu thng sn phm.
3. Trng hp pht hin nhng tc dng ph trm trng nh hng n tnh mng
ngi tiu dng do cht lng sn phm m phm, t chc v c nhn a sn phm ra th
trng phi bo co ti Cc Qun l dc - B Y t trong vng 07 ngy k t ngy nhn
c thng tin u tin v tc dng ph ny theo mu ti Ph lc s 18-MP. Bo co chi tit
v tc dng ph trm trng ny phi c gi v Cc Qun l dc - B Y t trong vng 08
ngy tip theo.

25

4. T chc, c nhn chu trch nhim a sn phm ra th trng phi lu gi H s

thng tin sn phm (PIF) trong thi gian ti thiu 03 nm k t khi l sn xut cui cng c
a ra th trng v xut trnh khi c quan chc nng kim tra, thanh tra yu cu.
5. Cc n v sn xut m phm phi trin khai p dng v p ng cc nguyn tc,
tiu chun "Thc hnh tt sn xut m phm" ca Hip hi cc nc ng Nam (CGMPASEAN).
6. T chc, c nhn kinh doanh m phm phi thc hin cc yu cu ca c quan nh
nc c thm quyn trong vic kim tra, thanh tra v cht lng m phm, thu hi m phm
vi phm v c quyn khiu ni v kt lun v hnh thc x l vi phm theo quy nh ca
php lut v khiu ni, t co.
7. T chc, c nhn chu trch nhim a sn phm ra th trng phi tun th cc quy
nh v lut php Vit Nam v s hu tr tu. Khi c kt lun ca c quan nh nc c thm
quyn v nhn hiu, kiu dng cng nghip vi phm quyn s hu tr tu, t chc, c nhn
phi ngng sn xut, bun bn, nhp khu tin hnh thay i nhn hiu, kiu dng cng
nghip theo ng quy nh v c trch nhim bi hon v x l hu qu (nu c).
iu 49. Quyn ca ngi tiu dng m phm
Ngi tiu dng c quyn c thng tin v m phm, c quyn khiu ni, t co v
yu cu n v kinh doanh m phm bi thng thit hi theo quy nh ca php lut do s
dng m phm sn xut, lu thng khng m bo cht lng, khng an ton.
Chng XI
T CHC THC HIN
iu 50. Thng tin v ch bo co
1. Cc Qun l dc - B Y t c trch nhim cp nht v trin khai cc quy nh lin
quan n Hip nh m phm ASEAN trn trang thng tin in t ca Cc Qun l dc (a
ch: www.dav.gov.vn). Thng xuyn ph bin cho n v c lin quan v cc t chc, c
nhn sn xut, kinh doanh m phm cc thay i v tiu ch k thut c quyt nh bi
Hi ng m phm ASEAN, ng thi phi hp trin khai cc thay i v quyt nh ti
Vit Nam. Mi quyt nh v qun l m phm c thng qua bi Hi ng m phm
ASEAN c p dng ti Vit Nam.
2. Cc Qun l dc, S Y t cc tnh, thnh ph trc thuc Trung ng, Ban Qun l
Khu kinh t ca khu Mc Bi (tnh Ty Ninh), Ban Qun l Khu kinh t tnh Qung Tr c
trch nhim a kt qu x l cc hnh vi vi phm trong lnh vc m phm theo thm quyn
trn trang thng tin in t ca c quan; c l trnh a danh sch cc sn phm m phm
cp s tip nhn Phiu cng b sn phm m phm v nhng ni dung thng tin, qung co
m phm gii quyt trn trang thng tin in t ca c quan phc v cng tc kim tra,
thanh tra, gim st hu mi.
3. nh k vo ngy 30 thng 6 v 31 thng 12 hng nm, S Y t cc tnh, thnh ph
trc thuc Trung ng, Ban Qun l Khu kinh t ca khu Mc Bi (tnh Ty Ninh), Ban
Qun l Khu kinh t tnh Qung Tr gi bo co tnh hnh qun l cht lng v cng tc hu
kim m phm ti a phng, bo co v vic cp s tip nhn Phiu cng b sn phm m

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phm (Ph lc s 15-MP), bo co v vic cp Phiu tip nhn h s ng k qung co m

phm, t chc hi tho, s kin gii thiu m phm (Ph lc s 16-MP) v Cc Qun l dc
- B Y t.
4. nh k ngy 30 thng 01 hng nm, t chc, c nhn chu trch nhim a sn
phm ra th trng phi gi bo co kt qu hot ng sn xut kinh doanh nm trc ca n
v mnh v Cc Qun l dc - B Y t v S Y t s ti (Ph lc s 17-MP).
iu 51. Biu mu, Ph lc km theo Thng t
1. Mu Phiu cng b sn phm m phm: Ph lc s 01-MP.
2. Ti liu hng dn v cng b sn phm m phm: Ph lc s 02-MP.
3. Hng dn ca ASEAN v cng b tnh nng ca sn phm m phm: Ph lc s
03-MP.
4. Quy c vit tt tn cc tnh, thnh ph trc thuc Trung ng v mt s Ban Qun
l Khu kinh t: Ph lc s 04-MP.
5. Thay i sau khi cng b sn phm m phm: Ph lc s 05-MP.
6. Quy nh ca ASEAN v gii hn kim loi nng v vi sinh vt trong sn phm m
phm: Ph lc s 06-MP.
7. H s thng tin sn phm: Ph lc s 07-MP.
8. Ti liu hng dn ca ASEAN v kim tra hu mi m phm: Ph lc s 08-MP.
9. Mu Bin bn ly mu m phm kim tra cht lng: Ph lc s 09-MP.
10. Mu Phiu ng k qung co m phm, t chc hi tho, s kin gii thiu m
phm: Ph lc s 10-MP.
11. Mu Phiu tip nhn h s ng k qung co m phm, t chc hi tho, s kin
gii thiu m phm: Ph lc s 11-MP.
12. Mu Giy chng nhn lu hnh t do (CFS): Ph lc s 12-MP.
13. Mu Phiu ng k kim tra thc hnh tt sn xut m phm: Ph lc s 13-MP.
14. Mu n hng nhp khu dng cho nghin cu, kim nghim: Ph lc s 14-MP.
15. Mu bo co danh sch m phm cp s tip nhn Phiu cng b sn phm m
phm: Ph lc s 15-MP.
16. Mu bo co danh sch m phm cp Phiu tip nhn h s ng k qung co,
t chc hi tho, s kin gii thiu m phm: Ph lc s 16-MP.
17. Mu bo co kt qu hot ng sn xut, kinh doanh m phm: Ph lc s 17-MP.
18. Mu thng bo tc dng bt li i vi m phm: Ph lc s 18-MP.
iu 52. Quy nh chuyn tip
1. K t ngy Thng t ny c hiu lc thi hnh, tt c cc t chc, c nhn chu trch
nhim a sn phm m phm ra th trng Vit Nam phi thc hin vic cng b sn phm
m phm theo quy nh ti Thng t ny.

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2. i vi trng hp cc sn phm cng b t ngy 10/3/2008 (theo quy nh ti

Quy ch Qun l m phm ban hnh km theo Quyt nh s 48/2007/Q-BYT ngy
31/12/2007 ca B trng B Y t) v c cp s tip nhn Phiu cng b sn phm m
phm cn hiu lc m p ng cc quy nh ti Thng t ny th c php tip tc sn xut
(i vi m phm sn xut trong nc), nhp khu (i vi m phm nc ngoi) n ht
thi hn ca Phiu cng b sn phm m phm.
3. Nhng sn phm m phm a ra lu thng khng p ng yu cu v an ton sn
phm m phm theo quy nh ti Chng IV ca Thng t ny, t chc, c nhn chu trch
nhim a sn phm ra th trng phi thu hi ton b sn phm v thc hin theo ng quy
nh ti Thng t ny.
4. Cc sn phm m phm a ra lu thng trong thi gian giy php cn hiu lc,
nu p ng yu cu v an ton sn phm m phm theo quy nh ti Chng IV ca Thng
t ny th c tip tc lu thng trn th trng n ht hn dng ca sn phm.
iu 53. Hiu lc thi hnh
1. Thng t ny c hiu lc thi hnh k t ngy 01/4/2011.
2. Bi b Quyt nh s 48/2007/Q-BYT ngy 31/12/2007 ca B trng B Y t v
vic ban hnh Quy ch qun l m phm, Quyt nh s 40/2008/Q-BYT ngy 26/12/2008
ca B trng B Y t v vic phn cp qun l nh nc v m phm i vi m phm sn
xut ti Vit Nam, Quyt nh s 22/2008/Q-BYT ngy 02/7/2008 ca B trng B Y t
v vic u quyn thc hin chc nng qun l m phm cho Ban Qun l Khu kinh t ca
khu Mc Bi, tnh Ty Ninh ti Khu thng mi cng nghip thuc Khu kinh t ca khu
Mc Bi, tnh Ty Ninh, Quyt nh s 3450/Q-BYT ngy 21/9/2010 ca B trng B Y
t v vic u quyn thc hin chc nng qun l m phm cho Ban Qun l Khu kinh t tnh
Qung Tr.
3. Th trng cc n v thuc B Y t, cc n v trc thuc B Y t; Gim c S
Y t cc tnh, thnh ph trc thuc trung ng v cc t chc, c nhn c lin quan chu trch
nhim thi hnh Thng t ny.
4. Trong qu trnh trin khai thc hin, nu c kh khn, vng mc, cc t chc, c
nhn gi bo co v B Y t (Cc Qun l dc, 138A Ging V, Ba nh, H Ni) B Y
t xem xt, gii quyt./.
KT. B TRNG
TH TRNG
Cao Minh Quang
Ph lc ban hnh km theo

Phu luc

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