Professional Documents
Culture Documents
Thong Tu Dang Ky My Pham
Thong Tu Dang Ky My Pham
c lp - T do - Hnh phc
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
1
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12
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.
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;
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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) 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:
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Kt. B trng
Th trng
( k)
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Ph lc s 01-MP
PHN DNH CHO C QUAN QUN L (FOR OFFICIAL USE)
________________________________________________________________
____________________________________________________________
2.
Kem, nh tng, sa, gel hoc du dng trn da (tay, mt, chn, .)
34
Creams, emulsions, lotions, gels and oils for skin (hands, face, feet,
etc.)
eyes
35
3.
Sn phm lm trng da
Skin whitening products
Sn phm chng nhn da
Anti-wrinkle products
Sn phm khc ( ngh ghi r)
Others (please specify)
4.
5.
C o u n t r y
Tel:
6.
Fax:
ng gi th cp
36
Primary assembler
Secondary assembler
C o u n t r y
Tel:
Fax:
Tel:
Fax
:
H v tn (Name of person):
37
Tel:
Email
:
Tel:
Fax
:
38
No
T l % ca
nhng cht c
gii hn v nng
, hm lng
1
2
3
4
5
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7
8
9
...
Cam kt (DECLARATION)
1. Thay mt cho cng ty, ti xin cam kt sn phm c cp trong Phiu cng
b ny t cc tt c cc yu cu ca Hip nh m phm ASEAN v cc ph
lc ca n.
I hereby declare on behalf of my company that the product in the notification
meets all the requirements of the ASEAN Cosmetic Directive, its Annexes and
Appendices.
2. Ti xin chu trch nhim tun th cc iu khon sau y (I undertake to
abide by the following conditions):
i. m bo c sn cung cp cc thng tin k thut v tnh an ton khi c
quan c thm quyn yu cu v c y h s v cc sn phm c
phn phi bo co trong trng hp sn phm phi thu hi.
Ensure that the products technical and safety information is made readily
available to the regulatory authority concerned (the Authority) and to keep
records of the distribution of the products for product recall purposes;
ii. Phi thng bo ngay cho c quan c thm quyn v cc tc dng ph nghim
trng gy cht ngi hoc e do tnh mng ca sn phm bng in thoi,
fax, th in t hoc vn bn trc 7 ngy k t ngy bit thng tin.
Notify the Authority of fatal or life threatening serious adverse event 1 as soon
as possible by telephone, facsimile transmission, email or in writing, and in
any case, no later than 7 calendar days after first knowledge;
iii. Phi hon thnh bo co tc dng ph ca sn phm (theo mu quy nh)
trong vng 8 ngy lm vic k t ngy thng bo cho c quan c thm quyn
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______________
__________________
Du ca cng ty
[Company stamp]
Ngy [Date]
41
Ph lc s 02-MP
TI LIU HNG DN V CNG B SN PHM m phm
GUIDANCE DOCUMENT ON PRODUCT NOTIFICATION
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Ph lc s 03-MP
HNG DN ca asean
V Cng b tnh nng ca sn phm m phm
Sn phm
1. Sn phm c cha cc
thnh phn c php bi
Hip nh m phm ASEAN
v khng c thnh phn no
b cm.
2. Sn phm tip xc vi nhng
b phn bn ngoi ca c th
(biu b, h thng tc, mng,
mi, b phn sinh dc ngoi)
hoc vi rng v cc mng nhy
ca khoang ming.
3. Sn phm c s dng vi
mc ch duy nht hoc
chnh l lm sch, lm thm
hoc iu chnh mi c th
hoc bo v, gi gn chng
trong nhng iu kin tt.
sai
Cu to sn
phm
Khng
phi m
phm
ng
sai
Khng
phi m
phm
V tr s
dng
ng
sai
Cng dng
chnh
Khng
phi m
phm
ng
47
ng
Hnh
thc
sn phm
Khng
phi m
phm
sai
5. Sn phm vnh vin
iu chnh, phc hi hoc
lm thay i chc nng c
th bng c ch min
dch, trao i cht hoc
c ch dc l.
Cng
khc
phm
dng
m
ng
Khng
phi m
phm
sai
Sn phm m
phm
Trong :
- Thnh phn cu to sn phm m phm
Sn phm ch cha nhng thnh phn tun th theo cc Ph
lc ca Hip nh m phm ASEAN v khng cha bt c thnh phn
no nm trong Ph lc cc cht cm s dng trong m phm vi iu
kin i km ca Hip nh m phm ASEAN.
- V tr s dng ca sn phm m phm
M phm ch tip xc bn ngoi vi nhng phn khc nhau ca
c th (biu b, h thng tc, mng, mi v c quan sinh dc ngoi)
hoc vi rng v cc mng nhy ca khoang ming.
Sn phm dng ung, tim, hoc tip xc vi nhng phn
khc ca c th v d nh mng nhy ca ng mi hoc b phn
sinh dc trong khng c xem l m phm.
- Cng dng chnh ca sn phm m phm
M phm c s dng cho nhng phn cho php ca c th vi
mc ch duy nht hoc mc ch chnh l lm sch, lm thm
hoc thay i v b ngoi hoc iu chnh mi c th hoc bo
v, gi gn chng trong iu kin tt.
(Lu sn phm c th c cng dng th hai hoc cng dng ph
nm ngoi phm vi ni trn).
- Cch th hin ca sn phm m phm
48
Chm sc tc
Phc hi t bo tc / nang tc
Lm dy si tc
Chng rng tc
Kch thch mc tc
Sn phm lm rng
lng
49
Sn phm chm sc
da
Sn phm v sinh
v chm sc rng
ming
Xo so
Tc dng t
Cha vim da
Dit nm
Dit virus
Gim d ng
Lm trng li cc vt do Tetracyline
Sn phm ngn mi
Dng qu trnh ra m hi
Tng cng cm xc
Hp dn gii tnh
Ph hp i vi loi da du
Lm cho da bn cm thy bt
du
50
Ph lc s 04-MP
Quy c
Tn tnh, thnh
ph
An Giang
Bc Cn
Bnh Dng
Bnh nh
Bc Giang
Bc Liu
Bc Ninh
Bnh Phc
Bn Tre
Bnh Thun
B Ra - Vng Tu
Cao Bng
C Mau
Cn Th
Nng
c Lc
c Nng
in Bin
ng Nai
ng Thp
Gia Lai
H Giang
H Nam
H Ni
H Tnh
Hi Dng
Hi Phng
Hu Giang
Ho Bnh
Hng Yn
Kin Giang
K hiu
STT
AG
BC
BD
B
BG
BL
BN
BP
BT
BTh
BV
CB
CM
CT
Na
L
N
B
N
T
GL
HG
HNa
HN
HT
HD
HP
HGi
HB
HY
KG
34
35
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38
39
40
41
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43
44
45
46
47
48
49
50
51
52
53
54
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56
57
58
59
60
61
62
63
64
32
Khnh Ho
KH
65
33
Kon Tum
KT
51
Ph lc s 05-MP
THAY I SAU KHI CNG B sn phm m phm
Cng b sn phm
Cng b mi
Thay i tn sn phm
Cng b mi
Cng b mi
Cng b mi
Thay i mc ch s dng
Cng b mi
Cng b mi
Cng b mi
B sung
Tn v/hoc a ch ca cng ty
chu trch nhim a sn phm ra
th trng nhng khng thay i s
Giy chng nhn ng k kinh
doanh hoc Giy chng nhn u
t.
B sung
Tn v/ hoc a ch ca cng ty
nhp khu
B sung
B sung
52
b.
53
Ph lc s 06-MP
quy nh ca ASEAN v Gii hn kim loi nng
v vi sinh vt trong sn phm m phm
Ch tiu
Gii hn
Thu ngn
Asen
Ch
Ch tiu
Sn phm khc
Tng s vi sinh
vt m c
=<500 cfu/g
=<1000 cfu/g
P. aeruginosa
Khng c c trong
0,1g hoc 0,1 ml
mu th
Khng c c trong
0,1g hoc 0,1ml
mu th
S. aureus
Khng c c trong
0,1g hoc 0,1 ml
mu th
Khng c c trong
0,1g hoc 0,1ml
mu th
C. albicans
Khng c c trong
0,1g hoc 0,1 ml
Khng c c trong
0,1g hoc 0,1ml
54
mu th
mu th
55
Ph lc s 07-MP
H s thng tin sn phm
56
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Ph lc s 08-MP
Ti liu hng dn ca ASEAN v
kim tra hu mi m phm
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Ph lc s 09-MP
Tn c quan ly mu
Theo giy gii thiu hoc th thanh tra (ghi r s, ngy, thng, nm v
tn c quan cp)
H v tn, chc v, c quan ca ngi tham gia ly mu:
1........................................................................................................
.........
2........................................................................................................
.........
3........................................................................................................
.........
Ngy ly mu:
Tn
c
s
c
mu: ....................................................................................
a
ch:
...............................................................
thoi: ..........................
STT Tn
m
phm
S l
SX,
ngy
SX,
hn
dng
n
v S l- Nc
ng gi ng
sn
nh
ly
xut
nht,
khi lng
hoc
th tch
Tn,
a
ch
t
chc chu
trch
nhim a
sn phm
ra th trng
ly
in
Nhn xt
tnh trng
l
sn
phm trc
khi
ly
mu
1
2
iu
kin
bo
qun
mu: ...........................................................
khi
ly
62
Ch k i din c s
c ly mu
(K v ghi r h
tn)
Ch k ngi chng
kin (khi cn
thit)
(K v ghi r h tn)
63
Ph lc s 10-MP
CNG HO X HI CH NGHA VIT NAM
c lp - T do - Hnh phc
PHIU NG K QUNG CO M PHM,
t chc HI THO, s kIN GII THIU M PHM
S: ....
Knh gi: S Y t tnh/ thnh ph ....
1. Tn n v ng k h s:
2. a ch:
3. S in thoi, Fax, E-mail:
4. S giy php hot ng (giy chng nhn ng k kinh doanh):
5. Tn, s in thoi ca ngi hoc b phn chu trch nhim ng
k h s:
6. Danh mc m phm ng k qung co, t chc hi tho, s kin
gii thiu m phm:
STT
Tn m
phm
1
2
7. Ti liu gi km:
- Ni dung (d kin) qung co hoc t chc hi tho, s kin gii
thiu m phm ca tng sn phm.
- Bn sao Phiu cng b sn phm m phm c cp s tip nhn.
8. Cam kt ca n v ng k qung co m phm:
Chng ti nghin cu k Thng t Quy nh v qun l m
phm s ... ngy ... thng ... nm ca B Y t v cam kt s tun
th cc quy nh ca Thng t ny v sc kho v li ch ca ngi s
dng m phm.
... , ngy ... thng ... nm ...
64
Gim c n v
(K tn, ng du)
(Ghi r h v tn ngi k)
65
Ph lc s 11-MP
UBND TNH/ TP
S Y T ...
S: .....................
PHIU TIP NHN h s ng k QUNG CO M PHM,
t chc HI THO, S KIN gii thiu M PHM
(K tn, ng du)
(Ghi r h v tn ngi k)
(*) Ghi ch: Cch ghi s Phiu tip nhn l a/XX/QCMP-A, trong :
- a l S Phiu tip nhn;
- XX l hai ch s cui ca nm cp;
- QCMP l cc k t vit tt ca cm t "qung co m phm";
- A l k hiu vit tt tn tnh, thnh ph c quy nh ti Ph lc s
04-MP.
V d: 268/11/QCMP-HN c ngha l s Phiu tip nhn h s qung co
m phm l 268 do S Y t H Ni cp nm 2011.
66
Ph lc s 12-MP
Address:
Tel:
Fax:
Nguyen Van A
Director
(Provincial/Municipal) health Service
67
Ph lc s 13-MP
TN N V
Knh gi:
Cc Qun l dc - B Y t
Fax:
E-Mail:
(K tn, ng du)
(Ghi r h v tn ngi
k)
68
Ph lc s 14-MP
TN N V
S: ...
n hng nhp khu m phm dng cho nghin cu, kim nghim
Knh gi:
Cc Qun l dc - B Y t
138A Ging V, Ba nh, H Ni
(n v) knh ngh Cc Qun l dc xt duyt n v
c nhn cc m phm dng cho kim nghim cht lng sau:
Tn m phm,
STT
Dng sn
phm
Thnh
phn
n
v
tnh
S lng
Tn cng
ty sn
xut, tn
nc
Gh
i
ch
1
2
3
Cc Qun l dc
thng nm
Chp thun n hng nhp khu gm
, ngy
Gim
c n v
(K tn,
ng du)
(Ghi r h v
tn ngi k)
ca Cc Qun l dc.
H Ni, ngy thng nm
Cc trng
69
Ph lc s 15-MP
UBND tnh/ tp
S Y t ...
(Hoc ban qun l
...)
S: .....
Cc Qun l dc - B Y t
138 A Ging V, Ba nh, H Ni
Tn sn phm
Dng sn phm
n v cng b
(Ghi r tn, a
ch)
S tip nhn
Phiu cng b
1
2
3
...
Tng
s
Th trng c quan
(K tn, ng du)
(Ghi r h v tn ngi k)
70
Ph lc s 16-MP
UBND tnh/ tp
S Y T ...
(Hoc ban qun
l ...)
S: ...
c lp - T do - Hnh phc
Tn sn phm
T chc, c
n v ng k Hnh thc qung co
nhn chu trch
qung co
nhim a sn
phm ra th trng
1
2
...
Tng s
Tn sn phm
n v ng k t chc hi
tho, s kin gii thiu m
phm
1
2
...
Tng s
71
Th trng c quan
(K tn, ng du)
(Ghi r h v tn ngi k)
72
Ph lc s 17-MP
Tn n v
c lp - T do - Hnh phc
... , ngy . thng ... nm ...
S: ...
Nm ...
Knh gi:
- Cc Qun l dc - B Y t
- S Y t tnh/ thnh ph
(n v) ... bo co hot ng sn xut, kinh doanh nm ... ca
n v nh sau:
1. Tng s sn phm cng b:
2. S mt hng sn xut/ nhp khu kinh doanh nm ...:
3. Sn lng hng ho sn xut/ nhp khu kinh doanh nm ...: (phn
theo nhm sn phm)
4. Kh khn vng mc ca n v:
5. xut, kin ngh (nu c).
Gim c n v
(K tn, ng du)
(Ghi r h v tn ngi k)
73
Ph lc s 18-MP
M PHM [BO MT]
Knh gi:
Cc Qun l dc - B Y t
138A Ging V, Ba nh, H Ni
THNG BO TC DNG BT LI
Fax:
Email:
Gii tnh
Tn gio/Quc tch
Thi gian xut hin tc dng bt li
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