CNG KIM NGHIM

Cu 1: Hy nu tm tt c s php l ban hnh Thng t s 04/2010/TT-BYT ngy

12/02/2010 v nhng ni dng c bn quy nh v iu kin,quyn hn v trch nhim ca
ngi ly mu?
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 Lut Dc ngy 14/6/2005;
Cn c Lut Cht lng sn phm, hng ha ngy 21/11/2007;
Cn c Ngh nh s 79/2006/N-CP ngy 09/8/2006 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Dc;
Cn c Ngh nh s 132/2008/N-CP ngy 31/12/2008 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Cht lng sn phm, hng ha;
iu 3. iu kin ngi ly mu
Ngi ly mu phi p ng cc yu cu sau:
1. Ngi ly mu phi l thanh tra vin, kim sot vin cht lng chuyn ngnh dc hoc
thnh vin ca on kim tra do c quan qun l, kim tra nh nc v cht lng thuc thnh
lp.
2. Ngi ly mu phi l cn b c hiu bit v phn tch hoc kim nghim thuc, nm vng
cc vn bn php lut v qun l cht lng thuc, cc th tc php l v cc thao tc k thut
ly mu.
3. Ngi ly mu phi c o to v k thut v cc quy nh lin quan, phi mc trang phc
bo h lao ng ph hp khi ly mu.
iu 4. Quyn hn v trch nhim ca ngi ly mu
1. Ngi ly mu khi thi hnh nhim v phi xut trnh th thanh tra vin hay kim sot vin
cht lng hoc giy gii thiu/quyt nh thnh lp on kim tra do th trng c quan qun
l, kim tra nh nc v cht lng thuc k.
2. Ngi ly mu c quyn yu cu c s c mu thuc xut trnh cc h s, ti liu lin quan
n ngun gc, s lng, cht lng ca l thuc c ly mu, a ra quyt nh v phng n
ly mu, s lng mu phn tch v mu lu c ly ca l thuc trong qu trnh ly mu.
3. Ngi ly mu c quyn ly bt k l thuc no hoc bao gi no trong l thuc khi c nghi
ng v cht lng.
4. Ngi ly mu thuc phi 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.

Cu 2: Hy nu tm tt c s php l ban hnh Thng t s 04/2010/TT-BYT ngy

12/02/2010 v gii thch cc thut ng chnh trong Thng t ny?
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 Lut Dc ngy 14/6/2005;
Cn c Lut Cht lng sn phm, hng ha ngy 21/11/2007;
Cn c Ngh nh s 79/2006/N-CP ngy 09/8/2006 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Dc;
Cn c Ngh nh s 132/2008/N-CP ngy 31/12/2008 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Cht lng sn phm, hng ha;
iu 2. Gii thch t ng:
Cc t ng trong thng t ny c hiu nh sau:
1. Ly mu thuc: l cc thao tc k thut nhm thu thp mt lng thuc (thnh phm thuc,
nguyn liu v bao b lm thuc) nht nh i din cho thc cht tnh trng cht lng ca l
thuc dng cho vic xc nh cht lng thuc.
2. L sn xut: l mt lng xc nh thuc (thnh phm, nguyn liu v bao b lm thuc) c
ch bin trong mt quy trnh n l hoc mt lot cc quy trnh v c tnh ng nht.
3. n v ly mu: l mt phn ring bit ca l sn xut nh mi gi, hp hay thng nguyn
vn hoc khng nguyn vn c chn ra ly mu.
4. Mu ban u: L mt lng thuc c ly ra trc tip t mt phn-mt v tr trong n v ly
mu. Ty theo mc ch ly mu, yu cu kim tra cht lng m lng thuc ca mu ban u
phi to mu phn tch v mu lu.
5. Mu ring: L mu thuc c to thnh bng cch trn u cc mu ban u ly ra t mt
n v ly mu.
6. Mu chung (Mu cui cng): L mu thuc c to thnh bng cch trn ln mt s hoc tt
c cc mu ring vi nhau, dng to mu phn tch v mu lu. (C th nghin trn vi nhau
nu l cht bt rn, trn ln vi nhau nu l cht lng, hoc c th t cnh nhau nu l cc n
v thuc phn liu).
7. Mu phn tch: L mt phn ca mu chung dng phn tch phng kim nghim. Lng
thuc trong mu phn tch phi thc hin tt c cc php th theo yu cu ca tiu chun
cht lng.
8. Mu lu: L mt phn ca mu chung c lu kim nghim li khi cn thit. Lng thuc
trong mu lu ti thiu phi bng mu phn tch.
9. Ngi ly mu: L ngi chu trch nhim thc hin cc thao tc ly mu.
10. S ly mu: L s m t v tr, s n v v/hoc lng nguyn liu cn thu thp.

Cu 3: Hy nu tm tt c s php l ban hnh Thng t s 04/2010/TT-BYT ngy

12/02/2010 v nhng ni dung quy nh v ni ly mu,dng c ly mu thuc v quy nh v
vn chuyn v bn giao mu?
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 Lut Dc ngy 14/6/2005;
Cn c Lut Cht lng sn phm, hng ha ngy 21/11/2007;
Cn c Ngh nh s 79/2006/N-CP ngy 09/8/2006 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Dc;
Cn c Ngh nh s 132/2008/N-CP ngy 31/12/2008 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Cht lng sn phm, hng ha;
iu 5. Ni ly mu thuc
Vic ly mu thuc cn c thc hin mt khu vc ring m bo cc yu cu v sinh (cp
sch) v cc yu cu k thut ring ca tng loi mu (nhit , m, nh sng, v
khun...), trnh nguy c gy nhim, nhim cho thay i phm cht ca mu ly cng nh
phn thuc cn li sau khi ly mu.
i vi nguyn liu thuc v trng, vic ly mu phi c tin hnh trong khu vc sch, v
trng.
iu 6. Dng c ly mu thuc
Dng c ly mu, ng mu phi c lm bng vt liu tr, sch thch hp vi c im
ca tng loi mu, m bo khng lm nh hng n cht lng mu, khng a tp cht vo
mu gy nhim, nhim cho i vi mu cng nh phi m bo an ton cho ngi ly mu
(Tham kho Ph lc 2).
iu 7. Vn chuyn v bn giao mu
1. Sau khi hon tt vic ly mu, ngi ly mu hoc on thanh tra, kim tra phi chuyn cc
mu ly km bin bn ly mu thuc v bn giao cng sm cng tt cho c quan kim
nghim. Trng hp c bit, mu c th gi n c quan kim nghim qua ng bu in,
nhng phi ghi r iu kin bo qun ca mu cn gi.
2. Cc mu thuc 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 qui nh, trnh b h hng, v trong
qu trnh vn chuyn. Cn ch cc mu thuc c yu cu bo qun c bit nh vc xin hay
cc sn phm sinh hc dng cho iu tr, chn on.
3. Trong trng hp cn thit, on thanh tra, kim tra c th tin hnh m ha mu m bo
mt s thng tin b mt trc khi tin hnh bn giao cho c quan kim nghim.

Cu 4: Hy nu tm tt c s php l ban hnh Thng t s 04/2010/TT-BYT ngy

12/02/2010 v nhng ni dung quy nh ly mu nguyn liu lm thuc,ly mu bn thnh
phm cha ng gi v ly mu thnh phm?
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 Lut Dc ngy 14/6/2005;
Cn c Lut Cht lng sn phm, hng ha ngy 21/11/2007;
Cn c Ngh nh s 79/2006/N-CP ngy 09/8/2006 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Dc;
Cn c Ngh nh s 132/2008/N-CP ngy 31/12/2008 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Cht lng sn phm, hng ha;
iu 11. Ly mu nguyn liu lm thuc.
1. Trng hp nguyn liu ch c mt bao gi:
a) Ly mu nguyn liu dng rn: Ly mu ban u cc v tr khc nhau ca thng hng (pha
trn, gia v y). Nu cc mu ban u khng c cc du hiu cm quan khc nhau th trn u
cc mu ban u thnh mu ring.
b) Ly mu nguyn liu dng lng hoc bn rn: Nu khng ng u th phi trn u trc khi
ly mu. VD: nu ch phm lng phn lp phi khuy u trc khi ly mu, hoc nu c cn
lng trong cht lng phi lm tan cn lng hoc phn tn u trc khi ly mu bng cch c th
lm m hoc khuy trn u.
2. Trng hp l nguyn liu c nhiu bao gi:
Ty theo mc ch ca ly mu kim tra, mc ng nht v cht lng ca l thuc m chn
phng n ly mu thch hp theo quy nh ti iu 16 ca Thng t ny.
iu 12. Ly mu bn thnh phm cha ng gi:
Cc sn phm loi ny l thuc bt, thuc nc, xiro thuc, thuc m, thuc cm, thuc vin,
thuc tim... cha trong cc bao gi ln chuyn n c s ng gi l. Mi l sn xut c
ly mu theo cch sau:
1. Nu l sn phm ch c 1-2 bao gi, th m c hai bao gi. Nu l sn phm c t 3 bao gi
tr ln th m ba bao gi. Ly t nht 03 mu ban u cc v tr khc nhau ca mi bao gi.
2. Trn cc mu ban u li thnh mu chung ri to mu cui cng gm mu phn tch v mu
lu.
iu 14. Ly mu thuc thnh phm
1. Ly mu thuc thnh phm kim tra hoc gim st cht lng:
a) Vic ly mu theo nguyn tc ly mu ngu nhin v phi ly mu nhng v tr khc nhau
ca l hng.
b) Cn c tiu chun cht lng thuc, s lng thuc c ly sao cho th nghim v lu
mu. Trng hp khng c thng tin tnh ton chnh xc s lng thuc cn ly, tham
kho s lng thuc thnh phm ti thiu cn ly theo quy nh ti Ph lc 5 ca Thng t ny.
c) Trnh t ly mu c thc hin trn c s hng dn ti Ph lc 3 ca Thng t ny.
2. Ly mu kim tra cm quan khi nhp thuc: S lng mu ly kim tra cm quan theo
quy nh ti Ph lc 4 ca Thng t ny.

Cu 5: Hy nu tm tt c s php l ban hnh Thng t s 09/2010/TT-BYT ngy

28/04/2010 v nhng quy nh p dng tiu chun quc t v Dc in nc ngoi?
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 Lut Dc ngy 14/6/2005;
Cn c Lut Tiu chun v Quy chun k thut ngy 29/6/2006;
Cn c Lut Cht lng sn phm, hng ha ngy 21/11/2007;
Cn c Ngh nh s 79/2006/N-CP ngy 09/8/2006 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Dc;
Cn c Ngh nh s 127/2007/N-CP ngy 01/8/2007 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Tiu chun v Quy chun k thut;
Cn c Ngh nh s 132/2008/N-CP ngy 31/12/2008 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Cht lng sn phm, hng ha;
bo m cht lng thuc trong sn xut, nhp khu, lu hnh v s dng, bo m
tun th cc quy nh ti Lut Dc, Lut Tiu chun v Quy chun k thut, Lut Cht lng
sn phm, hng ha v cc vn bn quy phm php lut c lin quan i vi cht lng thuc,
ph hp vi thng l quc t, p ng yu cu hi nhp quc t v dc, B Y t hng dn vic
qun l cht lng thuc trong qu trnh sn xut, nhp khu, lu hnh v s dng ti Vit Nam.
iu 5. Tiu chun cht lng v thuc
5. Quy nh v vic p dng tiu chun quc t, dc in nc ngoi:
a) C s kinh doanh thuc ti Vit Nam c php p dng trc tip cc dc in c s dng
thng dng trong thng mi dc phm quc t: Chu u, Anh, Hoa K, Quc t, Nht Bn.
Vic p dng phi bao gm ton b cc quy nh v tiu ch cht lng, mc cht lng v
phng php th quy nh ti dc in ;
b) Trng hp c s kinh doanh thuc p dng cc dc in khc cc dc in nu im a,
khon ny hoc tiu chun c s th tiu chun cht lng p dng ti thiu phi p ng cc yu
cu v ch tiu cht lng v mc cht lng c quy nh ti chuyn lun tiu chun cht
lng tng ng ca Dc in Vit Nam hoc ca cc dc in thng dng quy nh ti im
a, khon 5 ca iu ny;
c) Trng hp cc dc in thng dng quy nh ti im a, khon 5 ca iu ny khng c
chuyn lun tiu chun cht lng thuc tng ng, c s kinh doanh thuc c th p dng dc
in khc hoc tiu chun c s, nhng phi c nh gi theo quy nh v c B Y t xt
duyt;
d) Cc c s kinh doanh thuc phi kp thi cp nht tiu chun cht lng thuc p ng cc
quy nh ti cc phin bn mi nht ca cc dc in.

Cu 6: Hy trnh by quy nh p dng tiu chun quc t v Dc in nc ngoi v quy

nh p dng Dc in Vit Nam trong thng t 09/2010/TT-BYT ngy 28/4/2010?
5. Quy nh v vic p dng tiu chun quc t, dc in nc ngoi:
a) C s kinh doanh thuc ti Vit Nam c php p dng trc tip cc dc in c s dng
thng dng trong thng mi dc phm quc t: Chu u, Anh, Hoa K, Quc t, Nht Bn.
Vic p dng phi bao gm ton b cc quy nh v tiu ch cht lng, mc cht lng v
phng php th quy nh ti dc in ;
b) Trng hp c s kinh doanh thuc p dng cc dc in khc cc dc in nu im a,
khon ny hoc tiu chun c s th tiu chun cht lng p dng ti thiu phi p ng cc yu
cu v ch tiu cht lng v mc cht lng c quy nh ti chuyn lun tiu chun cht
lng tng ng ca Dc in Vit Nam hoc ca cc dc in thng dng quy nh ti im
a, khon 5 ca iu ny;
c) Trng hp cc dc in thng dng quy nh ti im a, khon 5 ca iu ny khng c
chuyn lun tiu chun cht lng thuc tng ng, c s kinh doanh thuc c th p dng dc
in khc hoc tiu chun c s, nhng phi c nh gi theo quy nh v c B Y t xt
duyt;
d) Cc c s kinh doanh thuc phi kp thi cp nht tiu chun cht lng thuc p ng cc
quy nh ti cc phin bn mi nht ca cc dc in.
4. Quy nh v vic p dng Dc in Vit Nam:
a) Cc c s sn xut, pha ch thuc c th p dng Dc in Vit Nam hoc xy dng tiu
chun c s cho sn phm do mnh sn xut trn c s cc quy nh ti Dc in Vit Nam v
cc vn bn php lut lin quan;
b) Cc yu cu v ch tiu cht lng v mc cht lng c quy nh ti tng chuyn lun tiu
chun cht lng thuc ca Dc in Vit Nam l yu cu bt buc p dng. B Y t khuyn
khch cc c s p dng cc phng php th ghi trong tng chuyn lun tiu chun cht lng
thuc quy nh ti Dc in Vit Nam;
c) Cc yu cu v ch tiu cht lng, mc cht lng v phng php th chung c quy nh
ti cc Ph lc ca Dc in Vit Nam l yu cu bt buc p dng. Mi s sai khc phi c
chng minh, i chiu bo m ti thiu phi tng ng vi quy nh ti Dc in Vit Nam;
d) Tiu chun c s ca thuc ti thiu phi p ng cc yu cu v ch tiu cht lng v mc
cht lng c quy nh ti chuyn lun tiu chun cht lng thuc tng ng ca Dc in
Vit Nam;
) Cc c s sn xut, pha ch thuc phi cp nht tiu chun cht lng thuc do mnh sn xut,
pha ch ph hp vi phin bn mi nht c hiu lc ca Dc in Vit Nam.

Cu 7: Hy nu tm tt c s php l ban hnh Thng t s 09/2010/TT-BYT ngy

28/04/2010 v nhng quy nh p dng Dc in Vit Nam?

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 Lut Dc ngy 14/6/2005;
Cn c Lut Tiu chun v Quy chun k thut ngy 29/6/2006;
Cn c Lut Cht lng sn phm, hng ha ngy 21/11/2007;
Cn c Ngh nh s 79/2006/N-CP ngy 09/8/2006 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Dc;
Cn c Ngh nh s 127/2007/N-CP ngy 01/8/2007 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Tiu chun v Quy chun k thut;
Cn c Ngh nh s 132/2008/N-CP ngy 31/12/2008 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Cht lng sn phm, hng ha;
bo m cht lng thuc trong sn xut, nhp khu, lu hnh v s dng, bo m
tun th cc quy nh ti Lut Dc, Lut Tiu chun v Quy chun k thut, Lut Cht lng
sn phm, hng ha v cc vn bn quy phm php lut c lin quan i vi cht lng thuc,
ph hp vi thng l quc t, p ng yu cu hi nhp quc t v dc, B Y t hng dn vic
qun l cht lng thuc trong qu trnh sn xut, nhp khu, lu hnh v s dng ti Vit Nam.
4. Quy nh v vic p dng Dc in Vit Nam:
a) Cc c s sn xut, pha ch thuc c th p dng Dc in Vit Nam hoc xy dng tiu
chun c s cho sn phm do mnh sn xut trn c s cc quy nh ti Dc in Vit Nam v
cc vn bn php lut lin quan;
b) Cc yu cu v ch tiu cht lng v mc cht lng c quy nh ti tng chuyn lun tiu
chun cht lng thuc ca Dc in Vit Nam l yu cu bt buc p dng. B Y t khuyn
khch cc c s p dng cc phng php th ghi trong tng chuyn lun tiu chun cht lng
thuc quy nh ti Dc in Vit Nam;
c) Cc yu cu v ch tiu cht lng, mc cht lng v phng php th chung c quy nh
ti cc Ph lc ca Dc in Vit Nam l yu cu bt buc p dng. Mi s sai khc phi c
chng minh, i chiu bo m ti thiu phi tng ng vi quy nh ti Dc in Vit Nam;
d) Tiu chun c s ca thuc ti thiu phi p ng cc yu cu v ch tiu cht lng v mc
cht lng c quy nh ti chuyn lun tiu chun cht lng thuc tng ng ca Dc in
Vit Nam;
) Cc c s sn xut, pha ch thuc phi cp nht tiu chun cht lng thuc do mnh sn xut,
pha ch ph hp vi phin bn mi nht c hiu lc ca Dc in Vit Nam.

Cu 8: Hy nu tm tt c s php l ban hnh Thng t s 09/2010/TT-BYT ngy

28/04/2010 v iu kin bo m cht lng thuc ti c s?
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 Lut Dc ngy 14/6/2005;

Cn c Lut Tiu chun v Quy chun k thut ngy 29/6/2006;
Cn c Lut Cht lng sn phm, hng ha ngy 21/11/2007;
Cn c Ngh nh s 79/2006/N-CP ngy 09/8/2006 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Dc;
Cn c Ngh nh s 127/2007/N-CP ngy 01/8/2007 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Tiu chun v Quy chun k thut;
Cn c Ngh nh s 132/2008/N-CP ngy 31/12/2008 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Cht lng sn phm, hng ha;
bo m cht lng thuc trong sn xut, nhp khu, lu hnh v s dng, bo m
tun th cc quy nh ti Lut Dc, Lut Tiu chun v Quy chun k thut, Lut Cht lng
sn phm, hng ha v cc vn bn quy phm php lut c lin quan i vi cht lng thuc,
ph hp vi thng l quc t, p ng yu cu hi nhp quc t v dc, B Y t hng dn vic
qun l cht lng thuc trong qu trnh sn xut, nhp khu, lu hnh v s dng ti Vit Nam.
iu 9. iu kin bo m cht lng thuc ti c s sn xut, pha ch
C s sn xut, pha ch thuc phi thc hin cc yu cu v qun l cht lng thuc trong sn
xut nh sau:
1. p dng cc nguyn tc, tiu chun Thc hnh tt trong sn xut, phn phi, bo
qun, kim nghim thuc v/hoc cc h thng qun l thch hp khc nhm bo m cht lng
sn phm do mnh sn xut ph hp vi tiu chun cht lng thuc ng k v c B Y t
chp nhn (i vi thuc lu hnh) hoc cng b (i vi thuc pha ch s dng).
2. ng k thuc theo quy nh ti Lut Dc, cc quy nh php lut lin quan v ghi
nhn theo quy nh ca php lut v nhn hng ho.
3. Tun th cc quy chun k thut lin quan n qu trnh sn xut, pha ch, kim tra
cht lng, bo qun, tiu chun cht lng v cc quy nh khc c lin quan.
4. Chu s kim tra ca c quan qun l, c quan kim tra cht lng nh nc v thuc
theo cc ni dung kim tra ti iu 24 ca Thng t ny.
iu 10. iu kin bo m cht lng thuc ti cc c s xut khu, nhp khu, bn
bun, bn l, tn tr bo qun, vn chuyn, s dng thuc
C s xut khu, nhp khu, bn bun, bn l, tn tr bo qun, vn chuyn thuc phi
thc hin cc yu cu v qun l cht lng sau y:
1. p dng cc nguyn tc, tiu chun Thc hnh tt trong bo qun, phn phi thuc
v cc bin php thch hp khc nhm duy tr cht lng ca thuc ph hp vi tiu chun cht
lng thuc ng k v c B Y t chp nhn n ngi s dng:
a) Tuyn dng, o to b tr nhn lc c nng lc chuyn mn theo quy nh;
b) Trang b cc phng tin bo qun, vn chuyn thuc bo m iu kin bo qun
theo yu cu trong qu trnh bo qun, vn chuyn thuc;
c) Trin khai, duy tr ch h s, s sch theo di vic lu thng ca thuc do c s
kinh doanh.
i vi thuc nhp khu, ngoi vic tun th cc quy nh nu trn, c s nhp khu
thuc phi tun th y cc quy nh lin quan n bo m cht lng thuc theo quy nh
v nhp khu thuc.

2. Chu s kim tra cht lng thuc ca c quan qun l, c quan kim tra cht lng
nh nc v thuc theo ni dung kim tra ti iu 24 ca Thng t ny.

Cu 9: Hy nu tm tt c s php l ban hnh Thng t s 09/2010/TT-BYT ngy

28/04/2010 v ni dung kim tra cht lng thuc ti c s kinh doanh thuc?
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 Lut Dc ngy 14/6/2005;

Cn c Lut Tiu chun v Quy chun k thut ngy 29/6/2006;
Cn c Lut Cht lng sn phm, hng ha ngy 21/11/2007;
Cn c Ngh nh s 79/2006/N-CP ngy 09/8/2006 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Dc;
Cn c Ngh nh s 127/2007/N-CP ngy 01/8/2007 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Tiu chun v Quy chun k thut;
Cn c Ngh nh s 132/2008/N-CP ngy 31/12/2008 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Cht lng sn phm, hng ha;
bo m cht lng thuc trong sn xut, nhp khu, lu hnh v s dng, bo m
tun th cc quy nh ti Lut Dc, Lut Tiu chun v Quy chun k thut, Lut Cht lng
sn phm, hng ha v cc vn bn quy phm php lut c lin quan i vi cht lng thuc,
ph hp vi thng l quc t, p ng yu cu hi nhp quc t v dc, B Y t hng dn vic
qun l cht lng thuc trong qu trnh sn xut, nhp khu, lu hnh v s dng ti Vit Nam
iu 11. Kim tra cht lng thuc ti c s kinh doanh thuc
1. Tt c cc thuc (k c nguyn liu, bao b) u phi c kim tra cht lng; ch khi
t tiu chun cht lng v ph hp vi cc quy nh c lin quan ca php lut mi c a
vo sn xut, pha ch v lu hnh.
2. Ngi ng u v ngi ph trch chuyn mn ca c s kinh doanh, pha ch, s
dng thuc phi chu trch nhim v cng tc qun l cht lng v kim tra cht lng thuc ti
c s v chu trch nhim v cht lng thuc do c s kinh doanh, pha ch s dng.
3. Cc c s kinh doanh, pha ch, s dng thuc c trch nhim t chc v thc hin
cng tc kim tra, kim sot cht lng thuc ti c s.
4. Cc c s sn xut, pha ch thuc phi t chc cng tc kim nghim vi phng tin
k thut v cn b chuyn mn ph hp kim nghim, xc nh, nh gi c cht lng
thuc trong qu trnh sn xut, xut xng.
5. Khuyn khch cc c s xut khu, nhp khu, bun bn, tn tr, s dng, ty thuc
vo phm vi hot ng, t chc cng tc kim nghim thuc nhm bo m theo di c cht
lng thuc do mnh kinh doanh.
6. C s kinh doanh thuc (c s ng k thuc, c s nhp khu thuc) c trch nhim
cung cp bn tiu chun cht lng thuc c B Y t chp nhn ti cc c quan kim tra
cht lng thuc a phng c thuc lu hnh khi c yu cu.

Cu 10: Hy nu tm tt c s php l ban hnh Thng t s 09/2010/TT-BYT ngy

28/04/2010 v trnh by quy nh v p dng tiu chun cht lng thuc trong kim nghim
thuc v quy nh lu mu thuc sau khi kim tra cht lng?
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 Lut Dc ngy 14/6/2005;

Cn c Lut Tiu chun v Quy chun k thut ngy 29/6/2006;

Cn c Lut Cht lng sn phm, hng ha ngy 21/11/2007;
Cn c Ngh nh s 79/2006/N-CP ngy 09/8/2006 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Dc;
Cn c Ngh nh s 127/2007/N-CP ngy 01/8/2007 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Tiu chun v Quy chun k thut;
Cn c Ngh nh s 132/2008/N-CP ngy 31/12/2008 ca Chnh ph quy nh chi tit thi hnh
mt s iu ca Lut Cht lng sn phm, hng ha;
bo m cht lng thuc trong sn xut, nhp khu, lu hnh v s dng, bo m
tun th cc quy nh ti Lut Dc, Lut Tiu chun v Quy chun k thut, Lut Cht lng
sn phm, hng ha v cc vn bn quy phm php lut c lin quan i vi cht lng thuc,
ph hp vi thng l quc t, p ng yu cu hi nhp quc t v dc, B Y t hng dn vic
qun l cht lng thuc trong qu trnh sn xut, nhp khu, lu hnh v s dng ti Vit Nam
iu 21. Quy nh v p dng tiu chun cht lng trong kim nghim thuc
1. Vic kim nghim thuc phi tin hnh theo ng tiu chun cht lng thuc ca c s sn
xut, c s nhp khu ng k, xin php lu hnh v c B Y t (Cc Qun l dc) chp
nhn.
Trng hp p dng phng php khc khng theo phng php trong tiu chun ng k th
phi c s chp thun ca B Y t. B Y t giao cho Vin Kim nghim thuc Trung ng,
Vin Kim nghim thuc Thnh ph H Ch Minh thm nh v quyt nh chp nhn phng
php p dng.
2. Trng hp c nghi ng v thnh phn hoc cht lng thuc, c s kim nghim ca Nh
nc v thuc c p dng cc phng php khc vi cc phng php trong tiu chun
ng k kim tra v a ra kt qu kim nghim cht lng thuc.
3. Ngi ng u cc c s kim nghim thuc phi chu trch nhim v kt qu kim nghim
thuc ca c s mnh trc php lut
iu 22. Qui nh vic ly mu thuc kim tra cht lng, tr li kt qu kim nghim,
lu mu v h s ti liu lin quan
3. Lu mu thuc:
a) Cc thuc sau khi kim tra cht lng v c kt lun cht lng phi c lu mu. Mu
thuc lu phi c nim phong v bo qun trong iu kin ph hp ghi trn nhn.
b) Thi gian lu mu:
- i vi cc c s sn xut, xut khu, nhp khu thuc, mu thuc thnh phm phi c lu t
nht 12 thng sau khi ht hn dng ca thuc;
- i vi nguyn liu l hot cht dng cho sn xut thuc, c s sn xut phi lu mu nguyn
liu t nht 12 thng sau khi ht hn dng ca thnh phm sn xut t nguyn liu ;
- i vi cc c quan kim nghim thuc, thi gian lu mu khng c di hai nm (24
thng), k t ngy ly mu hoc c s gi mu ti;
- i vi c quan nhn mu dng ng k thuc, sau khi thuc c cp s ng k phi lu
mu khng di 06 thng k t ngy cp s ng k.

Cu 11: Hy trnh by v phn tch v s ly mu nguyn liu ban u v vt liu bao gi

xc nh cht lng theo Thng t s 04/2010/TT-BYT ngy 12/02/2010?
iu 16. S ly mu nguyn liu ban u v vt liu bao gi
1. Trc khi thc hin vic ly mu, ngi ly mu phi kim tra tnh nguyn vn, mc h
hng ca thng ng, s ng u ca sn phm bn trong ca mi n v ly mu.
2. Vic ly mu c th c thc hin theo mt trong ba s ly mu ghi ti Bng 1 di y.
Bng 1: Cc gi tr n, p hoc r cho N n v bao gi*

Gi tr n, p, r

Gi tr N
S n
Ti 3
4-6
7 13
14 20
21 30
31 42
43 56
57 72
73 - 90

S p
Ti 25
25 56
57 100
101 156
157 - 225

S r
Ti 2
34
57
8 11
12 16
17 22
23 28
29 36
37 - 44

2
3
4
5
6
7
8
9
10
a) S n
S dng S n trong trng hp l nguyn liu cn ly mu c coi l ng nht v
c cung cp t mt ngun xc nh. C th ly mu t bt k phn no trong thng nguyn
liu (thng t lp trn cng). S n da trn cng thc n = 1 +N , vi N l s n v
bao gi ca l hng. S n v ly mu ti thiu n c c bng cch lm trn n gin. T n
n v ly mu c chn ngu nhin, ly ra cc mu ban u, ng trong cc ng mu
ring bit. Nu cc mu ban u ly c khng c nghi ng g v cm quan v nh tnh, cc
mu ban u c trn u thnh mu ring, mu chung chia thnh mu phn tch v mu lu
theo trnh t chung.
b) S p
S dng s p trong trng hp l nguyn liu c xem l ng nht, t mt ngun
xc nh v mc ch chnh l kim tra nh tnh. S p da vo cng thc p = 0,4^N
,vi N l s n v bao gi ca l hng. Gi tr p c c bng cch lm trn ln n s nguyn
ln nht tip theo. Cc mu ban u c ly t mi trong s N n v bao gi ca l hng v
c ng trong cc ng mu ring bit. Cc mu ban u ny c kim tra v cm quan,
nh tnh. Nu kt qu ph hp, p mu chung c to thnh bng cch trn ln thch hp cc
mu ban u lu hoc phn tch (nu cn thit).
c) S r
S dng s r khi l nguyn liu b nghi ng l khng ng nht v/hoc tip nhn t
ngun khng xc nh, dc liu hay cc nguyn liu ban u l dc liu c ch bin mt
phn. S ny da trn cng thc r = 1,5 ^N ,vi N l s n v bao gi ca l sn phm. Gi
tr r thu c bng cch lm trn ti s nguyn ln nht tip theo.
Cc mu ban u c ly t mi trong s N n v bao gi v c ng trong cc
ng mu ring bit. Cc mu ban u ny c kim tra cm quan v nh tnh. Nu kt qu
ph hp, la chn ngu nhin r mu thc hin kim nghim ring r. Nu kt qu kim
nghim ng nht, cc mu lu c th c gp li thnh 01 mu lu.
3. Ly mu nguyn liu ban u nh tnh i vi cc c s sn xut khng p dng cc s
trn m theo nguyn tc Thc hnh tt sn xut thuc theo khuyn co ca T chc y t th
gii (GMP-WHO).

Cu 12: Hy trnh by v phn tch v thao tc ly mu xc nh cht lng theo Thng t

s 04/2010/TT-BYT ngy 12/02/2010?
iu 10. Thao tc ly mu:
1. Nguyn tc ly mu:
- Ty theo mc ch kim tra v theo tng loi sn phm, ngi ly mu quyt nh la
chn phng php ly mu thch hp.
- Qu trnh ly mu phi c gim st v c ghi chp li y . Tt c cc du hiu
khng ng nht, h hng ca thuc v bao b bo qun u phi c ghi chp li.

- Quy trnh ly mu phi m bo sao cho c th kp thi pht hin tnh khng ng nht
ca thuc trong tng n v ly mu v ca c l thuc. Cc du hiu khng ng nht bao gm
s khc nhau v hnh dng, kch thc, hoc mu sc ca cc tiu phn cht rn dng kt tinh,
dng ht hoc dng bt; lp v m ca cc cht ht c tnh ht m; s lng ng cc dc cht
dng rn trong thuc dng cht lng hoc bn rn; s tch lp ca thuc dng cht lng.
- Khng trn ln, phi hp cc mu c ly t cc phn c du hiu khc nhau, t cc
bao b c nghi ng cht lng ca l thuc, v s trn ln ny lm che khut cc du hiu tp
nhim, hm lng thp hoc cc vn cht lng khc. Phi to thnh mu ring bit t cc
phn, cc bao b ny.
- i vi thnh phm thuc, quy trnh ly mu cn tnh n cc php th chnh thc v
php th b sung i vi tng dng thuc (v d: thuc vin nn, hoc thuc tim truyn...). Cc
php th b sung bao gm cc php th xc nh thuc gi mo, thuc b pha trn, thuc
thm cc cht khng c php.
- Khng nn trn li thuc ly ra khi bao b trc tip vi thuc cn trong bao b.
2. Trnh t ly mu
- Kim tra tnh trng vt l ca l hng: phn tch theo tng loi sn phm v tng l sn
xut, mi l li tch ring cc thng hng c du hiu b h hi, khng m bo v sinh kim
tra, ly mu ring. Loi b cc n v bao gi khng c nhn.
- T l sn phm ly ra cc n v ly mu, m cc bao gi ly cc mu ban u v
lm kn ngay li cc bao gi c ly mu. S lng nguyn liu trong mu ban u c
tnh ton chun b mu tip sau.
- Trn u cc mu ban u thnh nhng mu ring ca tng n v ly mu.
- Trn u cc mu ring thnh mt mu chung.
- To mu cui cng: T mu chung ly ra cc phn bng nhau to thnh mu cui cng gm
mu phn tch v mu lu.
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 thuc, tn nh sn xut, k hiu l sn xut, hn dng, s thng
ly mu, ni ly mu, s lng mu ly (nu mu ly l nguyn liu thuc gy nghin,
hng thn, tin cht dng lm thuc v nguyn liu thuc phng x s lng cn phi ghi bng
ch), ngy ly mu, cc iu kin bo qun ph hp vi bin bn ly mu.
4. Sau khi ly mu xong, cc thnh vin tham gia ly mu phi nim phong mu m
bo mu c an ton trong qu trnh vn chuyn t ni ly mu n ni giao mu. Trn nim
phong ca mu phi ghi r ngy thng ly mu v c t nht ch k ca ngi ly mu v i
din c s c ly mu.
Trong trng hp cn thit, phn cn li sau khi ly mu cng phi nim phong
phng s tro thuc.
5. Lp bin bn ly mu: bin bn ly mu phi ghi r s l, ngy ly mu, a im ly
mu, cc iu kin bo qun, ghi chp v bt c nhn xt no khc lin quan v nhng bt
thng ca qu trnh ly mu, c t nht tn v ch k ca ngi ly mu v i din c s c
ly mu.
Trong trng hp on kim tra cht lng tin hnh ly mu th phi c thm ch k
ca Trng on kim tra.

Trong trng hp i din c s c ly mu khng k bin bn, th bin bn c ch k

ca ngi ly mu v ngi chng kin.
Bin bn ny lm thnh t nht ba bn: mt bn lu ti c s c ly mu, mt bn lu
c quan kim nghim, mt bn lu ti c quan qun l, kim tra cht lng thuc. (Tham kho
Ph lc 1).
6.Trnh t c th tin hnh cc bc ly mu tham kho Ph Lc 3.

Cu 13: Hy gii thch cc thut ng chnh trong Thng t s 09/2010/TT-BYT ngy

28/04/2010 hng dn vic qun l cht lng thuc?
iu 3. Gii thch t ng
Trong Thng t ny, mt s t ng di y c hiu nh sau:
1. Thuc l cht hoc hn hp cc cht dng cho ngi nhm mc ch phng bnh, cha bnh,
chn on bnh hoc iu chnh chc nng sinh l c th bao gm thuc thnh phm, nguyn
liu lm thuc, vc xin, sinh phm y t, tr thc phm chc nng.
2. Vc xin l ch phm cha khng nguyn to cho c th kh nng p ng min dch, c
dng vi mc ch phng bnh.

3. Sinh phm y t l sn phm c ngun gc sinh hc c dng phng bnh, cha bnh v
chn on bnh cho ngi.
4. Nguyn liu lm thuc l cht tham gia vo thnh phn cu to sn phm trong qu trnh sn
xut thuc.
5. Dc cht (cn gi l hot cht) l cht hoc hn hp cc cht c hot tnh iu tr c s
dng trong sn xut thuc.
6. Thuc thnh phm l dng thuc qua tt c cc giai on sn xut, k c ng gi trong bao
b cui cng v dn nhn.
7. Tiu chun cht lng thuc bao gm cc quy nh v ch tiu, yu cu k thut, phng php
kim nghim, bao gi, ghi nhn, vn chuyn, bo qun v cc yu cu khc c lin quan n cht
lng thuc.
Tiu chun cht lng thuc c th hin di hnh thc vn bn k thut.
8. Quy chun k thut thuc l quy nh v mc gii hn ca c tnh k thut v yu cu qun
l m thuc, cc hot ng lin quan n thuc nh sn xut, kim nghim, bo qun, vn
chuyn phi tun th bo m cht lng v hiu qu ca thuc, an ton, v sinh, sc kho
con ngi; bo v ng vt, thc vt, mi trng; bo v li ch v an ninh quc gia, quyn li
ca ngi tiu dng v cc yu cu thit yu khc.
Quy chun k thut thuc do B trng B Y t ban hnh di dng vn bn bt buc p
dng.
9. Hn dng thuc l thi gian s dng c n nh cho mt l thuc m sau thi hn ny thuc
khng c php s dng.
Hn dng thuc thng c ghi bng s hoc bng ch trn nhn thuc.
10. L l mt lng xc nh nguyn liu ban u, nguyn liu bao gi, hoc sn phm c ch
bin trong mt quy trnh n l hoc mt lot cc quy trnh v c cht lng ng nht.
S l sn xut l k hiu bng s hoc bng ch, hoc kt hp c s v ch nhm nhn bit l
thuc v cho php truy xt ton b lai lch ca mt l thuc bao gm tt c cc cng on ca
qu trnh sn xut, kim tra cht lng v phn phi l thuc .
11. Thuc t cht lng l thuc t tiu chun cht lng ng k theo tiu chun dc
in hoc tiu chun c s ca nh sn xut.
12. Thuc km cht lng l thuc khng t tiu chun cht lng ng k vi c quan c
thm quyn.
13. Thuc gi l sn phm c sn xut di dng thuc vi la o, thuc mt trong
nhng trng hp sau y:
a) Khng c dc cht;
b) C dc cht nhng khng ng hm lng ng k;
c) C dc cht khc vi dc cht ghi trn nhn;
d) Mo tn, kiu dng cng nghip ca thuc ng k bo h s hu cng nghip ca c s
sn xut khc.
14. Thc hnh tt l nhng b nguyn tc, tiu chun v sn xut, bo qun, kim nghim, lu
thng thuc; nui trng, thu hoch v ch bin dc liu do B Y t ban hnh.
15. Kim nghim thuc l vic ly mu, xem xt tiu chun k thut, tin hnh cc th nghim
tng ng v cn thit nhm xc nh nguyn liu, bn thnh phm, thnh phm c p ng tiu
chun cht lng khng quyt nh vic chp nhn hay loi b thuc .

Cu 14: Hy trnh by ni dung kim tra cht lng thuc ca c quan kim tra cht lng
thuc c quy nh trong Thng t s 09/2010/TT-BYT ngy 28/04/2010 ?
iu 25. Ni dung kim tra cht lng ca c quan kim tra cht lng thuc
1. Kim tra cht lng thuc trong sn xut, pha ch:
a) Kim tra vic p dng cc nguyn tc, tiu chun Thc hnh tt trong sn xut, kim
nghim, bo qun thuc v cc quy nh ca php lut c lin quan;
- Kim tra vic chun b sn xut: cht lng v ngun gc nguyn liu, ph liu, vt
liu, bao b ng gi trc khi a vo sn xut;
- Kim tra cc iu kin sn xut, kim nghim v vic thc hin qui trnh cng ngh sn
xut v cc quy trnh kim nghim, v sinh nh xng, my mc v v sinh c nhn;

- Kim nghim bn thnh phm, sn phm ch ng gi v thnh phm;

- Kim tra sn phm trc khi nhp kho, xut xng;
- Kim tra vic chp hnh cc quy nh v xut nhp, bo qun, tn tr, cp pht, bo
m cht lng thuc.
b) Kim tra vic thc hin ng k thuc, nghin cu n nh, nghin cu pht trin
sn phm, ghi nhn thuc theo quy nh.
c) Tin hnh ly mu v thc hin kim nghim mu thuc theo tiu chun cht lng
ng k hoc tiu chun c s p dng (i vi thuc pha ch theo n hoc thuc pha ch s
dng trong bnh vin) v theo cc quy nh khc c lin quan.
2. Kim tra cht lng thuc xut khu, nhp khu, lu thng phn phi trn th trng:
a) Kim tra vic tun th cc nguyn tc, tiu chun Thc hnh tt trong phn phi, tn
tr v bo qun thuc, cc iu kin bo m cht lng thuc v cc quy nh lin quan n
iu kin bo qun, vn chuyn, lu thng phn phi thuc. Kim tra vic quy nh v trin khai
cc quy nh v kim tra, kim sot ngun gc, cht lng thuc trong qu trnh nhp kho, bo
qun, vn chuyn v xut kho;
b) Kim tra v s ng k thuc hoc giy php nhp khu thuc v s tun th v vic
ghi nhn thuc, hng dn s dng thuc;
c) Kim tra vic tun th cc thng bo thu hi thuc ca c quan kim tra cht lng v
ca c s sn xut, nhp khu, y thc nhp khu, bn bun;
d) Tin hnh ly mu phn tch, kim nghim xc nh cht lng thuc v thc hin
vic kim nghim mu thuc theo tiu chun cht lng ca thuc trong h s ng k thuc/h
s nhp khu thuc khng c s ng k c B Y t chp nhn.

Cu 15: Hy phn tch nhng ni dung c bn quy nh v nh ch lu hnh,thu hi thuc

v x l thuc vi phm cht lng trong Thng t s 09/2010/TT-BYT ngy 28/04/2010 ?
iu 13. Cc trng hp thuc b nh ch lu hnh, thu hi
1. Thuc b nh ch lu hnh, thu hi trong cc trng hp sau:
a) Thuc khng ng chng loi do c s nhm ln trong qu trnh cp pht, giao nhn;
b) Thuc khng t tiu chun cht lng ng k;
c) Thuc khng p ng y cc yu cu v ghi nhn hng ho ca thuc theo quy nh ti
iu 37 ca Lut Dc v cc quy nh khc ca php lut c lin quan;
d) Thuc c vt liu bao b v dng ng gi khng p ng yu cu bo m cht lng thuc;
) Thuc khng c s ng k hoc cha c php nhp khu;

e) Thuc c thng bo thu hi ca c s sn xut, c quan qun l, c quan kim tra cht lng
nh nc v thuc ca Vit Nam hoc nc ngoi:
- Thuc gi, thuc nhp lu, thuc khng r ngun gc, xut x;
- Thuc sn xut, nhp khu khng ng h s ng k hoc giy php nhp khu;
- Thuc c cha cc cht b cm s dng trong sn xut, hoc cha cc cht c hm lng, nng
vt qu gii hn hm lng, nng cho php;
- Thuc thnh phm sn xut t nguyn liu khng t tiu chun cht lng hoc nguyn liu
khng c ngun gc hp php (nhp lu, c s sn xut nguyn liu cha c giy chng nhn
iu kin kinh doanh dc hoc nguyn liu khng phi mc ch dng cho ngi hoc nguyn
liu cha c giy php s dng cho ngi);
- Thuc sn xut ti cc c s cha c cp giy chng nhn iu kin kinh doanh hoc
khng p ng iu kin sn xut (khng p ng cc nguyn tc tiu chun Thc hnh tt sn
xut thuc hoc cc quy nh khc v iu kin kinh doanh dc);
- Vc xin c bo qun khng ng theo iu kin bo qun yu cu;
- Thuc ht hn s dng;
g) Cc trng hp t nguyn thu hi ca c s kinh doanh thuc hoc theo quyt nh ca c
quan qun l, c quan kim tra cht lng nh nc v thuc.
2. Hnh thc thu hi:
a) Thu hi t nguyn: c s kinh doanh t pht hin, thu hi thuc khng p ng quy nh.
Khi pht hin thuc ca c s km cht lng, c nhm ln hoc s c, ngi ng u cc c
s kinh doanh thuc phi bo co ngay cho c quan qun l dc (Cc Qun l dc, S Y t
cc tnh, thnh ph trc thuc Trung ng) v nguyn nhn, mc vi phm, nh gi mc nguy
hi v d kin mc thu hi. Sau khi c kin ca C quan qun l, c s phi c thng bo
thu hi ti cc ni c thuc lu hnh v tin hnh hot ng thu hi nhm bo m thu hi ht
thuc trn th trng; ng thi theo di, gii quyt cc hu qu do thuc vi phm gy ra.
b) Thu hi bt buc:
Khi c quan qun l, kim tra nh nc v dc c thm quyn yu cu, c s kinh
doanh (ngi s hu giy php lu hnh, c s sn xut, xut nhp khu, y thc nhp khu)
phi tin hnh thu hi ngay cc thuc xc nh l c vi phm hoc nghi ng c vi phm nh
hng nghim trng n sc khe ca ngi s dng v ca cng ng.
3. Quy nh v cc mc vi phm:
a) Cn c phn loi mc vi phm: Cc mc vi phm cht lng c phn loi trn c s nh
gi mc nghim trng ca vi phm, nguy c nh hng ti hiu qu iu tr, s an ton ca
ngi s dng v phn ng khng mong mun ca thuc.
b) Phn loi cc mc vi phm:
- Mc 1: Vi phm gy nguy him c th nh hng n tnh mng ca ngi dng thuc, tn
thng nghim trng hoc gy cht ngi.
- Mc 2: Vi phm c th nh hng ti hiu qu iu tr v an ton khi s dng.
- Mc 3: Vi phm khng nh hng hoc t nh hng ti hiu qu iu tr v an ton khi
s dng.
4. Mc thng bo nh ch lu hnh v thc hin thu hi thuc
a) Mc 1: c thc hin i vi cc vi phm mc 1. Thng bo nh ch lu hnh thuc
c gi khn cp ti ngi s hu giy php lu hnh, c s sn xut, xut nhp khu, bn

bun, bn l, khoa dc ca c s s dng thuc, ng thi thng bo trn cc phng tin

thng tin i chng tt c cc c s kinh doanh, s dng v ngi s dng thuc bit. C s
kinh doanh c thuc vi phm phi khn cp thc hin cc bin php nhm thu hi trit thuc
vi phm trong thi gian ngn nht nhm hn ch hu qu xu xy ra.
b) Mc 2: c thc hin i vi cc vi phm mc 2, thng bo nh ch lu hnh c
gi n ngi s hu giy php lu hnh, c s sn xut, xut nhp khu, bn bun, bn l.
c) Mc 3: c thc hin i vi cc vi phm mc 3, thng bo nh ch lu hnh c
gi n c s sn xut, nhp khu, y thc nhp khu v c s bn bun.
d) Vic nh ch lu hnh v thu hi thuc c th c thc hin i vi mt l hoc mt s l
thuc xc nh hoc mt sn phm hoc ton b cc sn phm ca mt hoc nhiu c s sn xut
thuc.
5. Thm quyn thng bo thu hi
a) Cc Qun l dc ra thng bo nh ch lu hnh v thu hi thuc trong phm vi ton quc.
Thng bo c gi n S Y t cc tnh, thnh ph trc thuc Trung ng, Y t cc ngnh v c
s sn xut, nhp khu, y thc nhp khu.
b) S Y t tnh, thnh ph trc thuc Trung ng, Y t cc ngnh:
- Ra thng bo nh ch lu hnh v thu hi trong phm vi qun l i vi nhng thuc do c
quan kim tra cht lng thuc a phng/ngnh kim tra pht hin thuc vi phm;
- Ra thng bo nh ch lu hnh v thu hi trn a bn thc hin thng bo thu hi ca Cc
Qun l dc, x l vi phm theo quy nh ca php lut v bo co v Cc Qun l dc.
c) C s sn xut, xut nhp khu, y thc nhp khu ra thng bo thu hi i vi cc trng
hp thu hi t nguyn.
6. Trch nhim thu hi thuc:
a) C s sn xut, c s xut khu, nhp khu, y thc nhp khu, c s bn bun thuc
chu trch nhim thu hi trit thuc b thu hi. Cc c s khi thu hi hoc nhn c thng
bo thu hi t c quan qun l, kim tra cht lng nh nc v thuc hoc t c s cung ng
thuc phi:
- Thng bo thu hi ti cc c s bn bun, bn l v cc ni c thuc lu hnh;
- Tin hnh thu hi khn trng v trit cc mt hng hoc cc l thuc vi phm;
- Lp h s thu hi thuc. H s thu hi thuc phi th hin y cc bng chng v vic cung
cp thuc, bng chng v vic thc hin thu hi thuc ti c s bn bun, bn l, s dng
mua thuc theo biu mu ti Ph lc 3;
- Gi bo co tin trnh thu hi, kt qu thu hi v x l cc l thuc b thu hi theo biu mu ti
Ph lc s 4 v Cc Qun l dc v cc c quan chc nng c lin quan. Thi hn bo co l
72h i vi thu hi mc 1 v 30 ngy i vi thu hi mc 2 v 3;
- Gii quyt din bin v hu qu do thuc khng t tiu chun gy ra.
b) Cc c s bn l thuc v c s s dng thuc khi nhn c thng bo thu hi (thng tin thu
hi thuc bng vn bn hoc qua cc phng tin thng tin i chng) phi khn trng thc
hin v tr li thuc b thu hi cho c s cung ng.
c) Cc c s sn xut, xut khu, nhp khu, bn bun, bn l thuc phi chu trch nhim tip
nhn thuc b thu hi tr li t cc c s kinh doanh, s dng v ngi s dng mua thuc.

d) B Y t (Cc Qun l dc, Thanh tra B Y t), S Y t cc tnh, thnh ph trc thuc Trung
ng, Y t cc ngnh kim tra, gim st cc c s kinh doanh, s dng thuc thc hin vic thu
hi thuc.
e) Cc Qun l dc c vn bn hng dn chi tit v quy trnh x l, thu hi thuc, nh gi
hiu qu thc hin thng bo thu hi thuc ca cc c s sn xut, kinh doanh thuc.
iu 14. Hy thuc (x l thuc vi phm)
1. Cc thuc km cht lng, thuc vi phm v ghi nhn, ty theo mc vi phm c th c
x l, ti ch hoc hy b. C s c thuc vi phm mun ti ch phi lm n ngh km theo
quy trnh ti ch gi Cc Qun l dc. Vic ti ch ch c thc hin sau khi c kin ng
bng vn bn ca Cc Qun l dc.
2. Cc thuc gi, thuc nhp lu, thuc khng r ngun gc, thuc ht hn dng, thuc c cha
cc cht b cm s dng, thuc sn xut t nguyn liu khng t tiu chun cht lng, thuc
sn xut trong iu kin khng p ng quy nh, mu thuc lu khi ht thi gian lu u phi
hy b. C s kinh doanh thuc c thuc vi phm phi chu trch nhim v kinh ph hy thuc.
3. Th trng c s c thuc cn hy ra quyt nh thnh lp Hi ng hy thuc. Hi ng c t
nht l 03 ngi, trong phi c cn b ph trch n v v dc s chu trch nhim chuyn
mn.
4. Vic hy thuc phi bo m an ton lu di cho ngi, sc vt v trnh nhim mi trng
theo cc qui nh ca php lut v bo v mi trng.
5. Vic hy thuc gy nghin, thuc hng tm thn, tin cht dng lm thuc, thuc phng x
phi theo ng cc quy nh v hy thuc trong hng dn cc hot ng lin quan n thuc
gy nghin; thuc hng tm thn v tin cht dng lm thuc; thuc phng x. Hy thuc xong
phi bo co km theo bin bn hy thuc ti c quan qun l trc tip theo biu mu ti Ph
lc s 5.