K bi: Cng Thng tin in t Chnh ph

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C quan: Vn phng Chnh ph
Thi gian k: 08.04.2015 08:57:49 +07:00

22

CNG BO/S 667 + 668/Ngy 20-10-2013

PHN VN BN KHC
VN BN HP NHT
CNG HA X HI CH NGHA VIT NAM
c lp - T do - Hnh phc

QUYT NH CA B TRNG B Y T
V vic trin khai p dng nguyn tc Thc hnh tt bo qun thuc
B TRNG B Y T
Quyt nh s 2701/2001/Q-BYT ngy 29 thng 6 nm 2001 ca B trng
B trng B Y t v vic trin khai p dng nguyn tc "Thc hnh tt bo qun
thuc", c hiu lc k t ngy 14 thng 7 nm 2001 c sa i, b sung bi:
Thng t s 45/2011/TT-BYT ngy 21/12/2011 Sa i, b sung mt s iu
ca Quyt nh s 1570/2000/Q-BYT ngy 22/5/2000 ca B trng B Y t v
vic trin khai p dng nguyn tc Thc hnh tt phng kim nghim thuc;
Quyt nh s 2701/2001/Q-BYT ngy 29/6/2001 ca B trng B Y t v vic
trin khai p dng nguyn tc Thc hnh tt bo qun thuc; Thng t s
06/2004/TT-BYT ngy 28/5/2004 hng dn sn xut gia cng thuc; Quyt nh
3886/2004/Q-BYT ngy 03/11/2004 ca B Y t v vic trin khai p dng
nguyn tc, tiu chun Thc hnh tt sn xut thuc theo khuyn co ca t
chc y t th gii; Thng t s 13/2009/TT-BYT ngy 01/9/2009 ca B Y t
hng dn hot ng thng tin qung co thuc; Thng t s 22/2009/TT-BYT
ngy 24/11/2009 ca B Y t quy nh v ng k thuc; Thng t s 47/2010/TTBYT ngy 29/12/2010 hng dn hot ng xut khu, nhp khu thuc v bao b
tip xc trc tip vi thuc (sau y gi tt l Thng t s 45/2011/TT-BYT), c
hiu lc k t ngy 05 thng 02 nm 2012.
Cn c Lut bo v sc khe nhn dn ngy 11/7/1989 v iu l thuc phng
bnh, cha bnh ban hnh km theo Ngh nh s 23/HBT ngy 24/01/1991 ca
Hi ng B trng (nay l Chnh ph);
Cn c Php lnh cht lng hng ha ngy 24/12/1999;
Cn c Ngh nh s 68/CP ngy 11/10/1993 ca Chnh ph quy nh chc
nng nhim v, quyn hn v t chc b my B Y t;
Cn c Ngh nh s 86/CP ngy 08/12/1995 ca Chnh ph quy nh phn
cng trch nhim qun l Nh nc v cht lng hng ha;

CNG BO/S 667 + 668/Ngy 20-10-2013

23

Xt ngh ca Cc trng Cc Qun l Dc Vit Nam,1

QUYT NH:
iu 1. Trin khai p dng nguyn tc Thc hnh tt bo qun thuc ban
hnh km theo Quyt nh ny tt c cc n v sn xut, kinh doanh, xut nhp
khu, bun bn, tn tr thuc, kinh doanh dch v kho bo qun thuc, khoa dc
bnh vin, vin nghin cu v trung tm y t.
iu 2.2 Quyt nh ny c hiu lc sau 15 ngy k t ngy k, ban hnh.
iu 3. ng Cc trng Cc Qun l dc Vit Nam chu trch nhim hng
dn, kim tra v theo di vic trin khai p dng nguyn tc Thc hnh tt bo
qun thuc.
iu 4. Cc ng, B: Chnh vn phng, Chnh thanh tra B Y t, Cc trng
Cc Qun l dc Vit Nam, Th trng cc n v trc thuc B, Gim c S Y t
cc tnh, thnh ph trc thuc Trung ng, Th trng Y t cc ngnh chu trch
nhim thi hnh Quyt nh ny./.
B Y T

XC THC VN BN HP NHT

S: 02/QHN-BYT
H Ni, ngy 04 thng 10 nm 2013
KT. B TRNG
TH TRNG

L Quang Cng
1

Thng t s 45/2011/TT-BYT c cn c ban hnh nh sau:

"Cn c Lut Dc s 34/2005-QH-11 ngy 14 thng 6 nm 2005;
Cn c Ngh nh s 188/2007/N-CP ngy 27/12/2007 ca Chnh ph quy nh
chc nng, nhim v, quyn hn v t chc b my B Y t;
B Y t hng dn vic trin khai p dng nguyn tc, tiu chun Thc hnh tt
phng kim nghim thuc, Thc hnh tt bo qun thuc, Thc hnh tt sn xut
thuc, hng dn sn xut gia cng thuc, thng tin qung co thuc, hng dn hot
ng xut khu, nhp khu thuc v bao b tip xc trc tip vi thuc, quy nh v ng
k thuc nh sau:"
2
iu 8 Thng t s 45/2011/TT-BYT, c hiu lc k t ngy 05 thng 02 nm 2012
quy nh nh sau:
"iu 8. Hiu lc thi hnh
Thng t ny c hiu lc thi hnh k t ngy 05 thng 02 nm 2012."

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CNG BO/S 667 + 668/Ngy 20-10-2013

NGUYN TC THC HNH TT BO QUN THUC

(Ban hnh km theo Quyt nh s 2701/2001/Q-BYT ngy 29/6/2001
ca B trng B Y t)
Phn I
PHN CHUNG
1. Mc ch
m bo cung cp thuc c cht lng n tay ngi s dng i hi phi
thc hin tt tt c cc giai on lin quan n sn xut, bo qun, tn tr, lu
thng phn phi thuc.
Thc hnh tt bo qun thuc (ting Anh: Good Storage Practices, vit tt:
GSP) l cc bin php c bit, ph hp cho vic bo qun v vn chuyn nguyn
liu, sn phm tt c cc giai on sn xut, bo qun, tn tr, vn chuyn v
phn phi thuc m bo cho thuc c cht lng nh khi n tay ngi
tiu dng.
Vn bn ny quy nh cc nguyn tc c bn, cc hng dn chung v Thc
hnh tt bo qun thuc. Tuy nhin, cc nguyn tc, hng dn ny c th c
iu chnh p ng cc yu cu c th ring bit, nhng vn m bo thuc c
cht lng nh.
Cc nguyn tc Thc hnh tt bo qun thuc c p dng cho cc nh sn
xut, xut khu, nhp khu, bun bn, tn tr thuc, khoa dc bnh vin, vin
nghin cu v trung tm y t.
2. Gii thch t ng
Cc t ng c s dng trong bn nguyn tc ny c hiu nh sau:
2.1. Bo qun thuc: l vic ct gi an ton cc thuc, nguyn liu, bao gm
c vic a vo s dng v duy tr y cc h thng h s ti liu ph hp, k
c cc giy bin nhn v phiu xut.
2.2. Thuc: l nhng sn phm c ngun gc t ng vt, thc vt, khong vt,
ha dc hay sinh hc c bo ch dng cho ngi, nhm:
- Phng bnh, cha bnh.
- Phc hi, iu chnh chc nng c th.
- Lm gim triu chng bnh.
- Chn on bnh.
- Phc hi hoc nng cao sc khe.

CNG BO/S 667 + 668/Ngy 20-10-2013

25

- Lm mt cm gic mt b phn hay ton thn.

- Lm nh hng qu trnh sinh sn.
- Lm thay i hnh dng c th.
2.3. Nguyn liu: l cc cht c hot tnh hay khng c hot tnh, c bin i hay
khng b bin i c s dng trong qu trnh sn xut thuc. Bao gm hot cht,
t dc, thuc th, dung mi, sn phm trung gian, bao b ng gi v nhn thuc.
2.4. Hot cht: l mt cht hoc hn hp cc cht c hot tnh dc hc c
s dng trong sn xut thuc.
2.5. T dc: l cc cht, khng phi l hot cht, c nh gi y v
an ton v c a vo h phn b thuc.
2.6. Bao b ng gi: l mi vt liu c s dng trong vic ng gi sn
phm, loi tr cng-te-n c s dng ng sn phm, chuyn ch bng cc
loi phng tin vn ti khc nhau m khng phi xp d hng ha bn trong trc
khi n ni nhn.
2.7. Bn thnh phm: l nguyn liu c x l mt phn, v phi tri qua
cc x l tip theo trc khi tr thnh thnh phm.
2.8. Thnh phm: l thuc tri qua tt c cc giai on ca qu trnh sn
xut, bao gm c giai on ng gi.
2.9. Ngy kim tra li: l ngy m thuc, nguyn liu cn phi c kim tra,
nh gi li xem c t tiu chun cht lng theo quy nh khng.
2.10. Nhn: l bn in, hnh v, hnh nh, du hiu c in chm, in ni trc tip
trn bao b thng phm hoc c dn, gn chc chn trn bao b thng phm
ca thuc th hin cc thng tin cn thit v ch yu v thuc , gip ngi
dng la chn v s dng ng thuc, v lm cn c cc c quan chc nng
thc hin kim tra, gim st, qun l.
Nhn bao gm tt c cc nhn v cc phn in, vit hoc hnh ho trn bao b
trung gian ca sn phm hoc trn bao b, v hp cha ng sn phm , loi tr
cng-te-n.
2.11. Bit tr: l tnh trng thuc, nguyn liu c ring bit, trong mt
khu vc cch ly hoc bng bin php hnh chnh ch quyt nh x l hu b
hoc cho php nhp kho hoc xut kho cho bo ch, ng gi hoc phn phi.
2.12: FIFO l t vit tt ca ting Anh "First In/First Out", ngha l "nhp
trc - xut trc".
FEFO l t vit tt ca ting Anh "First Expired/First Out", ngha l "ht hn
dng trc - xut trc".

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CNG BO/S 667 + 668/Ngy 20-10-2013

2.13. Tp nhim: l vic xut hin mt cch khng mong mun cc tp cht c
bn cht ha hc hoc vi sinh vt, hoc cc vt ngoi lai vo trong nguyn liu,
bn thnh phm, thnh phm thuc trong qu trnh sn xut, ly mu, ng gi,
ng gi li, bo qun v vn chuyn.
2.14. Nhim cho: l vic tp nhim ca nguyn liu, sn phm trung gian
hoc thnh phm thuc vi nguyn liu hoc thuc khc trong qu trnh sn xut,
bo qun v vn chuyn.
Phn II
THC HNH TT BO QUN THUC
1. Nhn s
1.1. Theo quy m ca n v, kho thuc phi c nhn vin, c trnh ph
hp vi cng vic c giao lm vic ti khu vc kho. Mi nhn vin phi thng
xuyn c o to v Thc hnh tt bo qun thuc, v k nng chuyn mn
v phi c quy nh r trch nhim, cng vic ca tng ngi bng vn bn.
1.2. Cc cn b ch cht ca kho c chc nng gim st, kim tra, cn phi
trung thc, c nhng hiu bit, kinh nghim cn thit v phi c trnh ngh
nghip v k thut ph hp vi nhim v c giao, p ng cc quy nh ca
Nh nc.
1.3. Th kho phi l ngi c trnh hiu bit cn thit v dc, v nghip v
bo qun: phng php bo qun, phng php qun l s sch theo di xut nhp,
cht lng thuc...
1.4. Th kho phi c trnh ti thiu l dc s trung hc i vi cc c s
sn xut, bn bun thuc tn dc. i vi c s sn xut, bn bun thuc y hc
c truyn, dc liu, th kho phi c trnh ti thiu l lng dc hoc dc s
trung hc.
1.5. Th kho thuc c, thuc gy nghin v thuc hng tm thn phi p
ng c ng cc quy nh ca php lut c lin quan.
1.6. Th kho phi thng xuyn c o to cp nht nhng quy nh mi
ca nh nc v bo qun, qun l thuc, cc phng php, tin b khoa hc k
thut c p dng trong bo qun thuc.
2. Nh kho v trang thit b
Nh kho phi c thit k, xy dng, trang b, sa cha v duy tu mt cch
h thng sao cho c th bo v thuc, nguyn liu trnh c cc nh hng bt
li c th c, nh: s thay i nhit v m, cht thi v mi, cc ng vt,
su b, cn trng, m bo thuc c cht lng nh.

CNG BO/S 667 + 668/Ngy 20-10-2013

27

2.1. a im:
Kho phi c xy dng ni cao ro, an ton, phi c h thng cng rnh
thot nc, m bo thuc, nguyn liu trnh c nh hng ca nc ngm,
ma ln, v l lt..
Kho phi c mt a ch xc nh, nm ni thun tin cho vic xut nhp,
vn chuyn, bo v.
2.2. Thit k, xy dng:
a) Kho phi rng, v khi cn thit, cn phi c s phn cch gia cc khu
vc sao cho c th bo m vic bo qun cch ly tng loi thuc, tng l hng
theo yu cu;
b) Ty theo mc ch, quy m ca kho (kho ca nh sn xut, kho ca nh
phn phi, kho ca khoa dc bnh vin...) cn phi c nhng khu vc xc nh,
c xy dng, b tr hp l, trang b ph hp:
+ Khu vc tip nhn, bit tr v bo qun thuc, nguyn liu ch nhp kho;
+ Khu vc ly mu thuc, nguyn liu: khu vc ny phi c xy dng, trang
b thch hp v phi c h thng cung cp khng kh sch m bo yu cu ca
vic ly mu;
+ Khu vc bo qun thuc;
+ Khu vc bo qun thuc, nguyn liu c yu cu bo qun c bit;
+ Khu vc bo qun thuc, nguyn liu khng t tiu chun cht lng, ch
x l;
+ Khu vc bo qun nguyn liu, thnh phm xut kho ch a vo sn
xut hoc cp pht;
+ Khu vc ng gi, ra l v dn nhn;
+ Khu vc bo qun bao b ng gi;
+ Khu vc bo qun bit tr trc khi xut nguyn vt liu.
c) Nh kho phi c thit k, xy dng, b tr p ng cc yu cu v ng
i li, ng thot him, h thng trang b phng chy, cha chy;
d) Trn, tng, mi nh kho phi c thit k, xy dng m bo s thng
thong, lun chuyn ca khng kh, vng bn chng li cc nh hng ca thi tit
nh nng, ma, bo lt;
) Nn kho phi cao, phng, nhn, chc, cng v c x l thch hp
chng m, chng thm m bo hot ng ca nhn vin lm vic trong kho, v
hot ng ca cc phng tin c gii. Nn kho khng c c cc khe, vt nt
gy... l ni tch ly bi, tr n ca su b, cn trng

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CNG BO/S 667 + 668/Ngy 20-10-2013

2.3. Trang thit b:

Nh kho phi p ng cc yu cu sau:
a) C cc phng tin, thit b ph hp: qut thng gi, h thng iu ha
khng kh, xe ch hng, xe nng, nhit k, m k... m bo cc iu kin bo qun;
b) C nh sng bo m cc hot ng trong khu vc kho c chnh
xc v an ton;
c) C cc trang b, gi, k sp xp hng ho. Khng c thuc,
nguyn liu trc tip trn nn kho. Khong cch gia cc gi k, gia gi k vi
nn kho phi rng m bo cho vic v sinh kho, kim tra, i chiu, cp pht
v xp, d hng ha;
d) C cc trang thit b, cc bn hng dn cn thit cho cng tc phng
chng chy n, nh: h thng bo chy t ng, thng ct, h thng nc v vi
nc cha chy, cc bnh kh cha chy, h thng phng cha chy t ng...
) C ni quy quy nh vic ra vo khu vc kho, v phi c cc bin php
phng nga, ngn chn vic ra vo ca ngi khng c php;
e) C cc quy nh v bin php chng s xm nhp, pht trin ca cn
trng, su b, loi gm nhm...
2.4. Cc iu kin bo qun trong kho:
V nguyn tc cc iu kin bo qun phi l iu kin ghi trn nhn thuc.
Theo quy nh ca T chc Y t th gii, iu kin bo qun bnh thng l bo
qun trong iu kin kh, thong, v nhit t 15 - 250C hoc ty thuc vo iu
kin kh hu, nhit c th ln n 300C. Phi trnh nh sng trc tip gay gt,
mi t bn ngoi vo v cc du hiu nhim khc.
Nu trn nhn khng ghi r iu kin bo qun, th bo qun iu kin bnh
thng. Trng hp ghi l bo qun ni mt, ng lnh.... th vn dng cc quy
nh sau:
a) Nhit :
Kho nhit phng: Nhit trong khong 15 - 250C, trong tng khong thi
gian nhit c th ln n 300C.
Kho mt: Nhit trong khong 8 - 150C.
Kho lnh: Nhit khng vt qu 80C.
T lnh: Nhit trong khong 2 - 80C.
Kho ng lnh: Nhit khng vt qu -100C.
b) m: iu kin bo qun "kh" c hiu l m tng i khng
qu 70%.

CNG BO/S 667 + 668/Ngy 20-10-2013

29

2.5 Kho bo qun thuc, nguyn liu c yu cu bo qun c bit:

a) Cc bin php c bit cn c thc hin i vi vic bo qun cc cht
c, cht nhy cm vi nh sng, nhit , m..., cht c hot tnh cao, v cht
nguy him, nh: cc cht lng, cht rn chy n, cc kh nn, cc thuc gy nghin
v cc cht tng t, cc thuc v ha cht c c tnh cao, cc vt liu phng x,
dc liu;
b) Cc thuc, nguyn liu i hi cc iu kin bo qun c bit, cn phi
c bo qun cc khu vc ring bit c xy dng v trang b thch hp
m bo cc iu kin bo qun theo yu cu v cc quy nh ca php lut;
c) i vi cc cht lng, rn d chy n, cc kh nn... phi c bo qun
trong kho c thit k, xy dng thch hp cho vic bo qun cc sn phm chy
n theo quy nh ca php lut, phi xa cc kho khc v xa khu vc nh . Kho
phi thng thong v c trang b n chng chy n. Cc cng tc in phi
c t ngoi kho;
d) i vi thuc c, thuc gy nghin, thuc hng tm thn: phi c bo
qun ti khu vc kho p ng quy nh ti cc quy ch lin quan;
) Cc thuc, ha cht c mi nh tinh du cc loi, amoniac, cn thuc... cn
c bo qun trong bao b kn, ti khu vc ring, trnh mi hp th vo cc
thuc khc;
e) i vi thuc i hi iu kin bo qun c kim sot v nhit , m,
nh sng th nhng iu kin ny phi c theo di v bo m duy tr lin tc.
Cc thit b c s dng theo di iu kin bo qun: nhit k, m k...
phi c kim tra nh k, hiu chnh khi cn, v kt qu kim tra, hiu chnh ny
phi c ghi li v lu tr.
g) Khu vc ly mu, hoc cp pht l cc nguyn liu, sn phm ch ng gi
cn phi tch bit khi cc khu vc bo qun khc, v phi c trang b, c cc
dng c cn thit cho tin hnh cng vic, phi c cc thit b cung cp v thi kh,
phng chng tp nhim, nhim cho;
h) Phi thc hin cc bin php thch hp phng nga s tp nhim, nhim
cho v cung cp cc iu kin lm vic an ton cho cng nhn.
3. V sinh
3.1. Khu vc bo qun phi sch, khng c bi rc tch t v khng c c
cn trng su b. Phi c vn bn quy nh chng trnh v sinh, xc nh r tn
s v phng php v sinh nh xng, kho.
3.2. Tt c th kho, cng nhn lm vic ti khu vc kho phi c kim tra sc
khe nh k. Ngi mc cc bnh v ng h hp, hoc c vt thng h u

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CNG BO/S 667 + 668/Ngy 20-10-2013

khng c lm vic trong khu vc bo qun c trc tip x l thuc (nguyn liu,
thnh phm...) cn h.
Ni ra tay, phng v sinh phi c thng gi tt v b tr ph hp (cch ly
vi khu vc tip nhn, bo qun, x l thuc).
3.3. Cng nhn lm vic trong khu vc kho phi mc qun o bo h lao ng
thch hp.
4. Cc quy trnh bo qun
4.1. Yu cu chung:
a) Thuc, nguyn liu cn c bo qun trong cc iu kin m bo c
cht lng ca chng. Thuc, nguyn liu cn c lun chuyn cho nhng l
nhn trc hoc c hn dng trc s em s dng trc. Nguyn tc nhp trc xut trc (FIFO - First In/First Out) hoc ht hn trc - xut trc (FEFO- First
Expired/First Out) cn phi c thc hin;
b) Thuc ch loi b cn phi c nhn r rng v c bit tr nhm ngn
nga vic a vo sn xut, lu thng, s dng;
c) Ty theo tnh cht v iu kin bo qun ca sn phm, phi quy nh chng
trnh kim tra, nh gi nh k hoc t xut xc nh cht lng sn phm;
d) Phi c h thng s sch, cc quy trnh thao tc chun m bo cho cng tc
bo qun, kim sot, theo di vic xut, nhp v cht lng thuc.
4.2. Nhn v bao b:
a) Cc thuc phi c bo qun trong bao b thch hp, khng nh hng xu
n cht lng ca thuc, ng thi c kh nng bo v thuc khi cc nh hng
ca mi trng, trong mt s trng hp, khi c yu cu, iu ny bao gm c
vic chng nhim khun;
b) Trn tt c cc bao b ca thuc phi c nhn r rng, d c, c cc ni dung,
hnh thc p ng cc quy nh ca php lut v nhn v nhn hiu hng ha ca
thuc. Khng c s dng tn thuc vit tt, tn hoc m s khng c php;
c) i vi mi loi bao b, nhn hoc sn phm, phi c cc h s ghi chp
ring bit, trong ch ra cc iu kin bo qun, cc bin php phng cn
c ch v hn dng (nu c);
d) Phi c khu vc ring bo qun nhn thuc v cc bao b ng gi c in
n. Phi c quy nh c th cho vic nhp, cp pht cc loi nhn v bao b ny;
) Phi tun th cc yu cu ca dc in v cc quy nh php lut lin quan
n nhn v bao b.

CNG BO/S 667 + 668/Ngy 20-10-2013

31

4.3. Tip nhn thuc:

a) Vic tip nhn thuc phi c thc hin ti khu vc dnh ring cho vic
tip nhn thuc, tch khi khu vc bo qun. Khu vc ny phi c cc iu kin
bo qun bo v thuc trnh khi cc nh hng xu ca thi tit trong sut
thi gian ch bc d, kim tra thuc;
b) Thuc trc khi nhp kho phi c kim tra, i chiu vi cc ti liu
chng t lin quan v chng loi, s lng, v cc thng tin khc ghi trn nhn
nh tn hng, nh sn xut, nh cung cp, s l, hn dng...
c) Cc l hng phi c kim tra v ng nht, v nu cn thit, c chia
thnh cc l nh theo s l ca nh cung cp;
d) Tt c cc bao b ng gi cn c kim tra cn thn v nhim bn v
mc h hi, v nu cn thit, cn c lm sch hoc ring nhng bao b
nhim bn, b h hi xem xt tm nguyn nhn. Tt c cc thuc c bao b b h
hi, mt du nim phong hoc b nghi ng c tp nhim th phi c bo qun
khu vc bit tr ch x l, khng c bn, hoc ln vi cc thuc khc;
) Cc thuc i hi iu kin bo qun c bit (cc thuc gy nghin, thuc
c, cc thuc cn bo qun nhit lnh...) phi nhanh chng c kim tra,
phn loi v bo qun theo cc ch dn ghi trn nhn v theo cc quy nh ca
php lut;
e) Phi c v lu cc h s ghi chp cho tng ln nhp hng, vi tng l hng.
Cc h s ny phi th hin c tn thuc, dng thuc, nng hm lng, cht
lng, s lng, s l sn xut, hn dng, thi gian nhn hng, v m s (nu c).
Cn phi tun th cc quy nh ca php lut v lu tr h s;
g) Vic ly mu thuc kim tra cht lng phi c tin hnh ti khu vc
dnh cho vic ly mu, v do ngi c trnh chuyn mn thc hin. Vic ly
mu phi theo ng quy nh ti Quy ch ly mu thuc xc nh cht lng.
L thuc, nguyn liu c ly mu phi c bo qun bit tr. Cc l
thuc phi c ring bit trong thi gian bit tr v trong thi gian bo qun
tip theo;
h) Ch bit tr phi c thc hin hoc bng vic s dng khu bo qun
ring bit, hoc bng h thng x l d liu in t.
Cc bin php c p dng cn phi an ton phng trnh vic s
dng hoc cp pht thuc, nguyn liu cha c kim sot, kim nghim hoc
khng p ng yu cu quy nh;
i) Thuc, nguyn liu cn phi c lu gi trong ch bit tr cho n khi
c vn bn chp nhn hoc loi b ca phng kim tra cht lng. Cc bin php

32

CNG BO/S 667 + 668/Ngy 20-10-2013

an ninh cn phi c thc hin m bo thuc, nguyn liu b loi b s khng

c s dng. Trong khi ch quyt nh hu, ti x l hoc tr li nh cung cp,
cc thuc, nguyn liu ny phi c bo qun ring bit vi cc thuc, nguyn
liu khc.
4.4. Cp pht - quay vng kho:
a) Ch c cp pht cc thuc, nguyn liu t tiu chun cht lng, cn
trong hn s dng. Khng c cp pht, phn phi cc thuc, nguyn liu khng
cn nguyn vn bao b, hoc c nghi ng v cht lng;
b) Phi c v lu cc bn ghi chp (phiu theo di xut - nhp thuc, phiu
theo di cht lng thuc...) th hin tt c cc ln nhp kho, xut kho ca thuc,
nguyn liu ph hp vi s l sn xut;
c) Vic cp pht cn phi tun theo cc nguyn tc quay vng kho (nhp trcxut trc hoc ht hn trc - xut trc), c bit l thuc, nguyn liu c hn
dng. Ch khi mt loi thuc, nguyn liu nhp sau c hn dng ngn hn thuc,
nguyn liu cng loi c nhp trc th thuc, nguyn liu c hn dng ngn
hn phi c xut, cp pht trc;
d) Cc thng, bao thuc, nguyn liu c s dng mt phn cn phi c
ng kn li mt cch an ton trnh vic ri vi hoc tp nhim, nhim cho
trong thi gian bo qun;
e) Cc thng, bao thuc nguyn liu b h hng, khng cn nguyn nim
phong, mt nhn hoc nhn b rch, khng r rng th khng c bn, cp pht,
v phi thng bo ngay vi b phn kim tra cht lng.
4.5. Bo qun thuc:
a) Cc iu kin bo qun c yu cu nh: chng loi bao b, gii hn nhit
, m, vic bo v trnh nh sng... cn c duy tr trong sut thi gian bo
qun. Cn phi c s ch ti cc thuc cha hot cht km vng bn i vi
nhit , m, nh sng... (Tham kho Ph lc - Danh mc mt s hot cht t
vng bn)
b) Bao b thuc phi c gi nguyn vn trong sut qu trnh bo qun.
Khng dng ln ln bao b ng gi ca loi ny cho loi khc;
c) Thuc c, thuc gy nghin, thuc hng tm thn phi c bo qun
theo ng cc quy nh ti quy ch lin quan.
Cc thuc nhy cm vi nhit phi c bo qun kho lnh hoc trong t lnh.
Nhit trong kho phi c kim tra cc v tr khc nhau ca kho.
Cc thuc nhy cm vi nh sng phi c bo qun trong bao b kn, khng
cho nh sng truyn qua, trong phng ti.

CNG BO/S 667 + 668/Ngy 20-10-2013

33

Cc thuc d bay hi v cc thuc nhy cm vi m phi c bo qun

ti kho lnh, bao b ng kn. Cc cht ht m mnh phi c bo qun ti
phng kh, bao b bng thu tinh hoc nha ng kn. Nu c th th nt phi
c ph paraffin.
Cc thuc c mi phi c bo qun trong bao b kn, kho ring.
Dc liu phi c bo qun kho kh, thng thong. Cc thng hng phi
c sp xp hp l m bo cho khng kh lu thng. Cc vt liu thch hp
lm bao b bo qun dc liu c th l thu tinh, nha, giy... Cc dc liu cha
tinh du cng cn phi c bo qun trong bao b kn.
Cc cht d chy, n phi c bo qun ti kho ring, p ng cc quy nh
ca php lut.
d) Phi nh k tin hnh vic i chiu thuc trong kho theo cch so snh
thuc hin cn v lng hng cn tn theo phiu theo di xut nhp thuc.
Trong mi trng hp, vic i chiu phi c tin hnh khi mi l hng c
s dng ht;
) Tt c cc sai lch, tht thot cn phi c iu tra tm ra nguyn nhn
do ln ln, cu th hay cc vn sai tri khc;
e) Thng xuyn kim tra s l v hn dng m bo nguyn tc nhp
trc - xut trc hoc ht hn trc - xut trc c tun th, v pht hin
hng gn ht hoc ht hn dng;
g) nh k kim tra cht lng ca hng lu kho pht hin cc bin cht, h
hng trong qu trnh bo qun do iu kin nhit , m hoc cc yu t khc
c th nh hng n cht lng thuc, nguyn liu;
h) Thuc, nguyn liu khng t tiu chun cht lng, ht hn dng phi
c bo qun khu vc ring, phi dn nhn, c bin hiu thuc, nguyn liu ch
x l. Phi c cc bin php phng vic cp pht, s dng thuc, nguyn liu
ht hn dng, thuc, nguyn liu khng t tiu chun cht lng;
i) Phi c cc phng tin vn chuyn v bo qun thch hp nhm m bo
cho thuc, nguyn liu trnh v v h hng do cc iu kin kh hu vt qu
quy nh nh nng nng, m t... trong sut qu trnh vn chuyn, bo qun cn
lu nhng loi thuc, nguyn liu c yu cu iu kin bo qun c bit.
5. Thuc tr v
5.1. Tt c cc thuc xut ra khi kho, b tr v phi c bo qun ti khu
bit tr. Cc thuc ny ch c a tr li kho thuc lu thng, phn phi, s
dng sau khi b phn bo m cht lng nh gi l thuc t tiu chun cht
lng v m bo an ton cho ngi s dng.

34

CNG BO/S 667 + 668/Ngy 20-10-2013

5.2. Tt c cc thuc tr v, sau khi c b phn bo m cht lng nh gi

l khng m bo cht lng, khng m bo an ton cho ngi s dng th khng
c a vo s dng v phi c x l theo quy nh ca php lut.
5.3. Nhng thuc do bnh nhn tr li phi c khu vc ring, ch hy b.
6. Gi hng (Vn chuyn thuc bng cch gi hng)
6.1. Vic cp pht v xp hng ln phng tin vn chuyn ch c thc hin
sau khi c lnh xut hng bng vn bn.
Cc nguyn tc, quy nh v quy trnh vn chuyn thuc bng cch gi hng
(dispatch) phi c thit lp tu theo bn cht ca thuc v sau khi cn nhc
tt c cc bin php phng nga.
6.2. i vi nhng thuc c yu cu bo qun c bit, trong thi gian vn
chuyn, phi m bo duy tr cc iu kin .
6.3. Vic vn chuyn cc thuc c, thuc gy nghin, thuc hng tm thn
phi tun th theo ng quy nh ti cc quy ch lin quan.
6.4. Cc bao b vn chuyn cn phi bo v thuc trnh cc nh hng bn
ngoi v phi c dn nhn r rng, khng b ty xa hoc d b ty xa.
6.5. Ti liu vn chuyn gi hng cn phi ghi r:
- Thi gian vn chuyn.
- Tn v a ch khch hng.
- Tn v a ch ngi gi.
- Tn v a ch ngi vn chuyn.
- Tn thuc, dng thuc, hm lng, s lng v s l.
- iu kin vn chuyn, bo qun.
6.6. Tt c ti liu lin quan n vic vn chuyn, gi hng phi c lu ti
bn gi v bn nhn hng, v c bo qun ti ni an ton.
7. H s ti liu
7.1. Quy trnh thao tc: cn phi c sn, treo ti cc ni d c cc quy trnh
thao tc chun c ph duyt xc nh phng php lm vic trong khu vc
nh kho. Cc quy trnh ny phi m t chnh xc cc quy trnh v tip nhn v
kim tra thuc nhp kho, bo qun, v sinh v bo tr kho tng, thit b dng trong
bo qun (bao gm c cc quy trnh kim tra, kim sot cn trng, chut b...), quy
nh v vic ghi chp cc iu kin bo qun, an ton thuc ti kho v trong qu
trnh vn chuyn, vic cp pht thuc, cc bn ghi chp, bao gm c cc bn ghi v
n t hng ca khch hng, thuc tr v, quy trnh thu hi v xc nh ng i
ca thuc, v ca thng tin.... Cc quy trnh ny phi c xt duyt, k xc nhn
v ghi ngy thng xt duyt bi ngi c thm quyn.

CNG BO/S 667 + 668/Ngy 20-10-2013

35

7.2. Phi c mt h thng s sch thch hp cho vic ghi chp, theo di vic
xut nhp cc thuc, bao gm tn thuc, s l, hn dng, s lng, cht lng
thuc, nh cung cp, nh sn xut... p ng cc quy nh ca php lut. Nu cc
loi s sch c vi tnh ha th phi tun theo cc quy nh ca php lut. Phi c
cc quy nh, bin php phng nga c th trnh vic xm nhp, s dng, sa
cha mt cch bt hp php cc s liu c lu gi.
- Phiu theo di xut nhp thuc (mu nh km s 1-GSP/MB)
- Phiu theo di cht lng thuc (mu nh km s 2-GSP/MB)
- Cc biu mu khc theo quy nh ca cc B Ngnh c lin quan.
Phi c phiu theo di xut nhp thuc ring cho tng loi sn phm cng nh
cho tng loi quy cch sn phm.
i vi vic cp pht, tip nhn thuc c, thuc gy nghin, thuc hng tm
thn phi tun theo ng cc quy nh v h s ti liu ti cc quy ch lin quan.
Phn III
HNG DN THC HIN
1. Quy nh chung
1.1. Cc n v xut nhp khu, bun bn, tn tr thuc, cc n v lm dch
v kho bo qun thuc, khoa dc bnh vin, vin nghin cu, trung tm y t phi
xy dng k hoch tng bc u t nng cp, xy dng kho thuc theo nguyn
tc Thc hnh tt bo qun thuc.
1.2. Cc n v sn xut thuc trong qu trnh trin khai p dng cc nguyn
tc tiu chun Thc hnh tt sn xut thuc ng thi phi trin khai p dng
cc nguyn tc Thc hnh tt bo qun thuc.
2. T chc thc hin
2.1. o to
a) B Y t (Cc Qun l dc Vit Nam) t chc ph bin, hun luyn v
Thc hnh tt bo qun thuc cho Tng Cng ty dc Vit Nam, S Y t cc
tnh, thnh ph trc thuc Trung ng, Y t cc ngnh, cc n v sn xut, kinh
doanh, cc bnh vin trung ng v cc vin c ging bnh.
b) S Y t cc tnh, thnh ph trc thuc Trung ng, Tng Cng ty dc Vit
Nam, Y t cc ngnh c trch nhim ph bin, hun luyn, v o to cc nguyn
tc Thc hnh tt bo qun thuc cho cc n v trc thuc, k c khoa dc
bnh vin, vin nghin cu v trung tm y t ng trn a bn.
c) Cc n v t ph bin hun luyn cc nguyn tc "Thc hnh tt bo qun
thuc" cho cn b cng nhn vin ca n v.

36

CNG BO/S 667 + 668/Ngy 20-10-2013

2.2.3 ng k kim tra:

Cc c s sau khi t kim tra, nh gi t nguyn tc Thc hnh tt bo
qun thuc, gi 01 b h s ng k kim tra n c quan c thm quyn quy
nh ti im 2.3.1 Phn ny. H s ng k gm:
- Trng hp ng k kim tra ln u:
(1) Bn ng k kim tra Thc hnh tt bo qun thuc (mu 01/GSP);
(2) Bn sao Giy php thnh lp c s hoc Giy ng k kinh doanh hoc
Giy chng nhn u t c ch k ca ch c s v ng du xc nhn ca c s;
(3) Ti liu, chng trnh v bo co tm tt v hun luyn, o to Thc
hnh tt bo qun thuc ti c s;
(4) S t chc ca c s;
(5) S v tr a l v thit k ca kho;
(6) Danh mc thit b bo qun ca c s;
(7) Danh mc cc i tng c bo qun v iu kin bo qun tng ng.
- Trng hp ng k ti kim tra:
(1) Bn ng k ti kim tra Thc hnh tt bo qun thuc (Theo mu
02/GSP);
(2) Bn sao Giy php thnh lp c s hoc Giy ng k kinh doanh hoc
Giy chng nhn u t c ch k ca ch c s v ng du xc nhn ca c s;
(3) Bo co khc phc cc tn ti trong kim tra ln trc;
(4) Bo co nhng thay i ca c s trong 03 nm trin khai Thc hnh tt
bo qun thuc v h s lin quan, nu c.
2.3. Thm quyn thm nh h s, kim tra, cp giy chng nhn v tiu chun
cn b kim tra:
2.3.1. Thm quyn:
a) Cc Qun l dc chu trch nhim tip nhn v thm nh h s ng k,
thnh lp on kim tra, t chc kim tra thc t ti c s v cp Giy chng nhn
t nguyn tc Thc hnh tt bo qun thuc i vi nhng c s lm dch v
bo qun thuc;
b) S Y t tnh, thnh ph trc thuc Trung ng ni c a im kho ca c
s ng k kim tra Thc hnh tt bo qun thuc chu trch nhim tip nhn v
thm nh h s ng k, thnh lp on kim tra, t chc kim tra thc t ti c
3

Khon ny c sa i, b sung ti Khon 1 iu 2 ca Thng t s

45/2011/TT-BYT, c hiu lc k t ngy 05 thng 02 nm 2012.

CNG BO/S 667 + 668/Ngy 20-10-2013

37

s v cp Giy chng nhn t nguyn tc Thc hnh tt bo qun thuc i vi

cc trng hp cn li.
2.3.2. Tiu chun cn b kim tra:
- Cn b c trnh i hc tr ln, c kinh nghim trong cng tc qun l
dc ni chung v cng tc bo qun thuc ni ring.
- C phng php thanh tra, kim tra khoa hc, cng quyt; c kh nng pht
hin nhanh cc sai st ca c s ng thi phi a ra c cc bin php c tnh
thuyt phc gip c s khc phc thiu st.
- Trung thc, khch quan v nghim chnh chp hnh cc quy ch, quy nh
php lut trong qu trnh kim tra.
- C sc khe, khng mc cc bnh truyn nhim.
2.4. Thm nh h s v t chc kim tra
- Sau khi nhn h s ng k kim tra ca c s theo quy nh ti khon 2.2
Phn ny, c quan qun l c thm quyn theo quy nh ti im 2.3.1 Phn ny
tin hnh thm nh h s (c bin bn thm nh).
- Trong vng 05 ngy lm vic k t ngy nhn c h s v ph thm nh
theo quy nh, c quan qun l phi thng bo cho c s v tnh trng h s nu
cha t yu cu hoc k hoch kim tra.
- Trong vng 20 ngy lm vic k t ngy thng bo k hoch kim tra, c
quan qun l phi tin hnh kim tra thc t ti c s.
2.5. Kim tra, x l kt qu kim tra v cp giy chng nhn
* Kim tra
- on kim tra c trch nhim kim tra ton b cc hot ng ca c s theo cc
nguyn tc Thc hnh tt bo qun thuc v cc quy nh chuyn mn hin hnh.
- Cc c s ng k kim tra Thc hnh tt bo qun thuc phi tin hnh
bo co bng s , biu v cc s liu ngn gn v tnh hnh hot ng, cng
tc trin khai p dng nguyn tc Thc hnh tt bo qun thuc.
- Bin bn kim tra phi ch r cc tn ti trong vic trin khai p dng nguyn
tc Thc hnh tt bo qun thuc ti c s. Trong trng hp khng nht tr vi
kin ca on kim tra, bin bn phi ghi r tt c cc kin bo lu ca c s.
Bin bn c ph trch c s cng trng on kim tra k xc nhn; lm thnh
03 bn: 01 bn lu ti c s, 02 bn lu ti c quan qun l ra quyt nh thnh lp
on kim tra.
* X l kt qu kim tra v cp giy chng nhn:
- Trng hp 1: Nu c s c kim tra p ng cc nguyn tc Thc hnh
tt bo qun thuc, c quan qun l c thm quyn theo quy nh ti im 2.3.1

38

CNG BO/S 667 + 668/Ngy 20-10-2013

Phn ny cp Giy chng nhn t nguyn tc Thc hnh tt bo qun thuc

trong vng 05 ngy lm vic k t ngy kt thc vic kim tra.
- Trng hp 2: i vi c s c kim tra v c bn p ng nguyn tc
Thc hnh tt bo qun thuc cn mt s tn ti nhng khng nh hng n
cht lng thuc c bo qun v c th khc phc c trong thi gian ngn,
on kim tra s yu cu c s bo co khc phc, sa cha.
C s phi khc phc, sa cha v bo co kt qu khc phc nhng tn ti
m on kim tra nu ra trong bin bn gi v c quan qun l ra quyt nh
thnh lp on kim tra.
Trng on kim tra tng hp, bo co ngi c thm quyn xem xt cp
Giy chng nhn t nguyn tc Thc hnh tt bo qun thuc hoc c quan
qun l phi c thng bo kt qu chnh thc cho c s trong vng 05 ngy lm
vic k t ngy nhn c bo co khc phc.
Qu 02 thng k t ngy kt thc vic kim tra, nu c s khng gi bo co
khc phc hp l th phi tin hnh np h s ng k kim tra li t u.
- Trng hp 3: i vi c s cha p ng nguyn tc Thc hnh tt bo
qun thuc, c s phi tin hnh khc phc sa cha cc tn ti. Sau khi t kim
tra nh gi t yu cu, c s tin hnh np h s li t u.
* ng k ti kim tra
- nh k 03 nm 01 ln, trc khi Giy chng nhn t nguyn tc Thc
hnh tt bo qun thuc ht hn 02 thng, c s phi np h s ng k ti kim
tra, tr cc trng hp t xut do c s hoc c quan qun l yu cu.
- C s sau khi np h s ng k ti kim tra vn c php bo qun
thuc theo phm vi quy nh trong Giy chng nhn t nguyn tc Thc hnh tt
bo qun thuc v Giy chng nhn iu kin kinh doanh thuc (ang cn
hiu lc).
- Trong qu trnh kim tra, nu pht hin c s c cc tn ti mc nh
hng nghim trng ti cht lng thuc c bo qun, trng on kim tra lp
bin bn, bo co ngi c thm quyn ra quyt nh x l chnh thc.
3.4 Giy chng nhn t nguyn tc Thc hnh tt bo qun thuc c gi
tr 03 nm k t ngy k. Cc Giy chng nhn c Cc Qun l dc cp trc
y c thi hn hiu lc l 02 nm c tip tc gia hn hiu lc thm 01 nm k
t ngy ht hn. Cc Qun l dc ban hnh quyt nh gia hn km theo danh
sch cc c s c gia hn hiu lc Giy chng nhn t nguyn tc Thc hnh
tt bo qun thuc.
4

Khon ny c b sung ti Khon 3 iu 2 ca Thng t s 45/2011/TT-BYT, c

hiu lc k t ngy 05 thng 02 nm 2012.

CNG BO/S 667 + 668/Ngy 20-10-2013

Mu s 1-GSP/MB
Tn n v

39

Phiu s:.........

PHIU THEO DI XUT - NHP THUC

Nm..........

Kho:...................................
Tn thuc (nng , hm lng).......................n v tnh................
Ni sn xut.....................................Quy cch ng gi.......................
S lng

Din gii
Ngy
(Ni mua thng
bn)
Nhp Xut Tn

S lng tn ca tng l
sn xut
S l S l S l S l K tn
Hn Hn Hn Hn
dng dng dng dng

PHIU THEO DI CHT LNG THUC

Mu s 2-GSP/MB

Phiu s:..................

40

S
Ngy
Nhn xt Phn Din bin cht lng hng
S S l
Hn
Ngy S phiu Ngun lng,
Ghi
hng
cht
loi cht lu kho (Ngy kim/Tnh
phiu sn
dng
kim nhp/giao nhp quy
ch
KN xut
v
lng
lng
trng cht lng)
cch

Ni sn xut:...........................................................................................................................................................................

n v tnh...............................................................................................................................................................................

Tn thuc (nng , hm lng)............................................................................................................................................

Tn n v

Tn n v ch qun

40
40
CNG BO/S 667 + 668/Ngy 20-10-2013

CNG BO/S 667 + 668/Ngy 20-10-2013

41

Mu s 3-GSP/MB51
Mu s 01/GSP: Mu n ng k kim tra Thc hnh tt bo qun thuc
Tn n v ch qun
Tn n v

CNG HA X HI CH NGHA VIT NAM

c lp - T do - Hnh phc
..., ngy.... thng..... nm.....

N NG K KIM TRA THC HNH TT BO QUN THUC

Knh gi:..................................
1. Tn c s:
2. a ch (tr s chnh v kho bo qun)
3. in thoi:

Fax:

E-Mail:

4. Quyt nh thnh lp c s (hoc Giy ng k kinh doanh hoc Giy chng

nhn u t) s............... do................. cp.
Thi hnh Quyt nh s....../2001/Q-BYT ngy.... thng.... nm 2001 ca B
trng B Y t v vic trin khai p dng nguyn tc Thc hnh tt bo qun
thuc, sau khi tin hnh t thanh tra, c s chng ti xin ng k vi...............
c kim tra Thc hnh tt bo qun thuc" v cam kt khc phc kp thi
nhng tn ti ghi trong bin bn kim tra.
Chng ti xin gi km bn ng k ny cc ti liu lin quan sau y:
(1)- Ti liu, chng trnh v bo co tm tt v hun luyn, o to Thc
hnh tt bo qun thuc ti c s;
(2)-Bn sao Giy php thnh lp c s hoc Giy ng k kinh doanh hoc
Giy chng nhn u t c xc nhn ca c s;
(3)- S t chc ca c s;
(4)- S v tr a l v thit k ca kho;
(5)- Danh mc thit b bo qun ca c s;
(6)- Danh mc cc i tng c bo qun v iu kin bo qun tng ng./.
Ph trch c s
(Ch k, ghi r h tn, ng du)
5

Mu ny c sa i, b sung ti Khon 2 iu 2 ca Thng t s 45/2011/TT-BYT,

c hiu lc k t ngy 05 thng 02 nm 2012.

42

CNG BO/S 667 + 668/Ngy 20-10-2013

Mu s 02/GSP: Mu n ng k ti kim tra GSP

Tn n v ch qun
Tn n v

CNG HA X HI CH NGHA VIT NAM

c lp - T do - Hnh phc
..., ngy.... thng..... nm.....

N NG K TI KIM TRA THC HNH TT BO QUN THUC

Knh gi:..................................
1. Tn c s:
2. a ch (tr s chnh v kho bo qun)
3. in thoi:

Fax:

E-Mail:

4. Quyt nh thnh lp c s (hoc Giy ng k kinh doanh hoc Giy chng

nhn u t) s............... do................. cp.
Thi hnh Quyt nh s....../2001/Q-BYT ngy.... thng.... nm 2001 ca B
trng B Y t v vic trin khai p dng nguyn tc Thc hnh tt bo qun
thuc, sau khi tin hnh t thanh tra, c s chng ti xin ng k vi...............
c kim tra Thc hnh tt bo qun thuc" v cam kt khc phc kp thi
nhng tn ti ghi trong bin bn kim tra
Chng ti xin gi km bn ng k ny cc ti liu lin quan sau y:
(1)- Bn sao Giy php thnh lp c s hoc Giy ng k kinh doanh hoc
Giy chng nhn u t c xc nhn ca c s;
(2)- Bo co khc phc cc tn ti trong kim tra ln trc;
(3)- Bo co thay i ca c s trong 03 nm trin khai./.
Ph trch c s
(Ch k, ghi r h tn, ng du)

CNG BO/S 667 + 668/Ngy 20-10-2013

43

Ph lc
DANH MC MT S HOT CHT T VNG BN
Acid acetylsalicylic
Aminophyllin
Amitriptyllin hydrochlorid
Ammonium chlorid
Acid ascorbic (Vitamin C)
Amphotericin B
Ampicillin natri
Ampicillin trihydrat
Antimony natri tartrat
Acid undecylenic
Bacitracin
Bacitracin km
Bc nitrat
Benzathine benzylpenicillin
Benzylpencillin kali
Benzylpenicillin natri
Bephenium hydroxy naphthoat
Calci gluconat
Calci para-aminosalicylat
Carbenicillin natri
Cefalexin
Chloral hydrat
Chloramphenicol natri succinat
Chlorphenamin maleat
Chlorpromazin hydrochlorid
Chlortetracyclin hydrochlorid
Cloxacillin natri (monohydrat)
Codeine phosphat
Cholecalciferol
Dapson
Dexamethason natri phosphat

Dicloxacillin natri (monohydrat)

Diethylcarbamazin dihydrogen citrat
Doxycyclin hyclat
Emetin hydrochlorid
Ephedrin
Ephedrin sulfat
Epinephrin
Epinephrin hydrogen tartrat Ergocalciferol
Ergometrine hydrogen maleat
Ergotamin maleat
Ergotamin tartrat
Ethosuximid
Ethylmorphin hydrochlorid
Fluphenazin decanoat
Fluphenazin hydrochlorid
Formaldehyd solution
Gentamycin sulfat
Guanetidine sulfat
Hexylresorcinol
Hydralazin hydrochlorid
Hydrocortison natri succinat
Hydroxocobalamin
Hyoscyamin sulfat
Imipramin hydrochlorid
Ipecacuanha bt
Isoprenalin hydrochlorid
Isoprenalin sulfat

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CNG BO/S 667 + 668/Ngy 20-10-2013

Lidocain hydrochlorid
L Senna (Senna leaf)

Quinin bisulfat
Quinin dihydrochlorid

Malarsoprol
Metrofonat

Retinol (vitamin A)

Naloxon hydrochlorid
Natri calci edetat
Natri lactat
Natri nitrit
Natri para-aminosalicylat
Natri stibogluconat
Neomycin sulfat
Nystatin
Orciprenalin sulfat
Oxytetracyclin hydrochlorid
Phenobarbital natri
Paromomycin sulfat
Penicillamin
Pethidin hydrochlorid
Phenoxymethylpenicillin
Pehnoxymethylpenicillin calci
Phenoxymethylpenicillin kali
Phentolamin mesilat
Phenybutazon
Pilocarpin hydrochlorid
Pilocarpin nitrat
Procainamid hydrochlorid
Procain benzylpenicillin
Procain hydrochlorid
Procarbazin hydrochlorid
Promazin hydrochlorid
Promethazin hydrochlorid
Pyridoxin hydrochlorid

Salbutamol sulfat
St (II) sulfat
Sulfacetamid natri
Sulfadiazin natri
Sulfadimidin natri
Suxamethonium chlorid
Tetracain hydrochlorid
Tetracyclin hydrochlorid
Thiamin hydrochlorid
Thiamin mononitrat
Thiopental natri
Thu ngn oxide vng
Tolbutamid
Warfarin natri