05 2016 qh13 1712

QUC HI
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CNG HA X HI CH NGHA VIT NAM

c lp - T do - Hnh phc
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Lut s: 105/2016/QH13
H Ni, ngy 06 thng 4 nm 2016
LUT
DC
Cn c Hin php nc Cng ha x hi ch ngha Vit Nam;
Quc hi ban hnh Lut dc.
MC LC
Chng I. NHNG QUY NH CHUNG........................................................................ 5

iu 1. Phm vi iu chnh v i tng p dng...................................................... 5
iu 2. Gii thch t ng............................................................................................. 5
iu 3. D tr quc gia v thuc, nguyn liu lm thuc...........................................9
iu 4. C quan qun l nh nc v dc.............................................................. 10
iu 5. Hi v dc...................................................................................................10
iu 6. Nhng hnh vi b nghim cm......................................................................10
Chng II. CHNH SCH CA NH NC V DC V PHT TRIN CNG
NGHIP DC................................................................................................................ 12
iu 7. Chnh sch ca Nh nc v dc................................................................12
iu 8. Lnh vc u tin trong pht trin cng nghip dc.................................... 14
iu 9. Quy hoch pht trin cng nghip dc....................................................... 15
iu 10. Trch nhim trong pht trin cng nghip dc.........................................15
Chng III. HNH NGH DC..................................................................................17
iu 11. Vi tri cng vic phi c Chng ch hnh ngh dc...................................17
iu 12. Cp, cp li, iu chnh ni dung Chng ch hnh ngh dc................... 18
iu 13. iu kin cp Chng ch hnh ngh dc.................................................. 18

iu 14. iu kin cp Chng ch hnh ngh dc ti Vit Nam i vi ngi nc
ngoi v ngi Vit Nam nh c nc ngoi........................................................19
iu 15. iu kin i vi ngi chu trch nhim chuyn mn v dc v ngi
ph trch v bo m cht lng ca c s sn xut thuc, nguyn liu lm thuc. 20
iu 16. iu kin i vi ngi chu trch nhim chuyn mn v dc ca c s
bn bun thuc, nguyn liu lm thuc..................................................................... 21
xut khu, nhp khu thuc, nguyn liu lm thuc..................................................21
bn l thuc................................................................................................................ 22
kinh doanh dch v kim nghim thuc, nguyn liu lm thuc............................... 22
kinh doanh dch v th thuc trn lm sng, th tng ng sinh hc ca thuc.. 23
iu 21. iu kin i vi ngi ph trch cng tc dc lm sng ca c s khm
bnh, cha bnh......................................................................................................... 23
kinh doanh dch v bo qun thuc, nguyn liu lm thuc......................................23
iu 23. Thm quyn cp, cp li, iu chnh ni dung, thu hi Chng ch hnh
ngh dc...................................................................................................................24
iu 24. H s ngh cp Chng ch hnh ngh dc........................................... 24
iu 25. H s ngh cp li Chng ch hnh ngh dc...................................... 25
iu 26. H s ngh iu chnh ni dung Chng ch hnh ngh dc.................25
iu 27. Th tc cp, cp li, iu chnh ni dung Chng ch hnh ngh dc.......25
iu 28. Cc trng hp thu hi Chng ch hnh ngh dc................................... 25
iu 29. Quan ly Chng chi hanh ngh dc........................................................... 26
iu 30. Quyn ca ngi hnh ngh dc.............................................................. 27
iu 31. Ngha v ca ngi hnh ngh dc.......................................................... 27
Chng IV. KINH DOANH DC................................................................................ 28

iu 32. Hot ng kinh doanh dc v c s kinh doanh dc..............................28
iu 33. iu kin cp Giy chng nhn iu kin kinh doanh dc................. 29
iu 34. iu kin kinh doanh i vi thuc phi kim sot c bit v thuc thuc
danh mc hn ch bn l............................................................................................30
iu 35. C s c hot ng dc khng thuc din cp Giy chng nhn iu
kin kinh doanh dc.................................................................................................30
iu 36. Cp, cp li, iu chnh Giy chng nhn iu kin kinh doanh dc..31
iu 37. Thm quyn cp, cp li, iu chinh v thu hi Giy chng nhn iu
kin kinh doanh dc.................................................................................................32
iu 38. H s ngh cp, cp li, iu chnh Giy chng nhn iu kin kinh
doanh dc.................................................................................................................32
iu 39. Th tc cp, cp li, iu chnh Giy chng nhn iu kin kinh doanh
dc........................................................................................................................... 33
iu 40. Cc trng hp thu hi Giy chng nhn iu kin kinh doanh dc.. 33
iu 41. Qun l Giy chng nhn iu kin kinh doanh dc...........................34
iu 42. Quyn v trch nhim ca c s kinh doanh dc..................................... 34
iu 43. Quyn v trch nhim ca c s sn xut thuc, nguyn liu lm thuc... 35
iu 44. Quyn v trch nhim ca c s xut khu, nhp khu thuc, nguyn liu
lm thuc....................................................................................................................36
iu 45. Quyn v trch nhim ca c s kinh doanh dch v bo qun thuc,
nguyn liu lm thuc................................................................................................37
iu 46. Quyn v trch nhim ca c s bn bun thuc, nguyn liu lm thuc..37
iu 47. Quyn va trch nhim ca c s bn l l nh thuc..................................38
iu 48. Quyn v trch nhim ca c s bn l l quy thuc................................39
iu 49. Quyn v trch nhim ca c s bn l l t thuc trm y t x................ 39
iu 50. Quyn v trch nhim ca c s chuyn bn l dc liu, thuc dc liu,
thuc c truyn...........................................................................................................39
iu 51. Quyn v trch nhim ca c s kinh doanh dch v kim nghim thuc,
nguyn liu lm thuc................................................................................................40
iu 52. Quyn v trch nhim ca c s kinh doanh dch v th thuc trn lm
sng............................................................................................................................ 40
iu 53. Quyn v trch nhim ca c s kinh doanh dch v th tng ng sinh
hc ca thuc............................................................................................................. 41
Chng V. NG K, LU HNH, THU HI THUC V NGUYN LIU LM
THUC..............................................................................................................................42
iu 54. i tng v yu cu ng k thuc, nguyn liu lm thuc.....................42
iu 55. Hnh thc ng k thuc, nguyn liu lm thuc....................................... 43
iu 56. Thm quyn, h s, th tc, thi hn cp, gia hn, thay i, b sung giy
ng k lu hnh thuc, nguyn liu lm thuc........................................................ 44
iu 57. Quyn v trch nhim ca c s ng k thuc, nguyn liu lm thuc....46
iu 58. Thu hi giy ng k lu hnh thuc, nguyn liu lm thuc....................46
iu 59. Quy nh v lu hnh thuc, nguyn liu lm thuc.................................. 47
iu 60. Thuc, nguyn liu lm thuc c nhp khu, xut khu........................ 48
iu 61. Nhn thuc, nguyn liu lm thuc lu hnh trn th trng..................... 49
iu 62. Cc trng hp thu hi thuc, nguyn liu lm thuc................................50
iu 63. Hnh thc thu hi, mc vi phm, phm vi v thi gian thu hi v x l
thuc b thu hi.......................................................................................................... 51
iu 64. Trch nhim thu hi thuc.......................................................................... 52
iu 65. Thm quyn ra quyt nh thu hi thuc, th tc thu hi thuc................. 54
Chng VI. DC LIU V THUC C TRUYN................................................... 54
iu 66. Nui trng, thu hi, khai thc, ch bin dc liu...................................... 54
iu 67. Bo qun dc liu..................................................................................... 54
iu 68. Cht lng ca dc liu............................................................................ 55
iu 69. Kinh doanh thuc c truyn........................................................................55
iu 70. Cung ng, ch bin, bo ch v s dng thuc c truyn trong c s khm
bnh, cha bnh......................................................................................................... 56
iu 71. ng k, lu hnh, thu hi thuc c truyn................................................56

iu 72. Th thuc c truyn trn lm sng trc khi ng k lu hnh................. 57
iu 73. Cht lng thuc c truyn.........................................................................57
Chng VII. N THUC V S DNG THUC.....................................................58
iu 74. n thuc....................................................................................................58
iu 75. S dng thuc............................................................................................. 58
Chng VIII. THNG TIN THUC, CNH GIC DC V QUNG CO
THUC..............................................................................................................................58
iu 76. Ni dung v trch nhim thng tin thuc....................................................58
iu 77. Cnh gic dc........................................................................................... 60
iu 78. T chc hot ng thng tin thuc v cnh gic dc............................... 61
iu 79. Qung co thuc......................................................................................... 61
Chng IX. DC LM SANG.....................................................................................61
iu 80. Ni dung hot ng dc lm sng............................................................ 61
iu 81. Trin khai hot ng dc lm sng...........................................................62
iu 82. Quyn va nghia vu cua ngi lam cng tac dc lm sng....................... 62
iu 83. Chnh sch ca Nh nc i vi hot ng dc lm sng......................63
Chng X. QUN L THUC TRONG C S KHM BNH, CHA BNH......... 63
iu 84. Cung ng, bo qun, cp pht v s dng thuc........................................ 63
iu 85. Sn xut, pha ch thuc trong c s khm bnh, cha bnh...................... 64
Chng XI. TH THUC TRN LM SNG, TH TNG NG SINH HC
CA THUC.................................................................................................................... 64
iu 86. Cc giai on th thuc trn lm sng........................................................64
iu 87. Th thuc trn lm sng ng k lu hnh thuc.................................. 65
iu 88. Yu cu i vi thuc th lm sng........................................................... 65
iu 89. Thuc phi th lm sng, thuc min th lm sng hoc min mt s giai
on th lm sng khi ng k lu hnh thuc......................................................... 65
iu 90. iu kin ca ngi tham gia th thuc trn lm sng.............................. 66
iu 91. Quyn v ngha v ca ngi tham gia th thuc trn lm sng................66

iu 92. Quyn v trch nhim ca t chc, c nhn c thuc th lm sng........... 67
iu 93. Quyn v trch nhim ca c s nhn th thuc trn lm sng................. 67
iu 94. Nguyn tc v thm quyn ph duyt th thuc trn lm sng.................. 68
iu 95. H s, quy trnh th thuc trn lm sng....................................................68
iu 96. Cc giai on th tng ng sinh hc ca thuc v thuc phi th tng
ng sinh hc...........................................................................................................69
iu 97. iu kin, quyn v ngha v ca ngi tham gia th tng ng sinh
hc ca thuc............................................................................................................. 69
iu 98. Quyn v trch nhim ca t chc, c nhn c thuc th tng ng sinh
hc..............................................................................................................................70
iu 99. Quyn v trch nhim ca c s nhn th tng ng sinh hc ca thuc70
iu 100. Nguyn tc ph duyt vic th tng ng sinh hc ca thuc............. 71
iu 101. H s, quy trnh th tng ng sinh hc ca thuc..............................71
Chng XII. QUY CHUN, TIU CHUN CHT LNG V VIC KIM
NGHIM THUC, NGUYN LIU LM THUC, BAO B TIP XC TRC TIP
VI THUC......................................................................................................................72
iu 102. Quy chun, tiu chun cht lng thuc, nguyn liu lm thuc, bao b
tip xc trc tip vi thuc........................................................................................ 72
iu 103. Kim nghim thuc, nguyn liu lm thuc, bao b tip xc trc tip vi
thuc...........................................................................................................................73
iu 104. C s kim nghim thuc, nguyn liu lm thuc....................................73
iu 105. Gii quyt khiu ni v kt lun cht lng thuc, nguyn liu lm thuc,
bao b tip xc trc tip vi thuc............................................................................. 74
Chng XIII. QUN L GI THUC.......................................................................... 75
iu 106. Nguyn tc qun l nh nc v gi thuc............................................... 75
iu 107. Cc bin php qun l gi thuc............................................................... 75
iu 108. Trch nhim qun l nh nc v gi thuc............................................. 76
iu 109. Trch nhim qun l nh nc v gi thuc ca B Y t......................... 76
iu 110. Trch nhim qun l nh nc v gi thuc ca B Ti chnh................ 77

iu 111. Trch nhim qun l nh nc v gi thuc ca B Cng Thng......... 77
iu 112. Trch nhim qun l nh nc v gi thuc ca y ban nhn dn cp tnh77
iu 113. Trch nhim ca Bo him x hi Vit Nam trong qun l gi thuc......77
iu 114. Trch nhim ca cc c s thc hin u thu thuc............................... 78
Chng XIV. IU KHON THI HNH...................................................................... 78
iu 115. iu khon chuyn tip............................................................................ 78
iu 116. Hiu lc thi hnh.......................................................................................79
Chng I
NHNG QUY NH CHUNG
iu 1. Phm vi iu chnh v i tng p dng
1. Lut ny quy nh v chnh sch ca Nh nc v dc v pht trin cng nghip dc;
hnh ngh dc; kinh doanh dc; ng k, lu hnh, thu hi thuc v nguyn liu lm
thuc; dc liu v thuc c truyn; n thuc v s dng thuc; thng tin thuc, cnh
gic dc v qung co thuc; dc lm sng; qun l thuc trong c s khm bnh,
cha bnh; th thuc trn lm sng v th tng ng sinh hc ca thuc; qun l cht
lng thuc, nguyn liu lm thuc v qun l gi thuc.
2. Lut ny p dng i vi c quan, t chc, c nhn trong nc v t chc, c nhn
nc ngoi c lin quan n hot ng dc ti Vit Nam.
iu 2. Gii thch t ng
Trong Lut ny, cc t ng di y c hiu nh sau:
1. Dc l thuc v nguyn liu lm thuc.
2. Thuc l ch phm c cha dc cht hoc dc liu dng cho ngi nhm mc ch
phng bnh, chn on bnh, cha bnh, iu tr bnh, gim nh bnh, iu chnh chc
nng sinh l c th ngi bao gm thuc ha dc, thuc dc liu, thuc c truyn, vc
xin v sinh phm.
3. Nguyn liu lm thuc l thnh phn tham gia vo cu to ca thuc bao gm dc
cht, dc liu, t dc, v nang c s dng trong qu trnh sn xut thuc.
4. Dc cht (cn gi l hot cht) l cht hoc hn hp cc cht dng sn xut thuc,
c tc dng dc l hoc c tc dng trc tip trong phng bnh, chn on bnh, cha
bnh, iu tr bnh, gim nh bnh, iu chnh chc nng sinh l c th ngi.
5. Dc liu l nguyn liu lm thuc c ngun gc t nhin t thc vt, ng vt,
khong vt v t tiu chun lm thuc.
6. Thuc ha dc l thuc c cha dc cht c xc nh thnh phn, cng thc,
tinh khit v t tiu chun lm thuc bao gm c thuc tim c chit xut t dc
liu, thuc c kt hp dc cht vi cc dc liu c chng minh v tnh an ton v
hiu qu.
7. Thuc dc liu l thuc c thnh phn t dc liu v c tc dng da trn bng
chng khoa hc, tr thuc c truyn quy nh ti khon 8 iu ny.
8. Thuc c truyn (bao gm c v thuc c truyn) l thuc c thnh phn dc liu
c ch bin, bo ch hoc phi ng theo l lun v phng php ca y hc c truyn
hoc theo kinh nghim dn gian thnh ch phm c dng bo ch truyn thng hoc hin
i.
9. V thuc c truyn l dc liu c ch bin theo l lun v phng php ca y hc
c truyn dng sn xut thuc c truyn hoc dng phng bnh, cha bnh.
10. Sinh phm (cn gi l thuc sinh hc) l thuc c sn xut bng cng ngh hoc
qu trnh sinh hc t cht hoc hn hp cc cht cao phn t c ngun gc sinh hc bao
gm c dn xut ca mu v huyt tng ngi.
Sinh phm khng bao gm khng sinh, cht c ngun gc sinh hc c phn t lng thp
c th phn lp thnh nhng cht tinh khit v sinh phm chn on in vitro.
11. Sinh phm tham chiu (cn gi l thuc sinh hc tham chiu) l sinh phm c cp
php lu hnh ti Vit Nam trn c s c y d liu v cht lng, an ton, hiu qu.
12. Sinh phm tng t (cn gi l thuc sinh hc tng t) l sinh phm c s tng t
v cht lng, an ton, hiu qu so vi mt thuc sinh hc tham chiu.
13. Vc xin l thuc cha khng nguyn to cho c th kh nng p ng min dch c
dng vi mc ch phng bnh, cha bnh.
14. Thuc mi l thuc c cha dc cht mi, dc liu ln u tin c s dng lm
thuc ti Vit Nam; thuc c s kt hp mi ca cc dc cht lu hnh hoc cc
dc liu tng s dng lm thuc ti Vit Nam.
15. Thuc generic l thuc c cng dc cht, hm lng, dng bo ch vi bit dc

gc v thng c s dng thay th bit dc gc.
16. Bit dc gc l thuc u tin c cp php lu hnh trn c s c y d liu
v cht lng, an ton, hiu qu.
17. Thuc gy nghin l thuc c cha dc cht kch thch hoc c ch thn kinh d gy
ra tnh trng nghin i vi ngi s dng thuc Danh mc dc cht gy nghin do B
trng B Y t ban hnh.
18. Thuc hng thn l thuc c cha dc cht kch thch hoc c ch thn kinh hoc
gy o gic, nu s dng nhiu ln c th dn ti tnh trng nghin i vi ngi s dng
thuc Danh mc dc cht hng thn do B trng B Y t ban hnh.
19. Thuc tin cht l thuc c cha tin cht thuc Danh mc tin cht dng lm thuc
do B trng B Y t ban hnh.
20. Thuc dng phi hp c cha dc cht gy nghin l thuc c nhiu hot cht trong
c hot cht gy nghin vi nng , hm lng theo quy nh ca B trng B Y t.
21. Thuc dng phi hp c cha dc cht hng thn l thuc c nhiu hot cht trong
c hot cht hng thn vi nng , hm lng theo quy nh ca B trng B Y t.
22. Thuc dng phi hp c cha tin cht l thuc c nhiu dc cht trong c dc
cht l tin cht vi nng , hm lng theo quy nh ca B trng B Y t.
23. Thuc phng x l thuc c cha thnh phn ht nhn phng x dng cho ngi
chn on, iu tr bnh, nghin cu y sinh hc bao gm ng v phng x hoc ng v
phng x gn kt vi cht nh du.
24. ng v phng x l ng v ca mt nguyn t ha hc m ht nhn nguyn t ca
nguyn t trng thi khng n nh v pht ra bc x ion ha trong qu trnh phn r
tr thnh trng thi n nh.
25. Cht nh du (cn gi l cht dn, cht mang) l cht hoc hp cht dng pha
ch, gn kt vi ng v phng x to thnh thuc phng x.
26. Thuc, nguyn liu lm thuc phi kim sot c bit (sau y gi tt l thuc phi
kim sot c bit) bao gm:
a) Thuc quy nh ti cc khon 17, 18, 19, 20, 21, 22, 23 v 24 iu ny;
b) Nguyn liu lm thuc l dc cht hng thn, cht gy nghin, tin cht dng lm
thuc hoc cht phng x sn xut thuc quy nh ti cc khon 17, 18, 19, 20, 21, 22,
23 v 24 iu ny;
c) Thuc c, nguyn liu c lm thuc thuc danh mc do B trng B Y t ban hnh;

d) Thuc, dc cht thuc danh mc cht b cm s dng trong mt s ngnh, lnh vc c
th theo quy nh ca Chnh ph.
27. Thuc khng k n l thuc khi cp pht, bn l v s dng khng cn n thuc
thuc Danh mc thuc khng k n do B trng B Y t ban hnh.
28. Thuc k n l thuc khi cp pht, bn l v s dng phi c n thuc, nu s dng
khng theo ng ch nh ca ngi k n th c th nguy him ti tnh mng, sc khe.
29. Thuc thit yu l thuc p ng nhu cu chm sc sc khe ca a s Nhn dn
thuc Danh mc thuc thit yu do B trng B Y t ban hnh.
30. Thuc him l thuc phng, chn on, iu tr bnh him gp hoc thuc khng
sn c theo quy nh ca B trng B Y t.
31. Hn dng ca thuc l thi gian s dng n nh cho thuc m sau thi hn ny thuc
khng c php s dng.
Hn dng ca thuc c th hin bng khong thi gian tnh t ngy sn xut n ngy
ht hn hoc th hin bng ngy, thng, nm ht hn. Trng hp hn dng ch th hin
thng, nm th hn dng c tnh n ngy cui cng ca thng ht hn.
32. Thuc khng t tiu chun cht lng l thuc khng t tiu chun cht lng
ng k vi c quan nh nc c thm quyn.
33. Thuc gi l thuc c sn xut thuc mt trong cc trng hp sau y:
a) Khng c dc cht, dc liu;
b) C dc cht khng ng vi dc cht ghi trn nhn hoc theo tiu chun ng k
lu hnh hoc ghi trong giy php nhp khu;
c) C dc cht, dc liu nhng khng ng hm lng, nng hoc khi lng
ng k lu hnh hoc ghi trong giy php nhp khu, tr thuc khng t tiu chun
cht lng quy nh ti khon 32 iu ny trong qu trnh bo qun, lu thng phn phi;
d) c sn xut, trnh by hoc dn nhn nhm mo danh nh sn xut, nc sn xut
hoc nc xut x.
34. Dc liu gi l dc liu thuc mt trong cc trng hp sau y:
a) Khng ng loi, b phn hoc ngun gc c c s kinh doanh c ghi trn nhn
hoc ghi trong ti liu km theo;
b) B c trn ln hoc thay th bng thnh phn khng phi l dc liu ghi trn nhn;
dc liu b c chit xut hot cht;
c) c sn xut, trnh by hoc dn nhn nhm mo danh nh sn xut, nc sn xut
hoc nc xut x.
35. Phn ng c hi ca thuc l phn ng khng mong mun, c hi n sc khe, c
th xy ra liu dng bnh thng.
36. Hnh ngh dc l vic s dng trnh chuyn mn ca c nhn kinh doanh
dc v hot ng dc lm sng.
37. Thc hnh tt l b nguyn tc, tiu chun v sn xut, bo qun, kim nghim, lu
thng thuc, k n thuc, th thuc trn lm sng, nui trng, thu hi dc liu v cc
b nguyn tc, tiu chun khc do B trng B Y t ban hnh hoc cng b p dng
trn c s hng dn ca T chc Y t Th gii hoc ca cc t chc quc t khc m
Vit Nam l thnh vin hoc cng nhn.
38. Sinh kh dng l c tnh biu th tc v mc hp thu ca dc cht hoc cht
c tc dng t mt thuc vo c th dc cht hoc cht c tc dng xut hin ti
ni c tc dng trong c th.
39. Tng ng sinh hc l s tng t nhau v sinh kh dng gia hai thuc khi c
so snh trong cng mt iu kin th nghim.
40. Dc lm sng l hot ng nghin cu khoa hc v thc hnh dc v t vn s
dng thuc hp l, an ton, hiu qu nhm ti u ha vic s dng thuc.
41. Cnh gic dc l vic pht hin, nh gi v phng trnh cc bt li lin quan n
qu trnh s dng thuc.
42. Bao b tip xc trc tip vi thuc l bao b cha ng thuc, tip xc trc tip vi
thuc, to ra hnh khi hoc bc kn theo hnh khi ca thuc.
43. Kinh doanh dc l vic thc hin mt, mt s hoc tt c cc cng on ca qu
trnh u t, t sn xut n tiu th sn phm hoc cung ng dch v lin quan n
thuc v nguyn liu lm thuc trn th trng nhm mc ch sinh li.
iu 3. D tr quc gia v thuc, nguyn liu lm thuc
1. Nh nc thc hin d tr quc gia v thuc v nguyn liu lm thuc s dng
trong trng hp sau y:
a) Phng, chng dch bnh v khc phc hu qu thin tai, thm ha;
b) Bo m quc phng, an ninh;

c) Phng, chn on v iu tr cc bnh him gp;
d) Thuc khng sn c.
2. Vic xy dng, t chc, qun l, iu hnh v s dng thuc, nguyn liu lm thuc
d tr quc gia thc hin theo quy nh ca php lut v d tr quc gia.
iu 4. C quan qun l nh nc v dc
1. Chnh ph thng nht qun l nh nc v dc.
2. B Y t chu trch nhim trc Chnh ph thc hin qun l nh nc v dc.
3. B, c quan ngang b trong phm vi nhim v, quyn hn ca mnh thc hin qun l
nh nc v dc v phi hp vi B Y t trong vic thc hin qun l nh nc v dc
theo phn cng ca Chnh ph.
4. y ban nhn dn cc cp trong phm vi nhim v, quyn hn ca mnh thc hin qun
l nh nc v dc ti a phng.
iu 5. Hi v dc
1. Hi v dc l t chc x hi - ngh nghip hot ng trong lnh vc dc.
2. T chc, c nhn hot ng trong lnh vc dc c quyn tham gia v thnh lp hi v
dc.
3. T chc v hot ng ca hi v dc c thc hin theo quy nh ca Lut ny v
php lut v hi.
4. Hi v dc c cc trch nhim v quyn hn sau y:
a) Ban hnh quy tc o c ngh nghip trong hnh ngh dc trn c s nguyn tc
o c hnh ngh dc do B trng B Y t ban hnh;
b) Tham gia xy dng, t chc trin khai, gim st thi hnh vn bn quy phm php lut
v dc;
c) Tham gia gim st vic hnh ngh dc, thc hin o c hnh ngh dc v phn
bin x hi hot ng lin quan n dc;
d) Tham gia o to, cp nht kin thc chuyn mn v dc;
) Tham gia Hi ng t vn cp Chng ch hnh ngh dc.
iu 6. Nhng hnh vi b nghim cm
1. Kinh doanh dc m khng c Giy chng nhn iu kin kinh doanh dc hoc
trong thi gian b nh ch hot ng hoc trong thi gian b tc quyn s dng Giy
chng nhn iu kin kinh doanh dc.
2. Kinh doanh dc ti ni khng phi l a im kinh doanh dc ng k.
3. Kinh doanh thuc, nguyn liu lm thuc quy nh ti khon 26 iu 2 ca Lut ny
v thuc, nguyn liu lm thuc khc khng ng mc ch hoc cung cp khng ng
i tng m c quan qun l nh nc c thm quyn cho php.
4. Kinh doanh dc khng thuc phm vi chuyn mn c ghi trong Giy chng nhn
iu kin kinh doanh dc.
5. Kinh doanh dc thuc mt trong cc trng hp sau y:
a) Thuc gi, nguyn liu lm thuc gi;
b) Thuc, nguyn liu lm thuc khng t tiu chun cht lng; thuc, nguyn liu lm
thuc c thng bo thu hi ca c quan nh nc c thm quyn; thuc, nguyn liu
lm thuc khng r ngun gc, xut x; thuc, nguyn liu lm thuc ht hn dng;
c) Thuc, nguyn liu lm thuc thuc danh mc thuc, nguyn liu lm thuc cm nhp
khu, cm sn xut;
d) Thuc th lm sng;
) Thuc, nguyn liu lm thuc lm mu ng k, kim nghim, nghin cu khoa
hc, tham gia trng by ti trin lm, hi ch;
e) Thuc, nguyn liu lm thuc cha c php lu hnh;
g) Thuc thuc chng trnh mc tiu quc gia, thuc vin tr v thuc khc c quy nh
khng c bn;
h) Bn l thuc k n m khng c n thuc; bn l vc xin;
i) Bn thuc cao hn gi k khai, gi nim yt.
6. Lm gi, sa cha h s, giy t, ti liu, giy chng nhn ca c quan, t chc c
thm quyn v t chc, c nhn trong cc hot ng v dc.
7. Thay i, sa cha hn dng ca thuc, tr trng hp thay i hn dng ca thuc
quy nh ti khon 3 iu 61 ca Lut ny.
8. Hnh ngh m khng c Chng ch hnh ngh dc hoc trong thi gian b tc quyn
s dng Chng ch hnh ngh dc ti v tr cng vic quy nh ti iu 11 ca Lut ny.
9. Thu, mn, cho thu, cho mn hoc cho ngi khc s dng Chng ch hnh ngh
dc, Giy chng nhn iu kin kinh doanh dc hnh ngh hoc kinh doanh
dc.
10. Qung co trong trng hp sau y:
a) Qung co thuc khi cha c c quan qun l nh nc c thm quyn xc nhn ni
dung hoc khng ng vi ni dung c xc nhn;
b) S dng chng nhn cha c B Y t cng nhn, s dng li ch vt cht, li dng
danh ngha ca t chc, c nhn, cc loi biu tng, hnh nh, a v, uy tn, th tn, th
cm n qung co thuc;
c) S dng kt qu nghin cu lm sng, kt qu nghin cu tin lm sng, kt qu kim
nghim, kt qu th tng ng sinh hc cha c B Y t cng nhn qung co
thuc.
11. Khuyn mi thuc tri quy nh ca php lut.
12. Li dng vic k n thuc trc li.
13. Sn xut, pha ch, bn thuc c truyn c kt hp vi dc cht khi cha c php
ca c quan qun l nh nc c thm quyn.
14. Cp pht, bn thuc ht hn dng, thuc bo qun khng ng quy nh ghi trn
nhn thuc, thuc c thng bo thu hi ca c quan nh nc c thm quyn, thuc
khng r ngun gc, xut x cho ngi s dng.
15. Thng tin, qung co, tip th, k n, t vn, ghi nhn, hng dn s dng c ni
dung dng phng bnh, cha bnh, chn on bnh, iu tr bnh, gim nh bnh, iu
chnh chc nng sinh l c th ngi i vi sn phm khng phi l thuc, tr trang
thit b y t.
16. Xut khu dc liu thuc danh mc loi, chng loi dc liu qu, him, c hu
phi kim sot khi cha c php ca c quan qun l nh nc c thm quyn.
Chng II
CHNH SCH CA NH NC V DC V PHT TRIN CNG NGHIP
DC
iu 7. Chnh sch ca Nh nc v dc
1. Bo m cung ng , kp thi thuc c cht lng, gi hp l cho nhu cu phng

bnh, cha bnh ca Nhn dn, ph hp vi c cu bnh tt v yu cu quc phng, an
ninh, phng, chng dch bnh, khc phc hu qu thin tai, thm ha v thuc him.
2. Bo m s dng thuc hp l, an ton, hiu qu; u tin pht trin hot ng dc
lm sng v cnh gic dc.
3. u i u t sn xut thuc, nguyn liu lm thuc, thuc thit yu, thuc phng,
chng bnh x hi, vc xin, sinh phm, thuc dc liu, thuc c truyn, thuc him; u
i nghin cu khoa hc v cng ngh bo ch, cng ngh sinh hc sn xut cc loi
thuc mi.
4. i vi thuc mua t ngun vn ngn sch nh nc, qu bo him y t, ngun thu t
dch v khm bnh, cha bnh v cc ngun thu hp php khc ca c s y t cng lp
thc hin nh sau:
a) Khng cho thu thuc nhp khu thuc danh mc do B trng B Y t ban hnh
trn c s nhm tiu ch k thut khi thuc sn xut trong nc p ng yu cu v iu
tr, gi thuc v kh nng cung cp.
u tin mua thuc generic, sinh phm tng t u tin sn xut trong nc c cp
giy ng k lu hnh ti Vit Nam; thuc dc liu, thuc c truyn c sn xut t
ngun dc liu trong nc; thuc c s dng dc cht, t dc, v nang hoc bao b
tip xc trc tip vi thuc c sn xut bi c s trong nc p ng Thc hnh tt
sn xut; dc liu ti; thuc dc liu, thuc c truyn c sn xut trn c s nhim
v khoa hc v cng ngh cp quc gia, cp b hoc cp tnh;
b) Khng cho thu dc liu nhp khu thuc danh mc do B trng B Y t ban hnh
khi dc liu c nui trng, thu hi trong nc p ng yu cu v iu tr v kh
nng cung cp, gi hp l.
Chnh ph quy nh v gi hp l ti im ny;
c) u tin mua thuc thuc Danh mc sn phm quc gia.
5. To iu kin thun li v trnh t, th tc np n ng k lu hnh thuc generic sp
ht hn bng sng ch hoc c quyn c lin quan, sinh phm tng t u tin; u tin
v trnh t, th tc ng k lu hnh, cp php nhp khu thuc him, vc xin c
T chc Y t Th gii tin thm nh.
6. Kt hp u t ngn sch nh nc vi huy ng cc ngun lc khc cho pht trin
cng nghip sn xut vc xin, sinh phm, thuc dc liu, thuc c truyn, thuc sp ht
hn bng sng ch hoc c quyn c lin quan; nui trng, sn xut dc liu; pht hin,
bo tn v ng dng khoa hc, cng ngh trong nghin cu, pht trin ngun gen dc
liu qu, him, c hu.
7. H tr, to iu kin pht hin, th lm sng, ng k bo h quyn s hu tr tu c
lin quan, ng k lu hnh v k tha i vi thuc c truyn, thuc dc liu c ti
khoa hc v cng ngh cp quc gia, cp b hoc cp tnh c nghim thu; tm kim,
khai thc, s dng dc liu mi; xut khu dc liu nui trng; di thc dc liu; khai
thc dc liu thin nhin hp l; nghin cu, kho st, iu tra loi dc liu ph hp
nui trng ti a phng; pht trin cc vng nui trng dc liu; hin i ha sn
xut dc liu, thuc dc liu, thuc c truyn.
8. C chnh sch bo v b mt trong bo ch, ch bin v d liu th nghim lm sng
thuc c truyn; i ng hp l i vi ngi hin tng cho Nh nc bi thuc c truyn
qu; to iu kin cp chng ch hnh ngh y, dc c truyn cho ngi s hu bi
thuc gia truyn c B Y t cng nhn.
9. Khuyn khch chuyn giao cng ngh trong sn xut thuc; pht trin mng li lu
thng phn phi, chui nh thuc, bo qun v cung ng thuc theo hng chuyn
nghip, hin i v hiu qu, bo m cung ng kp thi, y thuc c cht lng, p
ng nhu cu s dng thuc ca Nhn dn; khuyn khch nh thuc, quy thuc hot ng
24/24 gi.
u i u t, h tr pht trin h thng cung ng thuc, c s bn l thuc lu ng cho
ng bo dn tc thiu s, ng bo min ni, hi o, vng c iu kin kinh t - x
hi c bit kh khn.
10. Huy ng c s y t thuc lc lng v trang nhn dn tham gia cung ng thuc v
nui trng dc liu nhm p ng nhu cu phng bnh, cha bnh ca Nhn dn ti
vng ng bo dn tc thiu s, min ni, hi o, vng c iu kin kinh t - x hi c
bit kh khn.
11. C chnh sch nng cao cht lng ngun nhn lc dc; u tin trong hnh ngh
dc i vi ngi c cp Chng ch hnh ngh dc theo hnh thc thi theo quy nh
ca Chnh ph.
iu 8. Lnh vc u tin trong pht trin cng nghip dc
1. Nghin cu sn xut nguyn liu lm thuc t ngun dc liu sn c ti Vit Nam
phc v cng nghip bo ch, sn xut thuc dc liu, thuc c truyn.
2. Sn xut thuc ngay khi ht hn bng sng ch hoc cc c quyn c lin quan, vc
xin, sinh phm, dc liu, thuc dc liu, thuc c truyn, thuc him.
3. Pht trin ngun dc liu, vng nui trng dc liu; bo tn ngun gen v pht trin
nhng loi, chng loi dc liu qu, him, c hu.
4. Cc hnh thc u i u t v h tr u t cho lnh vc u tin pht trin cng
nghip dc c thc hin theo quy nh ca php lut v u t.
iu 9. Quy hoch pht trin cng nghip dc
1. Quy hoch pht trin cng nghip dc bao gm cc quy hoch v sn xut, phn phi,
bo qun, kim nghim thuc, nguyn liu lm thuc, pht trin ngun dc liu lm
thuc v vng nui trng dc liu.
2. Quy hoch pht trin cng nghip dc phi p ng cc yu cu sau y:
a) Ph hp vi quy nh ca Lut ny v quy nh khc ca php lut c lin quan;
b) Ph hp vi chin lc pht trin kinh t - x hi ca t nc trong tng thi k; bo
v mi trng v pht trin bn vng;
c) nh hng tp trung, hin i ha v chuyn mn ha;
d) D bo khoa hc, p ng c yu cu thc t v ph hp vi xu th pht trin, hi
nhp quc t.
3. i vi quy hoch pht trin sn xut dc liu, thuc dc liu, thuc c truyn, quy
hoch pht trin ngun dc liu lm thuc v vng nui trng dc liu, ngoi quy nh
ti khon 2 iu ny cn phi p ng cc yu cu sau y:
a) Khai thc v s dng hp l ngun ti nguyn thin nhin; ph hp vi iu kin th
nhng, kh hu, sinh thi v iu kin t nhin, x hi ca tng a phng;
b) nh hng sn xut, bo ch dc liu quy m cng nghip, pht trin vng nui
trng dc liu, bo tn ngun gen v pht trin nhng loi, chng loi dc liu qu,
him, c hu trn c s tng cng u t k thut, cng ngh tin tin, kt hp vi
kinh nghim truyn thng.
4. Vic lp, ph duyt, qun l quy hoch pht trin cng nghip dc c thc hin
theo quy nh ca php lut.
iu 10. Trch nhim trong pht trin cng nghip dc
1. B Y t c cc trch nhim sau y:
a) Ch tr, phi hp vi b, c quan ngang b, c quan thuc Chnh ph c lin quan ban
hnh theo thm quyn hoc trnh cp c thm quyn ban hnh v t chc trin khai thc
hin vn bn quy phm php lut, chin lc, chnh sch, quy hoch, k hoch pht trin
cng nghip dc;
b) Ch tr, phi hp vi B Gio dc v o to xy dng k hoch o to, s dng
nhn lc i vi hot ng nghin cu, sn xut thuc generic, vc xin, sinh phm, thuc
dc liu, thuc c truyn, thuc him;
c) Ch tr, phi hp vi B Ti nguyn v Mi trng, B Nng nghip v Pht trin
nng thn v cc c quan c lin quan trong vic quy hoch pht trin vng nui trng
dc liu, t chc trin khai cc bin php bo tn, khai thc, s dng hp l v bn
vng ngun dc liu;
d) Ch tr, phi hp vi B Nng nghip v Pht trin nng thn v b, c quan ngang b,
c quan thuc Chnh ph c lin quan ban hnh danh mc loi, chng loi dc liu qu,
him, c hu phi kim sot.
2. B Cng thng c trch nhim ch tr, phi hp vi b, c quan ngang b, c quan
thuc Chnh ph c lin quan ban hnh theo thm quyn hoc trnh cp c thm quyn
ban hnh v t chc trin khai thc hin vn bn quy phm php lut, quy hoch, k
hoch v pht trin cng nghip ha dc.
3. B Nng nghip v Pht trin nng thn c cc trch nhim sau y:
a) Ch tr, phi hp vi B Y t, B Khoa hc v Cng ngh trong vic nghin cu khoa
hc trong chn, to ging, nui trng v thu hi dc liu; nghin cu v ph bin k
thut nui trng, phng, chng bnh hi trn cy thuc, ng vt lm thuc;
b) Ch tr, phi hp vi b, c quan ngang b, c quan thuc Chnh ph c lin quan
trnh Chnh ph ban hnh chnh sch c th v ging, vn v cng ngh trong pht trin
nui trng, khai thc dc liu.
4. B Ti nguyn v Mi trng c trch nhim ch tr, phi hp vi b, c quan ngang
b, c quan thuc Chnh ph c lin quan trnh Chnh ph ban hnh chnh sch v tip
cn ngun gen dc liu v chia s li ch t vic s dng ngun gen dc liu.
5. B K hoch v u t c cc trch nhim sau y:
a) B tr v cn i cc ngun lc u t cho pht trin cng nghip dc, vn ng cc
ngun vn nc ngoi u tin dnh cho pht trin cng nghip dc;
b) Ch tr, phi hp vi B Ti chnh v b, c quan ngang b, c quan thuc Chnh ph
c lin quan xy dng v trnh cp c thm quyn ban hnh cc quy nh c th chnh
sch u i u t, h tr u t trong lnh vc dc quy nh ti iu 8 ca Lut ny.
6. B Ti chnh c cc trch nhim sau y:

a) Ch tr, phi hp vi b, c quan ngang b, c quan thuc Chnh ph c lin quan xy
dng c ch ti chnh, huy ng v bo m ngun lc thc hin quy hoch, k hoch
pht trin cng nghip dc trnh cp c thm quyn ph duyt;
b) Ch tr, phi hp vi B Cng Thng, B Quc phng, B Y t, y ban nhn dn
cp tnh ni c ca khu v bin gii trong vic qun l, kim sot nhp khu thuc,
nguyn liu lm thuc cha c php lu hnh, nhp khu dc liu cha c php
ca c quan nh nc c thm quyn, xut khu dc liu thuc danh mc loi, chng
loi dc liu qu, him, c hu phi kim sot.
7. B Khoa hc v Cng ngh c cc trch nhim sau y:
a) Trnh cp c thm quyn hoc b tr theo thm quyn kinh ph t ngn sch nh nc
hng nm cho hot ng khoa hc v cng ngh trin khai nghin cu v a vo ng
dng kt qu nghin cu trong sn xut thuc, c bit i vi thuc thuc Danh mc sn
phm quc gia;
b) Ch tr, phi hp vi B Nng nghip v Pht trin nng thn, B Y t t chc nghin
cu, bo tn ngun gen v pht trin ngun dc liu qu, him, c hu;
c) Ch tr, phi hp vi B Y t xy dng c ch, chnh sch bo h s hu tr tu i vi
thuc c truyn.
8. y ban nhn dn cp tnh c cc trch nhim sau y:
a) Lp, ph duyt quy hoch, k hoch pht trin cng nghip dc, pht trin dc liu
(bao gm c vic khai thc v bo tn ngun dc liu t nhin) ca a phng ph hp
vi quy hoch, k hoch pht trin cng nghip dc cp quc gia, mc tiu pht trin
kinh t - x hi v li th ca a phng;
b) B tr qu t cho xy dng nh my, khu cng nghip dc; u tin b tr giao t
cho d n pht trin ngun dc liu lm thuc, vng nui trng dc liu theo quy nh
ca php lut v t ai.
Chng III
HNH NGH DC
Mc 1. CHNG CH HNH NGH DC
iu 11. V tr cng vic phi c Chng ch hnh ngh dc
1. Ngi chu trch nhim chuyn mn v dc ca c s kinh doanh dc.
2. Ngi ph trch v bo m cht lng ca c s sn xut thuc, nguyn liu lm

thuc.
3. Ngi ph trch cng tc dc lm sng ca c s khm bnh, cha bnh.
iu 12. Cp, cp li, iu chnh ni dung Chng ch hnh ngh dc
1. Cp Chng ch hnh ngh dc c thc hin theo hnh thc xt duyt cho ngi
ngh hoc hnh thc thi cho ngi c nhu cu v p dng i vi trng hp sau y:
a) Ngi ngh cp Chng ch hnh ngh dc ln u;
b) Ngi c cp Chng ch hnh ngh dc nhng Chng ch hnh ngh dc b
thu hi theo quy nh ti iu 28 ca Lut ny.
Trng hp b thu hi Chng ch hnh ngh dc theo quy nh ti khon 4, 6, 10 hoc
11 iu 28 ca Lut ny th Chng ch hnh ngh dc ch c cp sau 12 thng k t
ngy b thu hi.
2. Cp li Chng ch hnh ngh dc p dng i vi trng hp b mt hoc h hng.
3. iu chnh ni dung Chng ch hnh ngh dc p dng i vi trng hp ngi
c cp Chng ch hnh ngh dc nhng c thay i phm vi hnh ngh, hnh thc
cp Chng ch hnh ngh dc hoc thng tin ca ngi c cp Chng ch hnh ngh
dc.
iu 13. iu kin cp Chng ch hnh ngh dc
1. C vn bng, chng ch, giy chng nhn chuyn mn (sau y gi chung l vn bng
chuyn mn) c cp hoc cng nhn ti Vit Nam ph hp vi v tr cng vic v c
s kinh doanh dc bao gm:
a) Bng tt nghip i hc ngnh dc (sau y gi l Bng dc s);
b) Bng tt nghip i hc ngnh y a khoa;
c) Bng tt nghip i hc ngnh y hc c truyn hoc i hc ngnh dc c truyn;
d) Bng tt nghip i hc ngnh sinh hc;
) Bng tt nghip i hc ngnh ha hc;
e) Bng tt nghip cao ng ngnh dc;
g) Bng tt nghip trung cp ngnh dc;
h) Bng tt nghip cao ng, trung cp ngnh y;
i) Bng tt nghip trung cp y hc c truyn hoc dc c truyn;

k) Vn bng, chng ch s cp dc;
l) Giy chng nhn v lng y, giy chng nhn v lng dc, giy chng nhn bi
thuc gia truyn hoc vn bng, chng ch, giy chng nhn khc v y dc c truyn
c cp trc ngy Lut ny c hiu lc.
Vic p dng iu kin v vn bng, chng ch, giy chng nhn quy nh ti im l
khon ny do B trng B Y t quy nh ph hp vi iu kin pht trin kinh t - x
hi v nhu cu khm bnh, cha bnh ca Nhn dn tng a phng trong tng thi
k.
2. C thi gian thc hnh ti c s kinh doanh dc, b phn dc ca c s khm bnh,
cha bnh, trng o to chuyn ngnh dc, c s nghin cu dc, c s kim
nghim thuc, nguyn liu lm thuc, c quan qun l v dc hoc vn phng i din
ca thng nhn nc ngoi hot ng trong lnh vc dc ti Vit Nam (sau y gi
chung l c s dc); c s khm bnh, cha bnh ph hp vi chuyn mn ca ngi
hnh ngh theo quy nh sau y:
a) i vi ngi b thu hi Chng ch hnh ngh dc theo quy nh ti khon 9 iu 28
ca Lut ny th khng yu cu thi gian thc hnh nhng phi cp nht kin thc
chuyn mn v dc;
b) i vi ngi c trnh chuyn khoa sau i hc ph hp vi phm vi hnh ngh th
c gim thi gian thc hnh theo quy nh ca Chnh ph;
c) i vi ngi c vn bng chuyn mn quy nh ti im l khon 1 iu 13 ca Lut
ny th thi gian thc hnh theo quy nh ca B trng B Y t.
3. C giy chng nhn sc khe hnh ngh dc do c s y t c thm quyn cp.
4. Khng thuc mt trong cc trng hp sau y:
a) ang b truy cu trch nhim hnh s, ang chp hnh bn n, quyt nh ca Ta n;
trong thi gian b cm hnh ngh, cm lm cng vic lin quan n hot ng dc theo
bn n, quyt nh ca Ta n;
b) B hn ch nng lc hnh vi dn s.
5. i vi ngi t nguyn xin cp Chng ch hnh ngh dc theo hnh thc thi, phi
p ng iu kin theo quy nh ti iu ny.
iu 14. iu kin cp Chng ch hnh ngh dc ti Vit Nam i vi ngi nc
ngoi v ngi Vit Nam nh c nc ngoi
1. C iu kin theo quy nh ti iu 13 ca Lut ny.

2. p ng yu cu v s dng ngn ng trong hnh ngh dc theo quy nh ca B
trng B Y t.
iu 15. iu kin i vi ngi chu trch nhim chuyn mn v dc v ngi
ph trch v bo m cht lng ca c s sn xut thuc, nguyn liu lm thuc
1. iu kin i vi ngi chu trch nhim chuyn mn v dc ca c s sn xut
thuc, nguyn liu lm thuc l dc cht, t dc, v nang c quy nh nh sau:
a) Ngi chu trch nhim chuyn mn v dc ca c s sn xut thuc phi c vn
bng chuyn mn quy nh ti im a khon 1 iu 13 ca Lut ny v c 05 nm thc
hnh chuyn mn ti c s dc ph hp, tr trng hp quy nh ti im c khon ny;
b) Ngi chu trch nhim chuyn mn v dc ca c s sn xut nguyn liu lm thuc
l dc cht, t dc, v nang phi c vn bng chuyn mn quy nh ti im a hoc
im khon 1 iu 13 ca Lut ny v c 03 nm thc hnh chuyn mn ti c s dc
ph hp;
c) Ngi chu trch nhim chuyn mn v dc ca c s sn xut vc xin, sinh phm v
nguyn liu sn xut vc xin, sinh phm phi c mt trong cc vn bng chuyn mn quy
nh ti im a, b hoc d khon 1 iu 13 ca Lut ny v c 05 nm thc hnh chuyn
mn ti c s dc ph hp.
2. iu kin i vi ngi ph trch v bo m cht lng ca c s sn xut thuc,
nguyn liu lm thuc l dc cht, t dc, v nang c quy nh nh sau:
a) Ngi ph trch v bo m cht lng ca c s sn xut thuc phi c vn bng
chuyn mn quy nh ti im a khon 1 iu 13 ca Lut ny v c 05 nm thc hnh
chuyn mn ti c s sn xut thuc hoc c s kim nghim thuc, tr trng hp quy
nh ti im b v im c khon ny;
b) Ngi ph trch v bo m cht lng ca c s sn xut vc xin, sinh phm phi c
mt trong cc vn bng chuyn mn quy nh ti im a, b hoc d khon 1 iu 13 ca
Lut ny v c 05 nm thc hnh chuyn mn ti c s sn xut hoc kim nghim vc
xin, sinh phm y t;
c) Ngi ph trch v bo m cht lng ca c s sn xut nguyn liu lm thuc l
dc cht, t dc, v nang phi c vn bng chuyn mn quy nh ti im a hoc im
khon 1 iu 13 ca Lut ny v c 03 nm thc hnh chuyn mn ti c s sn xut
thuc, nguyn liu lm thuc hoc c s kim nghim thuc.
3. iu kin i vi ngi chu trch nhim chuyn mn v dc v ngi ph trch v

bo m cht lng ca c s sn xut dc liu c quy nh nh sau:
a) Ngi chu trch nhim chuyn mn v dc, ngi ph trch v bo m cht lng
ca c s sn xut dc liu phi c vn bng chuyn mn quy nh ti im a hoc im
c khon 1 iu 13 ca Lut ny v c 02 nm thc hnh chuyn mn ti c s dc ph
hp, tr trng hp quy nh ti im b khon ny;
b) Ngi chu trch nhim chuyn mn v dc, ngi ph trch v bo m cht lng
ca h kinh doanh, hp tc x sn xut dc liu phi c mt trong cc vn bng chuyn
mn quy nh ti im a, c, e, g, i hoc l khon 1 iu 13 ca Lut ny v c 02 nm
thc hnh chuyn mn ti c s dc ph hp, tr trng hp quy nh ti im c khon
2 iu 13 ca Lut ny;
c) Ngi chu trch nhim chuyn mn v dc c th ng thi l ngi ph trch v
bo m cht lng ca c s sn xut dc liu.
bn bun thuc, nguyn liu lm thuc
1. Ngi chu trch nhim chuyn mn v dc ca c s bn bun thuc, nguyn liu
lm thuc phi c vn bng chuyn mn quy nh ti im a khon 1 iu 13 ca Lut
ny v c 02 nm thc hnh chuyn mn ti c s dc ph hp, tr trng hp quy
nh ti khon 2 v khon 3 iu ny.
2. Ngi chu trch nhim chuyn mn v dc ca c s bn bun vc xin, sinh phm
phi c mt trong cc vn bng chuyn mn quy nh ti im a, b hoc d khon 1 iu
13 ca Lut ny v c 02 nm thc hnh chuyn mn ti c s dc ph hp.
3. Ngi chu trch nhim chuyn mn v dc ca c s bn bun dc liu, thuc
dc liu, thuc c truyn phi c mt trong cc vn bng chuyn mn quy nh ti im
a, c, i hoc l khon 1 iu 13 ca Lut ny v c 02 nm thc hnh chuyn mn ti c s
dc ph hp, tr trng hp quy nh ti im c khon 2 iu 13 ca Lut ny.
xut khu, nhp khu thuc, nguyn liu lm thuc
1. Ngi chu trch nhim chuyn mn v dc ca c s xut khu, nhp khu thuc,
nguyn liu lm thuc phi c vn bng chuyn mn quy nh ti im a khon 1 iu 13
ca Lut ny v c 02 nm thc hnh chuyn mn ti c s dc ph hp, tr trng hp
quy nh ti khon 2 v khon 3 iu ny.
2. Ngi chu trch nhim chuyn mn v dc ca c s xut khu, nhp khu vc xin,
sinh phm phi c mt trong cc vn bng chuyn mn quy nh ti im a, b hoc d
khon 1 iu 13 ca Lut ny v c 02 nm thc hnh chuyn mn ti c s dc ph
hp.
3. Ngi chu trch nhim chuyn mn v dc ca c s xut khu, nhp khu dc
liu, thuc dc liu, thuc c truyn phi c vn bng chuyn mn quy nh ti im a
hoc im c khon 1 iu 13 ca Lut ny v c 02 nm thc hnh chuyn mn ti c s
dc ph hp.
bn l thuc
1. Ngi chu trch nhim chuyn mn v dc ca nh thuc phi c vn bng chuyn
mn quy nh ti im a khon 1 iu 13 ca Lut ny v c 02 nm thc hnh chuyn
mn ti c s dc ph hp. Ngi chu trch nhim chuyn mn v dc ca nh thuc
c th ng thi l ngi lm cng tc dc lm sng ti nh thuc.
2. Ngi chu trch nhim chuyn mn v dc ca quy thuc phi c mt trong cc
vn bng chuyn mn quy nh ti im a, e hoc g khon 1 iu 13 ca Lut ny v c
18 thng thc hnh chuyn mn ti c s dc ph hp.
3. Ngi chu trch nhim chuyn mn v dc ca t thuc trm y t x phi c mt
trong cc vn bng chuyn mn quy nh ti im a, e, g hoc k khon 1 iu 13 ca
Lut ny v c 01 nm thc hnh chuyn mn ti c s dc ph hp hoc c s khm
bnh, cha bnh; trng hp trm y t x vng ng bo dn tc thiu s, min ni, hi
o, vng c iu kin kinh t - x hi c bit kh khn m cha c ngi p ng mt
trong cc vn bng chuyn mn quy nh ti im a, e, g hoc k khon 1 iu 13 ca
Lut ny th phi c vn bng chuyn mn quy nh ti im b hoc im h khon 1 iu
13 ca Lut ny v c 01 nm thc hnh chuyn mn ti c s khm bnh, cha bnh.
4. Ngi chu trch nhim chuyn mn v dc ca c s chuyn bn l dc liu, thuc
dc liu, thuc c truyn phi c mt trong cc vn bng chuyn mn quy nh ti im
a, c, e, g, i hoc l khon 1 iu 13 ca Lut ny v c 01 nm thc hnh chuyn mn ti
c s dc hoc c s khm bnh, cha bnh bng y hc c truyn, tr trng hp quy
nh ti im c khon 2 iu 13 ca Lut ny.
kinh doanh dch v kim nghim thuc, nguyn liu lm thuc
1. Ngi chu trch nhim chuyn mn v dc ca c s kinh doanh dch v kim

nghim thuc, nguyn liu lm thuc phi c vn bng chuyn mn quy nh ti im a
khon 1 iu 13 ca Lut ny v c 03 nm thc hnh chuyn mn ti c s dc ph
hp, tr trng hp quy nh ti khon 2 iu ny.
2. Ngi chu trch nhim chuyn mn v dc ca c s kinh doanh dch v kim
nghim vc xin, sinh phm phi c mt trong cc vn bng chuyn mn quy nh ti
im a, b hoc d khon 1 iu 13 ca Lut ny v c 03 nm thc hnh chuyn mn ti
c s dc ph hp.
kinh doanh dch v th thuc trn lm sng, th tng ng sinh hc ca thuc
1. Ngi chu trch nhim chuyn mn v dc ca c s kinh doanh dch v th thuc
trn lm sng, th tng ng sinh hc ca thuc phi c vn bng chuyn mn quy
nh ti im a hoc im b khon 1 iu 13 ca Lut ny v c 03 nm thc hnh
chuyn mn ti c s dc ph hp hoc bnh vin, vin c ging bnh, tr trng hp
quy nh ti khon 2 iu ny.
2. Ngi chu trch nhim chuyn mn v dc ca c s kinh doanh dch v th thuc
trn lm sng, th tng ng sinh hc ca thuc dc liu, thuc c truyn phi c
mt trong cc vn bng chuyn mn quy nh ti im a, b hoc c khon 1 iu 13 ca
Lut ny v c 03 nm thc hnh chuyn mn ti c s dc ph hp hoc bnh vin,
vin c ging bnh.
iu 21. iu kin i vi ngi ph trch cng tc dc lm sng ca c s khm
bnh, cha bnh
1. Ngi ph trch cng tc dc lm sng ca c s khm bnh, cha bnh phi c vn
bng chuyn mn quy nh ti im a khon 1 iu 13 ca Lut ny v c 02 nm thc
hnh chuyn mn ti c s dc ph hp hoc bnh vin, vin c ging bnh, tr
trng hp quy nh ti khon 2 iu ny.
2. Ngi ph trch cng tc dc lm sng ca c s khm bnh, cha bnh bng y hc
c truyn phi c vn bng chuyn mn quy nh ti im c khon 1 iu 13 ca Lut
ny v c 02 nm thc hnh chuyn mn ti bnh vin, vin c ging bnh c hot ng
y hc c truyn.
kinh doanh dch v bo qun thuc, nguyn liu lm thuc
1. Ngi chu trch nhim chuyn mn v dc ca c s kinh doanh dch v bo qun

thuc, nguyn liu lm thuc phi c vn bng chuyn mn quy nh ti im a khon 1
iu 13 ca Lut ny v c 02 nm thc hnh chuyn mn ti c s dc ph hp, tr
trng hp quy nh ti khon 2 iu ny.
2. Ngi chu trch nhim chuyn mn v dc ca c s kinh doanh dch v bo qun
vc xin, sinh phm phi c mt trong cc vn bng chuyn mn quy nh ti im a, b
hoc d khon 1 iu 13 ca Lut ny v c 02 nm thc hnh chuyn mn ti c s dc
ph hp.
iu 23. Thm quyn cp, cp li, iu chnh ni dung, thu hi Chng ch hnh
ngh dc
1. Gim c S Y t cp, cp li, iu chnh ni dung, thu hi Chng ch hnh ngh dc
theo hnh thc xt duyt.
Gim c S Y t thnh lp Hi ng t vn cp Chng ch hnh ngh dc c s tham
gia ca i din hi v dc t vn cho Gim c S Y t trong vic cp, cp li, thu
hi Chng ch hnh ngh dc.
2. B Y t cp Chng ch hnh ngh dc theo hnh thc thi.
iu 24. H s ngh cp Chng ch hnh ngh dc
1. n ngh cp Chng ch hnh ngh dc c nh chn dung ca ngi ngh c
chp trong thi gian khng qu 06 thng.
2. Bn sao c chng thc vn bng chuyn mn.
3. Giy chng nhn sc khe hnh ngh dc do c s y t c thm quyn cp.
4. Giy xc nhn v thi gian thc hnh chuyn mn do ngi ng u c s ni ngi
thc hnh cp.
5. Giy xc nhn hon thnh chng trnh o to, cp nht kin thc chuyn mn v
dc i vi trng hp b thu hi Chng ch hnh ngh dc quy nh ti khon 9
iu 28 ca Lut ny.
6. Bn sao c chng thc cn cc cng dn, giy chng minh nhn dn hoc h chiu.
7. Phiu l lch t php. Trng hp l ngi nc ngoi, ngi Vit Nam nh c
nc ngoi phi c l lch t php hoc vn bn xc nhn hin khng phi l ngi phm
ti hoc b truy cu trch nhim hnh s, khng thuc trng hp b cm hnh ngh, cm
lm cng vic lin quan n hot ng dc theo bn n, quyt nh ca Ta n do c
quan c thm quyn ca nc ngoi cp.
8. Trng hp cp Chng ch hnh ngh dc do b thu hi theo quy nh ti khon 3

iu 28 ca Lut ny th ngi ngh cp Chng ch hnh ngh dc ch cn np n
theo quy nh ti khon 1 iu ny.
iu 25. H s ngh cp li Chng ch hnh ngh dc
1. n ngh cp li Chng ch hnh ngh dc c nh chn dung ca ngi ngh
c chp trong thi gian khng qu 06 thng.
2. Bn sao Chng ch hnh ngh dc c cp, trng hp b mt phi c cam kt
ca ngi ngh cp li.
iu 26. H s ngh iu chnh ni dung Chng ch hnh ngh dc
1. n ngh iu chnh ni dung Chng ch hnh ngh dc c nh chn dung ca
ngi ngh c chp trong thi gian khng qu 06 thng.
2. Bn sao cc giy t chng minh ni dung thay i.
3. Bn sao Chng ch hnh ngh dc cp.
iu 27. Th tc cp, cp li, iu chnh ni dung Chng ch hnh ngh dc
1. Ngi ngh cp Chng ch hnh ngh dc np h s n c quan cp Chng ch
hnh ngh dc.
Trong thi hn 20 ngy k t ngy nhn h s ngh cp; 10 ngy k t ngy nhn
h s ngh cp li, iu chnh ni dung Chng ch hnh ngh dc, ngi ng u
c quan cp Chng ch hnh ngh dc cp Chng ch hnh ngh dc; trng hp
khng cp, phi tr li bng vn bn v nu r l do.
2. Thi hn cp Chng ch hnh ngh dc theo quy nh ti khon 8 iu 24 ca Lut
ny l 05 ngy lm vic k t ngy nhn c n ngh.
iu 28. Cc trng hp thu hi Chng ch hnh ngh dc
1. Chng ch hnh ngh dc c cp khng ng thm quyn.
2. Ngi c cp Chng ch hnh ngh dc ngh thu hi Chng ch hnh ngh dc
ca mnh.
3. Chng ch hnh ngh dc b ghi sai do li ca c quan cp Chng ch hnh ngh
dc.
4. Gi mo giy t trong h s ngh cp Chng ch hnh ngh dc.
5. C nhn c t 02 Chng ch hnh ngh dc tr ln.
6. Ngi c chng ch hnh ngh cho thu, cho mn, thu, mn hoc cho ngi khc
s dng Chng ch hnh ngh dc.
7. Ngi c cp Chng ch hnh ngh dc khng p ng mt trong cc iu kin
c cp Chng ch hnh ngh dc quy nh ti iu 13 hoc khon 2 iu 14 ca Lut
ny.
8. Ngi c cp Chng ch hnh ngh dc m khng hnh ngh trong thi gian 12
thng lin tc.
9. Ngi hnh ngh dc khng c giy xc nhn hon thnh chng trnh o to, cp
nht kin thc chuyn mn v dc trong thi hn 03 nm k t ngy c cp Chng
ch hnh ngh dc hoc k t ngy c giy xc nhn hon thnh chng trnh o to,
cp nht kin thc chuyn mn v dc gn nht.
10. Vi phm o c ngh nghip trong hnh ngh dc gy hu qu n tnh mng hoc
nh hng nghim trng n sc khe con ngi.
11. b x pht vi phm hnh chnh bng hnh thc tc Chng ch hnh ngh dc t
02 ln tr ln i vi mt hnh vi vi phm.
iu 29. Qun l Chng ch hnh ngh dc
1. Mi c nhn ch c cp mt Chng ch hnh ngh dc. Trn Chng ch hnh ngh
dc ghi y phm vi hnh ngh m ngi c Chng ch hnh ngh dc p ng
iu kin v c php hnh ngh. Chng ch hnh ngh dc khng quy nh thi hn
hiu lc v c gi tr trong phm vi c nc.
Chng ch hnh ngh dc ht hiu lc khi ngi hnh ngh cht hoc mt tch theo
quyt nh, bn n ca Ta n hoc khng c giy xc nhn hon thnh o to, cp nht
kin thc chuyn mn v dc trong thi hn 03 nm k t ngy c cp Chng ch
hnh ngh dc hoc k t ngy c giy xc nhn hon thnh chng trnh o to, cp
nht kin thc chuyn mn v dc gn nht.
2. Vic tha nhn Chng ch hnh ngh dc gia cc nc c thc hin theo quy
nh ca tha thun quc t m Vit Nam l mt bn, iu c quc t m nc Cng
ha x hi ch ngha Vit Nam l thnh vin.
3. Ni dung c bn ca Chng ch hnh ngh dc bao gm:
a) Thng tin c nhn ca ngi hnh ngh dc;
b) Vn bng chuyn mn;
c) Hnh thc hnh ngh;
d) Phm vi hot ng chuyn mn;

) Hnh thc cp Chng ch hnh ngh dc theo hnh thc xt duyt hoc hnh thc thi;
thi gian thi trong trng hp cp theo hnh thc thi;
e) Ngy cp, c quan cp, ngy c hiu lc.
4. Chnh ph quy nh chi tit h s; th tc cp, cp li, iu chnh ni dung, thu hi v
mu Chng ch hnh ngh dc; c s o to, chng trnh, ni dung, thi gian o to,
cp nht kin thc chuyn mn v dc; chun ha vn bng chuyn mn v cc chc
danh ngh nghip; mu giy xc nhn hon thnh o to, cp nht kin thc chuyn
mn v dc; mu giy xc nhn v thi gian thc hnh v c s thc hnh chuyn mn
ph hp; thi gian thc hnh i vi ngi c trnh chuyn khoa sau i hc; vic cp
Chng ch hnh ngh dc theo hnh thc thi.
Mc 2. QUYN V NGHA V CA NGI HNH NGH DC
iu 30. Quyn ca ngi hnh ngh dc
1. c o to, cp nht kin thc, trao i thng tin chuyn mn, php lut v dc.
2. c cp Chng ch hnh ngh dc khi p ng iu kin quy nh ti Lut ny.
3. Ngi chu trch nhim chuyn mn ca c s kinh doanh dc c y quyn cho
ngi c Chng ch hnh ngh dc ph hp khi vng mt chu trch nhim chuyn
mn theo quy nh.
4. Ngi chu trch nhim chuyn mn v dc ca nh thuc c thay th thuc k
trong n thuc bng mt thuc khc c cng hot cht, cch dng, liu lng khi c s
ng ca ngi mua v phi chu trch nhim v vic thay i thuc.
5. T chi thc hin hot ng chuyn mn tri vi quy nh ca php lut hoc o c
ngh nghip.
iu 31. Ngha v ca ngi hnh ngh dc
1. Tun th o c ngh nghip trong hnh ngh dc.
2. Ngi chu trch nhim chuyn mn ca c s bn l thuc phi c mt trong ton b
thi gian hot ng ca c s dc, tr trng hp y quyn khi vng mt theo quy nh
ti khon 3 iu 30 ca Lut ny.
3. Ch chu trch nhim chuyn mn i vi mt c s kinh doanh dc v ti mt a
im kinh doanh dc.
4. Hnh ngh dc theo ng phm vi hot ng chuyn mn ghi trong Chng ch hnh
ngh dc v quy nh chuyn mn k thut.
5. Chp hnh quyt nh ca c quan nh nc c thm quyn trong trng hp c dch
bnh nguy him, thin tai, thm ha.
6. Hon thnh chng trnh o to, cp nht kin thc chuyn mn v dc trong thi
hn 03 nm k t ngy c cp Chng ch hnh ngh dc hoc k t ngy c giy xc
nhn hon thnh chng trnh o to, cp nht kin thc chuyn mn v dc gn nht.
7. Thng bo vi c quan, ngi c thm quyn v hnh vi vi phm php lut, o c
hnh ngh dc ca ngi hnh ngh dc khc v phi chu trch nhim v nhng
thng tin thng bo.
Chng IV
KINH DOANH DC
Mc 1. C S KINH DOANH DC V IU KIN KINH DOANH DC
iu 32. Hot ng kinh doanh dc v c s kinh doanh dc
1. Hot ng kinh doanh dc bao gm:
a) Kinh doanh thuc, nguyn liu lm thuc;
b) Kinh doanh dch v bo qun thuc, nguyn liu lm thuc;
c) Kinh doanh dch v kim nghim thuc, nguyn liu lm thuc;
d) Kinh doanh dch v th thuc trn lm sng;
) Kinh doanh dch v th tng ng sinh hc ca thuc.
2. C s kinh doanh dc bao gm:
a) C s sn xut thuc, nguyn liu lm thuc;
b) C s xut khu, nhp khu thuc, nguyn liu lm thuc;
c) C s kinh doanh dch v bo qun thuc, nguyn liu lm thuc;
d) C s bn bun thuc, nguyn liu lm thuc;
) C s bn l thuc bao gm nh thuc, quy thuc, t thuc trm y t x, c s chuyn
bn l dc liu, thuc dc liu, thuc c truyn;
e) C s kinh doanh dch v kim nghim thuc, nguyn liu lm thuc;
g) C s kinh doanh dch v th thuc trn lm sng;
h) C s kinh doanh dch v th tng ng sinh hc ca thuc.

iu 33. iu kin cp Giy chng nhn iu kin kinh doanh dc
1. iu kin v c s vt cht, k thut v nhn s c quy nh nh sau:
a) C s sn xut thuc, nguyn liu lm thuc phi c a im, nh xng sn xut,
phng kim nghim, kho bo qun thuc, nguyn liu lm thuc, h thng ph tr, trang
thit b, my mc sn xut, kim nghim, bo qun thuc, h thng qun l cht lng,
ti liu chuyn mn k thut v nhn s p ng Thc hnh tt sn xut thuc, nguyn
liu lm thuc;
b) C s nhp khu thuc, nguyn liu lm thuc, c s xut khu thuc, nguyn liu lm
thuc, c s kinh doanh dch v bo qun thuc, nguyn liu lm thuc phi c a im,
kho bo qun thuc, trang thit b bo qun, phng tin vn chuyn, h thng qun l
cht lng, ti liu chuyn mn k thut v nhn s p ng Thc hnh tt bo qun
thuc, nguyn liu lm thuc;
c) C s bn bun thuc, nguyn liu lm thuc phi c a im, kho bo qun thuc,
trang thit b bo qun, phng tin vn chuyn, h thng qun l cht lng, ti liu
chuyn mn k thut v nhn s p ng Thc hnh tt phn phi thuc, nguyn liu lm
thuc;
d) C s bn l thuc phi c a im, khu vc bo qun, trang thit b bo qun, ti liu
chuyn mn k thut v nhn s p ng Thc hnh tt c s bn l thuc; i vi c s
chuyn bn l dc liu, thuc dc liu, thuc c truyn thc hin theo quy nh ti
im b khon 2 iu 69 ca Lut ny;
) C s kinh doanh dch v kim nghim thuc, nguyn liu lm thuc phi c a im,
phng kim nghim ha hc, vi sinh hoc sinh hc, h thng ph tr, trang thit b kim
nghim, ha cht, thuc th, h thng qun l cht lng, ti liu chuyn mn k thut v
nhn s p ng Thc hnh tt phng th nghim i vi kim tra cht lng thuc;
e) C s kinh doanh dch v th thuc trn lm sng phi c a im, phng th nghim
lm sng, phng xt nghim, thit b xt nghim sinh ha, h thng qun l cht lng,
ti liu chuyn mn k thut v nhn s p ng Thc hnh tt th thuc trn lm sng;
g) C s kinh doanh dch v th tng ng sinh hc ca thuc phi c a im, phng
th nghim phn tch dch sinh hc, trang thit b th nghim dng trong phn tch dch
sinh hc, khu vc lu tr v theo di ngi s dng thuc phc v cho vic nh gi
tng ng sinh hc, h thng qun l cht lng, ti liu chuyn mn k thut v nhn
s p ng Thc hnh tt phng th nghim i vi giai on phn tch dch sinh hc v

Thc hnh tt th thuc trn lm sng i vi giai on nghin cu trn lm sng.
Trng hp c s kinh doanh dch v th tng ng sinh hc ca thuc ch p ng
Thc hnh tt phng th nghim i vi phn tch dch sinh hc th phi k hp ng
hoc lin kt vi c s th thuc trn lm sng p ng Thc hnh tt th thuc trn lm
sng thc hin giai on nghin cu trn lm sng trong th tng ng sinh hc ca
thuc.
2. Ngi chu trch nhim chuyn mn v dc v v tr cng vic quy nh ti iu 11
ca Lut ny phi c Chng ch hnh ngh dc ph hp vi c s kinh doanh dc quy
nh ti khon 2 iu 32 ca Lut ny.
3. Vic nh gi iu kin v c s vt cht, k thut v nhn s quy nh ti khon 1
iu ny c thc hin 03 nm mt ln hoc t xut theo quy nh ca B trng B
Y t hoc iu c quc t m nc Cng ha x hi ch ngha Vit Nam l thnh vin.
iu 34. iu kin kinh doanh i vi thuc phi kim sot c bit v thuc thuc
danh mc hn ch bn l
1. C s kinh doanh thuc phi kim sot c bit phi c c quan qun l nh nc
c thm quyn v dc chp thun bng vn bn. Vic chp thun c cn c trn c s
cc iu kin sau y:
a) C iu kin quy nh ti iu 33 ca Lut ny ph hp vi iu kin ca tng c
s kinh doanh;
b) C cc bin php v an ninh, bo m khng tht thot thuc, nguyn liu lm thuc
phi kim sot c bit;
c) Trng hp kinh doanh thuc phng x phi p ng cc iu kin theo quy nh ca
Lut nng lng nguyn t v cc vn bn quy phm php lut khc c lin quan.
2. C s bn l thuc c bn thuc thuc danh mc thuc hn ch bn l do B trng B
Y t ban hnh phi c cc iu kin quy nh ti im d khon 1 iu 33 ca Lut ny
v c S Y t chp thun bng vn bn. Vic chp thun c cn c vo c cu bnh
tt v kh nng cung ng thuc trn a bn tnh, thnh ph trc thuc trung ng theo
hng dn ca B trng B Y t.
3. Chnh ph quy nh trnh t, th tc cho php kinh doanh thuc phi kim sot c bit
v thuc thuc danh mc thuc hn ch bn l; bin php v an ninh, bo m khng tht
thot thuc, nguyn liu lm thuc phi kim sot c bit.
iu 35. C s c hot ng dc khng thuc din cp Giy chng nhn iu

kin kinh doanh dc
1. C s c hot ng dc khng thuc din cp Giy chng nhn iu kin kinh
doanh dc bao gm:
a) C s c hot ng dc nhng khng v mc ch thng mi;
b) C s kinh doanh c t chc k thuc;
c) C s nui trng, thu hi dc liu;
d) C s y t thuc lc lng v trang nhn dn c hot ng cung ng thuc ti vng
ng bo dn tc thiu s, min ni, hi o, vng c iu kin kinh t - x hi c bit
kh khn.
2. iu kin hot ng ca cc c s ti khon 1 iu ny c quy nh nh sau:
a) C s quy nh ti im a khon 1 iu ny phi tun th iu kin kinh doanh quy
nh ti khon 1 iu 33 ca Lut ny;
b) C s quy nh ti im b khon 1 iu ny phi l c s c ng k kinh doanh, c
iu kin bo qun thuc ph hp vi iu kin bo qun ghi trn nhn thuc, c ngi
chu trch nhim chuyn mn c vn bng chuyn mn s cp dc tr ln v ch c
bn thuc thuc Danh mc thuc c bn ti k thuc do B trng B Y t quy nh;
c) C s nui trng, thu hi dc liu phi tun th Thc hnh tt nui trng, thu hi
dc liu;
d) C s quy nh ti im d khon 1 iu ny phi c iu kin bo qun thuc ph hp
vi iu kin bo qun ghi trn nhn thuc v c ngi chu trch nhim chuyn mn c
vn bng chuyn mn s cp dc tr ln.
3. B trng B Y t quy nh chi tit iu ny.
Mc 2. GIY CHNG NHN IU KIN KINH DOANH DC
iu 36. Cp, cp li, iu chnh Giy chng nhn iu kin kinh doanh dc
1. Cp Giy chng nhn iu kin kinh doanh dc trong trng hp sau y:
a) C s ngh cp ln u;
b) C s c cp Giy chng nhn iu kin kinh doanh dc nhng thay i loi
hnh c s kinh doanh dc hoc thay i phm vi kinh doanh dc m lm thay i iu
kin kinh doanh; thay i a im kinh doanh dc;
c) C s c cp Giy chng nhn iu kin kinh doanh dc nhng b thu hi

theo quy nh ti iu 40 ca Lut ny.
2. Cp li Giy chng nhn iu kin kinh doanh dc trong trng hp sau y:
a) Giy chng nhn iu kin kinh doanh dc b mt, h hng;
b) Thng tin ghi trn Giy chng nhn iu kin kinh doanh dc b ghi sai do li ca
c quan cp Giy chng nhn iu kin kinh doanh dc.
3. iu chnh Giy chng nhn iu kin kinh doanh dc trong trng hp c s
thay i v tn c s, a ch kinh doanh, ngi qun l chuyn mn, thay i phm vi
kinh doanh dc m khng thay i iu kin kinh doanh dc.
iu 37. Thm quyn cp, cp li, iu chnh v thu hi Giy chng nhn iu
kin kinh doanh dc
1. B trng B Y t cp, cp li, iu chnh v thu hi Giy chng nhn iu kin
kinh doanh dc i vi c s kinh doanh dc quy nh ti cc im a, b, c, e, g v h
khon 2 iu 32 ca Lut ny.
2. Gim c S Y t cp, cp li, iu chnh v thu hi Giy chng nhn iu kin
kinh doanh dc i vi c s kinh doanh dc quy nh ti im d v im khon 2
iu 32 ca Lut ny.
iu 38. H s ngh cp, cp li, iu chnh Giy chng nhn iu kin kinh
doanh dc
1. H s ngh cp Giy chng nhn iu kin kinh doanh dc i vi trng hp
quy nh ti im a v im c khon 1 iu 36 ca Lut ny bao gm:
a) n ngh cp Giy chng nhn iu kin kinh doanh dc;
b) Ti liu k thut tng ng vi c s kinh doanh dc quy nh ti khon 2 iu 32
ca Lut ny;
c) Bn sao c chng thc Giy chng nhn ng k doanh nghip hoc ti liu php l
chng minh vic thnh lp c s;
d) Bn sao c chng thc Chng ch hnh ngh dc.
2. H s ngh cp Giy chng nhn iu kin kinh doanh dc i vi trng hp
quy nh ti im b khon 1 iu 36 ca Lut ny bao gm:
a) n ngh cp Giy chng nhn iu kin kinh doanh dc;
b) Ti liu k thut tng ng vi iu kin kinh doanh thay i;
chng minh vic thnh lp c s;
d) Bn sao c chng thc Chng ch hnh ngh dc.
3. H s ngh cp li Giy chng nhn iu kin kinh doanh dc bao gm:
a) n ngh cp li Giy chng nhn iu kin kinh doanh dc;
b) Giy chng nhn iu kin kinh doanh dc b ghi sai do li ca c quan cp i
vi trng hp quy nh ti im b khon 2 iu 36 ca Lut ny.
4. H s ngh iu chnh Giy chng nhn iu kin kinh doanh dc bao gm:
a) n ngh iu chnh Giy chng nhn iu kin kinh doanh dc;
b) Bn sao c chng thc Chng ch hnh ngh dc i vi cc trng hp thay i v
tr cng vic yu cu phi c Chng ch hnh ngh dc;
chng minh vic thay i trong trng hp thay i tn, a ch ca c s.
5. Chnh ph quy nh chi tit iu ny.
iu 39. Th tc cp, cp li, iu chnh Giy chng nhn iu kin kinh doanh
dc
1. H s ngh cp, cp li, iu chnh Giy chng nhn iu kin kinh doanh dc
np n c quan c thm quyn quy nh ti iu 37 ca Lut ny.
2. Trong thi hn 30 ngy k t ngy nhn h s ngh cp; 20 ngy k t ngy nhn
h s ngh cp li, iu chnh, B trng B Y t hoc Gim c S Y t t chc
nh gi v cp Giy chng nhn iu kin kinh doanh dc theo thm quyn; trng
hp khng cp, phi tr li bng vn bn v nu r l do.
Trng hp cp li do li ca c quan cp Giy chng nhn iu kin kinh doanh
dc th ngi ngh cp Giy chng nhn iu kin kinh doanh dc np h s
theo quy nh ti khon 3 iu 38 ca Lut ny. Thi hn cp li Giy chng nhn
iu kin kinh doanh dc l 07 ngy lm vic k t ngy nhn h s.
iu 40. Cc trng hp thu hi Giy chng nhn iu kin kinh doanh dc
1. Chm dt hot ng kinh doanh dc.
2. Khng p ng mt trong cc iu kin cp Giy chng nhn iu kin kinh doanh
dc quy nh ti iu 33 v iu 34 ca Lut ny.
3. Giy chng nhn iu kin kinh doanh dc c cp nhng khng ng thm

quyn hoc c ni dung tri php lut.
4. Khng hot ng trong thi gian 12 thng lin tc m khng thng bo vi c quan
qun l nh nc v dc.
iu 41. Qun l Giy chng nhn iu kin kinh doanh dc
1. Giy chng nhn iu kin kinh doanh dc khng quy nh thi hn hiu lc.
2. Chnh ph quy nh chi tit cc ni dung sau y:
a) H s, th tc cp, cp li, iu chnh, thu hi Giy chng nhn iu kin kinh
doanh dc;
b) a bn v phm vi kinh doanh i vi c s bn l l quy thuc, t thuc trm y t
x;
c) L trnh thc hin Thc hnh tt i vi loi hnh c s kinh doanh dc.
Mc 3. QUYN V TRCH NHIM CA C S KINH DOANH DC
iu 42. Quyn v trch nhim ca c s kinh doanh dc
1. C s kinh doanh dc c cc quyn sau y:
a) Thc hin mt, mt s hoc tt c hot ng kinh doanh dc nu p ng iu
kin tng ng vi tng loi hnh c s kinh doanh theo quy nh ca Lut ny;
b) Hng chnh sch u i khi thc hin hot ng kinh doanh dc theo quy nh ca
php lut;
c) c thng tin, qung co thuc theo quy nh ca php lut;
d) Thc hin chng trnh h tr thuc min ph cho c s khm bnh, cha bnh iu
tr cho bnh nhn theo quy nh ca B trng B Y t;
) T chc c s bn l thuc lu ng ti vng ng bo dn tc thiu s, min ni, hi
o, vng c iu kin kinh t - x hi c bit kh khn theo quy nh ca Chnh ph.
2. C s kinh doanh dc c cc trch nhim sau y:
a) Phi c Giy chng nhn iu kin kinh doanh dc v ch c kinh doanh ng
loi hnh c s kinh doanh, phm vi v a im kinh doanh ghi trong Giy chng nhn
iu kin kinh doanh dc;
b) Bo m duy tr cc iu kin kinh doanh dc trong qu trnh hot ng kinh doanh
theo quy nh ca Lut ny;
c) Thu hi thuc, nguyn liu lm thuc theo quy nh ti iu 62 ca Lut ny;

d) Bi thng thit hi cho t chc, c nhn b thit hi do li ca c s theo quy nh
ca php lut;
) Chp hnh quyt nh ca c quan nh nc c thm quyn trong trng hp bo m
cung ng thuc, nguyn liu lm thuc khi xy ra dch bnh nguy him, thin tai, thm
ha;
e) Bo co B Y t hoc S Y t v thc hin cc ngha v theo quy nh ca php lut
trong trng hp tm dng hot ng t 06 thng tr ln hoc chm dt hot ng;
g) Thng bo, cp nht danh sch ngi c Chng ch hnh ngh dc ang hnh ngh
ti c s n c quan c thm quyn theo quy nh ca B trng B Y t;
h) Nim yt cng khai Chng ch hnh ngh dc v Giy chng nhn iu kin kinh
doanh dc ti c s kinh doanh;
i) Bo co hng nm v bo co theo yu cu ca c quan qun l v dc c thm quyn;
k) Tun th quy nh ca B Y t trong vic mua, bn thuc thuc Danh mc thuc hn
ch bn l;
l) Nim yt gi bn bun, bn l bng ng Vit Nam ti ni giao dch hoc ni bn
thuc ca c s kinh doanh dc thun tin cho vic quan st, nhn bit ca khch
hng, c quan qun l c thm quyn v tun th cc quy nh khc v qun l gi thuc;
m) Lu gi chng t, ti liu c lin quan n tng l thuc, nguyn liu lm thuc trong
thi gian t nht l 01 nm k t ngy thuc, nguyn liu lm thuc ht hn dng;
n) Bo qun thuc, nguyn liu lm thuc theo ng iu kin ghi trn nhn;
o) Ghi r tn thuc, hm lng, hn dng cho ngi s dng trong trng hp bn l
thuc khng ng trong bao b ngoi ca thuc; trng hp khng c n thuc i km,
phi ghi thm liu dng, s ln dng v cch dng;
p) Ch c bn thuc k n ti c s bn l thuc khi c n thuc.
3. Ngoi cc trch nhim quy nh ti khon 2 iu ny, c s kinh doanh dc khi kinh
doanh thuc phi kim sot c bit c cc trch nhim sau y:
a) Bo co nh k; bo co xut khu, nhp khu; bo co theo yu cu ca c quan
qun l c thm quyn;
b) Lp h s, lu gi chng t, ti liu c lin quan cho tng loi thuc, nguyn liu lm
thuc theo quy nh ca B Y t.
iu 43. Quyn v trch nhim ca c s sn xut thuc, nguyn liu lm thuc

1. C s sn xut thuc, nguyn liu lm thuc c cc quyn sau y:
a) Quyn quy nh ti khon 1 iu 42 ca Lut ny;
b) Nghin cu, sn xut th; sn xut thuc, nguyn liu lm thuc; nhng quyn v
nhn nhng quyn sn xut; gia cng v nhn gia cng thuc, nguyn liu lm thuc;
c) ng k lu hnh thuc, nguyn liu lm thuc; chuyn s hu giy ng k lu hnh
thuc, nguyn liu lm thuc; ngh thu hi giy ng k lu hnh thuc, nguyn liu
lm thuc m c s sn xut; ngh thu hi thuc, nguyn liu lm thuc theo quy
nh ca Lut ny;
d) Nhp khu, mua nguyn liu lm thuc phc v sn xut; nhp khu thuc, nguyn
liu lm thuc phc v nghin cu, kim nghim, s dng lm mu ng k lu hnh
thuc ca c s;
) Bn nguyn liu lm thuc nhp khu phc v sn xut thuc ca c s cho
c s sn xut thuc khc;
e) Bn bun thuc, nguyn liu lm thuc cho c s bn bun, bn l thuc v c s
khm bnh, cha bnh;
g) Xut khu thuc, nguyn liu lm thuc quy nh ti khon 4 v khon 5 iu 60 ca
Lut ny.
2. C s sn xut thuc, nguyn liu lm thuc c cc trch nhim sau y:
a) Trch nhim c lin quan quy nh ti cc im a, b, c, d, , e, g, h, i, k, l, m v n
khon 2 iu 42 ca Lut ny;
b) Sn xut thuc, nguyn liu lm thuc theo ng quy trnh sn xut v tiu chun cht
lng ng k hoc cng b;
c) Chu trch nhim v ngun gc, cht lng thuc, nguyn liu lm thuc do c s sn
xut v ch c php xut xng thuc, nguyn liu lm thuc t tiu chun cht lng
ng k;
d) Theo di cht lng, an ton, hiu qu ca thuc, nguyn liu lm thuc do c s sn
xut trong thi gian lu hnh trn th trng v thu hi thuc, nguyn liu lm thuc theo
quy nh ca Lut ny;
) Chu trch nhim v s lng thuc, nguyn liu lm thuc nhp khu, mua, bn,
s dng v bo co theo quy nh ca B trng B Y t.
iu 44. Quyn v trch nhim ca c s xut khu, nhp khu thuc, nguyn liu
lm thuc
1. C s xut khu, nhp khu thuc, nguyn liu lm thuc c cc quyn sau y:
a) Quyn quy nh ti cc im a, b, c v d khon 1 iu 42 ca Lut ny;
b) Nhp khu thuc, nguyn liu lm thuc quy nh ti iu 60 ca Lut ny;
c) ng k lu hnh thuc, nguyn liu lm thuc; chuyn s hu giy ng k lu hnh
lm thuc; ngh thu hi thuc, nguyn liu lm thuc theo quy nh ca Lut ny;
d) Bn thuc, nguyn liu lm thuc nhp khu cho c s bn bun, c s bn l thuc,
c s sn xut thuc v c s khm bnh, cha bnh. Trng hp khng c thc hin
quyn phn phi thuc ti Vit Nam, c s xut khu, nhp khu c bn thuc, nguyn
liu lm thuc nhp khu theo quy nh ca B trng B Y t;
) Xut khu thuc, nguyn liu lm thuc quy nh ti khon 4 v khon 5 iu 60 ca
Lut ny.
2. C s xut khu, nhp khu thuc, nguyn liu lm thuc c cc trch nhim sau y:
a) Trch nhim quy nh ti cc im a, b, c, d, , e, g, h, i, k, l, m v n khon 2 iu 42
ca Lut ny;
b) Chu trch nhim v s lng, cht lng thuc, nguyn liu lm thuc do c s xut
khu, nhp khu v bo co theo quy nh ca B trng B Y t.
iu 45. Quyn v trch nhim ca c s kinh doanh dch v bo qun thuc,
nguyn liu lm thuc
1. C s kinh doanh dch v bo qun thuc, nguyn liu lm thuc c cc quyn sau y:
a) Quyn quy nh ti cc im a, b v c khon 1 iu 42 ca Lut ny;
b) Bo qun thuc, nguyn liu lm thuc cho t chc, c nhn;
c) Xut khu thuc, nguyn liu lm thuc quy nh ti khon 4 v khon 5 iu 60 ca
Lut ny.
2. C s kinh doanh dch v bo qun thuc, nguyn liu lm thuc c trch nhim quy
nh ti cc im a, b, c, d, , e, g, h, i, m v n khon 2 iu 42 ca Lut ny.
iu 46. Quyn v trch nhim ca c s bn bun thuc, nguyn liu lm thuc
1. C s bn bun thuc, nguyn liu lm thuc c cc quyn sau y:
a) Quyn quy nh ti khon 1 iu 42 ca Lut ny;

b) Bn bun thuc, nguyn liu lm thuc;
c) Mua thuc, nguyn liu lm thuc;
d) ng k lu hnh thuc, nguyn liu lm thuc; chuyn s hu giy ng k lu hnh
lm thuc; ngh thu hi thuc, nguyn liu lm thuc theo quy nh ca Lut ny;
) Xut khu thuc, nguyn liu lm thuc quy nh ti khon 4 v khon 5 iu 60 ca
Lut ny.
2. C s bn bun thuc, nguyn liu lm thuc c cc trch nhim sau y:
a) Trch nhim quy nh ti cc im a, b, c, d, , e, g, h, i, k, l, m v n khon 2 iu 42
ca Lut ny;
b) Bo m vic giao, nhn, bo qun thuc, nguyn liu lm thuc phi do ngi c
trnh chuyn mn m nhn.
iu 47. Quyn v trch nhim ca c s bn l l nh thuc
1. C s bn l l nh thuc c cc quyn sau y:
a) Quyn quy nh ti cc im a, b, c v khon 1 iu 42 ca Lut ny;
b) Mua nguyn liu lm thuc pha ch thuc theo n v bn thuc ny ti c s.
Ngi qun l chuyn mn v dc ca nh thuc chu trch nhim qun l trc tip vic
pha ch thuc ti c s;
c) Mua thuc bn l, tr vc xin; trng hp mua, bn thuc phi kim sot c bit
v thuc thuc Danh mc thuc hn ch bn l thc hin theo quy nh ti iu 34 ca
Lut ny;
d) Tham gia cp pht thuc ca bo him, chng trnh, d n y t khi p ng yu cu
v iu kin ca bo him, chng trnh, d n ;
) Ngi c Bng dc s c thay th thuc k trong n thuc bng mt thuc
khc c cng hot cht, ng dng, liu lng khi c s ng ca ngi mua v phi
chu trch nhim v vic thay i thuc.
2. C s bn l l nh thuc c cc trch nhim sau y:
a) Trch nhim quy nh ti khon 2 iu 42 v khon 2 iu 81 ca Lut ny;
b) Bo m iu kin pha ch thuc theo quy nh ca B trng B Y t;
c) Khng c bn nguyn liu lm thuc, tr dc liu.

iu 48. Quyn v trch nhim ca c s bn l l quy thuc
1. C s bn l l quy thuc c cc quyn sau y:
b) Mua v bn l thuc thuc Danh mc thuc thit yu v Danh mc thuc khng k
n, tr vc xin; trng hp mua, bn thuc thuc Danh mc thuc phi kim sot c
bit v Danh mc thuc hn ch bn l thc hin theo quy nh ti iu 34 ca Lut ny.
i vi quy thuc vng ng bo dn tc thiu s, min ni, hi o, vng c iu
kin kinh t - x hi c bit kh khn th c bn thm mt s loi thuc khc theo quy
nh ca B trng B Y t;
c) Tham gia cp pht thuc ca bo him, chng trnh, d n y t khi p ng yu cu
v iu kin ca bo him, chng trnh, d n .
2. C s bn l l quy thuc c cc trch nhim sau y:
a) Trch nhim quy nh ti khon 2 iu 42 ca Lut ny;
b) Khng c bn nguyn liu lm thuc, tr dc liu.
iu 49. Quyn v trch nhim ca c s bn l l t thuc trm y t x
1. C s bn l l t thuc trm y t x c cc quyn sau y:
b) Mua v bn l thuc thuc Danh mc thuc thit yu ph hp vi phn tuyn chuyn
mn k thut; trng hp mua, bn thuc thuc Danh mc thuc phi kim sot c bit
v Danh mc thuc hn ch bn l thc hin theo quy nh ti iu 34 ca Lut ny;
c) Tham gia cp pht thuc ca bo him, chng trnh, d n y t khi p ng yu cu
2. C s bn l l t thuc trm y t x c cc trch nhim sau y:
b) Khng c bn nguyn liu lm thuc, tr dc liu.
iu 50. Quyn v trch nhim ca c s chuyn bn l dc liu, thuc dc liu,
thuc c truyn
1. C s chuyn bn l dc liu, thuc dc liu, thuc c truyn c cc quyn sau y:

b) Bn l dc liu, thuc dc liu, thuc c truyn;
c) Mua dc liu, thuc dc liu, thuc c truyn bn l;
d) Tham gia cp pht thuc ca bo him, chng trnh, d n y t khi p ng yu cu
2. C s chuyn bn l dc liu, thuc dc liu, thuc c truyn c cc trch nhim sau
y:
b) Khng c bn thuc ha dc, vc xin, sinh phm v nguyn liu lm thuc l dc
cht, t dc, v nang.
iu 51. Quyn v trch nhim ca c s kinh doanh dch v kim nghim thuc,
nguyn liu lm thuc
1. C s kinh doanh dch v kim nghim thuc, nguyn liu lm thuc c cc quyn sau
y:
a) Quyn quy nh ti im a v im b khon 1 iu 42 ca Lut ny;
b) Tin hnh kim nghim thuc, nguyn liu lm thuc theo quy nh;
c) Chng nhn kt qu kim nghim i vi mu thuc, nguyn liu lm thuc kim
nghim;
d) Nhp khu, mua ha cht, cht chun, mu thuc, mu nguyn liu lm thuc phc v
cho hot ng kim nghim thuc, nguyn liu lm thuc ca c s.
2. C s kinh doanh dch v kim nghim thuc, nguyn liu lm thuc c cc trch
nhim sau y:
a) Trch nhim quy nh ti cc im a, b, d, , e, g, h, i, m v n khon 2 iu 42 ca
Lut ny;
b) Bo m trung thc, khch quan trong kim nghim thuc, nguyn liu lm thuc;
c) Chu trch nhim v kt qu kim nghim i vi mu thuc, mu nguyn liu lm
thuc kim nghim.
iu 52. Quyn v trch nhim ca c s kinh doanh dch v th thuc trn lm
sng
1. C s kinh doanh dch v th thuc trn lm sng c cc quyn sau y:

b) Tin hnh hot ng th thuc trn lm sng theo quy nh;
c) Nhp khu, mua ha cht, cht chun, mu thuc phc v cho hot ng th thuc trn
lm sng;
d) S dng kt qu nghin cu th thuc trn lm sng theo tha thun vi c quan, t
chc, c nhn c thuc th lm sng.
2. C s kinh doanh dch v th thuc trn lm sng c cc trch nhim sau y:
a) Trch nhim quy nh ti cc im a, b, c, d, e, g, h, i, m v n khon 2 iu 42 ca
Lut ny;
b) Chu trch nhim v kt qu nghin cu th thuc trn lm sng;
c) Chu trch nhim v s an ton ca ngi tham gia th thuc trn lm sng v bi
thng thit hi cho ngi tham gia th thuc trn lm sng nu ri ro xy ra do li ca
c s kinh doanh dch v th thuc trn lm sng theo quy nh ca php lut;
d) Bo m trung thc, khch quan trong th thuc trn lm sng;
) c lp v kinh t, t chc nhn s i vi c quan, t chc, c nhn c thuc th trn
lm sng.
iu 53. Quyn v trch nhim ca c s kinh doanh dch v th tng ng sinh
hc ca thuc
1. C s kinh doanh dch v th tng ng sinh hc ca thuc c cc quyn sau y:
b) Tin hnh giai on nghin cu trn lm sng v giai on phn tch dch sinh hc
trong th tng ng sinh hc ca thuc.
Trng hp ch tin hnh giai on phn tch dch sinh hc th c k hp ng hoc
lin kt vi c s th thuc trn lm sng p ng Thc hnh tt th thuc trn lm sng
thc hin giai on nghin cu trn lm sng trong th tng ng sinh hc ca
thuc;
c) Tin hnh hot ng nghin cu th tng ng sinh hc ca thuc theo quy nh;
d) Nhp khu, mua ha cht, cht chun, mu thuc phc v cho hot ng th tng
ng sinh hc ca thuc;
) S dng kt qu nghin cu th tng ng sinh hc ca thuc theo tha thun vi

c quan, t chc, c nhn c thuc th tng ng sinh hc.
2. C s kinh doanh dch v th tng ng sinh hc ca thuc c cc trch nhim sau
y:
a) Trch nhim quy nh ti cc im a, b, c, d, e, g, h, i, m v n khon 2 iu 42 ca
Lut ny;
b) Chu trch nhim v kt qu nghin cu th tng ng sinh hc ca thuc i vi
mu thuc th;
c) Chu trch nhim v s an ton ca ngi tham gia th tng ng sinh hc v bi
thng thit hi cho ngi tham gia th tng ng sinh hc nu ri ro xy ra do li
ca c s kinh doanh dch v th tng ng sinh hc ca thuc theo quy nh ca
php lut;
d) Bo m trung thc, khch quan trong th tng ng sinh hc ca thuc;
) c lp v kinh t, t chc nhn s i vi c quan, t chc, c nhn c thuc th
tng ng sinh hc.
Chng V
NG K, LU HNH, THU HI THUC V NGUYN LIU LM THUC
Mc 1. NG K THUC, NGUYN LIU LM THUC
iu 54. i tng v yu cu ng k thuc, nguyn liu lm thuc
1. Thuc phi ng k trc khi lu hnh ti Vit Nam, tr trng hp sau y:
a) Thuc pha ch theo n ti nh thuc quy nh ti im b khon 1 iu 47; thuc sn
xut, pha ch ti c s khm bnh, cha bnh quy nh ti iu 85 ca Lut ny;
b) Thuc c nhp khu quy nh ti khon 2 iu 60 ca Lut ny;
c) Thuc c truyn theo quy nh ti khon 1 v khon 2 iu 70 ca Lut ny.
2. Nguyn liu lm thuc phi ng k trc khi lu hnh ti Vit Nam, tr trng hp
sau y:
a) Nguyn liu lm thuc l dc cht sn xut thuc theo h s ng k thuc c
giy ng k lu hnh ti Vit Nam;
b) Nguyn liu lm thuc c nhp khu theo quy nh ti khon 3 iu 60 ca Lut
ny.
3. C s c ng tn ng k thuc, nguyn liu lm thuc trong trng hp sau y:

a) C s c hot ng sn xut, bn bun, xut khu, nhp khu thuc, nguyn liu lm
thuc ti Vit Nam;
b) C s kinh doanh thuc, nguyn liu lm thuc ca nc ngoi c vn phng i din
ti Vit Nam.
4. Thuc, nguyn liu lm thuc c cp giy ng k lu hnh ti Vit Nam khi p
ng cc yu cu sau y:
a) Bo m yu cu v an ton, hiu qu;
b) c sn xut ti c s sn xut thuc, nguyn liu lm thuc p ng iu kin theo
quy nh ca Lut ny;
c) c sn xut theo quy trnh sn xut thuc, nguyn liu lm thuc v t tiu chun
cht lng theo quy nh ti iu 102 v iu 103 ca Lut ny.
5. i vi thuc, nguyn liu lm thuc nhp khu khi ng k lu hnh ti Vit Nam, c
s sn xut thuc, nguyn liu lm thuc ti nc ngoi phi c nh gi vic p ng
Thc hnh tt sn xut theo mt trong cc hnh thc sau y:
a) Thm nh h s lin quan n iu kin sn xut;
b) Cng nhn, tha nhn ln nhau v kt qu thanh tra, kim tra ca c quan qun l nh
nc v dc i vi yu cu p ng Thc hnh tt sn xut thuc, nguyn liu lm
thuc;
c) Kim tra ti c s sn xut thuc, nguyn liu lm thuc.
6. Chnh ph quy nh chi tit vic ng k lu hnh i vi dc liu, t dc, v nang
v khon 5 iu ny.
iu 55. Hnh thc ng k thuc, nguyn liu lm thuc
1. Thuc, nguyn liu lm thuc c ng k theo mt trong cc hnh thc sau y:
a) Cp giy ng k lu hnh thuc, nguyn liu lm thuc;
b) Gia hn giy ng k lu hnh thuc, nguyn liu lm thuc;
c) Thay i, b sung giy ng k lu hnh thuc, nguyn liu lm thuc.
2. Cp giy ng k lu hnh thuc, nguyn liu lm thuc trong trng hp sau y:
a) Thuc, nguyn liu lm thuc cha c cp giy ng k lu hnh ti Vit Nam;
b) Thuc c cp giy ng k lu hnh nhng c thay i v thnh phn dc cht,

dc liu; hm lng, nng hoc khi lng cc thnh phn dc cht, dc liu c
tc dng; dng bo ch; ng dng; c s sn xut, tr trng hp thay i c s ng
gi th cp, c s xut xng, a im xut xng;
c) Nguyn liu lm thuc c cp giy ng k lu hnh nhng c thay i v c s
sn xut, tr trng hp thay i c s ng gi th cp, c s xut xng, a im xut
xng.
3. Thay i, b sung giy ng k lu hnh thuc, nguyn liu lm thuc c cp ti
Vit Nam c cc thay i trong thi hn hiu lc, tr trng hp quy nh ti im b v
im c khon 2 iu ny.
4. Gia hn giy ng k lu hnh thuc, nguyn liu lm thuc khi giy ng k lu hnh
ht thi hn hiu lc bao gm c thuc, nguyn liu lm thuc c thay i v h s hnh
chnh ti thi im ng k gia hn.
iu 56. Thm quyn, h s, th tc, thi hn cp, gia hn, thay i, b sung giy
ng k lu hnh thuc, nguyn liu lm thuc
1. B trng B Y t cp, gia hn, thay i, b sung giy ng k lu hnh thuc, nguyn
liu lm thuc trn c s thm nh h s, t vn ca Hi ng t vn cp giy ng k
lu hnh thuc, nguyn liu lm thuc.
H s ngh cp, gia hn, thay i, b sung giy ng k lu hnh thuc, nguyn liu
lm thuc np ti B Y t.
2. H s ngh cp giy ng k lu hnh thuc, nguyn liu lm thuc bao gm:
a) H s hnh chnh bao gm n ngh cp giy ng k lu hnh thuc, nguyn liu
lm thuc; bn sao c chng thc Giy php thnh lp vn phng i din cn thi hn
hiu lc i vi c s kinh doanh thuc, nguyn liu lm thuc ca nc ngoi hoc
Giy chng nhn iu kin kinh doanh dc cn thi hn hiu lc i vi c s kinh
doanh thuc, nguyn liu lm thuc ca Vit Nam; bn gc hoc bn sao c chng thc
Giy chng nhn sn phm dc phm i vi thuc nhp khu cn thi hn hiu lc;
mu nhn thuc, nguyn liu lm thuc; thng tin v thuc v cc ti liu khc v kinh
doanh v lu hnh thuc, nguyn liu lm thuc;
b) H s k thut chng minh thuc, nguyn liu lm thuc p ng cc yu cu quy
nh ti khon 4 iu 54 ca Lut ny; i vi thuc mi, sinh phm tham chiu, vc xin,
thuc dc liu c ch nh i vi cc bnh thuc danh mc do B trng B Y t ban
hnh phi c thm h s lm sng chng minh t an ton, hiu qu; i vi sinh phm
tng t phi c thm h s chng minh tng t v cht lng, an ton, hiu qu so vi
mt sinh phm tham chiu; i vi thuc c yu cu th tng ng sinh hc phi c
thm bo co s liu nghin cu tng ng sinh hc ca thuc;
c) Mu nhn thc t ca thuc, nguyn liu lm thuc lu hnh ti nc s ti hoc nc
tham chiu i vi thuc nhp khu.
3. H s ngh gia hn giy ng k lu hnh thuc, nguyn liu lm thuc bao gm:
a) n ngh gia hn giy ng k lu hnh thuc, nguyn liu lm thuc;
b) Bn sao c chng thc Giy php thnh lp vn phng i din cn thi hn hiu lc
i vi c s kinh doanh thuc, nguyn liu lm thuc ca nc ngoi hoc Giy chng
nhn iu kin kinh doanh dc cn thi hn hiu lc i vi c s kinh doanh thuc,
nguyn liu lm thuc ca Vit Nam;
c) Bn gc hoc bn sao c chng thc Giy chng nhn sn phm dc phm cn thi
hn hiu lc i vi thuc nhp khu;
d) Bo co lu hnh thuc, nguyn liu lm thuc;
) Bo co an ton, hiu qu i vi thuc c yu cu tip tc theo di an ton, hiu qu;
e) Bn sao giy ng k lu hnh thuc, nguyn liu lm thuc ti Vit Nam.
4. H s ngh thay i, b sung giy ng k lu hnh thuc, nguyn liu lm thuc
bao gm:
a) n ngh thay i, b sung giy ng k lu hnh thuc, nguyn liu lm thuc;
b) H s k thut i vi ni dung thay i, b sung giy ng k lu hnh thuc,
nguyn liu lm thuc;
c) Bn sao giy ng k lu hnh thuc, nguyn liu lm thuc ti Vit Nam cn hiu lc.
5. Thi hn cp, gia hn hoc thay i, b sung giy ng k lu hnh thuc, nguyn liu
lm thuc:
a) Khng qu 12 thng k t ngy nhn h s i vi vic cp giy ng k lu hnh
thuc, nguyn liu lm thuc hoc k t ngy nhn h s i vi thuc mi, sinh
phm tham chiu, sinh phm tng t, vc xin, thuc dc liu c ch nh i vi cc
bnh thuc danh mc do B trng B Y t ban hnh trong c h s lm sng
chng minh t an ton, hiu qu;
b) Khng qu 03 thng k t ngy nhn h s i vi vic gia hn, thay i, b sung
giy ng k lu hnh thuc, nguyn liu lm thuc;
c) Trng hp khng cp, gia hn, thay i, b sung giy ng k lu hnh thuc,
nguyn liu lm thuc hoc cha p ng iu kin cp, gia hn, thay i, b sung
giy ng k lu hnh thuc, nguyn liu lm thuc phi c vn bn tr li v nu r l
do.
6. Thi hn hiu lc ca giy ng k lu hnh thuc, nguyn liu lm thuc l 05 nm
k t ngy cp hoc gia hn.
Thi hn hiu lc ca giy ng k lu hnh thuc l 03 nm k t ngy cp i vi
thuc c yu cu tip tc theo di an ton, hiu qu.
7. B trng B Y t quy nh chi tit h s, th tc cp, gia hn, thay i, b sung giy
ng k lu hnh thuc, nguyn liu lm thuc.
iu 57. Quyn v trch nhim ca c s ng k thuc, nguyn liu lm thuc
1. C s ng k thuc, nguyn liu lm thuc c cc quyn sau y:
a) c hng dn v ng k thuc, nguyn liu lm thuc; c bit tnh trng x l
h s ng k thuc, nguyn liu lm thuc v cc thng tin khc lin quan n thuc,
nguyn liu lm thuc sau khi c cp giy ng k lu hnh;
b) ngh thu hi giy ng k lu hnh ca thuc, nguyn liu lm thuc do c s ng
k.
2. C s ng k thuc, nguyn liu lm thuc c cc trch nhim sau y:
a) Thng bo cho c quan qun l trong trng hp thuc, nguyn liu lm thuc
c cp giy ng k lu hnh ti Vit Nam b thu hi bt k nc no trn th gii;
ngng sn xut, ngng cung cp hoc nguy c v tnh trng thiu thuc, nguyn liu lm
thuc; thay i c s ng k thuc, nguyn liu lm thuc trong thi gian giy ng k
lu hnh cn thi hn hiu lc;
b) Lu tr h s ng k thuc, nguyn liu lm thuc v cung cp h s cho c quan
qun l c thm quyn khi c yu cu;
c) Thc hin cc yu cu v kim tra, nh gi c s sn xut khi c yu cu ca c quan
qun l c thm quyn.
iu 58. Thu hi giy ng k lu hnh thuc, nguyn liu lm thuc
1. Giy ng k lu hnh thuc, nguyn liu lm thuc b thu hi trong trng hp sau
y:
a) Thuc b thu hi do vi phm mc 1;
b) Trong thi hn 60 thng c 02 l thuc b thu hi bt buc do vi phm mc 2

hoc 03 l thuc tr ln vi phm cht lng;
c) Thuc nhp khu b c quan c thm quyn ca nc ngoi thu hi Giy chng nhn
sn phm dc phm m giy l cn c B Y t cp giy ng k lu hnh thuc,
nguyn liu lm thuc ti Vit Nam;
d) Giy ng k lu hnh thuc, nguyn liu lm thuc c cp da trn h s gi mo;
) Thuc, nguyn liu lm thuc c sn xut khng ng a ch theo h s ng k;
e) Dc cht, dc liu hoc thuc c cha dc cht, dc liu c T chc Y t Th
gii, c quan qun l c thm quyn ca Vit Nam hoc nc xut x ca thuc khuyn
co khng an ton, hiu qu cho ngi s dng;
g) C s sn xut hoc c s ng k thuc, nguyn liu lm thuc ngh thu hi giy
ng k lu hnh thuc, nguyn liu lm thuc ti Vit Nam.
2. B trng B Y t quy nh chi tit h s, th tc thu hi giy ng k lu hnh thuc,
nguyn liu lm thuc.
Mc 2. LU HNH THUC, NGUYN LIU LM THUC
iu 59. Quy nh v lu hnh thuc, nguyn liu lm thuc
1. Cc loi thuc, nguyn liu lm thuc lu hnh trn th trng bao gm:
a) Thuc, nguyn liu lm thuc c cp giy ng k lu hnh;
b) Thuc, nguyn liu lm thuc nhp khu quy nh ti cc khon 1, 2, 3 v 4 iu 60
ca Lut ny;
c) Thuc quy nh ti im b khon 1 iu 47, khon 1 v khon 2 iu 70, khon 3
iu 85 ca Lut ny;
d) Thuc, nguyn liu lm thuc sn xut trong nc c php tip tc lu hnh n ht
hn dng trong trng hp c sn xut trc ngy giy ng k lu hnh ht thi hn
hiu lc;
) Thuc, nguyn liu lm thuc nhp khu c php tip tc lu hnh n ht hn dng
trong trng hp c giao hng ti cng i ca nc xut khu trc ngy giy ng k
lu hnh ht thi hn hiu lc;
e) Thuc, nguyn liu lm thuc sn xut trong nc hoc thuc nhp khu trc ngy
giy ng k lu hnh b thu hi theo quy nh ti iu 58 ca Lut ny, tr trng hp
thuc, nguyn liu lm thuc b thu hi theo quy nh ti iu 62 ca Lut ny.
2. Thuc lu hnh trn th trng phi p ng cc yu cu sau y:

a) t tiu chun cht lng v bo m v an ton, hiu qu;
b) p ng yu cu v nhn thuc quy nh ti iu 61 ca Lut ny v cc quy nh
khc ca php lut c lin quan;
c) Vt liu bao b v dng ng gi phi p ng yu cu bo m cht lng thuc.
3. Nguyn liu lm thuc lu hnh trn th trng phi p ng cc yu cu sau y:
a) t tiu chun cht lng sn xut thuc v bo m v an ton, hiu qu;
b) p ng yu cu v nhn thuc theo quy nh ti iu 61 ca Lut ny v cc quy
nh khc ca php lut c lin quan;
c) Vt liu bao b v dng ng gi phi p ng yu cu bo m cht lng nguyn
liu lm thuc.
iu 60. Thuc, nguyn liu lm thuc c nhp khu, xut khu
1. Thuc, nguyn liu lm thuc l dc cht c giy ng k lu hnh ti Vit Nam,
nguyn liu lm thuc l dc cht sn xut thuc theo h s ng k thuc c giy
ng k lu hnh thuc ti Vit Nam c nhp khu m khng phi thc hin vic cp
php nhp khu, tr thuc, nguyn liu lm thuc quy nh ti khon 4 iu ny.
2. Thuc cha c giy ng k lu hnh thuc ti Vit Nam c cp php nhp khu v
ch c nhp khu khng qu s lng ghi trong giy php nhp khu trong trng hp
sau y:
a) C cha dc cht cha c giy ng k lu hnh thuc hoc c giy ng k lu
hnh thuc nhng thuc cha p ng cho nhu cu iu tr;
b) C cha dc liu ln u s dng lm thuc ti Vit Nam hoc tng s dng lm
thuc ti Vit Nam nhng thuc cha p ng cho nhu cu iu tr;
c) p ng nhu cu cp bch cho quc phng, an ninh, phng, chng dch bnh, khc
phc hu qu thin tai, thm ha, nhu cu iu tr c bit;
d) Thuc him;
) Thuc c cng tn thng mi, thnh phn hot cht, hm lng hoc nng , dng
bo ch vi bit dc gc c giy ng k lu hnh thuc ti Vit Nam, c sn xut
bi chnh nh sn xut bit dc gc hoc bi nh sn xut c y quyn, c gi thp
hn so vi thuc bit dc gc lu hnh ti Vit Nam theo yu cu ca B trng B Y
t;
e) Phc v cho chng trnh y t ca Nh nc;

g) Vin tr, vin tr nhn o;
h) Th thuc trn lm sng, th tng ng sinh hc, nh gi sinh kh dng, lm mu
ng k, mu kim nghim, nghin cu khoa hc, tham gia trng by ti trin lm, hi
ch;
i) Trng hp khc khng v mc ch thng mi.
3. Nguyn liu lm thuc l dc cht cha c giy ng k lu hnh ti Vit Nam c
cp php nhp khu v ch c nhp khu khng qu s lng ghi trong giy php nhp
khu trong trng hp sau y:
a) lm mu ng k, mu kim nghim, nghin cu thuc, tham gia trng by ti trin
lm, hi ch;
b) sn xut thuc xut khu, thuc phc v yu cu quc phng, an ninh, phng,
chng dch bnh, khc phc hu qu thin tai, thm ha.
4. Thuc phi kim sot c bit phi thc hin vic cp php xut khu, nhp khu v
ch c xut khu, nhp khu khng qu s lng c ghi trong giy php.
Ty tng thi k pht trin kinh t - x hi, Chnh ph quy nh cc loi thuc, nguyn
liu lm thuc phi kim sot nhp khu.
5. Thuc, nguyn liu lm thuc c php xut khu khng cn giy php ca B Y t,
tr dc liu thuc danh mc loi, chng loi dc liu qu, him, c hu phi kim
sot, thuc phi kim sot c bit, nguyn liu lm thuc l dc cht hng thn, dc
cht gy nghin, tin cht dng lm thuc do B trng B Y t ban hnh hoc cht
phng x theo danh mc do Chnh ph ban hnh.
6. B Y t c trch nhim cng b thng tin lin quan n thuc c cp php nhp
khu theo quy nh ti cc im a, b, c v d khon 2 iu ny bao gm nh nhp khu,
nh sn xut, s lng, tn thuc v s giy php nhp khu; s lng giy ng k lu
hnh thuc i vi mi hot cht.
7. Chnh ph quy nh chi tit cc ni dung sau y:
a) Tiu ch, h s, th tc, thi gian cp php xut khu, nhp khu i vi thuc quy
nh ti cc khon 2, 3, 4 v 5 iu ny v danh mc thuc, nguyn liu lm thuc cm
nhp khu, cm sn xut;
b) Nhp khu dc liu, t dc, v nang, bao b tip xc trc tip vi thuc.
iu 61. Nhn thuc, nguyn liu lm thuc lu hnh trn th trng

1. Nhn thuc, nguyn liu lm thuc lu hnh trn th trng phi th hin cc ni dung
sau y:
a) Tn thuc, nguyn liu lm thuc;
b) Dng bo ch, tr nguyn liu lm thuc;
c) Thnh phn, hm lng, nng hoc khi lng dc cht, dc liu ca thuc,
nguyn liu lm thuc; nhn ca thuc c truyn thuc Danh mc b mt ca Nh nc
v ca thuc gia truyn c php khng th hin mt s thnh phn dc liu, hm
lng, khi lng dc liu v phi c dng ch Cng thc sn xut thuc l b mt nh
nc hoc Cng thc sn xut thuc l b mt gia truyn;
d) Quy cch ng gi;
) Tn, a ch ca c s sn xut;
e) Tn, a ch ca c s nhp khu i vi thuc, nguyn liu lm thuc nhp khu;
g) S giy ng k lu hnh hoc s giy php nhp khu, s l sn xut, ngy sn xut;
h) Hn dng ca thuc, nguyn liu lm thuc;
i) iu kin bo qun v thng tin cn thit khc theo quy nh.
2. T hng dn s dng thuc l mt phn khng th tch ri ca nhn thuc v c y
thng tin quy nh ti cc im a, b, c, d, , h v i khon 1 iu ny v c th hin
bng ting Vit, tr trng hp thng tin khng th dch ra ting Vit hoc dch ra ting
Vit khng c ngha.
3. B trng B Y t quy nh chi tit vic ghi nhn thuc, nguyn liu lm thuc, t
hng dn s dng thuc; quyt nh vic thay i hn dng ca thuc ghi trn nhn
thuc trong trng hp v l do quc phng, an ninh, phng, chng dch bnh, khc phc
hu qu thin tai, thm ha.
Mc 3. THU HI THUC, NGUYN LIU LM THUC
iu 62. Cc trng hp thu hi thuc, nguyn liu lm thuc
1. Thuc b thu hi trong trng hp sau y:
a) Khng thuc trng hp c php lu hnh quy nh ti khon 1 iu 59 ca Lut
ny;
b) Giy ng k lu hnh thuc b thu hi trong trng hp quy nh ti cc im a, b, d,

v e khon 1 iu 58 ca Lut ny;
c) Khng p ng yu cu quy nh ti khon 4 iu 54 hoc khon 2 iu 59 ca Lut
ny;
d) Thuc khng t tiu chun cht lng, thuc sn xut t nguyn liu lm thuc
khng t tiu chun cht lng;
) C kt lun ca c quan nh nc c thm quyn v thuc khng t yu cu v an
ton, hiu qu;
e) Thuc khng c bng chng c kim tra cht lng trong qu trnh sn xut v
trc khi xut xng;
g) C thng bo thu hi thuc ca c quan qun l v dc ca nc ngoi.
2. Nguyn liu lm thuc lu hnh trn th trng b thu hi trong trng hp sau y:
a) Nguyn liu lm thuc b s dng sai mc ch;
b) Giy ng k lu hnh nguyn liu lm thuc b thu hi trong trng hp quy nh ti
cc im d, v e khon 1 iu 58 ca Lut ny;
c) Khng p ng yu cu quy nh ti khon 4 iu 54 hoc khon 3 iu 59 ca Lut
ny;
d) Nguyn liu lm thuc khng t tiu chun cht lng sn xut thuc; nguyn liu
lm thuc khng ng xut x ng k lu hnh hoc giy php nhp khu;
) Nguyn liu lm thuc khng c bng chng c kim tra cht lng trong qu
trnh sn xut v trc khi xut xng;
e) C thng bo thu hi nguyn liu lm thuc ca c quan qun l v dc ca nc
ngoi.
iu 63. Hnh thc thu hi, mc vi phm, phm vi v thi gian thu hi v x l
thuc b thu hi
1. Hnh thc thu hi thuc bao gm:
a) Thu hi t nguyn l thu hi do c s ng k thuc, c s sn xut, c s nhp khu
hoc y thc nhp khu thuc t nguyn thc hin;
b) Thu hi bt buc l thu hi theo quyt nh ca c quan nh nc c thm quyn trong
trng hp thu hi quy nh ti iu 62 ca Lut ny.
2. Mc vi phm ca thuc bao gm:

a) Mc 1 l mc m thuc c nguy c gy tn hi nghim trng i vi sc khe
hoc nh hng n tnh mng ca ngi s dng;
b) Mc 2 l mc m thuc c bng chng khng bo m y hiu qu iu tr
hoc c nguy c khng an ton cho ngi s dng nhng cha n mc gy tn hi
nghim trng i vi sc khe hoc cha nh hng n tnh mng ca ngi s dng;
c) Mc 3 l mc khng thuc trng hp quy nh ti im a v im b khon ny
m do cc nguyn nhn khc nhng khng nh hng n hiu qu iu tr v an ton khi
s dng.
3. Phm vi v thi gian yu cu thu hi thuc c thc hin nh sau:
a) Thu hi tt c c s kinh doanh dc, c s khm bnh, cha bnh v ngi s dng
trong trng hp thuc vi phm mc 1. Vic thu hi phi hon thnh trong thi hn
03 ngy k t ngy c quyt nh thu hi;
b) Thu hi tt c c s kinh doanh dc, c s khm bnh, cha bnh v ngi s dng
trong trng hp thuc vi phm mc 2. Vic thu hi phi hon thnh trong thi hn
15 ngy k t ngy c quyt nh thu hi;
c) Thu hi tt c c s kinh doanh dc trong trng hp thuc vi phm mc 3.
Vic thu hi phi hon thnh trong thi hn 30 ngy k t ngy c quyt nh thu hi;
d) Trng hp vic thu hi thuc vi phm mc 1 v vic thu hi thuc vt qu kh
nng thu hi ca c s sn xut thuc trong nc, c s nhp khu, c s y thc nhp
khu thuc hoc qu thi hn thu hi m c s sn xut thuc trong nc, c s nhp
khu, c s y thc nhp khu thuc khng thc hin vic thu hi th b cng ch thu
hi theo quy nh ca php lut.
C quan nh nc c thm quyn trc tip t chc cng ch thu hi thuc; c s sn
xut thuc trong nc, c s nhp khu, c s y thc nhp khu thuc c trch nhim
thanh ton chi ph cho vic thu hi v x l thuc b thu hi.
4. X l thuc b thu hi c thc hin nh sau:
a) Thuc b thu hi theo quy nh ti im a v im b khon 2 iu ny phi b tiu hy;
b) Thuc b thu hi theo quy nh ti im c khon 2 iu ny c php khc phc, ti
xut hoc tiu hy trong trng hp khng th khc phc c.
iu 64. Trch nhim thu hi thuc
1. C s ng k thuc, c s sn xut thuc trong nc, c s c pha ch, ch bin, bo

ch thuc, c s nhp khu, c s y thc nhp khu thuc c thuc b thu hi c cc
trch nhim sau y:
a) Ngng kinh doanh thuc b thu hi;
b) Ch tr, phi hp vi t chc, c nhn c lin quan cng b thng tin v thuc b thu
hi v t chc thu hi, tip nhn thuc b thu hi;
c) X l thuc b thu hi;
d) Chi tr chi ph cho vic thu hi, x l thuc b thu hi, bi thng thit hi theo quy
nh ca php lut;
) Bo co B Y t v vic thu hi thuc v kt qu thu hi thuc;
e) Trng hp thu hi t nguyn th phi tm ngng kinh doanh thuc b thu hi v bo
co B Y t trc khi tin hnh vic thu hi thuc.
2. C s bn bun, bn l thuc c cc trch nhim sau y:
a) Ngng kinh doanh, cp pht thuc b thu hi;
b) Thng bo v t chc thu hi, tip nhn thuc b thu hi do c s kinh doanh, cung
cp, ngi s dng tr li;
c) Tr thuc b thu hi cho c s cung cp thuc;
d) Chi tr chi ph cho vic thu hi, x l thuc b thu hi v bi thng thit hi theo quy
nh ca php lut trong trng hp c li.
3. C s khm bnh, cha bnh v ngi s dng thuc c cc trch nhim sau y:
a) Ngng vic k n, bn, cp pht v s dng thuc b thu hi;
b) Tr li thuc b thu hi cho c s cung ng thuc.
4. B Y t c cc trch nhim sau y:
a) Cn c vo mc vi phm v cht lng, an ton, hiu qu, quyt nh vic thu hi,
x l thuc thu hi trn phm vi ton quc;
b) R sot bo co nh gi v tr li v xut t nguyn thu hi ca c s sn xut,
kinh doanh;
c) Kim tra, gim st vic t chc v thc hin thu hi thuc, nguyn liu lm thuc; x
l c s vi phm theo quy nh ca php lut;
d) Cng b thng tin v thuc b thu hi trn cng thng tin in t ca B Y t, i

truyn hnh Vit Nam v i ting ni Vit Nam i vi trng hp thu hi thuc vi
phm mc 1 ngay sau khi c quyt nh thu hi thuc.
5. i truyn hnh Vit Nam, i ting ni Vit Nam c trch nhim cng b thng tin v
thu hi thuc vi phm mc 1 v khng thu ph.
iu 65. Thm quyn ra quyt nh thu hi thuc, th tc thu hi thuc
1. B Y t ra quyt nh thu hi thuc trong trng hp thuc b thu hi bt buc v
trng hp thu hi t nguyn khi thuc vi phm mc 1, mc 2. Thi gian ra
quyt nh thu hi thuc khng qu 24 gi k t khi c kt lun thuc thuc trng hp
phi thu hi v mc vi phm ca thuc hoc c kt lun v vic thu hi thuc t
nguyn khng ph hp vi mc vi phm ca thuc.
2. Ngi ng u c s ng k thuc, c s sn xut thuc trong nc, c s pha ch,
ch bin, bo ch thuc, c s nhp khu hoc y thc nhp khu thuc ra quyt nh thu
hi thuc trong trng hp thu hi t nguyn thuc vi phm mc 3 sau khi c kin
ca B Y t. Thi gian ra quyt nh thu hi thuc khng qu 24 gi k t khi c kin
ca B Y t.
3. B trng B Y t quy nh chi tit vic kt lun thuc thuc trng hp phi thu hi,
mc vi phm ca thuc, th tc thu hi thuc v vic x l thuc b thu hi.
4. Chnh ph quy nh thm quyn, hnh thc, th tc thu hi nguyn liu lm thuc; bin
php x l nguyn liu lm thuc b thu hi.
Chng VI
DC LIU V THUC C TRUYN
Mc 1. DC LIU
iu 66. Nui trng, thu hi, khai thc, ch bin dc liu
1. Vic nui trng, thu hi dc liu tun th Thc hnh tt nui trng, thu hi dc liu.
2. Vic khai thc, ch bin dc liu t nhin phi bo m ng chng loi, quy cch,
quy trnh, thi im, phng php ch bin v cch bo qun ca tng dc liu.
3. B trng B Y t quy nh l trnh p dng Thc hnh tt nui trng, thu hi dc
liu v ban hnh cc nguyn tc, tiu chun khai thc dc liu t nhin ph hp vi iu
kin pht trin kinh t - x hi.
iu 67. Bo qun dc liu
1. Vic bo qun dc liu phi tun th Thc hnh tt v bo qun thuc, nguyn liu
lm thuc.
2. Dc liu lu hnh trn th trng phi c ng gi bng bao b t tiu chun v
c ghi nhn theo quy nh ca B trng B Y t.
iu 68. Cht lng ca dc liu
1. Dc liu phi t tiu chun cht lng, c ngun gc, xut x r rng. Khi a vo
sn xut, ch bin, bo ch thuc, mc tn d ha cht bo v thc vt, ha cht bo
qun, gii hn kim loi nng, gii hn vi sinh vt, gii hn c tnh ca dc liu khng
c vt mc quy nh.
2. T chc, c nhn sn xut, nhp khu, ch bin, cung ng dc liu phi cng b tiu
chun dc liu theo quy nh ca php lut v tiu chun v quy chun k thut trong
trng hp dc liu cha c giy ng k lu hnh v chu trch nhim v ngun gc,
cht lng ca dc liu; bo co vi c quan qun l nh nc v dc v s lng ca
dc liu c nhp khu kinh doanh v s dng pha ch, ch bin, sn xut thuc.
Mc 2. THUC C TRUYN
iu 69. Kinh doanh thuc c truyn
1. Vic kinh doanh thuc c truyn c p dng thc hin theo quy nh ti Chng IV
ca Lut ny.
2. C s sn xut thuc c truyn lu hnh ton quc, c s bn l thuc c truyn phi
p ng cc iu kin sau y:
a) C s sn xut thuc c truyn phi c a im, nh xng sn xut, phng kim
nghim, kho bo qun thuc, nguyn liu lm thuc, h thng ph tr, trang thit b, my
mc sn xut, kim nghim, bo qun thuc, h thng qun l cht lng, ti liu chuyn
mn k thut v nhn s tun th Thc hnh tt sn xut thuc i vi thuc c truyn;
b) C s chuyn bn l dc liu, thuc dc liu, thuc c truyn phi tun th quy nh
v a im, khu vc bo qun, trang thit b bo qun, ti liu chuyn mn k thut v
nhn s;
c) Ngi chu trch nhim chuyn mn v dc, ngi ph trch v cht lng thuc ca
c s sn xut thuc c truyn phi c vn bng chuyn mn quy nh ti im a hoc
im c khon 1 iu 13 ca Lut ny v c 02 nm thc hnh chuyn mn ti c s dc
ph hp vi chuyn mn ca ngi hnh ngh, tr trng hp quy nh ti im d khon
ny. Ngi chu trch nhim chuyn mn v dc ca c s sn xut thuc c truyn lu

hnh ton quc c th ng thi l ngi ph trch v bo m cht lng thuc ca c
s sn xut;
d) Ngi chu trch nhim chuyn mn v dc, ngi ph trch v bo m cht lng
thuc ca hp tc x, h kinh doanh sn xut thuc c truyn phi c mt trong cc vn
bng chuyn mn quy nh ti im a, c, e, g, i hoc l khon 1 iu 13 ca Lut ny v
c 02 nm thc hnh chuyn mn ti c s dc ph hp vi chuyn mn ca ngi
hnh ngh, tr trng hp quy nh ti im c khon 2 iu 13 ca Lut ny. Ngi chu
trch nhim chuyn mn v dc ca hp tc x, h kinh doanh sn xut thuc c truyn
c th ng thi l ngi ph trch v bo m cht lng thuc ca c s sn xut;
) Ngi chu trch nhim chuyn mn v dc ca c s bn l thuc c truyn thc
hin theo quy nh ti khon 4 iu 18 ca Lut ny.
3. Chnh ph quy nh chi tit vic kinh doanh thuc c truyn v qun l thuc c truyn
nhp khu vo Vit Nam.
iu 70. Cung ng, ch bin, bo ch v s dng thuc c truyn trong c s khm
bnh, cha bnh
1. C s khm bnh, cha bnh bng y hc c truyn c ch bin, bo ch, cn (bc)
thuc c truyn theo bi thuc, n thuc s dng v bn l theo n ti chnh c s
.
2. Thuc c truyn do bnh vin c chc nng khm bnh, cha bnh bng y hc c
truyn tuyn tnh tr ln ch bin, bo ch c bn cho c s khm bnh, cha bnh c
thc hin hot ng khm bnh, cha bnh bng y hc c truyn khc trong cng a bn
tnh, thnh ph trc thuc trung ng iu tr cho bnh nhn ti c s .
3. Ngi ng u c s khm bnh, cha bnh c ch bin, bo ch thuc c truyn
phi chu trch nhim v cht lng, an ton, hiu qu ca cc loi thuc do chnh c s
ch bin, bo ch.
4. B trng B Y t quy nh iu kin ch bin, bo ch v qun l thuc c truyn
quy nh ti iu ny.
iu 71. ng k, lu hnh, thu hi thuc c truyn
1. Thuc c truyn lu hnh trn th trng phi thc hin vic ng k, lu hnh, thu hi
thuc theo quy nh ti Chng V ca Lut ny, tr quy nh ti khon 2 iu ny.
2. Thi hn cp, gia hn, thay i, b sung giy ng k lu hnh thuc c truyn c
quy nh nh sau:
a) Khng qu 06 thng k t ngy nhn h s i vi vic cp giy ng k lu hnh
thuc c truyn;
b) Khng qu 12 thng k t ngy nhn h s i vi vic cp giy ng k lu hnh
thuc c truyn i vi thuc c truyn phi th lm sng;
c) Khng qu 01 thng k t ngy nhn h s i vi vic gia hn, thay i, b sung
giy ng k lu hnh thuc c truyn;
d) Trng hp khng cp, gia hn, thay i, b sung giy ng k lu hnh thuc c
truyn hoc cha p ng iu kin cp giy ng k lu hnh thuc c truyn theo
quy nh ca Lut ny th phi tr li bng vn bn v nu r l do.
3. Thuc c truyn c cn (bc) theo bi thuc, n thuc c ch bin, bo ch
trong c s khm bnh, cha bnh theo quy nh ti khon 1 v khon 2 iu 70 ca
Lut ny khng phi ng k lu hnh. Ngi ng u c s chu trch nhim thu hi
thuc theo quy nh khi pht hin thuc khng bo m cht lng, an ton, hiu qu.
iu 72. Th thuc c truyn trn lm sng trc khi ng k lu hnh
1. Thuc c truyn c min th, min mt s giai on th lm sng hoc phi th lm
sng y cc giai on.
2. Thuc c truyn c min th lm sng trong trng hp sau y:
a) Thuc c truyn c B Y t cng nhn;
b) Thuc c truyn c cp giy ng k lu hnh trc ngy Lut ny c hiu lc,
tr thuc c ngh phi th lm sng ca Hi ng t vn cp giy ng k lu hnh
thuc, nguyn liu lm thuc.
3. B trng B Y t quy nh tiu ch c th xc nh trng hp min mt s giai
on th thuc c truyn trn lm sng hoc phi th lm sng y cc giai on ti
Vit Nam.
iu 73. Cht lng thuc c truyn
1. Thuc c truyn c cn (bc) theo bi thuc, n thuc, c bo ch, ch bin
trong c s khm bnh, cha bnh quy nh ti khon 1 v khon 2 iu 70 ca Lut ny
phi bo m cht lng do B Y t quy nh.
2. Thuc c truyn lu hnh ton quc phi bo m cht lng theo quy nh ti iu
102 v iu 103 ca Lut ny.
3. B trng B Y t quy nh vic cng nhn bi thuc c truyn, bi thuc c truyn
qu him; cc bi thuc, n thuc c s dng cn (bc); hng dn v phng
php ch bin, bo ch hoc phi ng theo l lun v phng php ca y hc c truyn;
hng dn i vi cc thuc c truyn c dng bo ch hin i.
Chng VII
N THUC V S DNG THUC
iu 74. n thuc
1. n thuc l cn c bn thuc, cp pht thuc, pha ch thuc, cn (bc) thuc, s
dng thuc v hng dn s dng thuc.
2. B trng B Y t quy nh chi tit v n thuc, vic k n thuc.
iu 75. S dng thuc
1. S dng thuc trong cc c s khm bnh, cha bnh c thc hin theo quy nh
ca php lut v khm bnh, cha bnh.
2. S dng thuc ngoi c s khm bnh, cha bnh c quy nh nh sau:
a) Ngi s dng thuc c quyn la chn c s bn l thuc mua thuc; thc hin
theo ng hng dn ghi trong n thuc, t hng dn s dng thuc v hng dn
s dng thuc ca ngi bn l thuc;
b) Ngi k n thuc c trch nhim hng dn s dng cc thuc c k trong n
v chu trch nhim v n thuc k;
c) C s bn l thuc phi hng dn s dng thuc cho ngi s dng.
3. B trng B Y t quy nh vic thnh lp Hi ng lin ngnh xc nh nguyn nhn
v i tng chu trch nhim trong trng hp thuc gy nh hng nghim trng n
sc khe, tnh mng ngi s dng.
Chng VIII
THNG TIN THUC, CNH GIC DC V QUNG CO THUC
iu 76. Ni dung v trch nhim thng tin thuc
1. Thng tin thuc nhm mc ch hng dn s dng thuc hp l, an ton, hiu qu
cho ngi hnh ngh khm bnh, cha bnh v ngi s dng thuc.
2. Thng tin thuc phi cp nht, r rng, y , chnh xc da trn bng chng, d hiu,
ph hp vi i tng c cung cp thng tin.
3. Cn c xy dng ni dung thng tin thuc bao gm cc ti liu sau y, tr trng
hp thng tin quy nh ti im c khon 5 v im a khon 6 iu ny:
a) Dc th Quc gia Vit Nam;
b) T hng dn s dng thuc c B Y t ph duyt;
c) Ti liu, hng dn chuyn mn c lin quan n thuc do B Y t ban hnh hoc
cng nhn.
4. Dc th Quc gia Vit Nam l ti liu chnh thc v hng dn s dng thuc hp l,
an ton, hiu qu. B trng B Y t c trch nhim ban hnh v cp nht Dc th
Quc gia Vit Nam.
5. Ni dung thng tin thuc bao gm:
a) Thng tin cho ngi hnh ngh khm bnh, cha bnh bao gm tn thuc, thnh phn,
nng , hm lng, dng bo ch, ch nh, chng ch nh, liu dng, cch dng, s
dng thuc trn cc i tng c bit, cc thng tin lin quan n cnh bo v an ton
thuc v cc thng tin cn thit khc;
b) Thng tin cho ngi s dng thuc bao gm tn thuc, cng dng, ch nh, chng ch
nh, liu dng, cch dng v nhng vn cn lu trong qu trnh s dng thuc;
c) Thng tin cho c quan qun l nh nc v dc bao gm thng tin cp nht v cht
lng, an ton, hiu qu ca thuc.
6. Trch nhim cung cp thng tin thuc c quy nh nh sau:
a) C s kinh doanh dc, vn phng i din ca thng nhn nc ngoi hot ng
trong lnh vc dc ti Vit Nam, c s ng k thuc c trch nhim cp nht thng tin
thuc ca c s ang lu hnh trn th trng cho c quan qun l nh nc v dc;
b) C s kinh doanh dc, vn phng i din ca thng nhn nc ngoi hot ng
trong lnh vc dc ti Vit Nam, c s ng k thuc c trch nhim cung cp thng tin
thuc ph hp vi thng tin quy nh ti khon 3 iu ny cho ngi hnh ngh khm
bnh, cha bnh v ngi s dng thuc.
Ngi ca c s kinh doanh dc gii thiu thuc cho ngi hnh ngh khm bnh, cha
bnh theo quy nh ca B trng B Y t;
c) Ngi hnh ngh khm bnh, cha bnh c trch nhim cung cp thng tin thuc c
lin quan cho ngi s dng thuc trong qu trnh khm bnh, cha bnh;
d) C quan qun l nh nc v dc trong phm vi nhim v, quyn hn ca mnh c
trch nhim cng b thng tin v cht lng, an ton, hiu qu ca thuc.
7. T chc, c nhn cung cp thng tin thuc phi chu trch nhim v nhng thng tin
do mnh cung cp.
iu 77. Cnh gic dc
1. Ni dung hot ng cnh gic dc bao gm:
a) Theo di, pht hin, bo co thng tin lin quan n phn ng c hi ca thuc, sai st
lin quan n thuc, nghi ng thuc gi, thuc khng t tiu chun cht lng v thng
tin lin quan n thuc khng c hoc khng t hiu qu iu tr;
b) Thu thp, x l thng tin quy nh ti im a khon ny; nh gi li ch, nguy c, kt
lun, qun l ri ro lin quan n thuc;
c) Cng b kt lun ca c quan c thm quyn v cc vn an ton ca thuc.
2. Ngi s dng thuc khi c nhng du hiu bt thng trong qu trnh s dng cn
thng bo n ngi trc tip khm bnh, cha bnh hoc c s bn l thuc ni mua
thuc v n c s khm bnh, cha bnh c bin php x l kp thi.
3. Ngi hnh ngh khm bnh, cha bnh c cc trch nhim sau y:
a) Ch ng theo di, pht hin c du hiu bt thng, sai st lin quan n thuc v
nghi ng v cht lng, hiu qu ca thuc trong qu trnh hnh ngh;
b) nh gi, x l v d phng khi pht hin c du hiu bt thng, sai st hoc khi
nhn c thng tin t ngi s dng thuc quy nh ti khon 2 iu ny;
c) Bo co cho c quan c thm quyn v cc thng tin thu thp c khi thc hin trch
nhim quy nh ti im a v im b khon ny.
4. C s bn l thuc c cc trch nhim sau y:
a) T vn trong phm vi chuyn mn cho ngi s dng thuc v cc bin php x l khi
c du hiu bt thng trong qu trnh s dng thuc;
b) Thu thp, bo co cho c quan c thm quyn cc thng tin v du hiu bt thng
trong qu trnh s dng thuc.
5. C s sn xut thuc, c s pha ch, ch bin thuc, c s ng k thuc c cc trch
nhim sau y:
a) T chc theo di v cht lng, an ton, hiu qu ca thuc khi a ra lu hnh trn
th trng;
b) Bo co v cp nht thng tin cho c quan c thm quyn v cht lng, an ton, hiu
qu lin quan n thuc do c s mnh sn xut, ng k lu hnh, pha ch, ch bin.
6. B trng B Y t quy nh vic tm ngng kinh doanh, s dng v nim phong bo
qun trong trng hp thuc c du hiu khng an ton cho ngi s dng.
iu 78. T chc hot ng thng tin thuc v cnh gic dc
1. C s kinh doanh dc, c s khm bnh, cha bnh c trch nhim t chc hot ng
thng tin thuc v cnh gic dc ti c s.
2. B trng B Y t c trch nhim t chc h thng thng tin thuc v cnh gic dc.
3. Chnh ph quy nh chi tit thm quyn, h s, th tc tip nhn, thm nh v xc
nhn ni dung thng tin thuc.
iu 79. Qung co thuc
1. Vic qung co thuc thc hin theo ng ni dung qung co c B Y t xc
nhn v theo quy nh ca php lut v qung co c lin quan.
Trong thi hn 15 ngy k t ngy nhn h s ngh xc nhn ni dung qung co
thuc, B Y t thm nh v cp giy xc nhn ni dung qung co thuc. Trng hp
khng cp giy xc nhn ni dung qung co hoc c yu cu sa i, b sung ni dung
qung co, B Y t phi tr li bng vn bn v nu r l do.
2. iu kin i vi thuc c qung co c quy nh nh sau:
a) Thuc Danh mc thuc khng k n;
b) Khng thuc trng hp hn ch s dng hoc s dng di s gim st ca thy
thuc theo khuyn co ca c quan nh nc c thm quyn;
c) Giy ng k lu hnh thuc cn thi hn hiu lc ti Vit Nam.
3. Chnh ph quy nh chi tit ni dung qung co thuc, h s, th tc tip nhn, thm
nh v xc nhn ni dung qung co thuc.
Chng IX
DC LM SNG
iu 80. Ni dung hot ng dc lm sng
1. T vn trong qu trnh xy dng danh mc thuc ti c s khm bnh, cha bnh

bo m mc tiu s dng thuc hp l, an ton, hiu qu.
2. T vn v gim st vic k n v s dng thuc.
3. Thng tin, hng dn s dng thuc cho ngi hnh ngh khm bnh, cha bnh,
ngi s dng thuc v cng ng.
4. Tham gia xy dng quy trnh, hng dn chuyn mn lin quan n s dng thuc v
gim st vic thc hin cc quy trnh ny.
5. Phn tch, nh gi hiu qu s dng thuc ti c s khm bnh, cha bnh.
6. Tham gia theo di, gim st phn ng c hi ca thuc.
7. Tham gia hot ng nghin cu khoa hc lin quan n s dng thuc hp l, an ton,
hiu qu.
iu 81. Trin khai hot ng dc lm sng
1. Ngi ng u c s khm bnh, cha bnh c hot ng s dng thuc phi t chc
v trin khai hot ng dc lm sng theo ni dung quy nh ti iu 80 ca Lut ny.
2. Ngi chu trch nhim chuyn mn ca nh thuc phi trin khai hot ng dc lm
sng theo ni dung quy nh ti cc khon 2, 3 v 6 iu 80 ca Lut ny c th nh sau:
a) T vn, cung cp thng tin v thuc cho ngi mua, ngi s dng thuc;
b) T vn, trao i vi ngi k n trong trng hp pht hin vic k n thuc khng
hp l;
c) Tham gia theo di, gim st phn ng c hi ca thuc.
3. Chnh ph quy nh vic t chc, hot ng dc lm sng ca c s khm bnh, cha
bnh bao gm c c s khm bnh, cha bnh ca lc lng v trang nhn dn.
iu 82. Quyn v ngha v ca ngi lm cng tc dc lm sng
1. Ngi lm cng tc dc lm sng ti c s khm bnh, cha bnh c cc quyn v
ngha v sau y:
a) c tip cn ngi bnh, bnh n v n thuc t vn cho ngi k n trong
vic s dng thuc;
b) Trao i vi ngi hnh ngh khm bnh, cha bnh vic k n v s dng thuc
hp l, an ton, hiu qu.
c) c ghi kin chuyn mn v dc lm sng trong h s bnh n, n thuc; c

phn nh kin vi Hi ng thuc v iu tr ca c s khm bnh, cha bnh hoc
ngi ng u c s khm bnh, cha bnh trong trng hp c kin khc nhau v
vic k n, s dng thuc cho ngi bnh;
d) Tham gia hi chn chuyn mn, bnh bnh n, n thuc;
) Tham gia xy dng hng dn iu tr chun; danh mc thuc ti c s khm bnh,
cha bnh; quy trnh chuyn mn k thut lin quan n thuc;
e) Tham gia theo di, gim st phn ng c hi ca thuc;
g) Thc hin quyn v ngha v khc theo quy nh ca php lut.
2. Ngi lm cng tc dc lm sng ti nh thuc c cc quyn v ngha v sau y:
a) T vn, cung cp thng tin v thuc cho ngi mua, ngi s dng thuc;
b) T vn, trao i vi ngi k n trong trng hp pht hin vic k n thuc khng
hp l;
c) Tham gia theo di, gim st phn ng c hi ca thuc;
d) Thc hin quyn v ngha v khc theo quy nh ca php lut.
iu 83. Chnh sch ca Nh nc i vi hot ng dc lm sng
1. u t c s, vt cht, trang thit b v nhn lc ph hp cho hot ng dc lm sng
ti c s khm bnh, cha bnh ca Nh nc; u tin tuyn dng dc s chuyn khoa
dc lm sng ti c s khm bnh, cha bnh ca Nh nc.
2. u t c s, vt cht, trang thit b v nhn lc cho c s o to dc s chuyn
khoa dc lm sng ca Nh nc; ngn sch nh nc h tr hc ph i vi ngi hc
chuyn khoa dc lm sng.
3. Nh nc khuyn khch t chc, c nhn tham gia o to dc s lm cng tc dc
lm sng, u t c s vt cht, trang thit b cho hot ng dc lm sng.
Chng X
QUN L THUC TRONG C S KHM BNH, CH1A BNH
iu 84. Cung ng, bo qun, cp pht v s dng thuc
1. Ngi ng u c s khm bnh, cha bnh c trch nhim bo m cung ng
thuc c cht lng phc v cho nhu cu cp cu, khm bnh, cha bnh ti c s khm
bnh, cha bnh; t chc bn thuc ban m ti c s khm bnh, cha bnh tuyn huyn
tr ln.
2. Vic bo qun thuc trong c s khm bnh, cha bnh phi tun th cc quy nh v
thc hnh tt trong bo qun thuc v quy nh khc ca php lut c lin quan.
3. Vic cp pht thuc trong c s khm bnh, cha bnh phi thc hin theo ng y lnh
hoc n thuc, ghi r tn thuc, hm lng trn bao b ng thuc v c hng dn cho
ngi s dng.
4. Vic s dng thuc phng x ch c thc hin ti c s khm bnh, cha bnh c
thy thuc chuyn khoa y hc ht nhn v c B Khoa hc v Cng ngh cp giy
php tin hnh cng vic bc x theo quy nh ca php lut v nng lng nguyn t.
5. B trng B Y t quy nh v t l hao ht thuc v vic thanh ton chi ph hao ht
thuc ti c s khm bnh, cha bnh.
iu 85. Sn xut, pha ch thuc trong c s khm bnh, cha bnh
1. Ngi ng u c s khm bnh, cha bnh c sn xut, pha ch thuc s dng ti
c s khm bnh, cha bnh phi chu trch nhim v cht lng v vic qun l cc loi
thuc do c s mnh sn xut, pha ch.
2. C s khm bnh, cha bnh c php sn xut, pha ch phc v nhu cu iu tr
ca c s khi p ng cc iu kin theo quy nh ca B trng B Y t.
3. C s khm bnh, cha bnh sn xut, pha ch thuc phng x, ngoi vic thc hin
quy nh ti khon 1 v khon 2 iu ny, phi thc hin cc bin php v an ninh bo
m khng tht thot thuc, nguyn liu lm thuc phng x v c B Khoa hc v
Cng ngh cp giy php tin hnh cng vic bc x theo quy nh ca php lut v nng
lng nguyn t.
Thuc sn xut, pha ch theo quy nh ti khon ny c cung cp cho c s khm bnh,
cha bnh khc theo quy nh ca B trng B Y t.
Chng XI
TH THUC TRN LM SNG, TH TNG NG SINH HC CA
THUC
Mc 1. TH THUC TRN LM SNG
iu 86. Cc giai on th thuc trn lm sng
1. Giai on 1 l giai on u tin th nghim trn ngi nhm nh gi s b v tnh an

ton ca thuc.
2. Giai on 2 l giai on th nghim nhm xc nh liu ti u cho th nghim lm
sng v chng minh tnh an ton, hiu qu ca thuc bao gm c tnh sinh min dch ca
vc xin th trn i tng ch.
3. Giai on 3 l giai on th nghim c nghin cu trn quy m ln nhm xc nh
tnh n nh ca cng thc, tnh an ton, hiu qu iu tr mc tng th ca thuc hoc
nh gi hiu qu bo v v tnh an ton ca vc xin trn i tng ch.
4. Giai on 4 l giai on c tin hnh sau khi thuc c lu hnh nhm tip tc
nh gi tnh an ton, hiu qu iu tr ca thuc v theo di hiu qu bo v ca vc xin
sau khi c dng rng ri trong cng ng dn c theo ng iu kin s dng.
iu 87. Th thuc trn lm sng ng k lu hnh thuc
1. Th thuc trn lm sng giai on 1, 2 v 3 c thc hin trc khi ng k lu hnh
thuc.
2. Th thuc trn lm sng giai on 4 c thc hin sau khi ng k lu hnh thuc
theo yu cu ca c quan qun l v dc c thm quyn.
iu 88. Yu cu i vi thuc th lm sng
1. Thuc th lm sng phi bo m cc yu cu sau y:
a) c nghin cu giai on tin lm sng;
b) C dng bo ch n nh;
c) t tiu chun cht lng theo h s ng k th lm sng.
2. Nhn thuc th lm sng phi ghi dng ch Thuc dng cho th lm sng. Cm dng
cho mc ch khc.
iu 89. Thuc phi th lm sng, thuc min th lm sng hoc min mt s giai
on th lm sng khi ng k lu hnh thuc
1. Thuc phi th lm sng y cc giai on trong trng hp sau y:
a) Thuc mi, tr trng hp quy nh ti im a khon 2 v im b khon 3 iu ny;
b) Thuc dc liu c s kt hp mi ca dc liu tng s dng lm thuc ti Vit
Nam v c ch nh i vi cc bnh thuc danh mc do B trng B Y t ban hnh, tr
trng hp quy nh ti im b khon 2 v im c khon 3 iu ny;
c) Vc xin ln u tin ng k lu hnh ti Vit Nam, tr trng hp quy nh ti im

c khon 2 iu ny.
2. Thuc c min mt s giai on th lm sng trong trng hp sau y:
a) Thuc mi c cp php lu hnh ti t nht mt nc trn th gii nhng cha c
y d liu lm sng v an ton, hiu qu;
b) Thuc dc liu khng thuc trng hp quy nh ti im c khon 3 iu ny;
c) Vc xin c cp php lu hnh ti t nht mt nc trn th gii v c d liu lm
sng v an ton, hiu qu.
3. Thuc c min th lm sng trong trng hp sau y:
a) Thuc generic;
b) Thuc mi c cp php lu hnh ti t nht mt nc trn th gii v c y
d liu lm sng v an ton, hiu qu, tr vc xin;
c) Thuc dc liu c cp giy ng k lu hnh thuc trc ngy Lut ny c hiu
lc, tr thuc c ch nh i vi cc bnh thuc danh mc do B trng B Y t ban
hnh.
4. B trng B Y t quy nh chi tit yu cu v d liu lm sng bo m an ton,
hiu qu v tiu ch xc nh trng hp min th, min mt s giai on th thuc
trn lm sng ti Vit Nam v thuc phi yu cu th lm sng giai on 4.
iu 90. iu kin ca ngi tham gia th thuc trn lm sng
1. Phi l ngi tnh nguyn, p ng yu cu chuyn mn ca vic th thuc trn lm
sng v phi k tha thun tnh nguyn tham gia nghin cu vi c s kinh doanh dch
v th thuc trn lm sng, tr ngi b hn ch nng lc hnh vi dn s, mt nng lc
hnh vi dn s.
2. Trng hp cha n tui thnh nin, b hn ch nng lc hnh vi dn s, mt nng
lc hnh vi dn s th phi c s ng ca ngi i din hoc ngi gim h theo
quy nh ca php lut.
3. Trng hp l ph n mang thai hoc ang cho con b, h s nghin cu phi ghi r l
do tuyn chn v bin php ph hp bo v ngi tham gia th thuc trn lm sng.
iu 91. Quyn v ngha v ca ngi tham gia th thuc trn lm sng
1. Ngi tham gia th thuc trn lm sng c cc quyn sau y:
a) Trc khi th thuc, c cung cp thng tin y , trung thc v nhng ri ro c th

xy ra;
b) c t chc, c nhn c thuc th lm sng bi thng thit hi nu c thit hi do
th thuc gy ra;
c) c gi b mt v thng tin c nhn c lin quan;
d) Khng phi chu trch nhim khi n phng chm dt vic tham gia th thuc trn
lm sng;
) Khiu ni, khi kin, t co v hnh vi vi phm php lut ca t chc, c nhn c
thuc th lm sng v nhn th thuc.
2. Ngi tham gia th thuc trn lm sng c ngha v tun th hng dn ca nghin
cu vin theo h s th thuc trn lm sng c ph duyt.
iu 92. Quyn v trch nhim ca t chc, c nhn c thuc th lm sng
1. T chc, c nhn c thuc th lm sng c cc quyn sau y:
a) La chn t chc p ng yu cu v c s vt cht v cn b chuyn mn th
thuc;
b) S hu ton b kt qu nghin cu ca thuc th lm sng.
2. T chc, c nhn c thuc th lm sng c cc trch nhim sau y:
a) Bi thng thit hi cho ngi tham gia th thuc trn lm sng nu c ri ro xy ra
do th thuc theo quy nh ca php lut;
b) K kt hp ng v vic th thuc trn lm sng vi c s nhn th thuc;
c) Chu trch nhim trc php lut v cht lng v tnh an ton ca thuc do mnh
cung cp.
iu 93. Quyn v trch nhim ca c s nhn th thuc trn lm sng
1. C s nhn th thuc trn lm sng c cc quyn sau y:
a) Tin hnh hot ng th thuc trn lm sng theo quy nh;
b) Nhp khu, mua ha cht, cht chun, mu thuc phc v cho hot ng th thuc trn
lm sng;
c) S dng kt qu nghin cu th thuc trn lm sng theo tha thun vi t chc, c
nhn c thuc th lm sng.
2. C s nhn th thuc trn lm sng c cc trch nhim sau y:

a) Chu trch nhim v kt qu nghin cu th thuc trn lm sng;
b) Chu trch nhim v s an ton ca ngi tham gia th thuc trn lm sng v bi
thng thit hi cho ngi tham gia th thuc trn lm sng nu c ri ro xy ra do li
ca c s nhn th thuc trn lm sng theo quy nh ca php lut;
c) Bo m trung thc, khch quan trong th thuc trn lm sng;
d) c lp v kinh t, t chc nhn s i vi t chc, c nhn c thuc th lm sng.
iu 94. Nguyn tc v thm quyn ph duyt th thuc trn lm sng
1. Vic th thuc trn lm sng ch c thc hin sau khi c Hi ng o c
trong nghin cu y sinh hc cp quc gia nh gi v khoa hc v o c i vi h s
th thuc trn lm sng v c B trng B Y t ph duyt bng vn bn.
2. Vic th thuc trn lm sng, nh gi v khoa hc v o c i vi h s th thuc
trn lm sng v ph duyt th thuc trn lm sng c thc hin theo cc nguyn tc
c bn sau y:
a) Tn trng quyn t quyt ca ngi tham gia th thuc, bo v nhng ngi m quyn
t quyt ca h b hn ch;
b) Bo m cc li ch ca nghin cu ln hn cc nguy c, cc nguy c trong nghin
cu c cn nhc k lng v gim thiu ti a theo cc chun mc;
c) Bnh ng v li ch v trch nhim cho mi ngi tham gia th thuc, bo m li ch
v nguy c c phn b u cho ngi tham gia th thuc;
d) Bo m thc hin cc giai on th thuc trn lm sng v tun th Thc hnh tt th
thuc trn lm sng.
3. Hi ng o c trong nghin cu y sinh hc l hi ng c lp c thnh lp
cp quc gia v cp c s bo v cc quyn, s an ton v sc khe ca ngi tham
gia th thuc.
B trng B Y t quy nh vic thnh lp v chc nng, nhim v, quyn hn ca Hi
ng o c trong nghin cu y sinh hc.
iu 95. H s, quy trnh th thuc trn lm sng
1. H s th thuc trn lm sng bao gm:
a) n ngh th thuc trn lm sng;
b) H s thng tin sn phm nghin cu;

c) H s php l ca sn phm nghin cu;
d) cng nghin cu th thuc trn lm sng v bn thuyt minh;
) L lch khoa hc ca nghin cu vin;
e) Bn cung cp thng tin v phiu tnh nguyn tham gia nghin cu ca ngi tham gia
th thuc trn lm sng;
g) Bin bn nh gi v khoa hc v o c trong nghin cu ca Hi ng o c
trong nghin cu y sinh hc cp c s;
h) Nhn thuc nghin cu.
2. Quy trnh th thuc trn lm sng c quy nh nh sau:
a) ng k nghin cu th thuc trn lm sng;
b) Ph duyt nghin cu th thuc trn lm sng;
c) T chc thc hin th thuc trn lm sng;
d) Ph duyt kt qu th thuc trn lm sng.
Mc 2. TH TNG NG SINH HC CA THUC
iu 96. Cc giai on th tng ng sinh hc ca thuc v thuc phi th tng
ng sinh hc
1. Th tng ng sinh hc ca thuc gm cc giai on sau y:
a) Giai on nghin cu lm sng l giai on th nghim thuc i chng v thuc th
tng ng sinh hc t yu cu v an ton, hiu qu so snh sinh kh dng ca
02 thuc trn ngi tnh nguyn;
b) Giai on phn tch dch sinh hc ca ngi l giai on phn tch, xc nh nng
thuc i chng v thuc th tng ng sinh hc trong mu sinh hc ca ngi tnh
nguyn sau khi c dng giai on nghin cu lm sng nhm so snh sinh kh dng
v chng minh tnh tng ng sinh hc ca 02 thuc.
2. Thuc generic phi th tng ng sinh hc khi c dc cht, dng bo ch thuc
danh mc dc cht, dng bo ch phi th tng ng sinh hc do B trng B Y t
ban hnh.
iu 97. iu kin, quyn v ngha v ca ngi tham gia th tng ng sinh hc

ca thuc
1. Ngi tham gia th tng ng sinh hc ca thuc phi p ng iu kin quy nh
ti iu 90 ca Lut ny.
2. Quyn v ngha v ca ngi tham gia th tng ng sinh hc ca thuc thc hin
theo quy nh ti iu 91 ca Lut ny.
iu 98. Quyn v trch nhim ca t chc, c nhn c thuc th tng ng sinh
hc
1. T chc, c nhn c thuc th tng ng sinh hc c cc quyn sau y:
a) La chn t chc p ng yu cu v c s vt cht v cn b chuyn mn th
tng ng sinh hc ca thuc;
b) S hu ton b kt qu nghin cu ca thuc th tng ng sinh hc.
2. T chc, c nhn c thuc th tng ng sinh hc c cc trch nhim sau y:
a) Bi thng thit hi cho ngi tham gia th tng ng sinh hc nu c ri ro xy ra
do th tng ng sinh hc theo quy nh ca php lut;
b) K kt hp ng v vic th tng ng sinh hc vi c s nhn th tng ng
sinh hc ca thuc;
c) Chu trch nhim trc php lut v cht lng v tnh an ton ca thuc do mnh
cung cp.
iu 99. Quyn v trch nhim ca c s nhn th tng ng sinh hc ca thuc
1. C s nhn th tng ng sinh hc ca thuc c cc quyn sau y:
a) Tin hnh giai on nghin cu lm sng v giai on phn tch dch sinh hc trong
th tng ng sinh hc ca thuc.
Trng hp ch tin hnh giai on phn tch dch sinh hc th c k hp ng hoc
lin kt vi c s nhn th thuc trn lm sng p ng Thc hnh tt th thuc trn lm
sng thc hin giai on nghin cu lm sng trong th tng ng sinh hc ca
thuc;
b) Tin hnh hot ng th tng ng sinh hc ca thuc theo quy nh;
c) Nhp khu, mua ha cht, cht chun, mu thuc phc v cho hot ng th tng
ng sinh hc ca thuc;
d) S dng kt qu nghin cu th tng ng sinh hc ca thuc theo tha thun vi

t chc, c nhn c thuc th tng ng sinh hc.
2. C s nhn th tng ng sinh hc ca thuc c cc trch nhim sau y:
a) Chu trch nhim v kt qu nghin cu th tng ng sinh hc i vi mu thuc
th;
b) Chu trch nhim v s an ton ca ngi tham gia th tng ng sinh hc v bi
thng thit hi cho ngi tham gia th tng ng sinh hc nu c ri ro xy ra do li
ca c s nhn th tng ng sinh hc ca thuc theo quy nh ca php lut;
c) Bo m trung thc, khch quan trong th tng ng sinh hc ca thuc;
d) c lp v kinh t, t chc nhn s i vi t chc, c nhn c thuc th tng ng
sinh hc.
iu 100. Nguyn tc ph duyt vic th tng ng sinh hc ca thuc
1. Vic th tng ng sinh hc ca thuc ch c thc hin sau khi c Hi ng
o c trong nghin cu y sinh hc cp c s nh gi v khoa hc v o c i vi
h s th tng ng sinh hc ca thuc v c ngi chu trch nhim chuyn mn
ca c s nhn th tng ng sinh hc ca thuc ph duyt bng vn bn.
2. Vic ph duyt th tng ng sinh hc ca thuc phi thc hin theo cc nguyn tc
c bn sau y:
a) Nguyn tc theo quy nh ti cc im a, b v c khon 2 iu 94 ca Lut ny;
b) Tun th Thc hnh tt th thuc trn lm sng, Thc hnh tt phng th nghim phn
tch dch sinh hc v ph hp vi hng dn th tng ng sinh hc do B trng B
Y t quy nh.
3. Hi ng o c trong nghin cu y sinh hc cp c s nh gi v khoa hc v o
c trong nghin cu ca h s th tng ng sinh hc ca thuc v ph duyt
cng nghin cu.
iu 101. H s, quy trnh th tng ng sinh hc ca thuc
1. H s th tng ng sinh hc ca thuc bao gm:
a) n ngh th tng ng sinh hc;
b) H s thng tin v thuc;
c) cng nghin cu th tng ng sinh hc v bn thuyt minh;
d) L lch khoa hc ca nghin cu vin;

) Bn cung cp thng tin v phiu tnh nguyn tham gia nghin cu ca ngi tham gia
th tng ng sinh hc ca thuc;
e) Nhn thuc.
2. Quy trnh th tng ng sinh hc ca thuc c quy nh nh sau:
a) ng k nghin cu th tng ng sinh hc ca thuc;
b) Ph duyt nghin cu th tng ng sinh hc ca thuc;
c) T chc thc hin th tng ng sinh hc ca thuc;
d) Ph duyt kt qu th tng ng sinh hc ca thuc.
Chng XII
QUY CHUN, TIU CHUN CHT LNG V VIC KIM NGHIM
THUC, NGUYN LIU LM THUC, BAO B TIP XC TRC TIP VI
THUC
iu 102. Quy chun, tiu chun cht lng thuc, nguyn liu lm thuc, bao b
tip xc trc tip vi thuc
1. Quy chun k thut quc gia v thuc, nguyn liu lm thuc, bao b tip xc trc tip
vi thuc bao gm quy chun k thut v cht lng thuc, nguyn liu lm thuc, bao b
tip xc trc tip vi thuc v phng php kim nghim chung c quy nh trong
Dc in Vit Nam. Vic p dng phng php kim nghim trong tng chuyn lun
ca thuc, nguyn liu lm thuc, bao b tip xc trc tip vi thuc c ghi trong Dc
in Vit Nam c thc hin theo nguyn tc t nguyn p dng.
2. Tiu chun cht lng thuc, nguyn liu lm thuc, bao b tip xc trc tip vi thuc
c quy nh nh sau:
a) Tiu chun quc gia v thuc, nguyn liu lm thuc, bao b tip xc trc tip vi
thuc do B Y t xy dng, B Khoa hc v Cng ngh thm nh v cng b theo quy
nh ca Lut tiu chun v quy chun k thut;
b) Tiu chun c s do c s sn xut thuc, nguyn liu lm thuc, bao b tip xc trc
tip vi thuc xy dng p dng trong phm vi hot ng ca c s mnh nhng
khng c thp hn quy chun k thut quc gia tng ng c quy nh ti Dc
in Vit Nam. Trng hp Dc in Vit Nam cha c quy chun k thut quc gia v
thuc, nguyn liu lm thuc, bao b tip xc trc tip vi thuc tng ng, c s xy
dng tiu chun trn c s kt qu nghin cu khoa hc hoc theo quy nh ca Dc
in nc ngoi v c B Y t ph duyt.
3. B trng B Y t ban hnh Dc in Vit Nam trn c s Tiu chun quc gia v
thuc, nguyn liu lm thuc, bao b tip xc trc tip vi thuc v quy nh vic p
dng Dc in nc ngoi ti Vit Nam.
iu 103. Kim nghim thuc, nguyn liu lm thuc, bao b tip xc trc tip vi
thuc
1. Kim nghim thuc, nguyn liu lm thuc, bao b tip xc trc tip vi thuc l vic
ly mu, xem xt tiu chun k thut, tin hnh cc th nghim tng ng v cn thit
nhm xc nh thuc, nguyn liu lm thuc, bao b tip xc trc tip vi thuc c p
ng tiu chun cht lng quyt nh vic chp nhn hay loi b thuc, nguyn liu
lm thuc, bao b tip xc trc tip vi thuc.
2. Nguyn liu lm thuc, bao b tip xc trc tip vi thuc trc khi a vo sn xut
thuc phi c c s sn xut thuc tin hnh kim nghim v t tiu chun cht lng.
3. Thuc, nguyn liu lm thuc, bao b tip xc trc tip vi thuc trc khi xut xng
phi c c s sn xut thuc, nguyn liu lm thuc, bao b tip xc trc tip vi thuc
tin hnh kim nghim v t tiu chun cht lng.
4. Cc thuc sau y ngoi vic c kim nghim theo quy nh ti khon 3 iu ny
cn phi c kim nghim bi c s kim nghim thuc do c quan nh nc c thm
quyn ch nh trc khi lu hnh:
a) Vc xin;
b) Sinh phm l huyt thanh c cha khng th;
c) Thuc khc do B trng B Y t quy nh cn c trn kt qu nh gi nguy c v
cht lng thuc v din bin cht lng thuc sn xut, nhp khu.
iu 104. C s kim nghim thuc, nguyn liu lm thuc
1. C s kim nghim thuc, nguyn liu lm thuc bao gm:
a) C s kim nghim thuc, nguyn liu lm thuc ca Nh nc;
b) C s kinh doanh dch v kim nghim thuc, nguyn liu lm thuc;
c) Phng kim nghim ca c s kinh doanh dc.
2. C s kim nghim thuc, nguyn liu lm thuc ca Nh nc c cc trch nhim sau

y:
a) Thc hin vic kim tra xc nh cht lng thuc, nguyn liu lm thuc, bao b tip
xc trc tip vi thuc;
b) Kim tra, nh gi cht lng, thm nh tiu chun cht lng thuc, nguyn liu lm
thuc, bao b tip xc trc tip vi thuc theo yu cu ca B Y t;
c) T vn, xut vi B trng B Y t cc bin php k thut tng cng cng tc
qun l cht lng thuc ph hp vi iu kin pht trin kinh t - x hi;
d) Bo m trung thc, khch quan trong kim nghim thuc, nguyn liu lm thuc, bao
b tip xc trc tip vi thuc;
) Chu trch nhim v kt qu kim nghim i vi mu thuc, mu nguyn liu lm
thuc, bao b tip xc trc tip vi thuc kim nghim.
3. C s kinh doanh dch v kim nghim thuc, nguyn liu lm thuc c cc trch
nhim quy nh ti khon 2 iu 51 ca Lut ny.
4. Phng kim nghim ca c s kinh doanh dc chu trch nhim v kim tra, kim
nghim xc nh cht lng thuc, nguyn liu lm thuc, bao b tip xc trc tip vi
thuc ca c s.
5. Th tng Chnh ph ban hnh quy hoch h thng kim nghim ca Nh nc, c s
kinh doanh dch v kim nghim thuc, nguyn liu lm thuc; quy nh v h thng t
chc, c s vt cht v hot ng ca cc c s kim nghim thuc, nguyn liu lm
thuc ca Nh nc.
iu 105. Gii quyt khiu ni v kt lun cht lng thuc, nguyn liu lm thuc,
bao b tip xc trc tip vi thuc
1. C s kinh doanh dc c quyn khiu ni v kt lun cht lng thuc, nguyn liu
lm thuc, bao b tip xc trc tip vi thuc ca c quan qun l nh nc v dc c
thm quyn.
2. Trng hp c khiu ni v kt lun cht lng thuc, nguyn liu lm thuc, bao b
tip xc trc tip vi thuc, B Y t ch nh c s kim nghim thuc, nguyn liu lm
thuc c iu kin tiu chun ti thiu tng ng vi c s kim nghim c kt qu
kim nghim gy pht sinh tranh chp kim nghim li thuc, nguyn liu lm thuc,
bao b tip xc trc tip vi thuc c khiu ni v kt lun.
3. Thm quyn, th tc gii quyt khiu ni v kt lun cht lng thuc nguyn liu lm
thuc, bao b tip xc trc tip vi thuc thc hin theo quy nh ca php lut v khiu
ni.
Chng XIII
QUN L GI THUC
iu 106. Nguyn tc qun l nh nc v gi thuc
1. Qun l gi thuc theo c ch th trng, tn trng quyn t nh gi, cnh tranh v gi
ca t chc, c nhn kinh doanh thuc theo quy nh ca php lut.
2. Bo m cng khai, minh bch gi thuc khi lu hnh thuc trn th trng.
3. Bo v quyn, li ch hp php ca t chc, c nhn kinh doanh, ngi tiu dng v
li ch ca Nh nc.
4. Thc hin cc bin php bnh n gi v s dng cc bin php khc qun l gi
thuc ph hp vi iu kin pht trin kinh t - x hi trong tng thi k.
iu 107. Cc bin php qun l gi thuc
1. u thu thuc d tr quc gia theo quy nh ca Lut u thu v php lut v d tr
quc gia; u thu thuc mua t ngun vn ngn sch nh nc, qu bo him y t,
ngun thu t dch v khm bnh, cha bnh v cc ngun thu hp php khc ca c s y
t cng lp theo quy nh ca Lut u thu, tr trng hp quy nh ti khon 2 iu
ny.
2. u thu hoc t hng hoc giao k hoch i vi thuc phc v chng trnh mc
tiu quc gia, quc phng, an ninh, phng, chng dch bnh, khc phc hu qu thin tai,
thm ha theo quy nh ca php lut v cung ng dch v, sn phm cng ch.
3. K khai gi thuc trc khi lu hnh trn th trng v k khai li khi thay i gi
thuc k khai.
4. Nim yt gi bn bun, bn l thuc bng ng Vit Nam ti ni giao dch hoc ni
bn thuc ca c s kinh doanh dc; in, ghi hoc dn gi bn l trn bao b cha ng
thuc hoc bao b ngoi ca thuc; thng bo cng khai trn bng, trn giy hoc bng
cc hnh thc khc.
5. Thc hin cc bin php bnh n gi thuc theo quy nh ca Lut gi i vi thuc
thuc Danh mc thuc thit yu khi c bin ng bt thng v gi hoc mt bng gi
bin ng nh hng n s n nh kinh t - x hi.
6. Thc hin hnh thc m phn gi i vi gi thu mua thuc, dc liu ch c t 01

n 02 nh sn xut, thuc bit dc gc, thuc him, thuc trong thi gian cn bn
quyn, thuc c hm lng khng ph bin v trng hp c th khc.
7. Quy nh thng s bn l ti a i vi thuc bn ti c s bn l thuc trong khun
vin c s khm bnh, cha bnh.
8. Chnh ph quy nh chi tit iu ny.
iu 108. Trch nhim qun l nh nc v gi thuc
1. Chnh ph thng nht qun l nh nc v gi thuc.
2. B Y t chu trch nhim trc Chnh ph thc hin qun l nh nc v gi thuc.
3. B, c quan ngang b trong phm vi nhim v, quyn hn ca mnh phi hp vi B Y
t thc hin qun l nh nc v gi thuc.
4. y ban nhn dn cp tnh trong phm vi nhim v, quyn hn ca mnh thc hin qun
l nh nc v gi thuc ti a phng.
iu 109. Trch nhim qun l nh nc v gi thuc ca B Y t
Ch tr phi hp vi B Ti chnh, b, c quan ngang b, c quan thuc Chnh ph v y
ban nhn dn cp tnh thc hin qun l nh nc v gi thuc c cc nhim v sau y:
1. Ch tr xy dng, trnh c quan nh nc c thm quyn hoc ban hnh theo thm
quyn v t chc thc hin chnh sch, php lut v gi thuc;
2. Yu cu cc b, c quan ngang b, c quan thuc Chnh ph, y ban nhn dn cp
tnh bo co nh k, t xut v cng tc qun l nh nc v gi thuc;
3. Ch tr t chc thc hin cng tc ph bin, gio dc php lut v gi thuc;
4. Ch tr, phi hp vi B Ti chnh trin khai cc bin php bnh n gi thuc theo quy
nh ca php lut v gi;
5. Ch tr, phi hp vi B Ti chnh quy nh c th vic k khai gi thuc v nguyn
tc r sot, cng b gi thuc do doanh nghip sn xut, nhp khu k khai;
6. T chc tip nhn v r sot gi thuc nhp khu do c s nhp khu hoc c s y
quyn nhp khu k khai, k khai li; gi thuc sn xut trong nc do c s sn xut k
khai;
7. Hng dn thc hin vic nim yt gi thuc ti cc c s kinh doanh thuc;
8. Cng b trn cng thng tin in t ca B Y t v cc thng tin sau y:
a) Gi bn bun, bn l thuc k khai;

b) Gi thuc trng thu do Bo him x hi Vit Nam v c s y t cung cp;
c) Thuc thuc Danh mc thuc thit yu khi c bin ng bt thng v gi hoc mt
bng gi bin ng nh hng n n nh kinh t - x hi;
9. Kim tra, thanh tra v x pht vi phm php lut v gi thuc.
iu 110. Trch nhim qun l nh nc v gi thuc ca B Ti chnh
1. Phi hp vi B Y t thc hin cc nhim v sau y:
a) Quy nh c th vic k khai gi thuc v nguyn tc xem xt, cng b gi thuc do
doanh nghip sn xut, nhp khu k khai;
b) Trin khai bin php bnh n gi thuc theo quy nh ca php lut v gi;
c) Kim tra, thanh tra v x pht vi phm php lut v gi thuc.
2. Quy nh gi i vi mt hng thuc do c quan nh nc c thm quyn t hng,
giao k hoch t ngun ngn sch trung ng.
3. Cung cp cho B Y t thng tin v gi nhp khu thc t (gi CIF) ca thuc nhp
khu vo Vit Nam.
iu 111. Trch nhim qun l nh nc v gi thuc ca B Cng Thng
1. Cung cp thng tin gi thuc, nguyn liu lm thuc ti cc nc trong khu vc, trn
th gii theo ngh ca B Y t phc v cng tc qun l nh nc v gi thuc.
2. Phi hp vi B Y t kim tra, thanh tra v x pht vi phm php lut v gi thuc.
iu 112. Trch nhim qun l nh nc v gi thuc ca y ban nhn dn cp tnh
1. Qun l nh nc v gi thuc trn a bn tnh, thnh ph trc thuc trung ng theo
quy nh ca Lut ny v php lut c lin quan.
2. Theo di, bo co B Y t, B Ti chnh thng tin v tnh hnh gi thuc trn a bn
khi c bin ng bt thng v gi hoc mt bng gi bin ng nh hng n n nh
kinh t - x hi.
3. T chc tip nhn v r sot gi thuc sn xut trong nc do c s sn xut thuc trn
a bn k khai li v bo co B Y t cng b trn cng thng tin in t ca B Y t.
4. Kim tra, thanh tra v x pht vi phm php lut v gi thuc trn a bn qun l.
iu 113. Trch nhim ca Bo him x hi Vit Nam trong qun l gi thuc
Cng khai gi thuc trng thu trn cng thng tin in t ca Bo him x hi Vit Nam
v cung cp gi thuc trng thu n B Y t chm nht 05 ngy k t ngy nhn c
kt qu la chn nh thu ca c s thc hin u thu thuc.
iu 114. Trch nhim ca cc c s thc hin u thu thuc
1. Trong thi hn 10 ngy k t ngy c kt qu trng thu, cc c s thc hin u thu
thuc thuc phm vi qun l ca y ban nhn dn cp tnh phi gi n S Y t, Bo
him x hi cp tnh; cc c s y t khc c thc hin u thu thuc gi kt qu trng
thu thuc n B Y t v Bo him x hi Vit Nam.
2. Trong thi hn 10 ngy k t ngy c kt qu trng thu thuc i vi tnh, thnh ph
trc thuc trung ng t chc u thu thuc tp trung, S Y t phi bo co kt qu
trng thu thuc n B Y t v Bo him x hi Vit Nam.
Chng XIV
IU KHON THI HNH
iu 115. iu khon chuyn tip
1. C s kinh doanh dc c cp Giy chng nhn iu kin kinh doanh dc
theo quy nh ca Lut dc s 34/2005/QH11 c tip tc kinh doanh thuc cho n
ht thi hn hiu lc ca Giy chng nhn iu kin kinh doanh dc.
Trng hp Giy chng nhn iu kin kinh doanh dc khng ghi thi hn hiu lc,
c s c php kinh doanh n ht thi hn ghi trn giy chng nhn thc hnh tt
c cp.
2. H s ngh cp, cp li Chng ch hnh ngh dc, Giy chng nhn iu kin
kinh doanh dc, h s ng k thuc np trc ngy Lut ny c hiu lc thi hnh c
thc hin theo quy nh ca Lut dc s 34/2005/QH11, tr trng hp c s c
ngh thc hin theo quy nh ca Lut ny. Ngi hnh ngh dc c cp Chng
ch hnh ngh dc theo quy nh ca Lut dc s 34/2005/QH11 c tip tc hnh
ngh dc n ht thi hn hiu lc ca Chng ch hnh ngh dc cp.
3. i vi ngi c Chng ch hnh ngh dc c cp trc ngy Lut ny c hiu lc
th thi hn cp nht kin thc chuyn mn tnh t ngy Lut ny c hiu lc.
4. i vi Chng ch hnh ngh dc c thi hn c cp trc ngy Lut ny c hiu
lc m ht hn sau ngy Lut ny c hiu lc th c cp li Chng ch hnh ngh dc
theo quy nh ca Lut ny.
5. i vi Giy chng nhn iu kin kinh doanh dc c thi hn c cp trc

ngy Lut ny c hiu lc m ht hn sau ngy Lut ny c hiu lc th phi ngh cp
Giy chng nhn iu kin kinh doanh dc theo quy nh ca Lut ny.
iu 116. Hiu lc thi hnh
1. Lut ny c hiu lc thi hnh t ngy 01 thng 01 nm 2017.
2. Cc quy nh v p dng cc nguyn tc, tiu chun Thc hnh tt sn xut thuc ti
c s sn xut nguyn liu lm thuc; Giy chng nhn iu kin kinh doanh dc i
vi c s sn xut t dc, v nang, c s sn xut, ch bin dc liu; dc lm sng
ca c s khm bnh, cha bnh, nh thuc v cc c s khc c hot ng k n s
dng thuc c hiu lc t ngy 01 thng 01 nm 2021.
3. Chnh ph quy nh l trnh thc hin khon 2 iu ny, bo m n ngy 01 thng
01 nm 2021, cc bnh vin t hng 1 tr ln phi t chc hot ng dc lm sng quy
nh ti iu 80 ca Lut ny; tt c v tr cng vic quy nh ti iu 11 ca Lut ny
phi c Chng ch hnh ngh dc.
4. Lut dc s 34/2005/QH11 ht hiu lc k t ngy Lut ny c hiu lc thi hnh.
5. Chnh ph, c quan nh nc c thm quyn quy nh chi tit, hng dn thi hnh cc
iu, khon c giao trong Lut.
Lut ny c Quc hi nc Cng ha x hi ch ngha Vit Nam kha XIII, k hp

th 11 thng qua ngy 06 thng 4 nm 2016.
CH TCH QUC HI
Nguyn Th Kim Ngn

05 2016 qh13 1712

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QUC HI

CNG HA X HI CH NGHA VIT NAM

H Ni, ngy 06 thng 4 nm 2016

Chng I. NHNG QUY NH CHUNG........................................................................ 5

iu 13. iu kin cp Chng ch hnh ngh dc.................................................. 18

Chng IV. KINH DOANH DC................................................................................ 28

iu 71. ng k, lu hnh, thu hi thuc c truyn................................................56

iu 91. Quyn v ngha v ca ngi tham gia th thuc trn lm sng................66

iu 110. Trch nhim qun l nh nc v gi thuc ca B Ti chnh................ 77

15. Thuc generic l thuc c cng dc cht, hm lng, dng bo ch vi bit dc

c) Thuc c, nguyn liu c lm thuc thuc danh mc do B trng B Y t ban hnh;

b) Bo m quc phng, an ninh;

1. Bo m cung ng , kp thi thuc c cht lng, gi hp l cho nhu cu phng

6. B Ti chnh c cc trch nhim sau y:

2. Ngi ph trch v bo m cht lng ca c s sn xut thuc, nguyn liu lm

i) Bng tt nghip trung cp y hc c truyn hoc dc c truyn;

1. C iu kin theo quy nh ti iu 13 ca Lut ny.

3. iu kin i vi ngi chu trch nhim chuyn mn v dc v ngi ph trch v

1. Ngi chu trch nhim chuyn mn v dc ca c s kinh doanh dch v kim

1. Ngi chu trch nhim chuyn mn v dc ca c s kinh doanh dch v bo qun

8. Trng hp cp Chng ch hnh ngh dc do b thu hi theo quy nh ti khon 3

d) Phm vi hot ng chuyn mn;

h) C s kinh doanh dch v th tng ng sinh hc ca thuc.

s p ng Thc hnh tt phng th nghim i vi giai on phn tch dch sinh hc v

iu 35. C s c hot ng dc khng thuc din cp Giy chng nhn iu

c) C s c cp Giy chng nhn iu kin kinh doanh dc nhng b thu hi

3. Giy chng nhn iu kin kinh doanh dc c cp nhng khng ng thm

c) Thu hi thuc, nguyn liu lm thuc theo quy nh ti iu 62 ca Lut ny;

iu 43. Quyn v trch nhim ca c s sn xut thuc, nguyn liu lm thuc

a) Quyn quy nh ti khon 1 iu 42 ca Lut ny;

c) Khng c bn nguyn liu lm thuc, tr dc liu.

a) Quyn quy nh ti cc im a, b, c v khon 1 iu 42 ca Lut ny;

a) Quyn quy nh ti im a v im b khon 1 iu 42 ca Lut ny;

) S dng kt qu nghin cu th tng ng sinh hc ca thuc theo tha thun vi

3. C s c ng tn ng k thuc, nguyn liu lm thuc trong trng hp sau y:

b) Thuc c cp giy ng k lu hnh nhng c thay i v thnh phn dc cht,

b) Trong thi hn 60 thng c 02 l thuc b thu hi bt buc do vi phm mc 2

2. Thuc lu hnh trn th trng phi p ng cc yu cu sau y:

e) Phc v cho chng trnh y t ca Nh nc;

iu 61. Nhn thuc, nguyn liu lm thuc lu hnh trn th trng

b) Giy ng k lu hnh thuc b thu hi trong trng hp quy nh ti cc im a, b, d,

2. Mc vi phm ca thuc bao gm:

1. C s ng k thuc, c s sn xut thuc trong nc, c s c pha ch, ch bin, bo

d) Cng b thng tin v thuc b thu hi trn cng thng tin in t ca B Y t, i

ny. Ngi chu trch nhim chuyn mn v dc ca c s sn xut thuc c truyn lu

1. T vn trong qu trnh xy dng danh mc thuc ti c s khm bnh, cha bnh

c) c ghi kin chuyn mn v dc lm sng trong h s bnh n, n thuc; c

1. Giai on 1 l giai on u tin th nghim trn ngi nhm nh gi s b v tnh an

c) Vc xin ln u tin ng k lu hnh ti Vit Nam, tr trng hp quy nh ti im

a) Trc khi th thuc, c cung cp thng tin y , trung thc v nhng ri ro c th

2. C s nhn th thuc trn lm sng c cc trch nhim sau y:

b) H s thng tin sn phm nghin cu;

iu 97. iu kin, quyn v ngha v ca ngi tham gia th tng ng sinh hc

d) S dng kt qu nghin cu th tng ng sinh hc ca thuc theo tha thun vi

d) L lch khoa hc ca nghin cu vin;

2. C s kim nghim thuc, nguyn liu lm thuc ca Nh nc c cc trch nhim sau

6. Thc hin hnh thc m phn gi i vi gi thu mua thuc, dc liu ch c t 01

a) Gi bn bun, bn l thuc k khai;

5. i vi Giy chng nhn iu kin kinh doanh dc c thi hn c cp trc

Lut ny c Quc hi nc Cng ha x hi ch ngha Vit Nam kha XIII, k hp

Nguyn Th Kim Ngn

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