ࡱ> \WXYZ[^_`U o [ ibjbjYY D;p\;p\~~ 8B4vL 7(SL6666666$l<"?r6u3336H7y6y6y63V/6y636y6y6y6ς(LJ.y66^707y6@y6@y6@y6 33y63333366y633373333@333333333~> : CHNH PH -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: 155/2018/N-CPH Ni, ngy 12 thng 11 nm 2018 NGH NH  HYPERLINK "https://tailieuluat.com/nghi-dinh-155-2018-nd-cp-bo-y-te-vb6620.html" SA I, B SUNG MT S QUY NH LIN QUAN N IU KIN U T KINH DOANH THUC PHM VI QUN L NH NC CA B Y T Cn c Lut t chc Chnh ph ngy 19 thng 6 nm 2015; Xt  ngh ca B trng B Y t; Chnh ph ban hnh Ngh nh sa i, b sung mt s quy nh lin quan n iu kin u t kinh doanh thuc phm vi qun l nh nc ca B Y t. Chng I L(NH VC AN TON THC PHM iu 1. Bi b mt s vn bn, quy nh thuc l)nh vc an ton thc phm 1. Bi b iu 2 Chng I, Chng IV v Chng V ca Ngh nh s 67/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh v iu kin sn xut, kinh doanh thc phm thuc l)nh vc qun l chuyn ngnh ca B Y t. 2. Bi b im c khon 2 iu 5 Ngh nh s 15/2018/N-CP ngy 02 thng 02 nm 2018 ca Chnh ph quy nh chi tit thi hnh mt s iu ca Lut an ton thc phm (sau y gi tt l Ngh nh s 15/2018/N-CP). 3. Bi b Thng t s 15/2012/TT-BYT ngy 12 thng 9 nm 2012 ca B trng B Y t quy nh v iu kin chung bo m an ton thc phm i vi c s sn xut, kinh doanh thc phm. 4. Bi b Thng t s 16/2012/TT-BYT ngy 22 thng 10 nm 2012 ca B trng B Y t quy nh v iu kin bo m an ton thc phm i vi c s sn xut, kinh doanh thc phm, dng c, vt liu bao gi cha ng thc phm thuc phm vi qun l ca B Y t. 5. Bi b Thng t s 26/2012/TT-BYT ngy 30 thng 11 nm 2012 ca B trng B Y t quy nh cp Giy chng nhn c s  iu kin an ton thc phm i vi cc c s sn xut, kinh doanh thc phm chc nng, thc phm tng cng vi cht dinh dng, ph gia, cht h tr ch bin thc phm; nc khong thin nhin, nc ung ng chai; dng c, vt liu bao gi, cha ng thc phm thuc phm vi qun l ca B Y t. 6. Bi b Thng t s 30/2012/TT-BYT ngy 05 thng 12 nm 2012 ca B trng B Y t quy nh v iu kin an ton thc phm i vi c s kinh doanh dch v n ung, kinh doanh thc n ng ph. 7. Bi b Thng t s 47/2014/TT-BYT ngy 11 thng 12 nm 2014 ca B trng B Y t hng dn qun l an ton thc phm i vi c s kinh doanh dch v n ung. 8. Bi b khon 1, 3 iu 14, khon 1 iu 15 Thng t s 43/2014/TT-BYT ngy 24 thng 11 nm 2014 ca B trng B Y t v qun l thc phm chc nng. iu 2. Sa i, b sung mt s iu ca Ngh nh s 67/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh v iu kin sn xut, kinh doanh thc phm thuc l)nh vc qun l chuyn ngnh ca B Y t 1. iu 1 Chng I c sa i nh sau:  Ngh nh ny quy nh iu kin sn xut, kinh doanh thc phm v h s, trnh t, th tc, thm quyn cp Giy chng nhn c s  iu kin an ton thc phm (sau y gi tt l Giy chng nhn) thuc l)nh vc qun l chuyn ngnh ca B Y t i vi c s sn xut, kinh doanh sn phm v nhm thc phm trong Ph lc II ban hnh km theo Ngh nh s 15/2018/N-CP (sau y gi tt l c s sn xut, kinh doanh thc phm) v c s kinh doanh dch v n ung. Ring iu kin sn xut, kinh doanh v h s, trnh t, th tc, thm quyn cp, cp li Giy chng nhn c s  iu kin an ton thc phm t yu cu Thc hnh sn xut tt (GMP) thc phm bo v sc khe v iu kin sn xut kinh doanh ph gia thc phm thc hin theo quy nh ti Ngh nh s 15/2018/N-CP. 2. Chng II c sa i nh sau:  Chng II IU KIN BO M AN TON THC PHM I VI C S SN XUT, KINH DOANH THC PHM THUC THM QUYN QUN L CA B Y T V C S KINH DOANH DCH V N UNG iu 4. C s sn xut, kinh doanh thc phm thuc thm quyn qun l ca B Y t 1. Tun th cc quy nh ti iu 19, 20, 21, 22, 25, 26 v iu 27 Lut an ton thc phm v cc yu cu c th sau: a) Quy trnh sn xut thc phm c b tr theo nguyn tc mt chiu t nguyn liu u vo cho n sn phm cui cng; b) Tng, trn, nn nh khu vc sn xut, kinh doanh, kho sn phm khng thm nc, rn nt, m mc; c) Trang thit b, dng c tip xc trc tip vi thc phm d lm v sinh, khng thi nhim cht c hi v khng gy nhim i vi thc phm; d) C ng hoc giy, dp  s dng ring trong khu vc sn xut thc phm; ) Bo m khng c cn trng v ng vt gy hi xm nhp vo khu vc sn xut v kho cha thc phm, nguyn liu thc phm; khng s dng ho cht dit chut, cn trng v ng vt gy hi trong khu vc sn xut v kho cha thc phm, nguyn liu thc phm; e) Khng by bn ho cht dng cho mc ch khc trong c s kinh doanh ph gia, cht h tr ch bin thc phm. 2. Ngi trc tip sn xut, kinh doanh phi c tp hun kin thc an ton thc phm v c ch c s xc nhn v khng b mc cc bnh t, l, thng hn, vim gan A, E, vim da nhim trng, lao phi, tiu chy cp khi ang sn xut, kinh doanh thc phm. iu 5. C s kinh doanh dch v n ung 1. Tun th cc quy nh ti iu 28, 29 v iu 30 Lut an ton thc phm v cc yu cu c th sau: a) Thc hin kim thc ba bc v lu mu thc n theo hng dn ca B Y t; b) Thit b, phng tin vn chuyn, bo qun thc phm phi bo m v sinh v khng gy nhim cho thc phm. 2. Ngi trc tip ch bin thc n phi c tp hun kin thc an ton thc phm v c ch c s xc nhn v khng b mc cc bnh t, l, thng hn, vim gan A, E, vim da nhim trng, lao phi, tiu chy cp khi ang sn xut, kinh doanh thc phm. 3. Chng III c sa i, b sung nh sau:  Chng III THM QUYN, H S, TH TC CP GIY CHNG NHN C S  IU KIN AN TON THC PHM I VI C S SN XUT THC PHM THUC THM QUYN QUN L CA B Y T V C S KINH DOANH DCH V N UNG iu 6. Thm quyn, h s, th tc cp Giy chng nhn 1. Thm quyn cp Giy chng nhn: B Y t cp hoc phn cp, y quyn cp Giy chng nhn i vi c s sn xut nhiu loi thc phm thuc thm quyn qun l ca B Y t c quy nh ti khon 5 iu 37 v quy nh ti Ph lc II Ngh nh s 15/2018/N-CP. 2. H s xin cp Giy chng nhn thc hin theo cc quy nh ti khon 1 iu 36 Lut an ton thc phm v cc yu cu c th sau: a) n  ngh cp Giy chng nhn theo Mu s 01 Ph lc I km theo Ngh nh ny; b) Bn sao Giy chng nhn ng k kinh doanh hoc Giy chng nhn ng k doanh nghip c ngnh ngh ph hp vi loi thc phm ca c s sn xut (c xc nhn ca c s); c) Danh sch ngi sn xut thc phm, kinh doanh dch v n ung  c tp hun kin thc an ton thc phm c xc nhn ca ch c s. 3. Th tc cp Giy chng nhn thc hin theo cc quy nh ti khon 2 iu 36 Lut an ton thc phm v cc yu cu c th sau: a) Lp h s theo quy nh ti khon 2 iu ny v np qua h thng dch v cng trc tuyn hoc qua ng bu in hoc ti c quan tip nhn h s; b) Trng hp c yu cu sa i, b sung h s, c quan tip nhn h s c trch nhim thng bo bng vn bn cho c s trong thi hn 05 ngy lm vic k t khi nhn  h s. Trng hp qu 30 ngy k t khi nhn c thng bo, c s khng b sung, hon chnh h s theo yu cu th h s ca c s khng cn gi tr. T chc, c nhn phi np h s mi  c cp Giy chng nhn nu c nhu cu. c) Trng hp khng c yu cu sa i, b sung h s, c quan tip nhn h s c trch nhim thnh lp on thm nh hoc y quyn thm nh v lp Bin bn thm nh theo Mu s 02 Ph lc I km theo Ngh nh ny trong thi hn 15 ngy lm vic k t ngy nhn  h s. Trng hp y quyn thm nh cho c quan c thm quyn cp di th phi c vn bn y quyn; on thm nh do c quan c thm quyn cp Giy chng nhn hoc c quan c y quyn thm nh ra quyt nh thnh lp c t 03 n 05 ngi. Trong  c t nht 02 thnh vin lm cng tc v an ton thc phm (c th mi chuyn gia ph hp l)nh vc sn xut thc phm ca c s tham gia on thm nh c s). d) Trng hp kt qu thm nh t yu cu, trong thi gian 05 ngy lm vic k t ngy c kt qu thm nh, c quan tip nhn h s cp Giy chng nhn theo Mu s 03 Ph lc I ban hnh km theo Ngh nh ny. ) Trng hp kt qu thm nh ti c s cha t yu cu v c th khc phc, on thm nh phi ghi r ni dung, yu cu v thi gian khc phc vo Bin bn thm nh vi thi hn khc phc khng qu 30 ngy. Sau khi c bo co kt qu khc phc ca c s, trong thi hn 05 ngy lm vic, on thm nh nh gi kt qu khc phc v ghi kt lun vo bin bn thm nh. Trng hp kt qu khc phc t yu cu s c cp Giy chng nhn theo quy nh ti im d khon ny. Trng hp kt qu khc phc khng t yu cu th c quan tip nhn h s thng bo kt qu thm nh c s khng t yu cu bng vn bn cho c s v cho c quan qun l a phng; e) Trng hp kt qu thm nh khng t yu cu, c quan tip nhn h s thng bo bng vn bn cho c quan qun l a phng gim st v yu cu c s khng c hot ng cho n khi c cp Giy chng nhn. 4. Trng hp thay i tn ca doanh nghip hoc i ch c s, thay i a ch nhng khng thay i v tr v quy trnh sn xut thc phm, kinh doanh dch v n ung v Giy chng nhn phi cn thi hn th c s gi thng bo thay i thng tin trn Giy chng nhn v km bn sao vn bn hp php th hin s thay i  n c quan tip nhn h s  cp Giy chng nhn qua h thng dch v cng trc tuyn hoc qua ng bu in hoc ti c quan tip nhn h s. 5. Giy chng nhn c cp trc khi Ngh nh ny c hiu lc tip tc c s dng n ht thi hn ghi trn Giy chng nhn. iu 3. Sa i, b sung mt s iu ca Ngh nh s 15/2018/N-CP ngy 02 thng 02 nm 2018 ca Chnh ph quy nh chi tit thi hnh mt s iu ca Lut an ton thc phm 1. Sa i, b sung im a khon 2 iu 5 nh sau:  a) T chc, c nhn t cng b sn phm trn phng tin thng tin i chng hoc trang thng tin in t ca mnh hoc nim yt cng khai ti tr s ca t chc, c nhn v cng b trn H thng thng tin d liu cp nht v an ton thc phm (Trong trng hp cha c H thng thng tin d liu cp nht v an ton thc phm th t chc, c nhn np 01 bn qua ng bu in hoc trc tip n c quan qun l nh nc c thm quyn do y ban nhn dn tnh, thnh ph trc thuc trung ng ch nh  lu tr h s v ng ti tn t chc, c nhn v tn cc sn phm t cng b trn trang thng tin in t ca c quan tip nhn, trng hp t chc, c nhn c t 02 c s sn xut tr ln cng sn xut mt sn phm th t chc, c nhn ch np h s ti mt c quan qun l nh nc  a phng c c s sn xut do t chc, c nhn la chn. Khi  la chn c quan qun l nh nc  np h s th cc ln t cng b tip theo phi np h s ti c quan  la chn trc ). 2. B sung khon 6 iu 40 nh sau:  6. T chc cp Giy chng nhn c s  iu kin an ton thc phm i vi c s sn xut nc ung ng chai, nc khong thin nhin, nc  dng lin, nc  dng  ch bin thc phm, c s sn xut thc phm b sung, thc phm dinh dng y hc, thc phm dng cho ch  n c bit, sn phm dinh dng dng cho tr n 36 thng tui, ph gia, cht h tr ch bin thc phm, cc vi cht b sung vo thc phm, c s sn xut thc phm khc khng c quy nh ti danh mc ca B Cng Thng v B Nng nghip v Pht trin nng thn, c s kinh doanh dch v n ung. Chng II L(NH VC DC PHM iu 4. Bi b cc quy nh sau y ca Ngh nh s 54/2017/N-CP ngy 08 thng 5 nm 2017 ca Chnh ph quy nh chi tit mt s iu v bin php thi hnh Lut dc 1. im c v im g khon 1 iu 3. 2. im b khon 1 iu 4. 3. iu 9, iu 10, iu 11, iu 12, iu 13. 4. Khon 1, khon 3 v khon 4 iu 14. 5. Khon 4 iu 19. 6. im a, im b, im c, im d, im  v im e khon 2 iu 21. 7. Khon 2 iu 23. 8. iu 24. 9. iu 25. 10. iu 26. 11. iu 27. 12. Khon 1 iu 28. 13. Quy nh yu cu phi c thm ti liu chuyn mn k thut v nhn s theo nguyn tc Thc hnh tt phn phi thuc, nguyn liu lm thuc i vi trng hp c s  ngh cp Giy chng nhn  iu kin kinh doanh vi phm vi xut khu, nhp khu thuc, nguyn liu lm thuc c bn thuc, nguyn liu lm thuc nhp khu cho c s bn l, c s khm bnh, cha bnh ti im b khon 2 iu 32. 14. Khon 3 iu 32. 15. Khon 5 iu 38. 16. Khon 2 iu 40. 17. im d khon 1; im  khon 2; im b, c khon 3; im d khon 4; im c khon 5; im d khon 7; im b, d khon 10; im b, c khon 11 iu 43. 18. Quy nh kho, khu vc ring phi c tng v trn kin c c lm t vt liu chc chn quy nh ti im a khon 1, im a khon 2, im a khon 5 v im a khon 7 iu 43. 19. im c khon 1; im c khon 2; im b khon 3; im b khon 4; khon 5; im c khon 6; khon 7; im b khon 12 iu 44. 20. Khon 2 iu 49. 21. iu 50. 22. iu 52. 23. im b khon 1 iu 53. 24. im b, c khon 2 iu 58. 25. im c khon 3, im a khon 4 v im a khon 5 iu 60. 26. im c khon 2, im b khon 4 iu 62. 27. im c khon 1, im i khon 2 iu 65. 28. Yu cu phi c Bo co kt qu kinh doanh thuc trong h s  ngh cp php nhp khu thuc trong Danh mc thuc, dc cht thuc Danh mc cht b cm s dng trong mt s ngnh, l)nh vc quy nh ti im g khon 2 iu 65, im h khon 2 iu 66, im e khon 2 iu 69. 29. Yu cu phi c Giy chng nhn thc hnh tt sn xut ca c s tham gia sn xut thuc nhp khu trong h s  ngh cp php nhp khu thuc quy nh ti im h khon 2 iu 65, im i khon 2 iu 66, im g khon 2 iu 69, im h khon 2 iu 71, im i khon 2 iu 72 i vi trng hp trn Giy chng nhn sn phm dc  xc nhn c s sn xut t nguyn tc, tiu chun thc hnh tt sn xut. 30. im k khon 2 iu 66. 31. im a khon 1; khon 2 iu 68. 32. Yu cu phi c bn chnh Bn cam kt ca c s sn xut v c s cung cp thuc nc ngoi v vic m bo cht lng, an ton, hiu qu quy nh ti im e khon 3 iu 68 i vi trng hp nhp khu sinh phm. 33. im h khon 2 iu 69. 34. im b khon 2 iu 70. 35. im i khon 2 iu 71. 36. im  khon 2 iu 73. 37. im b khon 1 iu 74. 38. im b v im d khon 3 iu 75. 39. Yu cu phi lp n hng ring quy nh ti khon 1 iu 76 i vi trng hp nhp khu thuc theo quy nh ti iu 72. 40. im b khon 3 iu 76. 41. Yu cu v hp php ha lnh s i vi nhn thuc quy nh ti im d khon 3 iu 76. 42. Quy nh v yu cu Giy chng nhn sn phm dc phi c ni dung xc nhn thuc c lu hnh thc t  nc cp Giy chng nhn sn phm dc quy nh ti im  khon 4 iu 76. 43. Khon 2 iu 78. 44. im b khon 2 iu 82. 45. im b, im c khon 1 iu 84. 46. im  khon 2 iu 85. 47. im b khon 1 iu 86. 48. Quy nh c s cung cp nguyn liu lm thuc phi kim sot c bit c nhp khu  kim nghim, nghin cu hoc sn xut thuc xut khu theo quy nh ti iu 80; nguyn liu lm thuc nhp khu theo quy nh ti iu 82, 83, 84, 85; thuc vin tr, vin tr nhn o phi thc hin quy nh ti khon 15 iu 91. 49. Yu cu phi np bn chnh hoc bn sao c ng du xc nhn ca c s nhp khu Phiu kim nghim cho tng l thuc, nguyn liu lm thuc nhp khu c quy nh ti im c khon 4 iu 92 trong trng hp nhp khu thuc theo quy nh ti im a, b khon 1 iu 72. 50. Yu cu np bn sao c ng du xc nhn ca c s nhp khu i vi giy y quyn hoc giy php bn hng hoc giy chng nhn quan h i tc quy nh ti im d khon 2 iu 92 i vi thuc vin tr, vin tr nhn o. 51. Yu cu np bn sao c ng du xc nhn ca c s nhp khu i vi giy y quyn hoc giy php bn hng hoc giy chng nhn quan h i tc quy nh ti: im  khon 4 iu 92 i vi thuc nhp khu theo quy nh ti iu 68, iu 72, nguyn liu lm thuc phi kim sot c bit nhp khu  sn xut thuc xut khu quy nh ti iu 80, nguyn liu lm thuc nhp khu theo quy nh ti iu 84, 85. 52. im a, c, d v on  B trng B Y t quy nh c th danh mc dc liu phi ng k lu hnh. ti khon 1 iu 93. 53. im d v im  khon 2, im b v im c khon 3, im c khon 4 iu 98. 54. im h khon 2 iu 100. 55. Th tc ti xut nguyn liu lm thuc ti khon 4 iu 104. 56. Khon 2 v khon 3 iu 107. 57. im  khon 1 v im  khon 2 iu 108. 58. iu 109. 59. iu 110. 60. Khon 4 iu 111. 61. iu 114. 62. iu 115. 63. Khon 2 v 3 iu 120. 64. im  khon 1 v im  khon 2 iu 121. 65. iu 122. 66. iu 123. 67. Khon 4 iu 124. 68. im b khon 4 iu 130. 69. im , im e, im g khon 4 iu 131. 70. Khon 2, khon 3, khon 4 iu 134. 71. Quy nh v l trnh thc hin yu cu v chng ch hnh ngh dc ca ngi ph trch v bo m cht lng thuc ca c s sn xut quy nh ti khon 1, khon 4 iu 140. 72. Mu s 08, 09, 10, 11, 13, 14, 15, 16 v 17 Ph lc I. 73. Dng 120 v 159 Ph lc V. 74. Mu s 03 v 04 Ph lc VI. iu 5. Sa i mt s iu ca Ngh nh s 54/2017/N-CP ngy 08 thng 5 nm 2017 ca Chnh ph quy nh chi tit mt s iu v bin php thi hnh Lut dc 1. Khon 2 iu 2 c sa i, b sung nh sau:  2. Hi tho gii thiu thuc l bui gii thiu thuc hoc tho lun chuyn  lin quan n thuc cho ngi hnh ngh y, dc. 2. im a khon 1 iu 3 c sa i, b sung nh sau:  a) n  ngh cp Chng ch hnh ngh dc thc hin theo Mu s 02 ti Ph lc I ban hnh km theo Ngh nh ny. 3. im a khon 1 iu 4 c sa i, b sung nh sau:  a) n  ngh cp li Chng ch hnh ngh dc thc hin theo Mu s 04 ti Ph lc I ban hnh km theo Ngh nh ny. 4. im a khon 1 iu 5 c sa i, b sung nh sau:  a) n  ngh iu chnh ni dung Chng ch hnh ngh dc thc hin theo Mu s 05 ti Ph lc I ban hnh km theo Ngh nh ny. 5. im a v im c khon 3 iu 6 c sa i, b sung nh sau: a) im a c sa i, b sung nh sau:  a) Cp Chng ch hnh ngh dc trong thi hn 15 ngy, k t ngy ghi trn Phiu tip nhn h s; trng hp khng cp Chng ch hnh ngh dc phi c vn bn tr li v nu r l do; b) im c c sa i, b sung nh sau:  c) Cp li, iu chnh ni dung Chng ch hnh ngh dc trong thi hn 05 ngy lm vic, k t ngy ghi trn Phiu tip nhn h s; trng hp khng cp li, iu chnh ni dung Chng ch hnh ngh dc phi c vn bn tr li v nu r l do. 6. iu 8 c sa i, b sung nh sau:  iu 8. C s o to, cp nht kin thc chuyn mn v dc 1. C s o to, cp nht kin thc chuyn mn v dc phi l mt trong cc t chc sau: C s gio dc ngh nghip c o to chuyn ngnh y, dc; c s gio dc c o to m ngnh thuc khi ngnh khoa hc sc khe; vin nghin cu c chc nng o to chuyn ngnh y, dc; c s c chc nng o to nhn lc y t; cc hi ngh nghip v dc; 2. C s o to cp nht kin thc chuyn mn v dc phi xy dng chng trnh o to bao gm cc ni dung chnh sau y: a) Ni dung o to bao gm: - Kin thc chuyn ngnh; - Php lut v qun l chuyn mn v dc; b) Thi gian o to, cp nht kin thc chuyn mn v dc: ti thiu 08 gi. 7. im a khon 1 v im a khon 2 iu 15 c sa i, b sung nh sau: a) im a khon 1 c sa i, b sung nh sau:  a) Kim tra, gim st cc c s o to, cp nht kin thc chuyn mn v dc quy nh ti iu 8 ca Ngh nh ny; b) im a khon 2 c sa i, b sung nh sau:  a) Kim tra, gim st v phi hp vi cc c s o to, cp nht kin thc chuyn mn v dc trn a bn quy nh ti iu 8 ca Ngh nh ny trong vic t chc o to, cp nht kin thc chuyn mn v dc; 8. Khon 2 iu 21 c sa i, b sung nh sau:  2. Thi gian thc hnh chuyn mn ti c s dc ph hp quy nh ti iu 15, iu 16, iu 17, iu 18, iu 19, iu 20, iu 21 v iu 22 Lut dc c gim: a) 3/4 thi gian i vi ngi c bng tin s hoc chuyn khoa II v l)nh vc lin quan n ni dung chuyn mn thc hnh; b) 1/2 thi gian i vi ngi c bng thc s hoc chuyn khoa I v l)nh vc lin quan n ni dung chuyn mn thc hnh. 9. Khon 3 iu 28 c sa i, b sung nh sau:  3. B Y t c trch nhim ch nh c s  iu kin theo quy nh ti iu 23 ca Ngh nh ny t chc thi xt cp Chng ch hnh ngh dc trong trng hp khng c c s no t chc thi xt cp Chng ch hnh ngh dc. 10. iu 31 c sa i, b sung nh sau: a) Sa i im b khon 5 iu 31 nh sau:  b) C a im c nh, ring bit; c xy dng chc chn; din tch ph hp vi quy m kinh doanh; b tr  ni cao ro, thong mt, an ton, cch xa ngun nhim. b) Sa i im c khon 5 iu 31 nh sau:  Phi c khu vc bo qun v trang thit b bo qun ph hp vi yu cu bo qun ghi trn nhn. Dc liu c phi c by bn (nu c) v bo qun ti khu vc ring; trng hp c by bn v bo qun trong cng mt khu vc vi cc dc liu khc th phi  ring v ghi r  dc liu c  trnh nhm ln. C s chuyn bn l thuc dc liu, thuc c truyn hoc chuyn bn l dc liu th ch cn c khu vc bo qun tng ng  bo qun thuc dc liu, thuc c truyn hoc  bo qun dc liu, v thuc c truyn. 11. im a khon 2 iu 32 c sa i nh sau:  a) i vi c s sn xut thuc, nguyn liu lm thuc: Ti liu v 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 theo nguyn tc Thc hnh tt sn xut thuc, nguyn liu lm thuc. Trng hp c s  ngh cp Giy chng nhn  iu kin kinh doanh vi phm vi sn xut thuc, nguyn liu lm thuc c bn, giao thuc, nguyn liu lm thuc do c s sn xut cho c s bn bun, bn l, c s khm bnh, cha bnh th phi c thm ti liu chuyn mn k thut v nhn s theo nguyn tc Thc hnh tt phn phi thuc, nguyn liu lm thuc, tr trng hp giao hng ti kho ca c s sn xut . 12. Tiu , im a khon 3 v khon 4 iu 33 c sa i nh sau:  3. C quan tip nhn h s thc hin: a) Cp Giy chng nhn  iu kin kinh doanh dc trong thi hn 20 ngy, k t ngy ghi trn Phiu tip nhn h s i vi trng hp c s vt cht, k thut v nhn s  c kim tra, nh gi p ng Thc hnh tt ph hp vi phm vi kinh doanh, khng phi t chc nh gi thc t ti c s  ngh cp Giy chng nhn  iu kin kinh doanh dc; 4. Khi c yu cu sa i, b sung h s i vi trng hp quy nh ti im a khon 3 iu ny, trong thi hn 07 ngy lm vic, k t ngy ghi trn Phiu tip nhn h s, c quan tip nhn h s c vn bn gi c s  ngh, trong  phi nu c th cc ti liu, ni dung cn sa i, b sung. 13. im a khon 3 iu 34 c sa i nh sau:  a) Cp li, iu chnh Giy chng nhn  iu kin kinh doanh dc trong thi hn 15 ngy k t ngy ghi trn Phiu tip nhn h s i vi trng hp quy nh ti im a khon 2 v khon 3 iu 36 ca Lut dc; 14. Khon 3 iu 40 c sa i, b sung nh sau:  3. Trong thi hn 05 ngy lm vic, k t ngy nhn c thng bo ca c s t chc bn l thuc lu ng, S Y t c trch nhim cng b thng tin c s t chc bn l thuc lu ng trn Cng thng tin in t ca n v v thng bo cho Phng Y t huyn  gim st, kim tra. 15. Khon 2 iu 41 c sa i, b sung nh sau: a) Sa tiu  khon 2 iu 41 nh sau:  2. Cng b danh mc thuc, dc cht thuc danh mc cht b cm s dng trong mt s ngnh, l)nh vc: b) Sa i im b khon 2 iu 41 nh sau:  b) Sau khi nhn c danh mc cht b cm s dng ca cc b, c quan ngang b, B Y t cng b danh mc thuc, dc cht thuc danh mc cht b cm s dng trong mt s ngnh, l)nh vc trn cng thng tin in t ca B Y t. 16. Khon 2 iu 42 c sa i, b sung nh sau:  2. Trng hp trn a bn khng c c s kinh doanh thuc phi kim sot c bit, S Y t c trch nhim ch nh c s bn bun hoc c s bn l thc hin vic kinh doanh hoc khoa dc ca c s khm bnh, cha bnh nhng li thuc phi kim sot c bit  bo m  thuc cho ngi bnh. 17. im a khon 4 iu 43 c sa i, b sung nh sau:  a) C kho ring hoc khu vc ring p ng nguyn tc Thc hnh tt bo qun thuc, nguyn liu lm thuc  bo qun thuc gy nghin, thuc hng thn, thuc tin cht, nguyn liu lm thuc l dc cht gy nghin, dc cht hng thn, tin cht dng lm thuc. Kho hoc khu vc ny phi c ca, c kha chc chn; 18. Khon 6 iu 43 c sa i, b sung nh sau:  6. i vi c s xut khu, nhp khu, bn bun thuc phng x phi c h thng qun l, theo di bng h s s sch theo quy nh ca B trng B Y t. 19. im a khon 8 iu 43 c sa i, b sung nh sau:  a) Thuc gy nghin, thuc hng thn, thuc tin cht phi bo qun trong t ring hoc ngn ring c kha chc chn; 20. Khon 12 iu 43 c sa i, b sung nh sau:  12. i vi c s kinh doanh dch v th thuc trn lm sng, kinh doanh dch v th tng ng sinh hc ca thuc, kinh doanh dch v kim nghim thuc phi kim sot c bit tr cc trng hp quy nh ti khon 11 iu ny phi bo qun thuc gy nghin, thuc hng thn, thuc tin cht, nguyn liu lm thuc l dc cht gy nghin, dc cht hng thn, tin cht dng lm thuc, thuc dng phi hp c cha dc cht gy nghin, thuc dng phi hp c cha dc cht hng thn, thuc dng phi hp c cha tin cht trong khu vc ring c kha chc chn hoc t ring, ngn ring c kha chc chn. 21. iu 44 c sa i, b sung nh sau: Thay cm t  02 nm bng cm t  12 thng ti cc khon 1, 2, 4, 6, 10. 22. Khon 9 iu 44 c sa i, b sung nh sau:  9. i vi c s bn l thuc phng x: Ngi chu trch nhim bn l phi l ngi c bng tt nghip trung cp ngnh dc tr ln. 23. im c khon 2 iu 46 c sa i, b sung nh sau:  c) C s ng thi c giy chng nhn  iu kin kinh doanh dc phm vi xut khu, nhp khu thuc v bn bun thuc ch c bn thuc cho c s ng thi c giy chng nhn  iu kin kinh doanh dc phm vi xut khu, nhp khu thuc v bn bun thuc khc, c s khm bnh, cha bnh, c s nghin cu, kim nghim, c s cai nghin bt buc, c s iu tr nghin cht dng thuc phin bng thuc thay th, c s o to chuyn ngnh y, dc, nh thuc trn phm vi c nc, la chn 01 c s bn bun trn a bn 01 tnh  bn ton b cc mt hng do c s kinh doanh; 24. im d khon 2 iu 46 c sa i, b sung nh sau:  d) C s bn bun ch c bn thuc cho c s khm bnh, cha bnh, c s nghin cu, kim nghim, c s cai nghin bt buc, c s iu tr nghin cht dng thuc phin bng thuc thay th, c s o to chuyn ngnh y, dc, c s c hot ng dc khng v mc ch thng mi khc v nh thuc trn a bn tnh m c s bn bun t a im kinh doanh; 25. im  khon 2 iu 46 c sa i, b sung nh sau:  ) C s khm bnh, cha bnh, c s cai nghin bt buc, c s iu tr nghin cht dng thuc phin bng thuc thay th c mua thuc ti cc c s c quy nh ti cc im a, b, c v d khon ny theo kt qu trng thu ca c s hoc k hoch u thu  c ngi c thm quyn ph duyt. Cc c s khm bnh, cha bnh t nhn c mua thuc ti cc c s c quy nh ti cc im a, b, c v d khon ny theo n hng mua thuc  c c quan c thm quyn ph duyt. 26. im a khon 2 iu 48 c sa i, b sung nh sau:  a) C s  ngh hy np vn bn trc tip hoc gi qua ng bu in ti B Y t i vi c s sn xut, xut khu, nhp khu hoc ti S Y t ni c s  t tr s i vi cc c s kinh doanh dc khc tr cc c s trn; hoc ti Cc Qun y - B Quc phng i vi c s thuc B Quc phng; 27. im c, d khon 2 iu 48 c sa i, b sung nh sau:  c) Trng hp khng c yu cu sa i, b sung, c quan tip nhn h s hy c cng vn cho php hy trong thi hn 20 ngy k t ngy ghi trn Phiu tip nhn h s; d) Trng hp c yu cu sa i, b sung h s xin hy, c quan tip nhn c vn bn yu cu sa i, b sung h s xin hy trong thi hn 20 ngy, k t ngy ghi trn Phiu tip nhn h s; 28. Khon 3 iu 48 c sa i, b sung nh sau:  3. Vic hy thuc gy nghin, thuc hng thn, thuc tin cht, nguyn liu lm thuc l dc cht gy nghin, dc cht hng thn, tin cht dng lm thuc ch c thc hin sau khi c cng vn cho php ca B Y t hoc S Y t ni c s t a im kinh doanh hoc Cc Qun y - B Quc phng. 29. im b khon 4 iu 48 c sa i, b sung nh sau:  b) Vic hy thuc v nguyn liu lm thuc phi c s chng kin ca i din S Y t trn a bn hoc Cc Qun y - B Quc phng v c lp bin bn theo Mu s 16 ti Ph lc II ban hnh km theo Ngh nh ny; 30. im c khon 4 iu 48 c sa i, b sung nh sau:  17. Trong thi hn 10 ngy, k t ngy kt thc vic hy thuc v nguyn liu lm thuc, c s phi gi bo co vic hy thuc theo Mu s 17 ti Ph lc II ban hnh km theo Ngh nh ny km theo bin bn hy thuc ti B Y t hoc S Y t hoc Cc Qun y - B Quc phng. 31. Khon 1 iu 49 c sa i nh sau:  19. Ti liu thuyt minh c s p ng cc bin php bo m an ninh, khng tht thot thuc phi kim sot c bit theo Mu s 18 ti Ph lc II ban hnh km theo Ngh nh ny. 32. iu 51 c sa i nh sau:  iu 51. Trnh t, th tc cp giy chng nhn  iu kin kinh doanh dc cho c s kinh doanh thuc phi kim sot c bit 1. Trnh t, th tc cp giy chng nhn  iu kin kinh doanh dc cho c s kinh doanh thuc phi kim sot c bit thc hin theo iu 33 Ngh nh ny. 2. Trng hp c s  c cp Giy chng nhn  iu kin kinh doanh dc hoc  p ng Thc hnh tt theo quy nh ti iu 33 Lut Dc v c  ngh b sung phm vi kinh doanh thuc phi kim sot c bit, c quan tip nhn ch nh gi h s np theo iu 49 Ngh nh 54/2017/N-CP . 33. iu 53 c sa i nh sau: a) Sa i im a khon 2:  a) 01 bn n hng mua nguyn liu lm thuc l dc cht gy nghin, hng thn, tin cht dng lm thuc theo Mu s 19 ti Ph lc II ban hnh km theo Ngh nh ny; b) Sa i im b khon 3:  b) 01 bn n hng nhng li nguyn liu lm thuc l dc cht gy nghin, dc cht hng thn, tin cht dng lm thuc theo Mu s 19 ti Ph lc II ban hnh km theo Ngh nh ny; 34. Khon 1 iu 54 c sa i, b sung nh sau: a) im b khon 1 c sa i, b sung nh sau:  b) S Y t ni c s t a im kinh doanh i vi c s bn bun, bn l thuc, c s khm bnh, cha bnh t nhn, c s nghin cu, kim nghim, c s o to chuyn ngnh y, dc, c s cai nghin bt buc, c s iu tr nghin cht dng thuc phin bng thuc thay th, c s c hot ng dc khng v mc ch thng mi khc; b) B sung im c khon 1 nh sau:  c) Cc Qun y - B Quc phng i vi c s thuc B Quc phng. 35. iu 65 c sa i, b sung nh sau: a) im a v b khon 1 iu 65 c sa i, b sung nh sau:  a) c cp php lu hnh ti mt trong cc nc sau: Nc sn xut, nc thnh vin ca hi ngh quc t v hi ha ha cc th tc ng k dc phm s dng cho ngi (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - ICH) hoc Australia; b) Thuc thuc mt trong cc trng hp sau: - C trong cc hng dn chn on, phng bnh, iu tr do B Y t ban hnh hoc ph duyt; - Thuc dng cho mc ch cp cu, chng c, chng thi ghp; - Thuc dng trong chn on, d phng hoc iu tr i vi: bnh truyn nhim nhm A, bnh ung th, HIV/AIDS, bnh vim gan vi rt, bnh lao, bnh st rt; cc bnh khc do B trng B Y t quyt nh. b) im d v e khon 2 iu 65 c sa i, b sung nh sau:  d) Bn chnh 01 b mu nhn v t hng dn s dng ca thuc  nc sn xut hoc nc xut khu, tr trng hp mu nhn v t hng dn s dng hoc t tm tt c tnh sn phm c nh km Giy chng nhn sn phm dc; e) D liu lm sng v an ton, hiu qu theo quy nh v ng k thuc ca B trng B Y t. Min np ti liu ti im ny trong trng hp thuc  tng c cp php nhp khu theo quy nh ti iu ny v khng c thay i thng tin lin quan n ch nh, liu dng, i tng s dng. 36. im c, d v e khon 2 iu 66 c sa i, b sung nh sau:  c) H s cht lng theo quy nh ca B trng B Y t v p dng h s k thut chung ASEAN (ACTD) trong ng k thuc hoc tiu chun cht lng v kt qu nghin cu tng ng sinh hc theo quy nh ti khon 7 iu 76 Ngh nh ny. d) Bn chnh 01 b mu nhn v t hng dn s dng ca thuc  nc sn xut hoc nc xut khu, tr trng hp mu nhn v t hng dn s dng hoc t tm tt c tnh sn phm c nh km Giy chng nhn sn phm dc; e) H s lm sng i vi cc trng hp phi np h s lm sng theo quy nh ca B trng B Y t v ng k thuc. Min np ti liu ti im ny trong trng hp thuc  tng c cp php nhp khu theo quy nh ti iu ny v khng c thay i thng tin lin quan n ch nh, liu dng, i tng s dng. 37. im c khon 2 iu 67 c sa i, b sung nh sau:  c) Bn chnh hoc bn sao c ng du ca c quan c thm quyn vn bn  ngh hoc ph duyt ca c quan c thm quyn quy nh ti im a, b hoc c khon 1 iu ny, trong  phi th hin cc ni dung: tn hot cht i vi thuc ha dc, sinh phm hoc tn dc liu i vi thuc dc liu v thuc c truyn, dng bo ch, nng  hoc hm lng dc cht i vi thuc ha dc, sinh phm hoc khi lng dc liu i vi thuc dc liu v thuc c truyn, quy cch ng gi, nh sn xut, nc sn xut ca thuc. 38. iu 68 c sa i, b sung nh sau: a) im b khon 1 iu 68 c sa i, b sung nh sau:  b) Thuc cha p ng  nhu cu iu tr v thuc mt trong cc trng hp sau: - Thuc s dng cho mc ch cp cu, chng c; chng thi ghp; - Thuc thuc Danh mc thuc him; - Thuc c trong hng dn phng v x tr sc phn v do B Y t ban hnh hoc ph duyt; - Thuc c s dng cho ngi bnh c th ang iu tr ti c s khm bnh, cha bnh  chn on, d phng hoc iu tr i vi: bnh truyn nhim nhm A, bnh ung th, HIV/AIDS, bnh lao, bnh st rt; cc bnh him ngho khc do B trng B Y t quyt nh. b) im c khon 3 iu 68 c sa i, b sung nh sau:  c) Bn chnh vn bn ca c s khm bnh, cha bnh nu r l do  ngh nhp khu thuc, s lng bnh nhn d kin cn s dng thuc, nhu cu thuc tng ng v cam kt chu hon ton trch nhim lin quan n vic s dng thuc  ngh nhp khu. Vn bn phi km theo bn chnh hoc bn sao c ng du ca c s khm bnh, cha bnh bin bn hp Hi ng thuc v iu tr i vi nhu cu nhp khu thuc. Trng hp c s tim chng khng c Hi ng thuc v iu tr hoc trng hp thuc s dng cho mc ch cp cu, chng c m trong vn bn ca c s khm bnh, cha bnh  ghi r danh sch bnh nhn c nhu cu s dng thuc th khng phi np km theo Bin bn. c) im g khon 3 iu 68 c sa i, b sung nh sau:  g) Khng bt buc c s cung cp thuc phi thc hin quy nh ti khon 15 iu 91 ca Ngh nh ny nu c bn sao Giy php kinh doanh dc do c quan c thm quyn nc s ti cp c chng thc v hp php ha lnh s theo quy nh. 39. im d khon 2 iu 69 c sa i, b sung nh sau:  d) Bn chnh 01 b mu nhn v t hng dn s dng ca thuc  nc sn xut hoc nc xut khu, tr trng hp mu nhn v t hng dn s dng c nh km Giy chng nhn sn phm dc; 40. iu 71 c sa i, b sung nh sau: a) im b khon 1 iu 71 c sa i nh sau:  b) c cp php lu hnh ti mt trong cc nc sau: Nc sn xut, nc thnh vin ICH hoc Australia. b) im c, d v  khon 2 iu 71 c sa i nh sau:  c) H s cht lng theo quy nh ca B trng B Y t v p dng h s k thut chung ASEAN (ACTD) trong ng k thuc hoc tiu chun cht lng v kt qu nghin cu tng ng sinh hc theo quy nh ti khon 7 iu 76 Ngh nh ny; d) H s lm sng i vi cc trng hp c yu cu phi np h s lm sng theo quy nh ca B trng B Y t v ng k thuc. Min np ti liu ti im ny trong trng hp thuc  tng c cp php nhp khu theo quy nh ti iu ny v khng c thay i thng tin lin quan n ch nh, liu dng, i tng s dng; ) Bn chnh 01 b mu nhn v t hng dn s dng ca thuc  nc sn xut hoc nc xut khu, tr trng hp mu nhn v t hng dn s dng c nh km Giy chng nhn sn phm dc. 41. iu 72 c sa i, b sung nh sau: a) Khon 1 iu 72 c sa i nh sau:  1. Thuc ch c cp php nhp khu khi c cp php lu hnh ti nc sn xut hoc nc l thnh vin ca ICH hoc Australia v thuc mt trong cc trng hp sau: a) Thuc vin tr c cc on cng tc khm bnh, cha bnh nhn o ca nc ngoi mang theo  phc v cng tc khm bnh, cha bnh nhn o; b) Thuc c vin tr  s dng cho ngi bnh c th ang iu tr ti c s khm bnh, cha bnh theo  ngh ca c s khm bnh, cha bnh; c) Thuc c vin tr  s dng cho cc chng trnh y t nh nc hoc d n y t nh nc; d) Thuc vin tr khng thuc trng hp quy nh ti im a, b, c khon ny v khng phi l thuc gy nghin, thuc phng x, vc xin. b) im a, c, , e, g, h v k khon 2 iu 72 c sa i nh sau:  a) n hng nhp khu theo Mu s 24, 25 hoc 26 ti Ph lc III ban hnh km theo Ngh nh ny; c) Bn chnh hoc bn sao c chng thc vn bn ca c quan qun l nh nc c thm quyn ph duyt s dng thuc phc v chng trnh y t ca Nh nc hoc d n y t ca nh nc i vi thuc vin tr nc ngoi thng qua cc chng trnh, d n hoc bn chnh vn bn ph duyt ca c quan c thm quyn v vic thc hin hot ng khm, cha bnh nhn o i vi trng hp nhp khu theo quy nh ti im a khon 1 iu ny; ) H s cht lng theo quy nh ca B trng B Y t v p dng h s k thut chung ASEAN (ACTD) trong ng k thuc hoc tiu chun cht lng v kt qu nghin cu tng ng sinh hc theo quy nh ti khon 7 iu 76 Ngh nh ny; e) H s lm sng i vi cc trng hp c yu cu phi np h s lm sng theo quy nh ca B trng B Y t v ng k thuc. Min np ti liu ti im ny trong trng hp thuc  tng c cp php nhp khu theo quy nh ti iu ny v khng c thay i thng tin lin quan n ch nh, liu dng, i tng s dng; g) Bn chnh 01 b mu nhn v t hng dn s dng ca thuc  nc sn xut hoc nc xut khu, tr trng hp mu nhn v t hng dn s dng c nh km Giy chng nhn sn phm dc; h) 02 b mu nhn v t hng dn s dng ting Vit c ng du ca c s nhp khu; k) Min cc ti liu quy nh ti d, , e, g, h v i i vi trng hp nhp khu thuc quy nh ti im a, b khon 1 iu ny nhng phi c vn bn cam kt v vic thuc c cp php lu hnh ti nc sn xut hoc nc l thnh vin ca ICH hoc Australia v trong vn bn ca c s nhn vin tr ghi r danh sch ngi bnh c nhu cu s dng thuc i vi trng hp quy nh ti im b khon 1 iu ny; 42. iu 76 c sa i, b sung nh sau: a) im d khon 3 c sa i nh sau:  d) T hng dn s dng ca thuc  nc sn xut hoc nc xut khu, tr trng hp quy nh ti im d khon 2 iu 66, im d khon 2 iu 69, im  khon 2 iu 71 v im g khon 2 iu 72 Ngh nh ny. b) Tiu  khon 5, im b, c khon 5 iu 76 c sa i nh sau:  5. Yu cu v xc nhn mu nhn v t hng dn s dng ca thuc  nc sn xut hoc nc xut khu tr 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 nhp khu theo quy nh ti iu 70 ca Ngh nh ny: b) T hng dn s dng c du ca c quan nh nc c thm quyn cp Giy chng nhn sn phm dc ca nc sn xut hoc nc xut khu, tr trng hp quy nh ti im d khon 2 iu 66, im d khon 2 iu 69, im  khon 2 iu 71 v im g khon 2 iu 72; c) T hng dn s dng  thc hin quy trnh hp php ha lnh s phi l bn chnh. c) B sung im d vo khon 5 iu 76 nh sau:  d) Mu nhn quy nh ti im d khon 2 iu 65; mu nhn v t hng dn s dng quy nh ti im d khon 2 iu 66, im d khon 2 iu 69, im  khon 2 iu 71 v im g khon 2 iu 72 phi c ng du ca c s sn xut hoc ca c s s hu sn phm hoc ca c s s hu giy php sn phm (ghi trn Giy chng nhn sn phm dc) v ca c s nhp khu. d) B sung khon 7 iu 76 nh sau:  7. Quy nh v tiu chun cht lng v kt qu nghin cu tng ng sinh hc: a) Phi l bn sao c ng du ca c s sn xut hoc ca ch s hu sn phm hoc ca ch s hu giy php sn phm (ghi trn Giy chng nhn sn phm dc) v ca c s nhp khu; b) Kt qu nghin cu tng ng sinh hc ch yu cu i vi cc trng hp c yu cu phi bo co s liu nghin cu tng ng sinh hc theo quy nh ca B trng B Y t v ng k thuc. Min np ti liu ti im ny trong trng hp thuc c sn xut v cp php lu hnh (th hin trn Giy chng nhn sn phm dc) ti nc l thnh vin thng trc hoc sng lp ca ICH hoc Australia. 43. iu 77 c sa i nh sau: a) Tiu  khon 1, im g khon 1 iu 77 c sa i nh sau:  1. i vi trng hp cp php nhp khu thuc theo quy nh ti cc iu 65, 66, 69, 71, im c, d khon 1 iu 72 ca Ngh nh ny: g) Trng hp thuc nhp khu  phc v cc hot ng khm bnh, cha bnh nhn o  c c quan nh nc c thm quyn ph duyt m khng cung cp c ti liu theo quy nh ti im d, , e, g, h, i khon 2 iu 72 ca Ngh nh ny nhung cn thit cho nhu cu iu tr, B trng B Y t xem xt, quyt nh trn c s t vn ca Hi ng t vn cp Giy ng k lu hnh thuc. b) Tiu  khon 3 iu 77 c sa i nh sau:  3. i vi trng hp nhp khu thuc quy nh ti cc im b, c khon 1 iu 68, iu 70, im a, b khon 1 iu 72, 73, khon 1 iu 74 ca Ngh nh ny. c) im e khon 4 iu 77 c sa i nh sau:  e) Trong thi hn 03 thng, k t ngy S Y t c vn bn thng bo sa i, b sung, t chc, c nhn  ngh cp php nhp khu phi np h s sa i, b sung theo yu cu. Sau thi hn trn, t chc, c nhn khng sa i, b sung hoc sau 04 thng k t ngy np h s ln u m h s b sung khng p ng yu cu th h s  np khng cn gi tr. 44. Khon 3 iu 78 c sa i, b sung nh sau: a) Tiu  khon 3 iu 78 c sa i nh sau:  3. i vi thuc s dng cho mc ch cp cu, chng c, vc xin dng cho mt s trng hp c bit vi s lng s dng hn ch v cc thuc khc c cp php nhp khu theo quy nh ti cc im b, c khon 1 iu 68 ca Ngh nh ny: b) B sung im c vo khon 3 iu 78 nh sau:  c) Khng phi thc hin quy nh ti khon 4 iu 103 ca Lut dc. i vi cc thuc c yu cu bo qun  iu kin lnh hoc m su, c s nhp khu c trch nhim lu gi bng d liu theo di iu kin bo qun (dy chuyn lnh) trong qu trnh vn chuyn l hng nhp khu (c ng du xc nhn ca c s nhp khu) t cc thit b t ghi nhit , kt qu ch th ng bng (nu c). 45. Khon 3 iu 79 c sa i nh sau:  3. i vi thuc thuc danh mc thuc, dc cht thuc danh mc cht b cm s dng trong mt s ngnh, l)nh vc c tng s lng thuc  ngh nhp khu, s lng thuc cn tn ti thi im lp n hng v s lng thuc cn c th tip tc nhp khu t cc Giy php nhp khu  c cp trc  vt qu 150% so vi tng nhu cu kinh doanh thc t trong 01 nm trc thi im lp n hng th phi c vn bn gii trnh km ti liu chng minh. 46. im a, d, , e khon 1 iu 80 c sa i nh sau:  a) 01 bn chnh n hng nhp khu theo Mu s 35 hoc 36 hoc 41 ti Ph lc III ban hnh km theo Ngh nh ny. d) Bo co s dng nguyn liu lm thuc theo Mu s 37 ti Ph lc III ban hnh km theo Ngh nh ny, tr trng hp nhp khu nguyn liu c lm thuc, Bo co kt qu kinh doanh thuc thnh phm sn xut t nguyn liu lm thuc theo Mu s 38 ti Ph lc III ban hnh km theo Ngh nh ny, tr trng hp nhp khu nguyn liu c lm thuc. Min np bo co kt qu kinh doanh ti im ny i vi trng hp nguyn liu, cht chun nhp khu  kim nghim, nghin cu thuc, nguyn liu lm thuc; ) K hoch sn xut, s dng, kinh doanh i vi nguyn liu, cht chun  ngh nhp khu v k hoch kinh doanh d kin i vi thnh phm sn xut t nguyn liu  ngh nhp khu, tr trng hp nhp khu nguyn liu c lm thuc; Min np k hoch kinh doanh d kin i vi thnh phm sn xut t nguyn liu  ngh nhp khu ti im ny i vi trng hp nguyn liu, cht chun nhp khu  kim nghim, nghin cu thuc, nguyn liu lm thuc. i vi nguyn liu  ngh nhp khu thuc danh mc thuc, dc cht thuc danh mc cht b cm s dng trong mt s ngnh, l)nh vc c tng s lng nguyn liu  ngh nhp khu, s lng nguyn liu cn tn ti thi im lp n hng v s lng nguyn liu cn c th tip tc nhp khu t cc Giy php nhp khu  c cp trc  vt qu 150% so vi tng nhu cu kinh doanh, s dng thc t trong 01 nm trc thi im lp n hng th phi c ti liu chng minh; e) Trng hp nguyn liu, cht chun nhp khu  kim nghim, nghin cu thuc, nguyn liu lm thuc; nguyn liu c lm thuc, dc cht trong Danh mc thuc, dc cht thuc Danh mc cht b cm s dng trong mt s ngnh, l)nh vc nhp khu  sn xut thuc xut khu; nguyn liu lm thuc c giy ng k lu hnh ti Vit Nam hoc thuc Danh mc dc cht, t dc, bn thnh phm thuc  sn xut thuc theo h s ng k thuc  c Giy ng k lu hnh thuc ti Vit Nam th khng phi np ti liu quy nh ti cc im b v c khon ny. 47. iu 87 c sa i nh sau: a) Tn iu 87 c sa i nh sau:  iu 87. H s  ngh cp php nhp khu dc liu khng thuc trng hp quy nh ti cc iu 82, 83, 84, 85 v iu 86 ca Ngh nh ny b) im d v im  khon 1 iu 87 c sa i nh sau:  d) Khng bt buc c s cung cp dc liu nc ngoi phi thc hin quy nh ti khon 15 iu 91 Ngh nh ny nu c bn sao Giy php kinh doanh dc do c quan c thm quyn nc s ti cp c chng thc v hp php ha lnh s theo quy nh. ) Bn sao c chng thc Giy chng nhn thc hnh tt sn xut ca c s sn xut do c quan c thm quyn nc s ti cp. 48. iu 91 c sa i, b sung nh sau: a) Khon 5 iu 91 c sa i nh sau:  5. Vn phng i din ti Vit Nam ca c s sn xut, c s ng tn ng k, c s s hu giy php lu hnh ca thuc th lm sng, thuc nh gi sinh kh dng, th tng ng sinh hc; c s nhn th thuc trn lm sng, c s nhn nh gi sinh kh dng, th tng ng sinh hc c nhp khu thuc, nguyn liu lm thuc, bao b tip xc trc tip vi thuc v cht chun  phc v vic th lm sng, nh gi sinh kh dng, th tng ng sinh hc, ng k lu hnh, nghin cu, kim nghim thuc, nguyn liu lm thuc. b) B sung khon 5a vo sau khon 5 iu 91 nh sau:  5a. C quan, t chc di y p ng quy nh ti iu 35 Lut dc c php: a) Nhp khu thuc thuc trng hp quy nh ti iu 67 ca Ngh nh ny khi c B Quc phng, B Cng an hoc B Y t ch nh trong vn bn  ngh nhp khu. b) Nhp khu thuc vin tr, vin tr nhn o khi c c quan qun l nh nc c thm quyn ph duyt tip nhn vin tr, vin tr nhn o. c) im a khon 8 iu 91 c sa i nh sau:  a) S lng cp php nhp khu thuc c cha dc cht cha c giy ng k lu hnh thuc, thuc c cha dc liu ln u s dng ti Vit Nam theo quy nh ti iu 65 ca Ngh nh ny cn c vo nhu cu kinh doanh ca c s nhp khu; d) Khon 15 iu 91 c sa i nh sau:  15. C s cung cp thuc, nguyn liu lm thuc l c s nc ngoi k hp ng mua bn vi c s nhp khu. C s cung cp thuc, nguyn liu lm thuc phi thuc mt trong cc c s sau: a) C s sn xut thuc, nguyn liu lm thuc nhp khu; b) C s s hu sn phm hoc s hu giy php lu hnh ca thuc, dc cht nhp khu c ghi trn Giy chng nhn sn phm dc i vi thuc c cp giy ng k lu hnh theo quy nh ti Lut dc v thuc cha c giy ng k lu hnh ti Vit Nam; c) C s nc ngoi ng tn ng k thuc, nguyn liu lm thuc c giy ng k lu hnh thuc, nguyn liu lm thuc ti Vit Nam cn hiu lc ti thi im thng quan nhng khng phi l c s quy nh ti im a, b khon ny; d) Cc c s  c cp Giy php hot ng ca doanh nghip nc ngoi v thuc v nguyn liu lm thuc ti Vit Nam, giy php hot ng ca cng ty nc ngoi v vc xin, sinh phm y t v nguyn liu sn xut vc xin, sinh phm y t ti Vit Nam; ) Trng hp c s cung cp l c s quy nh ti im c hoc d hoc h khon ny th phi c c s quy nh ti im a hoc b khon ny y quyn bng vn bn  cung cp thuc vo Vit Nam, tr trng hp c s quy nh ti im d v im h khon ny chnh l c s quy nh ti im a hoc im b khon ny. Vn bn y quyn bao gm giy y quyn hoc giy php bn hng hoc giy chng nhn quan h i tc. Vn bn y quyn phi c th hin bng ting Vit hoc ting Anh v ti thiu c cc thng tin sau: Tn, a ch ca c s y quyn, c s c y quyn; phm vi y quyn trong  c hot ng cung cp thuc, nguyn liu lm thuc vo Vit Nam; thi hn y quyn hoc thi hn cho php bn hng; trch nhim ca cc bn trong vic bo m cht lng, ngun gc ca thuc, nguyn liu lm thuc cung cp vo Vit Nam; ch k xc nhn ca cc bn; e) C s cung cp thuc nhp khu theo quy nh ti cc iu 67, 73 v khon 1 iu 74 ca Ngh nh ny khng phi thc hin quy nh ti khon ny. g) C s cung cp thuc nhp khu theo quy nh ti iu 68, iu 70 ca Ngh nh ny khng phi thc hin quy nh ti im  khon ny; h) Cc c s c cng b theo quy nh ti khon 22 iu ny; ) Khon 16 iu 91 c sa i nh sau:  16. C s cung cp t dc, v nang, bao b tip xc trc tip vi thuc, cht chun, nguyn liu lm thuc phi kim sot c bit c nhp khu  kim nghim, nghin cu hoc sn xut thuc xut khu theo quy nh ti iu 80 ca Ngh nh ny; nguyn liu lm thuc nhp khu theo quy nh ti iu 82, 83, 84, 85 ca Ngh nh ny; thuc vin tr, vin tr nhn o khng phi thc hin quy nh ti khon 15 iu ny. e) B sung khon 22, 23, 24 vo iu 91 nh sau:  22. Trng hp B Y t nhn c vn bn ca c quan c thm quyn nc xut khu  ngh cng b danh sch cc c s sn xut, kinh doanh thuc, nguyn liu lm thuc ng k cung cp thuc, nguyn liu lm thuc vo Vit Nam, B Y t thc hin nh sau: a) Trong thi hn 30 ngy k t ngy nhn c vn bn  ngh ca c quan c thm quyn nc xut khu, B Y t cng b trn Cng thng tin in t ca B danh sch cc c s sn xut, kinh doanh thuc, nguyn liu lm thuc nc ngoi ng k cung cp thuc, nguyn liu lm thuc vo Vit Nam. b) Trng hp B Y t nhn c vn bn ca c quan c thm quyn nc xut khu  ngh thay i, b sung thng tin lin quan n cc c s cung cp thuc, nguyn liu lm thuc nc ngoi  c B Y t cng b, B Y t thc hin theo quy nh ti im a khon ny. 23. C quan c thm quyn nc xut khu quy nh ti khon 23 iu ny c trch nhim thng bo bng vn bn v B Y t theo quy nh sau: a) i vi trng hp c s cung cp thuc, nguyn liu lm thuc ang c B Y t cng b c thay i thng tin v tn, a im kinh doanh hoc phm vi kinh doanh: thng bo trong thi hn 01 thng k t ngy c vn bn ca c quan c thm quyn nc xut khu ph duyt vic thay i thng tin. b) i vi trng hp c s c thng bo tm ngng hoc chm dt hot ng sn xut, kinh doanh thuc, nguyn liu lm thuc ti nc xut khu: thng bo trong thi hn 15 ngy k t ngy c vn bn ca c quan c thm quyn nc ngoi v vic c s cung cp b ngng hoc chm dt hot ng. 24. Vn bn ca c quan c thm quyn nc xut khu quy nh ti khon 23 v 24 iu ny phi p ng cc quy nh sau: a) Ghi r tn, a ch v thng tin lin h ca c quan c thm quyn nc xut khu; thng tin v quc gia hoc vng lnh th ng k cung cp thuc, nguyn liu lm thuc vo Vit Nam; tn c s cung cp, a im kinh doanh, phm vi kinh doanh v thng tin lin h ca cc c s sn xut, kinh doanh thuc, nguyn liu lm thuc ng k cung cp thuc, nguyn liu lm thuc vo Vit Nam; b) L bn chnh c th hin bng ting Anh hoc ting Vit. Trng hp khng th hin bng ting Anh hoc ting Vit th phi c thm bn dch sang ting Anh hoc ting Vit v phi c cng chng theo quy nh. 49. iu 92 c sa i, b sung nh sau: a) im  khon 2 iu 92 c sa i nh sau:  ) Trng hp nhp khu thuc, nguyn liu lm thuc quy nh ti im  khon 1 iu 59 ca Lut dc v khng thuc trng hp phi c giy php nhp khu, c s nhp khu xut trnh vn ti n ca l thuc, nguyn liu lm thuc th hin hng ha c xut t cng i ca nc xut khu trc ngy giy ng k lu hnh ht thi hn hiu lc  c thng quan. b) B sung im e, g v h khon 2 iu 92 nh sau:  e) Trng hp nhp khu thuc, nguyn liu lm thuc quy nh ti im  khon 1 iu 59 ca Lut dc v thuc trng hp phi c giy php nhp khu, c s nhp khu xut trnh vn ti n ca l thuc, nguyn liu lm thuc th hin hng ha c xut t cng i ca nc xut khu trc ngy giy ng k lu hnh v giy php nhp khu ht thi hn hiu lc  c thng quan; g) Trng hp nhp khu nguyn liu lm thuc thuc danh mc dc cht, t dc, bn thnh phm thuc  sn xut thuc theo h s ng k thuc  c giy ng k lu hnh thuc ti Vit Nam v khng thuc trng hp phi c giy php nhp khu, c s nhp khu xut trnh vn ti n ca l nguyn liu lm thuc th hin hng ha c xut t cng i ca nc xut khu trc ngy giy ng k lu hnh ca thuc dng  cng b nguyn liu ht thi hn hiu lc  c thng quan (trong trng hp giy ng k lu hnh ca thuc dng  cng b nguyn liu ht thi hn hiu lc ti thi im thng quan); h) Trng hp nhp khu nguyn liu lm thuc thuc danh mc dc cht, t dc, bn thnh phm thuc  sn xut thuc theo h s ng k thuc  c giy ng k lu hnh thuc ti Vit Nam v thuc trng hp phi c giy php nhp khu, c s nhp khu xut trnh vn ti n ca l nguyn liu lm thuc th hin hng ha c xut t cng i ca nc xut khu trc ngy giy ng k lu hnh ca thuc dng  cng b nguyn liu v giy php nhp khu nguyn liu ht thi hn hiu lc  c thng quan (trong trng hp giy ng k lu hnh ca thuc dng  cng b nguyn liu hoc giy php nhp khu nguyn liu ht hiu lc ti thi im thng quan). c) im e khon 3 iu 92 c sa i nh sau:  e) Trng hp nhp khu dc liu, bn thnh phm dc liu quy nh ti im  khon 1 iu 59 ca Lut dc v khng thuc trng hp phi c giy php nhp khu, c s nhp khu xut trnh vn ti n ca l dc liu, bn thnh phm dc liu th hin hng ha c xut t cng i ca nc xut khu trc ngy giy ng k lu hnh ht thi hn hiu lc  c thng quan; d) B sung im h v im i vo khon 3 iu 92 nh sau:  h) Trng hp nhp khu dc liu, bn thnh phm dc liu quy nh ti im  khon 1 iu 59 ca Lut dc v thuc trng hp phi c giy php nhp khu, c s nhp khu xut trnh vn ti n ca l dc liu, bn thnh phm dc liu th hin hng ha c xut t cng i ca nc xut khu trc ngy giy ng k lu hnh v giy php nhp khu ht thi hn hiu lc  c thng quan. i) Trng hp nhp khu dc liu, bn thnh phm dc liu theo hnh thc giy php nhp khu cha c giy ng k lu hnh ti Vit Nam v ti thi im thng quan giy php nhp khu ht hiu lc, c s nhp khu xut trnh vn ti n ca l dc liu, bn thnh phm dc liu th hin hng ha c xut t cng i ca nc xut khu trc ngy giy php nhp khu ht thi hn hiu lc  c thng quan. ) B sung im e vo khon 4 iu 92 nh sau:  e) Trng hp nhp khu thuc, nguyn liu lm thuc theo hnh thc giy php nhp khu cha c giy ng k lu hnh ti Vit Nam v ti thi im thng quan giy php nhp khu ht hiu lc, c s nhp khu xut trnh vn ti n ca l thuc, nguyn liu lm thuc th hin hng ha c xut t cng i ca nc xut khu trc ngy giy php nhp khu ht thi hn hiu lc  c thng quan. 50. im  khon 1 iu 93 c sa i nh sau:  ) Dc liu nhp khu thuc Danh mc dc liu nui trng, thu hi trong nc p ng yu cu v iu tr v kh nng cung cp, gi hp l. 51. im b khon 5 iu 98 c sa i nh sau:  b) Giy chng nhn thc hnh tt sn xut, bo co kim tra thc hnh tt sn xut theo quy nh ti cc khon 1, 2, 3 v 4 iu ny, giy php sn xut quy nh ti cc khon 1, 2 v 3 iu ny phi l bn chnh hoc bn sao c chng thc v cn hiu lc ti thi im np h s. Trng hp khng ghi hiu lc, cc ti liu ny phi c cp hoc ban hnh trong thi hn khng qu 03 nm k t ngy cp. Min np Giy chng nhn Thc hnh tt sn xut hoc Giy php sn xut thuc trong trng hp  c cng b trn trang thng tin in t ca C quan qun l dc c thm quyn. 52. im a v b khon 1 iu 99 c sa i nh sau:  a) 20 ngy k t ngy nhn  h s i vi trng hp nh gi theo hnh thc cng nhn, tha nhn 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; b) 40 ngy k t ngy nhn  h s i vi trng hp nh gi theo hnh thc thm nh h s lin quan n iu kin sn xut; 53. im a khon 2, im c khon 3 v khon 4 iu 100 c sa i, b sung nh sau: a) im a khon 2 c sa i nh sau:  a) Cc trng hp b thu hi giy ng k lu hnh thuc, nguyn liu lm thuc quy nh ti cc im a, d,  khon 1 iu 58 ca Lut dc. b) im c khon 3 c sa i nh sau:  c) T 06 thng n 01 nm i vi cc trng hp quy nh ti im b khon 1 iu 58 ca Lut dc v im g khon 2 iu ny. c) Khon 4 c sa i nh sau:  4. H s  ngh cp, gia hn giy ng k lu hnh thuc, nguyn liu lm thuc ca cc c s c hnh vi vi phm quy nh ti im a, b, d, , e khon 2 iu ny np trc ngy b x l vi phm s khng cn gi tr. Khi ht thi hn tm ngng nhn h s quy nh ti khon 3 iu ny, c s mun ng k thuc, nguyn liu lm thuc phi np h s theo quy nh ti Lut dc. 54. iu 105 c sa i nh sau:  iu 105. Cc hnh thc thng tin thuc Thng tin thuc cho ngi hnh ngh y, dc c thc hin theo cc hnh thc sau: 1. Thng tin thuc thng qua  Ngi gii thiu thuc . 2. Pht hnh ti liu thng tin thuc. 3. Hi tho gii thiu thuc. 55. Tn iu 107 c sa i nh sau:  iu 107. Cc trng hp cp giy xc nhn ni dung thng tin thuc 56. im e khon 1 v im e khon 2 iu 108 c sa i nh sau:  e) Giy php thnh lp vn phng i din ca cng ty nc ngoi ti Vit Nam i vi c s nc ngoi ng tn  ngh xc nhn ni dung thng tin thuc hoc Giy chng nhn  iu kin kinh doanh dc i vi c s kinh doanh dc ca Vit Nam ng tn  ngh xc nhn ni dung thng tin thuc. Min np Giy chng nhn  iu kin kinh doanh dc do B Y t cp i vi c s kinh doanh dc ca Vit Nam ng tn  ngh xc nhn ni dung thng tin thuc. 57. iu 111 c sa i nh sau: a) Tn iu c sa i nh sau:  iu 111. Yu cu i vi ti liu trong h s  ngh cp giy xc nhn ni dung thng tin thuc b) Khon 2, khon 5 v khon 6 iu 111 c sa i nh sau:  2. Ti liu quy nh ti cc im d v e khon 1, im d v e khon 2 iu 108 l bn sao c ng du ca c s  ngh xc nhn ni dung thng tin thuc i vi ti liu do B Y t cp hoc bn sao c chng thc i vi ti liu khng do B Y t cp. 5. Ti liu quy nh ti cc im b khon 1, im b khon 2 iu 108 ca Ngh nh ny l bn chnh v lm thnh 02 bn. 6. Mi h s  ngh cp giy xc nhn ni dung thng tin thuc thc hin theo quy nh sau: 58. Khon 2 iu 113 c sa i nh sau:  2. Trong thi hn 10 ngy, k t ngy nhn  h s, c quan tip nhn h s cp Giy xc nhn theo Mu s 05 hoc 06 Ph lc VI ca Ngh nh ny. Trng hp khng cp Giy xc nhn, c quan tip nhn h s phi tr li bng vn bn v nu r l do khng cp. 59. Khon 3 iu 113 c sa i nh sau:  3. Trng hp c yu cu sa i, b sung h s, trong thi hn 10 ngy k t ngy nhn  h s, c quan tip nhn h s c vn bn  ngh c s sa i, b sung v thc hin nh sau: a) Vn bn  ngh sa i, b sung phi nu c th, chi tit nhng ti liu, ni dung cn sa i, b sung; b) Trong thi hn 10 ngy, k t ngy nhn c h s sa i, b sung theo yu cu, c quan tip nhn h s cp Giy xc nhn theo Mu s 05 hoc 06 ti Ph lc VI ban hnh km theo Ngh nh ny hoc tr li khng cp giy xc nhn bng vn bn v nu r l do; c) Trong thi hn 90 ngy, k t ngy c quan tip nhn h s c vn bn thng bo sa i, b sung, c s phi np h s sa i, b sung theo yu cu. Nu qu thi hn trn, h s  np khng cn gi tr. 60. iu 116 c sa i nh sau:  iu 116. Thm quyn cp giy xc nhn ni dung thng tin thuc 1. B Y t cp giy xc nhn i vi hnh thc thng tin thuc quy nh ti khon 2 iu 105 ca Ngh nh ny. 2. S Y t cp Giy xc nhn i vi hnh thc thng tin thuc quy nh ti khon 3 iu 105 ca Ngh nh ny. 61. Tn iu 120 c sa i nh sau:  iu 120. Cc trng hp cp giy xc nhn ni dung qung co thuc 62. im e khon 1 v im e khon 2 iu 121 c sa i nh sau:  e) Giy php thnh lp vn phng i din ca cng ty nc ngoi ti Vit Nam i vi c s nc ngoi ng tn  ngh xc nhn ni dung qung co thuc hoc Giy chng nhn  iu kin kinh doanh dc i vi c s kinh doanh dc ca Vit Nam ng tn  ngh xc nhn ni dung qung co thuc. Min np Giy chng nhn  iu kin kinh doanh dc do B Y t cp i vi c s kinh doanh dc ca Vit Nam ng tn  ngh xc nhn ni dung qung co thuc. 63. iu 124 c sa i nh sau: a) Tn iu 124 c sa i nh sau:  iu 124. Yu cu i vi h s  ngh xc nhn ni dung qung co thuc b) Khon 2, khon 5 v khon 6 iu 124 c sa i nh sau:  2. Ti liu quy nh ti cc im d v e khon 1, im d v e khon 2 iu 121 l bn sao c ng du ca c s  ngh xc nhn ni dung qung co thuc i vi ti liu do B Y t cp hoc bn sao c chng thc i vi ti liu khng do B Y t cp; 5. Ti liu quy nh ti cc im b khon 1, im b khon 2 iu 121 ca Ngh nh ny l bn chnh v lm thnh 02 bn; 6. Mi h s  ngh cp giy xc nhn ni dung qung co thuc thc hin theo quy nh sau: 64. iu 127 c sa i nh sau:  iu 127. Trnh t th tc cp giy xc nhn ni dung qung co thuc 1. C s  ngh cp giy xc nhn ni dung qung co thuc np h s ti B Y t. 2. Trnh t th tc cp giy xc nhn ni dung qung co thuc thc hin tng t quy nh ti iu 113 ca Ngh nh ny. 65. iu 128 c sa i nh sau:  iu 128. Thm quyn cp giy xc nhn ni dung qung co thuc B Y t cp giy xc nhn ni dung qung co thuc. 66. B sung iu 129a vo sau iu 129 nh sau:  iu 129a. Quy nh v vic iu chnh i vi cc ni dung  c cp giy xc nhn 1. Trng hp ni dung thng tin ghi trn giy xc nhn ni dung thng tin, qung co thuc b ghi sai do li ca c quan cp giy xc nhn, c s ng tn  ngh xc nhn ni dung thng tin, qung co thuc gi vn bn thng bo cho c quan cp giy xc nhn v nu r cc ni dung ghi sai cn nh chnh. Khi tip nhn vn bn thng bo, c quan cp giy xc nhn tr cho c s Phiu tip nhn vn bn thng bo ni dung thng tin thuc, qung co thuc cn nh chnh theo Mu s 07 ti Ph lc VI ban hnh km theo Ngh nh ny. C s c tin hnh hot ng thng tin, qung co thuc theo ni dung c s nh chnh v phi chu trch nhim v ni dung nh chnh. 2. Trng hp ni dung thng tin thuc, qung co thuc  c cp giy xc nhn c thay i ni dung nhng khng thuc cc trng hp quy nh ti im b khon 1 iu 107 hoc im b khon 1 iu 120 Ngh nh s 54/2017/N-CP, c s ng tn  ngh xc nhn ni dung thng tin, qung co thuc c vn bn thng bo cho c quan cp giy xc nhn v ni dung iu chnh. C s c t ng thc hin iu chnh v chu trch nhim v ni dung thng tin, qung co thuc iu chnh. 67. Khon 3 iu 130 c sa i nh sau:  3. H s k khai gi thuc i vi trng hp thay i Giy ng k lu hnh thuc thuc quy nh ti im b khon 2 iu 55 Lut dc thc hin theo quy nh khon 1 iu ny. 68. im c khon 1 iu 131 c sa i nh sau:  c) Khi c thay i Giy ng k lu hnh thuc thuc trng hp quy nh ti im b khon 2 iu 55 Lut dc hoc khi c thay i Giy php nhp khu thuc v trc khi a ra lu hnh l thuc u tin trn th trng Vit Nam, c s phi np h s k khai gi thuc. Trng hp thay i Giy ng k lu hnh thuc khng thuc quy nh ti im b khon 2 iu 55 ca Lut dc hoc thay i Giy php nhp khu thuc m khng c iu chnh gi so vi gi bn bun, gi bn l d kin ca chnh thuc   k khai th c s  k khai khng phi np h s k khai gi thuc m ch phi np h s theo quy nh ti khon 4 iu 130 ca Ngh nh ny. 69. im c khon 2 iu 131 c sa i nh sau:  c) Khi c thay i Giy ng k lu hnh thuc thuc trng hp quy nh ti im b khon 2 iu 55 Lut dc v trc khi a ra lu hnh l thuc u tin trn th trng Vit Nam, c s phi np h s k khai gi thuc. Trng hp thay i Giy ng k lu hnh thuc khng thuc quy nh ti im b khon 2 iu 55 ca Lut dc m khng c iu chnh gi so vi gi bn bun, gi bn l d kin ca chnh thuc   k khai th c s  k khai khng phi np h s k khai gi thuc m ch phi np h s theo quy nh ti khon 4 iu 130 ca Ngh nh ny. 70. im b, im c, im d khon 4 iu 131 c sa i nh sau:  b) Cn b tip nhn kim tra v thnh phn, s lng h s, trng hp h s c  thnh phn, s lng theo quy nh, cn b tip nhn thc hin ng du cng vn n c ghi ngy thng nm tip nhn vo h s v tr ngay 01 bn h s cho t chc, c nhn n np trc tip hoc chuyn ngay theo ng bu in 01 bn h s cho t chc, c nhn  gi h s theo ng cng vn km theo Phiu tip nhn h s theo Mu s 06 ti Ph lc VII ban hnh km theo Ngh nh ny i vi trng hp B Y t tip nhn h s v theo Mu s 07 ti Ph lc VII ban hnh km theo Ngh nh ny i vi trng hp y ban nhn dn tnh, thnh ph trc thuc trung ng tip nhn h s ng thi, chuyn ngay 01 bn h s n lnh o c quan, phng, ban nghip v c thm quyn. Trng hp h s khng  thnh phn, s lng theo quy nh, cn b tip nhn ghi r l do tr li, cc ni dung cn b sung v tr li ngay h s cho t chc, c nhn n np trc tip; hoc ti a khng qu 02 ngy lm vic k t ngy nhn c h s tip nhn gi theo ng cng vn. c) Trong thi hn 07 ngy k t ngy tip nhn  h s k khai, k khai li gi thuc, thay i thng tin ca thuc  k khai, k khai li gi, B Y t cng b gi thuc k khai, k khai li; thng tin b sung, thay i ca thuc trn Cng thng tin in t ca B Y t. d) i vi h s k khai li gi thuc sn xut trong nc: -   , 0 2 4 ʳjMjMjM41hRhB*CJOJQJ^JaJmH phsH 8hRh6B*CJOJPJQJ^JaJmH phsH 0hRh6B*CJOJPJQJ^JaJph5hRhB*CJOJPJQJ^JaJmH phsH )hRhB*CJOJQJ^JaJph-hRhB*CJOJPJQJ^JaJph0hRh5B*CJOJPJQJ^JaJph8hRh5B*CJOJPJQJ^JaJmH phsH $0 $x$Ifa$gdbkd$$Ifl0 "~  tt"644 lapyt$x$Ifa$gd0 2 4 H P  RnvJ $xa$gdxgdbkdl$$Ifl0 "~  tt"644 lapyt4 H J b$&^//V4X6dTUb@dëԒ{`KKKKKKK)hRhB*CJOJQJ^JaJph4hRh5B*CJOJQJ^JaJmH phsH ,hRh6B*CJOJQJ^JaJph0hh0J>*B*CJOJQJ^JaJph/jhhCJOJQJU^JaJ hhCJOJQJ^JaJ)jhhCJOJQJU^JaJ,hRh5B*CJOJQJ^JaJphJb#$0$d%&&'()l*t,V-^//|0113V4n45X66 $xa$gdxgd6b8h9:j;~<=>@AD&GHzJNO`SdTU&V]*^bbb@ddd $xa$gdxgddejeefDf\ftffffijHjrjkmn0nJndnnnVoop4rluuxgduuwwxJxxxyzxgd>ZRnJt2dXȔԕX"xgd 20$wBx"P>\$Pܑޑ˜:|ztJ4DF TBf. /|ggdnѺѺѺѺѺѺѺѺѺѺѺѺѺѸѺѺѺѺѺѺѺѺѺѺѺѺѺѺU,hRh5B*CJOJQJ^JaJph)hRhB*CJOJQJ^JaJph1hRhB*CJOJQJ^JaJmH phsH @"tb0&ZPH8HJff(ڮxgd,к&8:Zz8.@2dNxgdN6:Fb"H:(vHxgdH~^f2Xl  z > ,.Nxgd>:Pf!!^##$$Z%<'@()N+++H-n./P0d1126xgd678:<<?B@@V`@xgd@n x.P2^4NP"xgd"6$ P<lFV>\xgd\,&NFx  N4xgd("d!##Q^SdUUvZZ\\<^_Rddnee g~hhjllmmdqxgd Trong thi hn 03 ngy lm vic, k t ngy tip nhn  h s theo quy nh, y ban nhn dn tnh, thnh ph trc thuc trung ng phi bo co B Y t cc thuc k khai li theo Mu s 08 ti Ph lc VII ban hnh km theo Ngh nh ny. - Trong thi hn 04 ngy lm vic, k t ngy nhn c bo co ca y ban nhn dn tnh, thnh ph trc thuc trung ng, B Y t tng hp v cng b trn Cng thng tin in t ca n v. - Trng hp y ban nhn dn tnh, thnh ph trc thuc trung ng sau khi r sot c vn bn gi doanh nghip thc hin k khai gi yu cu bo co v mc gi k khai li ph hp vi bin ng ca yu t hnh thnh gi phi gi ng thi 01 bn v B Y t. 71. Khon 1 iu 132 c sa i nh sau:  1. Trong thi hn lu hnh ca thuc, c quan qun l nh nc c thm quyn cn c cc nguyn tc ti iu 134  r sot h s k khai, k khai li gi thuc  np bao gm r sot v ngy thc hin mc gi k khai, k khai li, pht hin h s k khai khng chnh xc, yu cu bng vn bn i vi doanh nghip thc hin k khai gi bo co v mc gi k khai ph hp vi yu t hnh thnh gi hoc mc gi k khai li ph hp vi bin ng ca yu t hnh thnh gi trong trng hp cn thit  phc v cng tc bnh n gi, qun l nh nc v gi, kim tra, thanh tra theo quy nh ca php lut. 72. im b khon 2 iu 132 c sa i nh sau:  b) Khng iu chnh gi nhng khng bo co theo vn bn yu cu ca c quan qun l nh nc v gi thuc i vi h s k khai, k khai li ca doanh nghip; bo co khng chnh xc cc yu t hnh thnh gi; 73. Khon 2, khon 3, khon 4 iu 133 c sa i nh sau:  2. C s kinh doanh dc c bn thuc k t ngy c s sn xut hoc c s t gia cng, c s nhp khu thuc  np h s k khai, k khai li gi thuc. 3. C s kinh doanh dc khng c bn bun, bn l thuc cao hn mc gi k khai, k khai li do chnh c s sn xut hoc c s t gia cng, c s nhp khu thuc   k khai, k khai li. 4. Trng hp c quan qun l nh nc c thm quyn c vn bn yu cu c s kinh doanh dc bo co v mc gi ca mt hng thuc do c s  k khai, k khai li, trong thi hn 60 ngy k t ngy c vn bn ca c quan qun l nh nc c thm quyn, c s phi c vn bn phn hi bo co v mc gi k khai ph hp vi cc yu t hnh thnh gi hoc iu chnh gi k khai, k khai li ph hp theo kin ca c quan qun l nh nc v gi thuc. Sau thi hn trn, nu c s kinh doanh dc khng c vn bn phn hi th h s k khai, k khai li  np khng cn gi tr. 74. Khon 1 iu 134 c sa i nh sau:  1. Vic r sot gi thuc do c s kinh doanh thuc k khai, k khai li m bo theo nguyn tc: a) Khng cao hn gi bn thuc ti cc nc Asean; b) Tnh chnh xc ca cc yu t chi ph cu thnh gi bn sn phm ca c s nhp khu thuc, c s sn xut thuc hoc c s t gia cng thuc k khai; c) S ph hp vi bin ng ca yu t hnh thnh gi sn phm nh nguyn liu, nhin liu, t gi, tin lng v cc chi ph khc lin quan trong trng hp thuc iu chnh tng gi. 75. Khon 5, 6 iu 134 c sa i, b sung nh sau:  5. C quan qun l nh nc v gi thuc thnh lp T chuyn gia v gi thuc  r sot tnh chnh xc ca h s gi thuc k khai, k khai li. 6. B trng B Y t thnh lp Hi ng lin ngnh v gi thuc gm i din B Y t, B Ti chnh, Bo him x hi Vit Nam v cc c quan, n v lin quan  t vn cho B trng B Y t v vic r sot gi thuc k khai, k khai li trong cc trng hp: a) Thuc k khai c nng , hm lng khc vi cc thuc  c cng b trn Cng thng tin in t ca B Y t; b) Thuc c dng bo ch khc vi cc thuc  c cng b trn Cng thng tin in t ca B Y t; c) Thuc mi; d) Thuc thuc Danh mc m phn gi, thuc bit dc gc, thuc sn xut trn dy chuyn sn xut t tiu chun EU-GMP hoc PIC/S-GMP ti c s sn xut thuc nc thnh vin ICH hoc Australia hoc thuc sn xut trn dy truyn sn xut t tiu chun WHO-GMP do B Y t Vit Nam cp Giy chng nhn v c c quan qun l quc gia c thm quyn cp php lu hnh ti nc thnh vin ICH hoc Australia k khai li c mc tng c th nh sau: - Trn 10% i vi thuc c gi tnh trn n v ng gi nh nht t trn 5.000 (nm nghn) ng n 100.000 (mt trm nghn) ng. - Trn 7% i vi thuc c gi tnh trn n v ng gi nh nht t trn 100.000 (mt trm nghn) ng n 1.000.000 (mt triu) ng. - Trn 5% i vi thuc c gi tnh trn n v ng gi nh nht trn 1.000.000 (mt triu) ng. 76. Khon 2 iu 136 c sa i nh sau:  2. C s bn l thuc trong khun vin c s khm bnh, cha bnh cng lp ch c mua thuc trng thu ca chnh c s khm bnh, cha bnh, thuc  c quyt nh trng thu ti cc c s y t tuyn tnh, tuyn trung ng trong vng 12 thng; thuc  c quyt nh trng thu mua sm tp trung cp a phng, cp quc gia trong thi hn ca hp ng hoc tha thun khung mua sm tp trung tnh n trc thi im mua thuc vi gi mua vo theo quy nh nh sau: a) i vi cc thuc c trong Danh mc trng thu ca chnh c s khm bnh, cha bnh, gi mua vo ca c s bn l thuc khng c cao hn gi thuc trng thu cng thi im; b) i vi thuc khng c trong Danh mc trng thu ca chnh c s khm bnh, cha bnh, gi mua vo khng c cao hn gi trng thu ca chnh thuc   trng thu ti cc c s y t tuyn tnh, tuyn trung ng trong vng 12 thng; trng thu mua sm tp trung cp a phng, cp quc gia trong thi hn ca hp ng hoc tha thun khung mua sm tp trung tnh n trc thi im mua thuc. Quy nh ny khng p dng i vi cc thuc c cp php nhp khu theo quy nh ti iu 67, iu 68 ca Ngh nh s 54/2017/N-CP; cc thuc gy nghin, thuc hng tm thn, thuc tin cht v thuc mi theo quy nh ti khon 14 iu 2 Lut dc cha trng thu ti cc c s y t. 77. Khon 2 iu 140 c sa i nh sau:  2. Chm nht n ngy 01 thng 01 nm 2021, ngi ph trch v bo m cht lng ca c s sn xut thuc, nguyn liu lm thuc phi c chng ch hnh ngh dc. 78. iu 143 c sa i nh sau: a) Sa i khon 3 nh sau:  3. Giy php xut khu, nhp khu thuc, nguyn liu lm thuc, n hng xut khu, nhp khu thuc, nguyn liu lm thuc v cc th tc hnh chnh c lin quan c thc hin theo quy nh ca Lut dc s 34/2005/QH11 v cc vn bn hng dn c lin quan c thc hin n ht thi hn hiu lc ca Giy php. Thuc, nguyn liu lm thuc quy nh ti khon ny c nhp khu vo Vit Nam hoc xut khu ra khi Vit Nam c thng quan nu p ng quy nh ca Lut dc s 34/2005/QH11 v cc vn bn hng dn c lin quan hoc theo quy nh ti Ngh nh ny k t ngy Ngh nh ny c hiu lc thi hnh. b) Sa i im a khon 5 nh sau:  a) Cc c s ang kinh doanh thuc phi kim sot c bit l thuc quy nh ti cc im a, b khon 26 iu 2 ca Lut dc c tip tc hot ng n ht ngy 30 thng 6 nm 2019. Sau thi hn ny, cc c s mun tip tc hot ng phi c Giy chng nhn  iu kin kinh doanh dc phm vi kinh doanh thuc phi kim sot c bit ph hp vi phm vi hot ng ca c s theo quy nh ti Mc 4 Chng III ca Ngh nh ny; c) Sa i khon 7 nh sau:  7. Chm nht t ngy 01 thng 01 nm 2021, dc liu trc khi lu hnh ti Vit Nam phi c giy ng k lu hnh hoc cng b tiu chun theo quy nh ti khon 1 v khon 2 iu 93 Ngh nh ny. d) Sa i khon 11 iu 143 nh sau:  11. Giy php hot ng ca doanh nghip nc ngoi v thuc v nguyn liu lm thuc ti Vit Nam, Giy php hot ng ca doanh nghip nc ngoi v vc xin, sinh phm y t v nguyn liu sn xut vc xin v sinh phm y t ti Vit Nam c cp trc ngy Ngh nh s 54/2017/N-CP c hiu lc c s dng n ht thi hn hiu lc ca Giy php. 79. Thay th cm t  S Y t ni c s  t tr s bng  S Y t ni t c s  t a im kinh doanh ti im b khon 1 iu 33, im b khon 1 iu 34, im b khon 1 iu 50, im b khon 1 iu 51, im b khon 2 iu 55. 80. Sa i Mu s 06, 07, 19 ca Ph lc I ban hnh km theo Ngh nh ny. 81. Sa i Mu s 19 ca Ph lc II ban hnh km theo Ngh nh ny. 82. Sa i Ph lc III: a) Sa cc mu s 03, 04, 05, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 30, 33, 34, 35, 36, 37, 38, 41, 43, 46, 47, 48, 49, 50. b) Sa tn ca cc mu s 03, 24, 25, 26, 38, 46. 83. Sa i Ph lc V: B sung  Thuc phin v cc ch phm t thuc phin . 84. Sa i Mu s 06 ban hnh ti Ph lc VI. 85. B sung Mu s 07 vo Ph lc VI. 86. Sa i Mu s 01, 02, 03, 04 ban hnh ti Ph lc VII. Chng III L(NH VC HIN, LY, GHP M, B PHN C TH NGI V HIN, LY XC iu 6. Bi b cc quy nh sau y ca Ngh nh s 118/2016/N-CP ngy 22 thng 7 nm 2016 ca Chnh ph sa i, b sung mt s iu ca Ngh nh s 56/2008/N-CP ngy 29 thng 4 nm 2008 ca Chnh ph quy nh v t chc, hot ng ca ngn hng m v Trung tm iu phi Quc gia v ghp b phn c th ngi 1. Tit 4 im b khon 2 iu 3a. 2. Tit 4 im c khon 2 iu 3a. 3. Tit 2 im d khon 1 iu 4. iu 7. Sa i, b sung mt s iu ca Ngh nh s 118/2016/N-CP ngy 22 thng 7 nm 2016 ca Chnh ph sa i, b sung mt s iu ca Ngh nh s 56/2008/N-CP ngy 29 thng 4 nm 2008 ca Chnh ph quy nh v t chc, hot ng ca ngn hng m v Trung tm iu phi Quc gia v ghp b phn c th ngi 1. iu 3a c sa i nh sau:  iu 3a. iu kin hot ng v cp Giy php hot ng ngn hng m 1. iu kin hot ng ca ngn hng m: Ngn hng m ch c hot ng sau khi c Giy php hot ng ngn hng m do B Y t cp. 2. iu kin cp Giy php hot ng ngn hng m: a) C Quyt nh thnh lp ngn hng m hoc ngn hng m c tn trong vn bn ca c quan c thm quyn quy nh c cu t chc ca c s y t i vi ngn hng m ca nh nc hoc Giy chng nhn doanh nghip i vi ngn hng m t nhn. b) C s vt cht ph hp, phi c cc b phn sau y: - Bung k thut  tip nhn, x l, bo qun v cung ng m; - Phng xt nghim. Ring ngn hng m thuc c s y t th vic xt nghim c th s dng chung vi b phn xt nghim ca c s y t; - Khu vc hnh chnh tng hp, qun l h s, t vn. c) Nhn lc ti thiu: - Ngi qun l chuyn mn ngn hng m phi  iu kin theo quy nh ti khon 4 iu 35 Lut hin, ly, ghp m, b phn c th ngi v hin, ly xc; - 01 bc s a khoa c chng ch hnh ngh v xt nghim (Sinh ha hoc Huyt hc hoc Vi sinh vt) hoc 01 c nhn xt nghim c chng ch hnh ngh khm bnh, cha bnh v xt nghim; - 01 k thut vin y hoc iu dng tt nghip trung cp tr ln v chuyn ngnh y, c chng ch hnh ngh khm bnh, cha bnh. i vi ngn hng m thuc c s y t th nhn lc c th kim nhim, ring k thut vin y hoc iu dng phi lm vic chuyn trch. d) Trang thit b: C  cc trang thit b theo Danh mc quy nh ti Ph lc I ban hnh km theo Ngh nh ny. i vi ngn hng m thuc c s y t c th s dng chung trang thit b vi c s y t. - Nu ngn hng m c hot ng v gic mc th phi p ng iu kin ti khon 3 iu ny. - Quy trnh qun l hnh chnh. - Quy trnh k thut ly, bo qun, phn phi ca tng loi m ngn hng ng k. 3. iu kin cp giy php hot ng i vi ngn hng gic mc (ngn hng m ch hot ng v gic mc): a) C s vt cht:  iu kin theo quy nh ti im b khon 2 iu ny. b) Trang thit b: C  trang thit b theo quy nh ti Ph lc I ban hnh km theo Ngh nh ny. c) Nhn lc: - C  nhn lc quy nh ti im c khon 2 iu ny; - Ngi ly gic mc phi c trnh  vn ha tt nghip ph thng trung hc, c o to v ly v bo qun, vn chuyn gic mc. 2. iu 4 c sa i nh sau:  iu 4. H s, th tc  ngh cp Giy php hot ng ngn hng m 1. H s  ngh cp Giy php hot ng ngn hng m bao gm: a) n  ngh cp Giy php hot ng ngn hng m theo mu quy nh ti Ph lc II ban hnh km theo Ngh nh ny; b) Bn sao quyt nh thnh lp ngn hng m hoc bn photocopy c bn chnh  i chiu hoc Giy chng nhn doanh nghip i vi ngn hng m t nhn; c) Bn k khai c s vt cht, trang thit b y t  chng minh  iu kin quy nh ti iu 3a Ngh nh ny; d) i vi ngn hng m c lp: Bn k khai nhn lc ca ngn hng m  chng minh  iu kin quy nh ti iu 3a Ngh nh ny. i vi ngi qun l chuyn mn cn phi c bn sao chng thc vn bng, chng ch; i vi ngn hng m thuc c s y t ch cn chng ch hnh ngh. 2. Trnh t th tc cp Giy php hot ng i vi ngn hng m: a) C quan, t chc, c nhn np 01 b h s  ngh cp Giy php hot ng quy nh ti khon 1 iu ny cho B Y t theo ng hnh chnh hoc np trc tip; b) Sau khi tip nhn, trong thi gian 03 ngy lm vic, B Y t c trch nhim xem xt tnh hp l ca h s. Trng hp h s cha hp l, B Y t c vn bn thng bo hng dn  c quan, t chc, c nhn hon thin h s; c) Trong thi gian 05 ngy lm vic k t ngy nhn  h s hp l, B trng B Y t ra Quyt nh thnh lp Hi ng thm nh cp Giy php hot ng ngn hng m. Thnh phn Hi ng thm nh ti thiu gm 5 thnh vin l i din n v c lin quan ca B Y t, chuyn gia v y t, php lut; d) Trong thi hn 17 ngy lm vic k t ngy c Quyt nh thnh lp, Hi ng tin hnh thm nh ti ngn hng m, lp bin bn thm nh v bo co kt qu thm nh cho B trng B Y t, cn c kt qu thm nh ca Hi ng, B trng B Y t cp Giy php hot ng cho ngn hng m theo mu quy nh ti Ph lc III km theo Ngh nh ny; Thi gian gii quyt: T khi nhn c h s hp l ca c s  ngh B Y t cp Giy php hot ng ngn hng m n khi B Y t cp php l 30 ngy. Chng IV L(NH VC HA CHT CH PHM DIT CN TRNG, DIT KHUN DNG TRONG L(NH VC GIA DNG V Y T iu 8. Bi b cc quy nh sau y ca Ngh nh s 91/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh v qun l ha cht, ch phm dit cn trng, dit khun dng trong l)nh vc gia dng v y t 1. Khon 1 iu 4. 2. im c khon 1 v khon 2 iu 5. 3. im c, e, g khon 1 v im c khon 2 iu 7. 4. Yu cu phi c giy t chng minh tun th quy chun k thut v khong cch an ton ca B Cng Thng ti im d khon 1 iu 7. 5. Khon 1 iu 10. 6. im b khon 2; cc im b, d,  v e khon 3 iu 14. 7. Khon 5 iu 15. 8. im b khon 1 iu 40. 9. Khon 1 v khon 3 iu 41. 10. Khon 3 iu 42. iu 9. Sa i mt s iu ca Ngh nh s 91/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh v qun l ha cht, ch phm dit cn trng, dit khun dng trong l)nh vc gia dng v y t 1. Khon 1 iu 6 c sa i nh sau:  p ng cc yu cu ti Mc 1 Chng II Ngh nh s 113/2017/N-CP ngy 09 thng 10 nm 2017 ca Chnh ph quy nh chi tit v hng dn thi hnh mt s iu ca Lut ha cht. 2. im d khon 2 iu 7 c sa i nh sau:  d) Giy t quy nh ti cc im d,  khon 1 iu ny phi c xc nhn ca c s sn xut. 3. Khon 4 iu 8 c sa i nh sau:  4. Trong thi hn 03 ngy lm vic, k t ngy ghi trn Phiu tip nhn h s, S Y t c trch nhim cng khai trn trang thng tin in t ca S Y t cc thng tin: Tn, a ch, s in thoi lin h ca c s sn xut. 4. im a khon 5 iu 8 c sa i nh sau:  a) Thay i v nhn s: Vn bn  ngh cp nht thng tin cng b  iu kin km theo giy t quy nh ti im b khon 1 iu 7 Ngh nh ny. 5. Khon 2 iu 10 c sa i nh sau:  2. t tiu chun ISO 17025:2005 hoc cc phin bn cp nht c cp chng nhn bi t chc chng nhn  ng k theo quy nh ca php lut v iu kin kinh doanh nh gi s ph hp. 6. iu 12 c sa i nh sau:  iu 12. Cng b  iu kin thc hin kim nghim 1. Trc khi thc hin kim nghim ln u tin, c s kim nghim gi thng bo gm cc giy t theo quy nh ti iu 11 Ngh nh ny n B Y t. Trng hp B Y t trin khai h thng trc tuyn th c s thng bo bng hnh thc trc tuyn. 2. Trong thi hn 03 ngy lm vic, k t ngy nhn c thng bo ca c s kim nghim, B Y t c trch nhim cng khai trn trang thng tin in t ca B Y t cc thng tin: Tn, a ch, s in thoi lin h ca n v kim nghim; danh mc cc loi ha cht m n v c kh nng kim nghim. 3. Trng hp c s kim nghim c thay i iu kin kim nghim so vi h s thng bo  iu kin thc hin kim nghim  gi n B Y t, trong thi hn 05 ngy lm vic, k t khi c s thay i, c s kim nghim c trch nhim gi thng bo n B Y t vi cc giy t theo quy nh ti iu 11 Ngh nh ny. 4. Trng hp pht hin c s kim nghim khng  cc iu kin theo thng bo  gi B Y t m khng khc phc trong thi hn theo yu cu ca B Y t, B Y t chm dt vic ng ti thng tin lin quan n c s kim nghim v c vn bn thng bo cho c s kim nghim v vic chm dt ng ti thng tin. C s kim nghim khng c php thc hin kim nghim k t ngy B Y t c vn bn thng bo v vic chm dt ng ti thng tin lin quan n c s kim nghim do khng  iu kin thc hin kim nghim. 7. im a khon 2 iu 14 c sa i nh sau:  a) Ngi ph trch b phn kho nghim c t nht 03 nm kinh nghim trong l)nh vc kho nghim ch phm. 8. im a khon 3 iu 14 c sa i nh sau:  a) C phng kho nghim c qun l, vn hnh theo tiu chun ISO 17025:2005 hoc tiu chun ISO 15189:2012 hoc phin bn cp nht. Trng hp c hot ng dch v th nghim th hot ng th nghim phi c ng k theo quy nh ca php lut v iu kin kinh doanh dch v nh gi s ph hp; 9. iu 16 c sa i nh sau:  iu 16. Cng b  iu kin thc hin kho nghim 1. Trc khi thc hin kho nghim ln u tin, c s kho nghim thng bo gm cc giy t theo quy nh ti iu 15 Ngh nh ny n B Y t. Trng hp B Y t trin khai h thng trc tuyn th c s thng bo bng hnh thc trc tuyn. 2. Trong thi hn 03 ngy lm vic, k t ngy nhn c thng bo ca c s kho nghim, B Y t c trch nhim cng khai trn trang thng tin in t ca B Y t cc thng tin: Tn, a ch, s in thoi lin h ca c s kho nghim; danh mc cc quy trnh kho nghim m c s kho nghim cng b  iu kin thc hin kho nghim. 3. Trng hp c s kho nghim c thay i cc iu kin so vi h s thng bo  gi n B Y t, trong thi hn 15 ngy k t khi c thay i, c s kho nghim c trch nhim gi thng bo n B Y t vi cc giy t theo quy nh ti iu 15 Ngh nh ny. 4. Trong thi hn 03 ngy lm vic, k t ngy nhn c thng bo ca c s kho nghim theo quy nh ti khon 3 iu ny, B Y t c trch nhim cp nht thng tin trn trang thng tin in t ca B Y t. 5. Trng hp pht hin c s kho nghim khng  cc iu kin theo thng bo  gi B Y t m khng khc phc trong thi hn theo yu cu ca B Y t, B Y t chm dt vic ng ti thng tin lin quan n c s kho nghim v c vn bn thng bo cho c s kho nghim v vic chm dt ng ti thng tin. C s kho nghim khng c php thc hin kho nghim k t ngy B Y t c vn bn thng bo v vic chm dt ng ti thng tin lin quan n c s kho nghim do khng  iu kin thc hin kho nghim. 10. im d khon 4 iu 26 c sa i nh sau:  d) Bn gc hoc bn sao hp l Kt qu kim nghim thnh phn v hm lng hot cht ca ch phm. Kt qu kim nghim phi c thc hin bi c s  iu kin thc hin kim nghim theo quy nh ti iu 10 Ngh nh ny. Trng hp cc c s kim nghim  Vit Nam khng  nng lc  kim nghim, c s ng k c s dng kt qu kim nghim ca n v sn xut hoc mt phng xt nghim c lp t ISO 17025:2005 hoc tiu chun ISO 15189:2012 hoc phin bn cp nht v n v ng k phi chu trch nhim trc php lut v tnh hp php ca kt qu kim nghim do mnh cung cp; 11. Khon 3 iu 40 c sa i nh sau:  3. T chc, c nhn mua bn cc ch phm dit cn trng, dit khun thng dng bao gm: Nhang (hng) xua, dit mui; tm ha cht xua mui dng trong gia dng v y t; bnh xt xua, dit cn trng; b dit cn trng; kem xoa, tm dn, vng xua cn trng dng cho ngi; dung dch bc hi xua, dit mui; mn, rm, giy tm ha cht xua, dit mui; ch phm dit khun dng trong gia dng khng phi p ng cc yu cu quy nh ti khon 1 v im c khon 2 iu ny. 12. Khon 2 iu 41 c sa i nh sau:  2. Ngi trc tip thc hin dit cn trng, dit khun phi c tp hun kin thc sau v c ch c s xc nhn  c tp hun v: a) Cch c thng tin trn nhn ch phm; b) K thut dit cn trng, dit khun ph hp vi dch v m c s cung cp; c) S dng v thi b an ton ch phm dit cn trng, dit khun. 13. Khon 2 iu 42 c sa i nh sau:  2. Danh sch ngi c tp hun kin thc c xc nhn ca ch c s. 14. B sung khon 1a vo trc khon 1 iu 63 nh sau:  1a. T chc tp hun cho ngi trc tip thc hin dit cn trng, dit khun ca c s. Trng hp khng t chc tp hun, ch c s phi c ngi trc tip thc hin dit cn trng, dit khun ca c s n hc ti cc n v c cung cp chng trnh tp hun c cc ni dung theo quy nh ti khon 2 iu 41 Ngh nh ny. 15. Sa i Mu s 01, 03, 04, 05, 06 v 08 Ph lc I; Ph lc VI; Ph lc VII v Ph lc IX ban hnh km theo Ngh nh ny. Chng V L(NH VC KHM BNH, CHA BNH iu 10. Bi b cc quy nh sau y ca Ngh nh s 109/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh cp chng ch hnh ngh i vi ngi hnh ngh v cp giy php hot ng i vi c s khm bnh, cha bnh 1. im d khon 1 iu 7. 2. Khon 17, 18 v 19 iu 22. 3. im a khon 3 iu 23. 4. im b, c v k khon 5 iu 23. 5. im b, c khon 2 iu 24. 6. Khon 3, khon 5 iu 24. 7. im a, c v d khon 2 iu 25. 8. im a khon 3 iu 25. 9. im b khon 4, khon 5 iu 25. 10. im a, d,  v e khon 1 iu 26. 11. Tit 9 ti im c khon 1 iu 26. 12. im a khon 2 iu 26. 13. im a, d v  khon 1 iu 27. 14. Tit th hai im a khon 2 v im a khon 3 iu 27. 15. Tit 10, 11 im a, im b v c khon 1 iu 28. 16. im a v tit 3 im b khon 3 iu 28. 17. im b v c khon 1 iu 29. 18. Khon 2 iu 29. 19. im a, b khon 3 iu 29. 20. im a, d v  khon 1 iu 30. 21. im a khon 2 iu 30. 22. im a khon 3 iu 30. 23. Tit 2 v 3 im b khon 3 iu 30. 24. im a khon 4 iu 31. 25. Khon 5 iu 31. 26. im b khon 2, im b khon 3 v im a khon 4 iu 32. 27. iu 33, 34, 35, 36, 37 v 38. 28. im b v c khon 1, im a khon 2 iu 39. iu 11. Sa i mt s iu ca Ngh nh s 109/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh cp chng ch hnh ngh i vi ngi hnh ngh v cp giy php hot ng i vi c s khm bnh, cha bnh 1. Sa i im b khon 1 iu 4 nh sau:  b) Cp iu chnh chng ch hnh ngh khi c thay i ni dung trong chng ch hnh ngh, bao gm: - B sung phm vi hot ng chuyn mn trong chng ch hnh ngh khi ngi hnh ngh  ngh thm chuyn khoa khc vi phm vi hot ng chuyn mn  c cp trong chng ch hnh ngh; i vi cc k thut chuyn mn thuc chuyn khoa khc vi chuyn khoa m ngi hnh ngh  c ghi trong chng ch hnh ngh, ngi hnh ngh c thc hin k thut sau khi c chng ch hoc chng nhn o to k thut chuyn mn  do c s o to hp php cp v c ngi chu trch nhim chuyn mn k thut ca c s cho php thc hin bng vn bn, m khng cn b sung phm vi hot ng chuyn mn ghi trn chng ch hnh ngh. - Thay i phm vi hot ng chuyn mn trong chng ch hnh ngh khi ngi hnh ngh  ngh thay i chuyn khoa khc vi chuyn khoa  c cp trong chng ch hnh ngh; 2. Sa i iu 7 nh sau:  iu 7. H s  ngh cp iu chnh chng ch hnh ngh 1. H s  ngh cp b sung phm vi hot ng chuyn mn trong chng ch hnh ngh bao gm: a) n  ngh cp b sung phm vi hot ng chuyn mn trong chng ch hnh ngh theo Mu 05 Ph lc I ban hnh km theo Ngh nh ny; b) Bn sao hp l chng ch hnh ngh  c cp; c) Bn sao hp l vn bng, chng ch, giy chng nhn o to do c s o to hp php cp vi thi gian o to ti thiu l 6 thng ph hp vi phm vi hot ng chuyn mn  ngh b sung. 3. Sa i iu 22 nh sau:  iu 22. Hnh thc t chc ca c s khm bnh, cha bnh C s khm bnh, cha bnh c thnh lp theo quy nh ca php lut v phi theo mt trong cc hnh thc t chc sau y: 1. Bnh vin bao gm bnh vin a khoa v bnh vin chuyn khoa. 2. Bnh x thuc lc lng Cng an nhn dn. 3. Phng khm a khoa. 4. Phng khm chuyn khoa, bao gm: a) Phng khm ni tng hp; b) Phng khm chuyn khoa thuc h ni: Tim mch, h hp, tiu ha, nhi v chuyn khoa khc thuc h ni; c) Phng khm t vn sc khe hoc phng t vn sc khe qua cc phng tin cng ngh thng tin, vin thng; d) Phng khm chuyn khoa ngoi; ) Phng khm chuyn khoa ph sn; e) Phng khm chuyn khoa nam hc; g) Phng khm chuyn khoa rng - hm - mt; h) Phng khm chuyn khoa tai - mii - hng; i) Phng khm chuyn khoa mt; k) Phng khm chuyn khoa thm m; l) Phng khm chuyn khoa phc hi chc nng; m) Phng khm chuyn khoa tm thn; n) Phng khm chuyn khoa ung bu; o) Phng khm chuyn khoa da liu; p) Phng khm chuyn khoa y hc c truyn; Phng chn tr y hc c truyn; q) Phng khm chuyn khoa dinh dng; r) Phng khm h tr iu tr cai nghin ma ty; s) Phng khm, iu tr HIV/AIDS; t) Phng xt nghim; u) Phng khm chn on hnh nh, Phng X-Quang; v) Phng khm, iu tr nghin cht dng thuc phin bng thuc thay th thc hin theo quy nh ti Ngh nh s 90/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh v iu tr nghin cc cht dng thuc phin bng thuc thay th; x) Phng khm, t vn v iu tr d phng; y) Phng khm, iu tr bnh ngh nghip; z) Phng khm chuyn khoa khc. 5. C s khm bnh, cha bnh y hc gia nh (hoc c s khm bnh, cha bnh theo nguyn l y hc gia nh): Thc hin th im theo quy nh ca B trng B Y t. 6. Nh h sinh. 7. C s dch v y t bao gm: a) C s dch v tim (chch), thay bng, m mch, o nhit , o huyt p; b) C s dch v chm sc sc kho ti nh; c) C s dch v cp cu, h tr vn chuyn ngi bnh trong nc v ra nc ngoi; d) C s dch v knh thuc; ) C s dch v thm m; e) C s dch v y t khc. 8. Trm y t cp x, trm x. 9. C s gim nh y khoa, c s gim nh php y, c thc hin khm bnh, cha bnh th phi t chc theo hnh thc t chc c s khm bnh, cha bnh quy nh ti khon 3 iu ny. C s gim nh php y tm thn c thc hin khm bnh, cha bnh th phi t chc theo mt trong cc hnh thc t chc c s khm bnh, cha bnh quy nh ti cc khon 1, 3 hoc im m khon 4 iu ny. Cc c s ny phi p ng iu kin tng ng vi tng hnh thc t chc c s khm bnh, cha bnh. 10. C s y t c quan, n v, t chc c thc hin vic khm bnh, cha bnh th phi thc hin theo mt trong cc hnh thc t chc quy nh ti khon 3 hoc im a khon 4 iu ny v phi p ng iu kin quy nh tng ng vi hnh thc t chc . 11. Trung tm y t c chc nng khm bnh, cha bnh th cp giy php hot ng theo hnh thc t chc l bnh vin a khoa hoc phng khm a khoa v phi p ng iu kin quy nh tng ng vi hnh thc t chc . Vic phn hng thc hin theo nguyn tc nu c cp giy php hot ng theo m hnh phng khm a khoa th c xp hng IV, nu c cp giy php hot ng theo m hnh bnh vin th c xp theo hng bnh vin tng ng vi quy m ca c s . 12. Trng hp cc c s khm bnh, cha bnh p ng  iu kin ca cc c s dch v y t quy nh ti Ngh nh ny th c b sung quy m v phm vi hot ng chuyn mn tng ng. 4. B sung iu 23a nh sau:  iu 23a. iu kin chung  cp giy php hot ng i vi cc c s khm bnh, cha bnh 1. C s vt cht: a) C a im c nh (tr trng hp t chc khm bnh, cha bnh lu ng); b) Bo m cc iu kin v an ton bc x, phng chy cha chy theo quy nh ca php lut; c) Phi b tr khu vc tit trng  x l dng c y t s dng li, tr trng hp khng c dng c phi tit trng li hoc c hp ng vi c s y t khc  tit trng dng c. 2. Trang thit b y t: a) C  trang thit b y t ph hp vi phm vi hot ng chuyn mn ca c s; b) Ring c s khm, iu tr bnh ngh nghip t nht phi c b phn xt nghim sinh ha; c) Phng khm t vn sc khe hoc phng t vn sc khe qua cc phng tin cng ngh thng tin, vin thng khng bt buc phi c trang thit b y t quy nh ti im a, b khon ny nhng phi c  cc phng tin cng ngh thng tin, vin thng, thit b ph hp vi phm vi hot ng ng k. 3. Nhn lc: a) Mi c s khm bnh, cha bnh phi c mt ngi chu trch nhim chuyn mn k thut. Ngi chu trch nhim chuyn mn k thut v trng cc khoa chuyn mn ca c s khm bnh, cha bnh phi p ng cc iu kin sau y: - L bc s c chng ch hnh ngh c phm vi hot ng chuyn mn ph hp phm vi hot ng chuyn mn ca c s. - Trng hp c s khm bnh, cha bnh gm nhiu chuyn khoa th chng ch hnh ngh ca ngi chu trch nhim chuyn mn k thut phi c phm vi hot ng chuyn mn ph hp vi t nht mt trong cc chuyn khoa lm sng m c s ng k hot ng. - i vi cc phng khm chuyn khoa di y, ngi chu trch nhim chuyn mn k thut cn phi p ng cc iu kin nh sau: + Phng khm chuyn khoa Phc hi chc nng: L bc s c chng ch hnh ngh v chuyn khoa vt l tr liu hoc phc hi chc nng; + Phng khm, iu tr h tr cai nghin ma ty: L bc s chuyn khoa tm thn, bc s a khoa c chng ch o to v chuyn khoa tm thn hoc bc s chuyn khoa y hc c truyn c chng ch o to v h tr cai nghin ma ty bng phng php y hc c truyn; + Phng khm, iu tr HIV/AIDS: L bc s chuyn khoa truyn nhim hoc bc s a khoa v c giy chng nhn  o to, tp hun v iu tr HlV/AIDS; + Phng khm chuyn khoa y hc c truyn: L bc s hoc y s chuyn khoa y hc c truyn; + Phng chn tr y hc c truyn: L lng y hoc l ngi c cp Giy chng nhn bi thuc gia truyn hoc l ngi c cp Giy chng nhn phng php cha bnh gia truyn; + Phng khm dinh dng: L bc s chuyn khoa dinh dng hoc bc s a khoa v c chng ch o to v chuyn khoa dinh dng hoc bc s y hc d phng v c chng ch o to v chuyn khoa dinh dng hoc c nhn chuyn ngnh dinh dng hoc bc s y hc c truyn v c chng ch o to v chuyn khoa dinh dng hoc c nhn y khoa v c chng ch o to v chuyn khoa dinh dng hoc y s v c chng ch o to v chuyn khoa dinh dng; + Phng khm chuyn khoa thm m: L bc s chuyn khoa phu thut to hnh hoc chuyn khoa phu thut to hnh thm m hoc chuyn khoa phu thut thm m; + Phng khm chuyn khoa nam hc: L bc s chuyn khoa nam hc hoc bc s a khoa v c chng ch o to v chuyn khoa nam hc; + Phng khm, iu tr bnh ngh nghip: L bc s chuyn khoa bnh ngh nghip c chng ch hnh ngh hoc bc s a khoa c chng ch hnh ngh v chng ch o to v bnh ngh nghip; + Phng xt nghim: L bc s hoc k thut vin chuyn ngnh xt nghim, trnh  i hc tr ln c chng ch hnh ngh chuyn khoa xt nghim hoc c nhn ha hc, sinh hc, dc s) trnh  i hc i vi ngi  c tuyn dng lm chuyn ngnh xt nghim trc ngy Ngh nh ny c hiu lc v c cp chng ch hnh ngh chuyn khoa xt nghim vi chc danh l k thut vin; + Phng khm chn on hnh nh, Phng X-Quang: L bc s chuyn khoa chn on hnh nh hoc c nhn X-Quang trnh  i hc tr ln, c chng ch hnh ngh; - C thi gian hnh ngh khm bnh, cha bnh t nht l 36 thng sau khi c cp chng ch hnh ngh hoc c thi gian trc tip tham gia khm bnh, cha bnh t nht l 54 thng. Vic phn cng, b nhim ngi chu trch nhim chuyn mn k thut ca c s khm bnh, cha bnh phi c th hin bng vn bn; - L ngi hnh ngh c hu ti c s. b) Ngoi ngi chu trch nhim chuyn mn k thut ca c s khm bnh, cha bnh, cc i tng khc lm vic trong c s nu c thc hin vic khm bnh, cha bnh th phi c chng ch hnh ngh v ch c thc hin vic khm bnh, cha bnh trong phm vi cng vic c phn cng. Cn c vo phm vi hot ng chuyn mn, vn bng, chng ch, chng nhn o to v nng lc ca ngi hnh ngh, ngi chu trch nhim chuyn mn k thut ca c s khm bnh, cha bnh phn cng ngi hnh ngh c thc hin cc k thut chuyn mn bng vn bn; c) K thut vin xt nghim c trnh  i hc c c v k kt qu xt nghim. Trng hp c s khm bnh, cha bnh khng c bc s chuyn khoa xt nghim hoc k thut vin xt nghim c trnh  i hc th bc s ch nh xt nghim c v k kt qu xt nghim; d) C nhn X-Quang c trnh  i hc c c v m t hnh nh chn on. Trng hp c s khm bnh, cha bnh khng c bc s chuyn khoa chn on hnh nh hoc bc s X-Quang th bc s ch nh k thut chn on hnh nh c v k kt qu chn on hnh nh; ) Cc i tng khc tham gia vo qu trnh khm bnh, cha bnh nhng khng cn phi cp chng ch hnh ngh theo quy nh ca Lut khm bnh, cha bnh th c php thc hin cc hot ng theo phn cng ca ngi chu trch nhim chuyn mn k thut ca c s khm bnh, cha bnh (k s vt l y hc, k s x tr, m ng tr liu, tm l tr liu v cc i tng khc), vic phn cng phi ph hp vi vn bng chuyn mn ca ngi . 4. C s khm sc khe p ng cc iu kin sau: a) L c s khm, cha bnh  c cp giy php hot ng theo quy nh ca php lut; b) Phi c  cc b phn khm lm sng, cn lm sng, nhn lc v thit b y t cn thit  khm, pht hin c tnh trng sc khe theo tiu chun sc khe v mu phiu khm sc khe c ban hnh km theo cc vn bn hng dn khm sc khe theo quy nh ca php lut. 5. C s dch v thm m khng thuc loi hnh phi c giy php hot ng nhng phi c vn bn thng bo p ng  iu kin cung cp dch v thm m theo mu quy nh ti Ph lc VIII ban hnh km theo Ngh nh ny gi v S Y t ni t tr s trc khi hot ng t nht 10 ngy. Cc dch v thm m c s dng thuc, cc cht, thit b  can thip vo c th ngi (phu thut, th thut, cc can thip c tim, chch, bm, chiu tia, sng, t hoc cc can thip xm ln khc) lm thay i mu sc da, hnh dng, cn nng, khim khuyt ca cc b phn trn c th (da, mii, mt, mi, khun mt, ngc, bng, mng v cc b phn khc trn c th ngi), xm, phun, thu trn da c s dng thuc gy t dng tim ch c thc hin ti bnh vin c chuyn khoa thm m hoc phng khm chuyn khoa thm m hoc c s khm bnh, cha bnh c phm vi hot ng chuyn mn v chuyn khoa thm m ty theo phm vi hot ng chuyn mn c c quan c thm quyn ph duyt. 5. Sa i iu 23 nh sau:  iu 23. iu kin cp giy php hot ng i vi bnh vin Ngoi vic p ng cc iu kin quy nh ti iu 23a Ngh nh ny, bnh vin phi p ng thm cc iu kin sau: 1. Quy m bnh vin: a) Bnh vin a khoa phi c t nht l 30 ging bnh; b) Bnh vin chuyn khoa, bnh vin y hc c truyn phi c t nht 20 ging bnh; ring i vi bnh vin chuyn khoa mt, tm thn phi c t nht l 10 ging bnh. 2. C s vt cht: Ngoi vic p ng cc iu kin quy nh ti iu 23a Ngh nh ny, ty theo quy m bnh vin a khoa hoc chuyn khoa, bnh vin phi c thit k, xy dng p ng cc iu kin sau y: a) B tr cc khoa, phng, hnh lang bo m hot ng chuyn mn theo m hnh tp trung, lin hon, khp kn trong phm vi khun vin ca bnh vin; b) i vi bnh vin a khoa, bnh vin chuyn khoa bo m din tch sn xy dng t nht l 50 m2/ging bnh tr ln; chiu rng mt trc (mt tin) bnh vin phi t t nht l 10 m; c) C my pht in d phng; d) Bo m cc iu kin v x l cht thi y t theo quy nh ca php lut v mi trng. 3. Thit b y t: C  phng tin vn chuyn cp cu trong v ngoi bnh vin. Trng hp khng c phng tin cp cu ngoi bnh vin, phi c hp ng vi c s khm bnh, cha bnh  c cp giy php hot ng v c phm vi hot ng chuyn mn v cung cp dch v cp cu h tr vn chuyn ngi bnh. 4. T chc: a) Cc khoa: - C t nht 02 trong 04 khoa ni, ngoi, sn, nhi i vi bnh vin a khoa hoc mt khoa lm sng ph hp i vi bnh vin chuyn khoa; - Khoa khm bnh: C ni tip n ngi bnh, phng cp cu, lu bnh, phng khm, phng tiu phu (nu thc hin tiu phu); - Khoa cn lm sng: C t nht mt phng xt nghim v mt phng chn on hnh nh. Ring i vi bnh vin chuyn khoa mt nu khng c b phn chn on hnh nh th phi c hp ng h tr chuyn mn vi c s khm bnh, cha bnh  c cp giy php hot ng c b phn chn on hnh nh; - Khoa dc; - Cc khoa, phng chuyn mn khc trong bnh vin phi ph hp vi quy m, chc nng nhim v. b) C cc phng, b phn  thc hin cc chc nng v k hoch tng hp, t chc nhn s, qun l cht lng, iu dng, ti chnh k ton v cc chc nng cn thit khc. 5. Nhn s: a) S lng ngi hnh ngh lm vic ton thi gian (c hu) trong tng khoa phi t t l t nht l 50% trn tng s ngi hnh ngh trong khoa; b) Trng cc khoa chuyn mn ca bnh vin phi c chng ch hnh ngh ph hp vi chuyn khoa  v phi l ngi hnh ngh c hu ti bnh vin; c) Trng khoa khc khng thuc i tng cp chng ch hnh ngh phi c bng tt nghip i hc vi chuyn ngnh ph hp vi cng vic c giao v phi l ngi hnh ngh c hu ti bnh vin. 6. Sa i iu 24 nh sau:  iu 24. iu kin cp giy php hot ng i vi bnh x thuc lc lng Cng an nhn dn Ngoi vic p ng cc iu kin quy nh ti iu 23a Ngh nh ny, bnh x thuc lc lng Cng an nhn dn phi p ng thm cc iu kin sau: 1. Quy m: a) Bnh x phi c t nht l 10 ging bnh tr ln; b) C t nht 02 chuyn khoa ni, ngoi, bao gm phng cp cu; phng ngi bnh; b phn cn lm sng. 2. C s vt cht: C phng khm, phng cp cu, phng ngi bnh, phng xt nghim c din tch   trin khai cc phng tin, dng c phc v cho cng tc khm bnh, cha bnh. 7. Sa i iu 25 nh sau:  iu 25. iu kin cp giy php hot ng i vi phng khm a khoa Ngoi vic p ng cc iu kin quy nh ti iu 23a Ngh nh ny, phng khm a khoa phi p ng thm cc iu kin sau: 1. Quy m phng khm a khoa: a) C t nht 02 trong 04 chuyn khoa ni, ngoi, sn, nhi; b) C b phn cn lm sng (xt nghim v chn on hnh nh). 2. C s vt cht: C phng cp cu, phng lu ngi bnh, phng khm chuyn khoa v phng tiu phu (nu thc hin tiu phu). Cc phng khm trong phng khm a khoa phi c  din tch  thc hin k thut chuyn mn. 3. Thit b y t: C hp thuc chng sc v  thuc cp cu chuyn khoa. 4. Nhn s: S lng bc s khm bnh, cha bnh hnh ngh c hu phi t t l t nht l 50% trn tng s bc s hnh ngh khm bnh, cha bnh ca phng khm a khoa. Ngi ph trch cc phng khm chuyn khoa v b phn cn lm sng (xt nghim v chn on hnh nh) thuc Phng khm a khoa phi l ngi lm vic c hu ti phng khm. 8. Sa i iu 26 nh sau:  iu 26. iu kin cp giy php hot ng i vi phng khm chuyn khoa Ngoi vic p ng cc iu kin quy nh ti iu 23a Ngh nh ny, tr iu kin v ngi chu trch nhim chuyn mn k thut, phng khm chuyn khoa phi p ng thm cc iu kin sau: 1. C s vt cht: a) Trng hp thc hin th thut, bao gm c k thut cy ghp rng (implant), chm cu, xoa bp day n huyt th phi c phng hoc khu vc ring dnh cho vic thc hin th thut. Phng hoc khu vc thc hin th thut phi c  din tch  thc hin k thut chuyn mn; b) Trng hp phng khm chuyn khoa thc hin c hai k thut ni soi tiu ha trn v ni soi tiu ha di th phi c 02 phng ring bit; c) Trng hp khm iu tr bnh ngh nghip phi c b phn xt nghim sinh ha. 2. Thit b y t: C hp thuc chng sc v  thuc cp cu chuyn khoa. 9. Sa i iu 30 nh sau:  iu 30. iu kin cp giy php hot ng i vi nh h sinh 1. Ngoi vic p ng cc iu kin quy nh ti iu 23a Ngh nh ny, nh h sinh phi p ng thm cc iu kin sau: a) C s vt cht: - Cc phng chc nng phi c thit k lin hon, hp l  thun tin cp cu, khm bnh, cha bnh; - C cc phng khm thai, khm ph khoa, phng nm ca sn ph. Cc phng ny phi  c din tch  thc hin k thut chuyn mn. b) Thit b y t: - C  phng tin vn chuyn cp cu trong v ngoi nh h sinh. Trng hp khng c phng tin cp cu ngoi nh h sinh th phi c hp ng vi c s khm bnh, cha bnh  c cp giy php hot ng v c php cung cp dch v cp cu, h tr vn chuyn ngi bnh; - C hp thuc chng sc v  thuc cp cu chuyn khoa. 2. Ngi chu trch nhim chuyn mn k thut ca nh h sinh phi p ng cc iu kin sau y: a) L bc s chuyn khoa sn ph khoa hoc h sinh vin trnh  i hc tr ln c chng ch hnh ngh; - C thi gian hnh ngh khm bnh, cha bnh v sn ph khoa t nht l 36 thng sau khi c cp chng ch hnh ngh hoc c thi gian trc tip tham gia khm bnh, cha bnh t nht l 54 thng. Vic phn cng, b nhim ngi chu trch nhim chuyn mn k thut ca nh h sinh phi c th hin bng vn bn. 3. Trng hp nh h sinh c  iu kin cung cp dch v khm bnh, cha bnh chuyn khoa nhi theo quy nh ti iu 27 Ngh nh ny hoc tim chng vc-xin theo quy nh ca php lut v tim chng th c b sung vo quy m, phm vi hot ng chuyn mn ca nh h sinh. 10. B sung iu 33a nh sau:  iu 33. iu kin cp giy php hot ng i vi c s dch v y t 1. C s vt cht: p ng cc iu kin quy nh ti im a khon 1 iu 23a Ngh nh ny. - Ring c s dch v y t nu cung cp dch v knh thuc th phi c din tch ti thiu l 15 m2. - Phng tim (chch), thay bng phi c din tch t nht l 10 m2. 2. Thit b y t: Ngoi vic p ng cc iu kin quy nh ti im a khon 2 iu 23a Ngh nh ny, c s dch v y t nu cung cp dch v: a) Tim (chch), thay bng, m mch, o nhit , o huyt p th phi c hp thuc chng sc; b) Vn chuyn cp cu phi c xe t cu thng; c hp thuc chng sc v  thuc cp cu. C hp ng vn chuyn cp cu vi cng ty dch v hng khng nu c s ng k vn chuyn ngi bnh ra nc ngoi. 3. Nhn s: Ngoi vic p ng cc iu kin quy nh ti iu 23a Ngh nh ny, tr iu kin v ngi chu trch nhim chuyn mn k thut, c s dch v y t nu cung cp dch v: a) Vn chuyn cp cu th ngi chu trch nhim chuyn mn k thut phi p ng cc iu kin sau: - L bc s c chng ch hnh ngh. - C vn bng chuyn mn hoc chng ch hoc giy chng nhn  c hc v chuyn ngnh hi sc cp cu. b) Tim (chch), thay bng, m mch, o nhit , o huyt p; dch v chm sc sc khe ti nh th ngi chu trch nhim chuyn mn k thut phi l ngi tt nghip trung cp y tr ln c chng ch hnh ngh v c thi gian khm bnh, cha bnh v tim (chch), thay bng, m mch, o nhit , o huyt p t nht l 45 thng; c) Knh thuc th ngi chu trch nhim chuyn mn k thut phi l ngi tt nghip trung cp y tr ln, c chng ch hnh ngh v c chng ch o to v chuyn khoa mt hoc o kim, chn on tt khc x mt; d) Thm m th ngi thc hin xm, phun, thu trn da khng s dng thuc gy t dng tim ti c s dch v thm m phi c giy chng nhn hoc chng ch o to, dy ngh v phun, xm, thu trn da do c s o to hoc dy ngh hp php cp; ) Cc c s dch v chm sc sc khe ti nh cung cp cc dch v nh thay bng, ct ch; vt l tr liu, phc hi chc nng; chm sc m v b; ly mu xt nghim, tr kt qu; chm sc ngi bnh ung th v cc dch v iu dng khc ti nh, ngi chu trch nhim chuyn mn k thut i vi c s dch v chm sc sc khe ti nh phi l ngi tt nghip trung cp y tr ln c chng ch hnh ngh v c thi gian khm bnh, cha bnh t nht l 45 thng . 11. B sung iu 45b nh sau:  iu 45b. Cp, cp li, thu hi giy chng nhn ngi s hu bi thuc gia truyn v phng php cha bnh gia truyn 1. H s  ngh cp, cp li Giy chng nhn ngi s hu bi thuc gia truyn v phng php cha bnh gia truyn (sau y gi tt l Giy chng nhn): a) H s cp mi: - n  ngh cp Giy chng nhn theo Mu s 01 Ph lc XV ban hnh km theo Ngh nh ny; - Bn thuyt minh v bi thuc gia truyn, phng php cha bnh gia truyn theo Mu s 02 Ph lc XV ban hnh km theo Ngh nh ny; - Giy chng nhn sc khe trong thi gian khng qu 06 thng tnh n ngy np n theo mu quy nh; - Hai nh 4 x 6 cm, nh mu, nn trng, trong thi gian khng qu 06 thng tnh n ngy np n. b) H s  ngh cp li Giy chng nhn do b mt, b hng hay b thu hi: - n  ngh cp li Giy chng nhn theo Mu s 04 Ph lc XV ban hnh km theo Ngh nh ny; - Giy chng nhn sc khe trong thi gian khng qu 06 thng tnh n ngy np n; - 02 nh 4 x 6 cm, nh mu, nn trng, trong thi gian khng qu 06 thng tnh n ngy np n. 2. Th tc cp mi Giy chng nhn ngi s hu bi thuc gia truyn v phng php cha bnh gia truyn: a) Ngi  ngh cp mi Giy chng nhn ngi c bi thuc gia truyn, phng php cha bnh gia truyn gi 01 b h s theo quy nh v S Y t ni c tr. Sau khi tip nhn h s, S Y t cp cho ngi  ngh Phiu tip nhn h s  ngh cp, cp li giy chng nhn ngi c bi thuc gia truyn hoc phng php cha bnh gia truyn theo Mu s 05 Ph lc XV ban hnh km theo Ngh nh ny; b) Trng hp c yu cu sa i, b sung h s, trong thi gian 05 ngy lm vic, k t ngy ghi trn phiu tip nhn h s, S Y t ni tip nhn h s c trch nhim gi vn bn thng bo cho ngi  ngh cp Giy chng nhn  sa i, b sung h s. Trong thi gian 60 ngy, k t ngy S Y t c vn bn yu cu sa i, b sung h s m ngi  ngh cp Giy chng nhn khng sa i, b sung h s th h s  ngh cp Giy chng nhn khng cn gi tr. Ngi  ngh phi np h s mi  c cp Giy chng nhn nu c nhu cu. c) Trng hp khng c yu cu sa i, b sung h s, trong thi gian 10 ngy lm vic, k t ngy nhn ghi trn phiu tip nhn h s, S Y t ni tip nhn h s c trch nhim gi h s n Hi ng y tnh, thnh ph trc thuc trung ng ni ngi  c tr  xin kin; c) Trong thi gian 30 ngy, k t ngy nhn c vn bn ca S Y t, Hi ng y tnh c trch nhim gi vn bn tr li theo Mu s 03 Ph lc XV ban hnh km theo Ngh nh ny; d) Sau khi nhn c vn bn tr li ca Hi ng y tnh, thnh ph trc thuc trung ng, S Y t c trch nhim t chc hp Hi ng  thm nh; ) Trong thi hn 10 ngy lm vic k t ngy c bin bn hp Hi ng thm nh, S Y t cp Giy chng nhn theo Mu s 06 Ph lc XV ban hnh km theo Ngh nh ny hoc ban hnh vn bn v vic t chi cp Giy chng nhn v nu r l do t chi. 3. Gim c S Y t tnh cp, cp li, thu hi Giy chng nhn ngi c bi thuc gia truyn, phng php cha bnh gia truyn. 4. Cc trng hp thu hi Giy chng nhn: a) Giy chng nhn c cp khng ng thm quyn; b) Giy chng nhn c ni dung tri php lut; c) C kt lun ca Hi ng chuyn mn ca S Y t thnh lp v vic ngi c cp Giy chng nhn c sai st chuyn mn gy hu qu nghim trng n sc kho v tnh mng ngi bnh; d) Ngi c cp Giy chng nhn thuc mt trong cc i tng quy nh ti khon 4 iu 18 ca Lut khm bnh, cha bnh. 12. B sung khon 5 iu 50 nh sau:  Phng khm a khoa khu vc c iu tr ni tr ch p dng i vi cc phng khm a khoa khu vc c iu tr ni tr  c thnh lp v hot ng trc ngy Ngh nh ny c hiu lc, ti cc khu vc min ni, vng su, vng xa, c y ban nhn dn tnh, thnh ph v S Y t cho php bng vn bn. Chng VI L(NH VC M PHM iu 12. Bi b mt s vn bn, quy nh thuc l)nh vc m phm 1. Bi b cc quy nh sau y ca Ngh nh s 93/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh iu kin sn xut m phm: a) Khon 1 iu 3. b) im c v e khon 3 iu 4. c) im d khon 1 iu 7. d) im b khon 2 iu 7. 2. Bi b mt s quy nh ca Thng t s 06/2011/TT-BYT ngy 25 thng 01 nm 2011 ca B Y t quy nh v qun l m phm: a) Khon 2 iu 4. b) im b, d v g khon 1 iu 34. c) Khon 1 iu 35. iu 13. Sa i im a khon 3 iu 4 ca Ngh nh s 93/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh iu kin sn xut m phm  a) Nguyn liu, ph liu, bn thnh phm dng trong sn xut m phm phi t tiu chun cht lng ca nh sn xut. Chng VII L(NH VC PHNG, CHNG BNH TRUYN NHIM iu 14. Bi b mt s quy nh thuc l)nh vc phng, chng bnh truyn nhim 1. Bi b mt s quy nh ca Ngh nh s 103/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh v bo m an ton sinh hc ti phng xt nghim: a) iu 2. b) im d khon 1 iu 4. c) im a, c, d,  v e khon 1 iu 5. d) im b v c khon 2 iu 5. ) im b, d khon 3 iu 5. e) im b, c, , e v g khon 4 iu 5. g) im c khon 2 iu 6. h) im b khon 4 iu 6. i) im  khon 1 iu 7. k) im c khon 2 iu 7. l) iu 8. m) im d, e, h khon 1 iu 11. n) im b khon 4 iu 11. 2. Bi b mt s quy nh ca Ngh nh s 104/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh v hot ng tim chng: a) im c khon 1 iu 8. b) im b, c, d,  v e khon 1 iu 9. c) im b v d khon 2 iu 9. d) im b khon 1 iu 10. 3. Bi b Thng t s 43/2011/TT-BYT ngy 05 thng 12 nm 2011 ca B Y t quy nh ch  qun l mu bnh phm bnh truyn nhim. iu 15. Sa i, b sung mt s quy nh thuc l)nh vc phng, chng bnh truyn nhim 1. Sa i mt s iu ca Ngh nh s 103/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh v bo m an ton sinh hc ti phng xt nghim: a) im d khon 1 iu 4 c sa i nh sau:  d) C s quy nh ti cc im a, b, c khon ny c php bo qun, lu gi, s dng, nghin cu, trao i v tiu hy mu mu, huyt thanh, huyt tng, nc tiu, phn, dch tit c th ngi, cc mu khc t ngi c cha hoc c kh nng cha tc nhn gy bnh truyn nhim cho ngi, cc chng vi sinh vt, mu c cha vi sinh vt c kh nng gy bnh cho ngi nu c cc trang thit b bo qun mu bnh phm v cc quy nh v thc hnh chun lin quan n vic lu gi, s dng, nghin cu, trao i v tiu hy mu bnh phm. b) im b khon 1 iu 5 nh sau:  b) C dng c ra mt khn cp, hp s cu. c) Khon 1 iu 9 c sa i nh sau:  1. C s xt nghim an ton sinh hc cp I, cp II, cp III phi tun th cc iu kin v c s vt cht, trang thit b, nhn s v thc hnh; bo tr, bo dng, hiu chun thit b xt nghim; gim st vic thc hnh trong xt nghim. d) Khon 1 iu 10 c sa i nh sau:  1. B trng B Y t thm nh, cp mi, cp li v thu hi Giy chng nhn c s xt nghim t tiu chun an ton sinh hc i vi cc c s xt nghim cp III (sau y gi tt l Giy chng nhn an ton sinh hc), tr cc c s xt nghim thuc thm quyn qun l ca B Quc phng. ) im b khon 1 iu 11 c sa i nh sau:  b) Bn k khai nhn s theo Mu s 03 ti Ph lc ban hnh km theo Ngh nh ny. e) im c,  khon 2 iu 11 c sa i nh sau:  c) Bo co v cc thay i lin quan n nhn s (nu c).  ) Bo co v cc thay i lin quan n c s vt cht. g) Khon 1 iu 17 c sa i nh sau;  1. B Y t kim tra nh k hoc t xut tin hnh thanh tra cc c s xt nghim  c cp Giy chng nhn an ton sinh hc cp III v cc c s xt nghim  t cng b t tiu chun an ton sinh hc cp I, cp II trn phm vi ton quc. h) Khon 2 iu 19 c sa i nh sau:  2. Hng nm, c s xt nghim an ton sinh hc cp III phi t chc din tp phng nga v khc phc s c an ton sinh hc theo quy nh ca B trng B Y t. i) Khon 4 iu 20 c sa i nh sau:  4. Trng hp s c xy ra ti c s xt nghim an ton sinh hc cp II, v cp III lan truyn rng, nh hng ln n cng ng dn c hoc an ninh quc gia th vic x l, khc phc s c thc hin theo quy nh ti Mc 2 Chng IV ca Lut phng, chng bnh truyn nhim. 2. Sa i, b sung iu 36 Ngh nh s 89/2018/N-CP ngy 25 thng 6 nm 2018 ca Chnh ph quy nh chi tit thi hnh mt s iu ca Lut phng, chng bnh truyn nhim v kim dch y t bin gii nh sau:  1. Kim dch vin y t thu thp: a) Giy khai bo y t i vi sn phm sinh hc, m, b phn c th ngi nhp khu nhm mc ch d phng, nghin cu, chn on, cha bnh; b) Giy khai bo y t v giy php nhp khu ca B Y t i vi mu mu, huyt thanh, huyt tng, nc tiu, phn, dch tit c th ngi, cc mu khc t ngi c cha hoc c kh nng cha tc nhn gy bnh truyn nhim cho ngi, cc chng vi sinh vt, mu c cha vi sinh vt c kh nng gy bnh cho ngi nhp khu nhm mc ch d phng, nghin cu, chn on, cha bnh. 2. H s  ngh nhp khu bao gm: a) Vn bn  ngh cp giy php nhp khu theo Mu s 25 quy nh ti Ph lc ban hnh km theo Ngh nh ny; b) Bn sao quyt nh ph duyt ca c quan c thm quyn cho php thc hin  ti hoc d n nghin cu cn hiu lc hoc bn sao  cng  ti hoc vn kin d n  c ph duyt hoc bn sao vn bn tha thun cn hiu lc hoc ti liu c lin quan gia cc c s trong nc v nc ngoi v vic nhp khu mu bnh phm; c) Bn sao bn t cng b t tiu chun an ton sinh hc i vi c s xt nghim an ton sinh hc cp I, II hoc Giy chng nhn c s xt nghim t an ton sinh hc i vi c s xt nghim an ton sinh hc cp III. 3. Th tc cp php nhp khu: a) C s  ngh cp php nhp khu np h s trc tip hoc gi qua ng bu in v B Y t; b) Trng hp khng c yu cu sa i, b sung h s, B Y t cp php nhp khu trong thi hn 15 ngy k t ngy ghi trn phiu tip nhn h s; c) Trng hp c yu cu sa i, b sung h s, B Y t gi vn bn cho c s  yu cu sa i, b sung h s trong thi hn 10 ngy k t ngy ghi trn phiu tip nhn h s; d) Trong thi hn 30 ngy, k t ngy B Y t c vn bn thng bo sa i, b sung, c s  ngh cp php nhp khu phi np h s sa i, b sung theo yu cu. Sau thi hn trn, c s khng sa i, b sung h s th phi thc hin li t u th tc nhp khu mu bnh phm; ) Trng hp h s sa i, b sung khng p ng yu cu, B Y t c vn bn thng bo cho c s theo quy nh ti im c khon ny. Trng hp khng c yu cu sa i, b sung i vi h s sa i, b sung, B Y t cp php nhp khu theo quy nh ti im b khon ny. 3. Sa i mt s iu ca Ngh nh s 104/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh v hot ng tim chng: a) im d khon 1 iu 8 c sa i nh sau:  d) C thit b theo di nhit  ca vc xin trong qu trnh vn chuyn, bo qun, s dng v ghi chp y  khi vn chuyn, giao hng. Ti c s bo qun vc xin phi theo di nhit  ti thiu 02 ln/ngy. b) im a khon 1 iu 9 c sa i nh sau:  a) Khu vc tim chng phi bo m che c ma, nng, kn gi, thng thong v b tr theo nguyn tc mt chiu t n tip, hng dn, t vn, khm sng lc, thc hin tim chng, theo di v x tr phn ng sau tim chng. c) im b khon 3 iu 9 c sa i nh sau:  b) Nhn vin y t tham gia hot ng tim chng phi c tp hun chuyn mn v tim chng. Nhn vin trc tip khm sng lc, t vn, theo di, x tr phn ng sau tim chng phi c trnh  chuyn mn t y s tr ln; nhn vin thc hnh tim chng c trnh  t trung cp Y hc hoc trung cp iu dng - H sinh tr ln. d) im c khon 1 iu 10 c sa i nh sau:  c) C phch vc xin v hp chng sc theo quy nh ca B trng Y t. ) im b khon 2 iu 10 c sa i nh sau:  b) C s vt cht: B tr theo nguyn tc mt chiu t n tip, hng dn, t vn, khm sng lc, thc hin tim chng, theo di v x tr phn ng sau tim chng. e) im c khon 2 iu 10 c sa i nh sau:  c) Trang thit b: C phch vc xin hoc hm lnh v hp chng sc theo quy nh ca B trng Y t. g) im d khon 2 iu 10 c sa i nh sau:  d) Nhn s: C ti thiu 02 nhn vin chuyn ngnh y p ng iu kin quy nh ti im b khon 3 iu 9 Ngh nh ny. h) Khon 2 iu 11 c sa i nh sau:  2. Trong thi hn 03 ngy lm vic, k t ngy nhn c thng bo  iu kin tim chng, S Y t phi ng ti thng tin v tn, a ch, ngi ng u c s  cng b  iu kin tim chng trn Trang thng tin in t ca S Y t (thi im tnh ngy phi cng b thng tin c xc nh theo du cng vn n ca S Y t). Chng VIII L(NH VC PHNG, CHNG HIV/AIDS iu 16. Bi b mt s quy nh thuc l)nh vc phng, chng HIV/AIDS 1. Bi b cc quy nh sau y ca Ngh nh s 75/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh iu kin thc hin xt nghim HIV: a) iu 3. b) im b khon 1 iu 5. c) im b khon 2 iu 5. 2. Bi b cc quy nh sau y ca Ngh nh s 90/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh v iu tr nghin cc cht dng thuc phin bng thuc thay th: a) im b, c v d khon 1 iu 12. b) Tit 6, 7 im a khon 2 iu 12. c) Ni dung  S lng nhn vin lm vic ton thi gian phi t t l t 75% tr ln trn tng s nhn vin ca c s iu tr thay th quy nh ti im h khon 3 iu 12. d) im b khon 1 iu 13. 3. Bi b Thng t s 15/2013/TT-BYT ngy 24 thng 5 nm 2013 hng dn bo m cht lng thc hin k thut xt nghim HIV. iu 17. Sa i, b sung mt s iu ca Ngh nh s 75/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph quy nh iu kin thc hin xt nghim HIV 1. iu 4 c sa i nh sau:  1. Xt nghim sng lc HIV do c s y t cung cp: a) Nhn s: C nhn vin xt nghim p ng cc iu kin sau: - C trnh  chuyn mn t trung hc chuyn nghip tr ln thuc mt trong cc chuyn ngnh sau: Y, dc, sinh hc, ha hc; -  c tp hun v k thut xt nghim HIV; b) C trang thit b xt nghim v bo qun sinh phm, mu bnh phm ph hp vi k thut xt nghim HIV m c s  thc hin; c) C s vt cht: C a im c nh. 2. Xt nghim sng lc HIV ti cng ng: a) Ngi lm xt nghim c kin thc v t vn, xt nghim HIV v thc hin xt nghim HIV theo hng dn ca nh sn xut; b) C dng c xt nghim, bo qun sinh phm ph hp vi loi sinh phm xt nghim HIV c s dng. 2. im a khon 1 iu 5 c sa i nh sau:  Nhn vin ph trch chuyn mn phi c trnh  i hc tr ln chuyn ngnh y, dc, sinh hc hoc ha hc, c kinh nghim v xt nghim HIV t 06 thng tr ln. 3. Khon 3 iu 5 c sa i nh sau:  3. C s vt cht bo m ti thiu cc iu kin sau: a) Khu vc thc hin xt nghim s dng cc vt liu khng thm nc, chu c nhit v cc loi ha cht n mn. Bo m nh sng, thong, sch, trnh bi, chng m v c nc sch; b) Bn xt nghim d lm sch bng cc cht ty ra thng thng, c t  v tr  nh sng v trnh lung gi; c) C ch ra tay; d) C phng tin hoc bin php x l cht thi trc khi chuyn vo ni cha cht thi chung. 4. im c khon 4 iu 5 c sa i nh sau:  c) C kt qu thc hin xt nghim chnh xc trn b mu kim chun ca c s xt nghim HIV c B Y t cng nhn. Chng IX L(NH VC SC KHE SINH SN iu 18. Bi b mt s quy nh thuc l)nh vc sc khe sinh sn 1. Bi b iu 7 Ngh nh s 88/2008/N-CP ngy 05 thng 8 nm 2008 ca Chnh ph v xc nh li gii tnh. 2. Bi b khon 1 iu 1 Ngh nh s 98/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph ban hnh sa i, b sung mt s iu ca Ngh nh s 10/2015/N-CP ngy 28 thng 01 nm 2015 ca Chnh ph quy nh v sinh con bng k thut th tinh trong ng nghim v iu kin mang thai h v mc ch nhn o. 3. Bi b Thng t s 29/2010/TT-BYT ngy 24 thng 5 nm 2010 hng dn thi hnh mt s iu Ngh nh s 88/2008/N-CP ngy 05 thng 8 nm 2008 ca Chnh ph v xc nh li gii tnh. iu 19. Sa i, b sung mt s quy nh thuc l)nh vc sc khe sinh sn 1. Sa i, b sung Ngh nh s 88/2008/N-CP ngy 05 thng 8 nm 2008 ca Chnh ph v xc nh li gii tnh nh sau: a) iu 8 c sa i nh sau:  iu 8. iu kin i vi c s khm bnh, cha bnh c php can thip y t  xc nh li gii tnh Bnh vin c thc hin can thip y t  xc nh li gii tnh khi p ng cc iu kin sau: 1. L bnh vin cng lp a khoa, chuyn khoa ngoi, sn, nhi tuyn tnh, tuyn trung ng hoc bnh vin t nhn c khoa ngoi v khoa sn hoc khoa nhi. 2. c cp c thm quyn ph duyt phm vi hot ng chuyn mn v can thip y t  xc nh li gii tnh. b) iu 10 c sa i nh sau:  C s khm bnh, cha bnh  thc hin vic can thip y t xc nh li gii tnh cp giy chng nhn y t cho cho ngi  c xc nh li gii tnh theo mu ca c s khm bnh, cha bnh. 2. Sa i, b sung Ngh nh s 10/2015/N-CP ngy 28 thng 01 nm 2015 ca Chnh ph quy nh v sinh con bng k thut th tinh trong ng nghim v iu kin mang thai h v mc ch nhn o nh sau: a) Khon 2 iu 7 c sa i nh sau:  2. C s vt cht, trang thit b y t v nhn s  thc hin k thut th tinh trong ng nghim bao gm: a) C s vt cht: - C phng hi sc cp cu; - C xt nghim ni tit sinh sn; - C n nguyn ring cho vic thc hin k thut th tinh trong ng nghim gm cc phng: Chc ht non; ly tinh trng; lab nui cy; xt nghim v lc ra tinh trng p ng cc tiu chun theo khuyn co ca T chc Y t th gii. b) Trang thit b y t: C ti thiu cc trang thit b y t: 02 t cy CO2; 02 t m; 01 bnh tr tinh trng; 01 my ly tm; 01 bnh tr phi ng lnh; 01 my siu m c u d m o; 01 knh hin vi o ngc; 02 knh hin vi soi ni; 01 b t thao tc. c) Nhn s: Nhn s trc tip thc hin k thut th tinh trong ng nghim phi p ng cc yu cu sau y: - C t nht 02 bc s c o to v k thut th tinh trong ng nghim v 02 cn b c trnh  i hc y, dc hoc sinh hc c o to v phi hc lm sng; - 02 bc s) lm sng phi c chng ch hnh ngh theo quy nh ca Lut khm bnh, cha bnh; - Cc nhn s phi c vn bng, chng ch hoc chng nhn  c o to v k thut th tinh trong ng nghim do c s o to trong nc hoc nc ngoi cp; - Cc nhn s phi c xc nhn  thc hnh t nht 20 chu k iu tr v sinh bng k thut th tinh trong ng nghim do c s  c B Y t cng nhn  iu kin thc hin k thut th tinh trong ng nghim cp. b) Sa i Mu s 02 - Bin bn Thm nh c s c thc hin k thut th tinh trong ng nghim, lu gi tinh trng, lu gi phi km theo Ngh nh s 10/2015/N-CP ngy 28 thng 01 nm 2015 ca Chnh ph quy nh v sinh con bng k thut th tinh trong ng nghim v iu kin mang thai h v mc ch nhn o. Chng X IU KHON THI HNH iu 20. Hiu lc thi hnh Ngh nh ny c hiu lc thi hnh t ngy k ban hnh. iu 21. iu khon chuyn tip 1. iu khon chuyn tip i vi Ngh nh s 89/2018/N-CP: a) i vi n v  c cp php xut, nhp khu mu bnh phm trc ngy Ngh nh ny c hiu lc thi hnh c thc hin vic nhp khu mu bnh phm theo cc ni dung  ghi trong giy php; b) i vi n v  ngh cp php xut, nhp khu mu bnh phm  np h s trc ngy Ngh nh ny c hiu lc thi hnh nhng cha c cp giy php th thc hin vic nhp khu mu bnh phm theo quy nh ti Ngh nh ny. 2. iu khon chuyn tip i vi Ngh nh s 103/2016/N-CP: a) Cc c s xt nghim  c cp giy chng nhn phi tip tc duy tr cc iu kin theo quy nh trong thi hn hiu lc ca giy chng nhn v thc hin vic t cng b hoc cp li giy chng nhn trc khi giy chng nhn ht hiu lc theo quy nh ti Ngh nh s 103/2016/N-CP v Ngh nh ny; b) Cc c s xt nghim  thc hin vic t cng b c s xt nghim t tiu chun an ton sinh hc phi tip tc duy tr cc iu kin theo quy nh ti Ngh nh s 103/2016/N-CP v Ngh nh ny; c) Cc c s xt nghim hot ng xy dng mi hoc ci to sau ngy Ngh nh ny c hiu lc phi p ng ng cc iu kin v an ton sinh hc ph hp vi tng cp  theo quy nh ti Ngh nh s 103/2016/N-CP v Ngh nh ny. 3. iu khon chuyn tip i vi Ngh nh s 104/2016/N-CP: a) C s tim chng  c cp giy chng nhn c s  iu kin tim chng phi tip tc duy tr cc iu kin theo quy nh trong thi hn hiu lc ca giy chng nhn v hon thnh vic t cng b c s  iu kin tim chng trc khi giy chng nhn ht hiu lc theo quy nh ti Ngh nh s 104/2016/N-CP v Ngh nh ny; b) i vi c s tim chng  cng b c s  iu kin tim chng phi tip tc duy tr cc iu kin theo quy nh ti Ngh nh s 104/2016/N-CP v Ngh nh ny; c) i vi c s tim chng hot ng sau ngy Ngh nh ny c hiu lc phi p ng cc iu kin theo quy nh ti Ngh nh s 104/2016/N-CP v Ngh nh ny. 4. iu khon chuyn tip i vi Ngh nh s 54/2017/N-CP: a) Cc h s  ngh cp chng ch hnh ngh hoc cp giy chng nhn  iu kin kinh doanh dc hoc cp php xut khu, nhp khu thuc, nguyn liu lm thuc theo quy nh ti Ngh nh s 54/2017/N-CP  np trc ngy Ngh nh ny c hiu lc thi hnh c thc hin theo quy nh ca Ngh nh s 54/2017/N-CP; b) Cc nguyn liu lm thuc  sn xut thuc theo h s ng k thuc  c giy ng k lu hnh thuc  c cng b trc ngy Ngh nh ny c hiu lc tip tc c php nhp khu n ht thi hn hiu lc ca giy ng k lu hnh thuc; c) Cc thuc  c cc c s bn l thuc trong khun vin c s khm bnh, cha bnh mua vo trc ngy Ngh nh ny c hiu lc c thc hin theo quy nh ti Ngh nh s 54/2017/N-CP. 5. iu khon chuyn tip i vi Ngh nh s 109/2016/N-CP: Cc h s  ngh cp chng ch hnh ngh hoc cp giy php hot ng trc thi im Ngh nh ny c hiu lc th p dng theo quy nh ca Ngh nh s 109/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph. iu 22. Trch nhim thi hnh Cc B trng, Th trng c quan ngang b, Th trng c quan thuc Chnh ph, Ch tch y ban nhn dn tnh, thnh ph trc thuc trung ng chu trch nhim thi hnh Ngh nh ny./. Ni nhn: - Ban B th Trung ng ng; - Th tng, cc Ph Th tng Chnh ph; - Cc b, c quan ngang b, c quan thuc Chnh ph; - HND, UBND cc tnh, thnh ph trc thuc trung ng; - Vn phng Trung ng v cc Ban ca ng; - Vn phng Tng B th; - Vn phng Ch tch nc; - Hi ng dn tc v cc y ban ca Quc hi; - Vn phng Quc hi; - Ta n nhn dn ti cao; - Vin kim st nhn dn ti cao; - Kim ton nh nc; - y ban Gim st ti chnh Quc gia; - Ngn hng Chnh sch x hi; - Ngn hng Pht trin Vit Nam; - y ban trung ng Mt trn T quc Vit Nam; - C quan trung ng ca cc on th; - VPCP: BTCN, cc PCN, Tr l TTg, TG Cng TTT, cc V, Cc, n v trc thuc, Cng bo; - Lu: VT, KGVX (2b). PC.TM. 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vc, nguyn liu c lm thucMu s 15 Ph lc IIIn hng nhp khu vc xin/sinh phm/thuc ha dc cha c giy ng k lu hnh thuc ti Vit Nam, tr thuc gy nghin, thuc hng thn, thuc tin cht, thuc dng phi hp c cha dc cht gy nghin, thuc dng phi hp c cha dc cht hng thn, thuc dng phi hp c cha tin chtMu s 16 Ph lc IIIn hng nhp khu thuc gy nghin/thuc hng thn/thuc tin cht/thuc dng phi hp c cha dc cht gy nghin/thuc dng phi hp c cha dc cht hng thn/thuc dng phi hp c cha tin cht cha c giy ng k lu hnh thuc ti Vit NamMu s 17 Ph lc IIIn hng nhp khu thuc dc liu/thuc c truyn cha c giy ng k lu hnh thuc ti Vit NamMu s 18 Ph lc IIIBo co kt qu kinh doanh thuc gy nghin/thuc hng thn/thuc tin cht/thuc phng x/thuc dng phi hp c cha dc cht gy nghin/thuc dng phi hp c cha dc cht hng thn/thuc dng phi hp c cha tin cht/thuc trong danh mc thuc, dc cht thuc danh mc cht b cm trong mt s ngnh, l)nh vcMu s 19 Ph lc IIIDanh mc vc xin/sinh phm/thuc ha dc cha c giy ng k lu hnh thuc ti Vit Nam  ngh nhp khu p ng nhu cu iu tr c bit, tr thuc gy nghin, thuc hng thn, thuc tin cht, thuc dng phi hp c cha dc cht gy nghin, thuc dng phi hp c cha dc cht hng thn, thuc dng phi hp c cha tin chtMu s 20 Ph lc IIIDanh mc thuc gy nghin, thuc hng thn, thuc tin cht, thuc dng phi hp c cha dc cht gy nghin, thuc dng phi hp c cha dc cht hng thn, thuc dng phi hp c cha tin cht cha c giy ng k lu hnh thuc ti Vit Nam  ngh nhp khu p ng nhu cu iu tr c bitMu s 21 Ph lc IIIDanh mc thuc dc liu/thuc c truyn cha c giy ng k lu hnh thuc ti Vit Nam  ngh nhp khu p ng nhu cu iu tr c bitMu s 22 Ph lc IIIBo co v vic s dng thuc nhp khu p ng nhu cu iu tr c bitMu s 23 Ph lc IIIBn cam kt ca c s sn xut/c s s hu giy php sn phm v vic m bo cht lng vc xin, sinh phm nhp khu vo Vit NamMu s 24 Ph lc IIIn hng nhp khu vc xin/sinh phm/thuc ha dc cha c giy ng k lu hnh thuc ti Vit Nam  vin tr, vin tr nhn o, tr thuc gy nghin, thuc hng thn, thuc tin cht, thuc dng phi hp c cha dc cht gy nghin, thuc dng phi hp c cha dc cht hng thn, thuc dng phi hp c cha tin chtMu s 25 Ph lc IIIn hng nhp khu thuc gy nghin, thuc hng thn, thuc tin cht, thuc dng phi hp c cha dc cht gy nghin, thuc dng phi hp c cha dc cht hng thn, thuc dng phi hp c cha tin cht cha c giy ng k lu hnh thuc ti Vit Nam  vin tr, vin tr nhn oMu s 26 Ph lc IIIn hng nhp khu thuc dc liu/thuc c truyn cha c giy ng k lu hnh thuc ti Vit Nam  vin tr, vin tr nhn oMu s 27 Ph lc IIIn  ngh nhp khu thuc cha c giy ng k lu hnh thuc ti Vit Nam khng v mc ch thng miMu s 30 Ph lc IIIMu Cng vn cho php nhp khu thuc dng phi hp c cha dc cht gy nghin, thuc dng phi hp c cha dc cht hng thn, thuc dng phi hp c cha tin chtMu s 33 Ph lc IIIn hng nhp khu thuc gy nghin, thuc hng thn, thuc tin cht, thuc dng phi hp c cha dc cht gy nghin, thuc dng phi hp c cha dc cht hng thn, thuc dng phi hp c cha tin cht c giy ng k lu hnh thuc ti Vit NamMu s 34 Ph lc IIIn hng nhp khu thuc phng x, thuc c, thuc trong danh mc thuc, dc cht thuc danh mc cht cm s dng trong mt s ngnh, l)nh vc c giy ng k lu hnh ti Vit NamMu s 35 Ph lc IIIn hng nhp khu nguyn liu lm thuc l dc cht gy nghin, dc cht hng thn, tin cht dng lm thucMu s 36 Ph lc IIIn hng nhp khu nguyn liu lm thuc l dc cht, bn thnh phm thuc, tr dc cht gy nghin, dc cht hng thn, tin cht dng lm thucMu s 37 Ph lc IIIBo co s dng nguyn liu lm thuc l dc cht gy nghin, dc cht hng thn, tin cht dng lm thuc, dc cht trong danh mc thuc, dc cht thuc danh mc cht cm s dng trong mt s ngnh, l)nh vc s dng trong sn xut thucMu s 38 Ph lc IIIBo co kt qu kinh doanh thuc thnh phm sn xut t nguyn liu  ngh nhp khuMu s 41 Ph lc IIIn hng nhp khu dc liu, bn thnh phm dc liuMu s 43 Ph lc IIIn hng nhp khu t dc, v nang, bao b tip xc trc tip vi thuc, cht chunMu s 46 Ph lc IIIDanh mc nguyn liu  sn xut thuc theo h s ng k thuc  c giy ng k lu hnh ti Vit Nam c nhp khu khng phi thc hin cp php nhp khu/Danh mc nguyn liu lm thuc phi kim sot c bit  sn xut thuc theo h s ng k thuc  c giy ng k lu hnh ti Vit Nam phi thc hin cp php nhp khuMu s 47 Ph lc IIIBo co nhp khu l vc xinMu s 48 Ph lc IIIBo co nhp khu l thuc cha c giy ng k lu hnh thuc ti Vit NamMu s 49 Ph lc IIIBo co xut khu, nhp khu vc xinMu s 50 Ph lc IIIBo co xut khu, nhp khu thuc, nguyn liu lm thucMu s 06 Ph lc VIGiy xc nhn ni dung thng tin thuc theo hnh thc hi tho gii thiu thuc/qung co thuc qua phng tin hi tho, hi ngh, s kin gii thiu thucMu s 07 Ph lc VIPhiu tip nhn vn bn thng bo ni dung thng tin thuc/qung co thuc cn nh chnhMu s 01 Ph lc VIIBng k khai gi thuc nc ngoi nhp khu vo Vit NamMu s 02 Ph lc VIIBng k khai gi thuc sn xut trong ncMu s 03 Ph lc VIIBng k khai li gi thuc nc ngoi nhp khu vo Vit NamMu s 04 Ph lc VIIBng k khai li gi thuc sn xut trong nc Mu s 06 Ph lc I S Y T & & -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc --------------- nhCHNG CH HNH NGH DC S hiu: /CCHN-D-SYT-& (1) & & & & & & .(2)& & & & & .. Chng nhn ng/B (3): .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & Ngy, thng, nm sinh: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & . S CMND/Th cn cc/H chiu/Cc giy t tng ng khc: & & & & & & & & Ngy cp: .& & & & & .& & & & & & & & & Ni cp: .& & & & & .& & & & & & & & & & & & . a ch thng tr: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & .. Vn bng chuyn mn: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & .. Phm vi hot ng chuyn mn: .& & & & & & (4) & & & & & & & & & & .  iu kin hnh ngh dc vi cc v tr hnh ngh sau: & & & & & & & .(5) & & & & & & .. Hnh thc cp Chng ch hnh ngh: Xt h s Yu cu c phin dch trong hnh ngh (6). Chng ch hnh ngh dc c hiu lc t ngy & & . thng & & . nm & & . c cp theo Quyt nh s: & ./Q-SYT ngy & & . thng & & . nm & & .. ca Gim c S Y t.... Thay th cho Chng ch hnh ngh dc s& & .. ngy & & . thng & & . nm & & .. (nu l trng hp cp li, iu chnh). & , ngy& thng& nm& C QUAN CP (K v ghi r h tn, ng du)Ghi ch: (1) Ghi m k hiu s Chng ch hnh ngh dc theo quy nh ti Mu s 24 Ph lc I ca Ngh nh s 54/2017/N-CP ngy 08/5/2017 ca Chnh ph quy nh chi tit mt s iu v bin php thi hnh Lut dc. (2) Ghi r hnh thc cp, ln cp trong trng hp cp li, iu chnh, v d: cp li ln 1: s CCHND, ngy cp...; hoc cp iu chnh ln 2; s CCHND, ngy cp .... (3) Ghi tn ngi c cp CCHND bng ch in hoa. (4) Ghi tt c cc phm vi hot ng chuyn mn m ngi  ngh cp CCHND  ngh v p ng yu cu. (5) Ghi tt c cc v tr chuyn mn m ngi  ngh cp CCHND  ngh v p ng yu cu. (6) Ch ghi dng ny trong trng hp cp Chng ch hnh ngh dc cho ngi nc ngoi, ngi Vit Nam nh c  nc ngoi cha c cng nhn bit ting Vit trong hnh ngh dc. Mu s 07 Ph lc I B Y T & & -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc --------------- nh CHNG CH HNH NGH DC S hiu: /CCHN-D-BYT & & & & & & .(1)& & & & & .. Chng nhn ng/B (2): .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & Ngy, thng, nm sinh: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & . S CMND/Th cn cc/H chiu/cc giy t tng ng khc: & & & & & & & & Ngy cp: .& & & & & .& & & & & & & & & Ni cp: .& & & & & .& & & & & & & & & & & & . a ch thng tr: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & .. Vn bng chuyn mn: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & .. Phm vi hot ng chuyn mn: .& & & & & .& & & & & & & & & (3) & & & & & & & & & & .  iu kin hnh ngh dc vi cc v tr hnh ngh sau: & & & & & & & .(4) & & & & & & .. Hnh thc cp Chng ch hnh ngh: Thi Kt qu thi c cng nhn ngy: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & Ti c s t chc thi: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & Chng ch hnh ngh dc c hiu lc t ngy .... thng .... nm.... c cp theo Quyt nh s: & & ./Q-BYT ngy .... thng.... nm & & . ca B trng B Y t. Thay th cho Chng ch hnh ngh dc s..... ngy & & . thng & & . nm & & .. (nu l trng hp cp li, iu chnh). & & & .., ngy & & . thng & & . nm & & .. C QUAN CP (K, ghi r h tn, ng du)Ghi ch: (1) Ghi r hnh thc cp, ln cp trong trng hp cp li, iu chnh, v d: cp li ln 1: s CCHND, ngy cp...; hoc cp iu chnh ln 2; s CCHND, ngy cp ... (2) Ghi tn ngi c cp CCHND bng ch in hoa. (3) Ghi tt c cc phm vi hot ng chuyn mn m ngi  ngh cp CCHND  ngh v p ng yu cu. (4) Ghi tt c cc v tr chuyn mn m ngi  ngh cp CCHND  ngh v p ng yu cu. Mu s 19 Ph lc I CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ------------- N  NGH Cp Giy chng nhn  iu kin kinh doanh dc Knh gi: & & & & & & .(1)& & & & & & & .. Tn c s .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & a ch: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & . Trc thuc & & & & & & & & & & (nu l c s trc thuc) & & & & & & & & & & & & & & . a ch: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & . Ngi chu trch nhim chuyn mn v dc .& & & & & .& & & & & & & & & & & & & & & . S CCHN Dc & & & & & & & & . Ni cp & & & & . Nm cp & & & & & & ..C gi tr n (nu c): & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & & & .. Ngi ph trch v bo m cht lng(2) .& & & & & .& & & & & & & & & & & & & & & & & S CCHN Dc & & & & & & & Ni cp & & & & . Nm cp & & & & & & & & & & & & & & . 1.  c cp Giy chng nhn thc hnh tt(3): % - Giy chng nhn thc hnh tt S: & & & & & & & & & & . Ngy cp: & & & & & & & & & & & & & & & & & & & & & & & & & - Giy chng nhn thc hnh tt S: & & & & & & & & & & . Ngy cp: & & & & & & & & & & & & & & & & & & & & & & & & & 2.  c cp Giy chng nhn  iu kin kinh doanh dc (4): % - Giy chng nhn  iu kin kinh doanh dc S:.& & & & & .& & & & & & & & & Ngy cp: .& & & & & .& & & & & & & & & & & & & & .. - Giy chng nhn  iu kin kinh doanh dc S:.& & & & & .& & & & & & & & & Ngy cp: .& & & & & .& & & & & & & & & & & & & & .. C s  ngh B Y t/S Y t cp Giy chng nhn  iu kin kinh doanh dc: + Loi hnh c s kinh doanh (5): .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & + Phm vi kinh doanh (6): .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & . + a im kinh doanh: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & .  ngh cp Giy chng nhn thc hnh tt km theo Giy chng nhn  iu kin kinh doanh(7): Hng dn thc hnh tt p dng (8): Chng ti xin cam kt tun th y  cc quy nh ca php lut c lin quan, chp hnh nghim s ch o ca B Y t/S Y t. C s xin gi km theo n ny: - Cc ti liu  ngh cp li giy CNKKDD quy nh ti iu 32 ca Ngh nh s: 54/2017/N-CP ngy 08/5/2017 ca Chnh ph quy nh chi tit mt s iu v bin php thi hnh Lut dc(9). - Cc ti liu  ngh cp li giy CNKKDD quy nh ti iu 49 ca Ngh nh s: 54/2017/N-CP ngy 08/5/2017 ca Chnh ph quy nh chi tit mt s iu v bin php thi hnh Lut dc (10). & & & .., ngy & thng & nm& NGI I DIN TRC PHP LUT/ NGI C Y QUYN (K, ghi r h tn, chc danh, ng du (nu c))Ghi ch: (1) C quan cp Giy chng nhn  iu kin kinh doanh dc. (2) Ch p dng i vi c s sn xut thuc, nguyn liu lm thuc v khi bt buc phi c CCHND i vi ngi ph trch m bo cht lng theo l trnh quy nh trong Ngh nh. (3) Lit k Giy chng nhn GPs cn hiu lc ti a im kinh doanh nu c. (4) Lit k Giy chng nhn  iu kin kinh doanh dc cn hiu lc nu c. (5) Ghi r loi hnh c s kinh doanh theo quy nh ti khon 2 iu 32 ca Lut dc. (6) Lit k cc phm vi kinh doanh tng ng vi iu kin kinh doanh dc m c s  ngh v p ng: - L mt hoc mt s phm vi theo quy nh ti cc iu 15 n 22, iu 33 v 34 ca Lut dc. - i vi phm vi kinh doanh thuc kim sot c bit: Ghi r tng phm vi kinh doanh thuc kim sot c bit theo quy nh ti khon 26 iu 2 ca Lut dc. (7) Ghi r loi giy chng nhn thc hnh tt  ngh c cp km Giy chng nhn  iu kin kinh doanh (nu c s c nhu cu). (8) p dng trong trng hp c s c php la chn mt trong cc hng dn v Thc hnh tt  c B Y t ban hnh hoc cng nhn  p dng khi kim tra vic p ng Thc hnh tt. (9) p dng i vi trng hp np h s theo quy nh ti iu 32 Ngh nh s 54/2017/N-CP. (10) p dng i vi trng hp np h s theo quy nh ti iu 49 Ngh nh s 54/2017/N-CP. Mu s 19 Ph lc II TN C S: ---------S:& & & &  N HNG MUA THUC GY NGHIN, THUC HNG THN, THUC TIN CHT/NGUYN LIU LM THUC L DC CHT GY NGHIN/DC CHT HNG THN/TIN CHT DNG LM THUC; NHNG LI NGUYN LIU LM THUC L DC CHT GY NGHIN/DC CHT HNG THN/TIN CHT DNG LM THUC Knh gi:.& & & & & .& & & & & & & & & TTNguyn liu/Tn thuc, hot cht dng bo ch nng / hm lng, quy cch ng gin v tnhPhn bo co k trc (T ngy....n ngy & & & .)S lng mua/nhng liDuytGhi chS lng tn kho k trcS lng nhp trong kTng sTng s xut trong kTn kho cui k(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11) Ni nhn: - Nh trn; - Lu ti c s. NGI LP BO CO& & , ngy & thng & nm& NGI I DIN PHP LUT/ NGI C Y QUYN (K, ghi r h tn, chc danh ng du (nu c))S: & & & .., ngy & & . thng & & . nm & & .. Chp thun ca c quan qun l: n hng ny gm & & .. trang& . khon c mua ti cng ty& & ./c nhng cho cng ty& . n hng ny c gi tr mt nm k t ngy k ban hnh C QUAN CHP THUN (K tn, ng du)- i vi cc c s kinh doanh thuc gy nghin, thuc hng thn, thuc tin cht, nguyn liu lm thuc l dc cht gy nghin, dc cht hng thn, tin cht dng lm thuc: Km theo ti liu ghi r tn v a ch khch hng, s lng, ngy bn. - n hng mua thuc c lm thnh 03 bn (c s lu 01 bn, ni bn 01 bn, c quan chp thun lu 01 bn). Mu s 03 Ph lc III TN C S -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & ..& & .. BO CO NGUYN LIU LM THUC L DC CHT GY NGHIN, DC CHT HNG THN, TIN CHT DNG LM THUC  SN XUT THUC XUT KHU Knh gi: B Y t. TTTn nguyn liun v tnhThng tin v thuc xut khuS nguyn liu s dng sn xutS nguyn liu s dng cho kim nghim v hao ht (nu c)*Tng s nguyn liu s dngS lng tn kho k trc tnh n: & . (ngy, thng, nm)S lng nhp khu/mua trong k& . (ngy, thng, nm)Tn kho cui k tnh n & . (ngy, thng, nm)Tn thuc xut khuNng , hm lng nguyn liu phi KSBS giy ng k lu hnhS lng thuc sn xut, n v tnh nh nht(1)(2)(3)(4)(5)(6)(7)(8)(9)(10) = (8)+ (9)(11)(12)(13) = (11) + (12)-(10)1.(Tn nguyn liu 1)(Tn thuc 1)(Tn thuc 2)2.(Tn nguyn liu 2)* Nu c, phi bo co chi tit Ni nhn: - Nh trn; - Lu ti c s.& & & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/ NGI C Y QUYN (K tn, ng du) Mu s 04 Ph lc III TN C S XUT KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & .. N HNG XUT KHU THUC PHNG X, THUC TRONG DANH MC THUC, DC CHT THUC DANH MC CHT B CM S DNG TRONG MT S NGNH, L(NH VC, THUC C Knh gi: B Y t. Tn c s xut khu: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & a ch: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & (Tn c s xut khu) knh  ngh B Y t xem xt cp php xut khu cc thuc sau  & & & & & (1)& & & theo quy nh ti iu ....(2)& & Ngh nh s & & & & .nh sau: STTTn thuc, dng bo ch, quy cch ng giHot cht, hm lng/ nng S giy ng k lu hnh, giy php nhp khu (nu c)n v tnhS lng (3)Tn nguyn liu phi kim sot c bit (4)Tn, a ch c s sn xut - Tn nc sn xutTn, a ch c s nhp khu - Tn nc nhp khu12Ca khu d nh s xut khu (ghi r tn sn bay, hi cng): .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & % C s  ngh B Y t cp CPP (hoc FSC) cho thuc ti khon s ............(5) C s xut khu cam kt chu trch nhim trc php lut v tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php xut khu v cam kt thc hin theo ng cc quy nh ca php lut c lin quan. B Y T Chp thun n hng xut khu gm& & .. trang& & ..khon km theo Cng vn s& & ./& & & ngy & & . thng & & . nm & & .. ca B Y t. H Ni, ngy & & . thng & & . nm & & .. B TRNG& & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/ NGI C Y QUYN (Ghi r h tn, k, ng du)Ghi ch: (1) in mc ch xut khu ph hp: - V mc ch thng mi. - Tham gia trng by ti trin lm, hi ch. - Th lm sng, th tng ng sinh hc, nh gi sinh kh dng, lm mu kim nghim, nghin cu khoa hc, lm mu ng k. (2) in s iu ti Ngh nh tng ng vi hnh thc xut khu. (3) i vi trng hp xut khu thuc trong Danh mc thuc, dc cht thuc danh mc cht b cm s dng trong mt s ngnh, l)nh vc theo quy nh ti iu 58 Ngh nh: phi nh km vn bn gii trnh v k hoch xut khu thuc d kin. (4) i vi thuc cha dc liu c ghi tn dc liu, b phn dng. Tn dc liu gm tn ting Vit km tn khoa hc. i vi bn thnh phm dc liu ghi thm dng bo ch. (5) B Y t ch cp CPP hoc FSC nu c s c chn ni dung ny. C s cn ghi r  ngh cp CPP hay FSC. Trng hp theo yu cu ca nc nhp khu, c th xc nhn thm cc ni dung so vi CPP mu v FSC mu. Mu s 05 Ph lc III TN C S XUT KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & .& & .. N HNG XUT KHU DC CHT TRONG DANH MC THUC, DC CHT THUC DANH MC CHT B CM S DNG TRONG MT S NGNH, L(NH VC, NGUYN LIU C LM THUC Knh gi: B Y t. Tn c s xut khu: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & a ch: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & (Tn c s xut khu) knh  ngh B Y t xem xt cp php xut khu cc nguyn liu lm thuc sau  & & & & & (1)& & & theo quy nh ti iu ....(2)& & Ngh nh s & & & & .nh sau: STTTn nguyn liu (3)n v tnhS lng (4)Tiu chun cht lngS giy ng k lu hnh, giy php nhp khuTn c s sn xut - Tn nc sn xutTn c s nhp khu - Tn nc nhp khu12Ca khu d nh s xut hng (ghi r tn sn bay, hi cng):.& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & C s xut khu cam kt chu trch nhim trc php lut v tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php xut khu v cam kt thc hin theo ng cc quy nh ca php lut c lin quan. B Y T Chp thun n hng xut khu gm& & .. trang& & ..khon km theo Cng vn s& & ./& & ngy & & . thng & & . nm & & .. ca B Y t. H Ni, ngy & & . thng & & . nm & & .. B TRNG& & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/ NGI C Y QUYN (Ghi r h tn, k, ng du)Ghi ch: (1) in mc ch xut khu ph hp: - V mc ch thng mi. - Tham gia trng by ti trin lm, hi ch. - Th lm sng, th tng ng sinh hc, nh gi sinh kh dng, lm mu kim nghim, nghin cu khoa hc, lm mu ng k. (2) in s iu ti Ngh nh tng ng vi hnh thc xut khu. (3) i vi dc liu c ghi tn dc liu, b phn dng. Tn dc liu gm tn ting Vit km tn khoa hc. (4) i vi trng hp xut khu dc cht trong Danh mc thuc, dc cht thuc danh mc cht b cm s dng trong mt s ngnh, l)nh vc theo quy nh ti iu 58 Ngh nh: phi nh km vn bn gii trnh v k hoch xut khu nguyn liu lm thuc d kin. Mu s 15 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & .& & .. N HNG NHP KHU VC XIN/SINH PHM/ THUC HA DC (1) CHA C GIY NG K LU HNH THUC TI VIT NAM Knh gi: B Y t. (Tn c s nhp khu) knh  ngh B Y t xem xt cp php nhp khu cc thuc (loi thuc nhp khu (2) hoc mc ch nhp khu (3)) theo quy nh ti im& ..khon& . iu & & ..(4)& & & Ngh nh s & & & & nh sau: Tn thuc, dng bo ch, quy cch ng giHot cht, hm lng/nng n v tnhS lngHn dng (5)Tiu chun cht lngCh nhTn c s sn xut - Tn nc sn xutTn c s s hu giy php lu hnh trn Giy chng nhn sn phm dcGi bn bun d kin (6)Tn c s cung cp thuc: (Ch p dng i vi trng hp nhp khu thuc quy nh ti iu 68 ca Ngh nh). (Tn c s nhp khu) cam kt chu trch nhim trc php lut v ngun gc, cht lng ca thuc  ngh nhp khu, tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php nhp khu, s dng thuc ng mc ch v thc hin cc quy nh khc ca php lut c lin quan. B Y T Chp thun n hng nhp khu gm& & .. trang & & ..khon km theo Cng vn s& & ./& & ngy & & . thng & & . nm & & .. ca B Y t. H Ni, ngy & & . thng & & . nm & & .. B TRNG& & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/ NGI C Y QUYN (K tn, ng du)Ghi ch: (1) Thuc gy nghin, thuc hng thn, thuc tin cht, thuc dng phi hp c cha dc cht gy nghin, thuc dng phi hp c cha dc cht hng thn, thuc dng phi hp c cha tin cht; lp n hng nhp khu theo Mu s 16 Ph lc III. (2) in loi thuc nhp khu ph hp: - C cha dc cht cha c giy ng k lu hnh thuc ti Vit Nam - C cha dc cht  c giy ng k lu hnh thuc ti Vit Nam nhng cha p ng  nhu cu iu tr - C cha dc liu cha c s dng lm thuc ti Vit Nam - C cha dc liu  c s dng lm thuc ti Vit Nam nhng cha p ng  nhu cu iu tr - Thuc Danh mc thuc him - Thuc c tn 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. (3) in mc ch nhp khu ph hp: - p ng nhu cu cp bch cho quc phng, an ninh, phng, chng dch bnh, khc phc hu qu thin tai, thm ha - p ng nhu cu iu tr c bit - Phc v cho chng trnh y t ca Nh nc - Lm mu kim nghim/nghin cu khoa hc/th nghim lm sng/nh gi sinh kh dng/tng ng sinh hc (4) in s im, khon, iu ti Ngh nh tng ng vi hnh thc nhp khu. (5) i vi thuc phng x: khng yu cu. (6) Ch p dng i vi trng hp nhp khu theo quy nh ti iu 70 ca Ngh nh. Mu s 16 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & & .. N HNG NHP KHU THUC GY NGHIN/THUC HNG THN/THUC TIN CHT/THUC DNG PHI HP C CHA DC CHT GY NGHIN/THUC DNG PHI HP C CHA DC CHT HNG THN/THUC DNG PHI HP C CHA TIN CHT CHA C GIY NG K LU HNH THUC TI VIT NAM Knh gi: B Y t. Tn c s nhp khu (bng ting Vit v ting Anh): .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & . a ch (bng ting Vit v ting Anh): .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & & & & & & & & (Tn c s nhp khu) knh  ngh B Y t xem xt cp php nhp khu cc thuc (loi thuc nhp khu (1) hoc mc ch nhp khu (2)) theo quy nh ti im& . khon& .. iu ....(3)& & Ngh nh s& & & nh sau: Tn thuc, dng bo ch, quy cch ng giHot cht, hm lng/ nng n v tnhS lng (4)Tn nguyn liu phi kim sot c bitTng s khi lng nguyn liu phi kim sot c bit tnh ra gamHn dngTiu chun cht lngCh nhTn v a ch c s sn xut - Tn nc sn xutTn v a ch c s xut khu - Tn nc xut khuTn c s s hu giy php lu hnh trn Giy chng nhn sn phm dc - Tn ncGi bn bun d kin (5)Ca khu d nh s nhp khu (ghi r tn sn bay, hi cng): .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & .. Tn c s cung cp thuc: (ch p dng i vi trng hp nhp khu thuc theo quy nh ti iu 68 Ngh nh) (Tn c s nhp khu) cam kt chu trch nhim trc php lut v ngun gc, cht lng ca thuc  ngh nhp khu, tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php nhp khu, s dng thuc ng mc ch v thc hin cc quy nh khc ca php lut c lin quan. Ni nhn: - B Y t; - Lu ti n v& & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/ NGI C Y QUYN (K tn, ng du)Ghi ch: (1) in loi thuc nhp khu ph hp: - C cha dc cht cha c giy ng k lu hnh thuc ti Vit Nam - C cha dc cht  c giy ng k lu hnh thuc ti Vit Nam nhng cha p ng  nhu cu iu tr - Thuc Danh mc thuc him - Thuc c tn 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. (2) in mc ch nhp khu ph hp: - p ng nhu cu cp bch cho quc phng, an ninh, phng, chng dch bnh, khc phc hu qu thin tai, thm ha - p ng nhu cu iu tr c bit - Phc v cho chng trnh y t ca Nh nc - Lm mu kim nghim/nghin cu khoa hc/th nghim lm sng/nh gi sinh kh dng/tng ng sinh hc - i vi thuc nhp khu theo quy nh ti iu 68 Ngh nh: ghi r thuc  s dng cho trng hp c th no quy nh ti im b hoc c khon 1 iu 68 Ngh nh. (3) in s im, khon, iu ti Ngh nh tng ng vi hnh thc nhp khu. (4) Gii trnh c th l do (km ti liu chng minh) trong trng hp s lng thuc  ngh nhp khu vt qu 150% s lng thc t  sn xut, kinh doanh trong k bo co lin trc. (5) Ch p dng i vi trng hp nhp khu theo quy nh ti iu 70 ca Ngh nh. Mu s 17 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & & .. n hng nhp khu thuc dc liu/thuc c truyn cha c giy ng k lu hnh thuc ti vit nam Knh gi: B Y t. (Tn c s nhp khu) knh  ngh B Y t xem xt cp php nhp khu cc thuc (loi thuc nhp khu (1) hoc mc ch nhp khu (2)) theo quy nh ti im& & . khon& .. iu & ......(3)& & & Ngh nh s & & & & & nh sau: Tn thuc, dng bo ch, quy cch ng giTn dc liu (4), b phn dng (5)n v tnhS lngHn dngTiu chun cht lngCh nhTn c s sn xut - Tn nc sn xutTn c s s hu giy php lu hnh trn Giy chng nhn sn phm dc (6)Gi bn bun d kin (7)Tn c s cung cp thuc: (ch p dng i vi trng hp nhp khu thuc quy nh ti iu 68 ca Ngh nh). (Tn c s nhp khu) cam kt chu trch nhim trc php lut v ngun gc, cht lng ca thuc  ngh nhp khu, tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php nhp khu, s dng thuc ng mc ch v thc hin cc quy nh khc ca php lut c lin quan. B Y T Chp thun n hng nhp khu gm& & .. trang& & ..khon km theo Cng vn s& & ./& & ngy & & . thng & & . nm & & .. ca B Y t. H Ni, ngy & & . thng & & . nm & & .. B TRNG& & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du)Ghi ch: (1) in loi thuc nhp khu ph hp: - C cha dc liu cha c s dng lm thuc ti Vit Nam - C cha dc liu  c s dng lm thuc ti Vit Nam nhng cha p ng  nhu cu iu tr - Thuc Danh mc 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. (2) in mc ch nhp khu ph hp: - p ng nhu cu cp bch cho quc phng, an ninh, phng, chng dch bnh, khc phc hu qu thin tai, thm ha - p ng nhu cu iu tr c bit - Phc v cho chng trnh y t ca Nh nc - Lm mu kim nghim/nghin cu khoa hc/th nghim lm sng/nh gi sinh kh dng/tng ng sinh hc - i vi thuc nhp khu theo quy nh ti iu 68 Ngh nh: ghi r thuc  s dng cho trng hp c th no quy nh ti im b hoc c khon 1 iu 68 Ngh nh. (3) in s im, khon, iu ti Ngh nh tng ng vi hnh thc nhp khu. (4) Ghi tn ting Vit km tn khoa hc. Trng hp khng c tn ting Vit th ghi theo tn ca nc xut khu km tn khoa hc. (5) i vi bn thnh phm dc liu, ghi dng bo ch. (6) i vi v thuc c truyn: khng bt buc ghi ni dung ny. (7) Ch p dng i vi trng hp nhp khu theo quy nh ti iu 70 ca Ngh nh. Mu s 18 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & .. BO CO KT QU KINH DOANH THUC GY NGHIN/THUC HNG THN/THUC TIN CHT/THUC PHNG X/THUC DNG PHI HP C CHA DC CHT GY NGHIN/THUC DNG PHI HP C CHA DC CHT HNG THN/THUC DNG PHI HP C CHA TIN CHT/THUC TRONG DANH MC THUC, DC CHT THUC DANH MC CHT B CM TRONG MT S NGNH, L(NH VC Knh gi: B Y t. (K bo co: T ngy & & & n ngy& & & . )** STTTn thuc, hm lng/nng , dng bo ch, quy cch ng giS giy ng k lu hnh, giy php nhp khun v tnhS lng thuc tn kho cui k bo co trcS lng thuc nhp khu trong k bo co*S lng xut bn trong k bo co*S lng thuc b tr v t cc c s khc*S lng hao ht (hng, v, ht hn dng, tiu hy,& .)Tn kho cui k bo coS lng thuc cn c th nhp khu tip t cc n hng nhp khu  c cp php trc *(1)(2)(3)(4)(5)(6)(7)(8)(9) (10) = (5) + (6) - (7)-(8)(11) Ni nhn: - B Y t; - Lu ti c s. NGI LP BO CO& & & ., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du)Ghi ch: * Nu c, phi bo co chi tit trong ph lc nh km: - Ct (6): thng tin v thi im nhp v s lng thuc  nhp theo tng thi im (nh km ti liu chng minh). - Ct (7): thng tin thi im bn, s lng thuc  bn theo tng thi im bn, tn v a ch c s  mua thuc. - Ct (8): thng tin v tn v a ch c s tr li thuc, thi im tr v s lng tr li tng ng cho tng ln tr li. - Ct (9): l do hao ht (hng, v, ht hn dng, tiu hy...) v khi lng hao ht tng ng. - Ct (11): c ph lc ghi r thng tin s giy php nhp khu  c cp cn c th s dng  nhp khu tip thuc, ngy ht hiu lc ca giy php, s lng thuc  c cp php, s lng thuc thc t  nhp, s lng cn c th c nhp khu tip (nh km ti liu chng minh). ** Bo co trong k 01 nm trc thi im lp bo co: i vi trng hp thuc nhp khu l thuc trong danh mc thuc, dc cht thuc danh mc cht b cm trong mt s ngnh, l)nh vc. Mu s 19 Ph lc III TN C S KHM BNH, CHA BNH -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. DANH MC VC XIN/SINH PHM/THUC HA DC (1) CHA C GIY NG K LU HNH THUC TI VIT NAM  NGH NHP KHU P NG NHU CU IU TR C BIT Knh gi: (Tn c s nhp khu). Tn c s khm bnh, cha bnh: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & a ch: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & & & & .. S ging bnh: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & ..  p ng  thuc phc v cng tc khm cha bnh, (tn c s khm bnh, cha bnh)  ngh (tn c s nhp khu) nhp khu cc thuc sau  cung cp cho nhu cu iu tr ca c s: STTTn thuc, dng bo ch, quy cch ng giHot cht, hm lng/nng n v tnhS lngCh nhTn nh sn xut - Tn nc sn xut12(Tn c s khm bnh, cha bnh) cam kt s dng cc thuc trn ng mc ch, ng ch nh theo cc quy nh hin hnh v chu hon ton trch nhim lin quan n vic s dng thuc  ngh nhp khu. & & & .., ngy & & . thng & & . nm & & .. C S KHM BNH, CHA BNH (K, ghi r h tn, ng du)Ghi ch: (1) Thuc gy nghin, thuc hng thn, thuc tin cht, thuc dng phi hp c cha dc cht gy nghin, thuc dng phi hp c cha dc cht hng thn, thuc dng phi hp c cha tin cht: lp danh mc theo Mu s 20. Mu s 20 Ph lc III TN C S KHM BNH, CHA BNH -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. DANH MC THUC GY NGHIN/THUC HNG THN/THUC TIN CHT/THUC DNG PHI HP C CHA DC CHT GY NGHIN/THUC DNG PHI HP C CHA DC CHT HNG THN/THUC DNG PHI HP C CHA TIN CHT CHA C GIY NG K LU HNH THUC TI VIT NAM  NGH NHP KHU P NG NHU CU IU TR C BIT Knh gi: (Tn c s nhp khu). Tn c s khm bnh, cha bnh: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & a ch: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & & & & .. S ging bnh: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & ..  p ng  thuc phc v cng tc khm cha bnh, (tn c s khm bnh, cha bnh)  ngh (tn c s nhp khu) nhp khu cc thuc sau  cung cp cho nhu cu iu tr ca c s: STTTn thuc, dng bo ch, quy cch ng giHot cht, hm lng/nng n v tnhS lngTn nguyn liu phi kim sot c bit -Tng s khi lng nguyn liu phi kim sot c bit tnh ra gamCh nhTn nh sn xut - Tn nc sn xut123(Tn c s khm bnh, cha bnh) cam kt s dng cc thuc trn ng mc ch, ng ch nh theo cc quy nh hin hnh v chu hon ton trch nhim lin quan n vic s dng thuc  ngh nhp khu. & & & .., ngy & & . thng & & . nm & & .. C S KHM BNH, CHA BNH (K, ghi r h tn, ng du) Mu s 21 Ph lc III TN C S KHM BNH, CHA BNH -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & .& & .. DANH MC THUC DC LIU/THUC C TRUYN CHA C GIY NG K LU HNH THUC TI VIT NAM  NGH NHP KHU P NG NHU CU IU TR C BIT Knh gi: (Tn c s nhp khu). Tn c s khm bnh, cha bnh: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & a ch: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & & & & ..  p ng  thuc phc v cng tc khm cha bnh, (tn c s khm bnh, cha bnh)  ngh (tn c s nhp khu) nhp khu cc thuc sau  cung cp cho nhu cu iu tr ca c s: TTTn thuc, hm lng, dng bo ch, quy cch ng giTn dc liu, b phn dng (1)Ch nhn v tnhS lngTn c s sn xut - Tn nc sn xut123(Tn c s khm bnh, cha bnh) cam kt s dng cc thuc trn ng mc ch, ng ch nh theo cc quy nh hin hnh v chu hon ton trch nhim lin quan n vic s dng thuc  ngh nhp khu. & & .., ngy & & . thng & & . nm & & .. C S KHM BNH, CHA BNH (K, ghi r h tn, ng du)Ghi ch: (1) i vi bn thnh phm dc liu ghi thm dng bo ch. Tn dc liu gm ting Vit km tn khoa hc. Trng hp khng c tn ting Vit th ghi theo tn ca nc xut khu km tn khoa hc. Mu s 22 Ph lc III TN C S KHM BNH, CHA BNH -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. BO CO V VIC S DNG THUC NHP KHU P NG NHU CU IU TR C BIT Knh gi:- (Tn c s nhp khu); - B Y t.Tn c s khm bnh, cha bnh: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & a ch: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & & & & .. S ging bnh: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & Trong thi gian t & & & .n& & & & (*), (tn c s khm bnh, cha bnh)& ..  s dng cc thuc sau phc v nhu cu iu tr ca c s: STTTn thuc, dng bo ch, quy cch ng giHot cht, hm lng/nng n v tnhS lng  s dng (**)Ch nhTn nh sn xut - Tn nc sn xutNhn xt v hiu qu iu tr,  an ton ca thuc trong trng hp  s dng thuc  ngh nhp khu (**)12C s khm bnh, cha bnh xin hon ton chu trch nhim v tnh chnh xc ca cc thng tin trn y. & & & .., ngy & & . thng & & . nm & & .. C S KHM BNH, CHA BNH (K, ghi r h tn, ng du)Ghi ch: (*) Thi hn bo co: trong vng 12 thng trc thi im lp Bo co. (**) i vi vc xin phi bo co c th v  tui ca i tng s dng. Mu s 23 Ph lc III BN CAM KT COMMITMENT m bo cht lng vc xin To ensure the quality of vaccine Knh gi: B Y t 138A, Ging V, H Ni, Vit Nam To: Ministry of Health of Viet Nam 138A Giang vo Street, Ha noi, Viet Nam Tn c s nhp khu/Importer s name: a ch/Address: in thoi /Telephone number Fax: Telex: Tn c s sn xut/s hu giy php sn phm/ Manufacturer s name/Product licence holder s name: a ch/Address: Chng ti xin bo m cc vc xin sau do chng ti cung cp: We ensure that the following vaccines distributed by our company: 1. (Tn vc xin 1, quy cch ng gi, cng dng)/(Name of vaccine/biological 1, packaging form, indications and uses) 2. (Tn vc xin, quy cch ng gi, cng dng)/(Name of vaccine/biological 2, packaging form, indications and uses) & . - c sn xut theo tiu chun GMP, ng thi t cc yu cu v cht lng vc xin, sinh phm ca c quan c thm quyn ti nc sn xut. - Produced according to GMP criteria and met with all requirements setting for the quality of vaccines and biological products of local authorities. - Vc xin trn hin ang c php lu hnh ti nc sn xut v c cp php ln u vo nm: - Curently licensed to be placed on the market for use in the original country and the first market authorisation was issued on: Chng ti xin chp hnh cc lut l v quy nh trong l)nh vc vc xin ca nc Cng ho x hi ch ngh)a Vit Nam v chu s thanh tra kim tra ca c quan c thm quyn ca Vit Nam. We commit ourself to comform to the law and regulation in the field of vaccine and accept the inspection and examination of Vietnam authorities. Chng ti xin hon ton chu trch nhim trc php lut v tiu chun cht lng ca vc xin trn. We will bear a responsibilities for the quality of the above vaccines. Director of Supplier (Gim c c s cung cp) Sign (k, ghi r h tn)& & .., ngy & & . thng & & . nm & & .. Director of Manufacturer (Gim c c s sn xut) Sign (k, ghi r h tn)Ghi ch: Cam kt ca c s sn xut v c s cung cp c th lm chung trong mt vn bn hoc tch thnh 2 vn bn ring. Mu s 24 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. N HNG NHP KHU VC XIN/SINH PHM/THUC HA DC (1) CHA C GIY NG K LU HNH THUC TI VIT NAM  VIN TR, VIN TR NHN O Knh gi: B Y t. (Tn c s nhp khu) knh  ngh B Y t xem xt cp php nhp khu cc thuc sau: STTTn thuc, dng bo ch, quy cch ng giHot cht, hm lng/ nng n v tnhS lngHn dngCh nhTn c s sn xut - Tn nc sn xutGhi ch123(Tn c s nhp khu) cam kt chu trch nhim trc php lut v ngun gc, cht lng ca thuc  ngh nhp khu, tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php nhp khu, s dng thuc ng mc ch v thc hin cc quy nh khc ca php lut c lin quan. B Y T Chp thun n hng gm & ..trang & & ..khon km theo Cng vn s& & ./& & ngy & & . thng & & . nm & & .. ca B Y t H Ni, ngy & & . thng & & . nm & & .. B TRNG& & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du)Ghi ch: (1) Thuc gy nghin, thuc hng thn, thuc tin cht, thuc dng phi hp c cha dc cht gy nghin, thuc dng phi hp c cha dc cht hng thn, thuc dng phi hp c cha tin cht: Lp danh mc theo Mu s 25 Ph lc III. Mu s 25 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. N HNG NHP KHU THUC GY NGHIN/THUC HNG THN/THUC TIN CHT/THUC DNG PHI HP C CHA DC CHT GY NGHIN/THUC DNG PHI HP C CHA DC CHT HNG THN/THUC DNG PHI HP C CHA TIN CHT CHA C GIY NG K LU HNH THUC TI VIT NAM  VIN TR, VIN TR NHN O Knh gi: B Y t. (Tn c s nhp khu) knh  ngh B Y t xem xt cp php nhp khu cc thuc sau: STTTn thuc, dng bo ch, quy cch ng giHot cht, hm lng/ nng n v tnhS lngTn nguyn liu phi kim sot c bit - Hm lng/Nng Tng s khi lng nguyn liu phi kim sot c bit tnh ra gamHn dngTiu chun cht lngTn v a ch c s sn xut - Tn nc sn xutTn v a ch c s xut khu - Tn nc xut khuTn c s s hu giy php lu hnh trn Giy chng nhn sn phm dc - Tn nc12Ca khu d nh s nhp khu (ghi r tn sn bay, hi cng): & & & & & & & & & & ..(Tn c s nhp khu) cam kt chu trch nhim trc php lut v ngun gc, cht lng ca thuc  ngh nhp khu, tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php nhp khu, s dng thuc ng mc ch, ng i tng v thc hin cc quy nh khc ca php lut c lin quan. & & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du) Mu s 26 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. N HNG NHP KHU THUC DC LIU/THUC C TRUYN CHA C GIY NG K LU HNH THUC TI VIT NAM  VIN TR, VIN TR NHN O Knh gi: B Y t. (Tn c s nhp khu) knh  ngh B Y t xem xt cp php nhp khu cc thuc sau: STTTn thuc, hm lng, dng bo ch, quy cch ng giTn dc liu (tn La tinh), b phn dng (1)n v tnhS lngHn dngCh nhTn c s sn xut - Tn nc sn xutGhi ch12(Tn c s nhp khu) cam kt chu trch nhim trc php lut v ngun gc, cht lng ca thuc  ngh nhp khu, tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php nhp khu, s dng thuc ng mc ch v thc hin cc quy nh khc ca php lut c lin quan. B Y T Chp thun n hng gm & & ..trang & & ..khon km theo Cng vn s& & ./& & & ngy & & . thng & & . nm & & .. ca B Y t H Ni, ngy & & . thng & & . nm & & .. B TRNG& & & ., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du)Ghi ch: (1) i vi bn thnh phm dc liu ghi thm dng bo ch. Tn dc liu gm ting Vit km tn khoa hc. Trng hp khng c tn ting Vit th ghi theo tn ca nc xut khu km tn khoa hc. Mu s 27 Ph lc III CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ------------- N  NGH NHP KHU THUC CHA C GIY NG K LU HNH THUC TI VIT NAM KHNG V MC CH THNG MI Knh gi: S Y t & & & ..(1)& & & & . Ti l .& & & & & .& & & & & & & & & (2).& & & & & .& & & & & & & & & & & & & & & & & & . Ni ng k h khu thng tr (i vi ngi Vit Nam) .& & & & & .& & & & & & & & & & & Ch  hin ti (ch  ti Vit Nam): .& & & & & .& & & & & & & & & .& & & & & .& & & & & & in thoi .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & . S chng minh th/H chiu/Th cn cc/Cc giy t tng ng khc & & & & & & & cp ngy .& & & & & .& & & ni cp .& & & & & .& & & Thi gian sng ti Vit Nam: Trong nm 20--, ti/(tn t chc)  nhp khu thuc khng v mc ch thng mi cc ln c th nh sau (nu c): Ln 1: Ngy nhn: & & & ./& & ../20--: Tn thuc: ; s lng: ; tr gi: Ln 2: Ngy nhn: & & & ./& & ../20--: Tn thuc: ; s lng: ; tr gi: Knh  ngh S Y t cho php ti/(tn t chc) mang vo Vit Nam cc thuc vi s lng c th nh sau: TTTn thucThnh phn, hm lng (nng )Quy cch ng giS lngTi cam kt cc thuc trn ch c dng  iu tr bnh cho bn thn ti v ti xin t chu trch nhim v ngun gc v cht lng ca thuc  ngh nhp khu/(tn t chc) cam kt cc thuc trn ch c dng  iu tr bnh cho bn thn ngi nhp cnh thuc (tn t chc) v chu trch nhim v ngun gc v cht lng ca thuc  ngh nhp khu. Ti/(tn t chc) xin cam oan thc hin nghim tc v y  cc quy nh v qun l thuc nhp khu khng v mc ch thng mi. Nu vi phm ti/(tn t chc) xin chu hon ton trch nhim trc php lut./. & & & .., ngy & .. thng & & nm & .. .& & & .(3)& & & & (K, ghi r h tn)(1) S Y t a phng ni ca khu lm th tc nhp cnh hoc ni ngi bnh ang sinh sng hoc tm tr hp php hoc ni t chc ngoi giao t tr s (2) Tn ca c nhn ng n hoc t chc c thuc nhp khu (3) Trng hp t chc xin nhn thuc  s dng cho cc c nhn thuc t chc th i din t chc k n (ng du) v km theo danh sch ngi s dng thuc. Mu s 30 Ph lc III B Y T -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: / V/v nhp khu thuc thnh phm dng phi hp c cha ...H Ni, ngy & .. thng& .. nm& &  Knh gi: C s ... B Y t nhn c n hng s ... ngy ... ca c s v vic nhp khu thuc thnh phm dng phi hp c cha dc cht gy nghin/thuc dng phi hp c cha dc cht hng thn/thuc dng phi hp c cha tin cht; Cn c & , B Y t c kin nh sau: ng  C s nhp khu thuc theo nhng ni dung sau: 1. Tn thuc: Tn thuc (hot cht, hm lng/nng ), dng bo ch, quy cch ng gi 2. S lng: (bng s v bng ch) Tng khi lng nguyn liu lm thuc phi kim sot c bit & : 3. Nh sn xut: - Tn: ... - a ch: & 4. Nh xut khu: - Tn: ... - a ch: & 5. iu kin nhp khu: - Hng s c nhp v qua ca khu: ... - Hng ha khng c php chuyn bng ng bu in. - Giy php ny khng c trao i. - Giy php c hiu lc: .... - C s phi thc hin cc quy nh ti ... v cc quy nh c lin quan. B Y t thng bo  C s bit v thc hin. Ni nhn: - & ; - & ; - B Cng an; - Lu: VT, ...B TRNG Mu s 33 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. N HNG NHP KHU THUC GY NGHIN/THUC HNG THN/THUC TIN CHT/THUC DNG PHI HP C CHA DC CHT GY NGHIN/THUC DNG PHI HP C CHA DC CHT HNG THN/THUC DNG PHI HP C CHA TIN CHT C GIY NG K LU HNH TI VIT NAM Knh gi: B Y t. Tn c s nhp khu (bng ting Vit v ting Anh): .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & & & & .. a ch (bng ting Vit v ting Anh): & & & & & & & & & & & & & & & & & & & & & & & & ...& & & & & .& & & & & & & & & & & & & & & (C s nhp khu) knh  ngh B Y t xt duyt cho nhp khu thuc gy nghin, thuc hng thn, thuc tin cht, thuc dng phi hp c cha dc cht gy nghin, thuc dng phi hp c cha dc cht hng thn, thuc dng phi hp c cha dc cht tin cht c giy ng k lu hnh sau: STTTn thuc, dng bo ch, quy cch ng giHot cht, hm lng/ nng S giy ng k lu hnhn v tnhHn dngS lng (1)Tn dc cht gy nghin, dc cht hng thn, tin cht dng lm thucTng khi lng cht gy nghin, dc cht hng thn, tin cht dng lm thuc) (quy ra gam)Tn v a ch c s sn xut - Tn nc sn xutTn v a ch c s xut khu - Tn nc xut khuGhi chCa khu d nh s nhp khu (ghi r tn sn bay, hi cng). (Tn c s nhp khu) cam kt chu trch nhim trc php lut v ngun gc, cht lng ca thuc  ngh nhp khu, tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php nhp khu, s dng thuc ng mc ch, ng i tng v thc hin cc quy nh khc ca php lut c lin quan. Ni nhn: - B Y t; - Lu ti n v.& & & ., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (Ghi r h tn, k, ng du)Ghi ch: (1) Gii trnh c th l do (km ti liu chng minh) trong trng hp s lng  ngh nhp khu vt qu 150% s lng thc t  kinh doanh trong k bo co lin trc. Mu s 34 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. N HNG NHP KHU THUC C/THUC TRONG DANH MC THUC, DC CHT THUC DANH MC CHT B CM S DNG TRONG MT S NGNH, L(NH VC/THUC PHNG X C GIY NG K LU HNH TI VIT NAM Knh gi: B Y t. Tn c s nhp khu:..& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & & & & & & & a ch: .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & (C s nhp khu) knh  ngh B Y t xt duyt cho nhp khu thuc c/thuc trong danh mc thuc, dc cht thuc danh mc cht b cm s dng trong mt s ngnh, l)nh vc/thuc phng x c giy ng k lu hnh ti Vit Nam sau: STTTn thuc, dng bo ch, quy cch ng giTn nguyn liu lm thuc phi kim sot c bitS giy ng k lu hnhn v tnh ca thuc  ngh nhp khuS lng thuc  ngh nhp khu (1)Tn c s sn xut - tn nc sn xutGhi chCa khu d nh s a hng v (ghi r tn sn bay, hi cng): .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & (Tn c s nhp khu) cam kt chu trch nhim trc php lut v ngun gc, cht lng ca thuc  ngh nhp khu, tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php nhp khu, s dng thuc ng mc ch, ng i tng v thc hin cc quy nh khc ca php lut c lin quan. B Y T Chp thun n hng nhp khu gm& & .. trang& & ..khon km theo Cng vn s& & ./& & ngy & & . thng & & . nm & & .. ca B Y t. H Ni, ngy & & . thng & & . nm & & .. B TRNG& & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (Ghi r h tn, k, ng du)Ghi ch: (1) i vi thuc trong Danh mc thuc, dc cht b cm s dng trong mt s ngnh, l)nh vc: Gii trnh c th l do (km ti liu chng minh) trong trng hp tng s lng thuc  ngh nhp khu, s lng thuc cn tn ti thi im lp n hng v s lng thuc cn c th tip tc nhp khu t cc Giy php nhp khu  c cp trc  vt qu 150% so vi tng nhu cu kinh doanh thc t trong 01 nm trc thi im lp n hng. Mu s 35 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & ..& & .. N HNG NHP KHU NGUYN LIU LM THUC L DC CHT GY NGHIN, DC CHT HNG THN, TIN CHT DNG LM THUC Knh gi: B Y t. 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Ngh nh s & & & .. nh sau: STTTn nguyn liun v tnhS lng (4)Tiu chun cht lngS giy ng k lu hnh/S cng vn cng b (nu c)Tn c s sn xut - Tn nc sn xutGhi ch12(Tn c s nhp khu) cam kt chu trch nhim trc php lut v ngun gc, cht lng ca nguyn liu lm thuc  ngh nhp khu, tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php nhp khu, s dng nguyn liu ng mc ch v thc hin cc quy nh khc ca php lut c lin quan. B Y T Chp thun n hng nhp khu gm & & ..trang & & ..khon km theo Cng vn s& & ./& & & ngy & & . thng & & . nm & & .. ca B Y t. H Ni, ngy & & . thng & & . nm & & .. B TRNG& & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du)Ghi ch: (1) Nguyn liu lm thuc l dc cht gy nghin, dc cht hng thn, tin cht dng lm thuc lp n hng theo Mu s 35 Ph lc III (2) in mc ch nhp khu ph hp: -  lm mu kim nghim, nghin cu thuc -  sn xut thuc xut khu -  sn xut thuc phc v yu cu quc phng, an ninh, phng, chng dch bnh, khc phc hu qu thin tai, thm ha - Lm mu kim nghim/nghin cu khoa hc/th nghim lm sng/nh gi sinh kh dng/tng ng sinh hc (3) in s iu ti Ngh nh tng ng vi hnh thc nhp khu (4) Thc hin nh sau: - i vi trng hp nhp khu dc cht trong Danh mc thuc, dc cht b cm s dng trong mt s ngnh, l)nh vc theo quy nh ti iu 80 Ngh nh: Gii trnh c th l do (km ti liu chng minh) trong trng hp tng s lng nguyn liu  ngh nhp khu, s lng nguyn liu cn tn ti thi im lp n hng v s lng nguyn liu cn c th tip tc nhp khu t cc Giy php nhp khu  c cp trc  vt qu 150% so vi tng nhu cu kinh doanh, s dng thc t trong 01 nm trc thi im lp n hng. - i vi trng hp nhp khu quy nh ti iu 82 v iu 84 Ngh nh: nh km vn bn ca c s nhp khu gii trnh c th v k hoch s dng i vi s lng dc cht, dc liu, bn thnh phm thuc, bn thnh phm dc liu  ngh nhp khu. Mu s 37 Ph lc III TN C S -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & ..& & .. BO CO S DNG NGUYN LIU LM THUC PHI KIM SOT C BIT Knh gi: B Y t. (K bo co: t ngy ... n ngy& & ..)** TTTn nguyn liu kim sot c bitNh sn xut nguyn liu, nc sn xutn v tnhS lng tn kho cui k bo co trcS lng nhp khu/mua trong k bo coS nguyn liu s dng trong sn xut (bao gm c s lng hao ht)*S nguyn liu s dng cho nghin cu, kim nghim*S lng nguyn liu bn cho c s khc*S lng nguyn liu b tiu hy*Tng s nguyn liu s dngTn kho cui k bo coTng s nguyn liu c th nhp khu tip theo giy php  c cp trc *S lng nhp khu*S lng mua t c s khc*(1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12) = (8) + (9) + (10)(13) = (5) + (6) + (7) - (11) -(12)(14)1.(Tn nguyn liu 1)2.(Tn nguyn liu 2)Ghi ch: * Nu c, phi bo co chi tit trong ph lc nh km: - Ct (6): C ph lc nh km ghi r thng tin v s giy ng k lu hnh hoc s giy php nhp khu nguyn liu (nu c), tn c s sn xut nguyn liu, s lng nguyn liu  nhp v thi im nhp cho tng ln nhp khu (nh km ti liu chng minh). - Ct (7): C ph lc nh km ghi r thng tin chi tit v tn v a ch c s  bn nguyn liu cho c s nhp khu, s lng nguyn liu  mua t c s  v thi im ca tng ln mua. - Ct (8): Thng tin v thuc thnh phm sn xut t nguyn liu nhp khu, bao gm: tn thuc, nng /hm lng nguyn liu phi kim sot c bit, s giy ng k lu hnh hoc s giy php nhp khu ca thuc, mc ch sn xut (thuc lu hnh trong nc hay thuc ch sn xut  xut khu), n v tnh ca thuc, tn nguyn liu kim sot c bit, s lng nguyn liu ca tng nh sn xut khc nhau  s dng  sn xut (ghi r thng tin v khi lng nguyn liu b hao ht trong qu trnh sn xut nu c). - Ct (9): C ph lc nh km ghi r thng tin chi tit v vic nghin cu, kim nghim. - Ct (10): C ph lc nh km ghi r thng tin chi tit v tn v a ch ca tng c s  mua nguyn liu t c s nhp khu, s lng nguyn liu  bn cho c s  v thi im ca tng ln bn. - Ct (11): C ph lc nh km ghi r l do tiu hy, s lng tiu hy v thi im tiu hy ca tng ln tiu hy. - Ct (14): C ph lc ghi r thng tin s giy php nhp khu  c cp cn c th s dng  nhp khu tip nguyn liu, ngy ht hiu lc ca giy php, s lng nguyn liu  c cp php, s lng nguyn liu thc t  nhp, s lng nguyn liu cn c th c nhp khu tip (nh km ti liu chng minh). ** Bo co trong k 01 nm trc thi im lp bo co i vi trng hp nguyn liu nhp khu l dc cht trong Danh mc thuc, dc cht b cm s dng trong mt s ngnh, l)nh vc. Ni nhn: - B Y t; - Lu ti c s& & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du) Mu s 38 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & & & .. BO CO KT QU KINH DOANH THUC THNH PHM SN XUT T NGUYN LIU KIM SOT C BIT  NGH NHP KHU Knh gi: B Y t. (K bo co: t ngy & & .. n ngy & & ..)(**) STTTn thuc, hm lng/nng , dng bo ch, quy cch ng giS giy ng k lu hnhn v tnhS lng thuc tn kho cui k bo co trcS lng thuc sn xut trong k bo coS lng thuc b tr li t cc c s khc (nu c)S lng xut bn trong k bo co*S lng hao ht (hng, v, ht hn dng, tiu hy)*Tn kho cui k bo coGhi ch(1)(2)(3)(4)(5)(6)(7)(8)(9)(10) = (5) + (6) +(7) -(8)-(9)(10)Ghi ch: * Nu c, phi bo co chi tit, c th nh sau: - Ct (8): C ph lc nh km ghi r Danh sch chi tit tn, a ch khch hng, nc xut khu (i vi thuc xut khu), s lng thuc mua theo tng thi im trong k bo co t c s nhp khu. - Ct (9): C ph lc nh km bo co chi tit v s lng hao ht i vi tng l do hao ht (hng, v, ht hn dng, tiu hy). ** Bo co trong k 01 nm trc thi im lp bo co i vi thuc thuc danh mc thuc, dc cht trong Danh mc thuc, dc cht b cm s dng trong mt s ngnh, l)nh vc. Ni nhn: - B Y t; - Lu ti c s. NGI LP BO CO& & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du) Mu s 41 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. N HNG NHP KHU DC LIU, BN THNH PHM DC LIU Knh gi: B Y t. (C s nhp khu) knh  ngh B Y t xt duyt cho nhp khu dc liu, bn thnh phm dc liu  & & & .(1)& & & . theo quy nh ti iu & & .(2)& & . Ngh nh s & & & & .. nh sau: STTTn dc liu (tn ting Vit) (3)B phn dngTn khoa hc (tn La tinh)n v tnhS lngTiu chun cht lngTn c s sn xut - Tn nc sn xutTn c s cung cp - Tn nc cung cp (4)Ghi ch12Ca khu d nh s nhp khu (ghi r tn sn bay, hi cng): (Tn c s nhp khu) cam kt chu trch nhim trc php lut v: 1. Ngun gc, cht lng ca nguyn liu lm thuc  ngh nhp khu, tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php nhp khu, s dng dc liu/bn thnh phm dc liu  ngh nhp khu ng mc ch v thc hin cc quy nh khc ca php lut c lin quan. 2. Thuc thnh phm sn xut t dc liu/bn thnh phm dc liu nhp khu ch  xut khu, khng lu hnh ti Vit Nam (5). B Y T Chp thun n hng nhp khu gm & & ..trang & & ..khon km theo Cng vn s& & ./& & & ngy & & . thng & & . nm & & .. ca B Y t H Ni, ngy & & . thng & & . nm & & .. B TRNG& & & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K, ghi r h tn, ng du)Ghi ch: (1) in mc ch nhp khu ph hp: -  lm mu kim nghim, nghin cu thuc -  sn xut thuc xut khu -  sn xut thuc phc v yu cu quc phng, an ninh, phng, chng dch bnh, khc phc hu qu thin tai, thm ha - Lm mu kim nghim/nghin cu khoa hc/th nghim lm sng/nh gi sinh kh dng/tng ng sinh hc -  sn xut, nghin cu sn xut thuc (i vi bn thnh phm dc liu) - Cc trng hp khc (i vi dc liu) (2) in s iu ti Ngh nh tng ng vi hnh thc nhp khu (3) i vi bn thnh phm dc liu ghi dng bo ch, tn dc liu bng ting Vit v tn khoa hc, b phn dng, hm lng/khi lng ca tng dc liu. Trng hp khng c tn ting Vit th ghi tn dc liu ca nc xut khu. (4) Ch yu cu trong trng hp nhp khu dc liu, bn thnh phm dc liu quy nh ti iu 87 Ngh nh. (5) Ch yu cu trong trng hp nhp khu dc liu, bn thnh phm dc liu quy nh ti iu 84 Ngh nh. Mu s 43 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. N HNG NHP KHU T DC, V NANG, BAO B TIP XC TRC TIP VI THUC, CHT CHUN Knh gi: B Y t. (C s nhp khu) knh  ngh B Y t xt duyt cho nhp khu t dc, v nang, bao b tip xc trc tip vi thuc, cht chun sau: STTTn nguyn liu, bao b tip xc trc tip vi thuc, cht chunn v tnhS lngTiu chun cht lngTn c s sn xut - Tn nc sn xutGhi ch123(Tn c s nhp khu) cam kt chu trch nhim trc php lut v ngun gc, cht lng ca t dc/v nang/bao b tip xc trc tip vi thuc/cht chun  ngh nhp khu  ngh nhp khu, tnh chnh xc, hp l ca cc thng tin, giy t trong h s  ngh cp php nhp khu, s dng t dc/bao b tip xc trc tip vi thuc/cht chun  ngh nhp khu ng mc ch v thc hin cc quy nh khc ca php lut c lin quan. B Y T Chp thun n hng nhp khu gm & & ..trang & & ..khon km theo Cng vn s& & ./& & & ngy & & . thng & & . nm & & .. ca B Y t. H Ni, ngy & & . thng & & . nm & & .. B TRNG& & & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du) Mu s 46 Ph lc III DANH MC Nguyn liu  sn xut thuc theo h s ng k thuc  c giy ng k lu hnh ti Vit Nam c nhp khu khng phi thc hin cp php nhp khu(1)/ Nguyn liu lm thuc phi kim sot c bit  sn xut thuc theo h s ng k thuc  c giy ng k lu hnh ti Vit Nam phi thc hin cp php nhp khu (2) STTS giy ng k lu hnh thucHiu lc Giy ng k lu hnh thuc (3)Tn nguyn liu lm thuc c cng b (4)Tiu chun cht lng ca nguyn liu (5)Tn c s sn xut nguyn liua ch c s sn xut nguyn liu (6)Tn nc sn xut nguyn liu1.2.Ghi ch: (1): p dng i vi Danh mc nguyn liu lm thuc c nhp khu khng phi thc hin vic cp php nhp khu. (2): p dng i vi Danh mc nguyn liu lm thuc phi kim sot c bit phi thc hin vic cp php nhp khu. (3): Trng hp thuc dng  cng b nguyn liu c vn bn gia hn, duy tr hiu lc s giy ng k lu hnh m hiu lc mi ny cha c cp nht ti Danh mc c B Y t cng b th hiu lc ti ct (4) c php t ng p dng theo hiu lc mi. (4): Tn nguyn liu lm thuc c th l tn chung quc t (INN) hoc theo tn theo danh php Vit Nam v c th km theo tn thng mi. (5): i vi nguyn liu lm thuc p dng tiu chun dc in, c s nhp khu c php nhp khu nguyn liu c tiu chun cht lng cp nht hn (nm ban hnh mi hn hoc s phin bn dc in cao hn). V d: Tiu chun cht lng cng b l USP 30/BP 2012, c s c php nhp khu nguyn liu c tiu chun cht lng USP 30, 31, 32..../BP 2012, 2013, 2014... (6): Ch p dng i vi nguyn liu l dc cht gy nghin, dc cht hng thn, tin cht dng lm thuc. Mu s 47 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. BO CO NHP KHU L VC XIN Knh gi:- B Y t; - Vin kim nh Quc gia Vc xin v Sinh phm y t.1. Tn v a ch c s nhp khu: 2. Thng tin v ngi lp bo co: - H v tn - S in thoi lin h: (C s nhp khu) bo co v s lng vc xin nhp khu theo quy nh ti im a khon 21 iu 91 ca Ngh nh s 54/2017/N-CP nh sau: STTTn vc xin, dng bo ch, quy cch ng gin v tnhTn c s sn xut, nc sn xutTn c s cung cp, nc xut khuThng tin v giy ng k lu hnh hoc php nhp khuThi im nhp khuS l sn xutNgy sn xut, hn dngS lng nhp khuCa khu nhp khuNgy gi mu kim nhS lng thuc cn c th nhp khu tip theo giy php nhp khu*S giy ng k lu hnh hoc s giy php nhp khuNgy cp php - Ngy ht hiu lcS lng c cp php (1)Ghi ch: (1) Ch p dng i vi trng hp nhp khu vc xin theo hnh thc giy php nhp khu cha c giy ng k lu hnh ti Vit Nam. NGI LP BO CO& & & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du) Mu s 48 Ph lc III TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. BO CO NHP KHU L THUC CHA C GIY NG K LU HNH THUC TI VIT NAM Knh gi: B Y t. 1. Tn v a ch c s nhp khu: 2. Thng tin v ngi lp bo co: - H v tn - S in thoi lin h: (C s nhp khu) bo co v s lng thuc c nhp khu theo hnh thc giy php nhp khu cha c giy ng k lu hnh ti Vit Nam theo quy nh ti im a khon 21 iu 91 ca Ngh nh s 54/2017/N-CP nh sau: STTTn thuc, dng bo ch, quy cch ng giTn hot cht*, nng  hoc hm lng,n v tnhTn c s sn xut, nc sn xutTn c s cung cp, nc xut khuThng tin v giy php nhp khuThi im nhp khuS l sn xutS lng nhp khuCa khu nhp khuS lng thuc cn c th nhp khu tip theo giy php nhp khuS giy phpNgy cp php -Ngy ht hiu lcS lng c cp php* i vi thuc dc liu, thuc c truyn: Ghi tn dc liu (tn ting Vit km tn khoa hc). Trng hp khng c tn ting Vit th ghi theo tn ca nc xut khu km tn khoa hc. i vi bn thnh phm dc liu, ghi thm dng bo ch. NGI LP BO CO& & & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du) Mu s 49 Ph lc III TN C S -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. BO CO XUT KHU, NHP KHU VC XIN (T .... n & & & & & ) Knh gi: B Y t. 1. Tn v a ch c s xut khu/nhp khu: 2. Thng tin v ngi lp bo co: - H v tn - S in thoi lin h: (C s xut khu/nhp khu) bo co v s lng vc xin c xut khu/nhp khu theo quy nh ti im b khon 21 iu 91 ca Ngh nh s 54/2017/N-CP nh sau: 1. Xut khu vc xin: STTTn thuc, dng bo ch, quy cch ng giCh nhS giy ng k lu hnh/S giy php nhp khu, ngy cpn v tnhS lngNgy xut khuTn c s sn xut - Tn ncTn c s nhp khu - Tn ncCa khu xut khu2. Nhp khu vc xin: STTTn thuc, dng bo ch, quy cch ng gi,Ch nhS giy ng k lu hnh/S giy php nhp khu, ngy cpn v tnhS lngS lHn dngNgy nhp khuS lng tn kho ti thi im lp bo coTn c s sn xut - Tn nc sn xutTn c s cung cp - Tn ncCa khu nhp khu NGI LP BO CO& & & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du) Mu s 50 Ph lc III TN C S -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & ..& & .. BO CO XUT KHU, NHP KHU THUC, NGUYN LIU LM THUC (T & & & . n& & & & .. ) Knh gi: B Y t. 1. Tn v a ch c s xut khu/nhp khu: 2. Thng tin v ngi lp bo co: - H v tn - S in thoi lin h: (C s xut khu/nhp khu) bo co v s lng thuc/nguyn liu lm thuc c xut khu/nhp khu theo quy nh ti im b khon 21 iu 91 ca Ngh nh s 54/2017/N-CP nh sau: 1. Xut khu nguyn liu lm thuc: STTTn nguyn liu lm thuc (1)Tn c s sn xutTn nc sn xutTiu chun cht lngTn c s nhp khuTn nc nhp khuS giy ng k lu hnh/S giy php xut khu, ngy cp (nu c)n v tnhS lng xut khuCa khu xut khu2. Xut khu thuc: STTTn thuc, nng  hoc hm lng, dng bo chTn hot cht (2)Quy cch ng giTn c s sn xutTn nc sn xutTn c s nhp khuTn nc nhp khuS giy ng k lu hnh/S giy php xut khu, ngy cp (nu c)n v tnhS lng xut khuCa khu xut khu3. Nhp khu nguyn liu lm thuc: STTTn nguyn liu lm thuc (1)Tn c s sn xutTn nc sn xutTiu chun cht lngTn c s cung cpTn nc xut khuS giy ng k lu hnh/S giy php xut khu, ngy cpn v tnhS lng nhp khuCa khu nhp khu4. Nhp khu thuc: STTTn thuc, nng  hoc hm lng, dng bo chTn hot cht (2)Quy cch ng giTn c s sn xutTn nc sn xutTn c s cung cpTn nc xut khuS giy ng k lu hnh/S giy php nhp khu, ngy cpn v tnhS lng nhp khuCa khu nhp khu NGI LP BO CO& & & & .., ngy & & . thng & & . nm & & .. NGI I DIN PHP LUT/NGI C Y QUYN (K tn, ng du)Ghi ch: (1) i vi dc liu ghi tn dc liu (tn ting Vit km tn khoa hc). Trng hp khng c tn ting Vit th ghi theo tn ca nc xut khu km tn khoa hc. i vi bn thnh phm dc liu, ghi thm dng bo ch. (2) i vi thuc dc liu, thuc c truyn: Ghi tn dc liu (tn ting Vit km tn khoa hc). Trng hp khng c tn ting Vit th ghi theo tn ca nc xut khu km tn khoa hc. i vi bn thnh phm dc liu, ghi thm dng bo ch. Mu s 06 Ph lc VI TN C QUAN XC NHN -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc --------------- GIY XC NHN NI DUNG THNG TIN THUC THEO HNH THC HI THO GII THIU THUC(1)/QUNG CO THUC QUA PHNG TIN HI THO, HI NGH, S KIN GII THIU THUC(2) Tn c quan xc nhn:.& & & & & .& & & & & & & & & Xc nhn ni dung thng tin thuc theo hnh thc hi tho gii thiu thuc(1)/qung co thuc qua phng tin hi tho, hi ngh, s kin gii thiu thuc (2): STTTn thucS giy ng k lu hnh/giy php nhp khu thuc12n  ngh s: Tn c s  ngh xc nhn: a ch: S giy xc nhn: a im t chc thng tin thuc(1)/qung co thuc(2): Thi gian t chc thng tin thuc(1)/qung co thuc(2): Tn tnh/thnh ph, ngy ... thng... nm... TH TRNG C QUAN XC NHN (K v ghi r h, tn, chc danh; ng du)Ghi ch: (1) p dng vi trng hp c quan xc nhn l S Y t; (2) p dng vi trng hp c quan xc nhn l B Y t. Lu : Giy xc nhn ch c gi tr i vi thi gian, a im t chc hi tho v ni dung  c xc nhn Mu s 07 Ph Ic VI TN C QUAN TIP NHN H S -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S:& & (1)& & . (a danh), ngy & . thng & . nm & & . PHIU TIP NHN VN BN THNG BO NI DUNG THNG TIN THUC(2)/QUNG CO THUC(3) CN NH CHNH 1. C s np: 2. a ch c s np vn bn (trng hp np h s qua ng bu in): & & & & & & & & .. 3. Hnh thc np: Trc tip % Bu in % 4. S, ngy thng nm vn bn ca c s: 5. Tn thuc  ngh xc nhn ni dung thng tin thuc(2)/qung co thuc(3): 6. S Giy xc nhn ni dung thng tin thuc(2)/qung co thuc(3)  c cp, ngy cp: 7. Ni dung thng tin thuc(2)/qung co thuc(3) cn nh chnh(4) 8. Danh mc ti liu km theo (nu c)(5): NGI NHN H S (K v ghi r h tn)Ghi ch: (1) S phiu tip nhn vn bn. (2) p dng i vi  ngh xc nhn ni dung thng tin thuc. (3) p dng i vi  ngh xc nhn ni dung qung co thuc. (4) Ghi tm tt cc yu cu cn nh chnh. (5) Cc ti liu chng minh cho ni dung cn nh chnh (lit k chi tit hoc danh mc km theo). Mu s 01 Ph lc VII TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & V/v bng k khai gi thuc nc ngoi nhp khu vo Vit Nam& & & & .., ngy & & . thng & & . nm 20& ..  BNG K KHAI GI THUC NC NGOI NHP KHU VO VIT NAM Knh gi: B Y t. Tn thuc, dng bo ch, quy cch ng giHot chtNng / hm lngNc sn xutS giy ng k lu hnh/Giy php nhp khun v tnhGi nhp khu thc t (CIF/FOB...)(*)Gi bn bun d kinGi bn l d kin (Nu c)1. Ti liu km theo: Bng thuyt minh v c cu gi (Theo Mu s 09 Ph lc VII km theo Ngh nh ny) Cc ti liu khc km theo (nu c): & & & & & & & & & & & & & & & & & & & & & & & & & & & . 2. i vi thuc cha c thuc cng hot cht, nng , hm lng, dng bo ch trn th trng Vit Nam,  ngh cung cp thng tin v gi nhp khu, gi bn bun ti nc s ti v ti cc nc ASEAN trong trng hp c bn ti cc nc ny. Trng hp khng bn ti cc nc ny ghi r thng tin  Thuc khng bn ti cc nc ASEAN C s cam kt v chu trch nhim trc php lut v tnh chnh xc ca cc thng tin  k khai. GIM C C S NHP KHU (K, ghi r h, tn v ng du)Ghi ch: - T gi ngoi t: ... ngy & /& /& - Gi nhp khu tnh theo ngoi t v ghi r t gi p dng. - Gi bn bun d kin v gi bn l d kin  bao gm thu gi tr gia tng v tnh theo VN. - n v tnh: Tnh theo quy cch ng gi nh nht. - (*)  ngh ghi r loi gi nhp khu: CIF hoc FOB hoc CIP... Mu s 02 Ph lc VII TN C S -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & V/v k khai gi thuc& & & & .., ngy & & . thng & & . nm 20& .. BNG K KHAI GI THUC SN XUT TRONG NC Knh gi: B Y t. Tn thuc, dng bo ch, quy cch ng giHot chtNng / Hm lngS giy ng k lu hnhn v tnhGi thnhGi bn bun d kinGi bn l d kin (Nu c)Cc ti liu km theo: - Bng thuyt minh v c cu gi (Theo Mu s 10 Ph lc VII km theo Ngh nh ny) - Ti liu khc km theo (nu c): .& & & & & .& & & & & & & & & .& & & & & .& & & & & & & & & C s cam kt v chu trch nhim trc php lut v tnh chnh xc ca cc thng tin  k khai. GIM C C S SN XUT THUC HOC C S T GIA CNG THUC (K, ghi r h tn, ng du)Ghi ch: - n v tnh: Tnh theo quy cch ng gi nh nht. - Gi bn bun, bn l d kin  bao gm thu gi tr gia tng v gi thnh tnh theo VN. Mu s 03 Ph lc VII TN C S NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & & .. V/v k khai li gi thuc& & & .., ngy & & . thng & & . nm 20& .. BNG K KHAI LI GI THUC NC NGOI NHP KHU VO VIT NAM Knh gi: B Y t. Tn thuc, dng bo ch, quy cch ng giHot chtNng / Hm lngS giy ng k lu hnh/Giy php nhp khun v tnhNc sn xutGi nhp khu thc t (CIF/FOB...)(*)Gi bn bun, bn l d kin (nu c) KK/KKL lin k (Ngy.../.../...)K khai liT l tng (%) KK/KKL lin k (Ngy.../.../...)K khai liT l tng (%)BunLBunLBunLCc ti liu km theo Bng k khai: 1. Vn bn gii trnh l do tng gi v thuyt minh v t l tng gi. 2. Ti liu chng minh l do tng gi v t l tng gi gm: - Bng thuyt minh v c cu gi (Theo Mu s 09 Ph lc VII km theo Ngh nh ny) - & C s cam kt v chu trch nhim trc php lut v tnh chnh xc ca cc thng tin  k khai. GIM C C S NHP KHU (K, ghi r h tn, ng du)Ghi ch: - T gi: ... ngy & ../& & /& & - Gi nhp khu tnh theo ngoi t v ghi r t gi p dng. - Gi bn bun d kin v gi bn l d kin  bao gm thu gi tr gia tng v tnh theo VN. - (*)  ngh ghi r loi gi nhp khu: CIF hoc FOB hoc CIP... Mu s 04 Ph lc VII TN C S -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & V/v bng k khai li gi thuc sn xut trong nc& & & & .., ngy & & . thng & & . nm 20& ..  BNG K KHAI LI GI THUC SN XUT TRONG NC Knh gi: y ban nhn dn tnh/thnh ph .... Tn thuc, dng bo ch, quy cch ng giHot chtNng / Hm lngS giy ng k lu hnhn v tnhGi thnhGi bn bun, bn l d kin (nu c) KK/KKL lin k (Ngy.../.../...)K khai liT l tng (%) KK/KKL lin k (Ngy.../.../...)K khai liT l tng (%)BunLBunLBunLCc ti liu km theo Bng k khai: 1. Vn bn gii trnh l do tng gi v thuyt minh v t l tng gi. 2. Ti liu chng minh l do tng gi v t l tng gi gm: - Bng thuyt minh v c cu gi (Theo Mu s 10 Ph lc VII km theo Ngh nh ny) - & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & . C s cam kt v chu trch nhim trc php lut v tnh chnh xc ca cc thng tin  k khai. GIM C C S SN XUT THUC HOC C S T GIA CNG THUC (K, ghi r h tn, ng du)Ghi ch: - Gi bn bun d kin v gi bn l d kin  bao gm thu gi tr gia tng v tnh theo VN. - Gi thnh tnh theo VN. PH LC III SA I CC MU KM THEO NGH NH S 91/2016/N-CP NGY 01 THNG 7 NM 2016 (Km theo Ngh nh s 155/2018/N-CP ngy 12 thng 11 nm 2018 ca Chnh ph) Mu s 01 Ph lc IVn bn cng b  iu kin sn xut ch phmMu s 03 Ph lc IVn bn cng b  iu kin thc hin kho nghimMu s 04 Ph lc IVn bn  ngh ng k lu hnh miMu s 05 Ph lc IVn bn  ngh ng k lu hnh b sungMu s 06 Ph lc IVn bn  ngh ng k gia hn s ng k lu hnhMu s 08 Ph lc IVn bn cng b  iu kin cung cp dch v dit cn trng, dit khun bng ch phmPh lc VIBo co qu trnh lu hnhPh lc VIIYu cu i vi giy y quynPh lc IXHng dn cch ghi nhn ha cht, ch phm dit cn trng, dit khunPh lc XPhiu tr li kt qu kho nghim Mu s 01 Ph lc I CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc --------------- & & 1& .., ngy & .. thng & .. nm 20... VN BN CNG B  iu kin sn xut ch phm Knh gi: & & & & & & 2& & & ..& & & 1. Tn c s: a ch tr s: & & & & & & & & & & & & ..3 in thoi: & & & & & & & & & & & & & & .& & Fax: Email: & & & & & & & & & & & & & & & & & & Website (nu c): 2. Ngi i din theo php lut ca c s sn xut: H v tn: in thoi c nh: & & & & & & & & & & & & & & in thoi di ng: Fax: & & & & & & & & & & & & & & & & & & & & . Email: 3. a ch ni sn xut: & & & & & & & & & & & & ..4 4. Cng b ln u %5 Cng b li % s phiu tip nhn & & & & & .6& & & & & 5. Cc ch phm do c s sn xut: STTLoi ch phmQuy m (& ....7& & ./nm)Ghi ch1Dit cn trng %2Dit khun %Sau khi nghin cu Ngh nh s 91/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph, chng ti cng b c s sn xut ca chng ti  iu kin sn xut ch phm v gi km theo vn bn ny b h s gm cc giy t sau: 1Vn bn cng b  iu kin sn xut ch phm%2Bn k khai nhn s%3Vn bn phn cng ngi iu hnh sn xut (i vi c s sn xut ha cht nguy him)%4S  mt bng nh xng, kho%5Giy t chng minh tun th quy chun k thut v khong cch an ton (i vi ha cht nguy him)%6Danh mc cc bin php phng nga, ng ph s c ha cht hoc k hoch phng nga, ng ph s c ha cht%C s cng b  iu kin sn xut ch phm xin cam kt v tnh chnh xc ca cc ti liu trong h s cng b./. NGI I DIN THEO PHP LUT (K trc tip, ghi r h tn v ng du)__________________ 1 a danh 2 S Y t ni c s sn xut t nh xng sn xut 3 Ghi theo a ch trn giy chng nhn ng k kinh doanh 4 Nu trng vi a ch ni ng k kinh doanh th ghi  ti tr s 5 nh du vo cng b ln u hoc cng b li 6 Ghi s phiu tip nhn ca ln cng b gn nht 7 n v trng lng hoc th tch Mu s 03 Ph lc I CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc --------------- & & 1& .., ngy & .. thng & .. nm 20... VN BN CNG B  iu kin thc hin kho nghim Knh gi: B Y t (Cc Qun l mi trng y t) 1. Tn c s: a ch tr s: in thoi: & & & & & & & & & & & .. Fax: Email: & & & & & & & & & & & & & & & & & .. Website (nu c): 2. Cng b ln u %2 Cng b li % s phiu tip nhn & & & 3& & & & Sau khi nghin cu Ngh nh s 91/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph, chng ti cng b c s kho nghim ca chng ti  iu kin thc hin kho nghim ch phm v gi km theo vn bn ny b h s gm cc giy t sau: 1Vn bn cng b  iu kin thc hin kho nghim%2Danh mc tn cc quy trnh kho nghim m c s c kh nng kho nghim%3Bn k khai nhn s%4Giy chng nhn t tiu chun ISO 17025: 2005 hoc tiu chun ISO 15189: 2012 hoc phin bn cp nht%C s cng b  iu kin thc hin kho nghim xin cam kt v tnh chnh xc ca cc ti liu trong h s cng b./. NGI I DIN THEO PHP LUT (K trc tip, ghi r h tn v ng du)______________________ 1 a danh 2 nh du vo cng b ln u hoc cng b li 3 Ghi s phiu tip nhn ca ln cng b gn nht Mu s 04 Ph lc I CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc --------------- & & 1& .., ngy & .. thng & .. nm & & ... VN BN  NGH NG K LU HNH MI Knh gi: B Y t (Cc Qun l mi trng y t). 2& & & & &  ngh ng k lu hnh mi ch phm nh sau: 1. Tn thng mi: & & & & & & ..3 2. Thnh phn v hm lng hot cht (%): & & & & & 4 3. Dng ch phm: .....................5 4. Quy cch ng gi: & & & & .6 5. Tn c s sn xut: 6. a ch ni sn xut: & & & & & & & & & & & & .in thoi:& & & & & & Fax: 7. Tn c s ng k: 8. a ch: 9. in thoi: & & & & & & & & & & & & & & & . Fax: 10. Tc dng ca ch phm: & & & & & & 7 11. Hn dng ca ch phm: & & & & & .8 12. Xin nhp khu (nu c) & & & & & & .9 NGI I DIN THEO PHP LUT (K trc tip, ghi r h tn v ng du)__________________ 1 a danh 2 Ghi tn c s ng k 3 i vi ch phm nhp khu, ghi chnh xc tn thng mi theo giy chng nhn lu hnh t do  c cp 4 Ch ghi cc hot cht v ph gia c tc dng cng hng. Hm lng hot cht ghi di dng % v ghi r theo khi lng/th tch (kl/tt hoc w/v), khi lng/khi lng (kl/kl hoc w/w) hoc th tch/th tch (tt/tt hoc v/v) ty theo tnh cht ca ch phm. 5 L dng thnh phm trong bao b, khng ghi quy cch ng gi. V d: dng thnh phm trong bnh xt l dng lng, nhang mui l dng rn. i vi cc ch phm dit cn trng c dng ch phm nh nhi du, huyn ph... th ghi dng ch phm bng ting Vit km theo tn vit tt ca dng ch phm bng ting Anh trong ngoc. V d: huyn ph (SC). 6 Ghi r dng chai, gi, ti... v km theo nh lng 7 Ghi ngn gn tc dng ca ch phm v ghi r phm vi s dng l gia dng hay y t hoc c hai. V d: dit mui dng trong gia dng; ra tay st khun dng trong gia dng v y t. 8 Ghi r bao nhiu nm hoc thng k t ngy sn xut. 9 Nu c cn ghi r nhp khu ch phm (i vi ch phm nhp khu) hay nhp khu nguyn liu  sn xut ch phm  lm kim nghim, kho nghim v bao gm cc thng tin sau: TTTn thng miHm lng hot chtn v tnhS lngTn, a ch nh sn xut Mu s 05 Ph lc I CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc --------------- & & 1& .., ngy & .. thng & .. nm & & ... VN BN  NGH NG K LU HNH B SUNG Knh gi: B Y t (Cc Qun l mi trng y t). & & & ..2& & & & & ..  ngh ng k lu hnh b sung ch phm nh sau: 1. Tn thng mi: & & & & & & & ..3 2. Thnh phn v hm lng hot cht (%): & & & & & & ..4 3. Dng ch phm: & & & & & & & & & & & & 5 4. Quy cch ng gi: & & & & & & & & & & .6 5. Ni dung  ngh ng k lu hnh b sung: & & & & & & & ..7 6. S ng k lu hnh: & & & & & & & & & & .. c gi tr n: 7. Tn c s sn xut: 8. a ch ni sn xut: & & & & & & & & & & . in thoi: & & & & & & Fax: 9. Tn c s ng k: 10. a ch: 11. in thoi: & & & & & & & & & & & & & .. Fax: NGI I DIN THEO PHP LUT (K trc tip, ghi r h tn v ng du)_______________________ 1 a danh 2 Ghi tn c s ng k 3 i vi ch phm nhp khu, ghi chnh xc tn thng mi theo giy chng nhn lu hnh t do  c cp 4 - Ch ghi cc hot cht v ph gia c tc dng cng hng. - Hm lng hot cht ghi di dng % v ghi r theo khi lng/th tch (kl/tt hoc w/v), khi lng/khi lng (kl/kl hoc w/w) hoc th tch/th tch (tt/tt hoc v/v) ty theo tnh cht ca ch phm. 5 L dng thnh phm trong bao b, khng ghi quy cch ng gi. V d: dng thnh phm trong bnh xt l dng lng, nhang mui l dng rn. i vi cc ch phm dit cn trng c dng ch phm nh nhi du, huyn ph... th ghi dng ch phm bng ting Vit km theo tn vit tt ca dng ch phm bng ting Anh trong ngoc. V d: huyn ph (SC). 6 Ghi r dng chai, gi, ti... v km theo nh lng 7 Ghi r cc ni dung  ngh thay i v s hu giy chng nhn, tn thng mi, a ch, thng tin lin lc, tc dng, ch tiu cht lng. Mu s 06 Ph lc I CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc --------------- & & 1& .., ngy & .. thng & .. nm & & ... VN BN  NGH NG K GIA HN S NG K LU HNH Knh gi: B Y t (Cc Qun l mi trng y t). & & & ..2& & & ..  ngh ng k gia hn s ng k lu hnh ch phm nh sau: 1. Tn thng mi: & & & & & & & ..3 2. Thnh phn v hm lng hot cht (%): & & & & & & ..4 3. Dng ch phm: & & & & & & & & & & & & 5 4. S ng k lu hnh: & & & & & & & & & & .. c gi tr n: 5. Cc thay i trong qu trnh lu hnh: & & & & & & & & & 6 . 6. Tn c s sn xut: 7. a ch ni sn xut: & & & & & & & & & & . in thoi: & & & & & & Fax: 8. Tn c s ng k: 9. a ch: 10. in thoi: & & & & & & & & & & & & & .. Fax: 11. Tc dng ca ch phm: & & & & & & & & & & & & & .7 12. Hn s dng: & & & & & & & & & & & & ..8 NGI I DIN THEO PHP LUT (K, ghi r h tn v ng du)_______________ 1 a danh 2 Ghi tn c s ng k 3 i vi ch phm nhp khu, ghi chnh xc tn thng mi theo giy chng nhn lu hnh t do  c cp 4 - Ch ghi cc hot cht v ph gia c tc dng cng hng. - Hm lng hot cht ghi di dng % v ghi r theo khi lng/th tch (kl/tt hoc w/v), khi lng/khi lng (kl/kl hoc w/w) hoc th tch/th tch (tt/tt hoc v/v) ty theo tnh cht ca ch phm. 5 L dng thnh phm trong bao b, khng ghi quy cch, ng gi. V d: dng thnh phm trong bnh xt l dng lng, nhang mui l dng rn. i vi cc ch phm dit cn trng c dng ch phm nh nhi du, huyn ph... th ghi dng ch phm bng ting Vit km theo tn vit tt ca dng ch phm bng ting Anh trong ngoc. V d: huyn ph (SC). 6 Lit k cc thay i trong qu trnh lu hnh, ghi r cc thay i  c chp thun, cc thay i cha c chp thun. 7 Ghi tc dng ca ch phm nh Giy chng nhn ng k lu hnh. 8 Ghi r bao nhiu nm hoc thng k t ngy sn xut. Mu s 08 Ph lc I CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc --------------- & & 1& .., ngy & .. thng & .. nm 20... VN BN CNG B  iu kin cung cp dch v dit cn trng, dit khun bng ch phm Knh gi: & & & & & & 2& & & & & & & & .. 1. Tn c s: a ch tr s: 3 in thoi: & & & & & & & & & & & & & & Fax: Email: & & & & & & & & & & & & & & & & .Website (nu c): 2. Cng b ln u %4 Cng b li % s phiu tip nhn & & & 5& & & . Sau khi nghin cu Ngh nh s 91/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph, chng ti cng b c s ca chng ti  iu kin cung cp dch v dit cn trng, dit khun bng ch phm v gi km theo vn bn ny b h s gm cc giy t sau: 1Vn bn cng b  iu kin cung cp dch v dit cn trng, dit khun bng ch phm%2Danh sch ngi c tp hun kin thc c xc nhn ca ch c s%C s cng b  iu kin cung cp dch v dit cn trng, dit khun bng ch phm xin cam kt v tnh chnh xc ca cc ti liu trong h s cng b./. NGI I DIN THEO PHP LUT (K trc tip, ghi r h tn v ng du)___________________ 1 a danh 2 S Y t ni c s cung cp dch v t tr s 3 Ghi theo a ch trn giy chng nhn ng k doanh nghip 4 nh du vo cng b ln u hoc cng b li 5 Ghi s phiu tip nhn ca ln cng b gn nht Ph lc VI BO CO QU TRNH LU HNH (Km theo Ngh nh s 91/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph) CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------- & & & & & .., ngy & & thng & .. nm 20& .. BO CO QU TRNH LU HNH CH PHM Knh gi: B Y t (Cc Qun l mi trng y t). Tn c s ng k: a ch: & & & & & & & & & & & & . in thoi: & & & ..& ..& & & & Fax: Tn c s sn xut: a ch: & & & & & & & & & & & & in thoi: & & & & & & .& & & . Fax: Tn c s nhp khu (i vi ch phm nhp khu) a ch: Tn thng mi: Thnh phn v hm lng hot cht (%): Hn s dng: Dng ch phm v quy cch ng gi: Thi gian sn xut/nhp khun v tnhS lng sn xut/nhp khuS lng tiu thVi phm php lut v ha cht, ch phm v hnh thc x phtNm 20& ..Nm 20& ..Nm 20& ..Tng cngChng ti cam kt cc ni dung nu trn l ng. Nu sai, chng ti hon ton chu trch nhim trc php lut./. NGI I DIN THEO PHP LUT (K trc tip, ghi r h tn v ng du) Ph lc VII YU CU I VI GIY Y QUYN (Km theo Ngh nh s 91/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph) 1. Ni dung: Giy y quyn phi c y  cc ni dung sau: - Tn, a ch ca ch s hu ch phm. - Tn, a ch ca t chc, c nhn c y quyn. - Phm vi y quyn (ng tn ng k lu hnh ch phm ti Vit Nam i vi trng hp y quyn ng k.) - Tn thng mi ca ch phm c y quyn. - a ch c s sn xut ch phm. - Thi hn y quyn. - Cam kt ch s hu ch phm cung cp y  h s thng tin ch phm cho t chc, c nhn c y quyn  thc hin vic ng k lu hnh. - Tn, chc danh, ch k trc tip ca ngi i din cho bn y quyn. 2. Trng hp ch s hu ch phm  y quyn cho mt c s ng k lu hnh ch phm ti Vit Nam v  c cp s ng k lu hnh; trong thi hn s ng k lu hnh cn hiu lc, ch s hu y quyn cho n v khc ng k lu hnh ti Vit Nam th giy y quyn mi phi km theo vn bn chp thun khng tip tc ng tn ng k lu hnh v  ngh rt s ng k lu hnh ca c s ang s hu s ng k lu hnh ch phm. 3. Hp php ha lnh s: Giy y quyn ca c s  nc ngoi phi c hp php ha lnh s theo quy nh, tr trng hp c min hp php ha lnh s theo iu c quc t m Vit Nam l thnh vin. Ph lc IX HNG DN CCH GHI NHN HA CHT, CH PHM DIT CN TRNG, DIT KHUN (Km theo Ngh nh s 91/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph) Ha cht, ch phm lu hnh trong nc, xut khu, nhp khu phi ghi nhn ph hp vi quy nh v ghi nhn hng ha ti Ngh nh s 43/2017/N-CP ngy 14 thng 4 nm 2017 ca Chnh ph v hng dn ca h thng hi ha ton cu v phn loi v ghi nhn ha cht theo quy nh ca B trng B Cng Thng. Ngoi ra, nhn ha cht, ch phm phi p ng cc yu cu sau: I. I VI CH PHM: 1. Ni dung bt buc phi ghi trn nhn: a) Tn thng mi; b) Thnh phn, hm lng hot cht; c) Tc dng v hng dn s dng; d) Hng dn bo qun; ) Thng tin cnh bo v nguy c gy hi n sc khe con ngi v mi trng; e) Bin php x l khi b nhim ch phm; g) Tn c s sn xut, a ch ni sn xut; h) Tn, a ch ca c s ng k; i) S l sn xut; k) Ngy, thng, nm sn xut hoc thng, nm sn xut; l) Hn s dng; m) S ng k lu hnh ti Vit Nam. 2. Hnh thc nhn: a) Cc t, k t to thnh tn thng mi phi c vit lin tc theo ng Vn bn  ngh ng k lu hnh, c chiu cao ti thiu bng k t ln nht trn nhn; b) Nhn phi c in r rng, d c, khng b m nht, rch nt trong qu trnh lu thng, bo qun, vn chuyn v s dng, chiu cao ch khng c thp hn 0,9 mm; c) Nhn phi c gn cht hoc in trn bao b ch phm; d) Nn nhn khng c dng mu trng vi mu ch  c ca ch phm. 3. Biu tng  c trn nhn theo phn loi ca T chc Y t th gii i vi cc ch phm dit cn trng c  c thuc nhm I, II, III theo phn loi ca T chc Y t th gii th nhn phi ghi thm cc hnh tng biu hin  c nh sau: a) Vch mu ch  c t  phn di cng ca nhn v c  di bng  di ca nhn, chiu cao tng ng 10% chiu cao ca nhn; b) Cc hnh tng biu hin  c v cnh bo tng ng ca mi loi ch phm phi t  pha trn tn thng mi ca sn phm nh sau:  cVch muNhm c Ia, IbRt c Hnh tng mu en trn nn mu trng.Nhm c IIc cao Hnh tng mu en trn nn mu trng.VngNhm c IIINguy him  EMBED PBrush Hnh tng mu en trn nn mu trng.Xanh lamII. I VI HA CHT: 1. Ni dung bt buc phi ghi trn nhn: a) Tn thng mi; b) Thnh phn, hm lng hot cht; c) Hng dn bo qun; d) Thng tin cnh bo v nguy c gy hi n sc khe con ngi v mi trng; ) Tn c s sn xut, a ch ni sn xut; e) Ngy, thng, nm sn xut hoc thng, nm sn xut; g) Hn s dng. 2. Hnh thc nhn: a) Nhn phi c in r rng, d c, khng b m nht, rch nt trong qu trnh lu thng, bo qun, vn chuyn v s dng, chiu cao ch khng c thp hn 0,9 mm; b) Nhn phi c gn cht hoc in trn bao b ha cht. Ph lc X PHIU TR LI KT QU KHO NGHIM (Km theo Ngh nh s 91/2016/N-CP ngy 01 thng 7 nm 2016 ca Chnh ph) N V KHO NGHIM -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: & & & & & & ., ngy & . thng & . nm 20& . PHIU TR LI KT QU KHO NGHIM (Km theo kt qu kho nghim chi tit) I. Tn ha cht, ch phm kho nghim: 1. Tn mu kho nghim: 2. Thnh phn v hm lng hot cht: 3. Tn nh sn xut: 4. a ch nh sn xut: 5. Ngy sn xut: 6. Hn s dng: 7. S lng mu s dng trong th nghim v lu: II. Mc ch kho nghim: III. n v yu cu kho nghim: IV. n v kho nghim: V. Ngy v a im kho nghim: VI. Liu lng v phng php s dng: VII. Kt qu:1 1. Hiu lc: An ton: VIII. Kt lun: 1. Hiu lc:2 2. An ton:3 3. kin  xut:4 TRNG PHNG TH NGHIMKHOA/PHNGGIM C/ VIN TRNG___________________ 1 Kt qu phi ghi chi tit cch nh gi v kt qu nh gi hiu lc ca ha cht, ch phm i vi cn trng th nghim theo liu lng v phng php s dng ghi trn nhn ch phm; cch nh gi v kt qu nh gi tc dng ph ca ch phm th nghim i vi ngi tham gia th nghim. 2 Tm tt kt lun v hiu lc ca ch phm theo tng phng php s dng v liu lng s dng. 3 Tm tt nh gi v tc dng ph ca ch phm i vi ngi tham gia th nghim. 4 Phi ghi r ch phm c th c ng k lu hnh hay khng v vi mc ch, phng php v liu lng s dng nh th no cn c trn kt lun v hiu lc v an ton. PH LC IV B SUNG MU S 25 KM THEO NGH NH S 89/2018/N-CP NGY 25 THNG 6 NM 2018 (Km theo Ngh nh s 155/2018/N-CP ngy 12 thng 11 nm 2018 ca Chnh ph) TN N V NHP KHU -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: / V/v & & & & & & & 1& & & ., ngy & .. thng & .. nm 20& .. VN BN  NGH CP GIY PHP NHP KHU MU BNH PHM Knh gi: B Y t (Cc Y t d phng). Cc ni dung nu trong cng vn bao gm: - Cn c  nhp khu mu bnh phm. - Cc thng tin v mu bnh phm nhp khu + Thng tin loi mu bnh phm (mu bnh phm c cha hoc c kh nng cha tc nhn gy bnh truyn nhim cho ngi). - Loi mu; - Ngun gc; - S lng; - Hnh thc ng gi; - Ni gi; - Ni nhn; - ng vn chuyn. + Cam kt ca n v nhp khu v vic thc hin ng quy nh v bo qun, vn chuyn, s dng.... mu bnh phm. + Cc ti liu km theo& & & & + H tn, s in thoi lin h ca cn b theo di. Ni nhn: - Nh trn; - Lu:TH TRNG N V (K tn, ng du)_________________ 1 a danh PH LC V SA I MU S 02 KM THEO NGH NH S 10/2015/N-CP NGY 28 THNG 01 NM 2015 (Km theo Ngh nh s 155/2018/N-CP ngy 12 thng 11 nm 2018 ca Chnh ph) B Y T -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: /BB-BYT& & .., ngy & thng & . nm 20&  BIN BN Thm nh c s c thc hin k thut th tinh trong ng nghim, lu gi tinh trng, lu gi phi ti & & & & Thc hin Quyt nh s: & & /Q-BYT ngy .... thng ... nm 20.... ca B trng B Y t v vic thnh lp on thm nh c s c thc hin k thut th tinh trong ng nghim thuc & & (ghi r thuc c s khm bnh, cha bnh no, nu c), hm nay, ngy.... thng.... nm 20..., on  tin hnh thm nh n v h tr sinh sn & & I. THNH PHN THAM D on thm nh B Y t gm: 1. ng/B & & & & & & . lnh o V, Cc ph trch cng tc chm sc sc khe b m, tr em, B Y t - Trng on; 2. ng/B & & & & & & .. lnh o V, Cc ph trch cng tc php ch, B Y t - Ph trng on; 3. & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & C s khm bnh, cha bnh & & & & & . gm: 1. ng/B & & & & & & & .. lnh o c s khm bnh, cha bnh .... 2& & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & .. II. KT QU THM NH 1. Tiu chun cn b TTNi dung yu cuKt quCKhng1C t nht 02 bc s c o to v k thut th tinh trong ng nghim v 02 cn b c trnh  i hc y, dc hoc c nhn sinh hc c o to v phi hc lm sng2- 02 bc s) lm sng c chng ch hnh ngh theo quy nh ca Lut khm bnh, cha bnh. - Cc nhn s phi c vn bng, chng ch hoc chng nhn  c o to v k thut th tinh trong ng nghim do c s o to trong nc hoc nc ngoi cp3Cc nhn s c xc nhn  thc hnh t nht 20 chu k iu tr v sinh bng k thut th tinh trong ng nghim do c s  c B Y t cng nhn  iu kin thc hin k thut th tinh trong ng nghim cpKt lun: & & & & & & & & & & & & & & & & & & & & & & & & & & & & & 2. Tiu chun trang thit b TTNi dung yu cuKt quCKhng123Kt lun:& & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & 3. Tiu chun c s h tng Kt lun: & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & III. KT LUN n v h tr sinh sn & & & & t/khng t cc iu kin v nhn s, trang thit b v c s h tng theo quy nh ti Ngh nh s....ngy& . ca Chnh ph. Trn c s kt qu thm nh, on thm nh trnh Bin bn  lnh o B Y t xem xt cng nhn/khng cng nhn c s  iu kin thc hin k thut th tinh trong ng nghim. Cuc hp thm nh kt thc vo thi gian:.... ngy.... thng.... nm 20.... ON THM NH (K, ghi r h tn)C S KHM BNH, CHA BNH (K, ghi r h tn, ng du) PH LC VI B SUNG PH LC XV KM THEO NGH NH S 109/2016/N-CP NGY 01 THNG 7 NM 2016 (Km theo Ngh nh s 155/2018/N-CP ngy 12 thng 11 nm 2018 ca Chnh ph) Mu s 01n  ngh cp giy chng nhn ngi c bi thuc gia truyn hoc phng php cha bnh gia truynMu s 02Bn thuyt minh v bi thuc gia truyn hoc phng php cha bnh gia truynMu s 03Giy xc minhMu s 04n  ngh cp li giy chng nhn ngi c bi thuc gia truyn hoc phng php cha bnh gia truynMu s 05Phiu tip nhn h s  ngh cp, cp li giy chng nhn ngi c bi thuc gia truyn hoc phng php cha bnh gia truynMu s 06Giy chng nhn bi thuc gia truyn hoc phng php cha bnh gia truyn Mu s 01 CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ------------------------ & & 1& & .., ngy.... thng... nm 20.... N  NGH Cp giy chng nhn ngi c bi thuc gia truyn hoc phng php cha bnh gia truyn Knh gi: & & & & & & & & 2& & & & & & & & H v tn: & & & & & & & & & & & & & & & & & & & & & & & & & & .Nam/N: Ngy, thng, nm sinh: Ch  hin nay: 3 Giy chng minh nhn dn/H chiu s/nh danh c nhn: Ngy cp: Ni cp: & in thoi: & & & & & & & & & & & & & & & & Email (nu c): Ti xin gi km theo n ny b h s gm cc giy t sau: 1. n  ngh cp giy chng nhn ngi c bi thuc gia truyn/phng php cha bnh gia truyn%2. Bn thuyt minh v bi thuc gia truyn, phng php cha bnh gia truyn%3. S yu l lch (trong thi gian khng qu 6 thng)%4. Giy chng nhn sc khe (trong thi gian khng qu 6 thng)%5. Hai nh 4 cm x 6 cm (mu, nn trng, thi gian khng qu 6 thng)%Knh  ngh qu c quan xem xt v cp giy chng nhn ngi c bi thuc gia truyn, phng php cha bnh gia truyn cho ti./. NGI LM N (K v ghi r h, tn)______________________ 1 a danh. 2 Tn c quan cp Giy chng nhn ngi c bi thuc gia truyn, phng php cha bnh gia truyn. 3 Ghi r a ch theo ni ng k h khu thng tr hoc tm tr. Mu s 02 CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ------------------------ & & 1& & .., ngy.... thng... nm 20.... BN THUYT MINH V BI THUC GIA TRUYN HOC PHNG PHP CHA BNH GIA TRUYN H v tn: Nam/N& & & & . Ngy, thng, nm sinh: Ch  hin nay: 2 Giy chng minh nhn dn/H chiu s/nh danh c nhn: Ngy cp: & & & & & & & & & & & & & & & & & & & & & & & & .Ni cp: in thoi: & & & & & & & & & & & & & & ..Email ( nu c): Ti c bi thuc gia truyn/phng php cha bnh gia truyn chuyn cha: Bi thuc gia truyn/phng php cha bnh gia truyn ny  c thc hin t i: 1. ng (b) & & & & & & & & & & & & & & & & & & & & & & & a ch 2. n ng (b) & & & & & & & & & & & & & & & & & & a ch 3. n ng (b) & & & & & & & & & & & & & & & & & & a ch A. Trng hp l bi thuc gia truyn phi ghi r: - Tn bi thuc; - Xut x ca bi thuc qua cc i trong dng tc, gia nh, ni  s dng bi thuc  iu tr; - Cng thc ca bi thuc (ghi r tn tng v, liu lng); - Cch bo ch; - c tnh (nu c) v phng php ch bin gim c tnh; - Dng thuc; - Liu dng; - Cch dng, ng dng; - Ch nh v chng ch nh; - Hiu qu cha bnh; - Tc dng khng mong mun (nu c), x l khi tc dng khng mong mun xy ra. B. Trng hp l phng php cha bnh gia truyn phi ghi r: - Tn phng php; - Hiu qu cha bnh; - Ch nh; - Chng ch nh; - Tai bin (nu c), cch x l tai bin khi xy ra; - K thut (thao tc thc hin). Ti xin hon ton chu trch nhim v ni dung ca bn thuyt trnh, nu sai ti hon ton chu trch nhim trc php lut. NGI THUYT MINH____________________ 1 a danh. 2 Ghi r a ch theo ni ng k h khu thng tr hoc tm tr. Mu s 03 CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ------------------------ & & 1& & .., ngy.... thng... nm 20.... GIY XC MINH Hi ng y tnh/thnh ph xc nhn ng/b: & & & & & & & & & & & & & & & & & .Nam/N: Ngy, thng, nm sinh: Ch  hin nay: 2 Giy chng minh nhn dn/H chiu s: Ngy cp: & & & & & & & & & & & & & & & & & & & & & & & & & .Ni cp: in thoi: & & & & & & & & & & & & & & & & & & & & & & Email (nu c): L ngi s hu hp php bi thuc gia truyn/phng php cha bnh gia truyn cha: - C thi gian thc hnh bi thuc gia truyn/phng php cha bnh gia truyn& & & & & & - C o c ngh nghip Hi ng y tnh/thnh ph & & & & & .& .... ngh Gim c S Y t xt duyt cp Giy chng nhn ngi c bi thuc gia truyn/phng php cha bnh gia truyn: (Tn bi thuc gia truyn/phng php cha bnh gia truyn). TM. BCH HI NG Y TNH (K tn, ng du)___________________________ 1 a danh. 2 Ghi r a ch theo ni ng k h khu thng tr hoc tm tr. Mu s 04 CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ------------------------ & & 1& & .., ngy.... thng... nm 20.... N  NGH Cp li giy chng nhn ngi c bi thuc gia truyn hoc phng php cha bnh gia truyn Knh gi: & & & & & & & & & & & & & ..2 & & & & & & & & & & & & & H v tn: Nam/N& & & & . Ngy, thng, nm sinh: Ch  hin nay: 3 Giy chng minh nhn dn/H chiu s: Ngy cp: & & & & & & & & & & & & & & & & & & & & & & & & & ..Ni cp: in thoi: & & & & & & & & & & & & & & & & & & & & & & & Email (nu c): S Giy chng nhn ngi c bi thuc/phng php cha bnh gia truyn ci: & & & & & & .Ngy cp:& & & & & & & & . Ni cp: Ti xin gi km theo n ny b h s gm cc giy t sau: 1. n  ngh cp li giy chng nhn ngi c bi thuc gia truyn/phng php cha bnh gia truyn: - Do b mt % - Do b h hng % - Do b thu hi % 2. Giy chng nhn sc khe (trong thi gian khng qu 6 thng) % 3. Hai nh 4 cm x 6 cm (mu, nn trng, thi gian khng qu 6 thng) % Knh  ngh qu c quan xem xt v cp li giy chng nhn ngi c bi thuc gia truyn, phng php cha bnh gia truyn cho ti. NGI LM N (K v ghi r h, tn)_____________ 1 a danh. 2 Tn c quan cp Giy chng nhn l lng y. 3 Ghi r a ch theo ni ng k h khu thng tr hoc tm tr. Mu s 05 & & & ..1& & & .. -------CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc ---------------S: /PTN-& ..2& ..& & ..3& & , ngy thng nm 20& . PHIU TIP NHN H s  ngh cp, cp li giy chng nhn ngi c bi thuc gia truyn hoc phng php cha bnh gia truyn H v tn: Ch  hin nay: 4 in thoi: Hnh thc cp giy chng nhn: Cp mi % Cp li %  nhn h s  ngh cp, cp li giy chng nhn ngi c bi thuc gia truyn, phng php cha bnh gia truyn bao gm: 1. n  ngh cp giy chng nhn ngi c bi thuc gia truyn/phng php cha bnh gia truyn%2. Bn thuyt minh bi thuc gia truyn/phng php cha bnh gia truyn%3. S yu l lch%4. Giy chng nhn sc khe%5. Hai nh mu 04 cm x 06 cm%Ngy hn cp, cp li giy chng nhn: & & & , ngy thng nm 20... NGI TIP NHN H S (K, ghi r chc danh, h v tn) Tip nhn h s b sung ln: ngy thng nm K nhn Tip nhn h s b sung ln: ngy thng nm K nhn Tip nhn h s b sung ln: ngy thng nm K nhn__________________ 1 Tn c quan cp Giy chng nhn ngi c bi thuc gia truyn, phng php cha bnh gia truyn. 2 Ch vit tt tn c quan cp Giy chng nhn. 3 a danh. 4 Ghi r a ch theo ni ng k thng tr hoc tm tr. Mu s 06 Y BAN NHN DN TNH/ THNH PH S Y T ------- CNG HA X HI CH NGH(A VIT NAM c lp - T do - Hnh phc --------------- nh GIY CHNG NHN BI THUC GIA TRUYN HOC PHNG PHP CHA BNH GIA TRUYN Cn c Lut khm bnh, cha bnh s 40/2009/QH12 ngy 23 thng 11 nm 2009; Cn c Lut dc s 105/2006/QH13 ngy 06 thng 4 nm 2016; Theo  ngh ca& & & & & & & & & & & & & & & & & .., GIM C S Y T: Chng nhn ng/b Nm sinh: a ch thng tr: Giy chng minh nhn dn/h chiu s c cp giy chng nhn bi thuc gia truyn/phng php cha bnh gia truyn: Tn bi thuc/tn phng php: Phm vi chuyn mn: Ch c khm cha bnh bng bi thuc gia truyn/phng php gia truyn  ghi  trn. & & & , ngy & & thng & & nm... 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