AI CNG V MN QUAN LY DC

* Muc tiu 1. Trinh bay c muc tiu va ni dung cua mn Quan ly Dc 2. Tom tt s lc lich s phat trin cua nganh Dc th gii va Vit Nam 1. Khai quat mn Quan ly Dc 1.1. Khai nim v mn hoc Mn quan ly dc la mn hoc nghip vu, chuyn nghin cu v t chc va quan ly chuyn mn v dc trong tt ca cac khu: xut nhp khu, san xut, pha ch, tn tr, bao quan, mua ban, cung ng va s dung thuc nhm am bao cht lng thuc phong va cha bnh cho nhn dn. 1.2. Muc tiu mn hoc - Trinh bay c t chc dc trong h thng nganh kinh t. - Trinh bay c ni dung c ban cua cac quy ch, ch quan ly trong xut nhp khu, san xut, pha ch, bao quan, tn tr, lu thng va s dung thuc, cac nguyn liu lam thuc, dam bao an toan, hp ly v thuc cho ngi tiu dung. - M ta cac hinh thc, phng phap t chc quan ly san xut va kinh doanh thuc. - Vn dung c nhng kin thc a hoc vao thc t trong qua trinh hoc tp tai trng cung nh trong cng tac dc sau nay. 1.3. Ni dung mn hoc Mn quan ly dc nghin cu cac vn sau y - Cac quy ch, ch chuyn mn dc a ban hanh. - T chc, quan ly linh vc v dc trong pham vi toan quc. 2. S lc lich s nganh Dc th gii va Vit Nam 2.1. S lc lich s nganh Dc th gii 2.2. S lc lich s nganh Dc Vit Nam

QUY CH QUAN LY CHT LNG THUC

* Muc tiu 1. Trinh bay c cac khai nim: cht lng hang hoa, cht lng thuc, thuc gia, thuc kem cht lng. 2. Trinh bay c 4 giai oan quyt inh cht lng thuc 3. Trinh bay cac quy inh chinh yu trong ni dung cua quy ch quan ly cht lng thuc. 1. Mt s khai nim 1.1. inh nghia thuc Thuc la nhng san phm co ngun gc t ng vt, thc vt, khoang vt, hoa tng hp hay sinh tng hp va c bao ch di dang thich hp (vin, dung dich tim, ung, m, siro,) dung cho ngi nhm muc ich: - Phong va cha bnh - Lam giam cac triu chng bnh - Chn oan bnh - Phuc hi va iu chinh chc nng cua c th. - Phuc hi hoc nng cao sc khoe - Lam mt cam giac cua mt b phn c th hay toan thn - Lam anh hng n qua trinh sinh e - Lam thy i hinh dang c th. 1.2. inh nghia cht lng thuc *Theo quan nim c in: Cht lng la mc phu hp vi quy inh cua c quan co thm quyn. *Theo quan im hin ai: Cht lng la mc phu hp cua san phm vi muc ich s dung va ap ng c nhu cu cua khach hang. Nh vy, cht lng cua mt san phm hay hang hoa noi chung c inh nghia khai quat nh sau: cht lng san phm la hiu qua cua mt san phm hoc mt dich vu nhm thoa man nhng nhu cu cua ngi s dung. Theo tng cuc o lng cua My thi: cht lng san phm la toan b c tinh va c trng cua san phm hay dich vu nhm thoa man nhu cu c nu ra. Cht lng thuc la tng hp cac c tinh cua thuc th hin mc phu hp nhng yu cu inh trc trong iu kin xac inh v kinh t, ky thut va xa hi. Nhng yu cu inh trc o la: - Co hiu qua phong va cha bnh - An toan, it co tac dung khng mong mun. - n inh cht lng trong mt thi han xac inh (han s dung) - Tin dung, d bao quan
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- Hinh thc gy c tin tng cho ngi s dung. 1.3. inh nghia thuc gia Theo WHO: thuc gia la ch phm c san xut khng ung vi nhan v phng din inh tinh, hay ngun gc cua thuc vi s c y la ao cua nha san xut. Khai nim thuc gia co th ap dung cho ca thuc gc ln bit dc. Thuc gia bao gm ca nhng ch phm c san xut vi ung hoc sai thanh phn cng thc a ng ky, khng co hay khng u ham lng hoat cht hoc c ong goi trong bao bi gia mao. Nh vy, thuc gia bao gm 4 loai: - Khng co hoat cht - Co hoat cht khac vi hoat cht ghi trn nhan - Co hoat cht nhng ham lng thp - Co u hoat cht nhng mao tn, mu ma san phm cua cac hang khac a ng ky bao h c quyn. 1.4. inh nghia thuc kem phm cht Thuc kem phm cht la thuc do chinh nha san xut a ng ky vi c quan quan ly nha nc v mu ma, nhan mac, tiu chun cht lng. Nhng khi nha san xut a ra thi trng lai khng at cac chi tiu cht lng a ng ky. Nha san xut khng co y la ao, nhng do quan ly cht lng yu kem trong qua trinh san xut hoc lu thng nn san phm kem cht lng lot ra ngoai thi trng. 2. Cac ly thuyt c ban v quan ly cht lng thuc 2.3. Cac giai oan quyt inh cht lng thuc Thuc c hinh thanh chu yu qua 4 giai oan: nghin cu, san xut, bao quan va s dung. Trong o, hai giai oan u tin tao ra cht lng, giai oan th ba duy tri cht lng va giai oan cui cung th hin cht lng. am bao cht lng cua thuc, WHO va cac t chc dc phm cung nh nhiu c quan y t va c quan quan ly dc cac quc gia a a ra nhiu quy ch, lut l va cac hng dn thc hanh, ap dung cho qua trinh nghin cu, phat minh, bao lu, duy tri va phat huy cht lng cua thuc. Cac hng dn thc hanh nay goi tt la cac GP (good practices) trong linh vc dc. Trong giai oan 1: GCP (good clinical practices); GLP (good laboratory pratices) Trong giai oan 2: GMP (good manufactoring practices); GLP, GSP (good storage practices) Trong giai oan 3: GDP (good distribution practices); GLP, GSP Trong giai oan 4: GPP (good prescribing practices); GPP (good pharmacy practices); GPP (good pharmacovigilance practices)
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2.4.

Cac nhn t quyt inh n cht lng cua thuc Cht lng cua thuc cung nh cht lng cua cac san phm khac phu thuc rt nhiu vao yu t ni tai cua nha san xut (4M:methods, menpower, material, machine). Ngoai ra, cht lng thuc cung phu thuc vao cac yu t vi m nh: trinh nn kinh t, khoa hoc cng ngh, h thng chinh sach phap lut cua Nha nc, cac yu t vn hoa xa hi khac. 3. Cac quy inh cua quy ch quan ly cht lng thuc (Ban hanh kem theo quyt inh cua B trng B y t s 09/2010/TT BYT ngay 28 thang 04 nm 2010). Trich mt s ni dung c ban sau: 3.1. Nhng quy inh chung iu 1. Phm vi iu chnh Thng t ny quy nh cc hot ng v qun l cht lng thuc trong qu trnh sn xut, xut khu, nhp khu, lu hnh v s dng ti Vit Nam; quyn v trch nhim ca c s kinh doanh thuc, ngi tiu dng v cc t chc, c nhn lin quan n cht lng thuc. iu 2. i tng p dng Thng t ny p dng i vi cc t chc, c nhn (sau y gi chung l c s) kinh doanh thuc v cc c quan, t chc, c nhn (sau y gi chung l n v) c lin quan n hot ng qun l cht lng thuc ti Vit Nam. iu 3. Gii thch t ng Trong Thng t ny, mt s t ng di y c hiu nh sau: 1. Thuc l cht hoc hn hp cc cht dng cho ngi nhm mc ch phng bnh, cha bnh, chn on bnh hoc iu chnh chc nng sinh l c th bao gm thuc thnh phm, nguyn liu lm thuc, vc xin, sinh phm y t, tr thc phm chc nng. 2. Vc xin l ch phm cha khng nguyn to cho c th kh nng p ng min dch, c dng vi mc ch phng bnh. 3. Sinh phm y t l sn phm c ngun gc sinh hc c dng phng bnh, cha bnh v chn on bnh cho ngi. 4. Nguyn liu lm thuc l cht tham gia vo thnh phn cu to sn phm trong qu trnh sn xut thuc. 5. Dc cht (cn gi l hot cht) l cht hoc hn hp cc cht c hot tnh iu tr c s dng trong sn xut thuc. 6. Thuc thnh phm l dng thuc qua tt c cc giai on sn xut, k c ng gi trong bao b cui cng v dn nhn.

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

15. Kim nghim thuc l vic ly mu, xem xt tiu chun k thut, tin hnh cc th nghim tng ng v cn thit nhm xc nh nguyn liu, bn thnh phm, thnh phm c p ng tiu chun cht lng khng quyt nh vic chp nhn hay loi b thuc . iu 4. n v v dng c o lng n v o lng v trang thit b, dng c o lng s dng trong ngnh dc tun th theo quy nh ca php lut v o lng. 3.2. Xy dng, cng b va ap dung tiu chun cht lng thuc iu 5. Tiu chun cht lng v thuc 1. Tiu chun quc gia: Dc in Vit Nam l b tiu chun quc gia v thuc. 2. Tiu chun c s: l tiu chun do c s sn xut, pha ch bin son, p dng i vi cc sn phm do c s sn xut, pha ch. 3. Tiu chun cht lng ca thuc c B Y t cho php lu hnh c gi tr nh bn cam kt ca c s kinh doanh, pha ch i vi cht lng ca thuc c sn xut, pha ch, lu hnh v s dng; l cn c c quan qun l, c quan kim tra cht lng thuc xc nh v kt lun v cht lng thuc trong qu trnh sn xut, lu hnh v s dng. Trong qu trnh qun l sn xut, lu hnh thuc, c s kinh doanh c th p dng tiu chun cht lng ni b, bao gm tiu chun cht lng thuc c B Y t xem xt v cc ch tiu cht lng b sung khc. 4. Quy nh v vic p dng Dc in Vit Nam: a) Cc c s sn xut, pha ch thuc c th p dng Dc in Vit Nam hoc xy dng tiu chun c s cho sn phm do mnh sn xut trn c s cc quy nh ti Dc in Vit Nam v cc vn bn php lut lin quan; b) Cc yu cu v ch tiu cht lng v mc cht lng c quy nh ti tng chuyn lun tiu chun cht lng thuc ca Dc in Vit Nam l yu cu bt buc p dng. B Y t khuyn khch cc c s p dng cc phng php th ghi trong tng chuyn lun tiu chun cht lng thuc quy nh ti Dc in Vit Nam; c) Cc yu cu v ch tiu cht lng, mc cht lng v phng php th chung c quy nh ti cc Ph lc ca Dc in Vit Nam l yu cu bt buc p dng. Mi s sai khc phi c chng minh, i chiu bo m ti thiu phi tng ng vi quy nh ti Dc in Vit Nam; d) Tiu chun c s ca thuc ti thiu phi p ng cc yu cu v ch tiu cht lng v mc cht lng c quy nh ti chuyn lun tiu chun cht lng thuc tng ng ca Dc in Vit Nam;
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) Cc c s sn xut, pha ch thuc phi cp nht tiu chun cht lng thuc do mnh sn xut, pha ch ph hp vi phin bn mi nht c hiu lc ca Dc in Vit Nam. 5. Quy nh v vic p dng tiu chun quc t, dc in nc ngoi: a) C s kinh doanh thuc ti Vit Nam c php p dng trc tip cc dc in c s dng thng dng trong thng mi dc phm quc t: Chu u, Anh, Hoa K, Quc t, Nht Bn. Vic p dng phi bao gm ton b cc quy nh v tiu ch cht lng, mc cht lng v phng php th quy nh ti dc in ; b) Trng hp c s kinh doanh thuc p dng cc dc in khc cc dc in nu im a, khon ny hoc tiu chun c s th tiu chun cht lng p dng ti thiu phi p ng cc yu cu v ch tiu cht lng v mc cht lng c quy nh ti chuyn lun tiu chun cht lng tng ng ca Dc in Vit Nam hoc ca cc dc in thng dng quy nh ti im a, khon 5 ca iu ny; c) Trng hp cc dc in thng dng quy nh ti im a, khon 5 ca iu ny khng c chuyn lun tiu chun cht lng thuc tng ng, c s kinh doanh thuc c th p dng dc in khc hoc tiu chun c s, nhng phi c nh gi theo quy nh v c B Y t xt duyt; d) Cc c s kinh doanh thuc phi kp thi cp nht tiu chun cht lng thuc p ng cc quy nh ti cc phin bn mi nht ca cc dc in. iu 6. Bin son B tiu chun quc gia v thuc, ban hnh p dng Dc in Vit Nam. 1. Hi ng Dc in Vit Nam c nhim v t chc nghin cu bin son B tiu chun quc gia v thuc theo k hoch tiu chun ho ca B Y t v nh k r sot, b sung, sa i tiu chun quc gia v thuc. 2. Cc Qun l dc lm u mi xem xt, ly kin, t chc thm tra v phi hp vi Hi ng Dc in hon chnh h s d tho B tiu chun quc gia v thuc; chuyn B Khoa hc v Cng ngh thm nh v cng b B tiu chun quc gia v thuc; trnh B trng B Y t ban hnh Dc in Vit Nam trn c s B tiu chun quc gia v thuc. Trnh t bin son, thm nh cng b B tiu chun quc gia v thuc, v ban hnh Dc in Vit nam tun th theo cc quy nh ti Thng t lin tch s 11/2008/TTLT/BYT-BKHCN ngy 29/12/2008 ca B Y t v B Khoa hc v Cng ngh hng dn xy dng, thm nh, cng b B tiu chun quc gia v thuc v ban hnh, xut bn Dc in Vit Nam. iu 7. Xy dng, cng b tiu chun cht lng ca thuc lu hnh 1. C s sn xut c th p dng tiu chun c s hoc p dng tiu chun dc in.
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Trng hp p dng tiu chun c s, c s sn xut phi t chc nghin cu, xy dng tiu chun cht lng (tham kho mu tiu chun c s ti Ph lc 1) v tin hnh thm nh, chng minh s ph hp ca phng php kim nghim ghi trong tiu chun c s. Trng hp p dng tiu chun dc in, c s sn xut phi tin hnh nh gi s ph hp ca phng php kim nghim p dng i vi thuc do c s sn xut. 2. i vi thuc ha dc, sinh phm y t, thuc ng y, thuc t dc liu: a) Cc c s sn xut thuc t nguyn tc, tiu chun Thc hnh tt sn xut thuc (GMP) gi bn tiu chun cht lng nh km theo h s ng k thuc n B Y t xem xt; b) Trng hp c s sn xut thuc ha dc, sinh phm y t cha t nguyn tc, tiu chun Thc hnh tt sn xut thuc: c s sn xut thuc gi bn tiu chun cht lng v mu thuc n mt trong s cc c s kim nghim ca Nh nc v thuc Trung ng hoc doanh nghip lm dch v kim nghim thuc c cp giy chng nhn iu kin kinh doanh dc thm nh xc nhn s ph hp ca phng php th nghim p dng trc khi gi h s ng k thuc n B Y t; c) Trng hp c s sn xut thuc ng y, thuc t dc liu cha t nguyn tc, tiu chun Thc hnh tt sn xut thuc: C s sn xut gi bn tiu chun cht lng v mu thuc n c s kim nghim ca Nh nc v thuc hoc doanh nghip lm dch v kim nghim thuc c cp giy chng nhn iu kin kinh doanh dc thm nh xc nhn s ph hp ca phng php kim nghim p dng trc khi gi h s ng k thuc n B Y t. 3. i vi vc xin, sinh phm y t l huyt thanh cha khng th dng phng bnh, cha bnh cho ngi: C s sn xut gi bn tiu chun cht lng v mu thuc ti Vin Kim nh quc gia vc xin v sinh phm y t thm nh xc nhn s ph hp ca tiu chun cht lng v phng php kim nghim, tnh an ton v hiu lc ca sn phm trc khi gi h s ng k thuc ti B Y t. 4. i vi sinh phm chun on Invitro: a) C s sn xut t nguyn tc, tiu chun Thc hnh tt sn xut thuc hoc tiu chun TCVN ISO 13485 gi bn tiu chun cht lng nh km h s ng k thuc n B Y t xem xt; b) Trng hp c s sn xut cha t nguyn tc, tiu chun Thc hnh tt sn xut thuc hoc tiu chun TCVN ISO 13485: c s sn xut phi gi bn tiu chun cht lng v mu sn phm n Vin Kim nh quc gia vc xin v sinh

phm y t thm nh, xc nhn s ph hp ca phng php kim nghim v nh gi hiu qu chun on ca sn phm trc khi gi h s ng k ti B Y t. 5. i vi thuc thuc Danh mc thuc sn xut trong nc np h s ng k ti S Y t a phng: a) C s sn xut t nguyn tc, tiu chun Thc hnh tt sn xut thuc gi bn tiu chun cht lng nh km h s ng k thuc n S Y t tnh, thnh ph trc thuc Trung ng s ti xem xt; b) Trng hp c s sn xut cha t nguyn tc, tiu chun Thc hnh tt sn xut thuc: C s sn xut gi bn tiu chun cht lng v mu thuc n c s kim nghim ca Nh nc v thuc hoc doanh nghip lm dch v kim nghim thuc c cp giy chng nhn iu kin kinh doanh dc thm nh xc nhn s ph hp ca phng php kim nghim p dng trc khi gi h s ng k thuc n S Y t tnh, thnh ph trc thuc Trung ng s ti. 6. Vic sa i tiu chun cht lng thuc phi c tin hnh theo trnh t, th tc c quy nh ti cc khon 2, khon 3, khon 4 v khon 5 ca iu ny v theo quy nh hin hnh v ng k thuc. iu 8. Xy dng, ban hnh tiu chun c s cc thuc pha ch Tiu chun c s ca cc thuc pha ch trong c s (bn thnh phm, thnh phm ch ng gi, thuc pha ch theo n, thuc pha ch s dng trong bnh vin, vin nghin cu c gng bnh) do c s xy dng v c ngi ng u n v xt duyt v ban hnh. Cc thuc pha ch ny khng c a phn phi, lu hnh trn th trng. 3.3. Quan ly kim tra cht lng thuc trong san xut, pha ch, lu hanh va s dung iu 9. iu kin bo m cht lng thuc ti c s sn xut, pha ch C s sn xut, pha ch thuc phi thc hin cc yu cu v qun l cht lng thuc trong sn xut nh sau: 1. p dng cc nguyn tc, tiu chun Thc hnh tt trong sn xut, phn phi, bo qun, kim nghim thuc v/hoc cc h thng qun l thch hp khc nhm bo m cht lng sn phm do mnh sn xut ph hp vi tiu chun cht lng thuc ng k v c B Y t chp nhn (i vi thuc lu hnh) hoc cng b (i vi thuc pha ch s dng). 2. ng k thuc theo quy nh ti Lut Dc, cc quy nh php lut lin quan v ghi nhn theo quy nh ca php lut v nhn hng ho. 3. Tun th cc quy chun k thut lin quan n qu trnh sn xut, pha ch, kim tra cht lng, bo qun, tiu chun cht lng v cc quy nh khc c lin quan.
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4. Chu s kim tra ca c quan qun l, c quan kim tra cht lng nh nc v thuc theo cc ni dung kim tra ti iu 24 ca Thng t ny. iu 10. iu kin bo m cht lng thuc ti cc c s xut khu, nhp khu, bn bun, bn l, tn tr bo qun, vn chuyn, s dng thuc C s xut khu, nhp khu, bn bun, bn l, tn tr bo qun, vn chuyn thuc phi thc hin cc yu cu v qun l cht lng sau y: 1. p dng cc nguyn tc, tiu chun Thc hnh tt trong bo qun, phn phi thuc v cc bin php thch hp khc nhm duy tr cht lng ca thuc ph hp vi tiu chun cht lng thuc ng k v c B Y t chp nhn n ngi s dng: a) Tuyn dng, o to b tr nhn lc c nng lc chuyn mn theo quy nh; b) Trang b cc phng tin bo qun, vn chuyn thuc bo m iu kin bo qun theo yu cu trong qu trnh bo qun, vn chuyn thuc; c) Trin khai, duy tr ch h s, s sch theo di vic lu thng ca thuc do c s kinh doanh. i vi thuc nhp khu, ngoi vic tun th cc quy nh nu trn, c s nhp khu thuc phi tun th y cc quy nh lin quan n bo m cht lng thuc theo quy nh v nhp khu thuc. 2. Chu s kim tra cht lng thuc ca c quan qun l, c quan kim tra cht lng nh nc v thuc theo ni dung kim tra ti iu 24 ca Thng t ny. iu 11. Kim tra cht lng thuc ti c s kinh doanh thuc 1. Tt c cc thuc (k c nguyn liu, bao b) u phi c kim tra cht lng; ch khi t tiu chun cht lng v ph hp vi cc quy nh c lin quan ca php lut mi c a vo sn xut, pha ch v lu hnh. 2. Ngi ng u v ngi ph trch chuyn mn ca c s kinh doanh, pha ch, s dng thuc phi chu trch nhim v cng tc qun l cht lng v kim tra cht lng thuc ti c s v chu trch nhim v cht lng thuc do c s kinh doanh, pha ch s dng. 3. Cc c s kinh doanh, pha ch, s dng thuc c trch nhim t chc v thc hin cng tc kim tra, kim sot cht lng thuc ti c s. 4. Cc c s sn xut, pha ch thuc phi t chc cng tc kim nghim vi phng tin k thut v cn b chuyn mn ph hp kim nghim, xc nh, nh gi c cht lng thuc trong qu trnh sn xut, xut xng. 5. Khuyn khch cc c s xut khu, nhp khu, bun bn, tn tr, s dng, ty thuc vo phm vi hot ng, t chc cng tc kim nghim thuc nhm bo m theo di c cht lng thuc do mnh kinh doanh.
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6. C s kinh doanh thuc (c s ng k thuc, c s nhp khu thuc) c trch nhim cung cp bn tiu chun cht lng thuc c B Y t chp nhn ti cc c quan kim tra cht lng thuc a phng c thuc lu hnh khi c yu cu. iu 12. Ni dung kim tra cht lng thuc ca cc c s kinh doanh thuc Ty theo phm vi, ni dung hot ng ca c s, cc c s kinh doanh thuc tin hnh t kim tra cht lng thuc theo cc ni dung kim tra cht lng theo quy nh ti iu 25 ca Thng t ny v cc quy nh ni b ca c s nhm bo m cht lng thuc sn xut, kinh doanh. 3.4. Quy inh v inh chi lu hanh, thu hi va x ly thuc vi pham cht lng iu 13. Cc trng hp thuc b nh ch lu hnh, thu hi 1. Thuc b nh ch lu hnh, thu hi trong cc trng hp sau: a) Thuc khng ng chng loi do c s nhm ln trong qu trnh cp pht, giao nhn; b) Thuc khng t tiu chun cht lng ng k; c) Thuc khng p ng y cc yu cu v ghi nhn hng ho ca thuc theo quy nh ti iu 37 ca Lut Dc v cc quy nh khc ca php lut c lin quan; d) Thuc c vt liu bao b v dng ng gi khng p ng yu cu bo m cht lng thuc; ) Thuc khng c s ng k hoc cha c php nhp khu; e) Thuc c thng bo thu hi ca c s sn xut, c quan qun l, c quan kim tra cht lng nh nc v thuc ca Vit Nam hoc nc ngoi: - Thuc gi, thuc nhp lu, thuc khng r ngun gc, xut x; - Thuc sn xut, nhp khu khng ng h s ng k hoc giy php nhp khu; - Thuc c cha cc cht b cm s dng trong sn xut, hoc cha cc cht c hm lng, nng vt qu gii hn hm lng, nng cho php; - Thuc thnh phm sn xut t nguyn liu khng t tiu chun cht lng hoc nguyn liu khng c ngun gc hp php (nhp lu, c s sn xut nguyn liu cha c giy chng nhn iu kin kinh doanh dc hoc nguyn liu khng phi mc ch dng cho ngi hoc nguyn liu cha c giy php s dng cho ngi); - Thuc sn xut ti cc c s cha c cp giy chng nhn iu kin kinh doanh hoc khng p ng iu kin sn xut (khng p ng cc nguyn tc tiu chun Thc hnh tt sn xut thuc hoc cc quy nh khc v iu kin kinh doanh dc);
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- Vc xin c bo qun khng ng theo iu kin bo qun yu cu; - Thuc ht hn s dng; g) Cc trng hp t nguyn thu hi ca c s kinh doanh thuc hoc theo quyt nh ca c quan qun l, c quan kim tra cht lng nh nc v thuc. 2. Hnh thc thu hi: a) Thu hi t nguyn: c s kinh doanh t pht hin, thu hi thuc khng p ng quy nh. Khi pht hin thuc ca c s km cht lng, c nhm ln hoc s c, ngi ng u cc c s kinh doanh thuc phi bo co ngay cho c quan qun l dc (Cc Qun l dc, S Y t cc tnh, thnh ph trc thuc Trung ng) v nguyn nhn, mc vi phm, nh gi mc nguy hi v d kin mc thu hi. Sau khi c kin ca C quan qun l, c s phi c thng bo thu hi ti cc ni c thuc lu hnh v tin hnh hot ng thu hi nhm bo m thu hi ht thuc trn th trng; ng thi theo di, gii quyt cc hu qu do thuc vi phm gy ra. b) Thu hi bt buc: Khi c quan qun l, kim tra nh nc v dc c thm quyn yu cu, c s kinh doanh (ngi s hu giy php lu hnh, c s sn xut, xut nhp khu, y thc nhp khu) phi tin hnh thu hi ngay cc thuc xc nh l c vi phm hoc nghi ng c vi phm nh hng nghim trng n sc khe ca ngi s dng v ca cng ng. 3. Quy nh v cc mc vi phm: a) Cn c phn loi mc vi phm: Cc mc vi phm cht lng c phn loi trn c s nh gi mc nghim trng ca vi phm, nguy c nh hng ti hiu qu iu tr, s an ton ca ngi s dng v phn ng khng mong mun ca thuc. b) Phn loi cc mc vi phm: - Mc 1: Vi phm gy nguy him c th nh hng n tnh mng ca ngi dng thuc, tn thng nghim trng hoc gy cht ngi. - Mc 2: Vi phm c th nh hng ti hiu qu iu tr v an ton khi s dng. - Mc 3: Vi phm khng nh hng hoc t nh hng ti hiu qu iu tr v an ton khi s dng. 4. Mc thng bo nh ch lu hnh v thc hin thu hi thuc a) Mc 1: c thc hin i vi cc vi phm mc 1. Thng bo nh ch lu hnh thuc c gi khn cp ti ngi s hu giy php lu hnh, c s sn xut, xut nhp khu, bn bun, bn l, khoa dc ca c s s dng thuc, ng thi thng bo trn cc phng tin thng tin i chng tt c cc c s kinh doanh, s dng v ngi s dng thuc bit. C s kinh doanh c thuc vi phm phi
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khn cp thc hin cc bin php nhm thu hi trit thuc vi phm trong thi gian ngn nht nhm hn ch hu qu xu xy ra. b) Mc 2: c thc hin i vi cc vi phm mc 2, thng bo nh ch lu hnh c gi n ngi s hu giy php lu hnh, c s sn xut, xut nhp khu, bn bun, bn l. c) Mc 3: c thc hin i vi cc vi phm mc 3, thng bo nh ch lu hnh c gi n c s sn xut, nhp khu, y thc nhp khu v c s bn bun. d) Vic nh ch lu hnh v thu hi thuc c th c thc hin i vi mt l hoc mt s l thuc xc nh hoc mt sn phm hoc ton b cc sn phm ca mt hoc nhiu c s sn xut thuc. 5. Thm quyn thng bo thu hi a) Cc Qun l dc ra thng bo nh ch lu hnh v thu hi thuc trong phm vi ton quc. Thng bo c gi n S Y t cc tnh, thnh ph trc thuc Trung ng, Y t cc ngnh v c s sn xut, nhp khu, y thc nhp khu. b) S Y t tnh, thnh ph trc thuc Trung ng, Y t cc ngnh: - Ra thng bo nh ch lu hnh v thu hi trong phm vi qun l i vi nhng thuc do c quan kim tra cht lng thuc a phng/ngnh kim tra pht hin thuc vi phm; - Ra thng bo nh ch lu hnh v thu hi trn a bn thc hin thng bo thu hi ca Cc Qun l dc, x l vi phm theo quy nh ca php lut v bo co v Cc Qun l dc. c) C s sn xut, xut nhp khu, y thc nhp khu ra thng bo thu hi i vi cc trng hp thu hi t nguyn. 6. Trch nhim thu hi thuc: a) C s sn xut, c s xut khu, nhp khu, y thc nhp khu, c s bn bun thuc chu trch nhim thu hi trit thuc b thu hi. Cc c s khi thu hi hoc nhn c thng bo thu hi t c quan qun l, kim tra cht lng nh nc v thuc hoc t c s cung ng thuc phi: - Thng bo thu hi ti cc c s bn bun, bn l v cc ni c thuc lu hnh; - Tin hnh thu hi khn trng v trit cc mt hng hoc cc l thuc vi phm; - Lp h s thu hi thuc. H s thu hi thuc phi th hin y cc bng chng v vic cung cp thuc, bng chng v vic thc hin thu hi thuc ti c s bn bun, bn l, s dng mua thuc theo biu mu ti Ph lc 3;

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- Gi bo co tin trnh thu hi, kt qu thu hi v x l cc l thuc b thu hi theo biu mu ti Ph lc s 4 v Cc Qun l dc v cc c quan chc nng c lin quan. Thi hn bo co l 72h i vi thu hi mc 1 v 30 ngy i vi thu hi mc 2 v 3; - Gii quyt din bin v hu qu do thuc khng t tiu chun gy ra. b) Cc c s bn l thuc v c s s dng thuc khi nhn c thng bo thu hi (thng tin thu hi thuc bng vn bn hoc qua cc phng tin thng tin i chng) phi khn trng thc hin v tr li thuc b thu hi cho c s cung ng. c) Cc c s sn xut, xut khu, nhp khu, bn bun, bn l thuc phi chu trch nhim tip nhn thuc b thu hi tr li t cc c s kinh doanh, s dng v ngi s dng mua thuc. d) B Y t (Cc Qun l dc, Thanh tra B Y t), S Y t cc tnh, thnh ph trc thuc Trung ng, Y t cc ngnh kim tra, gim st cc c s kinh doanh, s dng thuc thc hin vic thu hi thuc. e) Cc Qun l dc c vn bn hng dn chi tit v quy trnh x l, thu hi thuc, nh gi hiu qu thc hin thng bo thu hi thuc ca cc c s sn xut, kinh doanh thuc. iu 14. Hy thuc (x l thuc vi phm) 1. Cc thuc km cht lng, thuc vi phm v ghi nhn, ty theo mc vi phm c th c x l, ti ch hoc hy b. C s c thuc vi phm mun ti ch phi lm n ngh km theo quy trnh ti ch gi Cc Qun l dc. Vic ti ch ch c thc hin sau khi c kin ng bng vn bn ca Cc Qun l dc. 2. Cc thuc gi, thuc nhp lu, thuc khng r ngun gc, thuc ht hn dng, thuc c cha cc cht b cm s dng, thuc sn xut t nguyn liu khng t tiu chun cht lng, thuc sn xut trong iu kin khng p ng quy nh, mu thuc lu khi ht thi gian lu u phi hy b. C s kinh doanh thuc c thuc vi phm phi chu trch nhim v kinh ph hy thuc. 3. Th trng c s c thuc cn hy ra quyt nh thnh lp Hi ng hy thuc. Hi ng c t nht l 03 ngi, trong phi c cn b ph trch n v v dc s chu trch nhim chuyn mn. 4. Vic hy thuc phi bo m an ton lu di cho ngi, sc vt v trnh nhim mi trng theo cc qui nh ca php lut v bo v mi trng. 5. Vic hy thuc gy nghin, thuc hng tm thn, tin cht dng lm thuc, thuc phng x phi theo ng cc quy nh v hy thuc trong hng dn cc hot ng lin quan n thuc gy nghin; thuc hng tm thn v tin cht dng lm thuc; thuc phng x. Hy thuc xong phi bo co km theo bin bn hy thuc ti c quan qun l trc tip theo biu mu ti Ph lc s 5.
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3.5. Quan ly, kim tra cht lng vc-xin va sinh phm y t iu 15. Quy nh chung Tt c cc c quan, t chc, c nhn, doanh nghip tham gia vo cc hot ng qun l nh nc, sn xut, kinh doanh, s dng vc xin v sinh phm y t phi tun th cc quy nh v qun l, kim tra, sn xut, kinh doanh thuc ti Thng t ny v cc quy nh khc ca php lut c lin quan. iu 16. Quy nh v vic kim nh cht lng vc xin, sinh phm y t l huyt thanh cha khng th dng phng bnh, cha bnh cho ngi 1. B Y t giao cho Vin Kim nh Quc gia vc xin v sinh phm y t chu trch nhim kim nh, nh gi cht lng, an ton, hiu qu v cp giy php xut xng, a ra lu hnh, s dng cho vc xin v sinh phm y t l huyt thanh cha khng th dng phng bnh, cha bnh cho ngi. 2. C s sn xut, kinh doanh vc xin v sinh phm y t phi gi mu v h s sn xut vc xin, sinh phm y t l huyt thanh cha khng th dng phng bnh, cha bnh cho ngi n Vin Kim nh vc xin v sinh phm y t kim nh, nh gi trc khi xut xng, a ra lu hnh, s dng. Th tc v h s gi mu kim nh c quy nh ti iu 17 ca Thng t ny. C s sn xut, nhp khu vc xin v sinh phm y t ch c php xut xng, a ra lu hnh, s dng l vc xin, sinh phm y t l huyt thanh cha khng th dng phng bnh, cha bnh cho ngi sau khi c giy php xut xng do Vin Kim nh Quc gia vc xin v sinh phm y t cp, xc nhn l vc xin, sinh phm y t t tiu chun cht lng, bo m an ton, hiu lc. iu 17. Th tc v h s gi mu kim nh nh gi cht lng, an ton, hiu lc i vi vc xin v sinh phm y t l huyt thanh cha khng th dng phng bnh, cha bnh cho ngi 1. i vi vc xin v sinh phm y t l huyt thanh cha khng th dng phng bnh, cha bnh cho ngi sn xut trong nc: C s sn xut phi gi h s sn xut v mu ca l sn phm (thnh phm, bn thnh phm) ti Vin Kim nh Quc gia vc xin v sinh phm y t bao gm: a) Phiu gi mu kim nh; b) Mu vc xin, sinh phm y t kim nh (s lng mu theo qui nh cho tng loi vc xin, sinh phm y t); c) H s tm tt sn xut v kim tra cht lng ca l vc xin, sinh phm (bn sao c ng du xc nhn ca nh sn xut); d) Phiu kim nghim ca l sn xut. 2. i vi vc xin v sinh phm y t l huyt thanh cha khng th dng phng bnh, cha bnh cho ngi nhp khu: C s nhp khu phi gi h s sn
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xut v mu ca l sn phm ti Vin Kim nh Quc gia vc xin v sinh phm y t bao gm: a) Phiu gi mu kim nh; b) Mu vc xin, sinh phm y t kim nh (s lng mu theo qui nh cho tng loi vc xin, sinh phm y t); c) H s tm tt sn xut v kim tra cht lng ca l vc xin, sinh phm nhp khu (bn sao c ng du xc nhn ca nh sn xut); d) Giy php xut xng ca C quan c thm quyn nc s ti hoc c quan tng ng khc km theo i vi l sn phm nhp khu (bn sao c ng du xc nhn ca Gim c doanh nghip nhp khu); e) Bng chng bo m v iu kin bo qun (dy chuyn lnh) trong qu trnh vn chuyn l hng nhp khu. 3.6. H thng kim nghim thuc va hoat ng kim nghim thuc iu 18. H thng kim nghim thuc 1. C s kim nghim ca Nh nc v thuc - Trung ng: Vin kim nghim thuc Trung ng, Vin Kim nghim thuc Thnh ph H Ch Minh, Vin Kim nh Quc gia vc xin v sinh phm y t v cc Trung tm Kim nghim dc phm, m phm khu vc. - a phng: Trung tm kim nghim dc phm, m phm tnh, thnh ph trc thuc Trung ng. 2. Phng kim nghim thuc ca cc c s kinh doanh thuc. 3. Doanh nghip lm dch v kim nghim thuc: cc doanh nghip c lp lm dch v kim nghim hoc cc phng kim nghim ca cc c s kinh doanh thuc c chc nng lm dch v kim nghim thuc. iu 19. Bo m cht lng ti cc c s kim nghim thuc Cc c s kim nghim thuc ty theo quy m hot ng phi trin khai p dng cc nguyn tc, tiu chun Thc hnh tt phng kim nghim thuc v/hoc cc h thng qun l thch hp khc (v d: ISO/IEC 17025,...) nhm bo m tnh chnh xc ca kt qu kim nghim, phn tch mu thuc. iu 20. Hot ng ca c s kim nghim thuc 1. C s kim nghim ca Nh nc v thuc Trung ng thc hin: a) Kim tra, nh gi cht lng gip B trng B Y t trong vic xc nh cht lng thuc trn phm vi ton quc theo s phn cng ca B trng B Y t. Thm nh tiu chun cht lng thuc v cc sn phm khc theo yu cu ca B Y t. b) Nghin cu khoa hc; ch o chuyn mn k thut cho cc c s kim nghim ca Nh nc v thuc a phng.
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c) o to v o to li cn b kim nghim v chuyn mn k thut kim nghim. d) Thc hin dch v kim nghim. ) xut vi B trng B Y t cc bin php k thut qun l cht lng thuc ph hp vi iu kin pht trin kinh t - x hi ca t nc. e) Cc hot ng khc theo quy nh ca php lut c lin quan. 2. C s kim nghim ca Nh nc v thuc a phng thc hin a) Kim tra cht lng thuc gip Gim c S Y t trong vic xc nh cht lng thuc lu hnh trong phm vi a bn tnh, thnh ph trc thuc Trung ng qun l. b) Thm nh tiu chun cht lng i vi thuc t dc liu, thuc thuc Danh mc thuc sn xut trong nc np h s ng k ti S Y t theo hng dn vic ng k thuc hin hnh. c) Thc hin dch v kim nghim. d) Cc hot ng khc theo quy nh ca php lut c lin quan. 3. Phng kim nghim thuc ca c s sn xut, kinh doanh: a) Phng kim nghim thuc ca c s sn xut, kinh doanh l b phn kim nghim, t kim tra cht lng thuc ca c s, chu trch nhim v hot ng kim tra cht lng thuc ti c s; b) Thc hin vic phn tch, kim nghim xc nh cht lng nguyn liu, ph liu lm thuc, bn thnh phm trong qu trnh sn xut, thuc thnh phm v cc tham gia vo cc hot ng lin quan n nh gi, kim sot iu kin bo m cht lng thuc khc theo quy nh ca c s. 4. Doanh nghip lm dch v kim nghim thuc: a) Doanh nghip lm dch v kim nghim thuc phi t tiu chun v thc hnh tt trong kim nghim thuc. Trng hp phng kim nghim ca cc doanh nghip kinh doanh thuc mun lm dch v kim nghim thuc th doanh nghip phi lm th tc b sung chc nng lm dch v kim nghim thuc trong Giy chng nhn iu kin kinh doanh thuc theo quy nh ca php lut. b) Phm vi hot ng: lm dch v phn tch, kim nghim nguyn liu lm thuc, bn thnh phm trong qu trnh sn xut, thuc thnh phm cho cc c s sn xut, kinh doanh thuc. Trng hp doanh nghip lm dch v kim nghim thuc tham gia vo hot ng phn tch, kim nghim thuc phc v cho cng tc qun l, kim tra nh nc v cht lng thuc, doanh nghip phi lm cc th tc ng k lnh vc hot ng nh gi s ph hp vi B Y t v B Khoa hc v Cng ngh theo quy nh ti Thng t 08/2009/TT-BKHCN ngy 08/4/2009 ca B Khoa hc Cng ngh hng
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dn v yu cu, trnh t, th tc ng k lnh vc nh gi s ph hp v cc quy nh c lin quan. iu 21. Quy nh v p dng tiu chun cht lng trong kim nghim thuc 1. Vic kim nghim thuc phi tin hnh theo ng tiu chun cht lng thuc ca c s sn xut, c s nhp khu ng k, xin php lu hnh v c B Y t (Cc Qun l dc) chp nhn. Trng hp p dng phng php khc khng theo phng php trong tiu chun ng k th phi c s chp thun ca B Y t. B Y t giao cho Vin Kim nghim thuc Trung ng, Vin Kim nghim thuc Thnh ph H Ch Minh thm nh v quyt nh chp nhn phng php p dng. 2. Trng hp c nghi ng v thnh phn hoc cht lng thuc, c s kim nghim ca Nh nc v thuc c p dng cc phng php khc vi cc phng php trong tiu chun ng k kim tra v a ra kt qu kim nghim cht lng thuc. 3. Ngi ng u cc c s kim nghim thuc phi chu trch nhim v kt qu kim nghim thuc ca c s mnh trc php lut. iu 22. Qui nh vic ly mu thuc kim tra cht lng, tr li kt qu kim nghim, lu mu v h s ti liu lin quan 1. Ly mu thuc kim tra cht lng: a) Vic ly mu thuc kim tra cht lng do c quan kim tra cht lng thuc quy nh ti khon 1, iu 24 ca Thng t ny thc hin; b) Vic ly mu thuc xc nh cht lng phi theo ng Thng t hng dn ly mu thuc xc nh cht lng do B Y t ban hnh; c) C quan kim tra cht lng thuc phi tr tin mu thuc ly kim tra cht lng theo quy nh ca php lut. 2. Thi hn tr li kt qu phn tch kim nghim mu thuc: a) i vi mu thuc ly kim tra cht lng ca c quan qun l, c quan c quan kim tra cht lng: Thi hn tr li kt qu phn tch, kim nghim ti a l 30 ngy lm vic, k t ngy c s kim nghim nhn c mu thuc. Trong vng 02 ngy, k t khi ban hnh phiu phn tch, kim nghim, c s kim nghim thuc phi thng bo kt qu phn tch, kim nghim ti c quan qun l, c quan kim tra cht lng thuc v ti c s sn xut, kinh doanh thuc c ly mu. Phiu phn tch hoc phiu kim nghim phi c lm thnh t nht 03 bn: 01 bn lu ti c s kim nghim, 01 bn gi ti c quan kim tra cht lng thuc v 01 bn gi ti c s sn xut, kinh doanh thuc c ly mu. i vi cc trng hp cn thm nh hoc thm nh li tiu chun cht lng hoc nh gi li kt qu kim nghim; thiu thit b my mc, ha cht, thuc th,
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cht chun; c nghi ng v thnh phn v cht lng thuc phi p dng phng php kim nghim khc vi phng php ghi trong tiu chun cht lng ng k... thi hn tr li kt qu phn tch, kim nghim c th ko di hn. C s kim nghim phi c gii trnh v cc trng hp ny; b) i vi mu thuc do cc t chc, c nhn gi ti phn tch, kim nghim hoc thm nh tiu chun cht lng thuc: thi gian tr li kt qu phn tch, kim nghim theo tha thun ca cc bn, hoc do quy nh ni b ca c s sn xut, kinh doanh. 3. Lu mu thuc: a) Cc thuc sau khi kim tra cht lng v c kt lun cht lng phi c lu mu. Mu thuc lu phi c nim phong v bo qun trong iu kin ph hp ghi trn nhn. b) Thi gian lu mu: - i vi cc c s sn xut, xut khu, nhp khu thuc, mu thuc thnh phm phi c lu t nht 12 thng sau khi ht hn dng ca thuc; - i vi nguyn liu l hot cht dng cho sn xut thuc, c s sn xut phi lu mu nguyn liu t nht 12 thng sau khi ht hn dng ca thnh phm sn xut t nguyn liu ; - i vi cc c quan kim nghim thuc, thi gian lu mu khng c di hai nm (24 thng), k t ngy ly mu hoc c s gi mu ti; - i vi c quan nhn mu dng ng k thuc, sau khi thuc c cp s ng k phi lu mu khng di 06 thng k t ngy cp s ng k. 3. Lu h s, ti liu: a) H s, ti liu lin quan n cng tc kim tra cht lng thuc u phi lu gi theo quy nh; b) H s, ti liu lin quan n thuc gy nghin, thuc hng tm thn, tin cht dng lm thuc v thuc phng x: thi gian lu tr t nht l 02 nm sau khi ht hn dng ca thuc; c) H s, ti liu khi ht thi gian lu tr c x l theo cc quy nh hin hnh. iu 23. Chi ph ly mu thuc v kim nghim xc nh cht lng thuc 1. Kinh ph ly mu v kinh ph kim nghim mu thuc kim tra cht lng thuc trong sn xut, pha ch v lu hnh trn th trng do c quan kim tra cht lng thuc quyt nh vic ly mu v kim nghim mu chi tr theo quy nh ti Thng t lin tch s 28/2010/TTLT-BTC-BKHCN ngy 03/3/2010 ca lin b Ti chnh v Khoa hc v Cng ngh hng dn qun l v s dng kinh ph i vi hot ng kim tra nh nc v cht lng sn phm, hng ha.
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2. Trong trng hp mu thuc kim nghim c c quan kim tra cht lng thuc kt lun khng t tiu chun cht lng, c s sn xut, kinh doanh thuc vi phm cht lng phi chu trch nhim hon tr ton b kinh ph ly mu, v kinh ph kim nghim mu thuc cho c quan kim tra cht lng theo quy nh ti cc iu 10, iu 12, iu 14, iu 16 v iu 41 ca Lut Cht lng sn phm, hng ha nm 2007, Thng t lin tch s 28/2010/TTLT-BTC-BKHCN ngy 03/3/2010 ca lin b Ti chnh v Khoa hc v Cng ngh hng dn qun l v s dng kinh ph i vi hot ng kim tra nh nc v cht lng sn phm, hng ha v cc vn bn quy phm php lut c lin quan. 3. Trng hp thuc b khiu ni, t co v cht lng m c quan kim tra kt lun vic khiu ni, t co v cht lng thuc khng ng th ngi khiu ni, t co phi thanh ton hon tr chi ph ly mu v chi ph phn tch, kim nghim mu thuc cho c quan kim tra quy nh ti khon 1 iu ny. 4. Kinh ph ly mu thuc kim tra cht lng, kinh ph kim nghim mu thuc c b tr trong d ton kinh ph hot ng ca c quan kim tra cht lng nh nc v thuc theo quy nh ti Thng t lin tch s 28/2010/TTLT-BTCBKHCN ngy 03/3/2010 ca lin b Ti chnh v Khoa hc v Cng ngh hng dn qun l v s dng kinh ph i vi hot ng kim tra nh nc v cht lng sn phm, hng ha. 3.7. Kim tra, thanh tra Nha nc v cht lng thuc iu 24. Kim tra nh nc v cht lng thuc 1. C quan kim tra cht lng thuc: a) C quan kim tra cht lng thuc Trung ng: Cc Qun l dc - B Y t; b) C quan kim tra cht lng thuc a phng: S Y t tnh, thnh ph trc thuc Trung ng; c) Cc Qun l dc c trch nhim ch o, phi hp vi S Y t cc tnh, thnh ph trc thuc Trung ng v cc c quan khc c lin quan trong vic kim tra cht lng thuc. 2. Hng nm, Cc Qun l dc (phi hp vi Vin Kim nghim thuc Trung ng, Vin Kim nghim thuc thnh ph H Ch Minh, Vin Kim nh Quc gia vc xin v sinh phm y t) v S Y t cc tnh, thnh ph trc thuc Trung ng trn c s thu thp thng tin v cc nguy c khng bo m cht lng ca thuc, tnh hnh cht lng thuc sn xut, xut nhp khu, lu thng trn th trng, xy dng k hoch ly mu kim tra cht lng trnh B Y t hoc y ban nhn dn tnh, thnh ph trc thuc Trung ng xem xt, ph duyt v b tr ngn sch thc hin k hoch theo thm quyn.
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3. Vic kim tra nh nc v cht lng thuc c thc hin bi on kim tra hoc bi kim sot vin cht lng. Quyn hn v nhim v ca on kim tra v kim sot vin cht lng c quy nh ti cc iu 48, iu 49, iu 50 v iu 51 ca Lut Cht lng sn phm, hng ha nm 2007. a) on kim tra do ngi ng u c quan kim tra cht lng thuc (Cc Qun l dc, S Y t tnh, thnh ph trc thuc Trung ng) quyt nh thnh lp trn c s chng trnh, k hoch kim tra c ph duyt hoc trong trng hp c s sn xut, pha ch, kinh doanh thuc c cc hnh vi vi phm c tnh h thng hoc vi phm nghim trng v cht lng thuc hoc iu kin sn xut, kinh doanh thuc hoc trong trng hp c yu cu t xut khc. Ni dung kim tra thc hin theo quy nh ti khon 1 v khon 2, iu 25 ca Thng t ny; b) Kim sot vin cht lng thuc thc hin vic kim tra cht lng thuc sn xut, xut nhp khu, lu hnh trn th trng. Ni dung kim tra thc hin theo quy nh ti khon 2, iu 25 ca Thng t ny. iu 25. Ni dung kim tra cht lng ca c quan kim tra cht lng thuc 1. Kim tra cht lng thuc trong sn xut, pha ch: a) Kim tra vic p dng cc nguyn tc, tiu chun Thc hnh tt trong sn xut, kim nghim, bo qun thuc v cc quy nh ca php lut c lin quan; - Kim tra vic chun b sn xut: cht lng v ngun gc nguyn liu, ph liu, vt liu, bao b ng gi trc khi a vo sn xut; - Kim tra cc iu kin sn xut, kim nghim v vic thc hin qui trnh cng ngh sn xut v cc quy trnh kim nghim, v sinh nh xng, my mc v v sinh c nhn; - Kim nghim bn thnh phm, sn phm ch ng gi v thnh phm; - Kim tra sn phm trc khi nhp kho, xut xng; - Kim tra vic chp hnh cc quy nh v xut nhp, bo qun, tn tr, cp pht, bo m cht lng thuc. b) Kim tra vic thc hin ng k thuc, nghin cu n nh, nghin cu pht trin sn phm, ghi nhn thuc theo quy nh. c) Tin hnh ly mu v thc hin kim nghim mu thuc theo tiu chun cht lng ng k hoc tiu chun c s p dng (i vi thuc pha ch theo n hoc thuc pha ch s dng trong bnh vin) v theo cc quy nh khc c lin quan. 2. Kim tra cht lng thuc xut khu, nhp khu, lu thng phn phi trn th trng: a) Kim tra vic tun th cc nguyn tc, tiu chun Thc hnh tt trong phn phi, tn tr v bo qun thuc, cc iu kin bo m cht lng thuc v cc quy nh lin quan n iu kin bo qun, vn chuyn, lu thng phn phi thuc.
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Kim tra vic quy nh v trin khai cc quy nh v kim tra, kim sot ngun gc, cht lng thuc trong qu trnh nhp kho, bo qun, vn chuyn v xut kho; b) Kim tra v s ng k thuc hoc giy php nhp khu thuc v s tun th v vic ghi nhn thuc, hng dn s dng thuc; c) Kim tra vic tun th cc thng bo thu hi thuc ca c quan kim tra cht lng v ca c s sn xut, nhp khu, y thc nhp khu, bn bun; d) Tin hnh ly mu phn tch, kim nghim xc nh cht lng thuc v thc hin vic kim nghim mu thuc theo tiu chun cht lng ca thuc trong h s ng k thuc/h s nhp khu thuc khng c s ng k c B Y t chp nhn. iu 26. Thanh tra chuyn ngnh v cht lng thuc 1. Thanh tra v cht lng thuc do Thanh tra dc thc hin. 2. Thanh tra dc c trch nhim: a) Kim tra, thanh tra vic chp hnh php lut v cht lng thuc, kin ngh bin php phng nga, khc phc v chm dt hnh vi vi phm php lut v cht lng thuc; b) Xem xt, gii quyt tranh chp, khiu ni, t co v cht lng thuc; c) X l, x pht vi phm hnh chnh cc t chc, c nhn c hnh vi vi phm theo quy nh ca php lut. 3. S Y t cc tnh, thnh ph trc thuc Trung ng v Y t ngnh kim tra, thanh tra cng tc qun l cht lng thuc, x l cc hnh vi vi phm trong phm vi tnh, thnh ph, ngnh mnh qun l. 4. Th tc, trnh t, bin php tin hnh kim tra, thanh tra v hnh thc x l, x pht vi phm hnh chnh phi tun th cc quy nh ca php lut v x l vi phm hnh chnh. iu 27. Trch nhim ca cc c quan qun l, thanh tra, kim tra cht lng thuc trong cng tc phng chng thuc gi: 1. Thc hin vic tip nhn thng tin phn nh t mi t chc, c nhn c lin quan. Cng b cc a ch lin lc cn thit (s in thoi trc, email, fax..). 2. Truyn thng, ph bin cho ngi dn, doanh nghip v tc hi ca thuc gi, cc du hiu nhn bit, cc bin php nhm phng trnh mua phi thuc gi v cch thc thng bo cho cc c quan qun l nh nc v cc trng hp nghi ng thuc gi. 3. Thng bo cc trng hp thuc gi pht hin trn th trng, kt qu x l cc trng hp pht hin.

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4. Thc hin hoc phi hp vi cc c quan chc nng lin quan thc hin cng tc kim tra gim st th trng, kp thi pht hin cc thuc gi lu hnh trn th trng. 5. Phi hp v h tr cc c quan chc nng iu tra truy tm ngun gc ca thuc gi. 6. X l cc trng hp vi phm sn xut, bun bn thuc gi, thuc khng r ngun gc, thuc nhp lu theo quy nh. 7. Cc Qun l dc l u mi phi hp, lin lc, trao i thng tin v thuc gi vi cc t chc quc t lin quan (WHO....) v cc c quan qun l dc cc nc. 3.8. Trach nhim cua c quan Nha nc v cht lng thuc iu 28. Trch nhim ca c quan qun l nh nc v cht lng thuc Trung ng Cc Qun l dc chu trch nhim trc B trng B Y t thc hin cng tc qun l nh nc v cht lng thuc: 1. Xy dng quy hoch, k hoch v qun l cht lng thuc trnh B trng B Y t ph duyt v t chc thc hin theo k hoch c ph duyt. 2. Xy dng v trnh B trng B Y t ban hnh cc vn bn php quy v qun l cht lng, bo m cht lng (cc nguyn tc, tiu chun Thc hnh tt), quy chun k thut, tiu chun cht lng thuc, hng dn kim tra vic thc hin cc vn bn trn. u mi xem xt, thm tra, chuyn B Khoa hc v Cng ngh thm nh, cng b B tiu chun quc gia v thuc; trnh B trng B Y t ban hnh p dng Dc in Vit Nam. u mi trnh B trng B Y t ban hnh Dc th Quc gia Vit Nam. 3. Qun l vic ng k tiu chun cc sn phm thuc ca cc t chc, c nhn c php hot ng kinh doanh thuc. Cung cp thng tin v khoa hc k thut lin quan n bo m cht lng thuc. 4. Chu trch nhim v kim tra cht lng thuc sn xut, pha ch, lu hnh v s dng trn ton quc. Ch o, gim st h thng kim nghim thuc trn ton quc. Kt lun v cht lng thuc trn c s kt qu kim nghim thuc ca c s kim nghim ca nh nc v thuc Trung ng v cc h s lin quan. Theo di, thng k, tng hp tnh hnh qun l cht lng thuc. 5. Kim tra v cp giy chng nhn t nguyn tc, tiu chun Thc hnh tt sn xut thuc cho c s sn xut; Thc hnh tt phng kim nghim thuc cho

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c s kim nghim thuc v Thc hnh tt bo qun thuc cho c s dch v bo qun thuc. 6. u mi v phi hp vi cc c quan chc nng lin quan tuyn truyn, ph bin v t chc hng dn php lut; h tr t chc, c nhn sn xut kinh doanh thuc tm hiu thng tin v cht lng thuc. Ch o, hng dn nghip v cho cn b qun l cht lng thuc ca ngnh Y t, t chc o to v bi dng nghip v v tiu chun, o lng, cht lng thuc. 7. Phi hp vi Thanh tra B Y t thc hin chc nng kim tra, thanh tra nh nc v cht lng thuc v x l vi phm php lut v cht lng thuc theo thm quyn. 8. Phi hp vi cc c quan chc nng lin quan thc hin cc iu c quc t, tha thun quc t v tha nhn ln nhau trong nh gi s ph hp: chng nhn t nguyn tc, tiu chun Thc hnh tt sn xut thuc, kt qu th lm sng, tha nhn kt qu th tng ng sinh hc v sinh kh dng iu 29. Trch nhim ca c quan qun l nh nc v cht lng thuc a phng 1. S Y t ch o qun l ton din v cht lng thuc a phng. - Ch ng t chc v thc hin vic kim tra v x l cc vn v cht lng thuc trn a bn theo quy nh ca php lut. - Chu trch nhim v kim tra cht lng thuc sn xut, pha ch, lu hnh v s dng trn a bn. Kt lun v cht lng thuc trn c s kt qu kim nghim mu thuc ca c s kim nghim nh nc v thuc ti a phng v cc h s lin quan. 2. Ph bin, hng dn v t chc thc hin cc vn bn php lut v qun l cht lng thuc ti a phng, Theo di thng k, tng hp tnh hnh qun l cht lng thuc ti a phng. nh k bo co tnh hnh qun l, cht lng thuc v B Y t (Cc Qun l dc). Bo co v B Y t (Cc Qun l dc) v cc trng hp pht hin, thu hi thuc km cht lng, thuc gi trn a bn. 3. Thc hin chc nng kim tra, thanh tra nh nc v cht lng thuc v x l vi phm php lut v cht lng thuc trong phm vi a phng. 3.9. Quyn va trach nhim cua c s kinh doanh thuc. Quyn cua ngi tiu dung v cht lng thuc iu 30. Quyn v trch nhim ca c s kinh doanh 1. Cc c s kinh doanh phi trin khai, p dng cc nguyn tc, tiu chun Thc hnh tt trong sn xut, kim tra cht lng, bo qun thuc v cc bin php
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qun l cht lng thch hp theo quy nh ti iu 9 v iu 10 ca Thng t ny nhm bo m cht lng thuc trong qu trnh sn xut, nhp khu, tn tr, bo qun, lu thng phn phi, bo m thuc c cht lng nh d kin n tay ngi s dng. 2. C s sn xut, nhp khu, y thc nhp khu phi bo m cc l thuc xut xng, nhp khu t tiu chun ng k, cng b thng tin trung thc v cht lng thuc v chu trch nhim v cht lng thuc do c s sn xut, nhp khu, y thc nhp khu. 3. Cc c s bn bun, bn l thuc ch c kinh doanh thuc c ngun gc hp php, t tiu chun cht lng v phi chu trch nhim trc php lut v khch hng v cht lng thuc, cng b thng tin trung thc v cht lng thuc. Kp thi dng bn hng khi pht hin thuc khng t tiu chun cht lng hoc nhn c thng bo ca c quan qun l, c quan kim tra cht lng thuc. 4. Cc c s sn xut, kinh doanh thuc: a) Phi chu s kim tra, thanh tra v cht lng thuc ca cc c quan qun l, thanh tra, kim tra cht lng nh nc v phi thc hin nghim chnh cc yu cu ca cc c quan kim tra, thanh tra; Phi hon tr kinh ph ly mu, kinh ph phn tch, kim nghim mu thuc sau khi c quan qun l, c quan kim tra cht lng thuc kt lun mu thuc khng t cht lng hoc khiu ni, t co sai v cht lng thuc theo quy nh ti khon 2 v khon 3, iu 23 ca Thng t ny. b) c quyn khiu ni vi c quan tin hnh kim tra, thanh tra hoc c quan qun l cp trn v kt qu phn tch, kim nghim mu thuc c ly kim tra cht lng bi c quan qun l, c quan kim tra cht lng nh nc, khiu ni kt lun v cht lng thuc v v bin php x l ca c quan qun l, c quan kim tra cht lng thuc. c bi thng thit hi theo quy nh ti Mc 2 Chng V ca Lut Cht lng sn phm hng ha v cc quy nh khc ca php lut c lin quan. iu 31. Trch nhim ca c s kinh doanh trong phng chng thuc gi 1. Ch c mua thuc ti cc c s kinh doanh dc hp php, c ha n chng t xc nh r ngun cung cp. Bn thuc c ha n chng t km theo. 2. Thuc phi c s ng k hoc giy php nhp khu thuc ca B Y t. 3. Thuc gi khi c pht hin trong mng li cung cp thuc phi c tch ring ngay khi cc thuc khc v phi c ghi li. Cc thuc gi hoc nghi ng l thuc gi phi c dn nhn r rng, bo qun ring bit nhm phng trnh vic nhm ln a ra ti lu thng phn phi.
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4. Thng bo ngay cho cc c quan qun l, kim tra cht lng thuc, cc c quan nh nc khc c lin quan v c s sn xut, c s cung ng thuc v cc thuc c xc nh hoc c nghi ng l thuc gi . 5. Cung cp thng tin trung thc, chnh xc v phi hp vi cc c quan chc nng trong vic xc nh ngun gc thuc gi. iu 32. Quyn ca ngi tiu dng Ngi tiu dng c quyn c thng tin v cht lng thuc v hng dn s dng, bo qun thuc; tun th hng dn s dng an ton hp l v bo qun thuc; c quyn khiu ni v yu cu c s sn xut, bun bn thuc phi bi thng thit hi theo quy nh ca php lut do thuc sn xut, lu thng khng bo m cht lng gy ra. 3.10. X ly vi pham iu 33. X l vi phm trong qu trnh kim tra cht lng thuc trong sn xut Trong qu trnh kim tra cht lng sn phm trong sn xut, khi pht hin ngi sn xut khng thc hin ng cc yu cu v iu kin lin quan n qu trnh sn xut, kim nghim, bo qun thuc; v tiu chun cht lng thuc; v vic ghi nhn thuc v cc quy chun k thut tng ng i vi sn phm thuc th vic x l c thc hin theo quy nh sau y: 1. on kim tra yu cu ngi sn xut thc hin cc bin php khc phc, sa cha bo m cht lng thuc trc khi a ra th trng; 2. Trng hp c s sn xut c nhng vi phm cc nguyn tc tiu chun v iu kin kinh doanh dc (cc nguyn tc, tiu chun Thc hnh tt trong sn xut, bo qun, kim nghim thuc), hoc kt qu kim nghim xc nh sn phm khng t tiu chun cht lng, e da s an ton, tnh mng ca ngi s dng, c quan kim tra cht lng thuc ra thng bo nh ch lu hnh v thu hi sn phm, rt s ng k lu hnh, tm nh ch sn xut sn phm khng t tiu chun cht lng v kin ngh c quan qun l c thm quyn tm dng hoc thu hi giy chng nhn iu kin kinh doanh dc. 3. Trng hp khng nht tr vi kt qu kim nghim mu th trong thi gian 03 ngy k t ngy nhn c thng bo kt qu kim nghim mu thuc khng t tiu chun cht lng, c s sn xut c th ngh c quan qun l, kim tra cht lng nh nc ch nh c s kim nghim khc tin hnh phn tch, kim nghim xc nh kt qu kim nghim cht lng thuc trn nguyn tc c s kim nghim c cc iu kin t tiu chun ti thiu tng ng vi c s kim nghim ban u. iu 34. X l vi phm trong qu trnh kim tra cht lng thuc nhp khu
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Trong qu trnh kim tra cht lng thuc nhp khu, khi pht hin thuc khng p ng yu cu v ghi nhn, s ng k, yu cu v iu kin lin quan n qu trnh bo qun, vn chuyn thuc v cc bin php qun l cht lng theo quy chun k thut tng ng i vi thuc th x l nh sau: 1. Thuc nhp khu, c phiu kim nghim xc nh cht lng thuc nhng khng p ng yu cu v nhn hng ha th c quan kim tra cht lng sn phm, hng ho yu cu c s nhp khu, y thc nhp khu khc phc trc khi xc nhn lm th tc nhp khu vi c quan hi quan. 2. Trng hp thuc c B Y t cho php nhp khu, p ng yu cu v ghi nhn nhng phiu kim nghim xc nh cht lng thuc khng y ch tiu theo tiu chun cht lng hoc thuc c du hiu khng cn nguyn vn, bao b b h hi, thuc c bin i, khng ng nht v cm quan hoc khng m bo iu kin bo qun yu cu th c quan kim tra cht lng sn phm, hng ho yu cu c s nhp khu la chn mt trong s t chc gim nh c ch nh hoc tha nhn thc hin vic nh gi v cp phiu kim nghim xc nh cht lng thuc ti ca khu nhp. 3. Trong trng hp kt qu th nghim, gim nh cht lng hng ho xc nh thuc khng p ng tiu chun cht lng ng k, tu theo tnh cht, mc vi phm, c quan kim tra kin ngh c quan nh nc c thm quyn p dng mt hoc cc bin php x l sau y: a) Yu cu c s nhp khu ti xut hoc tiu hy hng ho ; b) C quan kim tra cht lng xem xt vic tng cng kim tra ti ca khu hoc kin ngh c quan nh nc c thm quyn ra quyt nh tm dng hoc dng nhp khu, rt s ng k lu hnh ca thuc vi phm hoc ton b cc thuc ca c s sn xut, cung cp thuc vi phm; ng thi c bin php x l i vi c s sn xut, c s cung cp v c s nhp khu theo cc quy nh hin hnh. iu 35. X l vi phm trong qu trnh kim tra cht lng thuc lu thng trn th trng 1. Trong qu trnh kim tra cht lng thuc lu thng trn th trng, khi pht hin sn phm thuc khng p ng yu cu v ghi nhn thuc, s ng k v cc bin php qun l cht lng theo quy chun k thut tng ng i vi thuc v yu cu v iu kin lin quan n qu trnh bo qun, phn phi thuc th x l theo cc bc sau: a) on kim tra, kim sot vin cht lng yu cu c s kinh doanh tm dng vic bn thuc v trong thi hn khng qu 24 gi phi bo co vi c quan kim tra cht lng thuc x l theo thm quyn;

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b) Trng hp thuc vi phm cc quy nh v ghi nhn thuc, ng k thuc, cht lng thuc, c quan kim tra yu cu c s sn xut, xut nhp khu, y thc nhp khu thc hin cc bin php x l, khc phc, sa cha hoc thu hi thuc; c) Trng hp c s kinh doanh thuc c cc vi phm v vic p dng quy nh, tiu chun v iu kin kinh doanh dc (cc nguyn tc tiu chun Thc hnh tt trong kinh doanh thuc), nh hng ti cht lng thuc kinh doanh, bo qun, on kim tra, kim sot vin cht lng bo co bng vn bn kin ngh c quan qun l, kim tra c thm quyn tm dng hot ng kinh doanh thuc v yu cu c s tin hnh sa cha khc phc trc khi tip tc hot ng. Trng hp c s khng khc phc, sa cha cc vi phm, c quan qun l c thm quyn rt giy chng nhn iu kin kinh doanh thuc ca c s vi phm theo quy nh hin hnh v x pht hnh chnh trong lnh vc y t. 2. Trong trng hp kt qu kim nghim mu thuc khng t tiu chun cht lng ng k hoc xin cp php, hoc cc quy nh c lin quan n cht lng thuc th tu theo tnh cht, mc vi phm, c quan kim tra cht lng c vn bn thng bo thu hi thuc, yu cu c s sn xut, xut nhp khu, y thc nhp khu, bn bun tin hnh thu hi thuc vi phm theo quy nh ti Chng IV ca Thng t ny. 3. Trng hp khng nht tr vi kt qu kim nghim mu th trong thi gian 03 ngy k t ngy nhn c thng bo kt qu kim nghim mu thuc khng t tiu chun cht lng, c s kinh doanh c th ngh c quan qun l, kim tra cht lng nh nc ch nh c s kim nghim khc tin hnh phn tch, kim nghim xc nh kt qu kim nghim cht lng thuc trn nguyn tc c s kim nghim c cc iu kin t tiu chun ti thiu tng ng vi c s kim nghim ban u. iu 36. X l t chc, c nhn kinh doanh thuc gi, thuc khng r ngun gc, thuc nhp lu 1. Cc t chc, c nhn sn xut, bun bn thuc gi ty theo mc s b x l hnh chnh hoc truy cu trch nhim hnh s. 2. Cc t chc, c nhn bun bn thuc khng r ngun gc, khng c ha n chng t hp l, thuc nhp lu, thuc khng c php lu hnh s b x l, x pht hnh chnh theo cc iu khon x pht cao nht v cc bin php x pht b sung theo quy nh ca php lut. 3.11. iu khoan thi hanh iu 37. iu khon chuyn tip 1. Cc c quan kim nghim ca Nh nc v thuc Trung ng v tnh, thnh ph trc thuc Trung ng tip tc thc hin vic ly mu thuc xc nh
28

cht lng cho n khi lc lng kim sot vin cht lng thuc cc cp c b nhim. a) Vin Kim nghim thuc Trung ng, Vin Kim nghim thuc Thnh ph H Ch Minh, Vin Kim nh Quc gia vc xin v sinh phm y t, theo chc nng, nhim v v phm vi hot ng c phn cng, chu trch nhim tin hnh ly mu thuc kim nghim xc nh cht lng thuc sn xut, lu hnh, s dng trn ton quc; b) Trung tm Kim nghim dc phm, m phm khu vc, Trung tm Kim nghim dc phm, m phm tnh, thnh ph trc thuc Trung ng chu trch nhim tin hnh ly mu thuc kim nghim xc nh cht lng thuc sn xut, lu thng, s dng trn a bn. 2. Trong thi gian tip tc thc hin quy nh ti khon 1 ca iu ny, kinh ph cho hot ng ly mu, th nghim mu thuc hng nm do cc c quan kim nghim thuc d tr v tip nhn s dng. iu 38. Hiu lc thi hnh 1. Thng t ny c hiu lc thi hnh t ngy 01/7/2010. Bi b Quyt nh s 2412/1998/BYT-Q ngy 15/9/1998 ca B trng B Y t v vic ban hnh Quy ch qun l cht lng thuc. 2. Cc trng Cc Qun l dc c trch nhim hng dn thc hin Thng t ny. 3. Cc ng/B: Chnh Vn phng B Y t, Chnh Thanh tra B Y t, V trng cc V Khoa hc v o to, K hoch - Ti chnh, Cc trng Cc Qun l dc, Vin trng cc Vin Kim nghim thuc Trung ng, Vin Kim nghim thuc Thnh ph H Ch Minh, Vin Kim nh Quc gia vc xin v sinh phm y t, Gim c S Y t cc tnh, thnh ph trc thuc Trung ng, Th trng Y t cc ngnh, Tng Gim c Tng cng ty dc Vit Nam, cc t chc, c nhn kinh doanh thuc v cc n v, c nhn lin quan c trch nhim thc hin Thng t ny. 4. Trong qu trnh thc hin nu c vn vng mc, ngh cc n v, c nhn kp thi phn nh v B Y t (Cc Qun l dc) xem xt, gii quyt.

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QUY CH CNG TAC DC BNH VIN

* Muc tiu 1. Nu c vi tri, chc nng, t chc va nhim vu cua khoa Dc bnh vin. 2. Trinh bay c cng tac cung ng, quan ly, cp phat, pha ch va s dung thuc cua khoa Dc bnh vin. 1. Vi tri, chc nng, nhim vu va t chc cua khoa Dc bnh vin 1.1. Vi tri, chc nng - Giup giam c bnh vin quan ly toan b cng tac dc bnh vin - Trong bnh vin, khoa Dc c b tri ia im thun tin, co u iu kin lam vic, h thng kho, phong pha ch, ni bao ch thuc y hoc c truyn, phong cp phat am bao ch v sinh sach se, cao rao, thoang mat, an toan, hp ly. 1.2. Nhim vu - Lp k hoach cung ng va am bao s lng, cht lng thuc thng thng va thuc chuyn khoa, hoa cht, vt dung tiu hao (bng bng, gac, cn,) cho iu tri ni tru va ngoai tru, ap ng c yu cu iu tri hp ly. - Pha ch mt s thuc dung cho bnh vin. - Kim tra, theo doi vic s dung thuc an toan, hp ly trong toan bnh vin. Trng khoa Dc va dc sy c uy nhim co quyn thay th thuc co cung chung loai. - Tham gia quan ly kinh phi thuc, thc hin tit kim co hiu qua cao trong phuc vu ngi bnh. - La c s thc hanh cua cac trng ai hoc, trung hoc y t, dc, khoa y trong cac trng ai hoc. - Tham gia cng tac nghin cu khoa hoc, thng tin v thuc. 1.3. T chc Tuy theo chc nng va bin ch ma khoa Dc bnh vin co th c t chc thanh t (phong) sau: - Tai chinh k toan - Pha ch kim nghim - Kho cp phat Ngoai ra, hin nay mt s bnh vin ln trn ca nc a thanh lp b phn dc lm sang. 2. Cng tac cung ng, quan ly, cp phat, pha ch va s dung thuc cua khoa Dc bnh vin 2.1. Cng tac cung ng, quan ly thuc va vt dung y t tiu hao
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2.1.1. D tru mua, vn chuyn va kim nhp - Lp k hoch thuc, ho cht vt dng y t tiu hao hng nm phi ng thi gian quy nh; phi st vi nhu cu v nh mc ca bnh vin; phi lm theo ng mu quy nh; trng khoa dc tng hp, gim c bnh vin k duyt sau khi c kin t vn ca hi ng thuc v iu tr bnh vin. + Khi nhu cu thuc tng vt xut phi lm d tr b sung. + Tn thuc trong d tr phi ghi theo tn gc, r rng v y n v, nng , hm lng, s lng. Trong trng hp thuc nhiu thnh phn c th dng tn bit dc. - Mua thuc: + Mua thuc ch yu ti doanh nghip Nh nc. + Phi bo m s lng, cht lng theo ng k hoch. + Thc hin ng cc quy nh hin hnh v mua sm ca Nh nc. + Thuc phi nguyn trong bao b ng gi, si nt kn. + Thuc phi c bo qun iu kin theo ng yu cu k thut, c trong lc vn chuyn. - Vn chuyn:: + Xe ch thuc phi i thng t ni mua v bnh vin. + Ngi i mua thuc phi l dc s. - Kim nhp: + Mi ngun thuc trong bnh vin: mua, vin tr u phi kim nhp. + Thuc mua v trong 24 gi phi kim nhp hng nguyn ai nguyn kin, trong vng mt tun l phi tin hnh kim nhp ton b, do hi ng kim nhp thc hin. + Thnh lp hi ng kim nhp gm: gim c bnh vin l ch tch, trng khoa dc l th k, trng phng ti chnh k ton, k ton dc ngi i mua thuc v th kho l u vin. + Vic kim nhp tin hnh i chiu ho n, phiu bo vi s lng thc t hng sn xut, quy cch ng gi hm lng, s lng, ni sn xut, s ng k, s kim sot, hn dng v nguyn nhn h hao, tha thiu.
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+ Bin bn kim nhp gm cc ni dung trn v c ch k ca hi ng. + Hng nguyn ai, nguyn kin b thiu phi thng bo cho c s cung cp b sung. + Thuc c bng A-B, thuc gy nghin phi lm bin bn kim nhp ring theo quy ch thuc c. - Cc l thuc nhp c tc dng sinh hc mnh phi c giy bo l sn xut v hn dng km theo. 2.1.2. Quan ly thuc, hoat cht va vt dung y t tiu hao tai cac khoa phong - Thuc theo y lnh lnh v phi c dng trong ngy; ring ngy l v ch nht thuc c lnh vo hm trc ngy ngh. Khoa dc t chc thng trc pht thuc cp cu 24 gi trong ngy. - Phiu lnh thuc thng phi theo ng mu quy nh; thuc c bng A-B, thuc gy nghin c phiu ring theo quy ch thuc c.
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Bng, bng, vt dng y t tiu hao, lnh hng tun. ho cht tinh khit v ho cht tinh khit kim nghim.

- Ho cht chuyn khoa, lnh hng thng hoc hng qu. Khng c san l cc - Thuc cp pht theo n khoa khm bnh cui thng s thanh ton vi phng ti chnh k ton bnh vin. - Trng khoa iu tr c trch nhim kim tra, theo di bo qun, s dng thuc ho cht, vt dng theo di tiu hao trong khoa. - Tu nhim v v yu cu cp cu c giao, cc kho iu tr, cn lm sng c t thuc trc, cp cu, vic s dng v bo qun phi theo ng quy ch s dng thuc. - Ho cht c ti kho dc do dc s gi, ti cc khoa khc ngi gi ho cht c t nht phi c trnh t trung hc tr ln, gim c bnh vin c vn bn quyt nh phn cng ngi gi . - Thc hin ng quy ch nhn v ni dung v hnh thc. - Thuc d ra trong ngy phi thc hin theo quy ch s dng thuc . - Nghim cm mi hnh thc t nhn, khoa phng bn thuc trong bnh vin.

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2.1.3. Kim k thuc, hoa cht, y cu tiu hao - Thc hin vic kim k nh k theo quy nh: hng thng i vi khoa dc, 2 ln trong nm i vi cc khoa, kim k t xut khi c xy ra v vic mt thuc. - Thnh lp hi ng kim k bnh vin: + Kim k thng gm: Trng khoa dc, k ton dc, th kho dc v phng ti chnh k ton. + Kim k cui nm gm: gim c bnh vin l ch tch hi ng; trng khoa dc l th k hi ng; trng phng ti chnh k ton, trng phng k hoch tng hp, trng phng y t (iu dng), k ton dc l u vin. + Khoa iu tr, khoa cn lm sng thnh lp t kim k, t nht c 3 ngi do trng khoa lm t trng, y t (iu dng) trng khoa, k thut vin trng khoa, y t (iu dng) chm sc v k thut vin. - Ni dung kim k ti khoa dc: + i chiu s xut, s nhp vi chng t. + i chiu s sch vi hin vt v s lng v cht lng. + nh gi li thuc, ho cht, vt dng y t tiu hao; tm nguyn nhn chnh lch, h hao. Nu cht lng khng t yu cu, hi ng lm bin bn xc nh trch nhim v ngh cho x l. + M s sch cho nm ti. - Ni dung kim k ca hi ng kim k bnh vin, cc u vin xung tng khoa: + Xc nh li s lng, cht lng v nguyn nhn tha thiu. + X l thuc, ho cht, vt dng y t tiu hao cn hu b . + iu ho thuc, ho cht tha thiu. + Tng kt cng tc kim k ton bnh vin. 2.1.4. Lp s sach thanh toan, thng k bao cao, ban giao va kim tra - M s sch theo di xut nhp thuc, ho cht, vt dng y t tiu hao: bng, bng, cn, gc: lu tr chng t, n thuc theo quy nh. - Thanh ton thuc:
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+ Khoa dc thng k v tng hp s lng thuc k c thuc pha ch, ho cht, dng c y t tiu hao pht ra; s liu phi ph hp vi cc chng t xut nhp v chuyn phng ti chnh k ton quyt ton. + Khoa iu tr tng hp thuc, ho cht, vt dng y t tiu hao s dng cho tng ngi bnh theo quy ch ra vin, ri chuyn phng ti chnh k ton thanh ton vin ph. + Phng ti chnh k ton tng hp cc chng t, ho n, bo co s dng thuc, ho cht, vt dng y t tiu hao thanh ton vin ph, bo him y t, c quan lao ng thng binh x hi... - Thng k, bo co s dng thuc: + Khoa dc c nhim v thc hin bo co 3 thng, 6 thng, 9 thng v 12 thng theo quy nh v bo co t xut khi cn thit. + Bo co gi ln cp trn phi c gim c bnh vin thng qua v k duyt. + Phi ghi y ct mc ng quy nh tng mu bo co. + Thng k bo co nhm ln v tai bin dng thuc thc hin hng thng, 3 thng, 6 thng, 9 thng, 12 thng. Trng hp nghim trng phi bo co t xut theo quy nh. - Bn giao: + Khi vin chc trc tip gi thuc, ho cht, vt dng y t tiu hao thay i cng tc phi tin hnh bn giao theo quy nh. + Trc khi bn giao, vin chc giao phi vo s y v kho s, s liu phi khp vi chng t xut, nhp ghi r cc khon tha thiu, h hao. + Ngi bn giao l trng khoa dc phi c s chng kin v k duyt bin bn bn giao ca gim c bnh vin; l vin chc khoa dc phi c s chng kin v k duyt bin bn bn giao ca trng khoa dc. + Ni dung bn giao bao gm cc s sch, giy t, chng t kho s, i chiu vi hin vt v s lng v cht lng, nhng vic cn theo di v hon thnh tip. + Tt c mi ti liu bn giao phi r rng, lu tr theo quy nh.
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- Cng tc kim tra: + Trng khoa dc c trch nhim xy dng lch, ni dung v t chc kim tra. + Kim tra ti cc khoa iu tr c s phi hp ca trng phng k hoch tng hp v trng phng y t (in dng); khi cn thit c s ch tr ca gim c bnh vin. 2.2. Kho va cng tac bao quan, cp phat 2.2.1. T chc - Kho chnh: trng kho phi l dc s gip trng khoa lm d tr mua thuc, ho cht, vt dng y t tiu hao, phi nm vng tnh hnh tn kho, cp pht thuc cho cc kho pht l v bung pha ch.
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Kho cp pht l: cp pht cho cc khoa iu tr, khoa cn lm sng, khoa khm bnh.

2.2.2. Quy inh kho Kho phi c thit k theo ng quy nh chuyn mn theo tng chng loi, bo m cao ro, thong mt, v sinh sch s, nh sng, phng tin bo qun v an ton chng mt trm.
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Vic sp xp trong kho phi bo m ngn np, c gi, k; xp theo chng loi d thy d ly. Phi thc hin 5 nm chng: + Nhm ln. + Qu hn + Mi, mt, chut, dn. + Trm cp. + Thm ho (chy, n, ngp lt).

- Phi c th kho ring cho tng loi thuc, c ghi s kim sot ca thuc. 2.2.3. Cp phat thuc - Thuc pha ch trong bnh vin phi bn giao cho kho cp pht l, trng hp hai c s xa nhau, s cp pht ngay ti phng pha ch. - Thuc c bng A-B, thuc gy nghin thc hin cp pht ng theo quy ch thuc c.
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- Phiu lnh thuc ghi sai hoc phi thay thuc sau khi c kin ca dc s khoa dc, bc s iu tr sa li v k xc nhn vo phiu. - Phiu lnh thuc phi c trng khoa dc hoc dc s c u nhim duyt v k tn. - Cc loi thuc bt, thuc nc phi c ng gi thnh liu nh cho tng ngi bnh; cc loi thuc c bng A-B, thuc gy nghin dng bt, nc phi do dc s t ng gi thnh liu nh. - Trc khi giao thuc dc s phi thc hin 3 kim tra, 3 i chiu theo quy ch s dng thuc. - Khoa dc chu trch nhim ton b v cht lng thuc do khoa dc pht ra. 2.3. Cng tac pha ch, san xut thuc va ch thuc y hoc c truyn 2.3.1. Pha ch thuc - Phng pha ch phi bo m dy chuyn mt chiu, bo m quy ch v sinh v khun; c phng pha ch thuc thng v phng pha ch thuc v khun. - Vin chc lm cng tc pha ch phi m bo tiu chun sc kho v chuyn mn theo quy nh; khi vo phng pha ch v khun phi thc hin quy nh v khun tuyt i.
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Pha ch thuc thng: + C khu vc hoc bn pha ch ring cho cc dng thuc khc nhau. + C trang b t lnh, cc t ng thuc c, thuc thng, nguyn liu v thnh phm + Nc ct phi t tiu chun dc in Vit Nam pha ch cho tng loi thuc; phi c bung ct nc v hng nc ct ring. + Ho cht phi bo m cht lng, c phiu kim nghim km theo. + Chai, l, nt phi t tiu chun ca ngnh, x l ng k thut. + Trc khi pha ch phi kim sot li n thuc, cng thc, chai v nhn thuc, vo s pha ch theo ng quy nh. Khi thay i nguyn liu pha ch dc s phi bo cho bc s k n bit. + Sau khi pha ch phi i chiu li n, kim tra liu lng, tn ho cht dng v phi dn nhn ngay.
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+ n thuc cp cu phi pha ngay, pha xong ghi thi gian vo n v giao thuc ngay. - Pha ch thuc v khun: + Ngoi nhng quy nh ca bung pha ch thuc thng cn ch : + Trong phng ch my v dng c cn thit. + Mt bn phi lt gch men chu acid hoc bng thp inox. + C thit b kh khun khng kh bng phng php vt l hay ho hc. + T ng nguyn liu, bn cn thuc b tr bung tin v khun. + Ngi pha ch, dng c pha ch phi bo m v sinh v khun nghim ngt theo quy nh. + Khi pha ch xong phi kim nghim thnh phm theo quy nh ca tng loi thuc. - Nghim cm pha ch nhiu th thuc trong cng mt thi gian hoc cng mt th thuc nhng nhiu nng khc nhau ti mt bung pha ch. 2.3.2. San xut va bao ch thuc y hoc c truyn - Phi c c s v phng tin ch bin sao tm thuc; c b tr khu vc ring hp l, v sinh v khun. - Dc liu phi m bo cht lng, khng b mi mt, nm mc. - C c s sc thuc cho ngi bnh ni tr. 2.4. Cng tac thng tin va t vn s dung thuc Trng khoa c gim st vic s dng thuc an ton, hp l v hiu qu.
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Thc hin dc lm sng trong bnh vin, dc s khoa dc t

vn cng bc s iu tr tham gia chn thuc iu tr i vi mt s ngi bnh nng, mn tnh c th. Khoa dc chu trch nhim thng tin v thuc, trin khai mng l theo di phn ng c hi ca thuc (ADR: adverse dung reactions), gii thiu thuc mi.

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KINH T DC
* Muc tiu 1. Trnh by nh ngha v Marketing dc v c im ca Marketing dc. 2. Trnh by c c trng trong quan h trao i trn th trng thuc v cc yu t nh hng n Marketing dc. 3. Trnh by c mc tiu, vai tr v ni dung ca Marketing dc. 4. Nu cc khi nim trong cng tc qun l ti chnh, vn, chi ph, li nhun. 5. Nu c ni dung cng tc qun l vn trong doanh nghip, vn dng tnh ton mt s chi tiu nh gi hiu qu s dng vn. 6. Trnh by ni dung chi ph trong doanh nghip, gi thnh chi ph lu thng. 7. Nu c li nhun trong doanh nghip, phn tch mt s yu t nh hng n li nhun.

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MT S QUY NH MI

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