B Y t

Cng ho x hi ch ngha Vit Nam

c lp - T do - Hnh phc
S: 06 /2011/TT-BYT

H Ni, ngy 25 thng 01 nm 2011

Thng t
Quy nh v qun l m phm
Cn c Ngh nh s 188/2007/N-CP ngy 27 thng 12 nm 2007 ca Chnh ph quy nh chc nng, nhim v, quyn hn v c cu t chc ca B Y t; Cn c Ngh nh s 132/2008/N-CP ngy 31 thng 12 nm 2008 ca Chnh ph quy nh chi tit thi hnh mt s iu ca Lut Cht lng sn phm, hng ho; Cn c Ngh nh s 24/2003/N-CP ngy 13 thng 3 nm 2003 ca Chnh ph quy nh chi tit thi hnh Php lnh Qung co; Cn c Ngh nh s 89/2006/N-CP ngy 30 thng 8 nm 2006 ca Chnh ph quy nh v ghi nhn hng ho; Cn c Ngh nh s 12/2006/N-CP ngy 23 thng 01 nm 2006 ca Chnh ph Quy nh chi tit thi hnh Lut Thng mi v hot ng mua bn hng ho quc t v cc hot ng i l mua, bn, gia cng v qu cnh hng ho vi nc ngoi; Cn c Quyt nh s 10/2010/Q-TTg ngy 10 thng 02 nm 2010 ca Th tng Chnh ph quy nh Giy chng nhn lu hnh t do i vi sn phm, hng ho xut khu v nhp khu; trin khai Hip nh ha hp trong qun l m phm c cc nc thnh vin Hip hi cc nc ng Nam k ngy 02 thng 9 nm 2003 (gi tt l Hip nh m phm ASEAN), B Y t quy nh v qun l m phm nh sau: Chng I quy nh CHUNG iu 1. Phm vi iu chnh v i tng p dng 1. Thng t ny quy nh vic qun l cc sn phm m phm sn xut trong nc, m phm nhp khu lu thng trong phm vi lnh th Vit Nam, bao gm: cng b sn phm m phm; h s thng tin sn phm; yu cu v an ton sn phm; 1

ghi nhn m phm; qung co m phm; xut khu, nhp khu m phm; ly mu m phm kim tra cht lng; kim tra, thanh tra v x l vi phm; trch nhim ca t chc, c nhn sn xut, bun bn, nhp khu m phm v quyn ca ngi tiu dng. 2. Thng t ny p dng i vi cc c quan qun l nh nc v m phm, cc t chc, c nhn tin hnh cc hot ng lin quan n cng b sn phm m phm, thng tin, qung co, xut khu, nhp khu, sn xut, bun bn sn phm m phm ti Vit Nam. iu 2. Gii thch thut ng Trong Thng t ny cc t ng di y c hiu nh sau: 1. Sn phm m phm l mt cht hay ch phm c s dng tip xc vi nhng b phn bn ngoi c th con ngi (da, h thng lng tc, mng tay, mng chn, mi v c quan sinh dc ngoi) hoc rng v nim mc ming vi mc ch chnh l lm sch, lm thm, thay i din mo, hnh thc, iu chnh mi c th, bo v c th hoc gi c th trong iu kin tt. 2. Tn m phm l tn c t cho mt sn phm m phm, c th l tn mi t t cng vi thng hiu hoc tn ca nh sn xut. Cc k t cu thnh tn sn phm phi l cc k t c gc ch ci Latin. 3. T chc, c nhn chu trch nhim a sn phm ra th trng l t chc, c nhn ng tn trn h s cng b sn phm m phm v chu trch nhim v sn phm m phm trn th trng. 4. S tip nhn Phiu cng b sn phm m phm l s do c quan qun l nh nc c thm quyn cp khi tip nhn h s cng b sn phm m phm. S tip nhn Phiu cng b c gi tr chng nhn sn phm m phm c t chc, c nhn chu trch nhim a sn phm ra th trng khai bo vi c quan qun l nh nc c thm quyn v vic m phm s c lu thng trn th trng m khng c gi tr chng nhn sn phm m bo tnh an ton, hiu qu, p ng tt c cc yu cu ca Hip nh m phm ASEAN v cc ph lc (Annexes) km theo. 5. Ch s hu sn phm m phm l t chc, c nhn s hu cng thc, quy trnh sn xut, tiu chun cht lng sn phm. 6. n nh ca sn phm l kh nng n nh ca sn phm khi c bo qun trong iu kin thch hp vn duy tr c nhng tnh nng ban u ca n, c bit l vn phi m bo c cc yu cu v tnh an ton. 2

7. nh lng ca hng ho l lng m phm c th hin bng khi lng tnh hoc th tch thc theo h mt hoc c h mt v h o lng Anh. 8. Nhn m phm l bn vit, bn in, bn v, bn chp ca ch, hnh v, hnh nh c dn, in, nh, c, chm, khc trc tip trn hng ho, bao b thng phm ca hng ho hoc trn cc cht liu khc c gn trn hng ho, bao b thng phm ca hng ha. 9. Ghi nhn m phm l th hin ni dung c bn, cn thit v m phm ln nhn ngi dng nhn bit, lm cn c la chn v s dng ng; nh sn xut, kinh doanh qung b cho hng ho ca mnh v lm cn c cc c quan chc nng thc hin vic kim tra, kim sot. 10. Nhn gc l nhn th hin ln u c gn trn bao b thng phm ca m phm. 11. Nhn ph l nhn th hin nhng ni dung bt buc c dch t nhn gc ca m phm bng ting nc ngoi ra ting Vit v b sung nhng ni dung bt buc bng ting Vit theo quy nh ca Thng t ny m nhn gc ca m phm cn thiu. 12. Bao b thng phm ca m phm l bao b cha ng m phm v lu thng cng vi m phm. Bao b thng phm ca m phm gm hai loi: Bao b trc tip v bao b ngoi. a) Bao b trc tip l bao b cha ng hng ho, tip xc trc tip vi hng ho, to ra hnh khi hoc bc kn theo hnh khi ca hng ha. b) Bao b ngoi l bao b dng bao gi mt hoc mt s n v hng ho c bao b trc tip. 13. Lu thng m phm l hot ng trng by, vn chuyn, lu gi hng ho trong qu trnh mua bn hng ha, tr trng hp vn chuyn hng ha ca t chc, c nhn nhp khu hng ha t ca khu v kho lu gi. 14. S l sn xut m phm l k hiu bng s hoc bng ch, hoc kt hp c s v ch nhm nhn bit l sn phm v cho php truy xt ton b lai lch ca mt l sn phm bao gm tt c cc cng on ca qu trnh sn xut, kim tra cht lng v phn phi l sn phm . 15. Ngy sn xut m phm l mc thi gian hon thnh sn xut, ch bin, ng gi hoc cc hnh thc khc hon thin cng on cui cng ca l sn phm. 16. Hn dng ca m phm (hn s dng) l mc thi gian c n nh cho mt l m phm m sau thi hn ny m phm khng c php lu thng, s dng. 3

17. S dng tt nht trc ngy l mc thi gian m nh sn xut khuyn dng khi cht lng sn phm ang t mc ti u. 18. Xut x hng ho ca m phm l nc hoc vng lnh th ni sn xut ra ton b m phm hoc ni thc hin cng on ch bin c bn cui cng i vi m phm trong trng hp c nhiu nc hoc vng lnh th tham gia vo qu trnh sn xut m phm . 19. Giy chng nhn lu hnh t do (CFS - Certificate of Free Sale) l giy chng nhn do c quan c thm quyn ca nc xut khu cp cho thng nhn xut khu m phm ghi trong CFS chng nhn rng m phm c sn xut v c php lu hnh t do ti nc xut khu. 20. Hng dn s dng l nhng thng tin cn thit hng dn cho ngi s dng m phm an ton, hp l. Hng dn s dng c th in trn bao b trc tip hoc theo dng ti liu i km theo bao b thng phm ca m phm trong ghi hng dn s dng v nhng ni dung khc theo quy nh. 21. Qung co m phm l cc hot ng gii thiu, qung b m phm nhm thc y qu trnh sn xut, bn, s dng m phm. 22. Hi tho, s kin gii thiu m phm l hi ngh gii thiu hoc tho lun chuyn vi ngi tiu dng v cc vn chuyn su lin quan n m phm. 23. Ngi qung co l t chc, c nhn c nhu cu qung co v m phm do mnh sn xut, phn phi. 24. Ngi pht hnh qung co l t chc, c nhn a sn phm qung co m phm n ngi tiu dng, bao gm c quan bo ch, truyn thanh, truyn hnh, nh xut bn, t chc qun l mng thng tin my tnh, ngi t chc chng trnh vn ho, th thao, hi ch, trin lm v t chc, c nhn s dng phng tin qung co khc. 25. Hi ng m phm ASEAN l c quan i din cho cc nc thnh vin ASEAN theo di, quyt nh v gii quyt cc tranh chp lin quan n vic thc hin Hip nh m phm ASEAN. Chng II CNG B sn phm M PHM iu 3. Quy nh v vic cng b sn phm m phm 1. Cc t chc, c nhn chu trch nhim a sn phm m phm ra th trng ch c php a m phm ra lu thng khi 4

c c quan qun l nh nc c thm quyn cp s tip nhn Phiu cng b sn phm m phm v phi hon ton chu trch nhim v tnh an ton, hiu qu v cht lng sn phm. C quan nh nc c thm quyn s tin hnh kim tra hu mi khi sn phm lu thng trn th trng. 2. L ph cng b sn phm m phm c thc hin theo quy nh hin hnh. 3. T chc, c nhn chu trch nhim a sn phm ra lu thng trn th trng phi c chc nng kinh doanh m phm ti Vit Nam. 4. Vic cng b tnh nng ca sn phm m phm (mc ch s dng ca sn phm) phi p ng hng dn ca ASEAN v cng b tnh nng sn phm m phm (Ph lc s 03-MP). iu 4. H s cng b sn phm m phm H s cng b sn phm m phm bao gm cc ti liu sau: 1. Phiu cng b sn phm m phm (02 bn) km theo d liu cng b (bn mm ca Phiu cng b); 2. Bn sao Giy chng nhn ng k kinh doanh ca t chc, c nhn chu trch nhim a sn phm ra th trng (c ch k v ng du ca doanh nghip). Trng hp m phm sn xut trong nc m t chc, c nhn chu trch nhim a sn phm ra th trng khng phi l nh sn xut th phi c bn sao Giy chng nhn ng k kinh doanh ca nh sn xut (c chng thc hp l); 3. Bn chnh hoc bn sao c chng thc hp l Giy y quyn ca nh sn xut hoc ch s hu sn phm y quyn cho t chc, c nhn chu trch nhim a sn phm ra th trng c phn phi sn phm m phm ti Vit Nam (p dng i vi m phm nhp khu v m phm sn xut trong nc m t chc, c nhn chu trch nhim a sn phm ra th trng khng phi l nh sn xut). i vi sn phm nhp khu th Giy u quyn phi l bn c chng thc ch k v c hp php ho lnh s theo quy nh ca php lut, tr trng hp c min hp php ho lnh s theo cc iu c quc t m Vit Nam l thnh vin. Giy u quyn phi p ng cc yu cu quy nh ti iu 6 Thng t ny. 4. Giy chng nhn lu hnh t do (CFS): Ch p dng i vi trng hp cng b sn phm m phm nhp khu v p ng cc yu cu sau: a) CFS do nc s ti cp l bn chnh hoc bn sao c chng thc hp l, cn hn. Trng hp CFS khng nu thi hn th phi l bn c cp trong vng 24 thng k t ngy cp.

b) CFS phi c hp php ho lnh s theo quy nh ca php lut, tr trng hp c min hp php ho lnh s theo cc iu c quc t m Vit Nam l thnh vin. iu 5. Cch lp Phiu cng b sn phm m phm v d liu cng b 1. Phiu cng b sn phm m phm: a) Phiu cng b sn phm m phm c lp theo mu Ph lc s 01-MP. Phiu cng b phi c ngi i din theo php lut k, c ng du gip lai ca t chc, c nhn chu trch nhim a sn phm ra th trng. Cch ghi cc ni dung trong Phiu cng b sn phm m phm theo hng dn ti Ph lc s 02-MP. b) Mi sn phm m phm c cng b trong mt Phiu cng b. Sn phm m phm c sn xut hon chnh ti mi cng ty sn xut khc nhau th cng b ring. Trng hp c trn mt cng ty tham gia cc cng on sn xut sn xut ra mt sn phm hon chnh th lp chung trong mt Phiu cng b v phi nu r tn v a ch y ca tng cng ty. Cc sn phm cng mt ch s hu sn phm thuc mt trong cc trng hp sau y c php cng b trong mt Phiu cng b: - Cc sn phm c ng di tn chung v c bn di dng mt b sn phm. - Cc sn phm cng tn, cng dng sn phm c cng thc tng t nhau nhng c mu sc hoc mi khc nhau. i vi sn phm nhum tc, nc hoa cng b ring cho tng mu, mi. - Cc dng khc s c Cc Qun l dc - B Y t quyt nh da vo quyt nh ca Hi ng m phm ASEAN. c) Cch ghi thnh phn cng thc c trong sn phm m phm: - Thnh phn c trong cng thc sn phm phi c ghi y theo th t hm lng gim dn. Cc thnh phn nc hoa, cht to hng v cc nguyn liu ca chng c th vit di dng hng liu (perfume, fragrance, flavour, aroma). Nhng thnh phn vi hm lng nh hn 1% c th lit k theo bt k th t no sau cc thnh phn c hm lng ln hn 1%. Cc cht mu c th c ghi theo bt c th t no sau cc thnh phn khc theo ch dn mu (CI) hoc theo tn nh trong Ph lc IV (Annex IV) ca Hip nh m phm ASEAN. Nhng sn phm m phm dng trang im, di dng cc mu khc nhau c th lit k tt c cc cht mu trong mc c th cha hoc +/-. - Nu y t l phn trm ca cc thnh phn c quy nh v gii hn nng , hm lng ti cc Ph lc (Annexes) ca 6

Hip nh m phm ASEAN. Gia hng n v v hng thp phn c nh du bng du phy (,). - Tn thnh phn phi c ghi bng danh php quc t (International Nomenclature of Cosmetic Ingredients - INCI) quy nh trong cc n phm mi nht: T in thnh phn m phm quc t (International Cosmetic Ingredient Dictionary), Dc in Anh (British Pharmacopoeia), Dc in M (United States Pharmacopoeia), D liu tm tt v ho hc (Chemical Abstract Services), Tiu chun Nht Bn v thnh phn nguyn liu m phm (Japanese Standard Cosmetic Ingredient), n phm ca Nht Bn v thnh phn nguyn liu m phm (Japanese Cosmetic Ingredients Codex). Tn thc vt v dch chit t thc vt phi c vit bng tn khoa hc bao gm chi, loi thc vt (tn chi thc vt c th rt ngn). Cc thnh phn c ngun gc t ng vt cn nu chnh xc tn khoa hc ca loi ng vt . Nhng cht sau y khng c coi l thnh phn ca m phm: - Tp cht trong nguyn liu c s dng. - Cc nguyn liu ph c s dng v mc ch k thut nhng khng c mt trong sn phm thnh phm. - Nguyn liu c s dng vi s lng cn thit nh dung mi hoc cht mang ca cc thnh phn to mi. d) Ngn ng trnh by trong Phiu cng b l ting Vit hoc ting Anh. Cc ni dung ghi ti mc 3 (Mc ch s dng), mc 7 (Thng tin v t chc, c nhn chu trch nhim a sn phm ra th trng), mc 8 (Thng tin v ngi i din theo php lut ca Cng ty), mc 9 (Thng tin v Cng ty nhp khu) trong Phiu cng b phi ghi bng ting Vit hoc ting Vit v ting Anh. 2. D liu cng b (bn mm ca Phiu cng b): Cc t chc, c nhn c th np d liu cng b quy nh ti khon 1 iu 4 ca Thng t ny theo mt trong hai cch thc sau: a) Khai bo trc tip: T chc, c nhn ng tn cng b sn phm m phm gi vn bn v Cc Qun l dc - B Y t c cp ti khon truy cp vo c s d liu v qun l m phm, khai bo trc tip trn c s d liu. Phiu cng b np cho c quan qun l nh nc c thm quyn phi c in ra t c s d liu . b) Truy cp vo trang thng tin in t ca Cc Qun l dc, ti c s d liu ca Phiu cng b sn phm m phm (Ph lc s 01-MP), in y thng tin theo quy nh vo c s d liu, sao lu vo phng tin lu gi in t (USB, CD-ROM, ...). 7

Phiu cng b np cho c quan qun l nh nc c thm quyn phi c in ra t c s d liu . T chc, c nhn ng tn cng b sn phm phi chu hon ton trch nhim v tnh ph hp cc ni dung ca Phiu cng b sn phm m phm (bn c k tn, ng du) vi d liu cng b (bn mm) khai bo hoc np cho c quan qun l. iu 6. Quy nh v Giy y quyn 1. Ngn ng trnh by l ting Vit, ting Anh hoc song ng ting Vit v ting Anh. 2. Giy u quyn phi c y cc ni dung sau: a) Tn, a ch ca nh sn xut; trng hp bn u quyn l ch s hu sn phm th cn nu r tn, a ch ca ch s hu sn phm v tn, a ch ca nh sn xut; b) Tn, a ch ca t chc, c nhn c y quyn; c) Phm vi y quyn (ng tn cng b v phn phi sn phm m phm ti Vit Nam); d) Nhn hng hoc tn sn phm c y quyn; ) Thi hn y quyn; e) Cam kt ca nh sn xut hoc ch s hu sn phm cung cp y H s thng tin sn phm (PIF) cho t chc, c nhn chu trch nhim a sn phm ra th trng ti Vit Nam; g) Tn, chc danh, ch k ca ngi i din cho bn u quyn. iu 7. Th tc tip nhn v gii quyt h s cng b sn phm m phm 1. H s cng b sn phm m phm c lm thnh 01 b, np trc tip hoc gi qua ng bu in ti c quan qun l nh nc c thm quyn sau: a) i vi m phm nhp khu: T chc, c nhn chu trch nhim a sn phm ra th trng np h s cng b sn phm m phm ti Cc Qun l dc - B Y t. b) i vi m phm sn xut trong nc: T chc, c nhn chu trch nhim a sn phm ra th trng np h s cng b sn phm m phm ti S Y t ni t nh my sn xut. Sn phm m phm c sn xut, ng gi t bn thnh phm nhp khu c coi nh sn phm sn xut trong nc. c) i vi m phm kinh doanh trong phm vi Khu thng mi cng nghip thuc Khu kinh t ca khu Mc Bi, tnh Ty Ninh thc hin cng b ti Ban Qun l Khu kinh t ca khu Mc Bi; m phm kinh doanh trong phm vi Khu kinh t - thng mi c 8

bit Lao Bo, tnh Qung Tr thc hin cng b ti Ban Qun l Khu kinh t tnh Qung Tr. Vic a m phm t Khu thng mi cng nghip thuc Khu kinh t ca khu Mc Bi, tnh Ty Ninh vo cc khu chc nng khc trong Khu kinh t ca khu Mc Bi, tnh Ty Ninh hoc a vo th trng ni a kinh doanh; a m phm t Khu Kinh t - Thng mi c bit Lao Bo, tnh Qung Tr vo th trng ni a kinh doanh phi thc hin cng b ti Cc Qun l dc - B Y t theo quy nh ca Thng t ny (t chc, c nhn ng tn cng b sn phm m phm phi c chc nng kinh doanh m phm ti Vit Nam v nm ngoi 2 khu ny). 2. Gii quyt h s cng b sn phm m phm: a) Trong vng 03 ngy lm vic k t ngy nhn c h s cng b hp l v l ph cng b theo quy nh, c quan qun l nh nc c thm quyn c trch nhim ban hnh s tip nhn Phiu cng b sn phm m phm. b) Trng hp h s cng b cha p ng theo quy nh ca Thng t ny th trong vng 05 ngy lm vic k t ngy nhn c h s, c quan tip nhn h s thng bo bng vn bn cho t chc, c nhn cng b bit cc ni dung cha p ng sa i, b sung h s (nu c th cc ni dung cha p ng). H s b sung ca n v gm: - Vn bn gii trnh v vic sa i, b sung ca t chc, c nhn ng tn cng b; - Phiu cng b sn phm m phm km theo d liu cng b (bn mm ca Phiu cng b) hoc ti liu khc c sa i, b sung; Trong vng 05 ngy lm vic k t ngy nhn c h s b sung p ng theo quy nh ca Thng t ny, c quan qun l nh nc c thm quyn c trch nhim ban hnh s tip nhn Phiu cng b sn phm m phm. Trng hp h s sa i, b sung khng p ng theo quy nh ca Thng t ny th trong vng 05 ngy lm vic k t ngy nhn c h s b sung, c quan tip nhn h s thng bo bng vn bn khng cp s tip nhn Phiu cng b sn phm m phm cho sn phm ny. c) Trong thi gian 03 thng k t ngy ban hnh vn bn thng bo theo quy nh ti im b khon ny, nu c quan qun l nh nc c thm quyn khng nhn c h s b sung ca t chc, c nhn ng tn cng b th h s cng b khng cn gi tr. Trong trng hp ny, nu t chc, c nhn mun tip

tc cng b th phi np h s mi v np l ph mi theo quy nh. iu 8. Quy nh v cch ghi s tip nhn Phiu cng b sn phm m phm S tip nhn phiu cng b sn phm m phm c quy nh nh sau: s th t c cp + gch cho + nm cp (hai ch s cui) + gch cho + CBMP + gch ngang + k hiu vit tt tn tnh, thnh ph, Ban Qun l Khu kinh t hoc Cc Qun l dc (QLD) theo Ph lc s 04-MP. V d: 135/11/CBMP-HN c ngha l s tip nhn Phiu cng b m phm l 135 do S Y t H Ni cp nm 2011. iu 9. Thay i cc ni dung cng b i vi cc sn phm m phm cng b v c cp s tip nhn Phiu cng b sn phm m phm, khi c thay i cc ni dung quy nh ti Ph lc s 05-MP, t chc, c nhn chu trch nhim a sn phm ra th trng phi c vn bn ngh b sung (i vi cc ni dung khng phi cng b mi) km theo ti liu c lin quan n ni dung b sung v phi c s chp thun bng vn bn ca c quan nh nc c thm quyn hoc thc hin cng b mi theo quy nh (i vi cc ni dung phi cng b mi). iu 10. Hiu lc ca s tip nhn Phiu cng b sn phm m phm S tip nhn Phiu cng b sn phm m phm c gi tr 05 nm k t ngy cp. Ht thi hn 05 nm, t chc, c nhn mun tip tc a sn phm m phm ra lu thng trn th trng th phi cng b li trc khi s tip nhn Phiu cng b sn phm m phm ht hn v phi np l ph theo quy nh. Chng III H s thng tin sn phm m phm iu 11. Quy nh chung v H s thng tin sn phm m phm Mi sn phm m phm khi a ra lu thng trn th trng phi c H s thng tin sn phm (PIF - Product Information File) theo hng dn ca ASEAN lu gi ti a ch ca t chc, c nhn chu trch nhim a sn phm ra th trng. iu 12. Ni dung ca H s thng tin sn phm m phm sau: 1. H s Thng tin sn phm m phm gm c 4 phn nh 10

a) Phn 1: Ti liu hnh chnh v tm tt v sn phm; b) Phn 2: Cht lng ca nguyn liu; c) Phn 3: Cht lng ca thnh phm; d) Phn 4: An ton v hiu qu. Ni dung chi tit ca H s Thng tin sn phm m phm quy nh ti Ph lc s 07-MP. 2. Phn 1 ca H s thng tin sn phm phi c xut trnh ngay cho c quan kim tra, thanh tra khi c yu cu; cc phn khc nu cha y th xut trnh trong vng 15-60 ngy k t ngy kim tra theo yu cu ca c quan chc nng. Chng IV YU CU V AN TON SN PHM m phm iu 13. Yu cu v an ton sn phm m phm Cc t chc, c nhn chu trch nhim a sn phm m phm ra th trng phi m bo cc sn phm ca mnh khng c hi i vi sc kho con ngi khi c dng trong nhng iu kin bnh thng hoc nhng iu kin thch hp c hng dn, ph hp vi dng bo ch, thng tin ghi trn nhn, hng dn s dng, thn trng c bit, cng nh cc thng tin khc cung cp bi nh sn xut hoc ch s hu sn phm. Nh sn xut, ch s hu sn phm phi nh gi tnh an ton trn mi sn phm m phm theo Hng dn nh gi tnh an ton m phm ca ASEAN. Gii hn kim loi nng v vi sinh vt trong m phm phi p ng yu cu ca ASEAN quy nh ti Ph lc s 06-MP. Thnh phn cng thc m phm phi p ng theo cc Ph lc (Annexes) - bn mi nht ca Hip nh m phm ASEAN (a ch truy cp: www.dav.gov.vn hoc www.aseansec.org). iu 14. Cc thnh phn cht cm, cc thnh phn c quy nh v gii hn nng , hm lng v iu kin s dng trong cng thc sn phm m phm Cc t chc, c nhn khng c a ra th trng nhng sn phm m phm c cha: 1. Cc cht cm s dng trong m phm vi iu kin i km c lit k trong Ph lc II (Annex II). 2. Cc thnh phn c lit k trong phn th nht ca Ph lc III (Annex III), vi nng , hm lng vt qu gii hn hoc nm ngoi iu kin cho php.

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3. Cc cht mu khc vi cc cht c lit k trong Ph lc IV (Annex IV), phn 1, tr trng hp cc m phm cha cc cht mu vi mc ch duy nht nhum tc. 4. Cc cht mu c lit k trong Ph lc IV (Annex IV), phn 1 c s dng ngoi iu kin nu. 5. Cc cht bo qun nm ngoi danh mc trong Ph lc VI (Annex VI), phn 1. 6. Cc cht bo qun c lit k trong Ph lc VI (Annex VI), phn 1, vi hm lng vt qu gii hn hoc nm ngoi iu kin cho php, tr trng hp cc cht ny c s dng vi mc ch c bit, khng lin quan n cng dng l cht bo qun. 7. Cc cht lc tia t ngoi nm ngoi danh mc trong Ph lc VII (Annex VII), phn 1. 8. Cc cht lc tia t ngoi nm trong Ph lc VII (Annex VII), phn 1 nhng c hm lng vt qu gii hn hoc iu kin cho php. S c mt ca cc cht c lit k trong Ph lc II (Annex II) vi hm lng vt vn c chp nhn nu v l do k thut khng th trnh c trong Thc hnh tt sn xut m phm v vn m bo yu cu v an ton ca m phm nh quy nh ti iu 13 ca Thng t ny. iu 15. Nhng sn phm m phm cha cc thnh phn sau y th vn c php lu thng trn th trng 1. Cc thnh phn hoc nguyn liu c lit k trong Ph lc III (Annex III), phn 2, trong gii hn v theo nhng iu kin nu, cho n ngy c quy nh trong ct (g) ca Ph lc ny. 2. Cc cht mu c lit k trong Ph lc IV, phn 2, trong gii hn cho php v trong iu kin c chp nhn, cho n ngy c quy nh trong ph lc ny. 3. Cc cht bo qun c lit k trong Ph lc VI, phn 2, trong gii hn cho php v trong iu kin c chp nhn, cho n ngy c cp n trong ct (f) ca Ph lc ny. Tuy nhin, mt vi thnh phn trong s ny c th c s dng nhng hm lng khc vi mc ch c th, c th hin r rng trong dng trnh by ca sn phm. 4. Cc cht lc tia t ngoi c quy nh trong phn 2 ca Ph lc VII (Annex VII), trong gii hn cho php v trong iu kin quy nh, cho n ngy c cp n trong ct (f) ca Ph lc ny. Quy nh v vic s dng cc cht nm trong cc Ph lc (Annexes) nu trn c th thay i theo quyt nh ca Hi ng m phm ASEAN. Cc quy nh ny s t ng c cp nht v c gi tr ti Vit Nam. 12

Chng V GHI NHN M PHM iu 16. V tr nhn m phm 1. Nhn m phm phi c gn trn hng ha, bao b thng phm ca hng ha v tr khi quan st c th nhn bit c d dng, y cc ni dung quy nh ca nhn m khng phi tho ri cc chi tit, cc phn ca hng ha. 2. Trng hp khng c hoc khng th m bao b ngoi th trn bao b ngoi phi c nhn v nhn phi trnh by y cc ni dung bt buc. iu 17. Kch thc, hnh thc v ni dung ca nhn 1. T chc, c nhn chu trch nhim a sn phm m phm ra th trng t xc nh kch thc ca nhn hng ho m phm nhng phi bo m thng tin ghi trn nhn phi d c bng mt thng. Ni dung ca nhn v nhn ph (nu c) phi trung thc, r rng, chnh xc v phn nh ng tnh nng ca sn phm. 2. Mu sc ca ch, ch s, hnh v, hnh nh, du hiu, k hiu trnh by trn nhn m phm phi r rng. Mu sc ca ch v s phi tng phn vi nn ca nhn. iu 18. Ni dung bt buc phi ghi trn nhn 1. Nhn sn phm m phm phi ph hp vi yu cu ghi nhn m phm ca ASEAN. Nhng thng tin sau phi c th hin trn nhn sn phm: a) Tn ca sn phm v chc nng ca n, tr khi dng trnh by sn phm th hin r rng chc nng ca sn phm; b) Hng dn s dng, tr khi dng trnh by th hin r rng cch s dng ca sn phm; c) Thnh phn cng thc y : Phi ghi r cc thnh phn theo danh php quc t quy nh trong cc n phm mi nht nu ti im c khon 1 iu 5 ca Thng t ny (khng phi ghi t l phn trm ca cc thnh phn); d) Tn nc sn xut; ) Tn v a ch ca t chc, c nhn chu trch nhim a sn phm ra th trng (ghi y bng ting Vit theo Giy chng nhn ng k kinh doanh hoc Giy php u t); e) nh lng th hin bng khi lng tnh hoc th tch, theo h mt hoc c h mt v h o lng Anh; g) S l sn xut; 13

h) Ngy sn xut hoc hn dng phi c th hin mt cch r rng (v d: ngy/thng/nm). Cch ghi ngy phi th hin r rng gm thng, nm hoc ngy, thng, nm theo ng th t. C th dng t ngy ht hn hoc s dng tt nht trc ngy, nu cn thit c th b sung thm iu kin ch nh cn tun th m bo s n nh ca sn phm. Vi nhng sn phm c n nh di 30 thng, bt buc phi ghi ngy ht hn; i) Lu v an ton khi s dng, c bit theo nhng lu nm trong ct "iu kin s dng v nhng cnh bo bt buc phi in trn nhn sn phm" c cp trong cc ph lc ca Hip nh m phm ASEAN, nhng thn trng ny bt buc phi th hin trn nhn sn phm. 2. Trong trng hp kch thc, dng hoc cht liu bao gi khng th in c y cc thng tin quy nh ti khon 1 iu ny trn nhn gc, nhng ni dung bt buc ny phi c ghi trn nhn ph nh km theo sn phm m phm v trn nhn m phm phi ch ra ni ghi cc ni dung . Cc thng tin sau y bt buc phi c ghi trn nhn gc ca bao b trc tip ca sn phm: a) Tn sn phm; b) S l sn xut. iu 19. Ngn ng trnh by trn nhn m phm Nhng ni dung quy nh ti iu 18 ca Thng t ny phi c trnh by bng ting Anh hoc ting Vit; ring cc thng tin ti im b, , i khon 1 iu 18 phi ghi bng ting Vit. iu 20. Cc ni dung khc th hin trn nhn m phm T chc, c nhn c php ghi trn nhn m phm nhng ni dung khc. Nhng ni dung ghi thm khng c tri vi quy nh ca php lut v phi m bo trung thc, chnh xc, phn nh ng bn cht ca hng ho, khng che khut, khng lm sai lch nhng ni dung bt buc ghi trn nhn m phm. Chng VI QUNG CO M PHM iu 21. Quy nh v qung co m phm 1. Qung co m phm c thc hin trn cc phng tin thng tin i chng nh truyn hnh, truyn thanh, trang thng tin in t (Internet, Website), sch, bo, tp ch, t ri, pano, p phch, vt th trn khng, vt th di nc hoc cc phng tin 14

qung co khc do n v kinh doanh m phm thc hin hoc ti tr, u quyn cho n v khc thc hin v cc hot ng t chc hi tho, thng tin, gii thiu sn phm m phm. 2. Cc n v ch c php qung co, t chc hi tho, s kin gii thiu cc sn phm m phm khi c Phiu tip nhn h s ng k qung co, t chc hi tho, s kin gii thiu m phm theo quy nh ca php lut. 3. Ni dung qung co m phm phi ph hp vi cc ti liu chng minh tnh an ton v hiu qu ca m phm v phi tun th theo hng dn v cng b tnh nng sn phm m phm ca ASEAN. iu 22. Ni dung qung co m phm, hi tho, s kin gii thiu m phm Ni dung qung co m phm, hi tho, s kin gii thiu m phm phi c cc thng tin sau: 1. Tn m phm; 2. Tnh nng, cng dng (nu cc tnh nng, cng dng ch yu ca m phm nu cha th hin trn tn ca sn phm); 3. Tn v a ch ca t chc, c nhn chu trch nhim a sn phm m phm ra th trng; 4. Lu khi s dng (nu c). iu 23. Qung co m phm trn phng tin truyn hnh, truyn thanh Qung co m phm trn phng tin truyn hnh, truyn thanh th cc khon 1, 3, 4 iu 22 phi c c to, r rng. Trng hp hin th bng ch trn mn hnh cc ni dung trn th tc hin th phi ph hp v c ch qung co ln bo m r rng, d c. iu 24. Qung co trn bo ch, t ri Qung co trn bo ch, t ri th cui trang u tin ca ti liu qung co m phm phi in: (a) S Phiu tip nhn h s ng k qung co ca S Y t; b) ngy ... thng ... nm ... nhn h s hp l ghi trn Phiu tip nhn. iu 25. H s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm 1. H s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm bao gm cc ti liu sau: a) Phiu ng k qung co m phm, t chc hi tho, s kin gii thiu m phm (Ph lc s 10-MP); 15

b) Bn sao Phiu cng b sn phm m phm c cp (c ng du ca t chc, c nhn ng k qung co); c) Bn sao Giy chng nhn ng k kinh doanh ca t chc, c nhn ng k qung co (c ng du ca t chc, c nhn ng k qung co); d) Th u quyn ca t chc, c nhn cng b m phm cho t chc, c nhn ng k qung co, t chc hi tho, s kin gii thiu m phm (trng hp t chc, c nhn ng k qung co, t chc hi tho, s kin gii thiu m phm khng phi l t chc, c nhn cng b sn phm m phm); ) Ti liu thuyt minh cho cc tnh nng, cng dng ca sn phm trong trng hp ni dung qung co, ni dung trnh by ti hi tho, s kin gii thiu m phm nu tnh nng, cng dng ca sn phm nm ngoi ni dung nu trong Phiu cng b sn phm m phm; e) 02 kch bn qung co (kch bn phi m t r phn hnh nh, phn li, phn nhc d nh s qung co) hoc 02 mu qung co d nh s pht hnh (p dng i vi h s ng k qung co m phm) hoc ti liu d nh trng by, pht hnh ti hi tho, s kin gii thiu m phm (p dng i vi h s ng k t chc hi tho, s kin gii thiu m phm). H s phi c du gip lai ca t chc, c nhn ng k qung co, t chc hi tho, s kin gii thiu m phm. 2. Cch lp h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm: a) H s ng k qung co m phm c th c lp cho mt hoc nhiu sn phm, c qung co trn mt hoc nhiu phng tin thng tin i chng khc nhau. Mu qung co, kch bn qung co m phm c th c lp cho mt hoc nhiu sn phm khc nhau. b) H s ng k t chc hi tho, s kin gii thiu m phm c th c lp cho mt hoc nhiu sn phm c t chc ti mt hoc nhiu a im trn a bn tnh, thnh ph. iu 26. Thm quyn tip nhn, gii quyt h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm 1. T chc, c nhn trc khi qung co m phm phi gi 01 b h s ng k qung co m phm theo quy nh hin hnh v S Y t ni t tr s chnh ca t chc, c nhn cng b sn phm m phm. Phong b ng h s ghi r "H s ng k qung co m phm".

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2. T chc, c nhn trc khi t chc hi tho, s kin gii thiu m phm phi gi 01 b h s theo quy nh hin hnh v S Y t a phng ni t chc hi tho, s kin gii thiu m phm. Phong b ng h s ghi r "H s ng k t chc hi tho, s kin gii thiu m phm". 3. S Y t cc tnh, thnh ph trc thuc Trung ng (tr cc hnh thc qung co thc hin theo Thng t lin tch s 06/2007/TTLT/BVHTT-BYT-BNN-BXD ngy 28/02/2007 ca lin B Vn ho Thng tin, B Y t, B Nng nghip v Pht trin nng thn, B Xy dng v vic hng dn th tc cp giy php thc hin qung co mt ca lin thng) tip nhn v gii quyt h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm. iu 27. Trnh t, th tc cp Phiu tip nhn h s ng k qung co, t chc hi tho, s kin gii thiu m phm 1. Sau khi nhn c h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm hp l theo ng quy nh ca Thng t ny v l ph theo quy nh hin hnh, S Y t gi cho n v np h s ng k mt Phiu tip nhn h s ng k qung co, t chc hi tho, s kin gii thiu m phm (Ph lc s 11-MP) km theo mu hoc kch bn qung co t yu cu (p dng vi h s ng k qung co m phm). Ngy ghi trn Phiu tip nhn h s l ngy S Y t nhn h s hp l. Sau 10 ngy lm vic, k t ngy nhn c h s, nu S Y t khng c vn bn yu cu sa i, b sung th n v c quyn qung co, t chc hi tho, s kin gii thiu m phm theo ng ni dung ng k. 2. Trng hp h s cha hp l theo quy nh ca Thng t ny th S Y t c vn bn thng bo cho n v b sung, hon chnh h s. a) Trong vn bn phi nu c th, chi tit nhng ti liu v ni dung cn sa i, b sung. b) n v phi sa i, b sung theo ng nhng ni dung c nu trong vn bn yu cu sa i, b sung v gi v S Y t. Khi n v b sung h s th S Y t gi mt Phiu tip nhn h s, ngy ghi trn Phiu tip nhn h s l ngy S Y t nhn c h s b sung hp l theo yu cu. Sau 10 ngy lm vic, k t ngy nhn c ni dung qung co sa i, b sung nu S Y t khng c vn bn yu cu sa i, b sung th n v c qung co, t chc hi tho, s kin gii thiu m phm nh ni dung sa i.

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c) Trng hp h s b sung khng p ng theo ng nhng ni dung c nu trong vn bn yu cu sa i, b sung th S Y t s thng bo cho n v khng c qung co, t chc hi tho, s kin gii thiu m phm theo ni dung ng k. Trong trng hp ny, nu n v mun tip tc qung co, t chc hi tho, s kin gii thiu m phm phi np h s; trnh t ng k v thm nh h s c thc hin li t u v phi np l ph theo quy nh. d) Trong thi gian 02 thng, k t ngy S Y t c vn bn gi n v np h s nhng ni dung cn b sung, nu S Y t khng nhn c vn bn km h s b sung th h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm np khng cn gi tr. co iu 28. Ph thm nh ni dung thng tin, qung

1. Ph thm nh ni dung qung co m phm cho mt h s thc hin theo quy nh hin hnh c tnh theo sn phm tng ng vi 01 Phiu cng b sn phm m phm c cp s tip nhn (khng ph thuc vo cc phng tin thng tin i chng s dng qung co). 2. Ph thm nh h s t chc hi tho, s kin gii thiu m phm (Ph thm nh ni dung thng tin, qung co) thc hin theo quy nh hin hnh c tnh theo sn phm tng ng vi 01 Phiu cng b sn phm m phm c cp s tip nhn (khng ph thuc s ln t chc v a im t chc hi tho, s kin gii thiu m phm). iu 29. Qung co m phm ti a phng khc Sau khi nhn c Phiu tip nhn h s ng k qung co m phm, n v mun qung co trn cc phng tin qung co thuc a phng khc ni gi h s ng k qung co th phi gi thng bo bng vn bn km theo bn sao c chng thc hp l Phiu tip nhn h s ng k qung co m phm v ton b ni dung qung co c lin quan ng k (kch bn hoc mu qung co) cho S Y t a phng ni d nh tin hnh qung co trc khi tin hnh qung co t nht 03 ngy lm vic. iu 30. Thay i, b sung ni dung qung co, t chc hi tho, s kin gii thiu m phm 1. n v ng k qung co, t chc hi tho, s kin gii thiu m phm phi np h s ng k b sung ti S Y t ni cp Phiu tip nhn h s khi c thay i mt trong cc ni dung sau: 18

a) Tn, a ch ca t chc, c nhn chu trch nhim a sn phm ra th trng m khng thay i s Giy chng nhn ng k kinh doanh hoc s Giy chng nhn u t; b) Tn, a ch ca n v ng k qung co, t chc hi tho, s kin gii thiu m phm m khng thay i s Giy chng nhn ng k kinh doanh hoc s Giy chng nhn u t; c) a im, thi gian chnh thc t chc hi tho, s kin gii thiu m phm so vi d kin ng k. 2. H s b sung bao gm: Vn bn ngh thay i, b sung v ti liu c lin quan n ni dung thay i, b sung. 3. Nhng thay i, b sung khc ngoi cc ni dung nu ti khon 1 iu ny, n v ng k qung co, t chc hi tho, s kin gii thiu m phm phi tin hnh ng k mi theo quy nh. 4. S Y t c trch nhim gii quyt h s b sung trong vng 10 ngy lm vic k t ngy nhn h s hp l. iu 31. Cc trng hp ht hiu lc ca ni dung qung co m phm, t chc hi tho, s kin gii thiu m phm 1. Ni dung qung co m phm, t chc hi tho, s kin gii thiu m phm ht gi tr trong cc trng hp sau: a) M phm c s ng k lu hnh, s Phiu tip nhn bn cng b tiu chun cht lng m phm, s tip nhn Phiu cng b sn phm m phm ht gi tr. b) M phm b c quan qun l nh nc c thm quyn khuyn co ngng s dng hoc b thu hi sn phm. c) C nhng thay i v thng tin nh hng n tnh an ton v cht lng ca m phm. 2. n v c ni dung qung co m phm, t chc hi tho, s kin gii thiu m phm ht gi tr c trch nhim thng bo cho cc c quan c lin quan, ngi pht hnh qung co ngng ngay vic pht hnh thng tin, qung co m phm . Chng VII Xut khu, Nhp khu m phm iu 32. Xut khu m phm Vic xut khu m phm thc hin ti c quan Hi quan theo quy nh php lut hin hnh v cc yu cu ca nc nhp khu. 19

iu 33. H s, th tc cp Giy chng nhn lu hnh t do (CFS) i vi m phm sn xut trong nc xut khu 1. H s ngh cp CFS bao gm: a) n ngh cp CFS (Ph lc IV ca Quyt nh s 10/2010/Q-TTg ngy 10/02/2010 ca Th tng Chnh ph quy nh Giy chng nhn lu hnh t do i vi sn phm, hng ho xut khu v nhp khu) c k khai hon chnh v hp l; b) Bn sao Phiu cng b sn phm m phm c c quan c thm quyn cp s tip nhn (bn sao c ng du ca thng nhn ngh cp CFS). 2. Vic cp Giy chng nhn lu hnh t do (CFS) i vi m phm sn xut trong nc xut khu thc hin theo quy nh ti Chng II Quyt nh s 10/2010/Q-TTg ngy 10/02/2010 ca Th tng Chnh ph quy nh Giy chng nhn lu hnh t do i vi sn phm, hng ha xut khu v nhp khu, ngoi ra: a) M phm sn xut trong nc xut khu c cp CFS khi sn phm c c quan qun l nh nc c thm quyn cp s tip nhn Phiu cng b sn phm m phm. b) Thng nhn xut khu phi ng k h s thng nhn ti S Y t ni t c s sn xut m phm v lm th tc cp CFS i vi hng ha m phm xut khu. c) Mi CFS c cp cho 01 hoc nhiu sn phm (mu CFS theo Ph lc s 12-MP) v c gi tr hiu lc trong vng 02 nm k t ngy cp. 3. Ph, l ph cp CFS thc hin theo quy nh hin hnh (Ph, l ph cp CFS tnh theo sn phm ng vi 01 Phiu cng b sn phm m phm c cp s tip nhn). 4. S Y t cc tnh, thnh ph trc thuc Trung ng l c quan c thm quyn cp v qun l CFS i vi m phm xut khu c sn xut trn a bn (ni t c s sn xut m phm). iu 34. H s, th tc cp Giy chng nhn c s p ng cc nguyn tc, tiu chun "Thc hnh tt sn xut m phm" ca Hip hi cc nc ng Nam (CGMPASEAN) phc v cho nhu cu xut khu 1. n v sn xut c nhu cu cp Giy chng nhn c s p ng cc nguyn tc, tiu chun Thc hnh tt sn xut m phm ca Hip hi cc nc ng Nam (CGMP-ASEAN) phc v cho xut khu gi h s ng k kim tra v Cc Qun l dc B Y t. H s bao gm:

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a) Phiu ng k kim tra Thc hnh tt sn xut m phm (Ph lc s 13-MP); b) Bn sao Giy ng k kinh doanh hoc Giy php u t; c) S t chc v nhn s ca c s (s t chc phi th hin r tn, chc danh, trnh chuyn mn k thut ca cc cn b ph trch cc b phn), qu trnh cng tc v kinh nghim trong lnh vc c phn cng ca cc cn b ph trch cc b phn (sn xut, kim tra cht lng, m bo cht lng, nh kho); d) Chng trnh tp hun, nh gi kt qu tp hun Thc hnh tt sn xut m phm ti n v; ) S v tr v thit k ca nh my (bao gm: s mt bng tng th; s ng i ca cng nhn; s ng i ca nguyn liu, bao b, bn thnh phm, thnh phm; s h thng x l cht thi); e) Danh mc thit b hin c ca nh my (bao gm thit b sn xut v thit b kim tra cht lng m phm) phi th hin c tn thit b, nm sn xut, nc sn xut v tnh trng ca thit b; g) Danh mc cc mt hng ang sn xut hoc d kin sn xut (ghi r dng sn phm); h) Bin bn t thanh tra Thc hnh tt sn xut m phm (Bin bn t thanh tra phi th hin r thi gian thanh tra, thnh phn on t thanh tra, mc tiu t thanh tra, kt qu t thanh tra v cc xut thi gian v bin php khc phc cc tn ti). 2. Thm quyn tip nhn v gii quyt h s: Cc Qun l dc - B Y t c trch nhim xem xt h s, ln k hoch v ra quyt nh thnh lp on kim tra, thng bo cho c s t nht 10 ngy trc khi tin hnh kim tra. 3. Giy chng nhn c s p ng cc nguyn tc, tiu chun "Thc hnh tt sn xut m phm" c gi tr 03 nm k t ngy cp. 4. n v sn xut (gi tt l c s ng k GMP) phi np ph thm nh tiu chun v iu kin sn xut m phm theo quy nh hin hnh. iu 35. Nhp khu m phm 1. Cc sn phm m phm c Cc Qun l dc - B Y t cp s tip nhn Phiu cng b sn phm m phm cn hiu lc c php nhp khu vo Vit Nam. Th tc nhp khu thc hin ti c quan Hi quan theo quy nh hin hnh. Khi lm th tc nhp khu, doanh nghip xut trnh vi c quan Hi quan Phiu

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cng b sn phm m phm c Cc Qun l dc - B Y t cp s tip nhn. 2. Nhp khu m phm trong mt s trng hp c bit (khng bt buc phi thc hin cng b sn phm m phm theo quy nh ca Thng t ny): a) T chc, c nhn nhp khu m phm nghin cu, kim nghim phi gi n hng nhp khu m phm dng cho nghin cu, kim nghim ti Cc Qun l dc - B Y t (Ph lc s 14-MP). S lng ti a cho mi sn phm l 10 mu. n hng nhp khu m phm dng cho nghin cu, kim nghim c lm thnh 03 bn. Sau khi c ph duyt, 02 bn c lu ti Cc Qun l dc, 01 bn gi n v. Bn gi n v c ng du Bn gi doanh nghip trnh c quan Hi quan khi lm th tc thng quan. Cc sn phm m phm nhp khu nghin cu, kim nghim phi c s dng ng mc ch, khng c php a ra lu thng trn th trng. b) T chc, c nhn nhn m phm l qu biu, qu tng lm th tc nhp khu ti c quan Hi quan theo quy nh. Tng tr gi mi ln nhn khng vt qu nh mc hng ha c min thu theo quy nh hin hnh. Cc mu m phm nhp khu l qu biu, qu tng khng c php a ra lu thng trn th trng. c) T chc, c nhn nhp khu m phm trng by ti hi ch, trin lm v cc trng hp tm nhp ti xut khc phi lm th tc xin cp giy php tm nhp ti xut ca B Cng Thng theo quy nh hin hnh. Chng VIII Ly mu m phm kim tra cht lng iu 36. Nguyn tc ly mu 1. Ly mu m phm kim tra hoc gim st cht lng theo nguyn tc ly mu ngu nhin v phi ly mu nhng v tr khc nhau ca l hng. 2. Lng mu cn ly phn tch v lu cn c vo yu cu kim tra, tiu chun cht lng, phng php th nhng t nht phi cho ba ln phn tch hoc phi thc hin php th m bo thu c kt qu chnh xc v tin cy. 3. Cc mu phn tch v mu lu phi c cho vo ng, hn kn v dn nhn. Nhn ca ng mu phi ghi r tn sn phm, tn t chc, c nhn chu trch nhim a sn 22

phm ra th trng, s l sn xut, hn dng, ni ly mu, ngy ly mu. 4. Lp bin bn ly mu m phm theo mu Ph lc s 09MP: Bin bn ly mu m phm phi ghi r tn sn phm, s l sn xut, ngy ly mu, a im ly mu, ghi chp v nhng bt thng ca qu trnh ly mu, tn v ch k ca ngi ly mu, i din c s c ly mu, ngi chng kin (khi cn thit). Bin bn c lm thnh 03 bn: mt bn lu ti c s c ly mu, mt bn lu ti c quan kim nghim, mt bn lu ti c quan qun l kim tra cht lng m phm. iu 37. Quyn hn v trch nhim ca ngi ly mu 1. Xut trnh th thanh tra vin hoc kim sot vin cht lng hoc giy gii thiu hoc quyt nh thnh lp on kim tra do th trng c quan kim tra cht lng m phm k khi thi hnh nhim v. 2. Yu cu c s c mu xut trnh cc h s, ti liu, lin quan n ngun gc, s lng, cht lng ca l m phm c ly mu, a ra phng n ly mu, s lng mu phn tch v mu lu c ly ca l m phm trong qu trnh ly mu. 3. Kim tra, ly mu bt k bao gi no trong l m phm khi c nghi ng v cht lng, tnh an ton ca sn phm. 4. Chu trch nhim trc php lut v cc thao tc k thut, th tc php l trong qu trnh ly mu, vn chuyn v bn giao mu cho c quan kim nghim. iu 38. Vn chuyn v bn giao mu 1. Sau khi hon tt vic ly mu, ngi ly mu phi chuyn cc mu ly km bin bn ly mu m phm v bn giao ngay cho c quan kim nghim. Trng hp c bit, mu c th gi n c quan kim nghim qua ng bu in. 2. Mu m phm ly phi c ng gi trong bao gi ph hp v vn chuyn bng phng tin thch hp m bo mu c bo qun theo ng quy nh, trnh h hng, v trong qu trnh vn chuyn. iu 39. Kt lun kt qu kim tra cht lng cc mu m phm 1. Cc mu m phm do cc c quan nh v kim tra cht lng ly mu m bo tnh m phm v c tin hnh phn tch ti cc c cng nhn th kt lun kt qu kim tra php l i vi c l m phm. nc c thm quyn i din cho c l phng th nghim cht lng c gi tr

2. Cc mu m phm do t chc, c nhn gi ti c quan kim tra cht lng ca nh nc xc nh cht lng th kt 23

lun kt qu kim tra cht lng ch c gi tr php l i vi mu gi ti. iu 40. Kinh ph ly mu m phm v kim nghim xc nh cht lng m phm 1. Kinh ph ly mu v kinh ph kim nghim mu m phm kim tra cht lng trong sn xut, pha ch v lu thng trn th trng do c quan kim tra cht lng 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. 2. Trong trng hp mu m phm kim nghim c c quan kim tra cht lng m phm kt lun khng t tiu chun cht lng, t chc, c nhn chu trch nhim a sn phm ra th trng phi hon tr ton b kinh ph ly mu v kinh ph kim nghim mu m phm 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 m phm b khiu ni, t co v cht lng m c quan kim tra kt lun vic khiu ni, t co v cht lng m phm 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 m phm cho c quan kim tra quy nh ti khon 1 iu ny. 4. Kinh ph ly mu m phm kim tra cht lng, kinh ph kim nghim mu m phm c b tr trong d ton kinh ph hot ng ca c quan kim tra cht lng nh nc v m phm 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. Chng IX KIM TRA, THANH TRA v x l vi phm iu 41. Kim tra nh nc v cht lng m phm 1. C quan kim tra cht lng m phm:

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a) C quan kim tra cht lng m phm Trung ng l Cc Qun l dc - B Y t. Cc Qun l dc ch o h thng kim nghim trn phm vi ton quc. Trong hot ng kim tra nh nc v cht lng m phm, Cc Qun l dc phi hp vi Thanh tra B Y t, Vin Kim nghim thuc Trung ng, Vin Kim nghim thuc thnh ph H Ch Minh, S Y t cc tnh, thnh ph trc thuc Trung ng trin khai v gim st cc hot ng v hu mi i vi cc sn phm m phm. Trn c s kt qu kim nghim m phm ca cc c quan kim nghim nh nc, Cc Qun l dc - B Y t l c quan kt lun cht lng m phm trn phm vi ton quc. b) C quan kim tra cht lng m phm a phng l S Y t tnh, thnh ph trc thuc Trung ng. S Y t cc tnh, thnh ph Trung ng t chc trin khai cc hot ng v hu mi i vi m phm sn xut trong nc, m phm nhp khu lu thng trn a bn v x l cc vn v cht lng m phm theo quy nh ca php lut. Theo di, thng k tnh hnh qun l cht lng m phm ti a phng. Kt lun cht lng m phm trn c s kt qu kim nghim m phm ca c s kim nghim nh nc v m phm ti a phng. gm: 2. H thng kim nghim ca nh nc v m phm bao

a) Trung ng: Vin Kim nghim thuc Trung ng, Vin Kim nghim thuc thnh ph H Ch Minh; b) a phng: Trung tm kim nghim thuc v m phm cc tnh, thnh ph trc thuc Trung ng. 3. Th trng cc c quan kim nghim cht lng m phm chu trch nhim v kt lun kt qu kim tra cht lng m phm trc php lut. iu 42. Hnh thc kim tra, thanh tra 1. Kim tra, thanh tra nh k: Kim tra, thanh tra nh k s c c quan c thm quyn thng bo trc cho n v c kim tra n v chun b v vic thanh tra trc khi tin hnh hot ng kim tra, thanh tra. 2. Kim tra, thanh tra t xut: Kim tra, thanh tra t xut khi pht hin nhng sn phm khng t cht lng, khng tun th quy nh lu thng trn th trng hoc do cc khiu ni ca khch hng. Trong trng hp khn cp, c quan c thm quyn c quyn kim tra, thanh tra khng cn bo trc. iu 43. Ni dung kim tra, thanh tra

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1. Kim tra, thanh tra vic chp hnh php lut v sn xut, bun bn m phm: a) Vic tun th cc nguyn tc, tiu chun "Thc hnh tt sn xut m phm" ca Hip hi cc nc ng Nam (CGMPASEAN) hoc tng ng c Hi ng m phm ASEAN tha nhn; b) Ghi nhn m phm; c) H s thng tin sn phm (PIF) theo quy nh ca ASEAN; d) Qung co m phm. 2. Kim tra, thanh tra vic gii quyt tranh chp, khiu ni, t co v cht lng v cc ni dung khc lin quan n m phm (nu c). 3. Kim tra, thanh tra vic thc hin thng bo thu hi m phm theo quy nh (nu c). iu 44. Th t u tin trong kim tra gim st hu mi Vic kim tra, thanh tra gim st hu mi m phm cn tp trung ti cc n v nhp khu, phn phi, sn xut. Th t u tin trong vic kim tra gim st hu mi m phm da vo loi sn phm, ngun gc xut x, nhn hng, thng hiu cng ty, thnh phn cng thc sn phm theo hng dn ca ASEAN v kim tra gim st hu mi (Ph lc s 08-MP). iu 45. nh ch lu hnh v thu hi m phm 1. M phm b nh ch lu hnh v thu hi khi xy ra mt trong cc trng hp sau: a) M phm lu thng khi cha c c quan qun l nh nc c thm quyn cp s tip nhn Phiu cng b sn phm m phm; b) M phm khng t cht lng, khng an ton cho ngi s dng; c) M phm lu thng c cng thc khng ng nh h s cng b; d) M phm lu thng c cha thnh phn cht cm s dng trong m phm, cc cht c nng , hm lng vt qu gii hn cho php; ) M phm lu thng c nhn ghi cng dng khng ph hp vi h s cng b hoc khng p ng quy nh v ghi nhn sn phm ca Thng t ny, ty mc vi phm c th b nh ch lu hnh v thu hi; e) M phm lu thng c sn xut ti c s khng p ng nguyn tc, tiu chun "Thc hnh tt sn xut m phm" ca Hip hi cc nc ng Nam (CGMP-ASEAN) hoc tng ng c 26

Hi ng m phm ASEAN tha nhn, tu mc vi phm c th b nh ch lu hnh v thu hi; g) M phm ht hn s dng hoc qu thi hn theo khuyn co ca nh sn xut; h) M phm gi, nhp lu, khng r ngun gc, xut x, m phm khng cn nguyn vn bao b; i) M phm do t chc, c nhn chu trch nhim a sn phm ra th trng c vn bn thu hi t nguyn. 2. Thm quyn ra quyt nh thu hi m phm vi phm: a) Cc Qun l dc - B Y t ra quyt nh thu hi m phm vi phm trong phm vi ton quc. b) S Y t tnh, thnh ph trc thuc Trung ng, Ban Qun l Khu kinh t ca khu Mc Bi (tnh Ty Ninh), Ban Qun l Khu kinh t tnh Qung Tr thc hin thng bo ca Cc Qun l dc - B Y t v thu hi m phm vi phm theo quy nh ca php lut trn a bn v bo co v Cc Qun l dc. iu 46. Thu hi s tip nhn Phiu cng b sn phm m phm 1. S tip nhn Phiu cng b sn phm m phm b thu hi khi xy ra mt trong cc trng hp sau: a) M phm lu thng c 2 l khng t cht lng do c quan qun l nh nc v cht lng m phm kt lun; b) M phm lu thng c cng thc khng ng nh h s cng b; c) M phm lu thng c nhn ghi sai lch ngun gc, xut x; d) M phm lu thng c nhn ghi sai lch bn cht tnh nng vn c ca sn phm; ) M phm khng an ton cho ngi s dng; e) M phm lu thng c cha thnh phn cht cm s dng trong m phm, cc cht c nng , hm lng vt qu gii hn cho php; g) M phm b cc c quan nh nc c thm quyn kt lun l vi phm quyn s hu tr tu hoc mo nhn ca sn phm khc c php lu hnh; h) M phm b cm lu hnh nc s ti; i) T chc, c nhn a sn phm ra th trng c vn bn ngh thu hi s tip nhn Phiu cng b sn phm m phm; k) Khng c H s thng tin sn phm (PIF) xut trnh cho c quan c thm quyn theo quy nh ti iu 12 ca Thng t ny; 27

l) Gi mo ti liu, s dng con du gi hoc gi mo ch k, du ca c quan chc nng Vit Nam hoc nc ngoi, ca nh sn xut hoc ch s hu sn phm; m) K khai khng trung thc cc ni dung trong Phiu cng b sn phm m phm. 2. Thm quyn ra quyt nh thu hi s tip nhn Phiu cng b sn phm m phm: a) Cc Qun l dc - B Y t ra quyt nh thu hi s tip nhn Phiu cng b sn phm sn xut trong nc do Cc Qun l dc cp s tip nhn trc ngy 25/4/2009, m phm nhp khu trong phm vi ton quc. b) S Y t tnh, thnh ph trc thuc Trung ng ra quyt nh thu hi s tip nhn Phiu cng b sn phm m phm sn xut ti a phng do n v mnh cp. c) Ban Qun l Khu kinh t ca khu Mc Bi (tnh Ty Ninh), Ban Qun l Khu kinh t tnh Qung Tr ra quyt nh thu hi s tip nhn Phiu cng b sn phm m phm do n v mnh cp. iu 47. Cc trng hp tm ngng tip nhn h s cng b sn phm m phm, h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm 1. C quan qun l nh nc c thm quyn s tm ngng xem xt v tip nhn h s cng b sn phm m phm 06 thng i vi cc t chc, c nhn c mt trong cc hnh vi sau: a) Kinh doanh m phm nhp lu, m phm gi, khng r ngun gc, xut x; b) Kinh doanh m phm cha c c quan qun l nh nc c thm quyn cp s tip nhn Phiu cng b sn phm m phm; c) Khng thc hin thu hi m phm vi phm theo thng bo ca c quan nh nc c thm quyn; d) Sn xut, kinh doanh m phm ti c s khng tun th cc nguyn tc, tiu chun "Thc hnh tt sn xut m phm" ca Hip hi cc nc ng Nam (CGMP-ASEAN) hoc tng ng c Hi ng m phm ASEAN tha nhn; ) Sn xut, kinh doanh m phm c thnh phn cht cm s dng trong m phm hoc vt qu gii hn cho php i vi cc cht c quy nh gii hn nng , hm lng s dng theo quy nh hin hnh ca php lut; e) S dng nguyn liu sn xut m phm b nc sn xut cng b cm lu thng trn th trng; 28

g) Nhp khu, kinh doanh m phm hoc nguyn liu sn xut m phm b nc sn xut cng b cm lu thng trn th trng; h) Sn xut, kinh doanh m phm c cng thc khng ng nh h s cng b; i) Gi mo ti liu, s dng con du gi hoc gi mo ch k, du ca c quan chc nng Vit Nam hoc nc ngoi, ca nh sn xut hoc ch s hu sn phm; k) K khai khng trung thc cc ni dung trong Phiu cng b sn phm m phm; l) Khng c H s thng tin sn phm (PIF) lu ti doanh nghip theo quy nh. 2. C quan qun l nh nc c thm quyn s tm ngng xem xt v tip nhn h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm 06 thng i vi t chc, c nhn c mt trong cc hnh vi sau: a) Qung co m phm, t chc hi tho, s kin gii thiu m phm khi cha c Phiu tip nhn h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm do c quan qun l nh nc c thm quyn cp theo quy nh ca php lut; b) Qung co m phm hoc t chc hi tho, s kin gii thiu m phm i vi cc sn phm m phm cha c cp s tip nhn Phiu cng b sn phm m phm; c) Qung co m phm c th lm cho ngi tiu dng hiu nhm sn phm l thuc; qung co m phm c s dng danh ngha, biu tng, hnh nh, th tn ca t chc y, dc, ca cn b y t; qung co m phm nu tnh nng cng dng cha c s khoa hc. 3. C quan qun l nh nc c thm quyn s xem xt tm ngng tip nhn h s cng b sn phm m phm, h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm i vi t chc, c nhn khng np bo co kt qu hot ng sn xut kinh doanh hng nm theo quy nh. Ht thi hn tm ngng xem xt, tip nhn h s, sau khi n v khc phc y cc vi phm v c bo co, c quan qun l nh nc c thm quyn s tip tc xem xt, tip nhn h s cng b sn phm m phm, h s ng k qung co m phm, t chc hi tho, s kin gii thiu sn phm m phm ca n v.

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Chng X TRCH NHIM CA T CHC, C NHN SN XUT, BUN BN, NHP KHU M PHM V QUYN CA NGI TIU DNG iu 48. Trch nhim ca t chc, c nhn sn xut, bun bn, nhp khu m phm lu thng trn th trng Vit Nam 1. T chc, c nhn chu trch nhim a sn phm m phm ra th trng phi chu hon ton trch nhim v cc ni dung k khai trong Phiu cng b sn phm m phm, chu hon ton trch nhim v tnh an ton, hiu qu v cht lng sn phm, m bo rng sn phm a ra lu thng p ng tt c cc yu cu ca Hip nh m phm ASEAN v cc Ph lc km theo. 2. T chc, c nhn a sn phm m phm lu hnh trn th trng c trch nhim theo di, pht hin v thu hi ngay m phm khng t tiu chun cht lng, thc hin thng bo thu hi ca c quan qun l nh nc c thm quyn, bo co v vic thu hi m phm gi c quan nh nc c thm quyn; gii quyt kp thi khiu ni ca khch hng v cht lng m phm, bi thng thit hi cho khch hng theo quy nh ca php lut. ng thi, phi hon tr li tin cho ngi mua hng v cc chi ph pht sinh trong qu trnh bo qun, vn chuyn, lu thng sn phm. 3. Trng hp pht hin nhng tc dng ph trm trng nh hng n tnh mng ngi tiu dng do cht lng sn phm m phm, t chc v c nhn a sn phm ra th trng phi bo co ti Cc Qun l dc - B Y t trong vng 07 ngy k t ngy nhn c thng tin u tin v tc dng ph ny theo mu ti Ph lc s 18-MP. Bo co chi tit v tc dng ph trm trng ny phi c gi v Cc Qun l dc - B Y t trong vng 08 ngy tip theo. 4. T chc, c nhn chu trch nhim a sn phm ra th trng phi lu gi H s thng tin sn phm (PIF) trong thi gian ti thiu 03 nm k t khi l sn xut cui cng c a ra th trng v xut trnh khi c quan chc nng kim tra, thanh tra yu cu. 5. Cc n v sn xut m phm phi trin khai p dng v p ng cc nguyn tc, tiu chun "Thc hnh tt sn xut m phm" ca Hip hi cc nc ng Nam (CGMP-ASEAN). 6. T chc, c nhn kinh doanh m phm phi thc hin cc yu cu ca c quan nh nc c thm quyn trong vic kim tra, thanh tra v cht lng m phm, thu hi m phm vi phm v 30

c quyn khiu ni v kt lun v hnh thc x l vi phm theo quy nh ca php lut v khiu ni, t co. 7. T chc, c nhn chu trch nhim a sn phm ra th trng phi tun th cc quy nh v lut php Vit Nam v s hu tr tu. Khi c kt lun ca c quan nh nc c thm quyn v nhn hiu, kiu dng cng nghip vi phm quyn s hu tr tu, t chc, c nhn phi ngng sn xut, bun bn, nhp khu tin hnh thay i nhn hiu, kiu dng cng nghip theo ng quy nh v c trch nhim bi hon v x l hu qu (nu c). iu 49. Quyn ca ngi tiu dng m phm Ngi tiu dng c quyn c thng tin v m phm, c quyn khiu ni, t co v yu cu n v kinh doanh m phm bi thng thit hi theo quy nh ca php lut do s dng m phm sn xut, lu thng khng m bo cht lng, khng an ton. Chng XI T chc thc hin iu 50. Thng tin v ch bo co 1. Cc Qun l dc - B Y t c trch nhim cp nht v trin khai cc quy nh lin quan n Hip nh m phm ASEAN trn trang thng tin in t ca Cc Qun l dc (a ch: www.dav.gov.vn). Thng xuyn ph bin cho n v c lin quan v cc t chc, c nhn sn xut, kinh doanh m phm cc thay i v tiu ch k thut c quyt nh bi Hi ng m phm ASEAN, ng thi phi hp trin khai cc thay i v quyt nh ti Vit Nam. Mi quyt nh v qun l m phm c thng qua bi Hi ng m phm ASEAN c p dng ti Vit Nam. 2. Cc Qun l dc, S Y t cc tnh, thnh ph trc thuc Trung ng, Ban Qun l Khu kinh t ca khu Mc Bi (tnh Ty Ninh), Ban Qun l Khu kinh t tnh Qung Tr c trch nhim a kt qu x l cc hnh vi vi phm trong lnh vc m phm theo thm quyn trn trang thng tin in t ca c quan; c l trnh a danh sch cc sn phm m phm cp s tip nhn Phiu cng b sn phm m phm v nhng ni dung thng tin, qung co m phm gii quyt trn trang thng tin in t ca c quan phc v cng tc kim tra, thanh tra, gim st hu mi. 3. nh k vo ngy 30 thng 6 v 31 thng 12 hng nm, S Y t cc tnh, thnh ph trc thuc Trung ng, Ban Qun l Khu kinh t ca khu Mc Bi (tnh Ty Ninh), Ban Qun l Khu kinh t tnh Qung Tr gi bo co tnh hnh qun l cht lng v cng tc hu kim m phm ti a phng, bo co v vic cp 31

s tip nhn Phiu cng b sn phm m phm (Ph lc s 15MP), bo co v vic cp Phiu tip nhn h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm (Ph lc s 16-MP) v Cc Qun l dc - B Y t. 4. nh k ngy 30 thng 01 hng nm, t chc, c nhn chu trch nhim a sn phm ra th trng phi gi bo co kt qu hot ng sn xut kinh doanh nm trc ca n v mnh v Cc Qun l dc - B Y t v S Y t s ti (Ph lc s 17-MP). iu 51. Biu mu, Ph lc km theo Thng t 1. Mu Phiu cng b sn phm m phm: Ph lc s 01-MP. 2. Ti liu hng dn v cng b sn phm m phm: Ph lc s 02-MP. 3. Hng dn ca ASEAN v cng b tnh nng ca sn phm m phm: Ph lc s 03-MP. 4. Quy c vit tt tn cc tnh, thnh ph trc thuc Trung ng v mt s Ban Qun l Khu kinh t: Ph lc s 04-MP. 5. Thay i sau khi cng b sn phm m phm: Ph lc s 05-MP.

32

6. Quy nh ca ASEAN v gii hn kim loi nng v vi sinh vt trong sn phm m phm: Ph lc s 06-MP. 7. H s thng tin sn phm: Ph lc s 07-MP. 8. Ti liu hng dn ca ASEAN v kim tra hu mi m phm: Ph lc s 08-MP. 9. Mu Bin bn ly mu m phm kim tra cht lng: Ph lc s 09-MP. 10. Mu Phiu ng k qung co m phm, t chc hi tho, s kin gii thiu m phm: Ph lc s 10-MP. 11. Mu Phiu tip nhn h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm: Ph lc s 11-MP. MP. 12. Mu Giy chng nhn lu hnh t do (CFS): Ph lc s 12-

13. Mu Phiu ng k kim tra thc hnh tt sn xut m phm: Ph lc s 13-MP. 14. Mu n hng nhp khu dng cho nghin cu, kim nghim: Ph lc s 14-MP. 15. Mu bo co danh sch m phm cp s tip nhn Phiu cng b sn phm m phm: Ph lc s 15-MP. 16. Mu bo co danh sch m phm cp Phiu tip nhn h s ng k qung co, t chc hi tho, s kin gii thiu m phm: Ph lc s 16-MP. 17. Mu bo co kt qu hot ng sn xut, kinh doanh m phm: Ph lc s 17-MP. 18. Mu thng bo tc dng bt li i vi m phm: Ph lc s 18-MP. iu 52. Quy nh chuyn tip 1. K t ngy Thng t ny c hiu lc thi hnh, tt c cc t chc, c nhn chu trch nhim a sn phm m phm ra th trng Vit Nam phi thc hin vic cng b sn phm m phm theo quy nh ti Thng t ny. 2. i vi trng hp cc sn phm cng b t ngy 10/3/2008 (theo quy nh ti Quy ch Qun l m phm ban hnh km theo Quyt nh s 48/2007/Q-BYT ngy 31/12/2007 ca B trng B Y t) v c cp s tip nhn Phiu cng b sn phm m phm cn hiu lc m p ng cc quy nh ti Thng t ny th c php tip tc sn xut (i vi m phm sn xut trong nc), nhp khu (i vi m phm nc ngoi) n ht thi hn ca Phiu cng b sn phm m phm. 33

3. Nhng sn phm m phm a ra lu thng khng p ng yu cu v an ton sn phm m phm theo quy nh ti Chng IV ca Thng t ny, t chc, c nhn chu trch nhim a sn phm ra th trng phi thu hi ton b sn phm v thc hin theo ng quy nh ti Thng t ny. 4. Cc sn phm m phm a ra lu thng trong thi gian giy php cn hiu lc, nu p ng yu cu v an ton sn phm m phm theo quy nh ti Chng IV ca Thng t ny th c tip tc lu thng trn th trng n ht hn dng ca sn phm. iu 53. Hiu lc thi hnh 1. Thng t ny c hiu lc thi hnh k t ngy 01/4/2011. 2. Bi b Quyt nh s 48/2007/Q-BYT ngy 31/12/2007 ca B trng B Y t v vic ban hnh Quy ch qun l m phm, Quyt nh s 40/2008/Q-BYT ngy 26/12/2008 ca B trng B Y t v vic phn cp qun l nh nc v m phm i vi m phm sn xut ti Vit Nam, Quyt nh s 22/2008/QBYT ngy 02/7/2008 ca B trng B Y t v vic u quyn thc hin chc nng qun l m phm cho Ban Qun l Khu kinh t ca khu Mc Bi, tnh Ty Ninh ti Khu thng mi cng nghip thuc Khu kinh t ca khu Mc Bi, tnh Ty Ninh, Quyt nh s 3450/Q-BYT ngy 21/9/2010 ca B trng B Y t v vic u quyn thc hin chc nng qun l m phm cho Ban Qun l Khu kinh t tnh Qung Tr. 3. Th trng cc n v thuc B Y t, cc n v trc thuc B Y t; Gim c S Y t cc tnh, thnh ph trc thuc trung ng v cc t chc, c nhn c lin quan chu trch nhim thi hnh Thng t ny. 4. Trong qu trnh trin khai thc hin, nu c kh khn, vng mc, cc t chc, c nhn gi bo co v B Y t (Cc Qun l dc, 138A Ging V, Ba nh, H Ni) B Y t xem xt, gii quyt./.
Ni nhn:
- Vn phng Chnh ph (Phng Cng bo, Website CP); - Cc B, c quan ngang B, c quan trc thuc Chnh ph; - B T php (Cc kim tra VBQPPL); - BT. Nguyn Quc Triu ( bo co); - UBND cc tnh, thnh ph trc thuc Trung ng; - S Y t cc tnh, thnh ph trc thuc Trung ng;

Kt. B trng Th trng

( k)

Cao Minh Quang

34

- Hip hi Tinh du, Hng liu v M phm Vit Nam; - Website BYT; - Lu: VT, PC, QLD (5).

35

Ph lc s 01-MP
PHN DNH CHO C QUAN QUN L (FOR OFFICIAL USE)

Ngy nhn (Date acknowledged): S cng b (Product Notification No .): Phiu cng b c gi tr 05 nm k t ngy nhn.

Phiu CNG B SN PHM M PHM TEMPLATE FOR NOTIFICATION OF COSMETIC PRODUCT

nh du vo thch hp (Tick where applicable)

THNG TIN SN PHM PARTICULARS OF PRODUCT

1. Tn nhn hng v tn sn phm (Name of brand & product) :

1.1 Nhn hng (Brand)

1.2 Tn sn phm (Product Name)

1.3 Danh sch cc dng hoc mu (List of Variants or Shade). Tn (Names)

______________________________________________________________ ______________________________________________________________
2. Dng sn phm (Product type(s))

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Kem, nh tng, sa, gel hoc du dng trn da (tay, mt, chn, .) Creams, emulsions, lotions, gels and oils for skin (hands, face, feet, etc.) Mt n (ch tr sn phm lm bong da ngun gc ho hc) Face masks (with the exception of chemical peeling products) Cht ph mu (lng, nho, bt) Tinted bases (liquids, pastes, powders) Phn trang im, phn dng sau khi tm, bt v sinh, Make-up powders, after-bath powder, hygienic powders, etc. X phng tm, x phng kh mi, Toilet soaps, deodorant soaps, etc Nc hoa, nc thm dng v sinh,. Perfumes, toilet waters and eau de Cologne Sn phm dng tm hoc gi (mui, x phng, du, gel, ) Bath or shower preparations (salts, foams, oils. gels, etc.) Sn phm ty lng Depilatories Sn phm kh mi v chng mi. Deodorants and anti-perspirants Sn phm chm sc tc Hair care products - Nhum v ty mu tc Hair tints and bleaches - Un tc, dui tc, gi np tc Products for waving, straightening and fixing, - Cc sn phm nh dng tc Setting products, - Sn phm lm sch (sa, bt, du gi) Cleansing products (lotions, powders, shampoos), - Sn phm cung cp cht dinh dng cho tc (sa, kem, du), Conditioning products (lotions, creams, oils), - Cc sn phm to kiu tc (sa, keo xt tc, sp) Hairdressing products (lotions, lacquers, brilliantines) Sn phm dng co ru hoc sau khi co ru (kem, x phng, sa,...) Shaving product (creams, foams, lotions, etc.) Sn phm trang im v ty trang dng cho mt v mt Products for making-up and removing make-up from the face and the eyes Sn phm dng cho mi Products intended for application to the lips Sn phm chm sc rng v ming Products for care of the teeth and the mouth Sn phm dng chm sc v t im cho mng tay, mng chn Products for nail care and make-up Sn phm dng v sinh c quan sinh dc ngoi

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Products for external intimate hygiene Sn phm chng nng Sunbathing products Sn phm lm sm da m khng cn tm nng Products for tanning without sun Sn phm lm trng da Skin whitening products Sn phm chng nhn da Anti-wrinkle products Sn phm khc ( ngh ghi r) Others (please specify)

3.

Mc ch s dng (Intended use) ___________________________________________________________________________ ___________________________________________________________________________

4.

Dng trnh by (Product presentation(s)) Dng n l (Single product) Mt nhm cc mu (A range of colours)

Bng cc mu trong mt dng sn phm (Palette(s) in a range of one product type) Cc sn phm phi hp trong mt b sn phm (Combination products in a single kit) Cc dng khc ( ngh ghi r). Others (please specify)

THNG TIN V NH SN XUT/ NG GI

( ngh nh km danh sch ring nu nh c nhiu hn mt cng ty tham gia sn xut/ ng gi to ra mt sn phm hon chnh)

PARTICULARS OF MANUFACTURER (S)/ASSEMBLER(S)

(Please attach in a separate sheet if there are more than one manufacturer/assembler)

5.

Tn nh sn xut (Name of manufacturer) :

a ch nh sn xut ( Nc sn xut) (Address of manufacturer (state country):

C o u n t r y Tel: Fax:

38

6.

Tn cng ty ng gi ( ngh nh du vo mc thch hp. C th nh du nhiu hn 1 (Name of assembler (Please tick accordingly. May tick more than one box)): ng gi chnh Primary assembler ng gi th cp Secondary assembler

a ch ca cng ty ng gi (Address of assembler (state country)):

C o u n t r y Tel: Fax:

THNG TIN V T CHC, C NHN CHU TRCH NHIM a SN PHM m phm ra TH TRNG PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC PRODUCT IN THE MARKET
7. Tn cng ty (Name of company):

a ch cng ty (Address of company):

Tel: :

Fax

S giy php kinh doanh/S giy php hot ng Business Registration Number/License to Operate Number

39

THNG TIN V NGI I DIN theo php lut ca cng ty PARTICULARS OF PERSON REPRESENTING THE LOCAL COMPANY
8. H v tn (Name of person):

Tel: :

Email

Chc v cng ty (Designation in the company) :

THNG TIN V CNG TY NHP KHU PARTICULARS OF IMPORTER

9. Tn cng ty nhp khu/ Name of Importer:

a ch cng ty nhp khu/ Address of importer:

Tel: :

Fax

DANH SCH THNH PHN PRODUCT INGREDIENT LIST

10. ngh kim tra sau y (Please check the following boxes) Ti kim tra bn sa i t Ph luc II n Ph lc VII ca danh mc cc thnh phn m phm ASEAN nh c cng b trn bn sa i gn y nht ca Hip nh m phm ASEAN. Ti xin xc nhn rng sn phm c cp n trong bn cng b ny khng cha bt c mt thnh phn b cm no v cng tun th vi danh mc hn ch v cc iu kin quy nh trong cc ph lc. I have examined the latest revisions of the Annexes II to VII of the ASEAN Cosmetic Ingredient Listing as published in the latest amendment of the ASEAN Cosmetic Directive and confirmed that the product in this notification does not contain any prohibited substances and is in compliance with the restrictions and conditions stipulated in the Annexes.

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 Ti m nhn trch nhim tr li v hp tc ton din vi c quan c thm quyn v bt k hot ng kim sot sau khi bn hng khi c yu cu bi c quan c thm quyn. I undertake to respond to and cooperate fully with the regulatory authority with regard to any subsequent post-marketing activity initiated by the authority. Danh sch thnh phn y (product full ingredient list) (Yu cu ghi y danh sch tt c cc thnh phn v t l % ca nhng cht c gii hn v nng , hm lng s dng trong m phm - To submit ingredient list with percentages of restricted ingredients) Tn y thnh phn (tn danh php quc t hoc s dng tn khoa hc chun c cng nhn) Full Ingredient name (use INCI or approved nomenclature in standard references) 1 2 3 4 5 6 7 8 9 ... T l % ca nhng cht c gii hn v nng , hm lng

No

Cam kt (DECLARATION)
1. Thay mt cho cng ty, ti xin cam kt sn phm c cp trong Phiu cng b ny t cc tt c cc yu cu ca Hip nh m phm ASEAN v cc ph lc ca n. I hereby declare on behalf of my company that the product in the notification meets all the requirements of the ASEAN Cosmetic Directive, its Annexes and Appendices. 2. Ti xin chu trch nhim tun th cc iu khon sau y (I undertake to abide by the following conditions): i. m bo c sn cung cp cc thng tin k thut v tnh an ton khi c quan c thm quyn yu cu v c y h s v cc sn phm c phn phi bo co trong trng hp sn phm phi thu hi. Ensure that the products technical and safety information is made readily available to the regulatory authority concerned (the Authority) and to keep records of the distribution of the products for product recall purposes;

41

ii. Phi thng bo ngay cho c quan c thm quyn v cc tc dng ph nghim trng gy cht ngi hoc e do tnh mng ca sn phm bng in thoi, fax, th in t hoc vn bn trc 7 ngy k t ngy bit thng tin. Notify the Authority of fatal or life threatening serious adverse event 1 as soon as possible by telephone, facsimile transmission, email or in writing, and in any case, no later than 7 calendar days after first knowledge; iii. Phi hon thnh bo co tc dng ph ca sn phm (theo mu quy nh) trong vng 8 ngy lm vic k t ngy thng bo cho c quan c thm quyn v nhng tc dng ph nghim trng nh nu trong mc 2ii ni trn v cung cp bt c thng tin no theo yu cu ca c quan c thm quyn. Complete the Adverse Cosmetic Event Report Form 1 within 8 calendar days from the date of my notification to the Authority in para 2ii. above, and to provide any other information as may be requested by the Authority; iv. Thng bo ngay cho c quan c thm quyn v cc phn ng ph nghim trng nhng khng gy cht ngi hoc e do n tnh mng ca sn phm v trong bt c trng hp no, vic bo co (s dng mu bo co) v tc dng ph phi c tin hnh trc 15 ngy k t ngy bit v tc dng ph ny. Report to the Authority of all other serious adverse events that are not fatal or life threatening as soon as possible, and in any case, no later than 15 calendar days after first knowledge, using the Adverse Cosmetic Event Report Form; v. Cng b vi c quan c thm quyn khi c bt c s thay i no trong bn cng b ny. Notify the Authority of any change in the particulars submitted in this notification; 3. Ti xin cam oan rng nhng thng tin c a ra trong bn cng b ny l ng s tht. Tt c cc ti liu, cc thng tin lin quan n ni dung cng b s c cung cp v cc ti liu nh km l bn hp php hoc sao y bn chnh. I declare that the particulars given in this notification are true, all data, and information of relevance in relation to the notification have been supplied and that the documents enclosed are authentic or true copies . 4. Ti hiu rng ti s c trch nhim m bo tt c cc l sn phm ca chng ti u p ng cc yu cu php lut, v tun th tt c tiu chun v ch tiu sn phm c cng b vi c quan c thm quyn. I understand that I shall be responsible for ensuring that each consignment of my product continues to meet all the legal requirements, and conforms to all the standards and specifications of the product that I have declared to the Authority. 5. Ti hiu rng trong trng hp c tranh chp php lut, ti khng c quyn s dng bn cng b sn phm m phm c c quan c thm quyn chp nhn nu sn phm ca chng ti khng t c cc yu cu v tiu chun, ch tiu m chng ti cng b.
Nh c nh ngha r rng trong ti liu hng dn cho cc cng ty v bo co tc dng ph ca sn phm m phm. As defined in the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products Trnh by trong ph lc I trong ti liu hng dn cho cc cng ty v bo co tc dng ph ca sn phm m phm. Set out in Appendix I to the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products
11

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I understand that I cannot place reliance on the acceptance of my product notification by the authority in any legal proceedings concerning my product, in the event that my product has failed to conform to any of the standards or specifications that I had previously declared to the Authority. __________________________________________________________ Tn v ch k ca ngi i din theo php lut ca cng ty [Name and Signature of person representing the local company]

______________ Du ca cng ty [Company stamp]

__________________

Ngy [Date]

43

Ph lc s 02-MP
TI LIU HNG DN V CNG B SN PHM m phm GUIDANCE DOCUMENT ON PRODUCT NOTIFICATION

1. Tn nhn hng v tn sn phm. Name of brand and product Tn y ca sn phm phi c cung cp, theo trnh t sau: tn nhn hng, dng sn phm (nu c), tn sn phm. Nu l mt mu ring l c cng b th ghi tn mu v s mu (v d: Loreal Feria Color 3D Hot Ginger). Nu c nhiu mu th tn v s mu ca mi mu phi c cng b. The complete name of the product should be given, in the following sequence: brand name, line name (if applicable), product name, if a single shade is notified, the shade name/number (e.g. Loreal Feria Color 3D Hot Ginger). If there are different shades, the shade name/number for each shade shall be declared. 2. Dng sn phm. Product types Danh sch minh ha l cha y v c th cp n cc dng sn phm khc khng c trong danh sch bng cch la chn mc cc dng khc v ghi r dng sn phm. C th la chn nhiu hn mt dng sn phm, v d bath hoc shower v sn phm chm sc tc nu nh sn phm s dng c trong cc trng hp ny. The illustrative list is not exhaustive and you can include other types of cosmetic products not in the list by selecting others and specifying what it is. More than one category can be selected, e.g. Bath or shower preparations and Hair-care products can be selected if your product is both a shower gel and hair shampoo. 3. Mc ch s dng. Intended use L thng tin v chc nng hoc cng dng ca sn phm, khng phi cch s dng, v d gi m cho da mt, da tay,... This refers to the function or use of the product and not the directions for use e.g. to moisturize the face, hand, etc. 4. Dng trnh by. Product presentation(s) Ch la chn mt dng thch hp nht trong 4 dng sn phm. Sau y l gii thch v cc dng sn phm. Please select only one out of the 4 choices that best fit the presentation type of the product. The following is an explanation of the presentation types: l. - Dng n l c trnh by trong mt dng ng gi n

44

A single product exists in a single presentation form. - Mt nhm cc mu l mt nhm cc sn phm m phm c thnh phn tng t nhau v c sn xut bi cng mt nh sn xut, c cng mc ch s dng, nhng c mu sc khc nhau (v d nh son, mu mt, hoc nh mng tay) nhng khng phi l dng ng gi kt hp ca cc dng sn phm khc nhau. "A range of colours is a range of cosmetic products, which are similar in composition and produced by the same manufacturer, and are intended for the same use but are available in different shades of colour (e.g. lipsticks, eye shadows or nail polish but not composite packs of different types). - Bng cc mu trong mt dng sn phm l mt nhm cc mu nh c nh ngha trn, c ng trong mt lot cc bng. "Palette(s) in a range of one product type refers to a range of colours as defined above, which may be presented in a series of palettes. - Cc sn phm phi hp trong mt b sn phm l cc dng sn phm ging hoc khc nhau v c bn trong cng mt bao gi. Khng th bn ring tng loi (v d nh mt hp cc mu mt v mi, mt hp cha c cc dng kem chm sc da). "Combination products in a single kit refer to similar and/ or different product types packed and sold in a single kit. They cannot be sold separately (e.g. a make-up kit of eye and lip colours; a set of skin-care products sold in a single kit). 5. Thng tin v nh sn xut/ ng gi. Particulars of the manufacturer(s)/ Assembler(s) C th c trn mt cng ty sn xut hoc ng gi cho mt sn phm (l cc cng ty tham gia cc cng on sn xut sn xut ra mt sn phm hon chnh). Phi nu r tn v a ch y ca tng cng ty (trng hp a ch tr s chnh khc a ch c s sn xut th phi khai bo c hai). There may be more than one manufacturer and/or assembler for one product. The full names and contact details of each of them must be submitted (If the address of main office and factory of the manufacturer are different, it is required to notify both of them). - Cng ty sn xut l cng ty tham gia vo bt k giai on no ca qu trnh to ra sn phm m phm. Qu trnh sn xut bao gm tt c cc giai on t sn xut bn thnh phm v thnh phm, xy dng cng thc v sn xut (v d nh nghin, trn, gi v hoc ng gi), kim tra cht lng, xut xng v cc qu trnh kim sot lin quan. A manufacturer is a company which is engaged in any process carried out in the course of making the cosmetic product. The

45

manufacturing process includes all operations of bulk intermediates and products, formulation and production (such as grinding, mixing, encapsulation and/ or packaging), quality control, release and the related controls. - Cng ty ng gi chnh l cng ty tham gia vo qa trnh ng gi sn phm vo bao b ng gi chnh/ trc tip, bao b ny c hoc s c dn nhn trc khi sn phm c bn hoc phn phi. A primary assembler is a company which is engaged in a process of enclosing the product in a primary/ immediate container which is labelled or to be labelled before the product is sold or supplied in it. - Cng ty ng gi th cp l cng ty ch tham gia vo qu trnh dn nhn cho bao gi m sn phm c ng vo trong bao gi chnh, hoc ng bao gi chnh vo trong hp carton, sau dn nhn, trc khi bn hoc phn phi. A secondary assembler is a company which is engaged only in a process of labelling the product container where the product is already enclosed in its primary container and/ or packing the product which is already enclosed in its labelled primary container into a carton which is labelled or to be labelled, before the product is sold or supplied. 6. Thng tin v t chc, c nhn chu trch nhim a sn phm ra th trng. Particulars of company l t chc, c nhn chu trch nhim a sn phm ra th trng, c th l cng ty sn xut trong nc hoc i l c u quyn bi nh sn xut bn sn phm ra th trng hoc , l cng ty chu trch nhim bn sn phm trn th trng Vit Nam. S Giy chng nhn ng k kinh doanh hoc giy php tng ng phi c nu r trong mu cng b, nu c. It refers to the local company responsible for placing the cosmetic products in the market, which may be a local manufacturer or an agent appointed by a manufacturer to market the product or the company that is responsible for bringing in the product for sale in Viet Nam, etc. The business registration number or its equivalent should be indicated in the notification form, if applicable. 7. Thng tin v ngi i din theo php lut cho cng ty. Particulars of the person representing the local company Ngi i din cho cng ty np h s cng b phi c trnh v kinh nghim theo quy nh ca lut php v lut hnh ngh ca cc nc thnh vin, l ngi i din theo php lut ca cng ty nu trn Giy chng nhn ng k kinh doanh

46

The person who represents the company to submit the product notification must possess adequate knowledge or experience in accordance with the legislation and practice of the Member Country. 8. Thnh phn y v danh php. Full ingredient listing and nomenclature a) Tt c cc thnh phn ca m phm phi c xc nh bng danh php trong n phm mi nht v danh php chun (International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstract Services, Japanese Standard Cosmetic Ingredient, Japanese Cosmetic Ingredients Codex). Tn thc vt v dch chit t thc vt phi c xc nh bng chi, loi. Tn chi thc vt c th rt ngn. Cc thnh phn c ngun gc t ng vt cn nu chnh xc tn khoa hc ca loi ng vt . Cc thnh phn sau y khng c coi l thnh phn ca sn phm: All the ingredients in the product must be specified by using the nomenclature from the latest edition of standard references (Refer to appendix A). Botanicals and extract of botanicals should be identified by its genus and species. The genus may be abbreviated. If ingredients derived from animals, it is required to specify the scientific name of the animals. The following are not regarded as ingredients: - Tp cht trong nguyn liu c s dng. Impurities in the raw materials used; - Cc nguyn liu c s dng v mc ch k thut nhng khng c mt trong sn phm thnh phm. Subsidiary technical materials used in the preparation but not present in the final product; - Cc ho cht c s dng vi mt s lng cn thit c kim sot cht ch nh dung mi hoc cht gi mi hoc cc thnh phn to mi. Cc thnh phn nc hoa v cht to hng v cc nguyn liu ca chng c th vit di dng hng liu (perfume, fragrance). Materials used in strictly necessary quantities as solvents, or as carriers for perfume and aromatic compositions. Nng ca cc thnh phn phi c cng b nu nh l cc thnh phn nm trong danh mc hn ch s dng c xc nh trong cc ph lc ca Hng dn v m phm ASEAN. The percentage of ingredients must be declared if they are substances with restrictions for use as specified in the annexes of the ASEAN Cosmetic Directive. b) i vi sn phm cha mt nhm cc mu hoc cc sn phm trong cng mt bao gi, cng b thnh phn y theo dng sau:

47

For a range of colours/shades or products in a single kit, complete the Product Ingredient List in the following format: - Danh sch thnh phn ca dng c bn List ingredients in the Base Formulation - C th cha v danh sch cc mu May contain and list each colour/shade c) Vi dng phi hp cc sn phm khc nhau trong cng mt ng gi, lit k mi sn phm v cng thc tng ng cho tng sn phm. C th m rng mu cng b nu cn thm khong trng in thng tin. For combination products in a kit, list each product and its corresponding formulation individually. You can extend the form when more space is needed.

48

Ph lc s 03-MP
HNG DN ca asean V Cng b tnh nng ca sn phm m phm

Vic nh gi cng b tnh nng sn phm (Product claim) khng th tch ri vi vic xem xt liu mt sn phm c phi l sn phm m phm hay khng. Vic quyt nh sn phm c phi l m phm hay khng phi da trn mt s yu t, trong , tnh nng sn phm (gi tt l Claim) l mt trong nhng yu t quan trng. Bn hng dn mt quy trnh n gin gm 5 bc quyt nh xc nh sn phm v cng b tnh nng c ph hp cho mt sn phm m phm khng. Bn hng dn cng a ra mt s v d v cng b tnh nng khng c chp nhn cho m phm. Tuy nhin, danh sch ny khng c xem l mt danh sch y , quyt nh cui cng vn l ca c quan qun l. Quy trnh quyt nh sn phm l m phm v cng b tnh nng sn phm m phm c php (xem biu tm tt)

Sn phm

1. Sn phm c cha cc thnh phn c php bi Hip nh m phm ASEAN v khng c thnh phn no b cm. 2. Sn phm tip xc vi nhng b phn bn ngoi ca c th (biu b, h thng tc, mng, mi, b phn sinh dc ngoi) hoc vi rng v cc mng nhy ca khoang ming. 3. Sn phm c s dng vi mc ch duy nht hoc chnh l lm sch, lm thm hoc iu chnh mi c th hoc bo v, gi gn chng trong nhng iu kin tt.

sai
Cu to sn phm ng sai V tr s dng ng sai Cng dng chnh Khng phi m phm Khng phi m phm Khng phi m phm

49

ng

4. Hnh thc sn phm c th hin nh phng bnh v cha bnh cho ngi.

ng Hnh thc sn phm sai Khng phi m phm

5. Sn phm vnh vin iu chnh, phc hi hoc lm thay i chc nng c th bng c ch min dch, trao i cht hoc c ch dc l.

Cng khc phm sai

dng m

ng Khng phi m phm

Sn phm m phm

Trong : - Thnh phn cu to sn phm m phm Sn phm ch cha nhng thnh phn tun th theo cc Ph lc ca Hip nh m phm ASEAN v khng cha bt c thnh phn no nm trong Ph lc cc cht cm s dng trong m phm vi iu kin i km ca Hip nh m phm ASEAN. - V tr s dng ca sn phm m phm M phm ch tip xc bn ngoi vi nhng phn khc nhau ca c th (biu b, h thng tc, mng, mi v c quan sinh dc ngoi) hoc vi rng v cc mng nhy ca khoang ming. Sn phm dng ung, tim, hoc tip xc vi nhng phn khc ca c th v d nh mng nhy ca ng mi hoc b phn sinh dc trong khng c xem l m phm. - Cng dng chnh ca sn phm m phm M phm c s dng cho nhng phn cho php ca c th vi mc ch duy nht hoc mc ch chnh l lm sch, lm thm hoc thay i v b ngoi hoc iu chnh mi c th hoc bo v, gi gn chng trong iu kin tt. (Lu sn phm c th c cng dng th hai hoc cng dng ph nm ngoi phm vi ni trn).

50

- Cch th hin ca sn phm m phm Sn phm m phm khng c th hin nh mt sn phm cha bnh hoc phng bnh cho ngi. Nhng c im sau cn phi c xem xt k: I. Li gii thiu tnh nng, qung co sn phm v ng cnh. II. Bao b/ ni dung nhn v nhn b sung (bao gm c hnh nh minh ho). III. Ti liu khuyn mi bao gm giy chng nhn hoc ti liu do cc bn gia cng ban hnh thay cho nh cung cp. IV. Cc hnh thc qung co. V. Hnh thc sn phm v cch n c s dng, v d nh: vin con nhng, thuc vin, dng tim,... VI. Mc tiu c bit ca cc thng tin qung co, v d: mt nhm ngi nht nh vi/hoc c nhng tn thng t bit i vi nhng bnh tt/ cc phn ng c hi. - Nhng nh hng sinh l hc ca sn phm Tt c cc sn phm c nh hng n chc nng ca c th u c nh hng n qu trnh trao i cht. c tnh ca m phm l to nn cc nh hng/ hiu qu khng vnh vin v cn phi s dng thng xuyn duy tr hiu qu. iu cn lu u tin l tt c nhng tnh nng ph hp dng cho cc loi sn phm nh trong danh mc cc sn phm m phm (Ph lc I ca Hip nh m phm ASEAN) hin nhin c xem l m phm. Mt s v d v cc tnh nng thng gp khng c chp nhn i vi m phm theo tng loi sn phm (y cha phi l danh mc y ): Loi Sn Phm Chm sc tc Cu gii thiu tnh nng sn phm khng c chp nhn Sn phm lm rng Loi b gu vnh vin Phc hi t bo tc / nang tc Lm dy si tc Chng rng tc Kch thch mc tc Ngn nga/ dng s pht trin ca lng

51

lng Sn phm dng cho mng Sn phm chm sc da cp n vic nui dng lm nh hng n s pht trin mng Ngn chn, lm gim hoc lm o ngc nhng thay i sinh l v s thoi ho do tui tc Xo so Tc dng t Tr mn, cha khi, lm lnh mn Cha vim da Gim kch thc c th Sn chc c th/ sn chc ngc Gim/ kim sot s sng ty ph n Loi b/ gim m/ gim bo Dit nm Dit virus Gim d ng Cha tr hay phng chng cc bnh p-xe rng, song nu, vim li, lot ming, nha chu, chy m quanh rng, vim vm ming, rng b x lch, bnh v nhim trng rng ming,... Lm trng li cc vt do Tetracyline Dng qu trnh ra m hi Tng cng cm xc Hp dn gii tnh

Sn phm v sinh v chm sc rng ming

Sn phm ngn mi Nc hoa/ Cht thm

Nhng tnh nng trn c th c lm gim nh i v mang tnh m phm hn. V d: i vi tnh nng loi b hon ton du cho da c th iu chnh lm nh hn nh sau: Gip loi b du cho da Ph hp i vi loi da du Gim bng cho da du Lm cho da bn cm thy bt du

52

Ph lc s 04-MP
Quy c

Vit tt tn cc tnh, thnh ph trc thuc Trung ng v mt s Ban qun l Khu kinh t
STT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Tn tnh, thnh ph An Giang Bc Cn Bnh Dng Bnh nh Bc Giang Bc Liu Bc Ninh Bnh Phc Bn Tre Bnh Thun B Ra - Vng Tu Cao Bng C Mau Cn Th Nng c Lc c Nng in Bin ng Nai ng Thp Gia Lai H Giang H Nam H Ni H Tnh Hi Dng Hi Phng Hu Giang Ho Bnh Hng Yn Kin Giang K hiu AG BC BD B BG BL BN BP BT BTh BV CB CM CT Na L N B N T GL HG HNa HN HT HD HP HGi HB HY KG STT 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 Tn tnh, thnh K hiu ph Lai Chu LC Lm ng L Lng Sn LS Lo Cai LCa Long An LA Nam nh N Ngh An NA Ninh Bnh NB Ninh Thun NT Ph Th PT Ph Yn PY Qung Bnh QB Qung Nam QNa Qung Ngi QNg Qung Ninh QN Qung Tr QT Tp. H Ch Minh HCM Sn La SL Sc Trng ST Ty Ninh TN Thi Bnh TB Thi Nguyn TNg Thanh Ho TH Tha Thin Hu TTH Tin Giang TG Tuyn Quang TQ Tr Vinh TV Vnh Long VL Vnh Phc VP Yn Bi YB Ban Qun l Khu BQLMB kinh t ca khu Mc Bi - tnh Ty Ninh Ban Qun l Khu BQLQT kinh t tnh Qung Tr

32

Khnh Ho

KH

65

33

Kon Tum

KT

53

54

Ph lc s 05-MP
THAY I SAU KHI CNG B sn phm m phm

Ty thuc vo ni dung thay i, quy nh nh sau: Ni dung thay i Thay i nhn hng Thay i tn sn phm Thay i cng ty chu trch nhim a sn phm ra th trng Thay i dng sn phm Thay i mc ch s dng Thay i cng thc Thay i nh sn xut hoc ng gi (tn v/hoc a ch) Thay i dng trnh by ca sn phm Tn v/hoc a ch ca cng ty chu trch nhim a sn phm ra th trng nhng khng thay i s Giy chng nhn ng k kinh doanh hoc Giy chng nhn u t. Tn v/ hoc a ch ca cng ty nhp khu Thay i ngi i din cho cng ty Cng b sn phm Cng b mi Cng b mi Cng b mi

Cng b mi Cng b mi Cng b mi Cng b mi

B sung

B sung

B sung B sung

Thay i kch c bao gi, cht liu B sung, nhng khng p bao b, nhn sn phm dng nu nh thng tin cn thit khng c

55

b.

cp n trong Phiu cng

56

Ph lc s 06-MP
quy nh ca ASEAN v Gii hn kim loi nng v vi sinh vt trong sn phm m phm

1. Gii hn kim loi nng (ACM THA 05 Testing Method): STT 1 2 3 Ch tiu Thu ngn Asen Ch Gii hn Nng ti a cho php c trong sn phm m phm l 1 phn triu (1 ppm) Nng ti a cho php c trong sn phm m phm l 5 phn triu (5 ppm) Nng ti a cho php c trong sn phm m phm l 20 phn triu (20 ppm)

2. Gii hn vi sinh vt (ACM THA 06 Testing Method): Gii hn ST T Ch tiu Sn phm dnh cho tr em di 03 tui, sn phm tip xc vi vng mt hoc nim mc =<500 cfu/g Khng c c trong 0,1g hoc 0,1 ml mu th Khng c c trong 0,1g hoc 0,1 ml mu th Khng c c trong Sn phm khc

1 2

Tng s vi sinh vt m c P. aeruginosa

=<1000 cfu/g Khng c c trong 0,1g hoc 0,1ml mu th Khng c c trong 0,1g hoc 0,1ml mu th Khng c c trong

S. aureus

C. albicans

57

0,1g hoc 0,1 ml mu th

0,1g hoc 0,1ml mu th

58

Ph lc s 07-MP
H s thng tin sn phm

(PIF - Product Information File) H s thng tin sn phm bao gm cc ni dung sau: Phn 1. Ti liu hnh chnh v tm tt v sn phm - Ti liu hnh chnh: + Bn sao Phiu cng b sn phm m phm c s tip nhn ca c quan qun l nh nc c thm quyn (i vi m phm nc ngoi v m phm sn xut trong nc cng b k t ngy 10/3/2008); Phiu tip nhn Bn cng b tiu chun cht lng m phm (i vi m phm sn xut trong nc c cp phiu tip nhn trc ngy 10/3/2008); Giy php lu hnh m phm (i vi m phm nc ngoi c cp s ng k lu hnh trc ngy 10/3/2008); + Giy u quyn ca nh sn xut hoc ch s hu sn phm hoc th tho thun lin quan n sn phm; + Giy chng nhn lu hnh t do - CFS (i vi m phm nc ngoi nhp khu); + Cc ti liu hnh chnh c lin quan khc (Giy chng nhn ng k kinh doanh hoc Giy php u t ca t chc, c nhn chu trch nhim a sn phm ra th trng); + Cc thnh phn v t l phn trm ca tt c cc thnh phn trong cng thc. - Nhn v thng tin sn phm: + Nhn sn phm; + T hng dn s dng (nu c). - Cng b v sn xut: + Cng b ca nh sn xut v vic sn phm c sn xut ph hp vi cc nguyn tc, tiu chun Thc hnh tt sn xut m phm ca Hip hi cc nc ng Nam (CGMP-ASEAN) hoc tng ng; + H thng ghi s l/ m sn phm. - nh gi an ton sn phm m phm: Cng b an ton (vi kin kt lun c ch k, tn v vn bng chng ch ca nh gi vin). - Tm tt nhng tc dng khng mong mun trn ngi (nu c).

59

- Ti liu thuyt minh tnh nng, cng dng ca sn phm m phm (tm tt): Bo co v nh gi tnh nng, cng dng ca sn phm da theo thnh phn v kt qu th nghim. Phn 2. Cht lng ca nguyn liu - Tiu chun cht lng v phng php kim nghim ca nguyn liu. i vi thnh phn hng liu, nu r tn v m s hng liu, tn v a ch nh cung cp, cam kt ph hp vi hng dn ca Hip hi Hng liu Quc t (IFRA). - D liu an ton ca nguyn liu da trn thng tin t nh cung cp, nhng d liu c cng b hoc bo co t cc U ban khoa hc (ACSB, SCCP, CIR). Phn 3. Cht lng ca thnh phm - Cng thc ca sn phm: Ghi tn y cc thnh phn theo danh php quc t v t l phn trm ca cc thnh phn trong cng thc. Nu r cng dng ca tng thnh phn nguyn liu; - Sn xut: + Thng tin chi tit v nh sn xut: quc gia, tn v a ch nh sn xut, nh ng gi; + Tm tt quy trnh sn xut; + Cc thng tin chi tit thm v quy trnh sn xut, qun l cht lng v cc h s lin quan v sn xut, cn c chun b sn sng tu theo yu cu c quan qun l. - Tiu chun v cc phng php th ca thnh phm: + Cc ch tiu s dng kim tra gii hn vi sinh trong thnh phm; + Cc phng php th tng ng vi tiu chun cht lng kim tra mc t; - Bo co tm tt v n nh ca sn phm (cho sn phm c tui th di 30 thng): Bo co v d liu nghin cu n nh hoc nh gi n nh thuyt minh cho hn s dng ca sn phm. Phn 4. An ton v hiu qu - nh gi tnh an ton: Bo co nh gi v tnh an ton trn ngi ca thnh phm da theo thnh phn trong cng thc, cu trc ho hc ca thnh phn v ngng gy hi (c tn v ch k ca nh gi vin); - S yu l lch ca nh gi vin v tnh an ton ca sn phm;

60

- Bo co mi nht v tc dng ph hay tc dng khng mong mun (nu c), c cp nht thng xuyn; - Ti liu thuyt minh tnh nng, cng dng ca sn phm cng b trn bao b sn phm: Bo co y v nh gi tnh nng, cng dng ca sn phm da theo thnh phn v kt qu th nghim (c tn v ch k ca nh gi vin).

61

Ph lc s 08-MP
Ti liu hng dn ca ASEAN v kim tra hu mi m phm

1. Xy dng chin lc kim tra hu mi: Vic xy dng chin lc kim tra hu mi cn cn c vo mt s yu t sau: a) Dng sn phm: Vic ly mu m phm kim tra hu mi cn tp trung vo mt s nhm sn phm sau: - Sn phm lm trng da. - Phn rm (bt Talc) hoc cc sn phm c cha khong cht. - Sn phm dng cho mt, mi. - Sn phm nhum tc, c bit l cc sn phm xut x t cc nc vn cho php s dng mt s cht nhum nm trong danh mc cc cht cm s dng trong m phm (Annex II). - Sn phm dnh cho tr em hoc ph n c thai. b) Ngun gc xut x ca sn phm: Cn ch cc sn phm c xut x: - T cc nc m lut khc so vi cc nc ASEAN. - Cc nc c tin s v cc sn phm khng t quy nh. c) Cng ty, nhn hng: - Da vo d liu v tin s vi phm. - Ch cc cng ty t tn tui, cha c bit ti. d) Thnh phn: - Ch nhng nguyn liu c nguy c c th cha mt s tp cht gy c nh kim loi nng, aming. - Mt s nguyn liu c nguy c c th cha mt s tp cht khng c php v d nh TEA tinh khit phi trn 99% (hm lng ti a DEA l 0,5%) hoc cc tp cht c th c tng tc vi cc thnh phn khc nh tc nhn nitro ho (cc Nitrit trong nc). 2. Khi nh gi, xem xt mu sn phm m phm, cn ch mt s ch tiu, thnh phn nh: - Sn phm lm trng da: Thy ngn, hydroquinone, hc mn (dch chit nhau thai). - Phn rm: Kim loi nng, Asbestos (Amiang), gii hn vi sinh; - Sn phm trang im mt: Kim loi nng, gii hn vi sinh; - Sn phm dng cho mi: Cht mu cm s dng;

62

- Sn phm nhum tc: Thnh phn cht to mu cm s dng; - Cc nguyn liu t cy c: D lng cht bo v thc vt, vi sinh vt. 3. Kim tra H s thng tin sn phm (PIF): sau: Khi kim tra h s thng tin sn phm cn ch nhng im - Cng thc sn phm. - Tiu chun ca nc s dng trong sn xut. - S hin din ca Benzene trong cc Carbomer. - Hm lng Dioxane trong cc nguyn liu ethoxylate ho, v d nh SLES. - Du khong/ Vaseline/ Paraffin: phi tun th cc yu cu trong hng dn ca COLIPA v qu trnh trng ct. - Nguy c c nhim Nitrosamine (Nitrit trong nc c th l ngun ca cc tc nhn Nitro ho). - nh gi tnh an ton. - Nhng yu t lin quan n cht lng, v d nh qun l ti liu, cng b GMP, s sch s, v sinh trong qu trnh sn xut. - Cc nguyn liu c ngun gc s dng cng ngh sinh hc (ch nguy c t bin gen). - Dch chit thc vt (ch dung mi s dng, nh gi tnh an ton, cht bo v thc vt, cht bo qun). 4. a im kim tra: C quan qun l cn lp danh sch cc knh phn phi, m bo khng b qua bt k mt a im no. Vic kim tra gim st hu mi m phm cn tp trung ni u ngun (cc n v u mi nhp khu, phn phi, sn xut). Ngoi ra, c th kim tra ti cc a im: - Ca hng m phm - Ca hng cc trung tm thng mi - Nh thuc - Ch bnh dn - Dch v lm p - Phng khm da liu, ... - C s sn xut khng tun th CGMP: cn c vo mc nh hng n cht lng v tnh an ton ca sn phm m c th yu cu doanh nghip c bin php khc phc ngay hoc cn khc phc trong thi gian ngn.

63

Th t u tin trong vic kim tra gim st hu mi m phm da vo loi sn phm, ngun gc xut x, nhn hng, thng hiu cng ty, thnh phn cng thc.

64

Ph lc s 09-MP
Tn c quan ly mu Cng ho x hi ch ngha vit nam c lp - T do - Hnh phc

...., ngy ..... thng ..... nm

Bin bn ly mu m phm kim tra cht lng

Theo giy gii thiu hoc th thanh tra (ghi r s, ngy, thng, nm v tn c quan cp) H v tn, chc v, c quan ca ngi tham gia ly mu: 1..................................................................................................... ............ 2..................................................................................................... ............ 3..................................................................................................... ............ Ngy ly mu: Tn c s c mu: .................................................................................... a ch: ............................................................... thoi: ..........................
STT Tn m phm S l SX, ngy SX, hn dng n v S l- Nc ng gi ng sn nh ly xut nht, khi lng hoc th tch Tn, a ch t chc chu trch nhim a sn phm ra th trng

ly in

Nhn xt tnh trng l sn phm trc khi ly mu

1 2 iu kin bo qun mu: ........................................................... khi ly

65

Bin bn c lm thnh 03 bn: 01 bn lu ti c s c ly mu, 01 bn lu ti c quan kim nghim, 01 bn lu ti c quan qun l kim tra cht lng. Ch k ngi ly mu (K v ghi r h tn) Ch k i din c s c ly mu (K v ghi r h tn, chc danh) Ch k ngi chng kin (khi cn thit) (K v ghi r h tn)

66

Ph lc s 10-MP
CNG HO X HI CH NGHA VIT NAM c lp - T do - Hnh phc PHIU NG K QUNG CO M PHM, t chc HI THO, s kIN GII THIU M PHM

S: .... Knh gi: S Y t tnh/ thnh ph .... 1. Tn n v ng k h s: 2. a ch: 3. S in thoi, Fax, E-mail: 4. S giy php hot ng (giy chng nhn ng k kinh doanh): 5. Tn, s in thoi ca ngi hoc b phn chu trch nhim ng k h s: 6. Danh mc m phm ng k qung co, t chc hi tho, s kin gii thiu m phm:
STT Tn m phm S tip nhn Phiu Hnh Thi gian, a im Ln th cng b sn phm thc d kin t chc hi m phm qung co tho, s kin gii (i vi thiu m phm (i h s vi h s ng k t ng k chc hi tho, s kin qung co gii thiu m phm) m phm)

1 2 7. Ti liu gi km: - Ni dung (d kin) qung co hoc t chc hi tho, s kin gii thiu m phm ca tng sn phm. - Bn sao Phiu cng b sn phm m phm c cp s tip nhn. 8. Cam kt ca n v ng k qung co m phm: Chng ti nghin cu k Thng t Quy nh v qun l m phm s ... ngy ... thng ... nm ca B Y t v cam kt s tun th cc quy nh ca Thng t ny v sc kho v li ch ca ngi s dng m phm.

67

... , ngy ... thng ... nm ...

Gim c n v

(K tn, ng du) (Ghi r h v tn ngi k)

68

Ph lc s 11-MP
UBND TNH/ TP S Y T ... CNG HO X HI CH NGHA VIT NAM c lp - T do - Hnh phc

S: .....................
PHIU TIP NHN h s ng k QUNG CO M PHM, t chc HI THO, S KIN gii thiu M PHM

S Y t tnh/ thnh ph ... tip nhn h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm s: ( ghi s phiu ng k h s qung co m phm, t chc hi tho, s kin gii thiu m phm ca n v) Ca n v: (ghi tn n v np h s) a ch: (ghi a ch ca n v np h s) in thoi: (ghi s in thoi ca n v np h s) Tn sn phm m phm ng k qung co, t chc hi tho, s kin gii thiu m phm: Hnh thc qung co: (i vi h s ng k qung co) Ngy nhn h s hp l: (Ngy/ thng/ nm) S Phiu tip nhn (*): , ngy ... thng ... nm ...
Th trng c quan

(K tn, ng du) (Ghi r h v tn ngi k)

(*) Ghi ch: Cch ghi s Phiu tip nhn l a/XX/QCMP-A, trong : - a l S Phiu tip nhn; - XX l hai ch s cui ca nm cp; - QCMP l cc k t vit tt ca cm t "qung co m phm"; - A l k hiu vit tt tn tnh, thnh ph c quy nh ti Ph lc s 04-MP. V d: 268/11/QCMP-HN c ngha l s Phiu tip nhn h s qung co m phm l 268 do S Y t H Ni cp nm 2011.

69

Ph lc s 12-MP

SOCIALIST REPUBLIC OF vietnam Independence - Freedom - Happiness

(Provincial/Municipal) Peoples Committee (Provincial/Municipal) health Service

Address: Tel: Fax:

Certificate of free sale No.: ... /CFS Date ... to whom it may concern We, (Provincial/Municipal) health Service, hereby certify that the following product manufactured by (Manufacturers name) is allowed to be sold freely in Viet Nam. - Manufacturer: - Address: - Kind of product: Cosmetics - Name of product:
Authorised Signature

Nguyen Van A

Director
(Provincial/Municipal) health Service

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Ph lc s 13-MP
TN N V NAM CNG HO X HI CH NGHA VIT c lp - T do - Hnh phc

... , ngy .... thng ... nm ...

Phiu NG K KIM TRA THC HNH TT SN XUT M PHM

Knh gi: 1- Tn c s: 2- a ch: 3 - in thoi:

Cc Qun l dc - B Y t

138A Ging V, Ba nh, H Ni

Fax:

E-Mail:

Thc hin Thng t Quy nh v qun l m phm s ... ngy .... thng.... nm ... ca B Y t, sau khi tin hnh t thanh tra v nh gi t tiu chun Thc hnh tt sn xut m phm, C s chng ti xin ng k vi Cc Qun l dc c kim tra CGMPASEAN. y: t. Xin gi km bn ng k ny cc ti liu lin quan sau

1. Giy Chng nhn ng k kinh doanh hoc giy php u 2. S t chc, nhn s ca c s. 3. Ti liu o to v Thc hnh tt sn xut m phm.

4. S v tr v thit k ca nh my, bao gm s mt bng tng th; s ng i ca cng nhn; s ng i ca nguyn liu, bao b, bn thnh phm, thnh phm; s h thng cung cp nc phc v sn xut; s x l cht thi. 5. Danh mc thit b hin c ca c s. 6. Danh mc cc mt hng ang sn xut hoc d kin sn xut. 7. Bin bn t thanh tra Thc hnh tt sn xut m phm.
Gim c n v

(K tn, ng du)

71

k)

(Ghi r h v tn ngi

72

Ph lc s 14-MP

TN N V

S: ...

CNG HO X HI CH NGHA VIT NAM c lp - T do - Hnh phc

n hng nhp khu m phm dng cho nghin cu, kim nghim

Knh gi: Cc Qun l dc - B Y t 138A Ging V, Ba nh, H Ni (n v) knh ngh Cc Qun l dc xt duyt n v c nhn cc m phm dng cho kim nghim cht lng sau:
Tn m phm, STT dng bo ch, quy cch ng gi Dng sn phm Thnh phn Tn cng ty sn xut, tn nc Gh i ch

n v tnh

S lng

1 2 3

Cc Qun l dc thng nm Chp thun n hng nhp khu gm

Gim c n v

, ngy

trang khon km theo cng vn

ng du)

(K tn,

s /QLD-CL ngy thng nm

tn ngi k)

(Ghi r h v

ca Cc Qun l dc. H Ni, ngy thng nm Cc trng

73

Ph lc s 15-MP
UBND tnh/ tp S Y t ... (Hoc ban qun l ...) CNG HO X HI CH NGHA VIT NAM c lp - T do - Hnh phc

S: .....

... , ngy ... thng ... nm ...

DANH SCH CC SN PHM CP S TIP NHN PHIU CNG B SN PHM M PHM

T thng ... n thng ... nm ... Knh gi: Cc Qun l dc - B Y t 138 A Ging V, Ba nh, H Ni

S Y t tnh/ thnh ph ... (hoc Ban Qun l...) bo co danh sch cc m phm c cp s tip nhn Phiu cng b sn phm m phm t thng ... n thng ... nm ... nh sau:
STT Tn sn phm Dng sn phm n v cng b (Ghi r tn, a ch) S tip nhn Phiu cng b

1 2 3 ... Tng s
Th trng c quan (K tn, ng du) (Ghi r h v tn ngi k)

74

Ph lc s 16-MP
UBND tnh/ tp S Y T ... (Hoc ban qun l ...) CNG HO X HI CH NGHA VIT NAM

c lp - T do - Hnh phc

S: ...

.... , ngy ... thng ... nm ...

Danh sch m phm cp Phiu tip nhn h s ng k qung co, t chc hi tho, s kin gii thiu m phm

T thng ... n thng ... nm ... Knh gi: Cc Qun l dc - B Y t 138A Ging V, Ba nh, H Ni S Y t tnh/ thnh ph ... (hoc Ban Qun l...) bo co danh sch m phm cp Phiu tip nhn h s ng k qung co m phm, t chc hi tho, s kin gii thiu m phm t thng ... n thng ... nm ... nh sau: 1. H s ng k qung co m phm:
STT Tn sn phm T chc, c n v ng k Hnh thc qung co nhn chu trch qung co nhim a sn phm ra th trng

1 2 ... Tng s

2. H s ng k t chc hi tho, s kin gii thiu m phm:

STT Tn sn phm T chc, c nhn chu trch nhim a sn phm ra th trng n v ng k t chc hi tho, s kin gii thiu m phm

1 2 ... Tng s

75

Th trng c quan

(K tn, ng du) (Ghi r h v tn ngi k)

76

Ph lc s 17-MP
Tn n v CNG HO X HI CH NGHA VIT NAM

c lp - T do - Hnh phc
S: ...

... , ngy . thng ... nm ...

Bo co kt qu hot ng sn xut, kinh doanh m phm

Nm ... Knh gi: - Cc Qun l dc - B Y t - S Y t tnh/ thnh ph (n v) ... bo co hot ng sn xut, kinh doanh nm ... ca n v nh sau: 1. Tng s sn phm cng b: 2. S mt hng sn xut/ nhp khu kinh doanh nm ...: 3. Sn lng hng ho sn xut/ nhp khu kinh doanh nm ...: (phn theo nhm sn phm) 4. Kh khn vng mc ca n v: 5. xut, kin ngh (nu c).

Gim c n v (K tn, ng du) (Ghi r h v tn ngi k)

77

Ph lc s 18-MP
M PHM [BO MT]

Knh gi:

Cc Qun l dc - B Y t 138A Ging V, Ba nh, H Ni

THNG BO TC DNG BT LI

I. Thng tin v cng ty Tn v a ch ca cng ty Tn v chc danh ngi thng bo S in thoi: II. Thng tin sn phm Tn sn phm ( ging nh tn trn n cng b) Danh sch thnh phn, dng (nh km theo danh sch thnh phn ring bit) ng gi Dng sn phm/ mc ch s dng Tn cng ty sn xut/ xut x Ngy sn xut hoc hn dng S l III. Bo co tc dng bt li chi tit Tn ngi s dng S chng minh nhn dn hoc h chiu Tui Tn gio/Quc tch Thi gian xut hin tc dng bt li
Gii tnh

Fax:

Email:

78

M t tc dng bt li (nh km bn m t tc dng bt li nu cn thit) Thi gian gia ln dng sn phm cui cng v thi im xut hin tc dng bt li: ___ pht ___gi _ ngy Sn phm c s dng nh th no: Ngi s dng c phi nhp vin v tc # C # Khng dng bt li khng?

Ngi s dng c phi iu tr y t # C # Khng khng? Kt qu # hi phc ( Ngy:_______ ) # T vong (Ngy: _______) # Vn cha hi phc # Khng bit Ngun cung cp # Chuyn gia y t ( ngh ghi r) # Khch hng # Ngun khc bo co ( ngh ghi r)

[Ch k ca ngi bo co tc dng bt li/ ngy thng nm]

79