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p tiP ~HO .. - $'1/h G9'm.-...THONG TIN VE TO CHUC, CA NHAN CHJU TMCH NHI:E:M DU A SAN PHAM MY PHAM...

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/ Phl) ll)c sfi 01-MP PHAN DANH CHO ca QUAN QUAN LY FOR OFFICIAL USE Ngay nht;in (Date acknowledged): r I i/lO,/t; SJ cong b6 (Product No.): ()./fl I/ C/jC(jU p _ tiP Phiiu cong b6 c6 gia trj 05 nam ki tit ngay nht;in.r GIAM DOC .. - $'1/h G9'm.- PHIEU CONG BO SAN PHAM MY PHAM TEMPLATE FOR NOTIFICATION OF COSMETIC PRODUCT 0 Danh·dfiu vao 6 thich hqp (Tick where applicable) THONG TIN SAN PHAM PARTICULARS OF PRODUCT 1. Ten nhan hang va ten san phfim (Name of brand & product) : 1. 1 Nhan hang (Brand) 1.2 Ten san phfim (Product Name) N lo' a c rR ir A rr A rY T M c A R lE . / J
Transcript
Page 1: p tiP ~HO .. - $'1/h G9'm.-...THONG TIN VE TO CHUC, CA NHAN CHJU TMCH NHI:E:M DU A SAN PHAM MY PHAM RA THJ TRUONG PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC

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Phl) ll)c sfi 01-MP PHAN DANH CHO ca QUAN QUAN LY FOR OFFICIAL USE

Ngay nht;in (Date acknowledged): ,,2~/ r I i/lO,/t;

SJ cong b6 (Product Notifica~ion No.): ()./fl I/ C/jC(jU p _ tiP

Phiiu cong b6 c6 gia trj 05 nam ki tit ngay nht;in.r

~HO GIAM DOC

~ .. - $'1/h G9'm.-

PHIEU CONG BO SAN PHAM MY PHAM TEMPLATE FOR NOTIFICATION OF COSMETIC PRODUCT

0 Danh·dfiu vao 6 thich hqp (Tick where applicable)

THONG TIN SAN PHAM PARTICULARS OF PRODUCT

1. Ten nhan hang va ten san phfim (Name of brand & product) :

1. 1 Nhan hang (Brand)

1.2 Ten san phfim (Product Name)

N lo' a c rR ir A rr A rY T M c A R lE .

/

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Page 2: p tiP ~HO .. - $'1/h G9'm.-...THONG TIN VE TO CHUC, CA NHAN CHJU TMCH NHI:E:M DU A SAN PHAM MY PHAM RA THJ TRUONG PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC

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1.3. Danh sach cac d?ng ho~c mau ( List of Variants or Shade). Ten (Name ).

2.

Khong mau

Mau xanh Ia

Mau vang

Mau h6ng

D?ng san phftm (Product type(s))

0 D~u dung tren da tay.

Oils for skin hands.

D M~t n? (chi tru san phftm lam bong da ngu6n g6c hoa hQc)

Face masks (with the exception of chemical peeling products) ,

D Chftt phu mau (long, nhao, b(>t)

Tinted bases (liquids, pastes, powders)

D Phftn trang diSm, phftn dung sau khi t~m, b(>t v~ sinh,. ..

Make-up powders, after-bath powder, hygienic powders, etc.

D Xa phong t~m, xa phong khfr mui,. ..

D

D

D

Toilet soaps, deodorant soaps, etc

Nuac hoa, nu6c thorn dung v~ sinh,. ...

Perfumes, toilet waters and eau de Cologne

San phftm dung dS t~m ho~c g(>i (mu6i, xa phong, d~u, gel,. .. )

Bath or shower preparations (salts, foams, oils. gels, etc.)

San phftm tfty long

Depilatories

D San phftm khfr mui va ch6ng mui.

Deodorants and anti-perspirants

D San phftm cham soc toe

Hair care products

- Nhu(>m va tfty mau toe

Hair tints and bleaches

- u6n toe, du6i toe, gifr n~p toe

Products for waving, straightening and fixing,

- Cac san phftm djnh d?ng toe

Setting products,

- San phftm lam S?ch (sfra, b(>t, d~u g(>i)

Cleansing products (lotions, powders, shampoos),

- San phftm cung dp chftt dinh du5ng cho toe (sfra, kem, d~u), JI//

/

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\ -. , , , -

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Page 3: p tiP ~HO .. - $'1/h G9'm.-...THONG TIN VE TO CHUC, CA NHAN CHJU TMCH NHI:E:M DU A SAN PHAM MY PHAM RA THJ TRUONG PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC

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Conditioning products (lotions, creams, oils),

- Cac san phAm t?o kiSu toe (sfra, keo xit toe, sap)

Hairdressing products (lotions, lacquers, brilliantines)

D San phAm dung C?O rau ho?c sau khi C?O rau (ke,m, xa phong, sfra, ... )

Shaving product (creams, foams, lotions, etc.) .

D San phAm trang diSm va tAy trang dung cho m?t va m~t

Products for making-up and removing make-up from the face and the eyes

D San phAm dung cho m6i

Products intended for application to the lips

D San phAm dS cham soc rang va mi~ng

Products for care of the ieeth and the mouth

D San phAm dung dS cham soc t6 diSm cho mong tay, mong chan

Products for nail care and make-up

D San phAm dung dS v~ sinh ca quan sinh d1,1c ngoai

Products for external intimate hygiene

D San phAm chbng n~ng

Sunbathing products

D San phAm lam S?m da ma kh6ng dn t~m n~ng

Products for tanning without sun

D San phAm lam tr~ng da

Skin whitening products

D San phAm chbng nhan da

Anti-wrinkle products

San phAm khac (d~ nghi ghi ro) : Nu&c rua tay

Others (please specify): Hand wash

/

3. M\lc dich su d1,1ng (Intended use)

4.

La111 s?ch da tay

D?ng trinh bay (Product presentation(s)) J

D D?ng dan le (Single product)

0 M()t nhom cac mau (A range of colours)

D

D

Bang cac mau trong m<)t d?ng san phAm (Palette(s) in a range of one product type)

Cac san phAm phbi hqp trong m<)t b9 san phAm (Combination products in a single kit)

D Cac d?ng khac (d~ nghi ghi r5). Others (please specify) IV

) /

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Page 4: p tiP ~HO .. - $'1/h G9'm.-...THONG TIN VE TO CHUC, CA NHAN CHJU TMCH NHI:E:M DU A SAN PHAM MY PHAM RA THJ TRUONG PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC

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THONG TIN VE NHA SAN XUAT/ DONG GOI

(D~ nghi dinh kem danh sach rieng n~u nhu co nhi~u han m(>t c6ng ty tham gia san xu§tl dong goi d~

ti;w ra m(>t san phAm hoan chinh)

PARTICULARS OF MANUFACTURER (S)/ASSEMBLER(S)

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

I

5. Ten nha san xu§t (Name of manufacturer) :

ff h' h' ' ~t ( N ' ~t) (Add !a c 1 n a san xua uac san xua f f: t (tt t ) ress o manu ac urer s a e coun ry :

s 6 7 5 lB I> u a N G 2 0 8 A N E> 0 N G ... A N

[D u a N G ... H A I p H <) N G

COUNTRY V I e T N kt\ M

Telt r r r f r r f ff r 11111 Fax: 1111111111111 H

6. Ten c6ng ty dong goi (d~ nghi danh d§u vao m1,1c thich hqp. Co th~ danh d§u nhi~u han I 6 (Name of assembler (Please tick accordingly. May tick more than one box)):

0 Dong goi chinh Primary assembler

D Dong goi tht'.r dp Secondary assembler

Dia chi cua c6ng ty dong goi (Address of assembler (state country)):

s 6 7 5 B D llr a N G ~ 0 8 A N [E> 0 N

D u a N G~ H A oc [P H <) N G

COUNTRY ~I E T N A M

G - A N '

' -, . ,

Tel:~ & 12lsbb19 b b ~~I I I I I Fax: I I I I I I I I I_ I I I I I I I I ~

4

:: .~ ...

;1

(

[

..... . , -:::

Page 5: p tiP ~HO .. - $'1/h G9'm.-...THONG TIN VE TO CHUC, CA NHAN CHJU TMCH NHI:E:M DU A SAN PHAM MY PHAM RA THJ TRUONG PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC

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THONG TIN VE TO CHUC, CA NHAN CHJU TMCH NHI:E:M DU A SAN PHAM MY PHAM RA THJ TRUONG

PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC PRODUCT IN THE MARKET

7. Ten cong ty (Name of company):

Tel:~ & & Is b b 19 b b ~ & I I I I I Fax: I I I I I I I I I I I I I I I I I

Dja chi cong ty (Address of company):

S6 gi~y phep kinh doanh/S6 gi~y phep ho~t d()ng

Business Registration Number/License to Operate Number

THONG TIN VE NGUOI D~I DI:E:N THEO PHAP LU~T CUA CONG TY PARTICULARS OF PERSON REPRESENTING THE LOCAL COMPANY

8. HQ va ten (Name of person):

blGluly~bl fflH~ I ~~bb~I ~kilablcl 11I11 I

Tel:~ 1918 b 1611 ~ & ~ 11 I I I I I I Email:ln ~ lu ~ k In It lh Ii It lh ~ In 111 ~ I lh lu b In Jg ~ ~ Ii 11 k k b ~ ~ le I. le lo Im ·1

J

Chuc Y\J 6 cong ty (Designatiom in the company): \. ·:',, ....

5

Page 6: p tiP ~HO .. - $'1/h G9'm.-...THONG TIN VE TO CHUC, CA NHAN CHJU TMCH NHI:E:M DU A SAN PHAM MY PHAM RA THJ TRUONG PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC

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THONG TIN VE CONG TY NH~P KHAU PARTICULARS OF IMPORTER

9. Ten cong ty nh?p khfru/ Name of Importer:

1111111111111111111.1111111111 /

Dia chi cong ty nh?p khfru/ Address of importer:

I..

Tel:l 111111111111111 Fax: 11111111111111111

DANHSACHTHANHPHAN PRODUCT INGREDIENT LIST

10. D~ nghi ki~m tra o sau day (Please check the following boxes)

0 Toi da ki~m tra ban sua d6i tu Phi) Jue II d~n Phi) ll)c VII cua danh ml)c cac thanh ph§n my

phfrm ASEAN nhu duqc cong b6 tren ban sua d6i g§n day nh§t cua Hi~p d!nh my phfrm

ASEAN. Toi xin xac nh?n rAng san phfrm duqc d~ c?p d~n trong ban cong b6 nay khong cht'.ra

b§t Clr m()t thanh ph§n bi dm nao va cling tuan thu v6i danh ml)C h~n ch~ Va CaC di~u ki~n quy

dinh trong CaC phi) )l)C.

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 A SEAN 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.

0 Toi dam ~h?n trach nhi~m tra Jeri va hqp tac toan di~n v6i CCY quan c6 thfrm quy~n v~ b§t ky ' ' ' .... '

ho~t d(mg kiem soat sau khi ban hang khi c6 yeu cau bai ca quan c6 tham quyeh.

I undertake to respond to and cooperate fully with the regulatory author~ty with regard to any

subsequent post-marketing activity initiated by the authority ·v ·' -

6

Page 7: p tiP ~HO .. - $'1/h G9'm.-...THONG TIN VE TO CHUC, CA NHAN CHJU TMCH NHI:E:M DU A SAN PHAM MY PHAM RA THJ TRUONG PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC

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.)

f f

Danh sach thanh phin diy du (product full ingredient list)

(Yeu du ghi dfty du danh sach t~t ca cac thimh phftn va ti I~% cua nhfrng ch~t co gi&i h?n v~ n6ng d(>,

ham lm;mg st'.r d1,mg trong my phAm - To submit ingredient list with percentages of restricted

ingredients)

Ten,dfty du thanh phftn (ten danh phap qu6c t~ ho?c st'.r di,mg ten khoa h9c

No chuan da duqc c6ng nh?n)

Full Ingredient name (use INCi or approved nomenclature in standard references)

NU'6'c rfra tay TM Care (khong mau, khong miti)

1 Water ...

2 Sodium Laureth Sulfate.

3 Cocamidopropyl Betaine

4 Cocamide DEA

5 Ammonium Chloride

6 Olive Oil PEG -7 Esters

7 Citric Acid

8 Methylchloroisothiazolinone, Methylisothiazolinone (3: l)

No

Ten dfty du thanh phftn (ten danh phap qu6c t~ ho?c st'.r di,mg ten khoa h9c chuAn da duqc c6ng nh?n)

Full Ingredient name (use INCi or approved nomenclature in standard re erences)

NU'6'c rfra tay TM Care (mau xanh la)

1 Water

2 Sodium Laureth Sulfate

3 Cocamidopropyl Betaine

4 Cocamide DEA

5 Ammonium Chloride

6 Fragrance

7 Olive Oil PEG -7 Esters

8 Citric Acid

9 CI 19140, CI 42090 (4:1)

10 Methylchloroisothiazolinone, Methylisothiazolinone (3: 1)

I.

'·'

j

Ti I~ % cua nhu·ng 9h~t.c6 gi&i h?n v~

n6ng d(>, ham luqng

0,0015

Ti I~ % cua nhu·ng ch~t c6 gi&i h?n v~ n6ng d(>, ham luqng

0,002

0,0015

7

Page 8: p tiP ~HO .. - $'1/h G9'm.-...THONG TIN VE TO CHUC, CA NHAN CHJU TMCH NHI:E:M DU A SAN PHAM MY PHAM RA THJ TRUONG PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC

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Ten.dfty du thanh phftn (ten danh phap qu6c t~ ho~c su d1,mg ten khoa h9c

No chuan da duqc c6ng nh?n)

Full Ingredient name (use INC! or approved nomenclature in standard references)

Nmrc rfra tay TM Care (mau vang)

1 Water

2 Sodium Laureth Sulfate

3 Cocamidopropyl Betaine

4 Cocamide DEA

5 Ammonium Chloride ....

6 Fragrance

7 Olive Oil PEG -7 Esters

8 Citric Acid

9 CI 19140

10 Methylchloroisothiazolinone, Methylisothiazolinone (3: 1)

No

Ten dfty du thanh phftn (ten danh phap qu6c t~ ho~c su d1,mg ten khoa .hQc chufin da duqc c6ng nh?n)

Full Ingredient name (use !NCI or approved nomenclature in standard references)

Nmrc rfra tay TM Care (mau hl>ng)

1 Water

2 Sodium Laureth Sulfate

3 Cocamidopropyl Betaine

4 Cocamide DEA

5 Ammonium Chloride ..

4

6 Fragrance

7 Olive oil PEG -7 Esters

8 Citric Acid

9 CI 45100

10 Methylchloroisothiazolinone, Methylisothiazolinone (3: 1)

Ti I~% cua nhCrng ch~t c6 gi6i h~n v~ n6ng d(>, ham luqng

I

0,0015

0,0015

Ti I~ % cua nhu·ng ch~t c6 gi6i h~n v~ n6ng d(>, ham luqng

. ., , J

\ . . , 0,0005

0,0015

8

'

" ' . E

' J

Page 9: p tiP ~HO .. - $'1/h G9'm.-...THONG TIN VE TO CHUC, CA NHAN CHJU TMCH NHI:E:M DU A SAN PHAM MY PHAM RA THJ TRUONG PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC

CAM KET (DECLARATION)

1. Thay m~t cho cong ty, toi xin cam k~t san phftm duqc dS c~p trong Phi~u cong b6 nay d?t duqcc t§t ca cac yeu du cua Hi~p djnh my phftm ASEAN va cac pht,1 l1,1c cua n6.

I hereby declare on behalf of my company that the p'.oduct in the not?fication meets all the requirements of the ASEAN Cosmetic Directive, its Annexes and Appendices.

2. Toi xin chju trach nhi~m tuan thu cac diSu khoan sau day (I undertake to abide by the following conditions): /

1. Dam bao c6 s~n dS cung dp cac thong tin ky thu~t va tfnh an toan khi ca quan c6 thftm quySn yeu du va c6 dcly du h6 SO' vs cac san phftm da duqc phan ph6i dS bao cao trong trnong hqp san phftm phai thu h6i.

Ensure that the product's 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;

11. Phai thong bao ngay cho ca quan c6 thftm quySn vS cac tac d1,1ng ph1,1 nghiem tn;mg gay ch~t nguoi ho~c de do? tfnh m?ng cua san phftm b~ng di~n tho?i, fax, thu di~n tt'.r ho~c van ban trn&c 7 ngay kS tu ngay bi~t thong tin.

Notify the Authority of fatal or life threatening serious adverse event1 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;

111. Phai hoan thanh bao cao tac d1,1ng pht,1 cua san phftm (theo m~u quy djnh) trong vong 8 ngay lam v~c kS tir ngay thong bao cho ca quan c6 thftm quySn vs nhilng tac d1,1ng ph1,1 nghiem tn;mg nhu da neu trong ffil,IC 2ii n6i tren Va Cung dp bftt Clr thong tin nao theo yeu cclu CUa CO' quan CO th ftm quySn.

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;

1v. Thong bao ngay cho ca quan c6 thftm quySn vS cac phan ung ph,1,1 nghiem tr9ng nhung khOng gay ch~t ngm'yj ho~C de do? d~n tfnh m?ng CUa San phftm Va trong bftt Clr tmang hqp nao, vi~c bao cao (sfr d1,1ng m~u bao cao) vs tac di.mg ph1,1 phai duqc ti~n hanh tm&c 15 ngay ks tu ngay bi~t vs tac d1,1ng pht,1 nay . .

J

I Nhu da duqc d!nh nghfa ro rahg trong tai li~u hu&ng dfin cho cac c6ng ty vs ~ao cao tac d\]ng ph\l cua san phfim my phfim. As defined in the Guide Manual for th~:/ndustry on Adverse Event Reporting a/Cosmetics Products I Trinh, bay trong ph\11\lC I trong tai li~u hu&ng dfin cho cac c6ng ty vs bao cao tac d\lng ph\l cua san phfim my phfim. Set out in Appendix I to the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products ~

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Page 10: p tiP ~HO .. - $'1/h G9'm.-...THONG TIN VE TO CHUC, CA NHAN CHJU TMCH NHI:E:M DU A SAN PHAM MY PHAM RA THJ TRUONG PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC

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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. Cong b6 v&i ca quan co thAm quySn khi co bAt Clr SlJ th~y d6i nao trong ban cong b6 nay.

Notify the Authority of any change in the particulars submitted in this notification;

3. Toi xin cam doan r~ng nhung thong tin duqc dua ra trong·ban cong b6 nay la dung SlJ th?t. TAt ca ' ' ' . I

cac tai li~u, cac thong tin lien quan den n<)i dung c6ng b6 se duqc cung cap va cac tai li~u dfnh kem la . ban hqp phap ho?c sao y ban chfnh.

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. I,.

4. Toi hi~u r~ng toi se co trach nhi~m d~ dam bao tAt ca cac lo san ph§m cua chung toi dSu dap t'.rng cac yeu du phap Iu?t, va tuan thu tAt ca tieu chuAn va chi tieu san phAm da duqc cong b6 v&i ca quan co thAm quySn.

· 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. Toi hi~u r~ng trong trucmg hqp co tranh ch~p phap Iu?t, t6i khong duqc quySn su d1,mg ban cong b6 san phAm my phAm da duqc ca quan co thk quysn ch~p nh?n n~u san phAm cua chung toi khong d~t duqc cac yeu du vs tieu chuAn, chi tieu ma chung toi da cong b6.

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.

NGUYEN THI THANH HUONG

Ten va chfr kY cua nguai d~i di~n theo phap Iu?t cua cong ty

D~u cua c6ng ty

[Company stamp J

'""

/JJ/ ~ 2/ UJ1 k' ~ \ .

·: ' ... ;

Ngay [Date]

10


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