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.
T«i ®¶m nhËn tr¸ch nhiÖm tr¶ lêi vµ hîp t¸c toµn diÖn víi c¬ quan cã thÈm quyÒn vÒ bÊt kú ho¹t ®éng kiÓm so¸t sau khi b¸n hµng khi cã yªu cÇu bëi c¬ quan cã thÈm quyÒn.
I undertake to respond to and cooperate fully with the regulatory authority with regard to any subsequent post-marketing activity initiated by the authority.
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;
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;
c) Ph¶i hoµn thµnh b¸o c¸o t¸c dông phô cña s¶n phÈm (theo mÉu quy ®Þnh t¹i Phô lôc sè …..-MP Th«ng t quy ®Þnh vÒ qu¶n lý mü phÈm) trong vßng 8 ngµy lµm viÖc kÓ tõ ngµy th«ng b¸o cho c¬ quan cã thÈm quyÒn vÒ nh÷ng t¸c dông phô nghiªm träng nh ®· nªu trong ®iÓm b Kho¶n 2 nãi trªn vµ cung cÊp bÊt cø th«ng tin nµo theo yªu cÇu cña c¬ quan cã thÈm quyÒn.
Complete the Adverse Cosmetic Event Report Form (Annex …….-MP of Cosmetic Regulation) within 8 calendar days from the date of my notification to the Authority in para 2b above, and to provide any other information as may be requested by the Authority;
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;
e) C«ng bè víi c¬ quan cã thÈm quyÒn khi cã bÊt cø sù thay ®æi nµo trong b¶n c«ng bè nµy.
Notify the Authority of any change in the particulars submitted in this notification;
3. T«i xin cam ®oan r»ng nh÷ng th«ng tin ®îc ®a ra trong b¶n c«ng bè nµy lµ ®óng sù thËt. TÊt c¶ c¸c tµi liÖu, c¸c th«ng tin liªn quan ®Õn néi dung c«ng bè sÏ ®îc cung cÊp vµ c¸c tµi liÖu ®Ýnh kÌm lµ b¶n hîp ph¸p hoÆc sao y b¶n chÝnh.
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 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. T«i hiÓu r»ng trong trêng hîp cã tranh chÊp ph¸p luËt, t«i kh«ng ®îc quyÒn sö dông b¶n c«ng bè s¶n phÈm mü phÈm ®· ®îc c¬ quan cã thÈm quyÒn chÊp nhËn nÕu s¶n phÈm cña chóng t«i kh«ng ®¹t ®îc c¸c yªu cÇu vÒ tiªu chuÈn, chØ tiªu mµ chóng t«i ®· c«ng bè.
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.
Tªn vµ ch÷ ký cña ngêi ®¹i diÖn theo ph¸p luËt cña C«ng ty
[Name and Signature of person representing the local company]
DÊu cña c«ng ty
[Company stamp] Ngµy [Date]
Phô lôc sè 02-MP
TµI LIÖU H¦íNG DÉN VÒ C¤NG Bè S¶N PHÈM mü phÈm
GUIDANCE DOCUMENT ON PRODUCT NOTIFICATION
1. Tªn ®Çy ®ñ cña s¶n phÈm (bao gåm nh·n hµng, tªn s¶n phÈm vµ d¹ng mµu (nÕu cã) - Name of brand and product).
Tªn ®Çy ®ñ cña s¶n phÈm ph¶i ®îc cung cÊp, theo tr×nh tù sau: tªn nh·n hµng, dßng s¶n phÈm (nÕu cã), tªn s¶n phÈm. NÕu lµ mét mµu riªng lÎ ®îc c«ng bè th× ghi tªn mµu vµ sè mµu (vÝ dô: s¶n phÈm cã tªn ®Çy ®ñ lµ “L’oreal Feria Color 3D Hot Ginger”, trong ®ã: nh·n hµng lµ “L’oreal”, tªn s¶n phÈm lµ “Feria Color 3D Hot Ginger”). NÕu cã nhiÒu mµu th× tªn vµ sè mµu cña mçi mµu ph¶i ®îc c«ng bè.
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. L’oreal Feria Color 3D Hot Ginger). If there are different shades, the shade name/number for each shade shall be declared.
2. D¹ng s¶n phÈm. Product types
Danh s¸ch minh häa lµ cha ®Çy ®ñ vµ cã thÓ ®Ò cËp ®Õn c¸c d¹ng s¶n phÈm kh¸c kh«ng cã trong danh s¸ch b»ng c¸ch lùa chän môc “c¸c d¹ng kh¸c” vµ ghi râ d¹ng s¶n phÈm. Cã thÓ lùa chän nhiÒu h¬n mét d¹ng s¶n phÈm, vÝ dô “ bath hoÆc shower” vµ “s¶n phÈm ch¨m sãc tãc” nÕu nh s¶n phÈm sö dông ®îc trong c¸c trêng hîp nµy.
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. Môc ®Ých sö dông. Intended use
Lµ th«ng tin vÒ chøc n¨ng hoÆc c«ng dông cña s¶n phÈm, kh«ng ph¶i c¸ch sö dông, vÝ dô gi÷ Èm cho da mÆt, 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.
"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).
"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. Th«ng tin vÒ nhµ s¶n xuÊt/ ®ãng gãi. Particulars of the manufacturer(s)/ Assembler(s)
Cã thÓ cã trªn mét c«ng ty s¶n xuÊt hoÆc ®ãng gãi cho mét s¶n phÈm (lµ c¸c c«ng ty tham gia c¸c c«ng ®o¹n s¶n xuÊt ®Ó s¶n xuÊt ra mét s¶n phÈm hoµn chØnh). Ph¶i nªu râ tªn vµ ®Þa chØ ®Çy ®ñ cña tõng c«ng ty (trêng hîp ®Þa chØ trô së chÝnh kh¸c ®Þa chØ c¬ së s¶n xuÊt th× ph¶i khai b¸o 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).
A manufacturer is a company which is engaged in any process carried out in the course of making the cosmetic product. The 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.
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.
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.
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.
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:
- T¹p chÊt trong nguyªn liÖu ®îc sö dông.
Impurities in the raw materials used;
- C¸c nguyªn liÖu ®îc sö dông v× môc ®Ých kü thuËt nhng kh«ng cã mÆt trong s¶n phÈm thµnh phÈm.
Subsidiary technical materials used in the preparation but not present in the final product;
Sản phẩm chống muỗi, nước hoa xịt phòng, nước xả vải, nước tẩy bồn cầu, dung dịch ô xi già, cồn sát trùng 70o, cồn 90o, sản phẩm làm sạch răng giả không tiếp xúc với khoang miệng, lông mi giả, dung dịch vệ sinh mắt/mũi/tai, sản phẩm chống nghẹt mũi, sản phẩm chống ngáy, gel bôi trơn âm đạo, gel siêu âm, sản phẩm tiếp xúc với bộ phận sinh dục trong, dung dịch thụt trực tràng, gây tê, giảm/kiểm soát sự sưng tấy/phù nề, chữa viêm da, giảm dị ứng, diệt nấm, diệt virus, sản phẩm kích thích mọc tóc/mọc lông mi, sản phẩm loại bỏ/giảm mỡ/giảm béo/giảm kích thước của cơ thể, sản phẩm giảm cân, ngăn ngừa/dừng sự phát triển của lông, sản phẩm dừng quá trình ra mồ hôi, mực xăm vĩnh viễn, sản phẩm xóa sẹo, giảm sẹo lồi, sản phẩm làm sạch vết thương.