Vietnam and ASEAN Cosmetic Regulations

 Vietnam cosmetic regulations are compatible with the ASEAN cosmetic regulations.

On September 2nd 2003, on behalf of the Government of Vietnam, the Vietnam Minister of Trade and Commerce signed an agreement on the ASEAN harmonized Cosmetic Regulatory Scheme, in which, the terms specified in the agreement is fully implemented since January 1st, 2008.

The agreement aims to unify cosmetic management in the ASEAN countries, and is toward a common market of ASEAN, strengthen cooperation between member States in ensuring safety, quality and beneficial feature of all cosmetic products on the ASEAN market and remove the restrictions on the cosmetic business between member States through the harmonization of technical regulations.

The agreement on the ASEAN Harmonized cosmetic regulatory scheme is considered a cosmetic treaty representing the unity of regulations on management of cosmetic member countries of the agreement. Being a member of the agreement, Vietnam cosmetic regulations are compatible with the ASEAN cosmetic regulations.

This publication is designed to provide updated information of legal matters, and does not constitute professional advice.

We help clients overcome cultural barriers and achieve their strategic and financial outcomes, while ensuring the best interest rate protection, risk mitigation and regulatory compliance. ANT lawyers have Attorneys in Hanoi, Attorneys in Ho Chi Minh and Attorneys in Danang.

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Cosmetic Regulations in Vietnam 2015 Webinar

   ANT Lawyers has teamed up with Chemlinked, a cosmetics portal to organize a Webminar on the topic of “Overview of Cosmetics Regulations in Vietnam 2015” on May 27th, 2015.

Mr Tuan Nguyen, an attorney at law of ANT Lawyers, a law firms in Vietnam will walk you through the regulations of cosmetics in Vietnam in general in the endeavor to comply with the ASEAN harmonized cosmetics regulatory scheme signed off since 2003, the regulations on cosmetics labeling, cosmetics proclamation, cosmetics advertising, and the considerations for setting up a trading company in Vietnam to import and place the cosmetic products on the market for sales.

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Cosmetics Product Proclamation in Vietnam

   Under Vietnam law, a cosmetic product made in Vietnam or imported into Vietnam must go through procedure of proclamation before being sold on the market.

Organizations or individuals distributing the cosmetic product on the market are only permitted when being granted the number of cosmetic product proclamation from the authority agencies. Such organizations or individuals are also responsible for safety, effectiveness, and quality of product.

Organizations, individuals who are responsible for putting products on market are organizations, individuals have name written in the cosmetic product announcement dossier and be responsible for cosmetics product in the market and must have the license of cosmetic business in Vietnam.

The cosmetic product manufacturers or importer may themselves conduct procedure in cosmetic product announcement or authorize for other organizations, individuals satisfying conditions as regulated to do this.

The cosmetic proclamation dossier includes the following documents:Cosmetic product proclamation report (02 versions) with the proclamation data (soft version of proclamation report);

Copy of business registration certificate of organizations, individuals who are responsible for circulation products into the market (with the enterprise’s signature and seal). In case the cosmetic domestic produced, but organizations, individuals who be responsible for putting products on the market are not the manufacturer must have a copy of business registration certificate of the producer (have legal notarized);

Original or notarized copy of letter of attorney from the producers or the owners of products authorized for organizations, individuals are responsible of putting products on the market in Vietnam (applied to the import or domestic cosmetic of which organizations or individuals are responsible of putting products on the market, be not the manufacturer). For the import product, the letter of attorney must be a copy notarized sign and consul legalized as provisions of law, except for being exempted of the consul legalization in regard to international treaties in which Vietnam is a member. The letter of attorney must satisfy requirements regulated at the Article 6 of this Circular.

Certificate of free sale (CFS) is only applied for import cosmetic product proclamation which satisfies the following requirements: (i) CFS which is issued by the current territory must have been original or legally notarized and still in the day of validity. In case CFS is not provided of the expiry day, it must be a certificate which has just been issued within 24 months; (ii) CFS must be consul legalized according to provisions of the law, except consul legalization immunity case according to the international treaties in which Vietnam is a member.

Depending on type of cosmetic, Vietnam law requires different competent state management agencies responsible for receiving dossier of cosmetic announcement. For the export of cosmetic, the medicine Management Bureau – the Ministry of Health is responsible for receiving proclamation dossier. For the cosmetic produced by domestic organizations, individuals, organizations or individuals who are responsible for bringing cosmetic into market shall apply the cosmetic product proclamation dossier at the Department of Health in which production factory is located. The product which is produced, packed from the import semi finished products shall be considered domestic produced products.

The results of handling the cosmetic product proclamation dossier: the competent state agencies shall issue or refuse to grant the number of receiving the cosmetic product proclamation report.

The receipt number of cosmetic product proclamation report shall be valid for 05 years since issuing date. After 05-year-expiry, if organizations or individuals wish to continue selling product in the market, they must make a proclamation again before the expiry of the receipt number of cosmetic product proclamation report and pay a regulated cost fee.

This publication is designed to provide updated information of legal matters, and does not constitute professional advice.

We help clients overcome cultural barriers and achieve their strategic and financial outcomes, while ensuring the best interest rate protection, risk mitigation and regulatory compliance. ANT lawyers have Law firm in Hanoi, Law firm in Ho Chi Minh City and Law firm in Da Nang.

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Cosmetics Safety Requirement in Vietnam

   Cosmetics safety has always been concern when such are on sale in an open market.

Compatible with the Combination Convention in the cosmetic management which has been signed by countries are member of the Association of Southeast Asian Nations on September 2nd, 2003 (ASEAN Cosmetic Convention), Vietnam law not only requires the organization or the individual which delivers the product to the market must guarantee that its product shall be harmless for people’s health when exerted in normal or appropriate conditions supplied by the producer or the owner, but also requires the producer or the owner to have obligation in evaluating the safety of every cosmetic product in accordance with the ASEAN safety norm. Besides, the heavy metal limit and the microorganisms in the cosmetic must satisfy the ASEAN’s requirements. The cosmetic Ingredients must satisfy the Appendix requirements (Annexes) – new version of the ASEAN Cosmetic Convention.

This publication is designed to provide updated information of legal matters, and does not constitute professional advice.

We help clients overcome cultural barriers and achieve their strategic and financial outcomes, while ensuring the best interest rate protection, risk mitigation and regulatory compliance. ANT lawyers have Law firm in Hanoi, Law firm in Ho Chi Minh City and Law firm in Da Nang.

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How to Ensure Cosmetics Labeling Complies in Vietnam?

   These are rules for cosmetics labeling to follow in Vietnam:

For cosmetic label content, Vietnam Law provides that the cosmetic product’s label must be suitable for requirements of the cosmetic label writing set by the ASEAN. The following contents must be presented on the label:The product’s name and function, unless the presented form of product has been displayed clearly the product’s function;

• The usage instruction, unless the presented form clearly been displayed the product’s using manner;
• The full formula ingredients: must write clearly ingredients according to the international nomenclature regulated for latest printed forms;
• The country where the product was made;
• The name and the address of organizations or individuals who are responsible for putting products on market (written fully in Vietnamese according to the business registration certificate or the investment license);
• Quantification is presented with weight or volume, in regard to the meter system or the meter system and the British system;
• The manufacture lot number;
• The manufacture day or the expiry must be clearly presented (i.e.: day/month/year). The date writing way must clearly be presented and involved of month/year or day/month/year in right order. The “expiry” or “the best using before date” can be exerted, if necessary, can add the instructed condition needs obey to make sure of the product’s stability.

Referring to products with the stability below 30 months, the writing of expiry day is compulsory;

• Warning about safety for usage; especially, warnings in the “usage condition and required alarms are compelled to be printed the product’s label” column is referred in Appendices of ASEAN Cosmetic Treaty; these alarms are compelled to be printed on the label.

In case, the size, the form, or the package material cannot be fully printed information on the original label, these required contents have to be printed on the auxiliary label attached with the cosmetic product and on the original label must figure out the position in which these contents are printed. The following information is compelled to be printed on the original label of product‘s the direct packing: the product’s name and the product lot number.

The current regulations also allow organizations and individuals to present other information on the label with the conditions that these information must not be opposite to the law and guarantee the honesty, the accuracy, the true reflection of the product’s quality without causing the imperative content or the cosmetic label hidden or deviated.

For the presented language on the cosmetic label, the contents of the usage instruction, the name and the address of organizations and individuals who are responsible for putting the cosmetic products on market, and the warning about safety for usage must be written in Vietnamese. For the remaining information, the language presented on the cosmetic label must be written in English or Vietnamese.

For the label location, the cosmetic label must be printed on the commodity, package of commercial article on a location which is easy be seen of full regulated contents without disconnecting details or parts of the commodity. In case the outward package is not permitted or impossible to open, there must be the label with the required information on the package.

Besides, the organizations and individuals who are responsible for putting products on the market may identify the size of cosmetic product label but must assure that the information written on the label must be readable by the ordinary customers at the time of purchase and usage.

This publication is designed to provide updated information of legal matters, and does not constitute professional advice.

We help clients overcome cultural barriers and achieve their strategic and financial outcomes, while ensuring the best interest rate protection, risk mitigation and regulatory compliance. ANT lawyers have Attorneys in Hanoi, Attorneys in Ho Chi Minh and Attorneys in Danang.

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Cosmetics Workshop, Event Organizing Registration Services

 In addition to the cosmetics advertising on mass media such as television, radio, electronic portals (Internet, Website), books, newspapers, magazines, flyers, posters, underwater objects or other means of advertising, the cosmetics business can make or sponsor, authorize other entities to carry out workshop activities to introduce cosmetic products.

The cosmetic businesses are only allowed to advertise, organize seminars and events to introduce the cosmetic products when having the Receipt of advertising, seminar, cosmetic introduction events registration dossiers as prescribed by law.

Cosmetic advertising content must be consistent with the documents proving the safety and efficacy of the cosmetics and must comply with published guidelines of ASEAN cosmetic product features.

1. Services that ANT Lawyers provide for customers:

+ Consultation on the announcement of cosmetics, import cosmetics, cosmetics advertising.

+ Consulting on the registration and documentation of organizing conferences, workshops to introduce and advertise cosmetics as requested by customers.

+ On behalf of customer to fill in the cosmetics advertising registration where business operates or where enterprise organizes conference, workshop to advertise cosmetics.

+ On behalf of customer to contact, work and receive information from the competent State agencies related to the implementation process.

+ Amend and supplement the dossier as prescribed by the competent State agencies upon requested.

+ Inform customers about the validity result from the competent State agencies.

2. Registration dossier includes:

+ Trader registrated to advertise cosmetics, orgasnize seminar, event to introduce cosmetic products.

+ A copy of the business registration.

+ A copy of the cosmetic product announcement card that has been granted.

+ POA of organizations and individuals that announce the cosmetic products for the one who organizing cosmetic seminar, introduction event (in case of the event organization or individual register for advertising, organizing the seminar, cosmetic introduction event which are the one who held, published cosmetic products).

+ Document disclosures for the features, the use of the product in the case of the advertising contents, the contents presented at the seminar, cosmetic introduction event mentioned features, the use of the product beyond the content stated in the cosmetic product announcement card.

+ 02 advertising scripts (script must clearly describe the pictures, lyrics, music intends to advertise) or 02 advertising forms intend to release (applicable to the advertising registration dosssier) or documents intend to display, release at the seminar, cosmetic introduction event (applicable to workshop registration dossier).

3. Ways to file registration of cosmetic advertising, organizing seminar, event introduced cosmetic products:

a) Cosmetic registration dossier may be compiled for one or more products, can advertised on one or more means of mass media.

Cosmetics advertisement, advertising script can be made ​​for one or more different products.

b) The event, workshop organizing registration dossier may be compiled for one or more products to be held in one or more locations in the province, city

The procedure time: 10 working days from the time when the customer provides valid records and documents as required.

We help clients overcome cultural barriers and achieve their strategic and financial outcomes, while ensuring the best interest rate protection, risk mitigation and regulatory compliance. ANT lawyers have Attorneys in Hanoi, Attorneys in Ho Chi Minh and Attorneys in Danang.

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Obligations of Cosmetics Manufacturers and Importer in Vietnam

Cosmetics lawyers inVietnam

The cosmetics manufacturers and importers who are responsible for putting cosmetic on the market have the obligations as the following:

-Be responsible for all contents declared in the cosmetic product proclamation report, for the safety, the efficiency, and the quality of the product; and guarantee that the circulated products satisfy all requirements of the ASEAN Cosmetic Treaty and the Appendix of Vietnam law;

-Follow, discover, and confiscate immediately the unqualified cosmetic, as well as implement the confiscation announcement from the state authority office and inform to the state authority office about the confiscation; punctually deal with the consumer’s complaints of the cosmetic’s quality and compensate for consumer’s loss in accordance with the regulation; refund to the buyer the produced cost in the maintenance, transportation, and circulation process;

-Report to the Medicine Management department – the Health Ministry within 07 days since the date receiving the first feedback from this side-effect in case finding side-effects which are serious and could damage the consumer’s life because of the cosmetic product’s quality;

-File the Product Information File (PIF) in at least 03 years since the latest manufacture lot is put on the market and presented to the checking and inspecting functional office when requested;

-Obey the Vietnamese Regulation and Law on the intellectual ownership. When having the conclusion of the state competent offices on the intellectual-ownership law-breaking label and industrial design, the organizations, the individuals must stop manufacturing, trading, and importing in order to conduct of changing the label and the industrial design as provided, and be responsible for refunding and resolving all damages (if any).

Besides, Vietnam law also provides that the organizations which manufacture the cosmetic must deploy to apply and satisfy principles, the “cosmetic good manufacturing practice” standard of the Asian Southeast Association Nations (CGMP-ASEAN).

Last but not least, the organizations, the individuals must conduct requirements of state competent offices about checking and inspecting the cosmetic quality, confiscating the violated cosmetics, and be entitle to complaints about the conclusion and the law-breaking judgment form in accordance with the law regulation on the complaint and the denouncement.

This publication is designed to provide updated information of legal matters, and does not constitute professional advice.

How ANT Lawyers Could Help Your Business?

Please click here to learn more about ANT Lawyers Foreign Investment Practice or contact our Law firms in Vietnam for advice via email ant@antlawyers.vn or call our office at +84 28 730 86 529

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Mandatory Announcement of Cosmetic Product

Business owners being organizations and individuals responsible for launching cosmetic products on the market are only allowed to put into circulation when the competent state agencies approve and the business owners must bear full responsibility for the safety, efficiency and product quality. Competent state agencies will conduct post-trade test when the products are being sold to the market.

Cosmetics lawyers inVietnam

Cosmetics are substances or preparations used in contact with the external parts of the human body (skin, hair, nails, lips and external genital organs) or the teeth and oral mucosa with the main purpose is to clean, perfume, change appearances, form, adjust body odor, or protect body or to keep the body in good condition. The following will provide conditions and list of cosmetic types subject to mandatory annoucement.

1. Conditions to apply:

– Organizations and individuals responsible for launching the product into circulation on the market must have function to doing cosmetics business in Vietnam

– The announcement of the features of cosmetic products (intended use of the product) must satisfy the ASEAN guidelines on disclosure features of cosmetic products

2. Kinds of cosmetic that have to announce the distribution of cosmetics:

Kinds of cosmetic products must disclose the circulation of cosmetic products:

– Cream, emulsion, lotion, gel and oil for skin (hand, face, feet)

– Face mask (with the exception of chemistry peeling products)

– Tinted (liquid, paste, powder)

– Makeup powder, after shower powder, toilet powder

– Bath soap, deodorant soap

– Perfume, toilet perfume

– Products for bath or shower (salt, foam, oil, gel)

– Hair removal products

– Deodorants and anti-perspirants

– Shaving products (cream, foam, lotion)

– The makeup and makeup remover products for face and eyes

– Products used for lips

– Products for take caring teeth and mouth

– Products for nail care and adorn

– The products used to clean the outside

– Sun cream products

– Products for tanning without sun

– Skin whitening products

– Anti-wrinkle products

– Other products

Some products which are not classified as cosmetics:

Anti-mosquito products, air freshener, fabric softener, bleach, toilet, oxygen liquid, antiseptic alcohol 700, alcohol 900, denture cleaning products that are not exposed to the oral cavity, fake eyelashes, liquids to take care of eyes/nose/ears, against nasal congestion product, anti-snoring products, vaginal lubrication gel, ultrasound gel, the product in contact with the genital, rectal enema, anesthesia , reduce/control the swelling/edema, dermatitis treatment, allergy relief, anti-fungal, anti-virus products, stimulate hair/eyelash growth, the product removed/reduced fat/ reduced body size, weight loss products, prevent/stop hair growth products, stop sweating process, permanent tattoo ink, remove keloid scars reduction products, wound cleaning products.

How ANT Lawyers Could Help Your Business?

Please click here to learn more about ANT Lawyers Foreign Investment Practice or contact our Law firms in Vietnam for advice via email ant@antlawyers.vn or call our office at +84 28 730 86 529

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Overview on Cosmetics Regulations in Vietnam

Cosmetics are areas of highly regulated in Vietnam as they apply on human and could create health concern. Hence, cosmetics imported into Vietnam have to be applied special procedures to ensure safety. Cosmetics regulations in Vietnam would lay out provisions that importers and manufacturers to follow.

Cosmetics lawyers inVietnam

To carry out the Combination Convention in the cosmetic management which has been signed by countries are member of the Association of Southeast Asian Nations on September 2nd, 2003 (commonly called ASEAN Cosmetic Convention), the Ministry of Health of Vietnam issued Circular 06/2011/TT-BYT on Cosmetic Management.

The Circular dated January 25th, 2011 regulating the management of cosmetic products manufactured in the country, as well as cosmetics imported for circular in Vietnam. Besides, the cosmetic regulations is also provided in related provisions.

According to the Vietnam cosmetic regulations, cosmetic product must be construed as a substance or a preparation which is used for touch with outside parts of human body (skin, hair system, finger nails, toenails, lip, and outside reproduction organ) or teeth and mouth mucous membrane with main purpose in order to cleanse, aromatize, change the outward characteristics, form, adjust body’s smell, safeguard body, or maintain the human body in good condition. In addition to the products being grouped as cosmetic products such as: creams, emulsion, lotions, gels and oils for skin (group 1); tinted bases (group 2); toilet soaps, deodorant soaps (group 3); … some products are not classified as cosmetic.

Under Vietnam law, a cosmetic product made in Vietnam or imported into Vietnam must go through procedure of proclamation before being is sold on the market. In particular, organizations or individuals circulating the cosmetic products on the market have to be responsible for obtaining permissions through cosmetic product proclamation from authority agencies as well as responsible for safety, effectiveness, and quality of product.

For exporting cosmetic, the exporter needs to obtain the Certificate of Free Sale (CFS) as regulated. CFS is issued when such domestic cosmetic is issued the cosmetic product proclamation receipt number by competent state management agency. For importing cosmetic, enterprises are only allowed to import the cosmetic into Vietnam when presenting to the Customs agency the valid receipt number of cosmetic product proclamation report which has been issued by the Medicine Management Department – the Health Ministry. However, Vietnam law also provide import of cosmetic in some special situations which are not obligated to implement the cosmetic product proclamation as the following:

– Organization or individual who imports cosmetic in order to study and experiment;

– The organizations, individuals who receive cosmetic as gifts;

– The organizations, individuals who import cosmetic for displaying at fair, gallery and other temporary import for re-export situations.

For manufacturing cosmetic, the cosmetic regulations require the organizations which manufacture the cosmetic must deploy to apply and satisfy principles, the “cosmetic good manufacturing practice” standard of the Asian Southeast Association Nations (CGMP-ASEAN).

Besides, compliance with the other requirements such as labeling, safety of ingredients, cosmetic advertising is also required.

How ANT Lawyers Could Help Your Business?

The changes of laws will be monitored by ANT Lawyers. For advice or service request, please contact us via email ant@antlawyers.vn or call +84 28 730 86 529

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Definition and Classification of Cosmetics in Vietnam

The definition of cosmetic in Vietnam regulations is currently compatible with the definition of ASEAN Cosmetic Convention provided in Article 2.1 of Schedule B of ASEAN Cosmetic Directive. Accordingly, cosmetic product is a substance or a preparation which is used for touch with outside parts of human body (skin, hair system, finger nails, toenails, lip, and outside reproduction organ) or teeth and mouth mucous membrane with main purpose in order to cleanse, aromatize, change the outward characteristics, form, adjust body’s smell, safeguard body, or maintain the human body in good condition.

Cosmetics lawyers inVietnam

For the classification of cosmetic, under the current Vietnam regulations, the criteria for the classification of cosmetic products based on the features, uses, recipe ingredients, route of administration of the product and the definition of cosmetic. Namely, beauty products are classified into 20 groups of products as the following:

-Creams, emulsions, lotions, gels and oils for skin (hands, face, feet, etc.)

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

-Tinted bases (liquids, pastes, powders)

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

-Toilet soaps, deodorant soaps, etc.

-Perfumes, toilet waters and eau de Cologne

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

-Depilatories

-Deodorants and anti-perspirants

-Hair care products include: hair tints and bleaches, products for waving, straightening and fixing, setting products, cleansing products (lotions, powders, shampoos), conditioning products (lotions, creams, oils), hairdressing products (lotions, lacquers, brilliantines)

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

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

-Products intended for application to the lips

-Products for care of the teeth and the mouth

-Products for nail care and make-up

-Products for external intimate hygiene

-Sunbathing products

-Products for tanning without sun

-Skin whitening products

-Anti-wrinkle products

Besides, some products are not classified as cosmetic as the following:

-The product permanently adjust, restore or alter the function of the body by the immune mechanism, metabolic or pharmacological mechanism

-Products sweetened oral, injection or contact with other parts of the body (i.e. the nasal mucous membranes, genitals in, …)

-The mosquito, air fresheners, fabric softeners, water, toilet bowl cleaner, liquid oxygen aging, alcoholic antiseptic 70 0,90 0 alcohol, product Clean dentures are not exposed to the oral cavity, false eyelashes, eye cleaning solution/nose/ear protection products nasal congestion, anti-snoring products, vaginal lubrication gel, ultrasound gel, the exposure in genital, rectal enema, anesthesia, reduce/ control the swelling/edema, dermatitis treatment, hypoallergenic, anti-fungal, anti-viral, stimulates hair growth products/grow eyelashes products removed/reduced fat/reduced fat/reduced body size, weight loss products, prevent/stop the growth of hair, the process stops sweating, permanent tattoo ink, product remove scars, keloids reduction, wound cleaning products.

How ANT Lawyers Could Help Your Business?

Please click here to learn more about ANT Lawyers Foreign Investment Practice or contact our Law firms in Vietnam for advice via email ant@antlawyers.vn or call our office at +84 28 730 86 529

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Vietnam and ASEAN Cosmetic Regulations

Vietnam cosmetic regulations are compatible with the ASEAN cosmetic regulations.

On September 2nd 2003, on behalf of the Government of Vietnam, the Vietnam Minister of Trade and Commerce signed an agreement on the ASEAN harmonized Cosmetic Regulatory Scheme, in which, the terms specified in the agreement is fully implemented since January 1st, 2008.

Cosmetics lawyers inVietnam

The agreement aims to unify cosmetic management in the ASEAN countries, and is toward a common market of ASEAN, strengthen cooperation between member States in ensuring safety, quality and beneficial feature of all cosmetic products on the ASEAN market and remove the restrictions on the cosmetic business between member States through the harmonization of technical regulations.

The agreement on the ASEAN Harmonized cosmetic regulatory scheme is considered a cosmetic treaty representing the unity of regulations on management of cosmetic member countries of the agreement. Being a member of the agreement, Vietnam cosmetic regulations are compatible with the ASEAN cosmetic regulations.

This publication is designed to provide updated information of legal matters, and does not constitute professional advice.

How ANT Lawyers Could Help Your Business?

Please click here to learn more about ANT Lawyers Foreign Investment Practice or contact our Law firms in Vietnam for advice via email ant@antlawyers.vn or call our office at +84 28 730 86 529

Read More