What documents are included in the cosmetic proclamation dossier in Vietnam?

What documents are included in the cosmetic proclamation dossier in Vietnam?

Pursuant to Article 4 of the Circular 06/2011/TT-BYT (amended by Clause 2.a Article 12 of the Decree 155/2018/ND-CP and Clause 1.a Article 1 of the Circular 29/2020/TT-BYT) stipulating the cosmetic proclamation dossier in Vietnam as follows:

The cosmetic proclamation dossier

The cosmetic proclamation dossier includes the following documents:

1. Cosmetic product proclamation report (02 versions) with the proclamation data (soft version of proclamation report);

2. (annulled);

3. 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.

4. Certificate of Free Sale (CFS) of imported cosmetic products:

a) Cases of CFS exemption:

...

b) Except for the cases of CFS exemption specified in Point a of this Clause, the application for notification of imported cosmetic products shall have a CFS that satisfies the following requirements:

...

As regulations above, the documents that are included in the cosmetic proclamation dossier in Vietnam are:

- Cosmetic product proclamation report with the proclamation data.

- 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).

- Certificate of Free Sale (CFS) of imported cosmetic products.

What documents are included in the cosmetic proclamation dossier in Vietnam? - image from internet

Which cosmetic products are compulsory to be proclaimed in Vietnam?

Pursuant to Article 4 of the Circular 06/2011/TT-BYT stipulating term interpretation as follows:

Term Interpretation

In this Circular, the following terms shall be construed as follows

1. 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.

...

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.

In the cosmetic proclamation form issued together with Circular 06/2011/TT-BYT (amended by Appendix 1 issued together with Circular 29/2020/TT-BYT), it stipulates the types of cosmetic products that are required to undergo the proclamation procedure, including:

- 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, lotions, foams, soaps, oils. gels, etc)

- Depilatories

- Deodorants and anti-perspirants

- Hair care products

+ 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

- Other products

What are procedures for issuance of the cosmetic proclamation certificate in Vietnam in 2023?

Pursuant to Article 7 of the Circular 06/2011/TT-BYT stipulating procedure of receiving and solving proclamation dossier as follows:

Step 1: Submission of dossier

- The collecting and solving cosmetic product proclamation dossier is packed up into one set, submitted directly or posted to the following competent state management agency:

+ Regarding to the export cosmetic: organizations or individuals who are responsible for bringing product into market apply the cosmetic product proclamation dossier at the Medicine Management Bureau – the Ministry of Health.

+ Regarding to the cosmetic produced by domestic organizations, individuals: organizations or individuals who are responsible for putting product on market apply the cosmetic product proclamation dossier at the Department of Health in which have production factory. The cosmetic products which are produced, packed from the import semi finished products shall be considered domestic produced products.

+ Regarding to the cosmetic trading in the scope of industrial trading area of Moc Bai border gate economic area in Tay Ninh province implement of the proclamation at the Moc Bai border gate Economical Area Management Board; the cosmetic trading in the scope of Lao Bao special economic -trade area in Quang Tri province implement of the proclamation at the Economic Area Management Board of Quang Tri province.

+ The transporting cosmetic from the industrial trade area of Moc Bai border gate economic area in Tay Ninh province into other function areas in Moc Bai border gate economic area of Tay Ninh province or into the domestic market for trading; transporting cosmetic from the Lao Bao special economic -trade area in Quang Tri province into the domestic market for trading must implement of the proclamation at the Medicine Management Department– the Health Ministry in accordance with regulations of this Circular (organizations or individuals, who undersign on the cosmetic proclamation, must have function to trade on cosmetic in Vietnam, and not located in two these areas).

Step 2: Handling the cosmetic product proclamation dossier

- Within 03 working days since receiving the regular proclamation dossier and proclamation fee as provided competent state management agencies are obligated to issue the number of receiving the cosmetic product proclamation report.

- In case the proclamation dossier which still does not satisfy provisions of this Circular, within 05 working days since receiving dossier, the dossier receiving agency must announce in writing for organizations or individuals of contents, which having not satisfied yet, to fix, amend dossier (figuring out unsatisfied contents in details).

Within 05 working days since receiving the supplementing dossier satisfying the regulations in this circular, competent state management agencies are obligated to issue the receipt number of the product proclamation report.

In case the amending and supplementing dossier does not satisfy this circular’s regulation, within 05 working days since receiving the supplementing dossier, the dossier receiving agency must announce organizations or individuals in a text document of not issuing the receipt number of the product proclamation report.

Within 03 months since the announcement document is issued as provided under this Circular; if competent state management agency still does not receive any supplementing dossier from organizations or individuals whose name are on the cosmetic proclamation, the proclamation dossier shall be invalid. In this case, if organizations or individuals want to continue the proclamation, they must submit a new dossier and pay a new fee according to the regulations.

Step 3: Issuance of the cosmetic proclamation certificate.

Best regards!