Regulations on cosmetic product proclamation in Vietnam

Regulations on the cosmetic product proclamation in Vietnam

- Organizations or individuals which are responsible of putting the cosmetic product on the market just permitted selling cosmetic when be issued the number of cosmetic product proclamation receiving by the authority agencies as well as responsible for safety, effectiveness, and quality of product. The authority agencies shall carry out after-sales inspection when the product has been being sold in the market.

- Cosmetic product proclamation fee is implemented in accordance with the regulations in force.

- Organizations or individuals who are responsible for putting the products on the market must have the function of cosmetic business in Vietnam.

- Cosmetic product feature proclamation (the cosmetic usage purpose) must satisfy the ASEAN’s instruction of the cosmetic product feature proclamation (Appendix No 3-MP).

Pursuant to: Article 3 of Circular 06/2011/TT-BYT

Regulations on cosmetic product proclamation in Vietnam (Internet image)

What is included in the cosmetic proclamation dossier?

Pursuant to Article 4 of Circular 06/2011/TT-BYT, Clause 2, Article 12 of Decree 155/2018/ND-CP and Clause 1, Article 1 of Circular 29/2020/TT-BYT, the cosmetic product announcement dossier include the following documents:

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

(2) 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 the following requirements:

- The presenting language must be Vietnamese or English or bilingual Vietnamese and English.

- The authorization certificate must have sufficient the following contents:

+ The producer’s name and address; in case the delegating party is the owner of product, must clearly state name and address of the owner of product, and name and address of the producer as well;

+ The name and address of authorized organizations, individuals;

+ The scope of authorization (undersigned on the proclamation and circulation product in Vietnam);

+ The label or name of authorized product;

+ The time-limit of authorization;

+ The commitment of the producer or the owner of product to provide sufficient product information file (PIF) for organizations or individuals who are responsible for putting product on market;

+ Name, position, and the signature of the delegating party’s representative.

(3) Certificate of Free Sale (CFS) of imported cosmetic products:

- Cases of CFS exemption:

+ The cosmetic products are manufactured in a member country of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) the participation in which has been approved and brought into effect by competent authorities of that country;

+ The cosmetics products are marketed in and exported from a CPTPP member country:

The enterprise responsible for marketing of the products shall submit documents proving that the products have been marketing in the CPTPP member country that are issued by competent authorities of the same country (marketing authorization or registered cosmetic product notification or other documents certifying the marketing of the products in the country) and consularly legalized as prescribed by law, unless:

++ These documents are exempt from consular legalization under an international treaty to which the Socialist Republic of Vietnam (hereinafter referred to as “Vietnam”) is a signatory or under principle of reciprocity between Vietnam and the issuing country;

++ A diplomatic authority, cosmetics management authority or issuing authority of the CPTPP country sends a physical document or email to Drug administration of Vietnam to certify these documents;

++ The enterprise responsible for marketing of the products obtains these documents from the website (in English) of the issuing authority of the CPTPP member country which bear the seal of the enterprise and sends it together with the link to that website to Drug Administration of Vietnam.

The enterprise shall be legally responsible for the legitimacy and accuracy of these documents and information;

+ The cosmetics products have been granted a product notification number in an ASEAN country, in which case the enterprise responsible for marketing of the products shall submit the cosmetic product notification which is consularly legalized, unless:

++ The cosmetic product notification is exempt from consular legalization under an international treaty to which Vietnam is a signatory or under principle of reciprocity between Vietnam and the issuing country;

++ A diplomatic authority, cosmetics management authority or issuing authority of the ASEAN country sends a physical document or email to Drug administration of Vietnam to certify the cosmetic product notification;

++ The enterprise responsible for marketing of the products obtains the cosmetic product notification from the website (in English) of the issuing authority of the CPTPP member country which bears the seal of the enterprise and sends it together with the link to that website to Drug Administration of Vietnam.

The enterprise shall be legally responsible for the legitimacy and accuracy of these documents and information;

- 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:

+ The CFS is still effective and issued by a competent authority of the country or origin or exporting country (original copy or authenticated copy). In case the CFS does not have an expiration date, it must be issued within the last 24 months;

+ The CFS is consularly legalized as prescribed by law, unless:

++ Consular legalization is exempt under an international treaty to which Vietnam is a signatory or under principle of reciprocity between Vietnam and the issuing country;

++ The issuing authority or a diplomatic authority sends a physical document or email to Drug Administration of Vietnam to certify the CFS;

+ The CFS contains at least the information specified in Article 36 of the Law on Foreign Trade Management and Clause 3 Article 10 of Decree 69/2018/ND-CP.

Mai Thanh Loi

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