A Vietnamese company is planning to trade cosmetics exported from South Korea. The company would like to consult lawyers about the necessary procedures to implement the business activity.

Under Annex III of Decree No. 69/2018 guiding Law on foreign trade management, a ‘cosmetic’ listed in imported goods, must be announced to conform with standards under the laws. At the same time, Article 3 of Circular No. 06/2011/TT-BYT provides that ‘organizations, individuals responsible for launching cosmetics into market are only permitted to circulate the cosmetics when they obtain the receipt number of a report on cosmetic declaration. They are totally responsible for the safety, effectiveness, and quality of the cosmetics. Competent state agencies will carry out after-sales inspection activities when the cosmetics are circulated into market’

Accordingly, the company needs to pay special attention to the procedure for the declaration of imported cosmetics to do its business activity. This is a mandatory procedure, and the company shall be responsible for the quality of the cosmetics.

The procedure for declaring cosmetics is governed as follows: 

• The person in charge of declaring cosmetics: The company which is responsible for launching cosmetics to market shall prepare applications to carry out the procedure for declaring these cosmetics to a competent licensing authority.
• Licensing authority: Drug Administration Agency of Vietnam – Ministry of Health
• Processing time: 03 working days from the date on which the licensing authority receives valid applications and enough state license fees under relevant laws.
• Procedure:

Step 1: Submit a set of the following applications for cosmetics declaration

• A report on cosmetic declaration together with relevant data
• An original, or a valid certified copy of a document, which proves that the company launching cosmetics into the market is licensed or authorized by the owner of the producer of the cosmetics. If the cosmetics are imports, such document must be in the form of a copy whose signature is certified with consular authentication under the laws, except for cases where the consular authentication is exempted under international treaties to which Vietnam is a party.
• The certificate of free sale (CFS) of these cosmetics in where it is granted must be an original one, or a valid certified copy, and must be unexpired. If the CFS does not contain its expiration time, it must be the one granted within 24 months from its birthday; the CFS also must be consularly authenticated under the laws, except for cases where the consular authentication is exempted under international treaties to which Vietnam is a party.

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Step 2: Receive and check applications  

Within 03 working days from the date on which the licensing authority receives valid applications and enough state license fees for cosmetics declaration under relevant laws, the authority is responsible for issuing a Cosmetics Declaration Record which reflects the number of applications receipt.

Step 3: Receive result

According to the application receipt, the company will receive result at the licensing authority.

• Result: A report on cosmetic declaration

Notes:

• After the company responsible for launching cosmetics into market receives the report on cosmetic declaration, the company will carry out customs procedures with competent state agencies to launch its cosmetics into the market.
• The receipt number on the Report on cosmetic declaration is valid for 5 years from its date of issuance. If the 5-year period is expired and the company still has the demand of launching the cosmetics to the market, it needs to re-declare the cosmetics and pay license costs under relevant laws.
• The company responsible for launching cosmetics into market must guarantee that its cosmetics are harmless for people’s health when these cosmetics are used in normal or appropriate conditions instructed, and suitable for the dosage forms, label information, instruction, special cautions, and other information provided by the producer or owner.

Conclusion

Hopefully the information in this article is useful to you, if you still have any questions about the procedure for declaration of imported cosmetics, or have demand of our service, please contact us via our email: Info@bizlawyer.vn or Hotline Call: 086.888.1900 for timely advice and support.