SOME NOTES ON COSMETIC PRODUCT ANNOUNCEMENT PROCEDURES IN VIETNAM - OTIS LAWYERS

1. Procedure for announcing cosmetic products

1.1. Competent state management authorities

• For imported cosmetics: The Drug Administration of Vietnam (Ministry of Health).  
• For domestically produced cosmetics: The Department of Health where the manufacturing plant is located.  

Note: Cosmetic products that are manufactured and packaged from imported semi-finished products are considered domestic products.

1.2. Processing time

Within 03 working days from the date of receiving the valid announcement dossier and prescribed fee, the competent state management authority is responsible for issuing the receipt number for the cosmetic product announcement form.  

If the dossier does not meet the requirements, within 05 working days from the date of receipt, the receiving agency must notify the organization or individual in writing of the contents that do not comply (specifying the unmet requirements) for modification and supplementation.  

Note: If the competent state authority does not receive the supplementary dossier within 03 months from the date of issuing the notification, the original dossier will no longer be valid. A new dossier and fee will be required to proceed.

2. Fees

The evaluation fee for cosmetic product announcements is 500,000 VND per dossier.

3. Changes to announced content

For cosmetic products that have been announced and issued a receipt number, any changes to the contents specified in Appendix No. 05-MP require the organization or individual responsible for marketing the product to submit a written request for supplementation (for changes that do not require a new announcement) along with supporting documents. The changes must be approved in writing by the competent state authority, or a new announcement must be made for changes that require it.

4. Validity of the receipt number for the cosmetic product announcement form

The receipt number is valid for 05 years from the date of issuance.  

After this period, to continue marketing the cosmetic product, a new announcement must be made before the receipt number expires, and the appropriate fee must be paid.

5. Revocation of the receipt number for the cosmetic product announcement form

The receipt number will be revoked if any of the following occur:

• The product has two batches with quality issues as concluded by state authorities.  
• The product's formula differs from the announced dossier.  
• The product label misrepresents origin or content.  
• The product label misrepresents the inherent nature or function of the product.  
• The product is unsafe for users.  
• The product contains banned substances or ingredients exceeding the allowable limit.  
• The product infringes on intellectual property rights or imitates the label of another product legally circulated.  
• The product is banned from circulation in its country of origin.  
• The organization or individual marketing the product submits a written request for revocation.  
• There is no Product Information File (PIF) available for inspection by authorities.  
• The dossier contains falsified documents, fake seals, or signatures from Vietnamese or foreign authorities, or the manufacturer or owner of the product.  
• False declarations in the product announcement form.

6. Suspension of circulation and recall of cosmetics

Cosmetics will be suspended from circulation and recalled in the following cases:

• The product circulates without a receipt number issued by the competent authority.  
• The product fails to meet quality standards or is unsafe for users.  
• The product's formula differs from the announced dossier.  
• The product contains banned substances or exceeds the allowable concentration limits.  
• The product label claims effects inconsistent with the announced dossier or does not meet the labeling requirements of this Circular. Depending on the violation level, the product may be suspended and recalled.  
• The product is manufactured at a facility that does not comply with the ASEAN Cosmetics Good Manufacturing Practices (CGMP-ASEAN) or equivalent standards recognized by the ASEAN Cosmetic Committee. Depending on the violation level, the product may be suspended and recalled.  
• The product has expired or is past the manufacturer’s recommended period.  
• The product is counterfeit, smuggled, has unknown origins, or has damaged packaging.  
• The organization or individual marketing the product submits a voluntary recall request.

7. Responsibilities of organizations and individuals producing, trading, or importing cosmetics for circulation in Vietnam

They must take full responsibility for the contents declared in the cosmetic product announcement form and ensure the safety, efficacy, and quality of the product. The product must comply with all requirements of the ASEAN Cosmetic Agreement and its appendices.  

They must monitor and immediately recall substandard products and comply with recall orders from authorities. Reports of product recalls must be submitted to the competent authorities. They must address customer complaints and compensate for any damages caused by the product.  

If severe adverse effects on consumers' health due to product quality are detected, they must report to the Drug Administration of Vietnam (Ministry of Health) within 07 days of receiving the first information. A detailed report must be submitted within 08 additional days.  

The Product Information File (PIF) must be kept for at least 03 years from the date the last batch was released for sale and be available for inspection.  

Manufacturing facilities must implement and comply with the ASEAN CGMP standards.  

They must follow state inspection requirements regarding cosmetic quality, recall products in violation, and have the right to appeal conclusions and penalties as per the law on complaints and denunciations.  

They must comply with Vietnamese intellectual property laws. If found violating intellectual property rights, production, trading, or importing activities must stop, and appropriate corrective actions must be taken. They are also responsible for compensating for any resulting damages.

For any questions or comments, please contact:
OTIS AND PARTNERS LAW FIRM
Office address: 2nd Floor, CT3 Building, Yen Hoa Park View Urban Area, No. 3 Vu Pham Ham Street, Yen Hoa Ward, Cau Giay District, Hanoi
Email: [email protected]
Hotline: 0987748111