Comprehensive Guide to Cosmetic Registration in Vietnam

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Comprehensive Guide to Cosmetic Registration in Vietnam

I. Introduction

Vietnam’s cosmetic market is expanding rapidly, driven by rising consumer demand and global beauty trends. To legally distribute cosmetic products in Vietnam, businesses must complete a mandatory registration process. This guide provides a step-by-step overview of the registration process, regulatory requirements, and key considerations to ensure compliance and smooth market entry.

II. Definition of Cosmetics in Vietnam

According to Vietnamese regulations, cosmetics are defined as substances or preparations applied to external parts of the body (such as skin, hair, nails, lips, and external genital organs) or the oral cavity to cleanse, perfume, protect, or alter appearance.

Important Considerations:

  • Classification standards in Vietnam may differ from other countries. Certain products considered cosmetics elsewhere may be categorized as pharmaceuticals or medical products in Vietnam.
  • Examples:
    • Acne treatment creams containing strong active ingredients (e.g., Benzoyl Peroxide, Tretinoin) may be classified as drugs.
    • Sunscreens with excessively high SPF or containing medicinal ingredients may require a pharmaceutical license.
  • In line with ASEAN Cosmetic Claims Guidelines, cosmetic products must not be marketed as treatments or preventive measures for diseases.

III. Regulatory Framework

Cosmetic registration in Vietnam is governed by the following key regulations:

  1. Circular 06/2011/TT-BYT – Outlines cosmetic product management.
  2. ASEAN Cosmetic Directive – Ensures regional harmonization of cosmetic safety and labeling standards.
  3. Decree 93/2016/ND-CP – Specifies licensing conditions for cosmetic manufacturing and trading.

The Drug Administration of Vietnam (DAV), under the Ministry of Health (MoH), is responsible for processing cosmetic product registrations.

IV. Eligibility and Documentation Requirements

1. Who Can Apply?

  • Enterprises with a valid business license covering cosmetic trading.
  • Importers and local manufacturers aim to introduce new cosmetic products to the market.

2. Essential Documents

 

Required Document For Local Manufacturers? For Importers? Notes
Enterprise Registration Certificate Must include cosmetic business scope
Letter of Authorization (LOA) Required for imported products
Product Formula Must comply with ASEAN safety standards
Certificate of Free Sale (CFS) Required for imported cosmetics
Product Labeling Details Must include Vietnamese translations
Statement of Product Safety Ensures compliance with health regulations

 

V. Step-by-Step Cosmetic Registration Process

1. Dossier Preparation

  • Gather all necessary documents, ensuring accuracy and compliance.
  • If any documents are in a foreign language, they must be translated into Vietnamese and notarized.

2. Online Submission

  • Register and submit the dossier via the Vietnam Ministry of Health’s Online Portal.
  • Pay the official registration fee (500,000 VND per product).

3. Review and Approval

  • Authorities review the application within 30 – 45 days.
  • If additional information is required, applicants must revise and resubmit their dossier within 15-30 days.
  • Once approved, a cosmetic product notification number is issued.

4. Post-Registration Compliance

  • The notification number allows the product to be legally sold in Vietnam.
  • Registration remains valid for five years.
  • Businesses must monitor post-market obligations, including reporting adverse reactions if necessary.

VI. Key Considerations for Successful Registration

  • Double-check all documents to prevent delays or rejections. 
  • Ensure product compliance with ASEAN cosmetic safety regulations. 
  • Label products correctly, including required Vietnamese translations. 
  • Avoid misleading claims – products must not be marketed as medical treatments.
  • Monitor post-market surveillance to ensure continued compliance.

VII. How Green NRJ Can Assist You

Navigating Vietnam’s cosmetic registration process can be complex and time-consuming. Green NRJ provides end-to-end support, including:

  • Expert consultation on regulatory requirements and legal procedures.
  • Dossier preparation & compliance review to prevent delays.
  • Submission & follow-up with the Ministry of Health.
  • Handling additional requests to expedite approval.
  • Translation & notarization of foreign documents.

📞 Contact us today for expert support and hassle-free registration!

VIII. Conclusion

Successfully registering cosmetic products in Vietnam requires thorough preparation, compliance with regulatory requirements, and accurate documentation. By following the outlined step-by-step process, businesses can streamline registration and avoid unnecessary setbacks.

For professional assistance, Green NRJ is ready to guide you every step of the way and ensure a smooth market entry process.

📢 Let’s get your products registered in Vietnam today! Contact us for a free consultation.

 

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