Vietnam Cosmetic Registration

Vietnam Cosmetic Registration (CFS+Notification under ASEAN Cosmetic Directive)

1. Regulatory Authority & Framework

Cosmetics in Vietnam are regulated under:

• Circular 06/2011/TT-BYT – core cosmetic regulation
• ASEAN Cosmetic Directive (ACD) – fully adopted
• CFS (Certificate of Free Sale) requirement
• DAV – Drug Administration of Vietnam (Ministry of Health)
• National Cosmetics Notification Portal

Regulatory authority:
DAV – Drug Administration of Vietnam (Cục Quản lý Dược)

Vietnam operates a post-market surveillance system:
cosmetic products are not “approved,” they are notified.

2. Registration Type – Cosmetic Notification (Notification Number)

Vietnam requires cosmetic notification, not pre-market approval.

Output:

• Notification Receipt Number (Số tiếp nhận Phiếu Công bố)
• Validity: 5 years

Foreign companies cannot submit directly and must appoint a local Vietnamese company as the Responsible Person (RP).

3. Responsible Person (RP) Requirements

The RP must be a Vietnamese legal entity (importer or distributor) responsible for:

• Submitting the cosmetic notification dossier
• Maintaining the PIF
• Handling PMS, adverse event reporting
• Managing recalls upon DAV request
• Ensuring labeling compliance (Vietnamese language)

The RP will appear on all labels.

4. Cosmetic Notification Dossier (Online Submission)

Vietnam’s cosmetic notification dossier is fully aligned with the ASEAN Cosmetic Directive.

The RP submits via the Vietnam National Cosmetic Portal.

Required Documents

1. Cosmetic Notification Form (Annex to Circular 06/2011)
2. Product Information File (PIF) including:
   • PIF Part I: Administrative documentation
   • PIF Part II: Quality documentation
   • PIF Part III: Safety assessment
   • PIF Part IV: GMP evidence
3. Label Artwork (Vietnamese or bilingual)
4. Ingredient list (INCI)
5. Certificate of Free Sale (CFS)
   • Must be legalized by Vietnamese Consulate
6. Authorization Letter / Power of Attorney for the local RP
7. GMP certificate (ISO 22716 strongly preferred)

5. Ingredient Requirements

Vietnam fully implements ASEAN Cosmetic Ingredient Lists:

• Annex II – Prohibited Ingredients
• Annex III – Restricted Ingredients
• Annex IV – Colorants
• Annex VI – UV filters
• Annex VII – Preservatives

Key rules:

• Hydroquinone, tretinoin, steroids, mercury → strictly prohibited
• Salicylic acid allowed only at cosmetic limits
• Sunscreens must use approved UV filters only
• Hair dyes require warning statements
• Nanomaterials are subject to ACD conditions

6. Labeling Requirements

Labeling must comply with Vietnamese MOH requirements and ACD:

Mandatory elements:

• Product name
• Function (e.g., shampoo, cream)
• Full ingredient list (INCI)
• Net content
• Batch/lot number
• Manufacturing date / expiry date
• Country of origin
• Instructions for use
• Warnings/precautions (if required by Annex III)
• Name & address of Responsible Person in Vietnam
• Language: Vietnamese

Bilingual (English + Vietnamese) labels are accepted.

Sticker labeling is acceptable for imported products.

7. Fees & Timeline

Government Fees

• Cosmetic Notification Fee: ~300,000 VND per product
  (approx. USD 12)

Timeline

• Dossier preparation: 1–2 weeks
• Submission to DAV: Instant submission
• Notification issuance: 3–7 working days
• Validity: 5 years

Vietnam has one of the fastest cosmetic notification systems in ASEAN.

8. Post-Market Surveillance (PMS)

DAV actively monitors:

• Labeling
• Claims
• Ingredient compliance
• Random sampling/testing
• Advertising and online sales
• GMP compliance of manufacturers

RP obligations:

• Maintain PIF for at least 3 years after last batch placed on market
• Report adverse events
• Manage voluntary recalls or DAV-mandated recalls
• Ensure claims substantiation

9. High-Risk Ingredients – Borderline Issues

Products containing the following may be considered drugs, NOT cosmetics:

• Acne treatment (“treats acne”, benzoyl peroxide, tretinoin)
• Eczema, dermatitis treatment claims
• Hair growth/anti-hair loss claims
• Skin lightening with medical claims (“treat melasma”)
• Antiseptic/disinfectant products
• SPF claims exceeding ACD limits

These require drug registration, not cosmetic notification.

10. Consulting Notes for Your Portfolio

11. Advantages of the Vietnam Cosmetic Market

• Fastest ASEAN notification (3–7 days)
• Very low government fee
• Harmonized with ASEAN Cosmetic Directive
• High demand for Korean/Japanese/Chinese cosmetic brands
• Clear regulatory expectations
• CFS is the only major legalized document needed