Starting 2026, the Vietnamese cosmetic industry will officially enter a new era of governance with the introduction of the Draft Decree on Cosmetic Management. The transition Circular 06/2011/TT-BYT to a Decree-level regulation is not merely a legal update but a revolution in quality standardization in alignment with the ASEAN Cosmetic Directive (ACD).
For investors and business owners, mastering the latest cosmetic regulations is crucial to maintaining a competitive edge. You may consult all relevant legal documents in the section: Cosmetic Regulations.
1. Elevation of Legal Validity and Regulatory Authority
The new legal framework has been elevated to a Government-issued Decree. This reaffirms that cosmetics is a conditional business sector, accompanied by strict enforcement measures regarding product recalls and the revocation of Receipt Numbers of Cosmetic Product Notification Forms to purify the market.
2. Standardizing the Mandatory Roadmap for CGMP Compliance
A decisive change is the shift a voluntary to a mandatory requirement for cosmetic manufacturing facilities to comply with the principles and standards of Cosmetic Good Manufacturing Practices (CGMP). All facilities, equipment, and Quality Management Systems (QMS) must be audited and certified as CGMP-compliant by the competent authorities.
3. Shift in Management Philosophy: From Pre-market Inspection to Post-market Surveillance
The Draft establishes a "Self-declaration and Self-responsibility" mechanism. However, regulatory bodies will intensify post-market surveillance (PMS). Within 03 months the notification date, the receiving authority will complete the post-notification dossier audit for conventional products (Group 1).
4. Strict Requirements for Personnel Qualification and Experience
Key personnel, including the Head of Production and the Head of Quality, must hold at least a university degree in Chemistry, Biology, or Pharmacy. Notably, they must work full-time, function independently of each other, and possess at least 02 years of practical experience in the fields of cosmetics, pharmaceuticals, or health supplements.
5. Immediate Presentation of the Product Information File (PIF)
The PIF must be maintained at the address of the notifying entity. The administrative documents and product summary (Part 1) of the PIF must be presented immediately at the time of inspection. Other technical parts, if incomplete, must be submitted within 30 days the inspection date.
6. Technical Barriers in Labeling and Advertising
Advertising content must strictly align with the inherent nature of the product, notified information, and the safety and efficacy documentation within the PIF. Product labels must comply with the ASEAN Cosmetic Directive, being clearly presented and indelible, including mandatory details such as ingredients, batch number, manufacturing date, and expiry date.
7. Enhanced Control over Imported Cosmetics
Imported products must possess a valid Notification Receipt Number and comply with regulations regarding the Certificate of Free Sale (CFS). High-risk products (Group 2), such as skin whitening, sunscreen, and baby care products, must be accompanied by a standard Certificate of Analysis (COA) during customs clearance.
8. Fully Online Cosmetic Governance
All procedures for product notification, renewal, and the issuance of Certificates of Eligibility for Cosmetic Production are conducted via the online public service system. The notifying entity bears full responsibility for the accuracy and legality of the content declared on the system.
9. Responsibility for Continuous Update of Ingredients and Safety
The notifying entity must ensure that the product formulation complies with the latest ASEAN Annexes regarding prohibited and restricted substances. In the event of a Serious Adverse Event (SAE), the entity must report to the Ministry of Health within 07 days of receiving the initial information.
10. Revocation Sanctions and Suspension of Dossier Reception
Regulatory authorities reserve the right to revoke the Notification Receipt Number and suspend the reception of new dossiers for 12 months if the entity fails to recall non-compliant products or operates in a non-standard facility. For acts of document falsification, the entity will face an indefinite suspension of dossier reception.
