Hanoi, March 2026. Viet Nam’s Ministry of Health (Drug Administration of Viet Nam) has circulated a draft Decree that would overhaul the national framework for cosmetic regulation, spanning product notification, domestic manufacturing conditions, import administration, product information files, labelling and advertising rules, digital procedures, risk-based inspection, and recall enforcement. The draft Decree is structured into 10 chapters and 52 articles and is intended to take effect on 1 July 2026.

What the Draft Decree Would Introduce

Cosmetic product notification becomes the central market-entry gate. Cosmetic products would be required to complete notification before being placed on the market for domestically produced goods, or before customs clearance for imports, with limited exemptions such as research or testing imports, diplomatic or personal non-commercial shipments, and certain temporary import scenarios.

A five-year validity period is proposed for the notification receipt number. Renewals would need to be filed before expiry, and products already manufactured or imported before notification expiry could continue to circulate until end of shelf life if safety and quality requirements remain met.

The notification dossier requirements are expanded and standardized. For imported cosmetics this includes the product notification form, quality standard documentation (where not publicly available), authorization from the product owner, a Certificate of Free Sale (CFS) subject to defined conditions and exemptions, and evidence of manufacturing compliance such as CGMP or ISO 22716 (or equivalent ASEAN-recognized standards). The draft also sets formal rules for legalization, certification, and acceptable electronic documentation where supported by issuing authorities.

Domestic Manufacturing and Certification Model

The draft establishes unified conditions for cosmetic manufacturing, linking eligibility to personnel competence, facilities and equipment, and a functioning quality management system consistent with CGMP principles. It also introduces periodic assessments every three years and allows for extraordinary inspections.

A key structural shift is decentralization. Provincial People’s Committees would be assigned authority to issue, amend, and revoke the Certificate of Eligibility for Cosmetic Manufacture and the CGMP Certificate, with defined revocation triggers such as prolonged inactivity, failure to meet conditions, or improper issuance.

Import Controls and Certificates of Free Sale for Exports

For imports, the draft retains a notification-first model with customs relying on published notification information via national systems. It also sets out a pathway for issuing Certificates of Free Sale for domestically manufactured cosmetics intended for export, with fees structured per product and a process aligned to the broader foreign trade management framework.

The draft also creates clearer rules for importing cosmetics for research and testing, including approval of import orders by provincial authorities and limits on sample quantities, with a one-time-use model for each approved import order.

Product Information Files, Labelling, and Advertising

The draft formalizes the Product Information File (PIF) requirement in line with ASEAN guidance, including language rules, recordkeeping expectations, and production timelines for documents when requested during inspection. It also reinforces that formula composition must comply with the latest ASEAN Cosmetic Agreement annexes, including prohibited and restricted substances, colourants, preservatives, and UV filters.

Labelling requirements follow general goods labelling law while incorporating ASEAN cosmetic labelling obligations. The draft specifies core mandatory label elements and introduces additional expectations such as clearer identification of animal-derived ingredients through text or symbols, and sunscreen-specific labelling aligned to ASEAN guidance. Where packaging constraints prevent full on-pack information, approved alternative formats such as inserts or display panels are contemplated, provided minimum identifiers remain on direct packaging.

Advertising is addressed under a post-market responsibility model. Cosmetic advertising would need to comply with the advertising law and remain consistent with the notified product information and substantiation held in the PIF, without requiring prior content approval.

Digital Procedures and Post-Market Supervision

The draft places procedures on an increasingly digital footing, providing rules for online dossiers, online processing, and electronic record retention. It also introduces a post-notification review and inspection system that differentiates between product groups.

A risk-based approach is proposed for quality inspection prioritization. The draft specifically highlights higher-scrutiny categories such as skin whitening products, talc powders, hair dyes and styling products, deodorants, sunscreens, anti-wrinkle products, acne products, products for children or pregnant women, and products with known physiological impacts or heightened adverse event potential.

The draft also strengthens adverse event reporting duties, including accelerated timelines for serious adverse events and structured follow-up reporting.

Recall, Revocation, and Application Suspension Tools

A dedicated chapter introduces clearer recall triggers and enforcement tools. Grounds for recall include unnotified products, false or inconsistent formula disclosure, prohibited or excessive restricted substances, non-compliant labelling, quality failures, unsafe products, expired products, production outside certified scope, missing PIF availability, falsified documents, and counterfeit or IP-infringing determinations.

Beyond recall, the draft provides for revocation of notification receipt numbers and, in defined cases, suspension of acceptance of new notification dossiers for violators, creating a stronger deterrence and compliance lever for repeat or severe breaches.

Implementation and Compliance Timeline

The draft proposes an entry into force date of 1 July 2026, with transitional provisions to maintain continuity from the existing regime while shifting responsibilities over time. A notable handover is scheduled for 1 January 2028, when provincial authorities would assume broader responsibility for processing cosmetic product notifications, expanding beyond the earlier split where the Ministry of Health handled imported products and provinces handled domestic products. Transitional arrangements also address legacy manufacturing eligibility certificates and the continued use of previously printed labels for a limited period after the new decree takes effect.

Outlook for Industry

If adopted, the decree would materially raise the compliance bar for both domestic manufacturers and importers by tightening dossier completeness, strengthening GMP-linked manufacturing controls, and expanding post-market accountability through risk-based inspection, adverse event reporting, and a broader recall and enforcement toolkit. Companies operating in Viet Nam should expect greater scrutiny on high-risk cosmetic categories, stronger expectations around PIF readiness and substantiation, and more structured interactions with provincial authorities as the system transitions toward decentralized processing.