Vietnam Strengthens Enforcement of Cosmetic Notification and PIF Compliance

On 15 December 2025, the Drug Administration of Vietnam (DAV), under the Ministry of Health, issued “Official Letter No. 5138/QLD-MP” on strengthening measures to combat smuggling, trade fraud, and counterfeit goods in the pharmaceutical and cosmetic sectors. The letter instructs authorities to intensify cross-agency enforcement actions across the pharmaceutical and cosmetic supply chains during the year-end peak period through March 2026.

Regulators emphasize a strict enforcement approach, with no prohibited areas and no exceptions. As a result of heightened regulatory scrutiny nationwide, cosmetic enterprises — particularly foreign brand owners and importers — should expect increased scrutiny of cosmetic product notification compliance and the proper maintenance of Product Information Files (PIFs).

For companies seeking to reduce inspection risk, get in touch with Cisema today.

Inspection Priorities for Cosmetics Under Vietnam’s 2025–2026 Enforcement Campaign

The Letter directs provincial Departments of Health to coordinate with market surveillance authorities, police, customs, and other competent bodies. Together, they will conduct comprehensive inspections across the cosmetic supply chain.

The inspection focus for cosmetics includes:

Legal status of cosmetic manufacturing and trading establishments
Valid Cosmetic Product Notification Numbers
Availability and completeness of the Product Information File (PIF)
Consistency between notified information and products actually placed on the market
Product labeling, advertising content, origin, and commercial documentation
Cosmetic business activities conducted via e-commerce platforms and social media

Cosmetic Notification as a Mandatory Condition for Market Access

Under current Vietnamese regulations, all cosmetic products must obtain a valid Cosmetic Product Notification Number before being marketed. During the current inspection peak, enforcement is expected to focus on common but high-risk violations.

Authorities are likely to take action against:

Trading cosmetics without notification or with invalid notification numbers
Products marketed inconsistently with notified content, including ingredients, dosage form, or intended use
Misuse of notification numbers belonging to other products or expired notifications
Imported cosmetics lacking lawful import dossiers, invoices, or supporting documents

Official Letter 5138 clearly reflects the authorities’ determination to tighten control over dossier accuracy and product consistency, particularly amid the rapid expansion of online cosmetic sales.

Product Information File (PIF) as a Core Inspection Target for 2025–2026

One of the strongest regulatory signals in “Official Letter No. 5138/QLD-MP” is the explicit requirement for enterprises to provide a complete and compliant Product Information File (PIF) upon request.

In practical terms, the PIF serves as regulatory evidence that a cosmetic product:

Has undergone a documented safety assessment prior to market placement
Contains clearly defined ingredients, quality specifications, and manufacturing processes
Is consistent with the notified information and approved product labeling
Is supported by comprehensive legal documentation covering manufacturers, raw materials, and testing

Failure to provide a complete, updated, and internally consistent PIF during inspections may lead to:

Administrative penalties
Mandatory product recalls
Suspension of product circulation
Referral to investigation authorities in serious or repeated cases

Greater Scrutiny of Online and Cross-Border Cosmetic Sales

The Letter also mandates intensified oversight of cosmetics sold via online channels. These include major e-commerce platforms such as Shopee, Lazada, Tiki, and TikTok Shop, as well as social media channels like Facebook, Instagram, TikTok, and YouTube.

The regulatory message is clear:

Online sales do not exempt products from cosmetic notification requirements
Advertising claims exceeding cosmetic functions will be strictly sanctioned
Online shop operators, distributors, and brand owners may all bear legal responsibility

In this environment, compliant notification dossiers and inspection-ready PIFs are critical safeguards during unannounced inspections.

Key Compliance Expectations for Foreign Cosmetic Enterprises

Several clear compliance expectations emerge from “Official Letter No. 5138/QLD-MP.” Together, they signal a shift away from formalistic compliance toward substantive, inspection-ready implementation.

Key points include:

Cosmetic notification is a core regulatory obligation, not a procedural formality
PIFs must be complete, consistent, and readily available at all times
Enterprises should proactively review their full portfolio, particularly products sold online
Reliance on so-called “fast-track notifications” or superficial PIF preparation carries elevated legal risk

For foreign manufacturers and overseas applicants, particular attention should be paid to alignment between notification dossiers, PIF content, product labeling, and the products actually circulating on the Vietnamese market. Inconsistencies across these elements are increasingly treated as material compliance failures rather than administrative oversights.

Final Thoughts: A More Enforcement-Driven Regulatory Environment

Within Vietnam’s broader efforts to combat counterfeit and smuggled goods, “Official Letter No. 5138/QLD-MP” sends a clear message: accurate notification, complete PIF documentation, and transparent market placement are essential for sustainable cosmetic operations.

As inspections intensify through early 2026, embedding compliance into long-term business strategy is essential. For international companies, common challenges include maintaining locally compliant documentation, ensuring PIF availability, and managing consistency across cross-border supply chains and online sales channels.

With a local presence in Vietnam, Cisema supports international cosmetic companies in navigating notification requirements, strengthening PIF compliance, and ensuring readiness for regulatory inspections. For companies seeking to reduce inspection risk and improve inspection readiness, get in touch with Cisema today.