Vietnam Introduces Post-Market Surveillance for Cosmetics Advertising, Abolishing Pre-Market Approval

Introduction

Vietnam’s cosmetics market has entered a milestone period of institutional transition in 2026. For a long time, the Ministry of Health (MOH) of Vietnam and its affiliated Drug Administration of Vietnam (DAV) implemented a strict pre-market approval system for cosmetics advertising, requiring enterprises to obtain a “Confirmation of Advertising Content” before releasing any marketing materials. However, driven by the rapid expansion of the global digital economy and the Vietnamese government’s strategic goal of simplifying administrative processes and improving market efficiency, the regulatory framework has undergone a fundamental shift.

On February 12, 2026, the Vietnam MOH issued Circular No. 03/2026/TT-BYT. Effective from February 15, 2026, enterprises are no longer required to submit advertisement registration to local health departments prior to product marketing. This Circular abolishes the pre-market licensing requirement for cosmetics advertising that has been in place for years, replacing it with a dynamic governance system centered on “post-market surveillance” (regulatory monitoring and enforcement conducted after a product or advertisement is already on the market).

Concurrently, the Vietnamese government issued Decree No. 342/2025/ND-CP on December 26, 2025, which also came into effect on February 15, 2026. As a government-level document, this Decree provides the higher-level legal basis for the abolishment of Circular No. 09/2015/TT-BYT. It fundamentally removes the legal requirement that “advertisements for special commodities must obtain approval,” while introducing corresponding regulations on digital advertising technologies and clearly defining the legal responsibilities of social media influencers (Key Opinion Leaders/Key Opinion Consumers, or KOLs/KOCs).

How the Previous Pre-Market Advertising Approval System (XNQC) Worked

Before the new regulations took effect, cosmetics advertising in Vietnam was strictly governed by Decree No. 181/2013/ND-CP and Circular No. 09/2015/TT-BYT. The core of this system was the “Confirmation of Advertising Content” (XNQC).

Previously, pre-market approval covered almost all mainstream media, including television, radio, newspapers, websites, social media platforms (such as Facebook and TikTok), as well as public relations events like seminars and new product launches. Enterprises had to obtain written confirmation from health authorities before releasing any advertisements or communication. Applicants were required to submit an application form, a valid cosmetics Notification Receipt, a draft of the proposed advertisement, with additional documents to justify the claims. The health authority would issue a conclusion within 10 working days upon receiving a complete dossier. This meant companies often had to wait three to four weeks or even longer to get their ads approved, and any modification to product claim/information could trigger a restart of the entire approval process.

Key Limitations of the Former XNQC Approval System

Although this pre-market approval system filtered out some false information at the source, it also brought significant negative impacts:

· Lag in Marketing Timeliness: The cosmetics industry has an extremely fast marketing pace. The multi-week approval process (plus potential time for corrections) frequently caused brands to miss out on market trends.

· Heavy Administrative Burden: Large enterprises had to process thousands of advertising materials annually. Fine-tuning each material could involve re-approval, resulting in immense administrative and labor costs.

· The Illusion of Compliance: Enterprises often believed that obtaining the XNQC equated to absolute compliance. Consequently, they neglected the dynamic management of efficacy evidence in their Product Information File (PIF - a comprehensive technical dossier detailing a cosmetic product’s formulation, safety, and claims).

Interpreting The New Regulations: Enterprise Compliance Requirements Under Vietnam's Post-Market Surveillance

With the synchronized implementation of Circular No. 03/2026/TT-BYT and Decree No. 342/2025/ND-CP, the responsibility for post-market compliance has completely shifted to the enterprises.

Mandatory Disclosure Elements

According to Article 4 of Decree No. 342/2025/ND-CP, although cosmetics advertisements no longer require pre-market approval, they must mandatorily include the following information, which must be consistent with the notification documents:

• Name of the product;

• Advertising content must completely match the notified product classification and function;

• Name and address of the organization or individual responsible for placing the product on the market;

• Necessary warning information.

Strict Prohibition on “Medicalized” Misleading Claims and Professional Endorsements

Even though pre-market approval is canceled, regulations still strictly prohibit cosmetics advertising from crossing the “cosmeceutical boundary.”

Ban on Drug Misleading: It is strictly forbidden to use any vocabulary or form that misleads consumers into believing the cosmetic product is a medicine (e.g., “treatment,” “completely eliminate,” “cure”).

Ban on Medical Imagery: It is strictly forbidden to use the images, names, or articles of medical institutions, doctors, pharmacists, or other medical personnel for promotional purposes in advertisements.

Technical Compliance Guidelines for Digital/Online Advertising (The “5-Second Rule”)

For advertising formats on the internet and social media platforms, Decree No. 342 introduces mandatory technical compliance standards, such as the 5-second time limit constraint: the mandatory viewing time for online video or animated advertisements must not exceed 5 seconds. After 5 seconds, a “skip” or “close” button must be provided. Furthermore, the close function must be “effective with a single click.” Obstructing users from closing advertisements through multi-layer redirects or hidden buttons is strictly prohibited. Previously, 15-second or even 30-second unskippable ads were common in the Vietnamese market; this practice is considered illegal after February 15, 2026.

Interpreting the New Regulations: Post-Market Enforcement and Penalties for Non-Compliant Advertising

The above compliance requirements are regulated by the Vietnam MOH and relevant departments through post-market spot checks, PIF reviews, and consumer complaint investigations. Violators will face penalties such as the revocation of notification numbers, mandatory product recalls, and administrative fines.

Additionally, under the post-market surveillance model, the Ministry of Culture, Sports and Tourism (MCST) of Vietnam and public security agencies have been granted rapid intervention rights. When advertising content is deemed illegal (such as containing prohibited content, false claims, or involving national security), the advertiser, advertising service provider, and platform operator must delete or block the content within 24 hours of receiving the request from the competent authorities.

Compliance Strategies for Cosmetics Companies Exporting to Vietnam: Building a Defense System Centered on the PIF

Under the brand-new “post-market surveillance” model, enterprises exporting to Vietnam can adopt the following measures to handle routine regulatory spot checks:

1. Appoint a professionally qualified local product responsible entity or a third party in Vietnam: As the compliance focus shifts from administrative approval to strengthening post-market surveillance defense, appointing a local partner with compliance capabilities is crucial. They can assist in conducting compliance reviews of all online and offline advertisements for the brand and provide explanations in response to inquiries from regulatory agencies.

2. Perfect the PIF Dossier: Ensure that the efficacy evidence in the Product Information File (PIF) is sufficient and authentic, ready to face inspections at any time. Any advertising claim should be backed up by a corresponding test report within the PIF. If an advertisement mentions “visible results in 7 days” or “tested by dermatologists,” the PIF must contain corresponding clinical trial data, sensory evaluation reports, or third-party laboratory certifications.

3. Control over KOLs and Livestreaming Rooms: Establish a mechanism for shared legal responsibility with KOLs/KOCs. Create an internal compliance manual to conduct pre-reviews of partnered KOLs and livestream scripts. Avoid using absolute terms or prohibited medical words, including the misuse of terminology caused by translation issues.

4. Regulatory Interaction: Under the 24-hour response mechanism, brands should establish active interaction channels with local Vietnamese regulatory agencies (such as the DAV and MCST). When a technical violation occurs due to translation misinterpretations, the brand should be able to swiftly submit a clarification statement through its local partner and rectify the issue immediately, in exchange for lenient treatment from regulatory authorities.

Looking Forward: What the 2026 Reform Means for the Future of Vietnam’s Cosmetics Market

The 2026 reform of Vietnam’s cosmetics regulation is a redistribution of “efficiency” and “responsibility,” marking a new starting point where enterprises’ compliance capabilities will face a true test. The abolition of pre-market filing unleashes the marketing creativity of brands and shortens the time-to-market for new products. However, post-market surveillance requires enterprises to abandon the traditional “borderline mentality” (the tendency to exploit regulatory loopholes) and invest more effort into solid compliance.

Future market competition will no longer be solely about product strength, but also about compliance response capabilities. Only those brands that can deeply integrate local professional resources, establish digital compliance management processes, and adhere to rigorous and scientific claims will be able to achieve steady and long-term success in the Vietnamese cosmetics consumer market.

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