Product Information File for Cosmetics in Vietnam: Master Compliance and Preparation Steps 2025

1. What is a Product Information File (PIF)?

A Product Information File (PIF) is a mandatory technical document required for every cosmetic product that is manufactured, imported, or distributed in the Vietnamese market. As stipulated by Vietnam’s cosmetic regulations—specifically under ASEAN Cosmetic Directive as adopted by the Ministry of Health (MOH)—the PIF acts as official evidence that a cosmetic product is safe for human use and fully compliant with applicable laws.

The Product Information File in Vietnam must include comprehensive and well-documented information that proves product quality, safety, and regulatory compliance. This dossier is essential for legal distribution and serves as the primary reference for government authorities during routine inspections or investigations.

A standard Vietnam cosmetic PIF must contain the following core components:

• Manufacturer and Distributor Information
  Full legal names, addresses, and business registration details of the product’s manufacturer and local distributor in Vietnam.

• Product Origin and Ingredient Safety Data
  Details about the country of origin, complete list of ingredients, and a safety assessment report conducted by a qualified professional, typically a cosmetic chemist or toxicologist.

• Manufacturing Process and Quality Control Protocols
  Documentation showing adherence to Good Manufacturing Practices (GMP), production methods, and quality control systems used to ensure product consistency and safety.

• Scientific Evidence Supporting Product Claims
  Data and studies supporting the product’s claimed functions and benefits (e.g., whitening, anti-aging, moisturizing), as well as its safety for topical human application.

According to Vietnamese law, the PIF must be stored at the primary business location of the local responsible entity (usually the cosmetic notification holder) and be readily accessible for inspection by regulatory agencies, including the Drug Administration of Vietnam (DAV), upon request.

Maintaining an up-to-date and fully compliant Product Information File is not just a legal obligation—it is a critical part of your risk management strategy. A missing or incomplete PIF can lead to serious consequences such as:

• Product recalls

• Administrative fines

• Market bans

• Damage to brand reputation

For any business involved in cosmetic imports, distribution, or production in Vietnam, preparing and managing the PIF correctly is a fundamental step toward long-term success and regulatory compliance.

2. Why is the PIF Mandatory?

Under Vietnamese cosmetic regulations, every cosmetic product must be supported by a complete and up-to-date Product Information File (PIF) in order to be legally circulated on the market. This requirement is based on two key legal documents:

• Circular No. 06/2011/TT-BYT issued by the Ministry of Health, which provides detailed guidance on the management of cosmetics, aligned with the ASEAN Cosmetic Directive.

• Decree No. 117/2020/NĐ-CP, which prescribes administrative penalties for violations in the healthcare and cosmetic sectors.

In Vietnam, the PIF is a legal obligation—not a formality. It plays a central role in proving a cosmetic product’s compliance with regulatory standards for safety, efficacy, and quality.

Consequences of Not Having a Compliant PIF:

Failing to comply with PIF regulations may lead to:

• Revocation of the Cosmetic Product Notification Receipt (CPNR)
  Your product will lose legal distribution status.

• Mandatory market recall
  Non-compliant products may be forced off the shelves, leading to financial and reputational damage.

• Fines and administrative sanctions
  Companies may be fined and face suspension of distribution and marketing activities.

In short: No PIF = No legal cosmetic distribution in Vietnam.
If your product lacks a valid Product Information File, it cannot legally be imported, sold, or marketed in Vietnam. Maintaining a compliant PIF is crucial for regulatory compliance, risk management, and business continuity in the Vietnamese cosmetics industry.

3. What Does a Complete PIF Include?

A fully compliant Product Information File (PIF) for cosmetics in Vietnam must contain detailed technical, safety, and administrative documentation. These requirements follow the structure set out in the ASEAN Cosmetic Directive, which has been officially adopted into Vietnamese law.

There are four main components of a complete and valid PIF:

1. Administrative Documents and Product Summary

• General product description: Overview of the cosmetic product’s type, presentation, and intended use.

• Product name and function: Clearly stated product name and its cosmetic function (e.g., whitening cream, moisturizing lotion).

• Manufacturer and distributor information: Legal names, addresses, and business registration details of both the manufacturer and the responsible distributor in Vietnam.

• Responsible safety assessor: Identification of the qualified professional (e.g., toxicologist, pharmacist) who is accountable for the product’s safety evaluation.

2. Raw Material Quality Data

• Full INCI ingredient list: A complete listing of all raw materials with International Nomenclature of Cosmetic Ingredients (INCI) names.

• Safety and technical data sheets: Technical specifications, potential hazards, and concentration limits for each ingredient.

• Certificates of Analysis (CoAs): Documents verifying the identity, purity, and compliance of each ingredient with safety standards.

3. Finished Product Quality Data

• Manufacturing process documentation: A detailed description of the production method, including Good Manufacturing Practice (GMP) standards.

• Stability and quality control test results: Reports on stability under various conditions, shelf-life validation, and physical-chemical consistency.

• Microbiological and contamination testing: Data showing the product is free from harmful microorganisms and complies with local microbial limits.

4. Safety and Efficacy Evaluation

• Toxicological safety assessment: A professional review of the product’s safety profile based on ingredient risks and exposure levels.

• Dermatological or clinical test results: Any available studies proving the product does not cause adverse effects and is suitable for human use.

• Supporting evidence for product claims: Scientific or clinical data validating claims such as “anti-aging,” “whitening,” or “for sensitive skin.”

Having all these components in your PIF ensures your cosmetic product is safe, effective, and fully compliant with Vietnam’s cosmetic laws.

4. Legal Basis for PIF Requirements

The legal foundation for the Product Information File requirement in Vietnam is based on the following two primary documents:

Circular No. 06/2011/TT-BYT

• Issued by the Vietnam Ministry of Health, this circular governs the management of cosmetic products in line with the ASEAN Cosmetic Directive.

• It mandates that every cosmetic product on the market must be supported by a complete and accessible Product Information File (PIF).

Decree No. 117/2020/NĐ-CP

• This regulation establishes administrative penalties for non-compliance in the health sector.

• Businesses that fail to provide a valid and up-to-date PIF may face:

  • Product seizures

  • Fines

  • Suspension of operations

  • Legal liability for unsafe or misleading products

Under these laws, all information in the PIF must be:

• Accurate

• Up-to-date

• Available for inspection within 72 hours of official request

Staying compliant is not only a matter of regulation—it’s essential for maintaining market access and protecting your brand in Vietnam’s growing cosmetics industry.

5. Who Needs to Prepare and Keep the PIF?

In Vietnam, the legal responsibility for preparing and maintaining a Product Information File (PIF) falls on the entity that is responsible for placing the product on the market. This includes:

1. Local Distributors and Importers

• Every cosmetic product imported into Vietnam must have a corresponding PIF prepared and kept by the local distributor or importer who submitted the Cosmetic Product Notification (CPN).

• This entity must ensure that the PIF complies with current Vietnam cosmetic regulations.

2. Domestic Cosmetic Manufacturers

• Vietnamese companies that manufacture cosmetic products for the local market are fully responsible for creating and updating the PIF for each product.

3. Foreign Cosmetic Brands (via Representatives or Holders)

• Foreign companies must collaborate with their authorized representative or Cosmetic Notification Holder in Vietnam to ensure that the PIF is prepared and stored locally.

• The foreign brand must provide all relevant documents needed for PIF compliance.

4. Storage and Access Requirements

• The PIF can be stored physically or electronically at the main office of the responsible business entity in Vietnam.

• It must be made readily available to the Department of Health or relevant regulatory authorities within 72 hours upon request.

6. Frequently Asked Questions about Product Information File for Cosmetics in Vietnam

What is a Product Information File for Cosmetics in Vietnam?

A Product Information File (PIF) for cosmetics in Vietnam is a comprehensive dossier containing detailed information about a cosmetic product, including its ingredients, manufacturing process, safety assessments, and compliance documents, required by the Ministry of Health.

Why is the PIF important for cosmetics in Vietnam?

The PIF ensures that cosmetic products meet safety and quality standards before they are marketed in Vietnam. It helps regulatory authorities verify compliance and protects consumers.

What are the key components of a PIF for Cosmetics in Vietnam?

The main components include product description, ingredient list, manufacturing details, safety assessments, labeling information, and proof of compliance with Vietnamese regulations.

How do I prepare a Product Information File for Cosmetics in Vietnam?

Preparing a PIF involves collecting all required documentation, ensuring data accuracy, and submitting the file to the relevant regulatory bodies as per Vietnam’s cosmetic laws.

What are common challenges in compiling it in Vietnam?

Challenges may include gathering complete documentation, understanding local regulatory requirements, and ensuring proper translation and formatting according to Vietnamese standards.

7. How We Can Help

Creating a fully compliant Product Information File (PIF) in Vietnam can be time-consuming and technically challenging—especially if you manage multiple cosmetic SKUs, imported brands, or private label products. That’s where Green NRJ comes in.

We offer comprehensive PIF services for cosmetic businesses looking to enter or operate in the Vietnamese market, ensuring full compliance with the ASEAN Cosmetic Directive and Vietnamese cosmetic regulations.

Our PIF Services Include:

• Full PIF creation and review services
• Consultation on safety and compliance
• Support in document collection, testing, and technical writing
• Assistance in dealing with regulatory inspections

We ensure your product meets all PIF requirements and stays compliant — so you can focus on building your brand and gaining customer trust.

📞 Need help creating a compliant PIF for your cosmetics?
Contact us today and let our experts handle the paperwork while you grow your brand with confidence!

Related Articles

• • Comprehensive Guide to Cosmetic Registration in Vietnam
  • How to Import and Sell Cosmetics in Vietnam
  • Should You Establish a Company or Use a Cosmetic Notification Holder in Vietnam?