Tiếng Việt
In the cosmetics business, strict compliance with legal requirements not only ensures that enterprises can legally place products on the market, but also protects consumers’ rights and health. Every cosmetic product circulated in Vietnam must have a Product Information File (PIF). This is considered the product’s most comprehensive “curriculum vitae,” reflecting every aspect from origin, manufacturing process, and quality to safety and efficacy.
This article helps businesses clearly understand the concept of PIF, its detailed structure, and important considerations when compiling the dossier to ensure legal compliance and enhance market credibility.
1. What is a PIF and why is it mandatory?
A PIF (Product Information File) is a standardized dossier under ASEAN Cosmetic Directive guidelines, containing all information related to a cosmetic product. The file must be kept at the address of the organization or individual responsible for placing the product on the market and be readily available for inspection upon request by the competent authority.
Functions of a PIF:
- Demonstrates that the product meets legal requirements for quality and safety.
- Serves as a traceability tool during inspections and audits.
- Enhances transparency and business reputation in the eyes of partners and consumers.
2. Detailed content of a PIF as required by law
A PIF consists of four main parts:
Part 1 – Administrative documents and product summary
- Cosmetic product notification form (with valid acknowledgement number).
- Power of Attorney, Free Sale Certificate (CFS) for imported cosmetics, business license.
- Product label and leaflet (if applicable).
- ASEAN CGMP declaration, batch coding system.
- Safety assessment report (signed and certified by a qualified expert).
- Summary of adverse effects and supporting evidence of product claims.
Part 2 – Quality of raw materials
- Specifications and testing methods of raw materials.
- Information on fragrance (name, code, supplier, IFRA compliance).
- Safety data from suppliers or recognized scientific committees such as ACSB, SCCP, CIR.
Part 3 – Quality of finished product
- Full formulation: INCI names, percentage composition, and functions of each ingredient.
- Manufacturing information, packaging process, and quality management system.
- Product testing specifications, microbiological limits.
- Stability report (particularly required for products with a shelf life of less than 30 months).
Part 4 – Safety and efficacy
- Safety evaluation based on formulation and threshold levels (signed by a qualified safety assessor).
- Curriculum vitae and credentials of the safety assessor.
- Regularly updated reports on adverse reactions.
- Scientific evidence substantiating efficacy and claimed product benefits.
3. Submission and retention requirements for PIF
- Part 1: Must be submitted immediately upon request for inspection.
- Parts 2, 3, and 4: May be provided within 15–60 days as required by authorities.
- Retention: Minimum of 3 years from the date the last batch is placed on the market. During this period, the PIF must always be available for inspection and updated promptly when there are changes in formulation, raw materials, manufacturing process, or when new adverse event reports arise.
Key updates under the 2025 Consolidated Regulation:
- Receiving authority: Ministry of Health (Drug Administration of Vietnam) or provincial-level health authorities (replacing “Department of Health”).
- Processing time for product notification: 5 working days from receipt of a valid supplementary dossier.
- Validity of notification: 5 years; products must be re-notified upon expiry.
- Annual reporting: Enterprises must submit an annual report on cosmetic business activities to the Drug Administration of Vietnam by January 30.
4. Key notes when preparing a PIF
To ensure compliance and avoid legal risks, businesses should:
- Provide accurate, transparent information using INCI nomenclature.
- Ensure safety assessments are carried out by qualified experts with valid credentials and signatures.
- Regularly update the PIF, especially when there are changes in formulation, raw materials, or safety-related issues.
- Comply with ASEAN CGMP to demonstrate safe manufacturing practices.
- Keep the PIF readily available to avoid delays or penalties during inspections.
The Product Information File (PIF) is not merely an administrative requirement, but also serves as solid proof of product quality, transparency, and safety for both consumers and regulatory authorities. Establishing and maintaining a compliant PIF strengthens business credibility and provides a foundation for sustainable growth in the highly competitive cosmetics industry.
A carefully prepared PIF not only ensures legal compliance, but also represents the company’s clearest commitment to protecting consumer health and rights.