Vietnam Plans for Substantial Revision of Cosmetics Overarching Regulation

Chapter II

Responsibilities of organizations and individuals responsible for the marketing, production, importation, and trade of cosmetics as well as consumer rights

Chapter III

Classification of cosmetic products and declaration of cosmetic features

Chapter IV

Notification

Chapter V

Product safety and ingredient use requirements

Chapter VI

Product information files (PIF)

Chapter VII

Advertising and labeling

Chapter VIII

Production

Chapter IX

Import and export

Chapter X

E-commerce activities

Chapter XI

Sampling inspection

Chapter XII

State management of cosmetics

Chapter XIII

Post-market inspection, testing and monitoring

Chapter XIV

Information and reporting regime

Chapter XV

Implementation effect

Cosmetic notification

Enhancing the regulations on cosmetics notification to ensure that the assessment of cosmetic features and functions aligns with international practices and Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS)

1. Introducing more detailed instructions on classifying and declaring cosmetic features

2. Enhancing the regulations on cosmetic notification documents

• For imported cosmetics, mandating the submission of a GMP Certificate and clearly requiring for the issuing institution of Certificate of Free Sale (CFS);

• For borderline products, requiring additional documents such as product labels and/or partial or complete documentation in the PIF;

• Reducing the validity period of cosmetic notification to align with the typical life cycle of most cosmetic products and international practices;

• Extending the processing time for document review to ensure practicality, and enabling thorough examination of notification information.

Post-market surveillance

Enhancing the post-inspection activities for cosmetic management and facilitating the information technology utilization in state cosmetics management. Streamlining and simplifying administrative procedures to create a favorable business environment while safeguarding consumer rights

1. Establishing a national cosmetics database through the implementation of a comprehensive information system for cosmetics management and traceability

Legalizing the comprehensive information system for managing and tracing the origin of cosmetics, ensuring the receipt and review of cosmetic notification dossiers, and ensuring other handling procedures in a unified manner nationwide. This will establish a national database for product management and enhance the quality control of cosmetics through online cosmetic recalls.

2. Simplifying the regulations on cosmetic advertising

Abolition of advertising registration process

3. Regarding responsibilities of   organizations and individuals responsible for marketing products

• Introducing specific regulations concerning the legal liability of notifiers in cases of fraudulent notifications, falsification of documents and seals, and intervention with legal documents. Establishing protocols for handling violations in such instances;

• Fostering collaboration with production facilities and relevant authorities both domestically and internationally to authenticate the legal documents and power of attorney included in the notification dossiers.

4. Strengthening the role and authority of state management agencies in cosmetic management, as well as enhancing the capabilities and status of cosmetic testing agencies

• Establishing regulations for the overseeing of cosmetic management by state management agencies to conduct post-inspections and collect cosmetic testing samples at cosmetic business establishments. Defining the legal provisions for coordination with other functional units in inspecting cosmetic businesses, particularly those not directly under the jurisdiction of MoH;

• Specifying the timeframe requirements for production facilities or notifiers to provide all quality standards and testing methods of the product to the testing system upon the notification receipt.

5. Enhancing the regulations concerning online cosmetic businesses, and provisions for tracing, inspecting, and verifying the source and origin of products when necessary

• Enhancing the regulations for online cosmetic businesses;

• Establishing a cosmetic identification code by restructuring the notification number, enabling the determination of cosmetics' origin, classification, and the responsibilities of businesses responsible for marketing products. The outer packaging should be labeled with a barcode, QR code, or DataMatrix Code (DMC) for management, identification, and traceability;

• Including the manufacturer's name and address on the label, in addition to the country of manufacture.

Enhancing the quality of Vietnamese domestically-produced cosmetics through the application of CGMP-ASEAN and the implementation roadmap

Ensuring consistency in assessing the production eligibility of Vietnamese domestic production facilities during self-inspection by production facilities and assessment by management agencies

• Establishing specific production requirements for cosmetics, including criteria and evaluation processes encompassing personnel, infrastructure, and quality management systems. Developing a checklist for regulatory agencies and businesses to conduct self-assessments;

• Clearly outlining the specific criteria that businesses must adhere to for their quality management systems. Non-compliance with these criteria may lead to the revocation of the production certification, which can be reinstated upon the pass of inspections and the fulfillment of the necessary conditions;

• Providing the procedures for granting certification of production compliance in cases where facilities undergo rearrangement or factory redesign;

• Implementing periodic re-evaluation for establishments that have obtained production certification, replacing the current practice of permanent certification.