Cosmetics

Draft Decree on the Management of Cosmetics; (78 page(s), in Vietnamese)

1. This draft Decree regulates the management of cosmetics, including:

a) Manufacture of cosmetics in Vietnam;

b) Cosmetic product notification;

c) Management of imported cosmetic products and issuance of Certificates of Free Sale for exported cosmetic products;

d) Product Information Files (PIF), labeling and advertising of cosmetics;

e) Inspection, surveillance and ensuring the safety and quality of cosmetic products;

g) Recall of cosmetic products, revocation of the registration number of the cosmetic product declaration form, and cessation of receiving applications for cosmetic product declarations.

2. This draft Decree applies to domestic and foreign agencies, organizations, and individuals involved in activities related to cosmetic products in Vietnam, including: Manufacturing, distribution, trading, advertising, quality control, and services related to the supply and use of cosmetic products.

3. This Draft Decree consists of 09 Chapters and 49 Articles, specifically:

1. Chapter I – General Provisions consists of 04 Articles providing for:

Scope of regulation and subjects of application; Interpretation of terms; Principles for management of cosmetic product quality and safety; Implementation of administrative procedures and data management in the electronic environment.

2. Chapter II – Cosmetic Manufacturing in Vietnam consists of 08 Articles providing for:

- Cosmetic manufacturing establishments must satisfy requirements relating to personnel, facilities, equipment and quality management systems, and shall undergo periodic assessments every three years or extraordinary assessments where necessary.

- Consolidation of the conditions for issuance of the Certificate of Eligibility for Cosmetic Manufacturing and the CGMP Certificate into a single set of conditions.

- Full decentralization to provincial-level People's Committees for the issuance, amendment and revocation of Certificates of Eligibility for Cosmetic Manufacturing and CGMP Certificates.

- Specific provisions on cases of revocation of Certificates of Eligibility for Cosmetic Manufacturing.

3. Chapter III – Cosmetic Product Notification consists of 08 Articles providing for:

- Cosmetic products must be notified to the competent state authority before being placed on the market.

- Provisions on dossiers and procedures for cosmetic product notification and post-notification amendments.

- Following notification and disclosure of cosmetic product information, competent state authorities shall conduct post-notification dossier reviews and inspection and surveillance of cosmetic products circulating on the Vietnamese market.

4. Chapter IV – Management of Imported Cosmetic Products and Issuance of Certificates of Free Sale for Exported Cosmetic Products consists of 02 Articles providing for:

Imported cosmetic products must be notified prior to customs clearance, except for cases exempted from notification, such as imports for research or testing purposes, imports by diplomatic missions, or personal gifts not intended for commercial purposes...; Issuance of Certificates of Free Sale (CFS) for domestically manufactured cosmetic products intended for export.

5. Chapter V – Product Information File (PIF), Advertising and Labeling of Cosmetic Products consists of 04 Articles providing for:

- Cosmetic products circulated on the market must have a Product Information File (PIF) in accordance with ASEAN guidelines.

- Requirements for Safety Assessment Reports within the PIF in accordance with ASEAN guidelines.

- Labeling of cosmetic products shall comply with the laws on goods labeling, while mandatory labeling contents shall comply with the ASEAN Cosmetic Directive.

- Advertising of cosmetic products shall comply with the laws on advertising and shall not require prior content approval.

6. Chapter VI – Inspection, Surveillance and Assurance of Cosmetic Product Safety and Quality consists of 08 Articles providing for:

- Classification of risk levels according to cosmetic product categories; inspection and surveillance of the quality and safety of cosmetic products circulated on the market.

- Detailed provisions on post-notification dossier review and remote inspection of documents extracted from the PIF.

- Detailed provisions on specialized inspections at establishments. Contents already found compliant through remote inspections shall not be re-inspected, except where there are signs of violations or where verification of original documents and actual conditions at the establishment is necessary.

- Specific forms and contents of quality inspection and quality surveillance.

- Provisions on the adverse event reporting system for cosmetic products.

7. Chapter VII – Recall of Cosmetic Products, Withdrawal of Notification Numbers and Suspension of Acceptance of Notification Dossiers consists of 05 Articles providing for:

- Cases in which cosmetic products are subject to recall; cases of withdrawal of cosmetic product notification numbers and suspension of acceptance of cosmetic product notification dossiers.

- Forms, competence and responsibilities for cosmetic product recall.

8. Chapter VIII – Organization of Implementation consists of 06 Articles providing for:

Responsibilities of ministries, sectors, organizations and individuals involved in the manufacture and trading of cosmetic products.

9. Chapter IX – Implementation Provisions consists of 04 Articles providing for:

Implementation roadmap, transitional provisions, effective date, and responsibilities for implementation.