Cosmetics

CGMP-ASEAN Certification for Cosmetic Manufacturing Facilities: Process and Key Requirements

As Vietnam’s cosmetic industry integrates more deeply into regional and global markets, compliance with manufacturing principles and standards is a prerequisite for sustainable growth. One of the most important benchmarks is CGMP-ASEAN (Cosmetic Good Manufacturing Practices – ASEAN), a set of principles and standards on Good Manufacturing Practices for cosmetics, established and recognized by ASEAN member countries.

To demonstrate production capacity and ensure product quality, cosmetic manufacturers must obtain a Certificate of Compliance with CGMP-ASEAN standards. So, what is the procedure, what documents are required, and what conditions must enterprises meet?

1. Legal Basis

The issuance of CGMP-ASEAN certificates is regulated under:

  • Decree No. 155/2018/ND-CP: detailing certain provisions and measures for implementing the Law on Food Safety and the Law on Pharmacy related to cosmetics.

  • Circular No. 06/2011/TT-BYT: on cosmetic management.

  • Circular No. 277/2016/TT-BTC: on fees in the pharmaceutical and cosmetic sector.

2. Overview of CGMP-ASEAN

CGMP-ASEAN ensures that cosmetics are produced under hygienic, safe, and well-controlled conditions throughout raw material handling, production, and final product stages. Certification not only strengthens domestic credibility but also facilitates access to ASEAN and global markets.

Enterprises must undergo rigorous assessment by the Drug Administration of Vietnam – Ministry of Health to obtain certification.

3. Procedure for Obtaining CGMP-ASEAN Certification

Step 1: Application submission

The manufacturer submits a complete dossier to the Drug Administration of Vietnam.

Step 2: Receipt of application

Within 1 working day, the authority acknowledges receipt, assigns a reference number, and requires the enterprise to pay the appraisal fee.

Step 3: Appraisal and inspection planning

The authority reviews the dossier, issues a decision to establish an inspection team, and notifies the facility at least 10 days in advance.

Step 4: On-site inspection

    • Conducted by the inspection team appointed by the Drug Administration.

    • Full operations are reviewed against CGMP-ASEAN standards.
  • An inspection report is prepared in 3 copies, signed by the team leader and facility representative, clearly outlining findings and corrective actions.

Step 5: Inspection results

  • If fully compliant: the facility is granted a CGMP-ASEAN certificate valid for 3 years.
  • If minor deficiencies exist but do not affect product quality: the facility must correct them within 2 months and submit a report. Once approved, certification is granted.
  • If not compliant: the facility must undertake corrective actions, conduct self-assessment, and reapply.

Step 6: Issuance of certificate

Within 30 days of satisfactory inspection results, the Head of the Drug Administration issues the CGMP-ASEAN certificate.

4. Required Application Documents

  • Application form for CGMP inspection.

  • Copy of Business Registration Certificate or Investment License.

  • Organizational structure and staffing chart.

  • Factory layout and design diagrams (including material and personnel flow, waste treatment systems).

  • List of equipment.

  • Internal audit report on compliance with CGMP-ASEAN.

5. Conditions for Certification

  • The facility must be legally established with a valid business registration.

  • The factory must fully comply with CGMP-ASEAN principles and standards or equivalent standards recognized by the ASEAN Cosmetic Committee.

6. Significance of CGMP-ASEAN Certification

CGMP-ASEAN certification is not only a legal requirement for cosmetic manufacturing in Vietnam but also a competitive advantage for businesses expanding into regional and global markets. Compliance helps enterprises to:

    • Strengthen brand reputation.

    • Ensure product safety and quality.

    • Facilitate cooperation with foreign partners and distributors.
  • Enhance the image of Vietnamese cosmetics internationally.

In today’s globalized market, achieving CGMP-ASEAN certification is both a regulatory obligation and a strategic “passport” for Vietnamese cosmetic products to affirm their position regionally and internationally. Enterprises should prepare comprehensive documentation, implement strict compliance from facility design to production, and actively cooperate during inspections to ensure smooth approval and long-term success.

For consultation on medical device registration, functional foods, cosmetics, and dietary supplements in compliance with current regulations, please contact us at Hotline: 098.546.1894.