On September 10, 2026, the Ministry of Health of Vietnam released the Consolidated Document No. 18/VBHN-QD-BYT "Regarding the Implementation and Guidance on the Principles and Standards of ‘Good Manufacturing Practices for Cosmetic’ (CGMP-ASEAN) of the Association of Southeast Asian Nations, which will take effect on September 26, 2026.
This is a "consolidated document", which integrates Vietnam's Decision No. 24/2006/QD-BYT (on the implementation of CGMP-ASEAN at cosmetic manufacturing enterprises) with its subsequent amendments—mainly the repeals introduced by Circular No. 47/2025/TT-BYT—into a single, currently applicable text. CIRS Group has now summarized the main contents of the document as follows for your reference!
Overview of the Document and Key Information
Vietnam signed the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme on September 2, 2003. Under the arrangement of the Agreement, from January 1, 2008, all cosmetic manufacturing enterprises within the ASEAN member states are required to implement CGMP-ASEAN. On this basis, Vietnam issued Decision No. 24/2006/QD-BYT on August 14, 2006, designating the Drug Administration of Vietnam (DAV) to organize the implementation, conduct inspections, and issue CGMP compliance certificates.
Key Change: CGMP Certificates No Longer Subject to a Two-Year Validity Period
The consolidated document incorporates the amendments made by Circular No. 47/2025/TT-BYT (effective from February 15, 2026), deleting the provision in the original text that "the CGMP certificate is valid for two years from the date of signing." In other words, the CGMP certificate obtained by an enterprise no longer expires upon a two-year term for renewal—as long as the enterprise continues to maintain compliance with the CGMP-ASEAN standards, the certificate remains valid indefinitely.
It should be noted that an indefinitely valid certificate does not mean "once and for all": the periodic re-inspection every two years is retained, and DAV will continue to monitor enterprises' GMP compliance through periodic re-inspections (as well as necessary ad hoc inspections).
Inspection and Certification Process
Inspection and certification are centrally handled by DAV: receiving applications, reviewing dossiers, establishing inspection teams, conducting on-site inspections, and issuing certificates.
Key points of the process:
1. Dossier review: After receiving complete and compliant application dossiers, DAV makes the decision to establish an inspection team within 30 days; where the dossiers are incomplete, DAV notifies the enterprise in writing to supplement them.
2. On-site inspection: All activities are checked item by item against CGMP-ASEAN standards and applicable regulations; the enterprise must remain in normal operation during inspection. Minutes are made in triplicate (one for the enterprise, two for DAV), signed by both the enterprise's person in charge and the inspection team head; any reservations by the enterprise must be truthfully recorded.
3. Handling of results: DAV issues the CGMP certificate to fully compliant facilities. For basically compliant facilities (deficiencies not affecting product quality and correctable in a short time), the enterprise must complete corrective actions within two months of the inspection date and report to DAV; the certificate is issued after review. Non-compliant facilities must rectify the deficiencies, self-assess compliance, and re-apply under the initial inspection procedure.
4. Certificate issuance timeline: Within 30 days from the date on which the inspection results meet the requirements, the Director General of DAV signs the decision on the issuance of the certificate.
5. Fees: Enterprises must pay the inspection fees in accordance with the regulations of the Ministry of Health of Vietnam and other applicable laws and regulations.
Periodic Re-inspection: Once Every Two Years
Periodic CGMP re-inspections are conducted once every two years (except for ad hoc inspections requested by the enterprise or required by the Ministry of Health or DAV). The application dossier for re-inspection includes:
- The re-inspection application form (Form No. 02/CGMP-MP);
- A report on the changes of the enterprise in implementing GMP over the past two years;
- A report on the operations of the enterprise over the past two years;
- A report on the corrective actions taken on the deficiencies listed in the previous inspection;
- A summary report on the training of the enterprise over the past two years;
- The most recent self-inspection and assessment report (conducted within three months).
Implications and Recommendations for Cosmetic Enterprises
1. Enterprises with factories in Vietnam or entrusting production to Vietnamese factories: It is recommended to check the status of existing CGMP certificates and note that certificates no longer "lapse upon expiry"; however, the two-year periodic re-inspection rhythm remains unchanged, and day-to-day GMP management must not be relaxed.
2. Brands exporting to Vietnam or using Vietnamese contract manufacturers: If products are manufactured within Vietnam, confirm that the partner factory holds a valid CGMP certificate, and incorporate the two-year re-inspection milestones into supplier management.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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