HANOI — At the Ministry of Health’s headquarters, Associate Professor, Dr. Nguyen Tri Thức, Deputy Minister of Health, chaired a technical session with the drafting committee responsible for amending and supplementing the long-standing Circular No. 06/2011/TT-BYT on cosmetic management. The institutional forum focused heavily on evaluating the structural framework and core regulatory updates required to eliminate historical operational bottlenecks while ensuring structural synchronization with the new draft Decree on Cosmetic Management currently being finalized for government issuance.
The documented regulatory updates, specialized technical clauses, and strategic directives delivered by the Ministry’s leadership include:
-
The Strategic Necessity of the Regulatory Overhaul: Deputy Minister Nguyen Tri Thức emphasized that revising Circular No. 06/2011/TT-BYT is an essential statutory step, given that ASEAN technical annexes and regional guidelines have been continuously updated over recent years. The modern framework is engineered to guarantee compliance with regional criteria, reinforce state oversight, maximize corporate competitiveness, and streamline manufacturing, commercial, and import-export environments for domestic and international enterprises.
-
Core Amendment Modules Contained in the Draft: According to parameters disclosed by the drafting desk, the revised circular concentrates on key structural updates, featuring:
-
Filing Pipeline Configurations: Adjusting regulations tracking the processing of pre-market notification dossiers and incorporating concrete guidelines for post-market technical audits (post-clearance inspection) anchored in risk-management principles.
-
Allocation of Statutory Liability: Clarifying the explicit roles and corporate liabilities of notifying establishments alongside the competent state regulatory agencies operating inside Vietnam.
-
Power of Attorney Authorization (Article 6): Defining mandatory minimum components, legal validity boundaries, validation protocols, electronic data recognition, and the administrative handling of fluctuations in authorization profiles. If the authorizing entity is the product owner, the application must include manufacturing contracts/agreements secured with the factory or a formal written confirmation from the manufacturer.
-
Product Revocation Sanctions: Restructuring the protocols for product recalls and the cancellation of notification receipt numbers when chemical formulations deviate from filed data or contain substances appearing as technical impurities to preserve safety assessment benchmarks.
-
-
Inter-Agency Execution Timelines: The specialized drafting task force (commissioned under Decision No. 595/QD-BYT dated March 10, 2026) alongside present industry delegates recommended fast-tracking the drafting schedules and opening wide-scale public consultation windows. This rapid implementation aims to launch the supplemental Circular concurrently with the central government’s upcoming Decree on Cosmetic Management, which is set to permanently replace the legacy Decree No. 93/2016/ND-CP.
-
Executive Mandates Formulated by Leadership: In his closing remarks, Deputy Minister Nguyen Tri Thức instructed the Drug Administration of Vietnam to collaborate directly with the Department of Legal Affairs to meticulously verify the legal progression, ensuring total harmony with higher statutory laws and matching issuance dates. The standing secretariat is charged with standardizing vocabulary, definitions, and technical drafting methodologies to fully encompass modern cosmetic distribution and e-commerce models within the evolving market setting.