Cosmetic Product Notification

Cosmetic products in Vietnam are subject to a **pre-market notification** regime — not a marketing authorisation. Circular 06/2011/TT-BYT (the "ACD Circular") transposes the ASEAN Cosmetic Directive (ACD, 2003) into national law, harmonising procedure, content, and substance controls with the other ASEAN member states. Before placing a cosmetic on the Vietnamese market, the **responsible company** (tổ chức/cá nhân chịu trách nhiệm đưa sản phẩm ra thị trường) — which must be a legal person established in Vietnam — files a notification form (Phiếu công bố sản phẩm mỹ phẩm) with the relevant authority: • **Imported cosmetics** — filed at the Drug Administration of Vietnam (DAV, Cục Quản lý Dược) at the Ministry of Health. • **Domestically manufactured cosmetics** — filed at the provincial Department of Health (Sở Y tế) where the manufacturer is located. Imports are submitted through the **National Single Window** (https://vnsw.gov.vn) since 2017; provincial DOHs have generally moved to their own online portals for domestic notifications. The statutory review window is **3 working days**; if no objection is raised, a notification receipt number is issued. A notification number is valid for **5 years** from issue. Renewal requires a fresh filing. Substantive changes — formula, brand name, manufacturer, or responsible company — require re-notification; minor changes (e.g., packaging colour) typically do not. The responsible company bears legal liability for product safety and must maintain a **Product Information File (PIF)** following the ASEAN PIF Guidelines (four parts: administrative, quality, safety, efficacy). The PIF must be available for inspection within 72 hours of an authority request. Notification of one product gives one number; one notification covers a single product identity (single brand + variant + shade family). Shade extensions within a colour cosmetics line can be grouped on a single notification under the ACD shade-extension rule.

Core framework: • Circular 06/2011/TT-BYT — issued 25 January 2011, effective 1 April 2011. The "ACD Circular": transposes the ASEAN Cosmetic Directive into national law. Defines cosmetics, notification procedure, content requirements, labelling, claims, GMP, advertising rules and inspection. • ASEAN Cosmetic Directive (ACD) — signed at the 35th AEM (ASEAN Economic Ministers) meeting, Phnom Penh, 2 September 2003. Provides the harmonised regulatory framework for cosmetics across ASEAN member states. • ASEAN Cosmetic Agreement on Mutual Recognition — recognition of GMP certification and notification across ASEAN. • ASEAN Guidelines for Cosmetic Good Manufacturing Practice (ACD Annex VIII / Schedule B). • ASEAN PIF Guidelines — four-part Product Information File required at the manufacturer or responsible company. Procedural and fee documents: • Circular 32/2019/TT-BYT — amended administrative procedures for cosmetic notification at DAV. • Decree 93/2016/NĐ-CP — conditions for cosmetic manufacturing establishments (cGMP-CSDT certification). • Circular 41/2023/TT-BTC (or successor) — fee schedule; cosmetic notification at DAV is currently 500,000 VND per product file. Penalty framework: • Decree 117/2020/NĐ-CP — administrative penalties in the health sector, including cosmetic violations (notification without number, banned substances, misleading claims). Amended by Decree 124/2021/NĐ-CP.

Online filing: • Notification of imported cosmetics has been mandatory through the National Single Window (vnsw.gov.vn) since the implementation of Decision 15/2017/QĐ-TTg. Provincial DOHs have followed at varying paces; HCMC and Hanoi DOH portals are fully online. Substance updates: • The ASEAN Cosmetic Scientific Body (ACSB) and ASEAN Cosmetic Committee (ACC) meet biannually. Banned and restricted substance updates are transposed by DAV via official letters (công văn) — recent transposed bans include MI/MCI in leave-on products, isopropyl- and isobutylparaben, and Lilial (Butylphenyl methylpropional), all following EU SCCS scientific opinions. Enforcement: • DAV has issued a growing number of public market-surveillance warnings (cảnh báo) against cross-border e-commerce listings of cosmetics with therapeutic claims, particularly skin-whitening, anti-acne, and anti-aging products that cross into pharmacological territory. • Failed notifications are commonly due to: incomplete PIF documentation, ingredient declarations that include Annex II substances, missing safety assessor signature, or claims that breach the ACD claim guidelines.