Cosmetic Notification Registration Process in Vietnam

Cosmetic products in Vietnam are subject to a pre-market notification regime — not a marketing authorisation. The instrument is the 化粧品届出書 (Phiếu công bố sản phẩm mỹ phẩm), and the number it carries (Số tiếp nhận Phiếu công bố) is what allows the product to be sold, advertised, or imported. Vietnam is one of ten ASEAN member states implementing the ASEAN Cosmetic Directive (ACD, 2003); Vietnamese cosmetic regulation is therefore harmonised — but not identical — to the regimes in Singapore, Thailand, Malaysia, Indonesia, and the Philippines.

A pre-existing topical overview at /cosmetic/product-notification/ describes what the notification is, who must file, what number is issued, and what validity it carries. This page is the operational companion: it walks the workflow step by step, with dossier contents, agency timelines, the mechanics of the National Single Window (VNSW), the PIF audit-readiness drill, and the practical pitfalls that account for most rejection rounds.

Scope of this page:

• Who can file and which authority receives the dossier (imported → DAV; domestic → provincial Sở Y tế).
• The full step-by-step process from substance-screening through completeness review to issuance of the number.
• Statutory 3-working-day window vs the real-world experience in 2024–2026, including the DAV question-cure cycle.
• PIF preparation under the ASEAN PIF Guidelines (four parts: administrative, quality, safety, efficacy) and the 72-hour rule for inspector access.
• Post-notification: renewal at the 5-year mark, change-of-formula triggers, change-of-responsible-company triggers, and the DAV substance-update channel.
• Practical pitfalls: claim language, Annex II substances, safety-assessor signature, missing PIF audit trail, and cross-border e-commerce enforcement.

How to read this page: The overview below sets the operational frame. "Key documents" lists the legal stack and ASEAN annexes in consultation order. "Recent updates" tracks the substance-control changes DAV has transposed via official letters and the enforcement posture on cross-border platforms. "Resources & links" gives the portals used for filing and lookup. The FAQ answers the most common sponsor questions.

Validity, renewal, and lifecycle:

• A notification number is valid for 5 years from the date of issue. Renewal is a fresh filing — there is no abbreviated renewal procedure under Circular 06/2011.
• Substantive changes (formula change, brand-name change, manufacturer change, responsible-company change) trigger a re-notification. Minor changes (e.g., packaging colour) typically do not.
• Validity is product-by-product. One notification → one number → one 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.
• The responsible company bears legal liability for safety; the PIF must be available within 72 hours of an inspector request.

Cosmetic-specific framework:

• Circular 06/2011/TT-BYT — the "ACD Circular"; transposes the ASEAN Cosmetic Directive into Vietnamese law. Chapters cover notification procedure, label content, ingredient annexes, and post-market obligations. Effective from 1 April 2011 and still the operative instrument for cosmetic regulation in Vietnam.
• ASEAN Cosmetic Directive (ACD, 2003) — the regional harmonisation instrument. Annexes I (banned), II (restricted), III (permitted colourants), IV (permitted preservatives), VI (permitted UV filters) are transposed into Vietnamese law via Circular 06/2011 and updated through DAV official letters (công văn) following ASEAN Cosmetic Scientific Body (ACSB) decisions.
• ASEAN PIF Guidelines — define the structure and content of the Product Information File the responsible company must maintain; the four-part structure (administrative, quality, safety, efficacy) is the operative reference for inspector requests.

General goods labelling:

• Decree 43/2017/NĐ-CP — labelling of goods, general framework; mandatory Vietnamese language; required commercial information.
• Decree 111/2021/NĐ-CP — amends Decree 43 on labelling.

Online filing and single-window:

• Decision 15/2017/QĐ-TTg — implements the National Single Window (VNSW); since 2017 the channel for cosmetic notification of imported goods. DAV connection is part of the second-wave VNSW expansion.
• Decree 85/2019/NĐ-CP — administrative procedures relating to imports through the National Single Window.

Advertising and enforcement:

• Law on Advertising No. 16/2012/QH13 — general framework for advertising; Article 7 lists prohibited claim categories relevant to cosmetics (medicinal claims).
• Decree 38/2021/NĐ-CP — administrative penalties for advertising and labelling violations; foundation for the joint-liability theory now applied to cross-border e-commerce platforms.

Substance-specific transpositions (selection — see DAV website for the current list):

• DAV official letters transposing ASEAN Cosmetic Committee (ACC) decisions: MI / MCI ban in leave-on products, isopropyl- and isobutylparaben ban, Lilial (Butylphenyl methylpropional) ban, Hydroxyethoxyphenyl Butanone (HEPB) permitted as preservative under Annex IV. The full list is maintained on the DAV website.

Note on numbering: Circular, Decree, and Decision numbers and effective dates should be verified against the DAV portal or the Official Gazette (Công báo) before relying on them for a notification.

This section walks through the cosmetic-notification workflow end-to-end, then surveys the substance-update channel and the enforcement posture against cross-border platforms.

1) Choosing the right authority and channel:

• Imported cosmetics — filed at DAV via the National Single Window (vnsw.gov.vn). The responsible company must be a Vietnamese legal entity; foreign brand owners must work through a Vietnamese distributor or set up a Vietnamese legal entity authorised to hold the notification.
• Domestically manufactured cosmetics — filed at the provincial Sở Y tế where the manufacturer is located. Many DOHs (notably Hà Nội and HCMC) operate online portals; smaller provinces still accept paper-and-disc submissions.

2) Step-by-step process — imported cosmetic via VNSW:

• Step 0 — Pre-submission. Confirm the brand is identified consistently across the certificate of free sale (CFS), the manufacturer GMP / ISO 22716 documentation, the formula breakdown, and the proposed Vietnamese-language label. Confirm that no Annex II substance is used without the required restriction conditions, and that no Annex I substance is present at any level. Run a claim-substantiation check against the ASEAN Cosmetic Claim Guidelines — medicinal claims (anti-acne, whitening with bleach, anti-aging beyond superficial appearance) drift into pharmaceutical territory and will be rejected.
• Step 1 — Online submission via the National Single Window (vnsw.gov.vn). The dossier is filed against the DAV process code; the system mirrors the application status across the DAV dossier-tracking interface.
• Step 2 — Mandatory dossier contents: (i) the Phiếu công bố form, signed by the responsible company's legal representative; (ii) a Letter of Authorisation (LoA) from the brand owner to the Vietnamese responsible company, consularised when the issuing country is not an Apostille party recognised by Vietnam; (iii) Certificate of Free Sale (CFS) from the country of origin, consularised under the same rule; (iv) the full formula breakdown showing each ingredient with its INCI name and percentage range; (v) the proposed Vietnamese-language label; (vi) the business registration of the responsible company.
• Step 3 — Completeness review by DAV. Statutory 3 working days; if no objection is raised, the number is issued.
• Step 4 — Substantive review (where triggered). If the completeness reviewer flags substance, labelling, or claim issues, a question round is issued; the applicant cures within the period in the request. Two rounds is typical; three signals risk of refusal.
• Step 5 — Number issuance. Format: NN/YY/CBMP-QLD where NN is the sequence and YY the year. The number is published on the DAV register.
• Step 6 — Build and lodge the PIF. The Product Information File must be ready before circulation begins, not after — inspectors can request it from the moment the product is on the market.

3) Step-by-step process — domestically manufactured cosmetic via provincial DOH:

• Substantively the same dossier, except (i) no CFS or LoA is required (the manufacturer is the responsible company by default), and (ii) the manufacturer must hold a current Cosmetic GMP certificate (CGMP — ISO 22716 or ASEAN Cosmetic GMP equivalent) issued by DAV.
• Number format: NN/YY/CBMP-{province code}. Provincial DOHs publish the issued numbers on their own portals.

4) Statutory timelines vs reality (the practice gap):

• On paper (Circular 06/2011): 3 working days for the completeness window; the number is issued by silence if no objection is raised.
• In practice: imported cosmetics filed cleanly at DAV often do receive the number within the statutory window, but dossiers that draw a question round routinely take 30–90 days end-to-end. Domestic dossiers at provincial DOHs fluctuate more — Hà Nội and HCMC are the fastest; some smaller provinces drift to 45+ days.

5) The PIF — what must be ready before the product moves:

• Part I — Administrative: identity of the responsible company, brand owner, manufacturer; LoA; CFS; copy of the notification.
• Part II — Quality: manufacturing-process description, in-process and finished-product specifications, stability data, GMP documentation, packaging-component specifications.
• Part III — Safety: Cosmetic Product Safety Report under the ASEAN safety assessment scheme — signed by a qualified safety assessor (toxicologist, pharmacist, or equivalent professional); ingredient toxicological profiles; exposure assessment; safety conclusion.
• Part IV — Efficacy: substantiation for each claim that appears on the label, in advertising, or on the product's website.
• 72-hour rule: when DAV or a provincial Sở Y tế requests the PIF, the responsible company has 72 hours to produce the relevant part.

6) Substance-update channel — how DAV transposes ACSB and ACC decisions:

• The ASEAN Cosmetic Scientific Body (ACSB) and the ASEAN Cosmetic Committee (ACC) meet biannually. Decisions to amend the ACD annexes (ban a substance, restrict its use, add a permitted UV filter) flow into Vietnamese law via DAV official letters (công văn) rather than through new circulars.
• Recent transpositions: MI / MCI prohibition in leave-on products; isopropylparaben and isobutylparaben prohibition; Lilial (Butylphenyl methylpropional) prohibition; HEPB permitted as preservative.
• Practical impact: a product notified under the old substance regime becomes non-compliant on the effective date of the transposing official letter. Reformulation and re-notification become mandatory; continued sale exposes the product to recall.

7) Enforcement posture — cross-border e-commerce and therapeutic-claim drift:

• DAV has issued an increasing number of public market-surveillance warnings against cross-border platform listings of cosmetics making therapeutic claims — particularly skin-whitening, anti-acne, and anti-aging products that cross into pharmacological territory and that lack a notification.
• Cross-border platforms (Shopee Global, Lazada Cross-Border, TikTok Shop international) are now operationally responsible for verifying seller documents and removing non-compliant listings; joint liability flows from Decree 38/2021/NĐ-CP.
• Common failed-notification triggers in 2024–2026: incomplete PIF documentation, ingredient declarations that inadvertently include Annex II substances, missing safety-assessor signature, claims that breach the ACD claim guidelines, and brand-name overlap with registered drug products.

8) Practical pitfalls (where most rejection cycles come from):

• Claim language: "anti-aging" is fine in the cosmetic sense; "anti-wrinkle treatment" or "regenerates skin cells" drifts into therapeutic territory. The ACD Claim Guidelines are the binding reference; rephrase before submission, not after rejection.
• Annex II substances without restriction conditions: most common with preservatives near their maximum limits and with UV filters used outside their permitted concentration envelope. Cross-check the current Annex IV / VI before finalising the formula.
• Safety-assessor signature: the Cosmetic Product Safety Report must be signed by an individual with documented qualifications. A QC manager or regulatory affairs officer without toxicology background does not qualify.
• Brand-name overlap: a brand name that overlaps with a registered drug or medical device (or implies a therapeutic use) will draw a substantive question. Check the DAV register before locking the brand for Vietnam.
• PIF audit-readiness: the responsible company must hold the PIF; "the brand owner has it overseas" is not an acceptable answer to a Sở Y tế or DAV inspector.
• Number-format errors: imported cosmetics receive NN/YY/CBMP-QLD (DAV); domestic receive NN/YY/CBMP-{province code}. Listings on retail or e-commerce that show the wrong format format expose the seller to enforcement attention.