Health Supplement Registration Process in Vietnam

A health-supplement product cannot be lawfully sold, imported, or advertised in Vietnam until its product declaration is on file with the competent authority. There are two parallel filing tracks, and the right track depends on what kind of food the product is:

• Tự công bố sản phẩm (self-declaration) — used for regular processed foods, food additives, food-contact materials and similar. The business prepares the declaration itself and lodges it with the provincial Sở Y tế or Sở Công Thương; circulation may begin the same day.
• Đăng ký bản công bố sản phẩm (product declaration registration) — used for the higher-risk categories: thực phẩm bảo vệ sức khỏe (TPBVSK — health-protection foods, the legal name for what the market commonly calls "dietary supplements"), thực phẩm dinh dưỡng y học (medical-purpose nutrition foods), thực phẩm dùng cho chế độ ăn đặc biệt (special-purpose dietary foods), and foods for infants and children under 36 months. These products require pre-market review and a written acceptance certificate (Giấy tiếp nhận đăng ký bản công bố sản phẩm) before sale.

This page focuses on the second track — the registration process for TPBVSK and similar pre-market-controlled food classes — because that is where most "dietary supplement" products on the Vietnamese market fall.

Scope of this page:

• What đăng ký bản công bố sản phẩm is, who is competent to issue the acceptance certificate, and which product categories it covers.
• The full step-by-step VFA process, from pre-submission manufacturer qualification through dossier acceptance, expert evaluation, and certificate issuance.
• Statutory timelines (7 working days for medical-purpose foods and infant foods, 21 working days for TPBVSK and special-diet foods) versus the much longer real-world experience under Decree 15/2018, and the redesigned regime under Decree 46/2026.
• The practical pitfalls that account for most rejection rounds: CFS legalisation, claim substantiation, GMP-for-TPBVSK certification, Vietnamese-language labelling, and the new HACCP/GMP system audit requirement that becomes operational by 31 December 2026.

How to read this page: The overview below frames the system. "Key documents" is the authoritative legal stack — consult it in the listed order. "Recent updates" focuses on the 2026 reform package, the customs-clearance crisis of late January 2026, the bridge period under Resolution 09/2026/NQ-CP, and what changed when Decree 46 resumed on 15 April 2026. "Resources & links" gives the operational portals applicants actually use. The FAQ closes the most frequent buyer/sponsor questions.

Authority — who decides:

• Cục An toàn thực phẩm (Vietnam Food Administration — VFA), under the Ministry of Health, is the issuing authority for TPBVSK, medical-nutrition foods, special-diet foods, and infant foods nationwide. From 15 April 2026 under Decree 46, packaging and food-contact materials also fall to MOH/VFA.
• Provincial Sở Y tế / Sở Công Thương / Sở Nông nghiệp & Môi trường issue acceptance certificates for products inside the narrower self-declaration perimeter.
• From 1 July 2026 (Resolution 21/2026/NQ-CP), advertising-content verification certificates for TPBVSK move from central VFA to provincial UBND — a decentralisation distinct from product registration itself.

Validity of an acceptance certificate:

• The Giấy tiếp nhận đăng ký bản công bố sản phẩm does not carry a fixed expiry date — it remains valid as long as the registered product, formula, manufacturing site, and labelling stay unchanged.
• Material changes — change of formula, change of manufacturing site, change of indication or claim, change of label format that alters the disclosures — trigger a fresh đăng ký bản công bố sản phẩm filing.
• Self-declarations made under Decree 15/2018 before 26 January 2026 remain valid for a transition window of 12 months from that date; after 26 January 2027 the new Decree 46 registration is the only lawful instrument for the affected product groups.

Food-safety law (Luật An toàn thực phẩm):

• Law on Food Safety No. 55/2010/QH12 — the foundational law on food safety; in force from 1 July 2011. Article 14 establishes the special controls applicable to functional foods including TPBVSK; Articles 38 and 39 govern the duty to declare products before circulation.

Implementing decrees (Nghị định) — currently in force:

• Decree 46/2026/NĐ-CP — signed 26 January 2026 to replace Decree 15/2018/NĐ-CP. Effective on the day of signing but immediately suspended by Resolution 09/2026/NQ-CP until 15 April 2026; in force as the operative implementing instrument from 15 April 2026. Eleven chapters, fifty-five articles, six headline reforms including the narrowed self-declaration perimeter, the conformity-declaration registration regime, mandatory HACCP/GMP for TPBVSK and additive manufacturers by 31 December 2026, and reorganised inter-ministerial responsibilities (MOH absorbs packaging and food-contact materials).
• Resolution 09/2026/NQ-CP — Government resolution dated 4 February 2026 suspending Decree 46 until 15 April 2026 and reinstating Decree 15/2018 plus its guidance for the bridge period. The practical reason the registration regime did not break in early 2026.
• Resolution 21/2026/NQ-CP — dated 29 April 2026; transfers the TPBVSK advertising-content verification authority from central VFA to provincial UBND with effect from 1 July 2026. Distinct from product registration but closely tied to compliance lifecycle.

Implementing decrees — historical context and transition:

• Decree 15/2018/NĐ-CP — operative from 2 February 2018 until 26 January 2026, when it was replaced by Decree 46. Self-declarations made under Decree 15 before 26 January 2026 remain valid for 12 months from that date; the actual cut-over date for the affected product groups is therefore 26 January 2027.
• Decree 155/2018/NĐ-CP — amends Decree 15 (under the old regime); cited in earlier acceptance certificates.

Functional-food specific guidance:

• Circular 43/2014/TT-BYT — management of functional foods, including definitions of dietary supplements, TPBVSK, medical-purpose foods, and infant nutrition foods. The substantive basis for the claim-evidence test in TPBVSK dossiers; still cited as the specialised functional-food regime under Decree 46.
• Circular 17/2023/TT-BYT — amends and supplements technical requirements for micronutrient fortification and use of vitamins/minerals in functional foods.

GMP, HACCP, and manufacturing-system standards:

• Decree 67/2016/NĐ-CP and amendments — conditions for food production and trading; basis for the "Cơ sở đủ điều kiện an toàn thực phẩm" certificate and for the special GMP-for-TPBVSK regime.
• Circular 18/2019/TT-BYT — Good Manufacturing Practice (GMP) requirements for TPBVSK manufacturers; the source of the "GMP-TPBVSK" certificate that must be referenced in the dossier for domestically-manufactured products.
• ISO 22000 / HACCP / GMP system certification — under Decree 46 Article 8 a manufacturing-system certificate must be operational by 31 December 2026 for TPBVSK and food-additive sites.

Labelling, claims, and advertising:

• Decree 43/2017/NĐ-CP — labelling of goods, general framework; mandatory Vietnamese language; required disclosures.
• Decree 111/2021/NĐ-CP — amends Decree 43 on labelling and adds specific TPBVSK rules.
• Decree 38/2021/NĐ-CP — administrative penalties for advertising violations, including the joint-liability theory applied to e-commerce platforms.

Note on numbering: Decree, Resolution, and Circular numbers and effective dates should be verified against the official publication on baochinhphu.vn, xaydungchinhsach.chinhphu.vn, or the Official Gazette (Công báo) before relying on them for a submission.

This section combines the official regulatory changes of 2026 with what they actually mean for sponsors and regulatory affairs teams placing TPBVSK products on the Vietnamese market. Read top-to-bottom for the chronological re-engineering of the registration regime.

1) Product categories and registration tracks (current state):

• Thực phẩm bảo vệ sức khỏe (TPBVSK — health-protection foods): the legal label for what most companies call a "dietary supplement". Always falls into đăng ký bản công bố sản phẩm. VFA-issued acceptance certificate is required before any commercial activity.
• Thực phẩm dinh dưỡng y học (medical-purpose nutrition foods): for patients with specific medical conditions, used under medical supervision. Đăng ký bản công bố sản phẩm at VFA; statutory 7 working days.
• Thực phẩm dùng cho chế độ ăn đặc biệt (special-purpose dietary foods): for athletes, weight management, lactose intolerance, etc. Đăng ký bản công bố sản phẩm; statutory 21 working days.
• Thực phẩm dinh dưỡng cho trẻ đến 36 tháng tuổi (foods for infants and children up to 36 months): Đăng ký bản công bố sản phẩm; statutory 7 working days.
• Other functional foods that do not satisfy the TPBVSK definition fall into the broader self-declaration perimeter, which Decree 46 has narrowed further; some products that used to be self-declared (processed packaged food, food additives, food-contact materials) now require đăng ký bản công bố hợp quy under Decree 46.

2) Step-by-step VFA process (đăng ký bản công bố sản phẩm for TPBVSK):

• Step 0 — Pre-submission. Confirm the manufacturer holds a current GMP-TPBVSK certificate (for domestic manufacturers under Circular 18/2019/TT-BYT) OR an equivalent GMP recognised by Vietnam (for imported products). Confirm the Vietnamese applicant is a legal entity authorised by the foreign manufacturer (Letter of Authorisation). Prepare a Certificate of Free Sale (CFS) from the country of origin; legalisation by the Vietnamese embassy in that country is required when the issuing country is not a Hague-Apostille party recognised by Vietnam.
• Step 1 — Online submission. The dossier is submitted via the national public-service portal (dichvucong.gov.vn) or the MOH portal (dichvucong.moh.gov.vn); the VFA dossier-tracking interface mirrors the application status.
• Step 2 — Mandatory dossier contents: (i) Bản công bố sản phẩm (the declaration form, per the Decree 15/2018 annex pending the equivalent Decree 46 form); (ii) test results from a designated laboratory covering the key physico-chemical and microbiological indicators set in the product specification, issued within the previous 12 months; (iii) scientific evidence supporting each claimed health effect — published clinical literature or in-house clinical study reports tied to the specific active substance and dose; (iv) CFS (or equivalent) for imported products, consularised where required; (v) GMP-TPBVSK certificate of the manufacturer (domestic) or equivalent GMP (imported); (vi) the proposed Vietnamese-language label; (vii) certificate of business registration for the applicant.
• Step 3 — Completeness review by VFA: confirms the dossier is formally complete. Failure here triggers a question round before the substantive evaluation starts.
• Step 4 — Substantive evaluation by VFA expert groups: claim substantiation, formula vs permitted-substance list, label review, manufacturing-site recognition.
• Step 5 — Question rounds (yêu cầu bổ sung). The applicant has 7 working days per round to respond (extended on request); two rounds is typical, three signals risk of refusal.
• Step 6 — VFA issues the Giấy tiếp nhận đăng ký bản công bố sản phẩm; the registration number is published on the VFA public register (congbosanpham.vfa.gov.vn) — the point at which the product appears on Medibase's VFA health-supplement search.
• Step 7 — Post-approval obligations: advertising-content verification certificate before any advertising (until 30 June 2026 from VFA, from 1 July 2026 from provincial UBND); periodic sampling and inspection; immediate re-registration upon material change.

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

• On paper (Decree 15/2018, carried through into Decree 46/2026): 7 working days for medical-purpose nutrition foods and foods for children under 36 months; 21 working days for TPBVSK and special-purpose dietary foods; the clock runs from formal acceptance of a complete dossier.
• In practice (2022–2025): real durations of 2–6 months for TPBVSK were common, driven by question rounds and a structurally understaffed evaluation function at VFA — even though the statutory pre-decision window was 21 working days, applicants frequently received the first round of questions only after the statutory window had already passed.
• Post-Decree-46 (from 15 April 2026): the statutory windows are unchanged, but the registration is now a stricter conformity-declaration registration with a real agency processing timeline and a central registry. The practical effect on TPBVSK timelines is still being measured — the first systematic data is expected in late 2026.

4) The Decree 46 customs-clearance crisis of late January 2026:

• Decree 46/2026/NĐ-CP took effect the day it was signed (26 January 2026), on the eve of Lunar New Year, with no transition period for goods already in transit.
• Within four to five days, more than 700 shipments and approximately 300,000 tonnes of food and agricultural product were stuck at land, sea, and air borders.
• On 4 February 2026, the Prime Minister issued a directive instructing eight ministries to "urgently remove difficulties" in inspecting food and import-export goods. The Government issued Resolution 09/2026/NQ-CP the same day, suspending Decree 46 until 15 April 2026 and reinstating Decree 15/2018 plus its guidance for the bridge period.
• Detained shipments began clearing customs on the evening of 5 February 2026.
• Decree 46 resumed on 16 April 2026. Companies should now operate on the assumption that the substantive design is permanent; only edge cases are being amended via technical circulars.

5) The 2026 reform package — what changed when Decree 46 resumed:

• Self-declaration perimeter narrowed: processed packaged food, food additives, processing aids, packaging materials and food-contact tools moved out of tự công bố and into đăng ký bản công bố hợp quy. Practical effect for TPBVSK businesses: the formula of a TPBVSK remains under đăng ký bản công bố sản phẩm, but packaging used for the product is now also under a registration regime — and is now centralised at MOH/VFA, not split between ministries.
• Mandatory HACCP / GMP / ISO 22000: TPBVSK and food-additive manufacturers must operate a HACCP, GMP, ISO 22000 or equivalent system no later than 31 December 2026. System-level certification of the manufacturing site is required — certifying only the product is no longer enough.
• Personnel criteria: new minimum-qualification rules for the quality officer and the food-safety officer of TPBVSK and food-additive manufacturers — turns TPBVSK manufacturing from a paperwork exercise into an operational-system audit.
• Inter-ministerial reorganisation: MOH/VFA now handles food additives, bottled water, TPBVSK, AND packaging materials. The package consolidates the new registration workflow into one ministry rather than splitting it.
• Advertising-content authority decentralisation: from 1 July 2026 (Resolution 21/2026/NQ-CP), the TPBVSK advertising-content verification certificate is issued by the provincial UBND rather than the central VFA. Existing VFA-issued certificates remain valid.
• Standardised mandatory warning: TPBVSK advertising must carry "Sản phẩm này không phải là thuốc và không có tác dụng thay thế thuốc" ("This product is not a medicine and does not substitute for medicine") in audio, image, or video form as the channel requires.
• Transition: products self-declared under Decree 15/2018 before 26 January 2026 may continue to circulate for 12 months. After 26 January 2027, only Decree 46 instruments are valid for the affected product groups.

6) Practical pitfalls (the questions that most rejection cycles come from):

• CFS / Free-Sale Certificate legalisation: imported TPBVSK requires a CFS from the country of origin, legalised by the Vietnamese embassy in that country. Missing or expired consularisation is the single most common Step 2 failure.
• Claim substantiation: every health claim in the label and the dossier must trace to dose-appropriate, ingredient-specific evidence. Generic references to ingredient-class literature ("the benefits of vitamin C") are rejected; the evidence must match the product's actual active substance and daily dose.
• GMP recognition: domestic manufacturers need GMP-TPBVSK certification under Circular 18/2019/TT-BYT; imported products need GMP recognised by Vietnam — and from 31 December 2026 also system-level HACCP / ISO 22000.
• Vietnamese-language labelling: mandatory under Decree 43/2017/NĐ-CP and the TPBVSK rules in Decree 111/2021/NĐ-CP; the label must include the mandatory "not a medicine" disclaimer for TPBVSK and must mirror the registered claims one-to-one.
• Local applicant required: a foreign manufacturer cannot file the dossier directly. A Vietnamese legal entity must be the declarant, backed by a Letter of Authorisation from the foreign manufacturer. A bare distribution agreement is not enough.
• Test laboratory eligibility: laboratory results must come from a lab designated by MOH or recognised under ISO/IEC 17025 in a scope accepted by VFA. Results from a non-recognised lab have no value at Step 2.
• Re-registration triggers: any material change (formula, manufacturer, claim, dose, or label format) requires a fresh đăng ký bản công bố sản phẩm — not a variation. Treating it as a variation is a common compliance failure.