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Supplement & food companies

TPCN and food companies — NĐ 15/2018 framework (NĐ 46/2026 suspended by NQ 15/2026), declarations, HACCP, advertising.

1

NĐ 15/2018 was supposed to be replaced by NĐ 46/2026 — what's the current status?

Decree 46/2026/NĐ-CP was signed on 26 January 2026 to replace Decree 15/2018/NĐ-CP, but it is not currently in operational force. It was suspended on 4 February 2026 by Resolution 09/2026/NQ-CP after a customs-clearance crisis, and the suspension was extended indefinitely on 6 April 2026 by Resolution 15/2026/NQ-CP — until the revised Food Safety Law and its implementing decrees take effect.

  • Decree 15/2018/NĐ-CP and its implementing documents continue to apply. The tự công bố / bản công bố framework you have been operating under is unchanged.
  • Dossiers filed before NQ 15/2026 (6 April 2026) are handled under NĐ 15/2018.
  • The HACCP/GMP/ISO 22000 obligations and the narrowed self-declaration scope that NĐ 46 would have introduced are not currently in force.
  • The revised Food Safety Law is expected at the September 2026 UBTVQH session (NQ 119/2026/UBTVQH15); only when it and its implementing decree take effect will the framework change.

See the deep-dive at /news/decree-46-vs-15-food-safety-comparison/.

2

My TPCN self-declaration was filed under NĐ 15/2018 — is it still valid?

Yes — and there is no fixed cutoff currently in force. NĐ 46/2026/NĐ-CP is suspended indefinitely (NQ 15/2026/NQ-CP), so Decree 15/2018/NĐ-CP continues to apply and the 12-month re-registration window once tied to NĐ 46 is not operating.

  • If your product formulation, manufacturing facility, and claims are unchanged, the existing self-declaration remains valid — no NĐ 46 re-registration is required while the suspension stands.
  • Material changes (formulation, manufacturer, claims) still require a new filing — under the current framework that means a new NĐ 15/2018-style self-declaration or registered declaration with the competent authority.
  • The 12-month transition window will only become relevant if NĐ 46 (or its successor under the revised Food Safety Law) takes effect. Watch for the September 2026 UBTVQH session on the amended law.
  • Note: Medibase's Expiry & Renewal Calculator at /tools/?tab=expiry currently models the NĐ 46 transition dates as if they were live — those outputs should be cross-checked against MOH announcements while the suspension is in force.
3

Is the 2026-12-31 HACCP / GMP / ISO 22000 deadline still in force?

Not currently. The 2026-12-31 deadline was set by NĐ 46/2026/NĐ-CP, which is suspended indefinitely under NQ 15/2026/NQ-CP. The deadline therefore is not operating right now.

  • Under the existing NĐ 15/2018 framework, GMP for TPBVSK already applies and most established TPBVSK manufacturers are compliant. That obligation is unchanged.
  • The extension of HACCP / GMP / ISO 22000 to all food-additive manufacturers — which NĐ 46 introduced — is in abeyance pending NĐ 46 (or its successor under the revised Food Safety Law) taking effect.
  • The direction of travel is clear, so manufacturers who started preparing for the NĐ 46 obligations should keep going — but the calendar date is no longer fixed.
  • Watch the September 2026 UBTVQH session (NQ 119/2026/UBTVQH15) for the revised Food Safety Law; new effective dates will be set there.
4

Food advertising approval moved to provinces — what does that mean for me?

Resolution 21/2026/NQ-CP (signed 2026-04-29, operational 2026-07-01) moves food and health-supplement advertising approval from the central VFA to the provincial People's Committee. Practical implications:

  • Submit advertising materials to the Sở Y tế of the province where your business is headquartered, not to VFA.
  • Pre-existing VFA-approved ads remain valid until the approval expires.
  • Provincial review committees set their own queue speeds; expect variation across provinces in the first 12 months.
  • Multi-province campaigns may need approvals from each target province's Sở Y tế — awaiting unified guidance from the MOH on this.

See /news/supplement-advertising-decentralised-2026-07-01/ for the implementation playbook.

5

What's the difference between tự công bố and bản công bố hợp quy?

Under the currently-applicable NĐ 15/2018 framework, these are two tiers of food declaration:

  • Tự công bố (self-declaration) — for most processed foods and general ingredients. The business prepares the declaration itself and lodges it with the provincial competent authority; circulation may begin the same day. Light-touch.
  • Bản công bố hợp quy / đăng ký bản công bố sản phẩm (conformity / registered declaration) — for higher-risk categories like TPBVSK, infant nutrition under 36 months, and food for special medical purposes. Pre-market review against the applicable technical regulation, with a written acceptance certificate (Giấy tiếp nhận đăng ký bản công bố) before sale.

NĐ 46/2026/NĐ-CP would have narrowed the self-declaration channel and routed most TPBVSK and special-purpose foods through registered declaration, but NĐ 46 is suspended indefinitely (NQ 15/2026) and the NĐ 15/2018 framework continues to apply. The tier mapping you operate under today is the NĐ 15 one.

6

Can I import a foreign supplement and sell it in Vietnam?

Yes, with the right declaration and import permit chain. Under the currently-applicable NĐ 15/2018/NĐ-CP framework (NĐ 46/2026 is suspended indefinitely by NQ 15/2026):

  • File the appropriate product declaration before first import — for TPBVSK and special-purpose foods, an đăng ký bản công bố sản phẩm at the Vietnam Food Administration (VFA); for ordinary processed foods, a tự công bố at the provincial competent authority. Dossier: product specifications, label, manufacturer GMP/HACCP/ISO 22000 certificate (where applicable), and country-of-origin Free Sale Certificate (FSC).
  • Vietnamese-language labelling on the consumer pack is mandatory.
  • Each shipment needs the customs import declaration plus the declaration receipt number; selected categories are subject to per-shipment quality inspection.
  • Health claims (especially disease-prevention or treatment) must be pre-approved and cannot exceed what the FSC supports.

Hague Apostille (in force for Vietnam 2026-09-11) simplifies legalisation of the FSC and manufacturer certificate when both countries are signatories.