Viet Nam Updates Veterinary and Aquatic Products Risk Classification

Viet Nam has issued a draft circular updating the risk classification for veterinary and aquatic products, including pharmaceutical veterinary drugs, veterinary vaccines, and aquatic feed, under medium and high risk management.

Compliance Analysis: Updated Risk Classification for Veterinary and Aquatic Products in Viet Nam

Direct Answer

Viet Nam’s Draft Circular amending and supplementing certain contents of the List of products and goods subject to medium and high risk under Circular No. 27/2026/TT-BNNMT (hereinafter "Draft Circular") revises the risk classification and compliance requirements for pharmaceutical veterinary drugs, veterinary vaccines, and aquatic feed, categorizing them as medium or high risk based on product type. The updates specify national technical regulations, conformity assessment routes, and declaration requirements for domestic and imported products¹. Key changes include stricter controls for veterinary drugs containing narcotic substances and live attenuated veterinary vaccines (high risk) and standardized testing for aquatic feed (medium risk)¹.

1. Scope of Products and Risk Classification

The Draft Circular amends Appendix I (entries 4.1, 4.3, 5.2) and Appendix II (new entry 2) of Circular No. 27/2026/TT-BNNMT, covering the following products¹:

2. Compliance Requirements by Risk Level

2.1 Medium-Risk Products

Applicable Products:

• Pharmaceutical veterinary drugs (non-narcotic)
• Veterinary vaccines (non-live attenuated)
• Aquatic feed (compound feed, supplements, live feed)

Key Requirements:

1. Conformity Declaration:
   • Manufacturers/importers must self-declare conformity with national technical regulations (QCVN) before market circulation¹.
   • For imported aquatic feed, conformity assessment must include pre-shipment testing or third-party certification¹.

1. Technical Regulations:
   • Veterinary drugs/vaccines: Compliance with QCVN on veterinary drug quality and safety (specific standards not detailed in sources)¹.
   • Aquatic feed: Adherence to QCVN on aquatic feed composition, contaminants, and labeling¹.

1. Testing and Certification:
   • Domestic products: Testing may be conducted by accredited laboratories in Viet Nam¹.
   • Imported products: Must provide certificates of analysis (CoA) from recognized foreign labs or undergo Viet Nam-based testing¹.

1. Documentation:
   • Product dossier (composition, manufacturing process, safety data)¹.
   • Conformity declaration form (submitted to the Department of Livestock Production and Veterinary Medicine)¹.

2.2 High-Risk Products

Applicable Products:

• Veterinary drugs containing narcotic substances
• Live attenuated veterinary vaccines

Key Requirements:

1. Mandatory Certification:
   • No self-declaration permitted. Products must undergo third-party conformity assessment by a designated certification body in Viet Nam¹.
   • Live attenuated vaccines: Additional biosafety evaluation required¹.

1. Technical Regulations:
   • Compliance with QCVN for high-risk veterinary products, including:
   • Narcotic veterinary drugs: Strict active ingredient limits and storage/handling protocols¹.
   • Live attenuated vaccines: Pathogen containment measures and post-market surveillance¹.

1. Import Controls:
   • Pre-import approval required from the Department of Livestock Production and Veterinary Medicine¹.
   • Batch testing for every shipment (no exemptions)¹.

1. Labeling:
   • High-risk warnings (e.g., "Narcotic Substance – Controlled Use")¹.
   • Vaccine-specific labels: Storage conditions, expiration dates, and biosafety handling instructions¹.

3. Regulatory Authorities and Enforcement

4. Timeline and Stakeholder Engagement

• Comment Period: Open until 22 September 2026 (60 days from notification)¹.
• Adoption/Publication: Dates to be determined¹.
• Entry into Force: Likely 6 months post-publication (exact date TBA)¹.

Submission of Comments:

• Addressed to:
  • Viet Nam SPS Authority (`spsvietnam@mae.gov.vn`)¹.
  • Department of Livestock Production and Veterinary Medicine (`quanlythuoc@gmail.com`)¹.

5. Legal Framework

The Draft Circular aligns with the following Vietnamese laws and decrees:

1. Law on Product and Goods Quality No. 05/2007/QH12 (amended by Law No. 78/2025/QH15)¹.
2. Law on Standards and Technical Regulations No. 68/2006/QH11 (amended by Law No. 35/2018/QH14 and Law No. 70/2025/QH15)¹.
3. Law on Veterinary Medicine No. 79/2015/QH13 (amended by Law No. 21/2017/QH14 and Law No. 146/2025/QH15)¹.
4. Decree No. 35/2025/ND-CP (MAE’s organizational functions)¹.
5. Decree No. 37/2026/ND-CP (implementation of the Law on Product and Goods Quality)¹.
6. Decree No. 22/2026/ND-CP (implementation of the Law on Standards and Technical Regulations)¹.

6. Summary Table of Key Requirements

Summary Answer

Viet Nam’s Draft Circular amending Circular No. 27/2026/TT-BNNMT introduces tiered risk classifications for veterinary and aquatic products, with medium-risk (e.g., non-narcotic veterinary drugs, non-live vaccines, aquatic feed) subject to self-declaration of conformity and high-risk (e.g., narcotic veterinary drugs, live attenuated vaccines) requiring third-party certification and pre-import approval¹. Compliance is enforced by the Department of Livestock Production and Veterinary Medicine under the Ministry of Agriculture and Environment, with technical standards derived from QCVN regulations¹. The draft aligns with Viet Nam’s Law on Product and Goods Quality, Law on Standards and Technical Regulations, and Law on Veterinary Medicine, and is open for public comment until 22 September 2026¹. No international standards (e.g., Codex, OIE) are referenced in the draft¹.

Sources

1. ↩ Draft Circular amending and supplementing certain contents of the List of products and goods subject to medium and high risk under the management responsibility of the Ministry of Agriculture and Environment, promulgated together with Circular No. 27/2026/TT-BNNMT dated 30 June 2026 https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/T/G/SPS/NVNM185.docx