On July 2, 2025, the Ministry of Health issued an Official Dispatch No. 4223/BYT-ATTP announcing the conclusion regarding the draft Decree amending and supplementing Decree No. 15/2018/NĐ-CP, with the following key contents:
- Strengthening Post-Market Surveillance and Product Quality Monitoring
- Agencies receiving self-declaration dossiers must develop post-market inspection plans.
- If violations are detected, product sampling and quality/safety monitoring will be conducted for products circulating on the market.
- Responsibilities of dossier-receiving agencies are clearly defined.
- Administrative Procedure Reform
- Adjust the translation of foreign language documents.
- Acceptance of electronic versions of legal documents issued by competent foreign authorities.
- Additional Regulations on Food Advertising
- Stricter control over advertising content, especially for health protection foods.
- Scientific evidence must be clear and transparent.
- Enhanced Intersectoral Coordination
- The Ministry of Health will coordinate with relevant ministries and sectors to develop the Decree under a simplified procedure.
- International management practices will be referenced, including those from the U.S., Japan, Australia, Canada, South Korea, and China.
Specific Changes to Self-Declaration:
|
|
Current Regulation |
Draft 08 (June 29, 2025) |
|
Scope |
Processed packaged foods, food additives, processing aids, food containers, packaging materials in direct contact with food |
Adds micronutrients to the scope
|
|
Registration form |
||
|
Self-Declaration form |
Not specified |
Adds section for declaring product quality criteria |
|
Authorization letter |
Not specified |
Specifies authorization letter from the manufacturer |
|
Translation requirements |
All foreign-language documents must be translated and notarized |
a) English documents may be translated into Vietnamese by the organization/individual, who is responsible for accuracy; b) Non-English documents must be translated into Vietnamese and certified; if not possible, they must be translated into English and certified in the country of origin/export, then translated into Vietnamese with responsibility for accuracy; c) If product labels are multilingual but do not include English, only the language of the country of origin/export must be translated |
|
Testing criteria |
Safety criteria only |
Includes both quality criteria and safety criteria |
|
Test result certificate |
Must be appropriate |
Pass or fail |
|
Deadline for posting self-declaration documents |
Not specified |
10–21 days |
As the draft Decree amends more than half of the articles in Decree 15/2018/NĐ-CP, it will be issued as a replacement Decree, based on the contents of the current draft.
Reference Documents:
Link to detailed Official Dispatch No. 4223/BYT-ATTP:
https://vfa.gov.vn/upload/files/CV4223%20TB%20doanh%20nghiep%20ND15%20sdbs%2001_7_2025_signed.pdf
Link to Draft Decree 15/2018/ND-CP 8th edition in detail:
https://vfa.gov.vn/upload/files/2_%20Du%20thao%208%20ngay%2029_6_2025-18h20-TB%20DN.pdf
