Decision No. 66.13/2026/NQ-CP on the announcement and registration of food products

This Decision stipulates the procedures for announcing health protection foods, medical nutrition foods, special diet foods, and dietary supplements. These products must be registered with the competent authority before being put into circulation. The authority will issue a Registration Receipt within thirty days from the date of receiving complete and valid application files. The file must include information about the product, the production facility, and safety and quality standards. Products that have self-announced prior to this Decision must complete their registration announcement files within twenty-four months from the effective date of the Decision.

Document No.66.13/2026/NQ-CP
Document typeResolution
Issuing authorityMinistry of Health
Signed byLê Thành Long — Phó Thủ tướng Chính phủ
Updated22/06/2026
SectorHealth
FieldFood Safety
Issued date27/01/2026
Effective date27/01/2026
Expiry date
StatusExpired
✦ Smart summary

This Decision stipulates the procedures for announcing health protection foods, medical nutrition foods, special diet foods, and dietary supplements. These products must be registered with the competent authority before being put into circulation. The authority will issue a Registration Receipt within thirty days from the date of receiving complete and valid application files. The file must include information about the product, the production facility, and safety and quality standards. Products that have self-announced prior to this Decision must complete their registration announcement files within twenty-four months from the effective date of the Decision.

Scope of application

Health protection foods, medical nutrition foods, special diet foods, and dietary supplements

Key points

  • Announcing the product before putting it into circulation
  • Registering the product announcement with the competent authority
  • Thirty-day period for issuing the Registration Receipt for the product announcement registration
  • The file includes information about the product, the production facility, and safety and quality standards
  • Completing the file within twenty-four months for products that have self-announced prior to the Decision

🌐 Social impact of this document

  • Reducing food safety risks
  • Strengthening state management
  • Preventing false and misleading advertising

❓ Frequently asked questions

Who is responsible for announcing the product?

The production facility or importer of health protection foods, medical nutrition foods, special diet foods, and dietary supplements must register the product announcement before putting them into circulation.

What is the deadline for completing the file?

Self-announcement product files must be completed within twenty-four months from the effective date of the Decision.

Full text

THE GOVERNMENT

_________

SOCIALIST REPUBLIC OF VIET NAM

Independence - Freedom - Happiness

_______________________________________

Number: 66.13/2026/NQ-CP

Hanoi, January 26, 2026

 

RESOLUTION
Regulations on Announcing and Registering Food Products

 

Pursuant to the Law on Government Organization No. 63/2025/QH15;

Pursuant to the Food Safety Law No. 55/2010/QH12;

Based on the Law on Product Quality and Trade Goods No. 05/2007/QH12, amended and supplemented by Law No. 35/2018/QH14, Law No. 78/2025/QH15;

Based on Resolution No. 206/2025/QH15 of the National Assembly on special mechanisms to address difficulties and obstacles caused by legal provisions;

At the proposal of the Minister of Health;

The Government issues this Resolution on announcing and registering food products.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Resolution stipulates the announcement of standards applicable to food and the registration of food product announcements.

2. This Resolution applies to food products including:

a) Processed packaged foods, food additives, and food processing aids, and packaging materials and containers for food without technical regulations on quality criteria or safety criteria, or without organizations implementing conformity assessment of national technical regulations according to the laws on standards and technical regulations or without conformity assessment methods;

b) Nutrient supplements;

c) Health foods;

d) Medical nutrition foods;

đ) Special dietary foods;

e) Supplementary foods;

g) Nutritional products for children up to 36 months old.

Article 2. Applicability

This Resolution applies to agencies, organizations, and individuals in Vietnam; foreign organizations and individuals in Vietnam involved in food production and business; and organizations and individuals engaged in activities related to food safety in Vietnam (hereinafter referred to collectively as organizations and individuals).

Article 3. Explanation of Terms

Scientific evidence includes scientific information, scientific data, and scientific documents proving the efficacy or health effects of the product or its components from scientific research works published in reputable national and international journals, ISI (Institute of Scientific Information) journals, and SCOPUS journals; or traditional medicine literature, medicinal plants, herbal medicines, medical and pharmaceutical literature, and food literature published in scientific publications.

Article 4. Application of Law

In addition to announcing and registering food products as prescribed in this Resolution, production, purchase, sale, export, import, state inspection, advertising, labeling, and traceability shall be carried out in accordance with the laws on food safety and specialized laws.

 

Chapter II
PROCEDURE FOR ANNOUNCING APPLICABLE STANDARDS

Article 5. Cases for Announcing Applicable Standards

1. Organizations and individuals responsible for bringing products to market shall announce applicable standards for:

a) Processed packaged foods, food additives, food processing aids, packaging materials, and utensils that directly contact food without technical regulations on quality criteria or safety criteria, or without organizations implementing conformity assessment of national technical regulations according to the laws on standards and technical regulations or without conformity assessment methods;

b) Nutrient supplements;

c) Dietary supplements containing only vitamins and minerals and not making health claims (Health claims).

2. Cases exempted from the procedure for announcing applicable standards:

a) Products and raw materials produced domestically or imported solely for the purpose of producing goods for export;

b) Raw materials and semi-finished products produced domestically (initial products) solely for internal production purposes of organizations and individuals and not sold in the domestic market;

c) Raw materials and semi-finished products imported (initial products) solely for internal production purposes of importing organizations and individuals and not sold in the domestic market;

d) Products and raw materials produced or imported solely for aid purposes;

đ) Products and raw materials produced or imported solely for testing purposes for product announcements;

e) Products and raw materials produced or imported solely for scientific research purposes.

Article 6. Documents and Procedures for Announcing Application Standards

1. The documents for announcing application standards include:

a) The announcement of application standards according to Model No. 01 attached as an appendix to this Resolution;

b) A test result sheet for the product in accordance with Model No. 06 attached as an appendix to this Resolution (a certified copy stamped by the organization or individual; or an electronically certified copy);

The test results must be within a twelve-month period from the date of submission of the documents, issued by a recognized testing organization that meets the ISO/IEC 17025 standard, including quality indicators and safety indicators, and must reflect the assessment of compliance with international quality and safety indicators or safety indicators according to corresponding standards set forth by organizations or individuals;

c) A power of attorney bearing the name of the announcement of application standards of the production facility or food product owner, containing all contents stipulated in Article 11 of this Resolution (in case of authorization) (a certified copy stamped by the organization or individual; or an electronically certified copy);

2. The procedure for announcing application standards shall be carried out as follows:

a) Organizations and individuals submit one set of documents for announcing application standards as prescribed in Clause 1 of this Article through online means (through the National Public Service Portal, the National Single Window Portal, or the Ministry-level or Provincial-level Administrative Procedure Information System) or postal services or directly to the competent state management agency designated by the provincial People's Committee; The National Public Service Portal or the National Single Window Portal or the central-level or provincial-level administrative procedure information system or postal service or directly to the state administrative agency authorized by the Provincial People's Committee;

b) Within fifteen days from the date of receiving the documents for announcing application standards, if there is no written comment, the competent state management agency will accept and publish the announcement documents on its electronic information page or online public service system;

Organizations and individuals are entitled to publicly disclose the announced application standards on product labels, packaging, accompanying documents, mass media, their own electronic information pages, or post them at their organizational or personal headquarters, and have the right to produce and trade products. They bear full responsibility for the legality, accuracy of the documents, and the quality and safety of the announced products, and may only put products into production and trade when the announcement documents are published on the electronic information page or online public service system of the receiving agency;

c) The competent state management agency accepts the documents for announcing application standards submitted by organizations and individuals for archiving and publishing the announcement documents on its electronic information page;

In cases where an organization or individual has two or more production facilities producing the same product, they only need to submit the documents to one state management agency in the locality chosen by the organization or individual. Once a state management agency is selected for submitting the documents, subsequent announcements must be submitted to the previously selected agency;

3. All documents in the set of documents for announcing application standards must be in Vietnamese;

a) In cases where the documents are in English, organizations and individuals must translate them into Vietnamese and bear full responsibility for the accuracy of the translation;

b) For documents in foreign languages other than English, they must be translated into Vietnamese and certified by the translator's signature. If it is not possible to translate into Vietnamese and certify, organizations and individuals must submit an English translation certified by the translator's signature in the country of production or export; organizations and individuals must then translate into Vietnamese and bear full responsibility for the accuracy of the translation;

c) In cases where the product label is in multiple languages but does not include English, only the language of the country of production or export should be translated;

The documents must remain valid at the time of announcement;

4. In cases where there are changes in the product name, origin, or product components (excluding additives), organizations and individuals must reannounce the application standards. For other changes, organizations and individuals must notify the competent state management agency in writing about the changes and can immediately produce and trade the product after sending the notification;

5. Organizations and individuals producing and trading products are responsible for publicly disclosing the documents for announcing application standards of food products when conducting business on e-commerce platforms in Vietnam;

Chapter III
PROCEDURE FOR ISSUING THE RECEIPT OF APPLICATION REGISTRATION

ANNOUNCEMENT DOCUMENT

Article 7. Cases for registering the product announcement

1. Organizations and individuals responsible for bringing products to the market must register the product announcement for the following products:

a) Health food, medical nutrition food, special diet food, food supplements (except food supplements containing only vitamins and minerals without health claims);

b) Nutritional products for children up to 36 months old.

2. Imported food products specified in Clause 1 of this Article are exempted from the procedure of registering the product announcement when they fall under any of the following cases:

a) For aid purposes;

b) Only for testing to serve the product announcement;

c) Only for scientific research.

3. Documents in the application dossier for registering the product announcement must be presented in Vietnamese.

a) In case the documents are in English, organizations and individuals must translate them into Vietnamese except for quality and safety standards, production processes, and product stability research reports, and bear full responsibility for the accuracy of the translation;

b) For documents in foreign languages other than English, they must be translated into Vietnamese and certified by the translator's signature. If it is impossible to translate and certify in Vietnamese, organizations and individuals must submit an English translation certified by the translator's signature at the place of production or export; organizations and individuals must then translate into Vietnamese and bear full responsibility for the accuracy of the translation; The documents must remain valid at the time of submitting the application dossier for registering the product announcement.

c) In cases where the product label is in multiple languages but does not include English, only the language of the country of production or export should be translated;

Documents must still be valid at the time of submitting the application registration dossier for product declaration;

4. Organizations and individuals responsible for bringing products to the market shall bear full responsibility for the legality, accuracy of the dossier, and the quality and safety of the announced products, and may only put the products into production and business after receiving the Registration Acceptance Certificate for the Product Announcement.

Article 8. Application dossier for registering the product announcement for imported food products

1. The general application dossier for registering the product announcement for imported food products includes:

a) The product announcement form as stipulated in Model No. 02 of the Appendix issued together with this Resolution;

b) A Free Sale Certificate, Export Certificate, Health Certificate, or other relevant certificates issued by the competent authority of the producing or exporting country (legalized copy or electronic version with self-search results from the issuing authority’s website or database in English, and stamped by the organization or individual);

These certificates must include at least the following contents: name of the issuing authority or organization; date of issuance; name of the product or goods; type or group of products or goods; name and address of the manufacturing facility; name and signature of the certifier; assurance of safety for users or suitability for users or free sale in the producing or exporting country's market;

c) Test result certificate of the product as stipulated in Model No. 06 of the Appendix issued together with this Resolution (certified copy stamped by the organization or individual or certified electronic version);

The test result certificate must be within 12 months from the date of submission, issued by a recognized testing organization meeting ISO/IEC 17025 standard or a laboratory of the manufacturing facility meeting Good Manufacturing Practice (GMP) requirements, and must reflect the assessment of compliance with international quality and safety criteria or corresponding national standards published by the organization or individual;

d) Documentation proving the efficacy and effects of the product in one of the following forms:

Scientific evidence proving the efficacy and effects of the product or its components that have been announced;

Trial report on the efficacy of the product as stipulated in Clause 3 of Article 14 of the Food Safety Law No. 55/2010/QH12;

When using scientific evidence proving the efficacy and effects of the product or its components that have been announced, related content on efficacy and dosage can be cited from the scientific evidence or documentation evaluated and published by domestic and foreign management agencies (certified copy stamped by the organization or individual), and the daily dosage of the product or component in the product must be at least 15% of the usage amount of that component or traditional medicine formula mentioned in the documentation; or traditional herbal prescriptions mentioned in the documents;

e) Authorization letter for registering the product announcement from the manufacturing facility or owner of the food product containing all the contents prescribed in Article 11 of this Resolution (in case of authorization for registration) (certified copy stamped by the organization or individual and presenting the original for comparison when submitting or receiving administrative procedure results or certified electronic version);

2. Application dossier for registering the product announcement for health food:

a) Documents prescribed in Clause 1 of this Article;

b) Certificate of a facility meeting food safety conditions and Good Manufacturing Practice (GMP) requirements or equivalent certification (stamped copy or electronic version with self-search results from the issuing authority’s website or database in English, and stamped by the organization or individual);

c) Product label sample and user guide (if any);

d) Report on the research and development process of the product;

e) Documentation on quality and safety standards;

f) Documentation on production procedures;

g) Report on the stability research results of the product;

h) In addition to the documents specified in points a, b, c, d, đ, e, and g of Clause 2 of this Article, organizations and individuals may submit other documents to explain, clarify, and prove the contents included in the registration dossier.

The detailed guidance for these documents and the registration dossier for declaring the product information of health food products is provided in Model No. 03 of the Appendix issued together with this Resolution.

3. Registration dossier for declaring the product information for medical nutrition foods, special diet foods, nutritional products for children up to 36 months old, and dietary supplements (excluding dietary supplements containing only vitamins and minerals without health claims):

a) Documents prescribed in Clause 1 of this Article;

b) Certificate of Hazard Analysis and Critical Control Points (HACCP) system or Food Safety Management System ISO 22000 or International Food Standard (IFS) or Global Food Safety Standard (BRC) or Food Safety System Certification (FSSC 22000) or equivalent certification or Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) (original copy stamped by the organization or individual or electronic copy accompanied by the result of self-search from the website or English database of the issuing authority or competent authorities of foreign countries and stamped by the organization or individual);

c) Product label sample and user guide (if any);

d) Report on the research and development process of the product;

e) Documentation on quality and safety standards;

f) Documentation on production procedures;

g) Report on the stability research results of the product;

h) In addition to the documents specified in points a, b, c, d, đ, e, and g of Clause 3 of this Article, organizations and individuals may submit other documents to explain, clarify, and prove the contents included in the registration dossier.

Detailed guidance for these documents and the registration dossier for declaring the product information of medical nutrition foods, special diet foods, nutritional products for children up to 36 months old, and dietary supplements (excluding dietary supplements containing only vitamins and minerals without health claims) is provided in Model No. 04 of the Appendix issued together with this Resolution.

Article 9. Registration dossier for declaring the product information for domestically produced food products

1. General registration dossier for declaring the product information for groups of domestically produced food products includes:

a) The product announcement form as stipulated in Model No. 02 of the Appendix issued together with this Resolution;

b) Product testing result report as stipulated in Model No. 06 of the Appendix issued together with this Resolution (certified copy stamped by the organization or individual or certified electronic copy);

The test result certificate must be within 12 months from the date of submission, issued by a recognized testing organization meeting ISO/IEC 17025 standard or a laboratory of the manufacturing facility meeting Good Manufacturing Practice (GMP) requirements, and must reflect the assessment of compliance with international quality and safety criteria or corresponding national standards published by the organization or individual;

c) Documentation proving the efficacy and effects of the product in one of the following forms:

Scientific evidence proving the efficacy and effects of the product or its components that have been announced;

Trial report on the efficacy of the product as stipulated in Clause 3 of Article 14 of the Food Safety Law No. 55/2010/QH12;

When using Scientific Evidence to prove the efficacy and effects of the product or its components that have been announced, relevant content related to efficacy and dosage can be cited from scientific evidence or documentation evaluated and announced by domestic and international regulatory agencies to prove the efficacy and effects of the product or its components that have been announced (certified copy stamped by the organization or individual), and the daily dosage of the product or its component in the product must be at least 15% of the usage amount of that component or traditional prescription mentioned in the documentation;

d) Authorization letter for registering the declaration of the product information from the food production facility or the owner of the food product containing all the contents prescribed in Article 11 of this Resolution (in case of authorization for registration) (certified copy stamped by the organization or individual and presenting the original for verification when submitting or receiving the administrative procedure results or certified electronic copy);

2. Application dossier for registering the product announcement for health food:

a) Documents prescribed in Clause 1 of this Article;

b) Product label sample and user guide (if applicable);

c) Report on the research and development process of the product;

d) Documentation on quality and safety standards;

đ) Documentation on production processes;

e) Report on the research results of product stability;

g) Information about packaging and equipment directly contacting the product;

h) In addition to the documents specified in points a, b, c, d, đ, e, and g of Clause 2 of this Article, organizations and individuals may submit other documents to explain, clarify, and prove the contents included in the registration dossier.

The detailed guidance for these documents and the registration dossier for declaring the product information of health food products is provided in Model No. 03 of the Appendix issued together with this Resolution.

3. Registration dossier for declaring the product information for medical nutrition foods, special diet foods, nutritional products for children up to 36 months old, and dietary supplements (excluding dietary supplements containing only vitamins and minerals without health claims):

a) Documents prescribed in Clause 1 of this Article;

b) Certificate of Hazard Analysis and Critical Control Points (HACCP) system or Food Safety Management System ISO 22000 or International Food Standard (IFS) or Global Food Safety Standard (BRC) or Food Safety System Certification (FSSC 22000) or equivalent certification or Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) (certified copy stamped by the organization or individual);

c) Product label sample and user guide (if any);

d) Report on the research and development process of the product;

e) Documentation on quality and safety standards;

f) Documentation on production procedures;

g) Report on the stability research results of the product;

h) In addition to the documents specified in points a, b, c, d, đ, e, and g of Clause 3 of this Article, organizations and individuals may submit other documents to explain, clarify, and prove the contents included in the registration dossier.

Detailed guidance for these documents and the registration dossier for declaring the product information of medical nutrition foods, special diet foods, nutritional products for children up to 36 months old, and dietary supplements (excluding dietary supplements containing only vitamins and minerals without health claims) is provided in Model No. 04 of the Appendix issued together with this Resolution.

Article 10. Procedure for registering product announcement

1. Organizations and individuals producing and trading food shall submit registration application for product announcement in an online form (through the National Public Service Portal, the Single Window National Portal, or the Information System for Administrative Procedures at the ministry or provincial level) or through postal services or directly to the agency receiving the application as follows: or postal service or direct submission to the file receiving agency as stipulated below;

a) Submit to the Ministry of Health for health-related foods;

b) Submit to the competent state management agency designated by the People's Committee of the province for medical nutrition products, special diet products, nutritional products for children up to 36 months old, and supplementary foods (excluding supplementary foods containing only vitamins and minerals without health claims);

c) In cases where organizations and individuals have two or more production facilities producing the same product, they shall only handle the registration procedure for product announcement at one state management agency in the locality chosen by the organization or individual (except for products registered with the Ministry of Health). Once a state management agency is selected for registration, subsequent registrations must be made at the selected agency.

2. Within a maximum period of 90 days from the date of receipt of the complete application for product announcement registration, the agency receiving the application as stipulated in Clause 1 of this Article shall be responsible for reviewing the application and issuing the Registration Receipt for Product Announcement according to Model No. 05 attached as an appendix to this Resolution;

During the review period, the agency receiving the application shall establish specialized sub-committees to review and issue the Registration Receipt for Product Announcement for products with components as specified in Clause 2, Clause 3 of Article 8 and Clause 2, Clause 3 of Article 9 of this Resolution. If necessary, the agency may establish an Advisory Council for issuing the Registration Receipt for Product Announcement and not participate directly in the review of the announcement application.

3. In case the agency receiving the application as stipulated in Clause 1 of this Article does not agree with the product announcement application of the organization or individual or requests modifications or supplements, it must issue a written document specifying the requirements for modification or supplementation, reasons, and legal and professional grounds for such requests. The agency receiving the application may request modifications or supplements only twice for each application.

a) Within 60 days from the date of receipt of the written request for modification or supplementation from the agency receiving the application, the organization or individual shall complete and resubmit the modified or supplemented application. The organization or individual may modify or supplement only twice;

b) Within 20 days from the date of receipt of the written request for modification or supplementation from the agency receiving the application, if the organization or individual finds that there is insufficient time to complete the application, they shall issue a written request for extension of time and specify the reasons. The extension period shall not exceed 120 days from the date of receipt of the written request for modification or supplementation from the agency receiving the application as stipulated in Point a of this Clause. Beyond the modification or supplementation deadline or the extended period, the application will lose its validity;

c) Within 60 days from the date of receipt of the modified or supplemented application from the organization or individual, the agency receiving the application shall be responsible for reviewing the application and issuing the Registration Receipt for Product Announcement as stipulated in Clause 2 of this Article or issue a written notice that the application has lost its validity in case it does not agree with the product announcement application of the organization or individual.

4. In cases where the product undergoes changes in name, origin, product composition (excluding auxiliary materials), function, target group, or dosage, the organization or individual must reannounce the product. For other changes, the organization or individual shall notify the agency receiving the application as stipulated in Clause 1 of this Article in writing about the changed content and may produce and trade the product immediately after sending the notification.

5. The agency receiving the application for product announcement registration shall be responsible for publicly announcing the name and product of the organization or individual whose application has been accepted on its electronic information website and the food safety database.

6. Organizations and individuals producing and trading products shall be responsible for publicly displaying the Registration Receipt for Product Announcement when conducting business on e-commerce platforms in Vietnam and paying the application review fee according to the laws on fees and charges.

Article 11. Provisions on the Power of Attorney

1. The language used shall be Vietnamese, English, or bilingual Vietnamese and English.

2. The power of attorney for product registration must comply with relevant laws on power of attorney and include the following contents:

a) Name and address of the production facility; in cases where the principal is the owner of food products, the name and address of the food product owner and the name and address of the production facility must also be specified.

b) Name and address of the entity or individual authorized.

c) Scope of authorization (to sign off on product registration and jointly bear responsibility for all issues related to the product).

d) Name of the authorized product.

3. The principal shall have the responsibility to notify in writing the competent state management agency in case of changes in the content of the authorization.

4. Both the principal and the authorized party shall be jointly liable in cases where the product violates quality and food safety standards, resulting in consequences.

Article 12. Withdrawal of Product Registration Acceptance Certificate and Removal of Product Information from the State Management Agency's Website

1. The competent state management agency that accepts the registration dossier shall withdraw the Product Registration Acceptance Certificate and remove the product information posted on its website within five working days from the date of receiving information or discovering any of the following situations:

a) One of the certificates has been revoked by a foreign authority, which was the basis for organizations or individuals to self-declare or declare applicable standards or register for conformity declaration or apply for a Product Registration Acceptance Certificate in Vietnam; issue a Receipt for Registration of Product Declaration in Vietnam;

b) The product registration dossier is based on forged or inaccurate documents;

c) The trademark of the product is found to infringe intellectual property rights by competent state authorities;

d) In cases where it is discovered that the product has not been produced or imported for three consecutive years since the issuance of the Product Registration Acceptance Certificate or declaration of applicable standards or registration for conformity declaration;;

f) In cases where organizations or individuals voluntarily withdraw the Product Registration Acceptance Certificate or the declaration of applicable standards dossier or the conformity declaration dossier for commercial reasons;

e) In cases where organizations or individuals voluntarily withdraw the Product Registration Acceptance Certificate or the declaration of applicable standards dossier or the conformity declaration dossier due to non-compliance with quality and safety standards;

g) The Product Registration Acceptance Certificate was issued beyond jurisdiction;

h) Change of location of the organization or individual responsible for bringing the product to market without notifying the agency accepting the self-declaration/draft declaration of product registration;

i) When notified or concluded by the investigation agency that the product is counterfeit or contains prohibited substances. In this case, the Product Registration Acceptance Certificate for all products will be withdrawn and all product information posted on the website of the management agency accepting the manufacturer's and the organization's or individual's dossiers will be removed;

k) In cases where organizations or individuals fail to complete the product registration dossier in accordance with this Resolution and Decree No. 46/2026/NĐ-CP dated January 26, 2026, of the Government detailing the implementation of certain provisions and measures under the Food Safety Law and guiding its enforcement.

2. Authority to issue decisions to withdraw the Product Registration Acceptance Certificate and remove product information posted on the website of the agency accepting the product registration dossier:

a) The Ministry of Health shall issue a decision to withdraw the Product Registration Acceptance Certificate and remove product information posted on its website for products for which the Ministry of Health issued the Product Registration Acceptance Certificate;

b) Competent state management agencies designated by provincial People's Committees shall issue decisions to withdraw the Product Registration Acceptance Certificates issued by their units; they shall require the withdrawal of self-declaration dossiers, declaration of applicable standards dossiers, and removal of product information posted on the website of the agency accepting the product registration dossier including products registered for conformity declaration;

3. Handling of food products after withdrawing the Product Registration Acceptance Certificate and removing product information posted on the website:

a) Cease circulation and recall food products currently circulating in the market in cases stipulated in point a, b, e, i of Clause 1 of this Article;

b) Food products produced before the withdrawal of the Product Registration Acceptance Certificate and removal of product information posted on the website may continue to circulate until their expiration date in cases stipulated in points c, d, f, g, h, k of Clause 1 of this Article.

Article 13. Suspension of Acceptance and Processing of Product Registration Dossiers

1. The competent state management agency that accepts and processes product registration dossiers shall suspend consideration and acceptance of product registration dossiers from organizations or individuals engaging in any of the following behaviors:

a) Producing or trading in smuggled products, counterfeit products, or products of unknown origin or source;

b) Producing or trading in products that have not been issued a Product Registration Acceptance Certificate by a competent state management agency in Vietnam or have not conducted self-declaration or declaration of applicable standards or registration for conformity declaration;

c) Failing to recall products in violation of notifications from competent state authorities;

d) Producing or trading in health food products at facilities without a certificate of compliance with Good Manufacturing Practices (GMP) for health food products;

f) Producing or trading in medical nutrition foods, special diet foods, nutritional products for children up to 36 months old, and dietary supplements (excluding dietary supplements containing only vitamins and minerals without health claims). at the facility without a certificate for Hazard Analysis and Critical Control Points (HACCP) system or Food Safety Management System ISO 22000 or International Food Standard (IFS) or Global Food Safety Standard (BRC) or Food Safety System Certification (FSSC 22000) or equivalent certification or Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) requirements;

e) Producing, trading products containing prohibited substances in health foods;

g) Importing, trading products or raw materials for food production that have been banned from circulation on the market by the producing country;

h) Producing, trading food with product components (excluding additives) not matching the declaration; having labels with false origin or place of manufacture information;

i) The declaration file uses fake documents, seals, or signatures;

k) Falsely declaring contents in the product declaration file;

2. After organizations and individuals have fully remedied violations and submitted a report to the competent state management agency to accept and process the registration declaration of the product announcement, the competent state management agency will continue to review and accept the registration declaration of the product announcement;

Chapter IV
IMPLEMENTING PROVISIONS

Article 14. Implementation clause

1. This Resolution takes effect from the date of issuance until the date when the Food Safety Law of June 17, 2010 is replaced but not later than February 28, 2027;

2. Products not specified in Clause 1, Article 5 of this Resolution must implement standard declarations according to the provisions of Article 23 of the Product Quality Law;

3. Regulations for registering advertising content for products specified in Clause 1, Article 7 of this Resolution:

a) Do not use images, equipment, attire, names, titles of healthcare units, hospitals, doctors, pharmacists, medical staff, patient opinions, statements, writings of doctors, pharmacists, medical staff to advertise food. Strictly prohibit advertising food that causes misunderstanding, exaggerating the effects of food as medicinal treatments or cures;

b) Influencers promoting functional food or nutritional products for children under 36 months old must clearly disclose their sponsorship relationships when advertising, except where such advertising is prohibited under Article 7 of the Advertising Law;

Article 15. Transitional Provisions

1. For product registration declaration files submitted before the effective date of this Resolution or food products already issued with a Registration Receipt for Declaration Announcement or dietary supplements transitioning from self-declaration to registration declaration:

a) Organizations and individuals are responsible for completing the product registration declaration file according to this Resolution within 24 months from the effective date of this Resolution;

b) The receiving agency is responsible for reviewing the file according to the provisions of Article 10 of this Resolution;

2. For products that were self-declared before the effective date of this Resolution, organizations and individuals are responsible for completing the standard declaration according to this Resolution within 12 months from the effective date of this Resolution;

3. Upon expiration of the periods specified in Clauses 1 and 2 of this Article, self-declaration files or product registration declaration files or Registration Receipts for Declaration Announcements will no longer be valid for production or importation, and products with Registration Receipts for Declaration Announcements produced within 24 months after the effective date of this Resolution, and self-declared products produced within 12 months after the effective date of this Resolution may continue to circulate until the end of their shelf life, and the product owner shall bear responsibility for those products;

Article 16. Responsibility for Implementation

1. Responsibilities of the Ministry of Health:

a) Organizing the receipt and management of files, issuing, and revoking Registration Receipts for Declaration Announcements for health foods;

b) Within 30 days from the date of issuing the Registration Receipt for Declaration Announcement, the receiving agency is responsible for providing testing methods for safety and quality indicators of the manufacturer's products to designated inspection facilities serving state management of food safety to implement sampling for market quality monitoring;

2. Responsibilities of the Provincial People's Committee:

a) Organizing the receipt and management of files, issuing, and revoking Registration Receipts for Declaration Announcements for medical nutrition, special diet foods, nutritional products for children up to 36 months old, and dietary supplements (excluding dietary supplements containing only vitamins and minerals without health claims);

Within 30 days from the date of issuing the Registration Receipt for Declaration Announcement, the receiving agency is responsible for providing testing methods for safety and quality indicators of the manufacturer's products to designated inspection facilities serving state management of food safety to implement sampling for market quality monitoring;

b) Organizing the receipt of standard application declaration files according to assigned levels;

c) The agency receiving the standard application declaration files is responsible for developing and implementing post-inspection plans for files after organizations and individuals complete the declaration, if non-compliant declarations are discovered, they shall be handled according to the law. Based on the allocated budget at the local level, annually, the agency develops inspection plans, allocates funds for sampling to monitor quality and safety indicators for products circulating on the market, focusing on high-risk groups such as children, the elderly, pregnant women, and patients. Based on monitoring results, post-inspections are conducted at production and trading establishments; if violations are found, they shall be handled according to the law.

3. The agency responsible for receiving and processing product registration files shall be responsible for issuing decisions to establish, develop principles for the organization and operational mechanisms of specialized sub-committees to review and issue certificates of receipt for product registration announcements, and the Certificate Issuance Committee for product registration announcements (if necessary).

4. Ministers, heads of ministerial-level agencies, heads of government-affiliated agencies, Chairpersons of provincial People's Committees, and relevant organizations and individuals shall be responsible for implementing this Resolution.

 

Place of Receipt:
- Central Party Committee Secretariat;
- Prime Minister, Deputy Prime Ministers;
- Ministries, ministerial-level agencies, agencies under the Government;
- People's Councils, People's Committees of provinces and centrally-administered cities;
- Central Party Office and Party Committees;
- General Secretary's Office;
- President's Office;
- Ethnic Council and Committees of the National Assembly;
- National Assembly's Office;
- Supreme People's Court;
- Supreme People's Procuracy;
- State Audit Office;
- Vietnam Fatherland Front Central Committee;
- Central agencies of political-social organizations;
- VPCP: BTCN, all PCN, Assistant PM, Director General of the Government Portal,

various Departments, Bureaus, subordinate units, Official Gazette;
- To be filed: VT, KGVX (2b).

PRIME MINISTER

DEPUTY PRIME MINISTER

DEPUTY PRIME MINISTER

 

Nguyen Sinh Nhat Tan

 

Le Thanh Long

ANNEX

(Attached to Resolution No. 66.13/2026/NQ-CP dated January 26, 2026 of the Government)

Standard Application Announcement

 

 

Form No. 01

Product Announcement

Form No. 02

Set of Documents for Product Registration Announcement for Health-Promoting Foods

Implementation Report of Production Projects of Supporting Industry Products Confirmed with Incentives

Set of Documents for Product Registration Announcement for Medical Nutrition Foods, Special Diet Foods, Nutritional Products for Children up to 36 Months Old, and Food Supplements (excluding food supplements containing only vitamins and minerals without health claims)

Form number 04

Certificate of Receipt for Product Registration Announcement

Form number 05

Test Result Sheet

Form number 06

ANNOUNCEMENT OF APPLIED STANDARDS

 

 

Form No. 01

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
________________________________________

 

Number: …../Name of Enterprise/Year of Announcement

I. Information on the Organization or Individual Announcing the Product

Name of Organization or Individual: …

Legal Representative of the Organization or Individual: …

Address of the Organization or Individual: …

Email: …

Telephone: …Fax: …

Business Registration Number: …

Food Safety Permit Number: …Date of Issue/Issuing Authority: …(for establishments required to obtain a Food Safety Permit under regulations)

II. Announcement of Applied Standards

1. Product Information

1.1. Product Name: …

1.2. Ingredients: …

1.3. Shelf Life of the Product: …

1.4. Packaging Specifications and Packaging Material: …

1.5. Name and Address of the Product Manufacturer: …

2. Information on the Announced Basic Standard

2.1. Code, Date of Issuance, Issuing Unit of the Announced Basic Standard (Basic Standard Document and Basic Standard Construction File attached).

2.2. Quality Indicators and Safety Indicators of the Product: …

III. Product Label Sample

(attached product label sample or proposed product label sample) We hereby commit to fully comply with all laws related to food safety and take full responsibility for the legal validity of the announcement filing and the quality and safety of the announced product.

…, day…. month…. year…

 

 

REPRESENTATIVE OF THE ORGANIZATION OR INDIVIDUAL
Number: ………
(Signature, stamp)

Form No. 02

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
_______________________________________

ANNOUNCEMENT DOCUMENT

Name of Organization or Individual: …

Name of Organization or Individual: …

Legal Representative of the Organization or Individual: …

Food Safety Permit Number: …Date of Issue/Issuing Authority: …

Email: …

Telephone: …Fax: …

E-mail: …

Business Registration Number:...

(for establishments required to obtain a Food Safety Permit under regulations)

II. Product Information

1. Product Name: …

2. Ingredients: …

3. Product Quality Indicators: …

4. Shelf Life of the Product: …

5. Packaging Specifications and Packaging Material: …

6. Name and Address of the Product Manufacturer: …

IV. Requirements for Quality and Food Safety

(attached product label sample or proposed product label sample) We hereby commit to fully comply with all laws related to food safety and take full responsibility for the legal validity of the announcement filing and the quality and safety of the announced product.

1. Announcement in compliance with the basic standard as stipulated in Article 23 of the Law on Product Quality and Related Guidance Documents (Basic Standard Document and Basic Standard Construction File attached).

2. Announcement meeting food safety requirements according to:

- National Technical Regulations No...; or

- Circulars of Ministries and Sectors; or

- Local Technical Regulations; or

- National Standards (in cases where there are no national technical regulations, circulars of ministries and sectors, local technical regulations); or

- Codex Alimentarius Commission standards, regional standards, foreign standards (in cases where there are no national technical regulations, circulars of ministries and sectors, local technical regulations, national standards); or

- Basic Standards (in cases where there are no national technical regulations, circulars of ministries and sectors, local technical regulations, national standards, Codex Alimentarius Commission standards, regional standards, foreign standards).

V. Explanation of Product Components

In cases where the product contains vitamins and minerals, the organization or individual must provide information on the maximum tolerable intake levels and RNI levels for vitamins and minerals according to the table below:

Table 1 - Information on Maximum Tolerable Intake Levels and RNI Levels for Vitamins and Minerals

Vitamin/Mineral

From … to … years old

Age Group

Daily Dosage or Usage Amount

Daily Dosage or Usage Amount

Daily Dosage or Usage Amount

Maximum Tolerable Intake Level/Daily

 

 

 

RNI

 

 

 

For health-promoting foods, the components include product ingredients and additives. Quantitative ingredient labeling does not apply to additives. Organizations or individuals must provide information on product components according to the following table:

Male

 

 

 

Female

 

 

 

Table 2 - Information on Product Components

Component Name

No.

Daily Usage Amount

Amount in Documentation/Daily

% Compared to Documentation

Documentation Used

Function

Warnings/Contraindications (if applicable)

Use the information declared in the above table for product registration announcement purposes.

1

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Note: We hereby commit to fully comply with all laws related to food safety and take full responsibility for the legal validity of the announcement filing and the quality and safety of the announced product and will only produce and market the product after obtaining a Certificate of Receipt for Product Registration Announcement.

…, day…. month…. year……

 

 

SET OF DOCUMENTS FOR PRODUCT REGISTRATION ANNOUNCEMENT
Number: ………
(Signature, stamp)

Implementation Report of Production Projects of Supporting Industry Products Confirmed with Incentives

NAME OF THE ORGANIZATION, INDIVIDUAL
_____________

SOCIALIST REPUBLIC OF VIET NAM

Independence - Freedom - Happiness

_______________________________________

 

 

HEALTH-PROMOTING FOODS …

I. Product Name and Name of the Organization or Individual Registering the Announcement

 

II. General Structure of the Set of Documents

II. General Structure of the Dossier;

Table of contents for the list of documents in the dossier.

III. General Information

Product announcement.

IV. Legal Documents

1. Certificate of Free Sale or Certificate of Exportation or Health Certificate or other relevant certificates issued by the competent authority of the exporting country or exporter for exported food products (applicable to imported health foods) (legalized consular copy or electronic version with self-search results from the official website or English database of the issuing authority or competent authorities of the countries and stamped with confirmation seal of organizations or individuals).

2. Certificate of Good Manufacturing Practice (GMP) or equivalent certification for the food production facility or imported health food product (certified copy stamped by organization or individual or electronic version with self-search results from the official website or English database of the issuing authority or competent authorities of the countries and stamped with confirmation seal of organization or individual).

3. Power of attorney for registering the product announcement from the manufacturing facility or product owner (in case of authorized registration) (certified copy stamped by organization or individual and original presented for verification upon submission or receipt of administrative procedure result or certified electronic copy).

4. Intellectual property rights certificate (if applicable).

V. Product Labeling Samples and User Guide

1. Product Labeling Sample

- Design of label attached to commercial packaging;

- Containing all mandatory information as prescribed.

2. User Guide (if applicable)

Presented in written form accompanying the product, including:

- Ingredients;

- Product functions;

- Target users;

- Dosage instructions;

- Usage method and timing;

- Allergy warnings, interaction warnings, precautions, contraindications (if applicable);

- Storage conditions;

- Packaging specifications;

- Shelf life of finished products and within shelf life for high-risk products such as multi-dose liquid preparations (syrup, solution, suspension, gel, etc.) (if applicable);

- Stating the phrase: "This food is not medicine and does not replace medical treatment".

3. Commitment to the accuracy of labeling and usage guide information

Signed and confirmed by representatives of organizations or individuals that the information does not mislead consumers and is consistent with submitted documents.

4. Complete packaging image sample (if applicable).

- Can submit scanned or photographed trial printed packaging (with three sides) if available;

- Must be consistent with the design presented in the dossier.

VI. Report on Research and Development Process of the Product

1. Product Development Report

- Explanation of the selection of formula components for function, other ingredients (if any) and excipients;

- Study on interactions between product components and excipients, packaging, and direct contact utensils conducted by organizations or individuals or summarized literature;

- Overview of completed tests (internal, clinical - if applicable).

2. Explanation of each component's origin and function contributing to the overall product function

- Clearly state the origin of components (synthetic, plant, animal, mineral, microorganism);

- Explain the role of each component in the formula and its contribution to the product's function;

- Explain why the product is intended for the target groups listed on the label and the rationale behind the recommended dosage.

3. Scientific evidence proving the product's function or the function of components announced (citing scientific evidence related to function and dosage) (certified copy stamped by organization or individual).

4. Clinical trial report for the product (if applicable).

5. Commitment that all product components and excipients do not fall under the prohibited list for use in food and health food production and trade. - Column (7): Land area in land allocation decisions, lease decisions, or documents of the competent authority or actual land area managed and used (applicable to assets that are buildings and land). VII. Documentation on Quality Standards and Safety

1. Product Safety and Quality Standards

1.1. Product safety standards (heavy metal limits, microbiological indicators, and other toxins if applicable)

1.2. Product quality standards

- Clearly specify sensory indicators (state, color, taste, etc.), other characteristics if applicable;

- Quantify active ingredient components (vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, or other biologically active substances) contributing to the product's function;

- For components contributing to the product's function originating from plants, minerals, microorganisms, animals:

+ If there are national standards or regulations approved by the competent food authority regarding qualitative and quantitative indicators, these must be included;

+ If there are no national standards or regulations regarding qualitative and quantitative indicators, organizations or individuals must establish and apply their own base standards.

1.3. Methods for testing product quality

1.4. Test results sheet for the product including safety and quality indicators

2. Quality Standards for Each Product Component

May follow the manufacturer's base quality standards or national standards, ISO, pharmacopoeia (if applicable).

2.1. Names of components forming the product

2.2. Quality standards for components contributing to the product's function

- Clearly specify sensory indicators (state, color, taste, etc.), other characteristics if applicable, quantify active ingredient components (vitamins, minerals, or other biologically active substances added) contributing to the product's function;

- For components contributing to the product's function originating from plants, minerals, microorganisms, animals: must include qualitative and quantitative indicators if there are national standards or regulations regarding qualitative and quantitative indicators for these components or if there are approved qualitative and quantitative methods for these components by the competent food authority.

2.3. Standards for excipient components

3. Information on materials for direct contact packaging (primary packaging)

3. Information on Direct Contact Packaging Materials with the Product (Primary Packaging);

3.1. Description of packaging type used

- Clearly state the type of direct contact packaging with the product: bottle, jar, bag, blister pack, aluminum foil film...

- Material: plastic (PP, PE, PET...), glass, metal, paper, composite film...

3.2. Information on material components

Main composition of the packaging (for example: 100% PET, or outer layer PET, inner layer PE, middle layer aluminum foil).

3.3. Standards for packaging that directly contacts the product (primary packaging)

VIII. Documentation on production process

1. Composition (formula) for one unit of packaging or smallest dosage form and for one production batch

- Clearly state the name of each component (product ingredients and excipients);

- Clearly state the quantity or range of quantity for components contributing to efficacy;

- Classify the function of components: efficacy components, formula stabilizing components including antioxidant components, components preventing interaction between efficacy components, other product components, excipients (thickening agents, lubricants, coloring agents, flavoring agents, taste modifiers...).

2. Summary production process flowchart

A block diagram (flowchart) showing the entire production process - Clearly indicate critical control points (CCPs).

3. Production process description and production conditions

- Briefly describe each step: from raw materials → preliminary processing → mixing → shaping → packaging

- Include auxiliary processes such as drying, grinding, filling, packaging treatment...

- If the product uses new technology (nano, liposome, phytosome...), provide quality documentation, including: technological process, quality standards, stability of raw materials, intermediate products, and finished products. Additionally, provide toxicity and safety data for raw materials, intermediate products (if applicable).

4. Information on production equipment and production conditions

- List of main equipment used (state machine type, equipment and role of equipment in the production process, not required to state trade name or serial number of machines);

- Environmental conditions in the production area at each production stage (temperature, air humidity...).

5. In-process control (IPC) during production

Some inspection criteria during production (IPC): Moisture content of powder or uncoated tablets, active ingredient content (if quantified) in one semi-finished product unit, hardness, disintegration time, abrasion resistance (for tablets), density with syrup...

IX. Report on product stability research results

Stability study under storage conditions (long-term) (30°C, 25°C) to determine shelf life and expiration date of the finished product. Conduct accelerated aging studies (severe, forced conditions) (40°C / 75% RH (Relative Humidity - relative humidity of air)) of the product to predict the stability of the formulation, except for products containing heat-sensitive components like enzymes, probiotics... Encourage organizations and individuals to conduct stability studies after opening the container (or during usage period - stability in use) for high-risk products such as multi-dose liquid formulations (syrup, solution, suspension, gel).°C, 25°C) to determine the shelf life and expiration date of the finished product. Conduct accelerated aging studies (severe, forced conditions) (40°C / 75% RH (Relative Humidity - relative humidity of air)) of the product to predict the stability of the formulation, except for products containing heat-sensitive components such as enzymes, probiotics... It is encouraged that organizations and individuals study the stability of the finished product after opening the container (or during the period of use - stability in use) for high-risk products such as multi-dose liquid formulations (syrup, solution, suspension, gel).

For products already granted registration acceptance certificates, only provide reports on long-term storage stability studies.

X. Other documents

In addition to the documents specified in point a, b, c, d, đ, e, g Clause 2 Article 8, 9 of this Resolution, organizations and individuals may submit other documents to explain, clarify, and prove the contents included in the application dossier.

Form number 04

NAME OF THE ORGANIZATION, INDIVIDUAL
____________

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness

_______________________________________

 

 

HEALTH-PROMOTING FOODS …

MEDICAL NUTRITIONAL FOODS, FOODS FOR SPECIAL DIETARY USE, NUTRITIONAL PRODUCTS FOR CHILDREN UP TO 36 MONTHS OF AGE, FUNCTIONAL FOODS (excluding functional foods containing only vitamins and minerals without health claim announcements)...

SPECIAL DIETARY PRODUCTS, NUTRITIONAL PRODUCTS FOR CHILDREN UP TO 36 MONTHS OF AGE, FOOD SUPPLEMENTS (excluding food supplements containing only vitamins, minerals and without health claim declarations)...

 

II. General Structure of the Set of Documents

II. General Structure of the Dossier;

Table of contents for the list of documents in the dossier

III. General Information

Set of Documents for Product Registration Announcement for Health-Promoting Foods

IV. Legal Documents

1. Certificate of Free Sale (Certificate of Free Sale) or Certificate of Exportation (Certificate of Exportation) or Health Certificate (Health Certificate) or other relevant certificates issued by the competent authority of the producing or exporting country for exported food products (applies to imported products) (legalized copy or electronic version with self-search results from the issuing agency's or authorized foreign agencies' official website or database in English and stamped by the organization or individual);

2. Certificate of Hazard Analysis and Critical Control Point (HACCP) system or Food Safety Management System ISO 22000 or International Food Standard (IFS) or Global Food Safety Standard (BRC) or Food Safety System Certification (FSSC 22000) or equivalent certification or Certificate of Food Safety Conditions regarding Good Manufacturing Practices (GMP) for dietary supplements, medical nutrition foods, and special diet foods (stamped copy of the organization or individual or electronic version with self-search results from the issuing agency's or authorized foreign agencies' official website or database in English and stamped by the organization or individual);

3. Power of attorney for product declaration registration from the food product manufacturer or owner (in cases where authorization is granted for registration) (certified copy stamped by the organization or individual and original presented for verification upon submission or receipt of administrative procedure results or certified electronic copy);

4. Intellectual property rights certificate (if applicable).

V. Product Labeling Samples and User Guide

1. Product Labeling Sample

- Design of label attached to commercial packaging;

- Containing all mandatory information as prescribed.

2. User Guide (if applicable)

Presented in written form accompanying the product, including:

- Ingredients;

- Purpose of the product for medical nutrition foods, special diet foods, and nutritional products for children up to 36 months old. For dietary supplements (excluding those containing only vitamins and minerals), only record the additional components declared with health claims;

- Target users;

- Dosage instructions;

- Usage method and timing;

- Allergy warnings, interaction warnings, precautions, contraindications (if applicable);

- Storage conditions;

- Packaging specifications;

- Product shelf life.

3. Commitment to the accuracy of labeling and usage guide information

Signed and confirmed by representatives of organizations or individuals that the information does not mislead consumers and is consistent with submitted documents.

4. Complete packaging image sample (if available)

- Can submit scanned or photographed trial printed packaging (with three sides) if available;

- Must be consistent with the design presented in the dossier.

VI. Report on Research and Development Process of the Product

1. Product Development Report

- Explanation of the selection of formula ingredients forming the product component (if applicable) and additives;

- Overview of completed tests (internal, clinical - if applicable).

2. Description of product components, origin, and purpose of each component

- Clearly state the origin of components (synthetic, plant, animal, mineral, microorganism);

- Clearly explain the function of each ingredient in the formula;

- Explain why the product is intended for the target groups listed on the label and the reasons for the recommended usage amount as stated on the label;

3. Scientific evidence proving the efficacy of the product or the components that create the declared efficacy for medical nutrition foods, special diet foods, and nutritional products for children up to 36 months old (citing scientific evidence related to efficacy and recommended usage amounts) or Scientific evidence proving the health claim of the supplement component for dietary supplements (excluding those containing only vitamins and minerals without health claims) (certified copy stamped by the organization or individual);

4. Clinical trial report for the product (if available)

5. Commitment statement that all components do not fall within the prohibited use list - Column (7): Land area in land allocation decisions, lease decisions, or documents of the competent authority or actual land area managed and used (applicable to assets that are buildings and land). in food production and business

VII. Documents on quality and safety

1.1. Product safety standards (heavy metal limits, microbiological indicators, and other toxins if applicable)

1.1. Product safety standards (heavy metal content, microorganisms, mycotoxins, other pollutants... if applicable).

- Clearly specify sensory indicators (state, color, taste, etc.), other characteristics if applicable;

- Clearly state sensory criteria (state, color, taste...), other characteristics if applicable.

- Quantify active components (vitamins, minerals, or biologically active substances added).

The maximum daily dose of vitamins and minerals in the product according to the manufacturer's recommendation must not exceed the maximum tolerable intake levels of vitamins and minerals as stipulated by the Ministry of Health.

+ If there are national standards or regulations approved by the competent food authority regarding qualitative and quantitative indicators, these must be included;

+ If there are no national standards or regulations regarding qualitative and quantitative indicators, organizations or individuals must establish and apply their own base standards.

1.3. Methods for testing product quality

- Other quality criteria (if applicable)

- For nutritional products for children up to 36 months old and other products produced according to national standards: clearly indicate the national standard number replacing sections 1.1, 1.2, and 1.3 of this item.

1.4. Test results sheet for the product including safety and quality indicators

2. Quality Standards for Each Product Component

2. Quality standards for product components

May follow the manufacturer's quality standards or national standards, ISO, pharmacopoeia (if applicable)

2.2. Quality standards for components contributing to the product's function

2.2. Quality standards for components creating the product's efficacy

- Clearly state sensory criteria (state, color, taste...), other characteristics if applicable.

- Quantify active components (vitamins, minerals, or biologically active substances added) creating the product's efficacy.

+ If there are national standards or regulations approved by the competent food authority regarding qualitative and quantitative indicators, these must be included;

+ If there are no national standards or regulations regarding qualitative and quantitative indicators, organizations or individuals must establish and apply their own base standards.

1.3. Methods for testing product quality

2.3. Additive standards

- If food additives (flavor enhancers, stabilizers, preservatives...) are used, their names and standards must be clearly stated.

- Comply with corresponding technical standards or regulations.

3. Information on Direct Contact Packaging Materials with the Product (Primary Packaging);

3.1. Description of direct contact packaging and equipment

- Clearly state the type of packaging directly contacting the product: bottles, jars, bags, blister packs, aluminum foil...

- Material: plastic (PP, PE, PET...), glass, metal, paper, composite film...

3.2. Direct contact packaging standards for food

3.3. Commitment: all packaging used ensures food hygiene safety and guarantees that direct contact packaging does not interact to produce harmful substances for users.

VIII. Documentation on production process

1. Composition (Formula) for one production batch

- Clearly state the name of each component (product ingredients and excipients);

- Clearly state the quantity of components creating the efficacy for one production batch;

- Categorize component functions: product components, additives (coloring agents, flavor enhancers...).

2. Summary production process flowchart

Flowchart showing the entire production process - Clearly identify critical control points (CCPs).

3. Production process description and production conditions:

- Briefly describe each step: from raw materials → preliminary processing → mixing → dosing → packaging

- Include auxiliary processes such as drying, grinding, filling, packaging treatment...

- If the product uses new technology (nano, liposome, phytosome...), provide quality documentation including: technological process, quality standards, stability of raw materials, semi-finished products, and finished products. Additionally, provide toxicity and safety documentation for raw materials and semi-finished products (if applicable).

4. Information on production equipment and production conditions

- List of main equipment used (state machine type, equipment and role of equipment in the production process, not required to state trade name or serial number of machines);

- Environmental conditions in the production area at each production stage (temperature, air humidity...).

5. In-process control (IPC): certain critical indicators during the production process.

6. Commitment: to carry out the production process in accordance with Good Manufacturing Practices (GMP) standards or Hazard Analysis and Critical Control Points (HACCP) system or Food Safety Management System ISO 22000 or International Food Standard (IFS) or Global Food Safety Initiative (BRC) standard or Food Safety System Certification (FSSC 22000) and corresponding standards.

IX. Report on product stability research results

Stability study under storage conditions (long-term) (30°C, 25°C) to determine shelf life and expiration date of the finished product. Conduct accelerated aging studies (severe, forced conditions) (40°C / 75% RH (Relative Humidity - relative humidity of air)) of the product to predict the stability of the formulation, except for products containing heat-sensitive components like enzymes, probiotics... Encourage organizations and individuals to conduct stability studies after opening the container (or during usage period - stability in use) for high-risk products such as multi-dose liquid formulations (syrup, solution, suspension, gel).°C or 25°C or 2 - 8°C) to determine the shelf life of finished products. Additionally, for heat-resistant products, accelerated aging studies can be conducted under harsh conditions (40°C) to predict product stability during transportation, circulation, and distribution.

Encourage organizations and individuals to study the stability of finished products after opening (or during usage period - stability in use).

For products already granted registration acceptance certificates, only provide reports on long-term storage stability studies.

X. Other documents:

In addition to the documents specified in points a, b, c, d, đ, e, g Clause 3 Article 8, 9 of this Resolution, organizations and individuals may submit other documents to explain, clarify, and prove the contents included in the dossier.

Form number 05

NAME OF THE ADMINISTRATIVE AUTHORITY
NAME OF THE AUTHORITY RECEIVING PRODUCT REGISTRATION APPLICATION
____________

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
_____________________________________

SET OF DOCUMENTS FOR PRODUCT REGISTRATION ANNOUNCEMENT

 

CERTIFICATE OF RECEIPT FOR PRODUCT REGISTRATION APPLICATION

Number: …/year ……/DKSP

 

……… (Name of the authority receiving the registration application for the product announcement)……. confirms receipt of the Product Announcement from: …(name of the organization or individual responsible for bringing the product to market) address…telephone…Fax…Email …for the product:…produced by …(name, address of the place of production and country of production) …, conforming to technical regulations/requirements/standards... (number, code, name) …

The enterprise must bear full responsibility for the suitability of the announced product.

 

Place of Receipt:
- Organizations and individuals;
- To be filed:…

AUTHORIZED REPRESENTATIVE
OF THE AUTHORITY ISSUING THE CERTIFICATE
(Signature, stamp)

Form number 06

TESTING FACILITY/PRODUCTION FACILITY
____________

Number: …/…..

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness

______________________________________

 

TESTING RESULT FORM

TEST REPORT
(The test result is only valid for the sample tested)

1. Sample Name: (Write the name of the sample being tested)

2. Sample Code:

3. Place where the sample was sent: Address:

4. Place of production: Address:

5. Date of sample receipt:

6. Date of sample collection: Quantity of samples:

7. Testing time:

8. Sample description: (condition of the sample upon receipt, sample weight, date of production, expiration date, storage condition)

9. Sample retention time:

10. Accompanying documents: (clearly state the content, number, date, month, year of accompanying letters or documents)

11. Test results (the designated criteria by the testing facility):

No.

Test criterion

Testing Method

Unit

Results

Compared to …

 

 

 

 

 

 

 

 

 

 

 

 

12. Conclusion:...

(It is necessary to clearly state whether the sample meets the requirements or not)

13. Notes: - Column (7): Land area in land allocation decisions, lease decisions, or documents of the competent authority or actual land area managed and used (applicable to assets that are buildings and land).

 

REPRESENTATIVE OF THE TESTING FACILITY/PRODUCTION FACILITY
(Sign and write full name)

 

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