The procedure for registration for imported health supplements

Health Supplements are defined in Clause 1, Article No. 3 of the Decree No. 15/2018/ND-CP of the Government detailing the implementation of a number of articles of the Law on Food Safety, whereby, Health Supplements mean the products used as a supplement to the daily diet to improve user’s health and immunity.

With the important role of Health Supplements at the same time, it also has the general characteristics of food which are products that people eat and drink in fresh form or have been preliminarily processed, processed, etc preservation, therefore, the impact of Health Supplements on the safety of users’ health can be seen as quite special and important.

Therefore, the laws and regulations regulating the management of business activities of individuals and organizations producing, importing and trading this group of products is also quite strict.

Current legal regulations require that, before importing Health Supplements from abroad into Vietnam for business and distribution, the individuals, organizations need to carry out procedures for registration of the declaration at a competent state agency to be granted the circulation license for the products which is expected to import them into Vietnam (Clause 1, Article 6 of the Decree 15/2018/ND-CP).

The procedures for product registration shall be carried out according to the following steps:

– Step 1: Individuals and organizations importing products contact the manufacturers, product owners abroad to request the required technical documents from these units in accordance with the law. Request these units to consular legalize some documents required by law.

– Step 2: Conducting the product testing of the safety criteria of the product which shall be imported into Vietnam. Carrying out notarized translation of technical documents related to the product if such documents are presented in a foreign language.

– Step 3: Drafting the registration dossier. Checking, comparing and completing the registration dossier.

– Step 4: Signing and sealing the documents. Preparing a full registration dossier with the technical documents as prescribed in Clause 1, Article No. 7 of Decree No. 15/ND-CP to submit the registration dossier. The registration dossier includes:

• The signed, sealed declaration which has been made according to the form of the regulation;
• The Certificate of Free Sale, Certificate of Exportation or Health Certificate issued by a competent authority of the country of origin/exporting country, which assures safety of users or permit free sale of the products in the country of origin/exporting country (the certificate must be consularly legalized);
• Original copy or certified true copy of the food safety data sheet issued within 12 months before the self-declaration is made by an designated laboratory or a laboratory complying with ISO 17025; the data sheet must specify safety indicators prescribed by the Ministry of Health according to risk management principles under international regulations (or standards applied by the supplier if relevant regulations of the Ministry of Health are not available);
• Documents about scientific evidence of the effects of the product or ingredients (original or authenticated copy). If scientific evidence of effects of the ingredients is used, the daily dose must be greater or equal to 15% of the content of such ingredients mentioned in the document;
• The certificate of Good Manufacturing Practice (GMP) or an equivalent certificate if the imports are dietary supplements (a copy authenticated by individual, organizations);

– Step 5: Submitting the registration dossier on the registered account of the individuals or organizations. Making a Payment of Government fees for verification of registration dossiers.

– Step 6: Waiting for the appraisal results from the competent state agency.

Note: The registration dossiers are submitted to the Food Administration – Ministry of Health. The timeline for appraisal of the registration dossier is 21 working days from the date of submission of all valid documents. In case the registration dossier is requested to be amended or supplemented, the individuals, organization must amend and supplement the revised registration dossier to the competent authority within 90 days from the date of receipt of the written request for amendment and supplementation (Article No. 8 Decree No. 15/2018/ND-CP).

Above is some information we provide on the basis of legal provisions and the practice of registration for imported Health Supplements products. Based on that, the individuals, organizations may consider, refer and better prepare for their product registration.

Date Written: 20/07/2025

Share: