Health Supplement

CHANGES THAT REQUIRE RE-REGISTRATION OF HEALTH SUPPLEMENT PRODUCT ANNOUNCEMENT

To legally circulate health supplements (HS) in the Vietnamese market, businesses are required to register a product announcement dossier. According to Decree No. 15/2018/ND-CP, the product announcement for HS products is valid indefinitely, meaning companies only need to register once per product.

However, during business operations, if there are any changes related to the product, companies must clearly determine whether the change requires only a supplementary notification or a complete re-registration. Understanding these regulations helps businesses avoid violations and risks during post-market inspections by authorities.

1. Changes That Only Require Supplementary Notification

In the following cases, businesses only need to submit a written notification of changes to the relevant authority:

  • Change of company name 
  • Change of head office address 
  • Change of legal representative stated in the Business Registration Certificate 
  • Minor corrections such as spelling errors in the initial registration dossier 

2. Changes That Require Re-Registration of Product Announcement

If there are significant changes that affect the essential characteristics of the product, companies must re-register the product announcement, including:

  • Change of product name 
  • Change in product composition 
  • Change in product functions, target users, or usage warnings 
  • Change of product origin 

3. Procedure for Registering the Product Announcement

For changes requiring only supplementary notification, businesses must prepare the following documents:

  • An official letter explaining the changes 
  • Supporting documents evidencing the changes 

After submitting the notification, the company may continue production and business activities.

For cases requiring re-registration of product announcements, companies must follow the proper procedure and submit the application via the Public Service Portal.
The dossier review period is counted from the date the application is submitted online or from the date received if submitted by post or in person.

If the dossier does not meet requirements, the competent authority will issue a request for amendment/supplementation, and may only request once.

Businesses must submit the amended dossier within 90 working days. Otherwise, the dossier will become invalid. Companies must pay the dossier appraisal fee according to the applicable laws on fees and charges.

Important Note:
 A fine ranging from VND 20 million to VND 30 million shall apply for any of the following violations:

a) Failing to re-register the product announcement when there are changes to the product name, origin, or composition as required by law;
 b) Failing to notify changes in writing to the competent authority after registration, or submitting inaccurate notifications, or lacking supporting documents as prescribed by law.

4. Important Notes When Preparing Product Announcement Dossiers for Health Supplements

To avoid risks and mistakes when submitting dossiers, businesses should pay attention to the following:

  • CFS (Certificate of Free Sale) must be legalized and can sometimes be substituted with EC/HC documents.

The CFS must include at least the following information:

 

  • Name of the issuing authority/organization 
  • Certificate number and issuance date 
  • Product name 
  • Product type or group 
  • Manufacturer’s name and address 
  • A statement that the product is manufactured and freely sold in the country of production or the country issuing the CFS 
  • Full name, signature of the issuer, and official stamp of the issuing authority/organization 
  • GMP certificate must still be valid at the time of registration. 
  • For the product standard sheet: 
  • List ingredients in descending order by weight. 
  • For herbal ingredients, provide the scientific (Latin) names. 
  • For vitamins, indicate the form according to Circular No. 44/2015/TT-BYT, and ensure the daily dosage does not exceed the Tolerable Upper Intake Levels (ULs). 
  • For excipients, specify the group of additives (e.g., anti-caking agents like Talc).
     Particularly for colorants, flavorings, and sweeteners, specify whether they are natural, nature-identical, synthetic, or artificial. 

For free consultation on dossier preparation and registration procedures for medical devices, health supplements, cosmetics, and pharmaceuticals, please contact our hotline at 098.546.1894.