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What is needed to declare a health supplement?


According to Decree 15/2018/ND-CP, health supplements fall under the category that, before being marketed, must be declared to, inspected and evaluated by the Ministry of Health for quality before circulation. So, what are the procedures for health supplement declaration? To gain a deeper understanding of this matter, TIN Holdings kindly refer the businesses to the following article.

Why register a health supplement declaration ?

As material living standards improve, health care matters are receiving more attention. Currently, health supplements are of interest to a number of people who seek to use them for themselves and their family members with the aim of protecting and enhancing health.

Therefore, to protect consumers’ rights and health and facilitate control by regulatory bodies, businesses are required to declare their health supplements before entering the market. Failure to do so will result in penalties and legal responsibilities.

Declaring product quality is not only a responsibility but also promotes better business operations. Products that are declared receive more attention, build trust, and customers feel more secure when choosing and using them.

Dossier for health supplement declaration

  • Health supplement declaration form
  • Detailed information of product to be declared: composition, images, expiry date, production date, quantitative composition, weights or volumes, etc.
  • Enterprise registration certificate (02 notarized copies)
  • Product testing report (In cases where the product has not been tested, TIN Holdings assists businesses in sending samples for testing at recognized laboratories or designated by state authority).
  • Certificate of food safety.
  • Dossier for product efficacy

Registration of health supplement declaration is as follows:

Step 1: Individuals or organizations prepare a complete dossier as above and submit it to the Ministry of Health.

Step 2: The Ministry of Health receives and processes the dossier

  • For complete and valid dossier as per regulations, it will be accepted and a Receipt of dossier issued.
  • For incomplete or invalid dossier, guidelines will be provided for the individual or organization to supplement and complete the dossier.

Step 3: Within 30 working days from the receipt of the complete product declaration dossier, the Ministry of Health is responsible for appraising the dossier and issuing a Receipt of product declaration to the enterprise.

Health supplements must be declared before being marketed

Process of health supplement declaration

  • Consulting on legal matters related to the health supplement declaration
  • Entering into a transaction contract with clients requiring product declaration;
  • Collecting, compiling necessary information and documents;
  • Setting criteria and conducting product quality testing at the testing center;
  • Monitoring and receiving the testing report on behalf of the clients;
  • Compiling the product declaration dossier and handing it over to the client for signature and seal;
  • Submitting the Product Declaration dossier to the Department of Food Safety;
  • Updating the product declaration dossier on the website of the Department of Food Safety;
  • Handing over to the client upon completing the quality declaration dossier.

Time for health supplement declaration

  • Product testing period is from 07 to 10 working days
  • Time for processing the declaration dossier: 30 working days
  • Authority: Department of Food Safety

For details about the Health supplement declaration (domestically produced and imported health supplements), please contact TIN Holdings for advice and guidance.