What is a health supplement?

The concept of a health supplement?

(According to Article 3, Decree No. 15/2018/NĐ-CP issued on February 2, 2018: Detailed regulations for the implementation of some provisions of the Food Safety Law)

Health Supplements are those that are added to the daily diet to maintain, enhance, and improve the functions of the human body, reducing the risk of diseases. These products contain one or more of the following substances:

a) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other biologically active substances;

b) Naturally sourced substances, including those from animals, minerals, and plants in the form of extracts, isolates, concentrates, and transformations;

c) Health Supplements are formulated in the form of soft/hard capsules, tablets, film-coated/sugar-coated tablets, granules, powder, liquid, and other formulations, and are dosed into small units, depending on the formulation of the product.

 

Why is it necessary to register the declaration of health supplement?

Nowadays, there is a growing concern for health, and the consumer demand for health protection is increasing. To ensure the safety and quality of health supplements, Vietnamese law stipulates that all health supplements intended for production or importation for circulation in the market must undergo registration and declaration with the Department of Food Safety. The registration process is outlined in Decree 15/2018/NĐ-CP.

Online Registration Procedure for Health Supplement Declaration

Step 1: Prepare a complete set of documents for product declaration registration.

Step 2: Log in to the company’s account and submit the application to the Department of Food Safety – Ministry of Health on the website: https://nghidinh15.vfa.gov.vn/. Pay the evaluation fee.

Step 3: Within 21 working days for the initial successful submission on the website and 7 days from receiving modification or supplementation, the competent authority will review the application and notify the result on the system.

Step 4: If the application is approved, a certificate of acceptance for the registration of the health supplement declaration will be issued. If not approved, the competent authority will issue an official dispatch specifying the required modifications, and the business must make the necessary adjustments and resubmit the documents to the Department (approved files will be issued the certificate for product declaration)

To receive consultation on dossier services and procedural process for declaring health supplements, please contact Hotline: 098.546.1894