PROCEDURES FOR DECLARATION OF DOMESTICALLY PRODUCED HEALTH SUPPLEMENTS

Health supplements is one of the functional foods used to add to the daily diet to maintain, enhance and improve the functions of the human body, and reduce the risk of diseases. Therefore, more and more pharmaceutical companies trading health supplements were born to meet the increased demand for these items. To trade this type of food, one of the issues that enterprises have to pay attention to is the procedure of publication of health supplements. The requirements for procedures and documents of items imported from abroad will be different from those domestically produced. To the extent of this article, LVI Law Firm will provide readers with the process of declaring domestic health supplements.

1. Conditions for the declaration of health supplements

According to the Law on Food Safety and Decree No.15/2018/ND-CP elaborating some articles of the Law on Food Safety: Health food businesses must apply for product announcement before putting it on the market at the Department of Health or Ministry of Health.

Conditions of the establishments:

Organizations carrying out the publication procedures have to have business registration, have a profession in producing and trading food;

The health supplement suppliers must ensure that they meet food safety conditions and obtain, in particular, one of the following certifications: The certificate of Good Manufacturing Practice (GMP)

Conditions of products:

The product has to be tested for quality to ensure compliance with the safety criteria prescribed by the Ministry of Health according to risk management under international regulations (or standards applied by the supplier if relevant regulations of the Ministry of Health are not available).

2. Composition of documents for publication of supplements

The product declaration is specified in Form No. 02 of Appendix I enclosed with Decree No. 15/2018/ND-CP;

Original copies or certified copies of food safety test data sheet (within 12 months up to the date of submission of the application) issued by a designated laboratory or a laboratory complying with ISO 17025, including 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);

Scientific evidence of the effects of the products or ingredients (originals or authenticated copies). When using scientific evidence of the effects of the ingredients, the daily dose of the product must be at least greater than or equal to 15% of the amount of such ingredient stated in the document.

The certificate of food safety if one is required (a authenticated copy by the supplier);

The certificate of Good Manufacturing Practice if the domestic health supplements applicable from July 1, 2019 (authenticated copies of suppliers).

The documents in the registration dossier of the product announcement must be expressed in Vietnamese; in case there are documents in a foreign language, they must be translated into Vietnamese and notarized. The document must be valid when the product declaration registration dossier is submitted.

3. Order of announcing health supplements

Step 1: Apply for registration of product announcement via the online public service system or by post, or directly, to the following receiving authorities:

Ministry of Health if the products are health supplements, mixed food additives with new uses, and food additives that are not included in the list of additives permitted to be used in food determined by the Minister of Health;

If the suppliers have more than one factory producing the same product, they shall only register the application to a regulatory authority of one of the provinces of suppliers’ choices (except for products registered at the Ministry of Health). Once selected, subsequent registrations must be submitted to the same authority.

Step 2: Within 21 working days (for health supplements), the receiving authority is responsible for verifying the dossier and issuing a certificate of registered product announcement. The time to evaluate the dossiers is counted from when the dossiers are submitted on the online public service system or follow a date stamp of the receiving authority (if the application is submitted by post or in-person).

If there is a disagreement with the product announcement dossier of the suppliers or a request for amendment or supplement, the receiving authority has to make a document clearly stating the reasons and legal grounds for the request. The receiving authority may only request amendments and supplements once.

Within 07 (seven) working days from the date of receipt of the amended and supplemented dossier, the receiving authority shall appraise the dossier and give a written reply. After 90 working days from the date of receipt of a written request for amendment and supplementation, if the organization or individual does not amend or supplement the dossier, the dossier is no longer valid.

4. The state authority has the authority to publish health supplements: Safety Department - Ministry of Health.

Hopefully, the sharing of LVI Law Firm on the content of the procedure for declaring domestic health supplements will be helpful to readers. If you have any questions, please contact us for timely advice and answers. Best regards!