PROCEDURE TO ANNOUNCE IMPORTED HEALTH/ DIETARY SUPPLEMENTS

In order to conduct health/dietary supplement, one of the essential factors that businesses need to pay attention to is the product announcement procedure. There are different requirements in procedure for imported items and domestically produced items. In this article, LVI Law Firm will provide readers with the process of declaring imported health protection products.

1. Conditions to announce health supplements

A Certificate of Exportation or a Certificate of Medical Examination provided by the authority of the exporting country to ensure that the products are freely traded in the exporting country.

A product announcement as prescribed in Form No. 02, Appendix I together with Decree No. 15/2018/ND-CP published by the Government.

A certificate of food safety test results of the product within 12 months until the day of by the designated testing laboratory or qualified testing laboratories according to ISO 17025 including safety criterias promulgated by the Ministry of Health (original or certified copy).

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;

A GMP Certificate or an equivalent certificate in case the imported product is a health supplement applied from July 1 2019 (certified copy).

2. Contents of required documents for declaration of health/dietary supplements

The product announcement specified in Form No. 02, Appendix I of Decree 15/2018/ND-CP;

Certificate of Free Sale or Certificate of Exportation or Health Certificate performed by a competent authority of the exporting country to ensure safety for users or to prove that products are freely traded in the market of the producing/exporting country (consular legalization);

Original copy or certified true copy of the food safety data sheet of the product within 12 months until the day of by the designated testing laboratory or qualified testing laboratories according to ISO 17025 including safety criterias promulgated by the Ministry of Health (original or certified copy).

Scientific evidence to prove the use of the product or the use of the ingredients that create the announced uses (the original or a certified copy). While using the ingredients scientific evidence to create the use of the product, the daily dose of the product must be at least equal or over 15% of the use of that ingredient stated in the brochure.

A GMP Certificate or an equivalent certificate in case the imported product is a health supplement applied from July 1 2019 (certified copy).

3. Process to announce health/dietary supplements

Step 1: Organizations and individuals that produce and trade goods shall submit an registration application of the product announcement via the online public service system or by post or directly to the Food Safety Department.

Step 2: Within 21 days testing effects of the products, the Food Safety Department shall qualify the products record according to regulations. The process of qualifying products starts at the moment the product files are submitted on the online public service system or to the receiving authority (on condition that files are submitted by post or directly).

Step 3: In case companies or individuals disagree with the product announcement file or demand for modification and supplement, the Food Safety Department is required to provide documents clearly stating reasons and legal basis coming from the requests. The receiving authority may request the applicant to supplement the application 01 time.

Within 07 days from the date of receiving documents of supplementation and amendment, the Food Safety Department shall appraise the documents and give a written reply. Subsequently 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 documents are no longer valid.

In case a product has a change in product name, origin or composition, the organization or individual must re-announce the product. In case of other changes, the organization or individual shall notify in writing of the changed content to the application-receiving authority specified in Clause 1, Article 8 of Decree No. 15/2018/ND-CP and receive permission to do so. produce and trade products right after sending the notice.

The authority that receives the application for registration of the product announcement shall publicly announce the name and product of the organization or individual that has received the registration of the product announcement on the website. and its food safety database.

4. The authorized authority that responsible for announcing valid health supplements

Food Safety Department - The Ministry of Health is the authority that receives, evaluates, and decides to announce health-protecting foods.

Hopefully, readers will find the information about the procedure of declaring health supplements from LVI Law Firm helpful. If you have any questions, please contact LVI Law Firm so we can provide you with a team of lawyers and legal experts to support you as soon as possible. Best regards!