Products subject to declaration registration in Vietnam

Specifically, according to Article 6 of Decree No. 15/2018/NĐ-CP of Vietnam’s Government, food suppliers must register the declarations of the following products:

- Dietary supplements, medical foods, food for special dietary uses.

- Dietary products for children up to 36 months.

- Mixed food additives with new uses, food additives that are not on the list of permitted food additives or not used for intended foods as prescribed by the Ministry of Health.

Application for registration of the product declaration is prescribed as follows:

- An application for regulations of the declaration of imported products consists of:

+ The declaration form (Form No. 02 in Appendix I hereof);

+ The Certificate of Free Sale, Certificate of Exportation or Health Certificate issued by a competent authority of the country of origin/exporting country, which assures safety of users or permit free sale of the products in the country of origin/exporting country (the certificate must be consular legalized);

+ Original copy or certified true copy of the food safety data sheet issued within 12 months before the self-declaration is made by an designated laboratory or a laboratory complying with ISO 17025; the data sheet must specify 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)

+ 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;

+ The certificate of Good Manufacturing Practice (GMP) or an equivalent certificate if the imports are dietary supplements, applicable from July 01, 2019 (a copy authenticated by the supplier).

- An application for regulations of the declaration of domestic products consists of:

+ The declaration form (Form No. 02 in Appendix I hereof);

+ Original copy or certified true copy of the food safety data sheet issued within 12 months before the self-declaration is made by an designated laboratory or a laboratory complying with ISO 17025; the data sheet must specify 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 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;

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

+ The certificate of Good Manufacturing Practice (GMP) if the domestic products are dietary supplements, applicable from July 01, 2019 (a copy authenticated by the supplier).

The documents must be written in Vietnamese language; documents in other languages must be translated into Vietnamese language and notarized. The documents must be unexpired when the application is submitted.

This is the content specified in Article 7 of Decree No. 15/2018/NĐ-CP of Vietnam’s Government, which is effective from the date of its issuance.

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