Decree No. 15/2018/NĐ-CP

Step 1: Prepare a set of the following documents

1. Declaration of imported products consists of:

a) The declaration form;

b) 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 consularly legalized);

c) 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)

d) 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;

dd) 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).

2. An application for regulations of the declaration of domestic products consists of:

a) The declaration form;

b) 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);

c) 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;

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

dd) 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).

Step 2: Submit the file to Ministry of Health

Step 3: The Ministry shall, within 21 working days from the date of receipt of the file, assess the file and grant a certificate of registration of product declaration, or in case of refusal, request for supplementation, amendment and clearly specifies the reasons for refusal. There is only one chance to supplement, amend the file. Within 07 working days from the date of receipt of amended, supplemented file, the Ministry shall assess and send a written reply.