Registration of the product declaration of imported dietary supplements in Vietnam

Registration of the product declaration of imported dietary supplements in Vietnam

Procedures for registration of the product declaration of imported dietary supplements in Vietnam

1 Application for registration of the product declaration of imported dietary supplements

a) The declaration form (Form No. 02 in Appendix I Decree No.15/2018/NĐ-CP);

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;

e) 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).

The documents of registration of the product declaration of imported dietary supplements in Vietnam 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.

2. Procedures for registration of the product declaration of imported dietary supplements inVietnam

a)The applicant shall submit the application for registration of the product declaration of imported dietary supplements, whether online, by post or directly, to the Ministry of Health;

b)Within 21 working days from the day on which adequate documents are received, the the Ministry of Health shall verify the application and issue a certificate of registered product declaration (Form No. 03 in Appendix I Decree 15/2018/NĐ-CP).
The time limit for document verification begins on the date of receipt according to the online public service system (if the application is submitted online) or date stamp of the Health Ministry (if the application is submitted by post or directly).

c)If the application needs to be supplemented, the Health Ministry shall provide explanation in writing and specify the legal basis. The Health Ministry may request the applicant to supplement the application 01 time. Within 07 working days from the day on which the supplemented application is received, the Health Ministry shall verify it and make a written response. If the applicant fails to supplement the application within 90 working days from the day on which a written request is made, the application will be invalidated.

d)In case of change to the product name, origin or ingredients, another application shall be submitted. In case of other changes, the applicant shall submit a written notification to the Health Ministry and is entitled to carry on the production or sale of the product afterwards.

e)The Health Ministry shall post on its website and update on the food safety database the names and products of suppliers whose product declarations have been registered.

f)The applicant shall pay fees for document verifications in accordance with regulations of law on fees and charges.
 
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LAWYER VN LAW FIRM