GUIDELINES FOR ANNOUNCING

DOMESTICALLY PRODUCED FUNCTIONAL FOODS

1. Registration Dossier for Announcing Domestically Produced Functional Foods

According to current regulations, the registration dossier for announcing domestically produced functional foods includes:

- A product announcement form according to Form No. 02, Appendix I, issued together with Decree 15/2018/ND-CP.

- A food safety testing result certificate: This certificate must be valid within 12 months from the date of submission, issued by a testing laboratory that meets ISO 17025 standards and is designated or recognized as compliant. The testing results must include safety criteria as prescribed by the Ministry of Health or according to the announced standards if there are no specific regulations.

- Scientific evidence proving the product's or ingredient's efficacy: Businesses must provide scientific documents proving the efficacy of the product or the ingredients that create the announced efficacy, ensuring that the daily dosage in the product must reach at least 15% compared to the reference documents.

- A certificate of food safety conditions: A certified copy for establishments that are required to obtain a food safety conditions certificate as prescribed.

- A certificate of food safety conditions meeting GMP: A certified copy for establishments applying good manufacturing practices.

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2. Procedure for Registering the Announcement of Functional Foods

Businesses need to follow the procedure below to register the announcement of functional foods:

Step 1: Prepare the dossier.

Businesses must prepare all the necessary documents mentioned above, ensuring that all documents are in Vietnamese. In case there are documents in a foreign language, they must be translated into Vietnamese and notarized. All documents must be valid at the time of submission.

Step 2: Submit the dossier.

The registration dossier for the product announcement can be submitted through the online public service system, by postal mail, or directly at the Ministry of Health.

Step 3: Review the dossier.

The Ministry of Health will review the dossier within 21 working days from the date of receiving a complete dossier. If the dossier does not meet the requirements, the reviewing agency will issue a written request for amendments or supplements with specific reasons. The request for amendments or supplements can only be made once. If the business does not comply with the amendment request within 90 days from the date of the request, the dossier will be canceled.

Step 4: Public announcement of information.

After the dossier is approved, the Ministry of Health will publicly announce the name and information of the product on the official electronic information page.

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3. Fee for appraisal of registration dossier of announcement

According to Circular 67/2021/TT-BTC, the fee for appraisal of registration dossiers for declaration of domestically produced functional foods is 1,500,000 VND for each registration/product.

Enterprises need to pay the appraisal fee in accordance with regulations so that the dossier is received and processed in a timely manner.

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