Product Announcement Registration Dossier for Imported Functional Foods

Quick answer: Organizations and individuals importing functional foods (health supplements, medical nutrition foods, foods for special dietary uses…) must register the product announcement with the Ministry of Health (Food Safety Department) before import and market circulation. The dossier follows Article 7 of Decree No. 15/2018/ND-CP (as amended and supplemented — the amended version must be cross-checked when preparing the dossier).

Legal basis

• Decree No. 15/2018/ND-CP — Article 6 (subjects required to register product announcements), Article 7 (dossier);
• The documents amending and supplementing Decree No. 15/2018 (to be cross-checked when preparing the dossier);
• Law on Food Safety 2010.

Which products must register a product announcement?

• Health supplements, medical nutrition foods, foods for special dietary uses;
• Nutritional products for children up to 36 months of age;
• Mixed food additives with new uses, or additives not on the permitted list or used for unprescribed purposes as regulated by the Ministry of Health.

Dossier for registering the product announcement of imported products

Under clause 1, Article 7 of Decree No. 15/2018/ND-CP (cross-check the amended version), the dossier comprises:

1. The product announcement using the prescribed form;
2. Certificate of Free Sale or Certificate of Exportation or Health Certificate issued by the competent authority of the country of origin;
3. Food safety test result sheet for the product within 12 months (issued by a designated testing laboratory or one recognized as ISO 17025 compliant);
4. Scientific evidence proving the announced uses of the product or of the ingredients creating the announced uses;
5. Certificate of food safety eligibility of the establishment meeting Good Manufacturing Practice (GMP) requirements or an equivalent certificate (for health supplements).

Implementation procedure (overview)

1. Prepare the complete dossier as prescribed;
2. File the product announcement registration dossier with the Ministry of Health (Food Safety Department);
3. Receive the Receipt of product announcement registration;
4. Import and circulate the product only after the Receipt is granted.

Key notes

• Decree No. 15/2018 has been amended and supplemented — when preparing the dossier, cross-check the latest amended version; do not use the original 2018 text;
• Importing or trading functional foods that have not been announced may result in administrative penalties in the food safety sector.

Related articles

• Principles of administrative penalties for food safety violations

How ANT Legal can help

ANT Legal advises on and drafts product announcement registration dossiers and represents clients before competent authorities. For advice on your specific case, please contact our lawyers at 0966.475.966.