In the previous article, Foodmate mainly introduced the basic procedures and requirements for self-declaration. In this article, Foodmate will continue to introduce the product categories that require registration declaration, the basic registration procedures and the documents that need to be submitted. Compared with self-declared products, registered declaration products have a higher risk level, so they are mainly approved by the Ministry of Health, more materials need to be submitted and the requirements are more stringent.
I. Product Categories Requiring Registration Declaration
"Functional food categories excluding supplemented food": Health supplements, medical foods, food for special dietary uses;
Dietary products for children up to 36 months;
"Unregistered food additives": Mixed food additives with new uses, food additives that are not on the list of permitted food additives compiled by the Ministry of Health.
II. documents Required for Registration Declaration
An application for regulations of the declaration of imported products consists of the following：
The product self-declaration(Form 2 in Appendix I of Decree 15/2018/ND-CP);
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);
Original copy or certified true copy of the testing results issued by recognized laboratories or ISO 17025 accredited laboratories within 12 months up to the date of document submission. The testing results must specify safety indicators prescribed by MOH according to risk management principles under international regulations or standards applied by the organizations or individuals if relevant MOH's regulations 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 than 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 health supplements, applicable from July 01, 2019 (a copy authenticated by the organizations or individuals).
III. Registration Declaration Procedure
The organizations or individuals shall submit an application for product declaration via the online public service system, by post, or directly, to the following receiving authorities:
MOH for declarations of health supplements and "unregistered food additives";
A competent authority designated by the People's Committee of the province for medical foods, food for special dietary uses and dietary products for children up to 36 months;
In the cases where the declaration includes of the products mentioned in both above, the application may be submitted to either receiving authority.
Generally speaking, within 7 working days (for "unregistered food additives", medical foods, food for special dietary uses, dietary products for children up to 36 months) or 21 working days (for health supplements) from the day on which adequate documents are received, the receiving authority mentioned above shall verify the application and issue a Certificate of Registered Product Declaration (Form 3 in Appendix I of Decree 15/2018/ND-CP).
Summary:
Although the regulations stipulate the approval time limit for registration declarations and self-declared products, in practice, the approval cycle is often extended indefinitely because there are too many documents to be reviewed, or the company cannot complete the rectification and submission at one time after receiving the modification opinions.
Foodmate can assist in the application of product registration declarations in Vietnam, or assist companies in reviewing and guiding the application documents, helping companies to quickly pass the approval. Welcome to contact us via global_info@foodmate.net.