Tiếng Việt
What is the Certificate of Free Sale (CFS) for Health Supplements?
The Certificate of Free Sale (CFS) for health supplements is a crucial component of the dossier required for the notification of imported health supplements. The CFS must be issued by the competent authority of the country of origin/export and must confirm that the product is safe for consumer use or is legally available for sale in the domestic market of the manufacturing/exporting country (with consular legalization).
The CFS is also essential for businesses and manufacturers of health supplements seeking to export and commercialize their products in international markets. This certificate facilitates international market access and ensures that the product has undergone rigorous safety and quality assessments.
Requirements for the Certificate of Free Sale (CFS) for Exported and Imported Health Supplements
The CFS must contain at least the following information:
a) Name of the issuing authority or organization.
b) CFS number and issuance date.
c) Name of the product covered by the CFS.
d) Category or group of products covered by the CFS.
đ) Name and address of the manufacturer.
e) A statement confirming that the product is manufactured and legally sold in the domestic market of the producing country or the country issuing the CFS.
g) Full name, signature of the signatory, and the official seal of the issuing authority or organization.
Required Documentation for the Issuance of a Certificate of Free Sale (CFS) for Exported Health Supplements
Businesses seeking to obtain a Certificate of Free Sale (CFS) must prepare and submit the following documents:
- A written request for the issuance of a CFS, specifying the product name, HS code, product standard certification number or registration number, standard identification number (if applicable), ingredient composition (if applicable), and the importing country. This document must be submitted in both Vietnamese and English (original copy).
- A copy of the Investment Certificate or Business Registration Certificate, or Enterprise Registration Certificate, stamped by the applicant company.
- A list of production facilities (if applicable), including the name and address of each facility and the products manufactured for export (original copy).
- A copy of the product standards applicable to the goods, including the labeling requirements (on the product label, packaging, or accompanying documents), stamped by the applicant company.
Quantity: One (01) complete set of documents.
Procedures for Obtaining a Certificate of Free Sale (CFS) for Health Supplements
According to Decree No. 69/2018/NĐ-CP, issued by the Government on May 15, 2018, in Annex V, health supplements, pharmaceuticals, cosmetics, and medical devices fall under the regulatory authority of the Ministry of Health. Therefore, businesses must submit their applications directly, by postal mail, or online (if applicable) to the Vietnam Food Administration (VFA).
Within three (03) working days from the date of receiving the application, the Vietnam Food Administration will notify the applicant if the dossier requires supplementation or correction.
The processing time for issuing a CFS is no more than three (03) working days from the date the business submits a complete and compliant dossier. In cases where a CFS is not granted, the Vietnam Food Administration will provide a written explanation stating the reasons for the rejection.
The Vietnam Food Administration may conduct on-site inspections at manufacturing facilities if it determines that a documentary review is insufficient to approve the CFS or if there are indications of regulatory violations related to previously issued CFS certificates.
Fees and Charges:
Fee: 1,000,000 VND per product
Charge: None
(As per Circular No. 279/TT-BTC, dated November 14, 2016, on fees and charges for food safety and hygiene management.)
For free consultation on dossier preparation and registration procedures for medical devices, health supplements, cosmetics, and pharmaceuticals, please contact our hotline: 098.546.1894.