Importing dietary supplements involves a strict and complex procedure. Join us as we explore the detailed process of importing this type of product.
1 What are Dietary Supplements?
Dietary Supplement Registration Dossier
Dietary supplements are primarily made from natural ingredients and are designed to support beauty, boost the body’s immune system, enhance mental well-being, and improve conditions like insomnia and dizziness.
According to Article 3 of Circular No. 43/2014/TT-BYT:
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Imported and domestically produced dietary supplements with technical regulations: Must be declared for conformity and registered at the Ministry of Health (Department of Food Safety) before being circulated on the market.
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Imported and domestically produced dietary supplements without technical regulations: Must be declared for compliance with food safety regulations and registered at the Ministry of Health (Department of Food Safety) before being circulated on the market.
Referring to Clause 1, Article 14, Decree No. 38/2012/ND-CP dated April 25, 2012 issued by the Government: “All food, food ingredients, food additives, food processing aids, utensils, and food packaging materials imported into Vietnam must be inspected by competent state inspection agencies designated by the Ministries managing the sectors.”
2 Steps to Import Dietary Supplements
Dietary Supplement Registration Dossier
Here are the steps to import dietary supplements:
Step 1 Register for Food Hygiene and Safety Inspection
To import dietary supplements, you need to go to competent authorities such as the Center for Standardization, Metrology, and Quality Control 1, Center for Technical Standards, Metrology, and Quality 3, or the National Institute for Food Hygiene and Safety Control, etc., to register for food hygiene and safety inspection.
Step 2 Declare and Transmit Customs Declaration
In this step, you need to prepare the attached V5 procedures and the reviewed paper.
Step 3 Customs Procedures
When going through customs procedures, you should prepare a letter requesting to bring the goods back for storage to save time in case the customs officer asks for it. You can learn more about customs procedures.
Step 4 Center Specialist Inspects the Warehouse and Takes Samples for Testing
At this stage, a specialist from the center where you registered will visit your warehouse and take samples for testing.
Step 5 Release Test Results
After the tests, if the results are satisfactory, your goods will be cleared for import. If the results are unsatisfactory, you will have to return the batch.
3 Dietary Supplement Declaration (Food Safety Inspection)
Dietary Supplement Registration Dossier
According to regulations, companies and facilities processing dietary supplements must declare the quality of their products before selling them on the market to ensure they are safe and of good quality for consumers.
The steps to declare dietary supplements are as follows:
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Step 1: Send a complete dossier with legal documents as prescribed to the Food Safety Department.
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Step 2: The Food Safety Department receives and checks the dossier. Within 30 days from the date of receipt of a valid dossier, the Ministry of Health will issue a Certificate of Receipt of Declaration of Compliance with Food Safety Regulations.
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Step 3: Return the Certificate of Receipt of Declaration to the organization or individual.
The dietary supplement declaration dossier includes the following documents:
Dietary Supplement Registration Dossier
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Business License: Business Registration Certificate of the importing company or Investment Certificate.
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Certificate of Free Sale or Certificate of Export and Health Certificate: Issued by the competent authority of the exporting or importing country and legalized by the consulate.
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Documentation Proving Efficacy: Scientific evidence proving the efficacy and composition of the product, ensuring it is suitable for consumers.
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HACCP or ISO 22000/2005 Certificate (if any).
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Product Declaration Certificate: Certificate of facility meeting food safety conditions and test results from a competent authority in Vietnam.
Note:
– All documents in the product declaration dossier must be valid and in Vietnamese.
– If you need to change the name, origin, or composition of a declared dietary supplement, you must declare it again.
– According to Decree 15/2018/ND-CP, production and import units do not need to re-declare when the declaration expires.
– Periodic testing is not mandatory under Decree 15/2018/ND-CP.
– If you are unfamiliar with the law, seek assistance from a reputable service unit specializing in product quality declaration.
The above is a detailed guide to the procedures for importing dietary supplements. We hope you find this information useful. Wishing you good health!
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