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Nutraceutical Regulations and Registration in Vietnam (MoH)

Vietnam's nutraceutical market has been steadily expanding as the population becomes more health-conscious and seeks products that can enhance overall well-being. This demand is driven by various factors, including increasing disposable income, a rising middle class, and greater awareness of the link between nutrition and health. As a result, a wide range of nutraceutical products, including dietary supplements, functional foods, herbal extracts, and probiotics, have flooded the market.

Probiotic Yogurt as a health supplement has seen the highest growth in the Dairy market with a CAGR of 12% approx. functional food markets have experienced rapid growth, worth USD 17.4 billion in 2016 and a 9% CAGR is forecast between 2015 and 2020 (L.E.K. Research & Analysis, 2018).

By the year 2030, the projected value of the nutrition and supplements market in Vietnam is expected to reach approximately $691.87 billion, a substantial increase from its 2022 value of $1.91 billion. This growth trajectory is attributed to a compounded annual growth rate (CAGR) of about 7.8% during the period from 2022 to 2030.

Nutraceutical Regulations and Registration in Vietnam (MoH)

This article covers the Nutraceutical Regulations and Registration in Vietnam (MoH)

Nutraceutical Regulatory Framework Vietnam

The regulation and registration of nutraceuticals and dietary supplements in Vietnam falls under the purview of several government agencies, primarily the Ministry of Health (MOH) and the Ministry of Agriculture and Rural Development (MARD). These agencies are responsible for overseeing the safety, labeling, and advertising of nutraceutical products to protect consumer interests.

Health Supplement Product Classification:

  1. Dietary Supplements: Dietary supplements are products that contain vitamins, minerals, herbs, amino acids, or other dietary ingredients.

  2. Functional Foods: Functional foods are foods that provide additional health benefits beyond basic nutrition.

  3. Herbal Extracts and Traditional Medicines: Herbal extracts and traditional medicines are derived from plants and natural sources.

  4. Probiotics and Fermented Products: Probiotics are live microorganisms that are believed to provide health benefits when consumed.

  5. Nutritional Beverages: Nutritional beverages include products like energy drinks, and beverages containing added vitamins, minerals, or other nutrients.

Health supplement Registration process Vietnam:

The health supplement registration process typically concludes within 3 to 4 weeks upon submission. Upon approval, the Ministry of Health (MOH) Circular 43/2014/TT-BYT issues an enduring certificate. For imported health supplements in Vietnam:

  • Declaration form

  • Original notarized copy of product's food safety testing result issued by a designated or ISO 17025-compliant laboratory, dated within 12 months before submission

  • Scientific evidence of product or ingredient effects, either original or authenticated copy. If ingredient effects are used, their daily dose must be equal to or exceed 15% of the content mentioned in the document

  • Certificate of Good Manufacturing Practice (GMP) or equivalent, mandated from July 1, 2019 (authenticated copy).

  • Documents required for nutraceutical registration Vietnam:

The application dossier should include several documents such as:

  1. Certificate of Free Sale or Health Certificate.

  2. Licenses of a Vietnamese importer consisting of.

  3. Investment registration certificate (IRC).

  4. Enterprise registration certificate (ERC).

  5. Product samples.

  6. Product label.

  7. Certificate of Good Manufacturing Process (GMP).

Health supplement Labelling requirement:

In general, a label should be put on the package of the health supplement and contain the following mandatory information:

  • Name of the product.

  • Composition.

  • Quantity of product.

  • Manufacturing date.

  • Usage and preservation instructions.

  • Shelf life.

  • Country of origin.

  • Name and address of manufacturer/responsible party.

  • Nutritional information.

Health Supplement/nutraceutical Registration Timeline:

  • Document Preparation: this phase could take 1 to 2 months.

  • Submission and Review. The review phase may take around 2 to 3 months.

  • Testing and analysis: laboratory testing could take an additional 1 to 2 months.

  • Labeling and Packaging Review: Authorities may review labeling and packaging, which could take an additional 1 month.

  • Approval and Certificate Issuance: Once all requirements are met, the registration certificate is issued, concluding the process.

Health Supplement/nutraceutical Registration Fees:

  • Application Fee: Around $200 to $300 (USD) for the submission of the application dossier.

  • Review and Evaluation Fee: Approximately $500 to $800 (USD) for the regulatory authorities to review and evaluate the application.

  • Product Testing Fee: If testing is required, it could range from $500 to $1,000 (USD) or more, depending on the type of tests needed.

  • Certificate Issuance Fee: Approximately $100 to $200 (USD) for the issuance of the registration certificate.



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