Health Supplement, Knowledge

Things you need to know about health supplement business

Currently, the interest of organizations and businesses in the production, business, and distribution of dietary supplements  is on the rise. However, with the advancements in science and technology, coupled with the boom of Industry 4.0, businesses in this field increasingly need to focus and pay special attention to legal issues related to their business and product distribution.

Procedure for Registering the Announcement of Health Supplement:

Documentation for Product Announcement:

For Domestic Products:

  1. Product announcement document
  2. Certificate of compliance with Good Manufacturing Practice (GMP)
  3. Product testing Results (valid for 12 months)
  4. Documentation proving the product’s functions or the functions of its components that have been announced
  5. Dosage table, Recommended Nutrient Intake (RNI) table
  6. Product Specification (SPEC)
  7. Product label sample

For Imported Products:

  1. Product announcement document
  2. Certificate of compliance with GMP 
  3. Product testing Results (valid for 12 months)
  4. Certificate of free sale (CFS) – Requires consular legalization
  5. Documentation proving the product’s functions or the functions of its components that have been announced
  6. Dosage table, RNI table
  7. Product Specification (SPEC)
  8. Product label sample
  9. Expected supplementary label content

Sequence of Registering Product Announcement

– Login to Decree 15 Website: https://nghidinh15.vfa.gov.vn/.

– Submit Online Application to the Food Safety Department and Pay State Fees:

– Processing Time: Within 21 working days for the first successful submission on the website and 7 days from the receipt of amended or supplemented documents. The evaluating agency will process the dossier and announce the evaluation results on the system.

– Result Notification:

  • If the dossier is approved, Business will be received Product Announcement Certificate
  • If not approved, an official letter is issued specifying the required amendments or changes. The business makes the necessary adjustments and resubmits to the Department (if the dossier is approved, Business will be received Product Announcement Certificate).

After obtaining the announcement number for the dietary supplement, businesses that want to circulate, sell, and promote their products extensively through various media need to proceed with the process of obtaining advertising certificates for these dietary supplements. This is a crucial step to ensure that all advertising conforms to regulations and receives official approval from regulatory authorities, contributing to compliance and transparency in product advertising to convey accurate and safe messages to consumers.

Procedure for Obtaining Advertising License for Health Supplement

Application Documents for Advertising Confirmation:

  1. Application form confirming the intended content for advertising the product.
  2. Registration Certificate for the product announcement and Product announcement document
  3. Product label sample (approved by the competent authority issuing the product announcement registration certificate).
  4. For advertisements in print or visual media, include a script and the intended advertising content (recorded in both video and audio formats); for other media, provide a sample of the intended advertising content (approved by the entity wishing to advertise the product).

Procedure for Obtaining Advertising Confirmation:

– Within 10 working days (excluding Saturdays and Sundays) from the date of receiving a complete and valid dossier, the receiving agency reviews the dossier and notifies the advertising entity of the result.

– If there are issues or errors in the dossier that require modification or supplementation, the receiving agency must provide a written explanation of the reasons and legal basis for requesting the unit to make changes. Within 10 working days (excluding Saturdays and Sundays) from the date of receiving the amended dossier, the receiving agency evaluates the dossier and provides a written response to the advertising unit.

After obtaining the advertising content confirmation along with the product announcement registration certificate, organizations and businesses are free to sell their products in the market.

For consultation on dossier services, the procedural process, and advertising for health supplements both domestically and for imports, please contact our Hotline: 098.546.1894

 

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