Domestic Medical Nutrition Product Registration

Domestic medical nutrition product registration is a mandatory procedure for domestic manufacturers before market circulation. Proper execution of the declaration dossier ensures compliance with food safety regulations and affirms product legality and transparency. Long Phan Consulting Company analyzes the conditions, dossiers, and processes for medical nutrition food product declaration below.

Cases requiring product declaration registration

Product declaration registration controls safety levels for food groups posing direct health risks. Article 6 of Decree 15/2018/NĐ-CP mandates registration for specific organizations and individuals. Entities requiring registration include:

• Health supplements, medical nutrition foods, and foods for special dietary uses.
• Nutritional products for children up to 36 months of age.
• Mixed food additives with new effects, additives not on the permitted list, or additives used for unintended targets as prescribed by the Ministry of Health.

Manufacturers must complete domestic medical nutrition product registration with competent state agencies before distribution.

Required documents for registering a declaration of domestically produced medical nutritional food products.

Part 6, Annex V of Decree 148/2025/NĐ-CP outlines the required documentation. A complete dossier includes:

• Product Declaration: Completed according to Form No. 03 issued with the Annex.
• Food Safety Testing Results: Issued within 12 months by a designated laboratory or an ISO 17025 accredited laboratory. The results must cover safety indicators issued by the Ministry of Health or applicable technical regulations (original or certified copy).
• Scientific Evidence: Documents proving the claimed effects of the product or its ingredients. If using ingredient evidence, the daily dose must be at least 15% of the reference amount (original or certified copy).
• Food Safety Eligibility Certificate: Required for facilities subject to certification (certified copy).
• Translations: All documents must be in Vietnamese. Foreign documents require notarized translation and must remain valid at the submission time.

The competent authority is responsible for registering the product declaration.

Article 28 of Decree 148/2025/NĐ-CP decentralizes authority for domestic medical nutrition product registration. The competent authority is the head of the specialized health agency under the Provincial People’s Committee (currently the Director of the Department of Health) or an assigned specialized agency.

Procedures for registering a declaration of domestically produced medical nutritional food products.

Applicants submit dossiers via the public service system, postal service, or directly. Clause 2, Part 6, Annex V of Decree 148/2025/NĐ-CP defines the steps:

Step 1: Dossier Submission Manufacturing and trading entities submit the dossier to the Department of Health. Entities with two or more production facilities for the same product must choose one local agency for the initial registration. Subsequent registrations must occur at the chosen agency.

Step 2: Dossier Appraisal The receiving agency appraises the dossier within 07 working days of receipt. Upon approval, the agency issues the Receipt of Product Declaration Registration (Form No. 04).

Step 3: Amendment Handling If the dossier is inadequate, the agency issues a written request stating legal grounds. Applicants may supplement documents once. If the applicant fails to amend within 90 working days, the dossier becomes invalid.

Step 4: Information Publication Upon issuance of the Receipt, the agency publishes the organization name and product details on its website and the food safety database. Changes to product name, origin, or composition require re-registration. Other changes only require written notification.

Long Phan provides consulting services for product registration procedures.

Long Phan Consulting Company provides comprehensive solutions for domestic medical nutrition product registration. Our experts ensure regulatory compliance and time optimization. Our services include:

• Product Analysis: Determining the exact food category based on ingredients and intended use.
• Testing Guidance: Constructing safety indicators compliant with National Technical Regulations (QCVN) to optimize costs.
• Evidence Review: Evaluating scientific evidence validity and advising on dosage adjustments.
• Drafting: Preparing the Product Declaration, labels, and technical explanations.
• Translation: Notarized translation of specialized medical documents.
• Representation: Submitting dossiers and monitoring appraisal progress at state agencies.
• Explanation: Rapidly addressing agency requests for amendments.
• Post-Licensing Advice: Consulting on labeling and advertising regulations.

>>> See more at: Register advertising content for medical nutritional products

Frequently Asked Questions

Below are some frequently asked questions regarding the registration of domestically produced medical nutritional food products; please refer to them:

Submission location for domestic medical nutrition products?

Authority has been decentralized to the local level. Organizations submit dossiers to the specialized health agency under the Provincial People’s Committee (Department of Health) where the production facility is located, not the Ministry of Health. Legal Basis: Clause 1, Article 28, Decree 148/2025/NĐ-CP.

Is GMP (Good Manufacturing Practice) mandatory?

Yes. Medical nutrition food production facilities must meet food safety conditions, including GMP compliance suitable for the dosage form and declared standards. Legal Basis: Article 28, Decree 15/2018/NĐ-CP.

Penalties for failure to register product declaration?

Manufacturing or importing medical nutrition food without a Receipt of Product Declaration Registration results in a fine of 40,000,000 to 50,000,000 VND. Remedial measures include product recall and destruction. Legal Basis: Clause 2, Article 21, Decree 115/2018/NĐ-CP.

State appraisal fee?

The appraisal fee for a medical nutrition food product declaration is 1,500,000 VND per product per submission. This fee is non-refundable if the dossier fails requirements. Legal Basis: Fee Schedule under Circular 67/2021/TT-BTC.

Changing the receiving agency for multiple facilities?

No. If an entity has multiple facilities producing the same product, they select one local agency for the first registration. All subsequent registrations for that product must occur at the initially selected agency to ensure management consistency. Legal Basis: Point a, Clause 2, Part 6, Annex V, Decree 148/2025/NĐ-CP.

Conclusion

Domestic medical nutrition product registration requires legal expertise and technical precision. Thorough preparation ensures prompt market entry. Long Phan Consulting Company commits to supporting clients throughout this process. Contact Hotline 1900636389 for immediate assistance.