SERVICES FOR THE PROCEDURES RELATED TO THE DECLARATION OF QUALITY STANDARDS FOR TRADITIONAL MEDICINES AND HERBAL MEDICINAL MATERIALS

Against the backdrop of an increasing demand for traditional herbal ingredients and medicinal materials, the declaration of product quality standards is not only a mandatory legal requirement but also a crucial factor in affirming prestige, enhancing brand value, and ensuring consumer safety. However, the process of executing quality standard declaration procedures typically requires businesses and manufacturing establishments to thoroughly understand specialized regulations, complex documentation, and legal workflows.

With extensive experience and expertise in the field of pharmaceutical and medical law, Huy Hoang Law Firm provides comprehensive, all-inclusive advisory and support services for the quality standard declaration procedures of traditional herbal ingredients and medicinal materials. We assist our valued Clients in saving time, mitigating risks, and swiftly launching products into the market in full, lawful compliance with applicable regulations.

1. Legal Basis

Law on Pharmacy 2016 and the Law amending and supplementing a number of articles of the Law on Pharmacy 2024.

Decree No. 163/2006/ND-CP and Law on Pharmacy No. 105/2016/QH13 dated April 6, 2016.

Circular No. 41/2023/TT-BTC issued by the Ministry of Finance.

Circular No. 32/2025/TT-BYT on the quality management of traditional medicines and medicinal materials.

2. Requirements for Implementation

Applicable Subjects for Declaration:

• Traditional herbal ingredients and medicinal materials whose quality standards have not yet been specified in the Vietnamese Pharmacopoeia or reference pharmacopoeias.

• Traditional herbal ingredients and medicinal materials whose quality standards are specified in the Vietnamese Pharmacopoeia or reference pharmacopoeias, but the establishment wishes to declare quality indicators and quality levels higher than those stipulated in the pharmacopoeias.

Dossier Requirements and Conditions:

• A product quality standard declaration form for traditional herbal ingredients/medicinal materials.
• A Certificate of Analysis (CoA) showing that the traditional herbal ingredients/medicinal materials meet the declared quality standards. This must be issued by a state-owned testing establishment meeting GLP (Good Laboratory Practice) standards, or a pharmaceutical testing service enterprise holding a valid Certificate of Eligibility for Pharmacy Business within the scope of testing services.
• Documentation proving the origin and provenance of the traditional herbal ingredients and medicinal materials, specifically as follows:

For traditional herbal ingredients:

• Certificate of Registration for Circulation of traditional herbal ingredients OR the quality standard declaration number (including numbers self-declared by the establishment);
• Documentation proving the origin and provenance of the medicinal materials used to manufacture such traditional herbal ingredients.

For medicinal materials:

• For imported medicinal materials: A Certificate of Origin (C/O) for each batch of medicinal materials, issued by the competent state authority of the exporting country;
• For domestically cultivated, harvested, or exploited medicinal materials meeting GACP standards: A certificate certifying that the medicinal materials comply with GACP (Good Agricultural and Collection Practices);
• For domestically cultivated, harvested, or exploited medicinal materials NOT meeting GACP standards: A written commitment regarding the local cultivation and harvesting location of the medicinal materials.

• All documents in the declaration dossier must be presented in Vietnamese or English. Traditional herbal ingredient/medicinal material business establishments and medical examination and treatment facilities shall bear full legal responsibility for the accuracy, legality, and truthfulness of all documents included in the declaration dossier.

3. Dossier Composition

Section I. Dossier components include:

• A product quality standard declaration form for traditional herbal ingredients/medicinal materials;
• A copy of the Certificate of Analysis (CoA) showing that the traditional herbal ingredients/medicinal materials meet the declared quality standards, issued by a state-owned GLP-compliant testing facility or an authorized pharmaceutical testing service enterprise;
• A copy of documentation proving the origin and provenance of the traditional herbal ingredients/medicinal materials;
• All documents in the declaration dossier must be presented in Vietnamese or English; the business establishments or medical facilities shall bear full legal responsibility for the accuracy, legality, and truthfulness of the entire dossier.

Section II. Quantity of dossiers: 01 full set.

4. Implementation Procedure

Step 1. Dossier Submission:

The declaring establishment shall submit one (01) set of the self-declaration dossier as prescribed in Clause 1 of this Article to the Traditional Medicine Administration of Vietnam (TMA).

Step 2. Dossier Receipt:

Upon receiving a self-declaration dossier that contains all required components, meets formatting requirements, and has the prescribed fees paid, the Traditional Medicine Administration of Vietnam shall issue a Dossier Receipt Form to the declaring establishment.

Step 3. Post-Receipt Workflow:

Immediately upon receiving the Receipt Form, the declaring establishment is entitled to trade the declared traditional herbal ingredients/medicinal materials and shall bear sole responsibility for their quality in accordance with the registered dossier;

Within 07 working days, the Traditional Medicine Administration of Vietnam is responsible for publishing the Quality Standard Self-Declaration on its electronic portal using Form No. 02 enclosed with this Circular;

In the event of any changes to the quality indicators or quality levels of the traditional herbal ingredients/medicinal materials, the organization or individual must re-submit the quality standard declaration dossier to re-execute the declaration procedure from the beginning.

5. Method of Implementation

Submissions can be made in person, online, or sent via postal services.

6. Processing Timeframe

Within 7 working days from the date of receiving a complete and valid dossier.

7. Eligible Applicants

Enterprises, Foreign-Invested Enterprises (FIEs), Organizations (excluding enterprises and cooperatives), Foreign Organizations, and Cooperatives.

8. Executing Authority

Traditional Medicine Administration of Vietnam (TMA) – Ministry of Health (MOH)

9. Regulatory Advisory Services for Quality Standard Declaration of Traditional Herbal Ingredients and Medicinal Materials by Huy Hoang Law Firm

With the motto “Accurate – Prompt – Effective”, Huy Hoang Law Firm pledges to accompany our valued Clients throughout the entire process of executing quality standard declaration procedures for traditional herbal ingredients and medicinal materials. We do not merely assist in preparing and finalizing legal dossiers; we also consult on optimal strategies to ensure your products are legally circulated in the market at the earliest opportunity.

The trust and satisfaction of our Clients serve as the driving force for Huy Hoang Law Firm to continuously strive to deliver professional, reputable, and dedicated legal advisory services.

Huy Hoang Law Firm

📞 Telephone: +84 944 580 222
📧 Email: tuvan@luathuyhoang.vn
🌐 Website: https://luathuyhoang.vn/
🏢 Address: 2nd Floor, LK05 – Urban Area 54, Alley 85 Ha Dinh Street,
Thanh Xuan Trung Ward, Thanh Xuan District, Hanoi, Vietnam