You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

July 31, 2024

Vietnam Issues First National Technical Regulation for Health Supplements

Subscribe to Updates

On July 18. 2024, Vietnam’s Ministry of Health issued Circular No. 12/2024/TT-BYT promulgating National Technical Regulation QCVN 20-1:2024/BYT on the limits of contaminants for health supplements (“Circular 12”). The new national technical regulation is the very first relating to health supplements, and is expected to have a great impact on the control of health supplement quality in Vietnam. Circular 12 will take effect on August 1, 2025.

Contents of Circular 12

The new circular prescribes limits of contaminants (heavy metals and microorganisms), testing samples and testing methods, management requirements, and responsibilities of entities manufacturing and trading in health supplements.

Supplemented alcohol products which are declared as health supplements are notably excluded from the scope of the regulation.

Transitional Provisions

Health supplements which (i) have been granted a declaration registration certificate, and (ii) are manufactured before August 1, 2025, are allowed to continue to be imported, traded, and circulated until the expiry date of the product, even if it is not aligned with Circular 12, except when there is food safety warning.

Declaration registration dossiers for health supplements submitted before August 1, 2025, will continue to be handled in accordance with the prevailing regulations at the time of submission.

From August 1, 2025, if a health supplement with a granted declaration registration certificate has a manufacturer’s standard that does not comply with Circular 12, the party manufacturing/trading in the product must adjust the product standard to conform to Circular 12 and notify the authority of this adjustment.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

February 25, 2020
The Thailand updates of Thomson Reuters’ Practical Law Life Sciences Global Guide  have been released online, with legal practitioners from Tilleke & Gibbins contributing the Pharmaceutical Intellectual Property and Competition Law section.The guide is a Q&A-style overview of the regulatory frameworks of the life sciences industries across multiple jurisdictions worldwide, with this chapter addressing the following issues as they relate to Thailand:
Read More
February 5, 2020
Southeast Asian food exporters to China should be aware of new regulations announced in late November 2019 by China’s General Administration of Customs (GAC) for all food products. The first is still in draft form and seeks to expand the scope of the GAC’s role in policing all food products, while the second update—already implemented–makes the application process for an import license for animal and plant food products much more rigorous.
Read More
January 28, 2020
Tilleke & Gibbins authors have provided the latest update to the Thailand Q&A section of Doing Business in… , a Q&A-style guide published by Thomson Reuters Practical Law that presents an overview of recent legal developments affecting doing business in 59 jurisdictions worldwide. The Thailand chapter of the guide was written by attorneys from Tilleke & Gibbins and presents an overview of Thailand’s legal system and key laws applicable to foreign companies doing business in the country.
Read More
January 6, 2020
On December 13, 2019, the Vietnamese government issued Decree No. 94/2019/ND-CP (Decree 94) providing detailed guidance on some articles of the Law on Crop Production related to plant varieties and cultivation. Decree 94 will come into effect on February 1, 2020.Notably, Decree 94 includes a list of plant variety genetic resources banned from export. In addition, it provides detailed regulations on labeling, conditions for trading or manufacturing, and administrative procedures related to plant varieties to facilitate the manufacture, trade or import of plant varieties.
Read More