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​ 

November 17, 2011
Medical devices are part of a rapidly growing business driven by technological achievements and developments, as well as the desire for increased life expectancy and better healthcare. Emerging technologies require new legal regulation so that all combined and borderline products are properly covered. These products are becoming increasingly standardized, which facilitates their worldwide distribution and use.
Read More
August 1, 2011
The registration of a pharmaceutical product with the Food and Drug Administration (FDA) can be extremely time consuming, even for straightforward cases. In order to avoid any delays, it is important that the product dossier be meticulously prepared prior to submitting all relevant documents to the FDA, especially the quality part of the documentation.
Read More
June 29, 2011
Advertising of pharmaceutical products is heavily regulated in many jurisdictions, and Vietnam is no exception. The Vietnam chapter of The International Comparative Legal Guide to: Pharmaceutical Advertising 2011, written by Tra Thanh Nguyen and Dung Thi Kim Vu of Tilleke & Gibbins, provides essential advice for pharmaceutical companies as they seek to market their products in this country.
Read More
May 12, 2011
In response to regular queries received from our multinational clients, David Lyman, Chairman & Chief Values Officer of Tilleke & Gibbins, has been providing periodic updates on the ongoing political events in Thailand since 2006. This Viewpoint summarizes and updates several of these reports, while providing observations on the Thai political landscape ahead of the upcoming elections.
Read More