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

August 26, 2021

Vietnam’s Ministry of Health Issues List of Substances Prohibited from Use in Health Supplements

Subscribe to Updates

The Ministry of Health of Vietnam recently issued Circular No. 10/2021/TT-BYT dated June 30, 2021, stipulating the list of substances prohibited from use in the production and trading of health supplements (“Circular 10”). Circular 10 will come into effect on September 1, 2021.

Accordingly, substances found on the following lists will be prohibited from use in health supplements:

  1. The list of drugs and drug materials prohibited from importation and production found in Annex V of Decree No. 54/2017/ND-CP of the Government dated May 8, 2017, guiding the implementation of Law on Pharmacy (Decree 54).
  2. Lists promulgated with Decree No. 73/2018/ND-CP of the Government dated May 15, 2018, stipulating the list of narcotic substances and precursors, including:
  • List I: Narcotic substances banned from use in healthcare and daily life, the use of which for analysis, testing, scientific research, and criminal investigation is subject to permission by competent authorities.
  • List II: Narcotic substances restricted from analysis, testing, scientific research, criminal investigation, or healthcare as regulated by competent authorities.
  • List III: Narcotic substances permitted in analysis, testing, scientific research, criminal investigation, healthcare, and veterinary medicine as regulated by competent authorities.
  • List IVA: Essential precursors involved in forming the structure of narcotic substances.
  1. The list of narcotic active ingredients found in Annex I of Circular No. 20/2017/TT-BYT of the Ministry of Health, detailing articles of the Law on Pharmacy and Decree 54 related to drugs and drug materials under special control.
  2. The list of toxic drugs and toxic drug materials under Circular No. 06/2017/TT-BYT of the Ministry of Health dated May 3, 2017.
  3. Lists under Circular No. 42/2017/TT-BYT of the Ministry of Health dated November 13, 2017, stipulating the lists of toxic herbal materials, including:
    • Annex I: List of toxic herbal materials of plant origin.
    • Annex II: List of toxic herbal materials of animal origin.
    • Annex III: List of toxic herbal materials of mineral origin.
  4. A list of 80 additional chemical substances included as an Annex to Circular 10, including 1-3-dimethylamulamine, sildenafil, betamethasone, etc.
Related Professionals

Industries

Consumer Products

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

July 31, 2024
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.
Read More
July 9, 2024
On July 3, 2024, the Committee on Contracts of Thailand’s Consumer Protection Board announced the Notification re: Stipulation of Cash-on-Delivery (COD) Logistics Services as a Controlled-Receipt Business under the Consumer Protection Act B.E. 2522 (1979). The notification regulates businesses “providing goods transportation services that collect cash on delivery,” which refers to business operators responsible for transporting goods from sender (i.e., the merchant of the goods) to consumer (i.e., the purchaser of the goods) and upon delivery collects payment from the consumer either in cash or via bank transfer. The obligations that the notification imposes on these business operators are described below. Receipts Business operators must prepare a receipt as evidence of payment according to the specified requirements and deliver it to the consumer immediately upon receiving payment for the goods. The receipt must include text in Thai that is clearly visible and legible, with a font size of at least two millimeters and no more than 11 characters per inch. The text must contain essential information and conditions as specified in the notification, including: The duration that the business operator will hold the money received from the consumer before releasing it to the sender; The timeframe within which the consumer must notify the business operator to return the goods and request a refund; Information about the employees who deliver the goods and collect payment from consumers; The name of the person authorized to issue the receipt; Details about the parcel specifying the nature of the goods, including the name, type, kind, characteristics, size, weight, quantity, color, volume or capacity, and price of the goods; and A statement that the consumer has the right to reject the delivered goods or receive a refund. The receipt also must not contain any statement prohibited by the notification. Examples include: Text stipulating that
Read More
June 24, 2024
Thailand’s Minister of Public Health recently promulgated the Ministerial Notification Re: Category 5 Narcotics Which Are Not Cannabis or Hemp Extract and Whose Consumption is Permitted for Treatment of Disease or for Research Purposes (2024). The notification took effect on April 23, 2024. The substances whose regulatory controls are affected by this new notification are psilocybin mushroom (Psilocybe cubensis (Earle) Singer), opium poppy (Papaver somniferum L. and Papaver bracteatum Lindl.), and other plants in these genera from which opium, opium alkaloids, psilocybin, or psilocin may be derived. As a result of this notification, these substances are now classified as category 5 narcotics that can be applied in medical treatment. Without the implementation of this notification, patients could not access newly developed medicines containing these substances, as Thailand’s Narcotic Code prohibits the possession and use of category 5 narcotics. Nonetheless, this does not mean that psilocybin mushrooms and opium can be used without any conditions. There is still a long process to go through before these substances can be used in medical treatment or clinical studies. Under the new notification, the FDA must first approve any medicinal drug formulation containing any of the above substances, and subsequently, the production must be approved for medical use or research purposes. The importation of medicinal drug formulations containing psilocybin mushrooms or opium is not allowed. This seemingly small regulatory change addresses the previous legal obstacle to the research and development of such medicines. According to the previous regulation, a physician or researcher could apply to the Thai FDA for a license to produce or possess medicines containing the aforementioned narcotics. However, production and consumption are considered different activities, and consuming a narcotic-containing medicine, even if it was produced under a valid license, is prohibited by the Narcotics Code and is punishable by imprisonment,
Read More
June 11, 2024
Advances in biotechnology have enabled the development of a range of new agricultural tools. From DNA sequencing to plant tissue culture and gene editing, these advances are facilitating the development of better crops. Genetically modified organisms (GMOs) are one well-known example of agricultural biotechnology. GMOs are organisms whose genetic material has been artificially altered by inserting a piece of foreign DNA. This DNA may be synthetic in origin or sourced from other organisms. Genome editing (also called gene editing or GEd) involves making precise changes to an organism’s genome without the integration of foreign DNA elements. Several approaches to genome editing have been developed. A well-known one is called CRISPR-Cas9, in which scientists make precise “cuts” in the DNA to create a new genetic variation. Unlike with GMOs, this introduces only minor modifications that are indistinguishable from natural mutations, typically by transplanting genes that code desirable traits from one species into another. GEd technology has been recognized and supported by the Food and Agriculture Organization of the United Nations (FAO). Thirteen FAO-member countries who are also members of the Organization for Economic Cooperation and Development (OECD) announced their support of the use of GEd technology for commercial uses and consumption at a recent WTO meeting. In addition, over 40 countries around the world, such as Argentina, Australia, Brazil, Canada, Chile, China, England, Japan, Kenya, the Philippines, Russia, the UK, and the US, have published policies emphasizing that foods free of transgenes (i.e., foods that do not contain genes transferred from external sources) are not GMOs, concluding that GEd plants are as safe as normal plants. In February 2024, the European Parliament approved new genomic techniques (NGTs), or GEd. As a result, plants that are produced using GEd technology are not classified by the EU as GMOs, and the EU
Read More