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​ 

September 26, 2023
Cambodia has issued a set of regulations that aim to encourage greater energy efficiency from appliances marketed in the country. The regulations follow Cambodia’s adoption of its National Energy Efficiency Policy, which sets out the government’s energy efficiency targets and policies to reach them by 2030, including the ambitious national target of reducing the country’s total energy consumption by at least 19%. This set of regulations for appliances marketed in Cambodia is contained in Sub-Decree No. 254 on the Management and Improvement of Energy Efficiency of Electrical Appliances, dated August 11, 2023. This sub-decree sets out product registration and energy efficiency labeling requirements for electrical appliances marketed in Cambodia. It further provides that appliances should meet energy efficiency standards and all other mandatory standards that apply to electrical appliances. During the product registration process, the appliances are checked against such standards, and registration is only granted if the standards are met. The sub-decree identifies the Ministry of Mines and Energy as the main ministry responsible for the implementation of the sub-decree. To assist with the wide scope of regulations as set by the sub-decree, it further appoints assisting ministries that may implement and enforce only certain aspects. These effective implementation and enforcement mechanisms suggest that once the sub-decree’s 12-month implementation period has passed, there is likely to be a rather strict enforcement approach to the requirements. Key Features of the Sub-Decree Several mandatory standards have already been applied to most electrical appliances over the past years, but the required product registration process to check for compliance with those standards has not always been completed by those importing, distributing, or manufacturing electrical appliances in Cambodia. The new sub-decree clearly mandates a product registration requirement as a check to verify the applicable standards are met, and sets penalties for non-compliance. Penalties
Read More
September 21, 2023
Myanmar’s Ministry of Commerce has announced its E-commerce Guidelines to regulate stakeholders engaging in e-commerce. The guidelines—which were issued on September 5, 2023, and took immediate effect—are mandatory for e-commerce business operators (both entities and individuals), and failure to comply with the guidelines’ requirements may result in penalties under relevant laws. The E-commerce Guidelines come as Myanmar seeks to increase its regulation of e-commerce activities. The guidelines were preceded by a July 2023 notification requiring e-commerce business operators to register their activities with the Ministry of Commerce by January 21, 2024. Definitions “E-commerce” is defined as the sale of goods or services on the internet or other digital platforms. The term also covers sales promotions, marketing, logistics, ordering, and delivery. An “e-commerce platform entrepreneur” is a person who manages an e-commerce platform where two or more entrepreneurs can conduct e-commerce. An “e-commerce business operator” is a person operating or authorized to operate e-commerce activities. This includes e-commerce platform entrepreneurs, entrepreneurs selling on e-commerce platforms, and sellers through social media platforms. Electronic Contracts Acceptable forms of electronic contracts, which must comply with the Electronic Transactions Law, Contract Act, and other relevant laws, include: Click-wrap, click-through, and web-wrap contracts; Browse-wrap contracts; and Agreements between seller and buyer on social media platforms, such as by accepting or rejecting an offer via direct message. Samples of contract forms are appended to the guidelines. Consumer Protection Disclosure notices for consumers must be comprehensible, correct, consistent, simple, accessible, and visible. They can be written in Myanmar language, English, or Myanmar language and another language. They must also comply with the relevant provisions of the Consumer Protection Law. The guidelines provide that if the agreed delivery date is eclipsed by more than 15 days, the consumer may terminate the contract and request a full refund of
Read More
September 20, 2023
Thailand is preparing to open its first renewal period for drug marketing authorizations (MAs) since the passage of the Drug Act (No. 6) B.E. 2562 (2019). Before 2019, MAs for pharmaceuticals and vaccines in Thailand had lifelong validity. The 2019 Drug Act stipulated that all new MAs would be valid for seven years and could be renewed. The 2019 law also set out expiration dates for existing pharmaceutical products registered and approved prior to the implementation of the law (i.e., before October 13, 2019): Drug MAs issued before January 1, 1997, expire on October 13, 2024. Drug MAs approved between January 1, 1997, and December 31, 2007, expire on October 13, 2026. Drug MAs approved between January 1, 2008, and October 13, 2019, expire on October 13, 2028. Based on these dates, the first renewal period for drug MAs will commence in the fourth quarter of 2023. To facilitate the renewal process, the Thai Food and Drug Administration (FDA) has publicized draft regulations and notifications on the required application form and documents, the rules and conditions, and the process for renewing an MA. In May 2023, the Thai FDA issued Ministerial Regulation Re: Renewal of Drug MA Licenses B.E. 2566 (2023) to prescribe the essential requirements for filing a renewal application: To renew a drug MA, holders must submit their renewal application to the Thai FDA within the one-year period before the MA’s expiration date. Renewal applications can only be submitted online via the Thai FDA’s electronic system. The Thai FDA will grant approval for an MA renewal if the following conditions are satisfied: The documents in relation to efficacy and safety are up-to-date, accurate, and in accordance with academic principles. The specification and analytical method comply with the official pharmacopeias as prescribed in the Drug Act, as amended.
Read More
September 15, 2023
In May 2023, Thailand issued a regulation on conditional approval for emergency use of medicinal products, replacing a series of similar notifications that had been issued to aid mitigation efforts during the COVID-19 pandemic. During the pandemic, regulatory authorities worldwide—including the Thai Food and Drug Administration (FDA)—reshaped the approval pathway for emergency drugs intended for the treatment of COVID-19. The Thai FDA published five Notifications Re: Conditional Approval for the Emergency Use of Medicinal Products to outline the registration requirements and channels of distribution for drugs intended for the diagnosis, treatment, or prevention of COVID-19. As the threat from COVID-19 was receding, the Thai FDA saw fit to prepare for the potential emergence of other serious communicable diseases by enabling the supply of timely medications for disease diagnosis, treatment, and prevention. The Thai FDA therefore cancelled the five COVID-19-related emergency use notifications, which were published in 2020 and 2022, and replaced them with the Notification Re: Conditional Approval for Emergency Use of Medicinal Products published in May 2023. Under the May 2023 FDA notification on emergency use, conditional approval can be applied to drugs supported by empirical scientific evidence demonstrating their capacity to diagnose, treat, alleviate, cure, or prevent a serious communicable disease. The drugs eligible for approval under this new emergency pathway include novel drugs that are not yet approved in Thailand, as well as existing drugs approved in Thailand but recently discovered to have additional potential indications for the diagnosis, treatment, alleviation, cure, or prevention of a serious communicable disease. Distribution The 2023 FDA notification also clearly defines permissible distribution channels based on the dosage form of drug products: Vaccines can be distributed to governmental organizations that have a duty to prevent or treat diseases, such as the Thai Red Cross Society (TRCS), the Government Pharmaceutical Organization
Read More