Tilleke & Gibbins has contributed the Thailand chapter to the 2024 edition of Pharmaceutical Advertising from the International Comparative Legal Guides (ICLG) series published by Global Legal Group. This detailed guide offers an in-depth examination of pharmaceutical advertising laws and regulations in multiple jurisdictions around the globe. Each chapter of the guide, structured in a Q&A format, is organized into comprehensive sections covering various aspects of pharmaceutical advertising, including: General rules and codes of practice governing pharmaceutical advertising Required arrangements for ensuring compliance with advertising regulations Procedures for obtaining advertising approvals from regulatory authorities Penalties for non-compliance with advertising rules Guidelines for providing information prior to product authorization Requirements for advertisements directed at healthcare professionals Restrictions on the content of pharmaceutical advertisements The complete Thailand chapter is available as a PDF below. The Thailand chapter—and the full Pharmaceutical Advertising guide—are also freely available on the ICLG website.

On July 19, 2024, Thailand’s Ministry of Public Health Notification No. 450 B.E.2567 (2024) came into effect after being published in the Government Gazette the day before. The notification introduces significant updates to the labeling requirements for prepackaged foods. This new regulation consolidates and updates Thailand’s rules for food labeling by repealing and replacing several previous notifications. The notification’s key changes and their implications for food businesses are identified below. 1. Clarified “Best Before” Definition The notification aligns the definition of “best before” with Codex standards. It now refers to the date marking the end of the period during which the food maintains its best quality under stated storage conditions. After this date, food quality may change, and the product cannot be marketed. 2. Updated Labeling Exceptions Certain foods are exempt from labeling requirements, with the latest list including: Foods sold directly to consumers by manufacturers who can provide product information. Unprocessed foods. Some fresh foods not sold directly to consumers. Prepackaged foods produced and sold for immediate consumption in food service settings. However, any of these exempt foods that have received food serial numbers must still have labels that comply with the notification. 3. Expiration Date and Best-Before Date Display The notification provides clearer language for displaying the expiration date and best-before date. If specific wording is required by other notifications, it must be followed. English equivalents are now permitted alongside Thai text. 4. Warning Displays Multiple applicable warnings can now be consolidated and displayed together, provided the complete message is included as specified. 5. Claims about Substances or Ingredients New guidelines have been established for making claims about food additives and ingredients. Claims should be factual, not deceptive, and provably not false. 6. Label Placement and Design Labels must be permanently affixed, proportionate to the packaging, and

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.

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,