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. For noncompendial specifications or methods, justification or evidence that substantiates the quality,

Attorneys from Tilleke & Gibbins have prepared the Laos, Myanmar, and Thailand sections of the recently released Global Merger Notification Guide from Lex Mundi. The guide provides answers to key questions related to the merger notification requirements in jurisdictions of Lex Mundi member firms in 57 jurisdictions around the world. Each country-specific section contains in-depth information on the jurisdiction’s legal framework governing merger notifications, addressing the following questions and topics: Regulatory agency for merger notifications Transactions subject to national rules Timeline for filing merger notifications Merger review process Sanctions for not fulfilling merger notification requirements Remedial options for addressing the regulator’s competition concerns Current regulatory outlook and other notable information The guide draws on the expertise of Lex Mundi member firms from around the world. Its innovative format allows users to compare current information from multiple jurisdictions in a side-by-side, customizable report. To browse the contributions, generate country-specific reports, and compare regulatory guidance on merger notification requirements across multiple jurisdictions, please visit the Lex Mundi website.

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 (GPO), public hospitals, private hospitals, medicinal

Thailand is a member state of the ASEAN Economic Community, and next year, it is expected that the ASEAN Harmonization of Traditional Medicines and Health Supplements will be signed by the economic minister of each ASEAN country. Following ratification, the ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines and Health Supplements will become the standard guidelines in the region, and various implementation efforts and instruments will follow. These guidelines cover a wide range of medicines and supplements; however, it is not possible to cover all herbal products. There are three types of health supplement claims: nutritional claims, functional claims, and disease risk reduction claims. Examples of the three types of claims include the following: Nutritional claims: supplements nutrition, nourishes the body, supports healthy growth and development, etc. Functional claims: maintains healthy joints, supports immunity, maintains liver function, etc. Disease risk reduction claims: helps to reduce risk of dyslipidemia, helps to reduce risk of osteoporosis, etc. The degree of evidence required for substantiating disease risk reduction claims is higher than for functional claims and nutritional claims. Functional claims and disease risk reduction claims must be substantiated by efficacy studies and the relevant toxicity data. It is the responsibility of the health supplement company to provide the required evidence in order to comply with the criteria for making such claims. Tips on Health Claims for Health Supplements 1. Nutritional Claims For essential nutrients such as vitamins and minerals, as listed by the Thai Food and Drug Administration (FDA), the amount included in a supplement must be between 15% and 100% of the Thai Recommended Daily Intake (RDI) values. Rules for specific kinds of nutritional claims are provided in the Notification of the Thai FDA RE: Nutrient Function Claims. For example, the nutrients that can be claimed as boosting the immune system include vitamin A, B6, B12, folic

With Vietnam’s entertainment industry booming, the demand for music to be used in films and video games has sharply increased. Sometimes a song featured in a movie’s soundtrack can become as popular as the movie itself. In order to use a song in a film, the producer of the film will typically need to enter into an agreement with the owner of a copyrighted work to have permission to use that work – with an agreed amount of royalty. Otherwise, their use could be considered a copyright infringement. However, what happens if the producer enters into an agreement with a song’s purported copyright owner, only to later find that such person does not really own the song entirely? A recent high-profile case in Vietnam brought this issue to light. The Dispute and Court Rulings The film “Face Off 4 – The Walking Guests,” financed and produced by Ly Hai Promotion Co., Ltd (“Ly Hai”) premiered in April 2019, and soon became a big success. In this film, Ly Hai used a song called “Ganh Me” on the basis of a March 2019 contract to use the song signed with the musician Quach Beem, who was recognized as the song owner in a copyright certificate issued on 24 April 2019 by the Copyright Office of Vietnam (COV). The dispute arose in November 2019 when an individual named Truong Minh Nhat discovered that the lyrics of “Ganh Me” were almost identical to a poem he had written and posted on his Facebook page in June 2014, well before the COV had issued the copyright certificate to Quach Beem. Mr. Nhat initiated a lawsuit against two defendants, Quach Beem and Ly Hai, for copyright infringement. In his petition, Mr. Nhat requested the court to, among other things, recognize him as the author and owner of the lyrics

When your company suffers a data breach, taking prudent, careful action can limit and perhaps even rectify some of the damage. First of all, it is important to document everything, starting with the time the data breach was discovered. Secure the data systems and preserve all evidence so that investigators can determine what happened, and begin following the protocol that all companies handling personal data should have in place to guide their data breach response. It is also crucial to seek timely legal assistance to ensure that every aspect of the response is planned and carried out according to the law. While applicable legal advice for each situation can only be obtained by consulting a legal advisor, this guide gives an overview of what companies in Southeast Asian jurisdictions can expect if they suffer a data breach. This guide from Tilleke & Gibbins is a quick-reference resource covering key regulatory issues regarding data breach responses in Cambodia, Laos, Myanmar, Thailand, and Vietnam. The full guide can be downloaded through the button below.

Laos’ Ministry of Health (MOH) has promulgated a regulation detailing registration and notification protocols for medical devices. Decision on the Registration and Notification of Medical Devices No. 1470/MOH will come into force 60 days after both the signing of the regulation (which already occurred in July) and publication in the Official Gazette, which has not yet been specified by the government. Registration of medical devices in Laos is mentioned in the country’s Law on Drugs and Medical Products No. 07/NA, dated December 21, 2011, but a registration procedure has not been put in place. There was only a separate requirement to furnish certain required documents when importing medical devices. Now, the decision outlines the registration and notification process for medical devices through the Ministry of Health’s Food and Drug Department (FDD), in line with the regulatory principles in the ASEAN Medical Device Directive of 2015, which Laos has ratified. Medical Devices in Laos The decision defines medical devices as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article intended for any of the following uses in humans: Diagnosis, prevention, monitoring, recovery from, or alleviation or treatment of a disease; Diagnosis, monitoring, recovery from, or alleviation of or compensation for an injury; Replacement, modification, or support of anatomy or a physiological process; Supporting and sustaining life; Controlling or assisting in conception; or Disinfection and sterilization of tools and medical devices. Medical devices in Laos are given one of four classifications based on their level of risk: Class A – Low risk (e.g., rubber belts, cotton for medical purposes, nonwoven swabs, adhesive bandages) Class B – Low-moderate risk (e.g., neonatal suction equipment, surgical gloves, gastro-catheters) Class C – Moderate-high risk (e.g., endoscopic surgical equipment, anesthesia equipment, peritoneal dialysis equipment) Class D – High risk (e.g., cardiological catheters, craniotomy surgical equipment) Registration and Notification Imported and locally

Since the June 9, 2022, delisting of all parts of the cannabis plant according to the Narcotics Code, there has been an explosion of cannabis dispensaries operating in Thailand. The Department of Thai Traditional and Alternative Medicine (DTTAM) has issued more than 12,000 cannabis dispensary licenses to businesses in Thailand. A license allows a dispensary to sell cannabis flowers legally. In addition, the DTTAM requests the cooperation of dispensaries in submitting monthly reports about the sourcing, selling, and inventory of cannabis flowers. The DTTAM may suspend the selling license of dispensaries that fail to submit these reports. Apart from the enforcement duties and administrative acts of the DTTAM, the enactment of the laws and regulations pertaining to cannabis seemed to be drastically winding down. One of the reasons was that Thailand had delays in the process of forming a new government following the general election of May 14, 2023. These delays dampened Thailand’s thriving cannabis industry. In particular, the industry has concerns about the uncertainty of the nascent cannabis law. On August 11, 2023, the Narcotics Control Division of the Thai Food and Drug Administration (FDA) posted the Draft Regulation Re: Application for Approval and Approval for Manufacture, Importation, Exportation, Distribution or Possession of Narcotics under Category 5 (Extracts from Cannabis or Hemp Plants Only). This may be the first regulation that the newly formed government implements with regard to cannabis extracts. Unlike the DTTAM’s enforcement activities, the Thai FDA requests that a domestic manufacturer, importer, exporter, or seller of cannabis extracts apply for a license. The Thai FDA, as the authority, will consider granting a license only in the following cases: For medical benefits; For commercial or industrial benefits; For the benefit of medical or scientific analysis or research; and For use by the government for preventing and suppressing narcotics-related offenses. Nonetheless, there is currently