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INSIGHTS

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We provide you with all of the latest legal developments in Southeast Asia, ensuring that you have the up-to-date knowledge you need to navigate the ever-changing legal landscape affecting your business. You can browse our entire library of publications below, and email [email protected] to sign up for updates that are relevant to your interests, delivered straight to your mailbox, as they emerge.

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June 11, 2025
Myanmar’s Ministry of Commerce has established new regulatory measures for importing electric vehicles (EVs) as part of a pilot project running from January 2025 to March 31, 2026, while the Ministry of Planning and Finance has reduced customs duty rates for fuel-powered vehicles manufactured domestically under semi-knocked down (SKD) and completely knocked down (CKD) systems, effective June 1, 2025, to May 31, 2026. Importation of EVs On May 29, 2025, Myanmar’s Ministry of Commerce (MOC) issued an announcement regarding the importation of EVs from abroad as part of its pilot project, detailed in MOC Notification No. 40/2025. The MOC notification establishes the following regulatory measures to support the development of EVs and related businesses: Approval must be obtained from the National-Level Steering Committee for the Development of Electric Vehicles and Related Enterprises. A registration certificate for an EV sales showroom must be secured. Vehicles must be imported in accordance with the permitted number and standards defined by the National-Level Steering Committee for the Development of Electric Vehicles and Related Enterprises. The importing company must provide necessary arrangements for warranties on imported EVs, spare parts, and after-sales services. For companies wishing to open a sales showroom, the following requirements apply: The company must be a registered national or joint venture entity with the Directorate of Investment and Company Administration. The company must be officially appointed as a distributorship or dealership by the original company or regional office for each brand. A permit from the respective state or regional government and a business license from the respective Municipal Committee must be obtained. The company must provide evidence of tax clearance issued by the Internal Revenue Department. Standards for the showroom, building, and warehouse, as issued periodically by the MOC, must be adhered to, including: Compound area: 10,000 square feet (the total area for the showroom, service center, and waiting room must be 5,000 square feet). Warehouse:
June 11, 2025
Thailand’s tax dispute resolution framework has undergone a significant transformation with the enactment of the Act Establishing the Tax Court and the Procedure for Tax Cases (No. 3) B.E. 2568. Published in the Government Gazette on May 27, 2025, the amended act will come into force on November 24, 2025, which is 180 days after its publication. The amended act marks a pivotal shift in the jurisdiction and procedures of the Tax Court, most notably by empowering it to adjudicate certain criminal tax cases for the first time. Background and Rationale The Tax Court was originally established in 1985 as a specialized forum to handle complex tax disputes, including those related to revenue, customs, and excise taxes. The creation of the Tax Court recognized the need for judicial expertise in tax law, given its technical and specialized nature. The latest amendment is designed to address procedural inefficiencies, modernize court processes, and align Thailand’s tax litigation system with international standards. The reform demonstrates Thailand’s commitment to enhancing the efficiency, transparency, and fairness of its tax dispute resolution mechanisms. Key Amendments and Provisions Six of the key changes in the amendment are highlighted below. Expansion of jurisdiction to criminal tax cases. The most significant change is the extension of the Tax Court’s jurisdiction to include criminal offenses under the Revenue Code, customs law, excise tax law, and other tax-related laws that may be specified by royal decree. New sections in the act explicitly grant the Tax Court authority to hear and decide criminal tax cases, so individuals and entities accused of criminal tax evasion or other tax-related crimes will now have their cases heard by judges with specialized tax expertise. The law also clarifies the Tax Court’s jurisdiction when a single act constitutes multiple offenses (some tax-related, some not) or when there are multiple related offenses.
June 10, 2025
タイ食品医薬品局(FDA: Food and Drug Administration)は、オンライン販売される健康関連製品に対する規制監督を強化するため、大手電子商取引プラットフォームのLazadaおよびShopeeとの戦略的提携を開始した。本提携は、消費者保護の強化、タイの保健関連規制の遵守の徹底、そして健康関連製品のより安全なデジタルマーケットプレイスの促進を目指す、より広範な取り組みの一環である。 この取り組みの一環として、タイ食品医薬品局は、すべての販売業者、特に越境販売業者に対し、市場参入前に製品の適切なFDA登録を取得するよう強く求めている。その目的は、合法的に認可され、安全で品質が保証されたヘルスケア製品のみがタイの消費者に提供されるようにすることである。 この目標達成のため、タイ食品医薬品局は、LazadaおよびShopeeと緊密に協力し、不適合であったり、基準を満たさない、または未登録の製品を特定・削除するための積極的な監視メカニズムを導入してきた。このような連携は既に目に見える成果を上げている。2023年9月から2024年の間に、Lazadaは9,454件の不適合商品を削除し、30社の販売業者をリストから削除することで、規制の執行を支援した。さらに、134社の販売業者が規制違反で法的措置を受けた。Shopeeも同様に厳格な姿勢をとっており、FDA規制に違反していることが判明した製品は直ちに削除することを約束している。Shopeeはまた、販売業者向けの教育資料を提供し、説明責任を強化するために消費者からの苦情受付メカニズムも導入している。 タイ食品医薬品局は今後、API技術を活用したデータ統合システムを導入し、タイ食品医薬品局と電子商取引プラットフォームとの間で規制データをシームレスかつ安全に交換できるようにする予定である。このシステムは、タイ食品医薬品局職員と電子商取引担当者との両方を対象とした包括的な研修によってサポートされ、特にタイ政府のLaw Enforcement Request Portal(政府機関とプラットフォーム運営者と間のエンフォースメント措置を調整するための安全なコミュニケーション・チャネル)の活用に重点が置かれている。 さらに、LazadaおよびShopeeとの提携により、共同製品検査フレームワークの開発が現在進められている。このフレームワークには、厳格なコンプライアンス基準が組み込まれており、公衆衛生法に違反する販売業者に対してエンフォースメント可能な罰則が規定されている。タイ食品医薬品局はまた、オンラインマーケットプレイスにおける違法な健康関連製品の販売の検出及び防止を強化するために、先進技術を駆使した次世代のインテリジェント検査システムの導入も準備している。 これらの共同の取り組みは、急速に進化する電子商取引環境において、タイ食品医薬品局が公衆衛生及び法令遵守に継続的に取り組んでいることの具体的な例である。したがって、これらのプラットフォームで事業を展開する越境販売業者は、自社製品がタイの規制要件を完全に遵守していることを強く推奨します。遵守しない場合、製品の撤去や法的措置につながる可能性がある。   備考:本和文は英文記事を翻訳したものです。原文については、以下のリンクをご参照ください。 Thai FDA Partners with E-commerce Platforms to Regulate Health Products Online
June 10, 2025
ベトナム保健省(Ministry of Health )は、2025年5月16日、医薬品及び医薬品原料の登録に関する通達第12/2025/TT-BYT(Circular No. 12/2025/TT-BYT on registration of drugs and drug materials)(以下、通達第12号という。)を公布した。通達第12号は、医薬品登録に関する現行規則である通達第08/2022/TT-BYT(改正版)、委託製造及び技術移転における医薬品の登録に関する通達第16/2023/TT-BYT、並びに市販薬リストを公表する通達第07/2017/TT-BYTに代わるものであり、2025年7月1日に施行される。 通達第12号の主な規定の一部を以下に概説する。   市販薬の規制 通達第12号は、従来通達第07/2017/TT-BYTで規定されていた市販(over-the-counter)薬の詳細なリストを廃止するものである。分類用固定リストに依拠する方法に代えて、通達第12号では、非処方薬/市販薬の分類に関する原則、基準、および具体的な方法に基づく新たな枠組みを導入している。このアプローチは、安全性の向上、迅速なアクセスの確保、実際の使用状況と供給状況の反映、そして国際基準への適合を目的としている。 既に承認されている医薬品は、販売承認(marketing authorization)の有効期間中、その分類(すなわち、処方薬または非処方薬)が維持され、販売承認の更新時に再分類が検討される。分類の変更を申請する場合、販売承認保有者はベトナム医薬品管理局(Drug Administration of Vietnam)に変更申請用書類(variation registration dossier)を提出する必要がある。 現在 ベトナム医薬品管理局 によって評価中の医薬品登録用書類については、通達第12号に定められた新しい規定に従って分類が評価される。   医薬品登録 通達第12号の規則は、医薬品証明書(Certificate of Pharmaceutical Product)の提出要件を緩和している。すべての医薬品登録において、製造国の管轄当局、または欧州医薬品庁(European Medicines Agency)加盟国もしくはSRA(Stringent Regulatory Authority)が発行し、当該医薬品がその国で認可され、積極的に販売されていることを確認する医薬品証明書が1通あれば十分となる。従前の規則では、特定の状況において追加の医薬品証明書または同様の法的文書が必要となる場合があった。 他の機関によって評価された登録用書類の参照結果を利用した医薬品の登録に関して、 ・登録用書類は、評価報告書に記載されているとおり、欧州医薬品庁またはSRAによる医薬品の初回承認日から5年以内にベトナムに提出する必要がある。 ・ベトナムに提出される登録用書類には、( i )欧州医薬品庁またはSRAが発行した評価報告書、および(ii)ベトナムの医薬品登録用書類と欧州医薬品庁/SRAが承認した書類との類似点の比較表が含まれている必要がある。 販売承認延長:新しい規則では、販売承認の有効期限が切れる前であればいつでも延長用書類を提出できる。 追加登録用書類のタイムライン:ベトナム医薬品管理局からの欠陥通知に応じて追加登録用書類を提出する期限は、すべてのケースで 6月間に短縮されている。 追加申請回数の制限:通常、ベトナム医薬品管理局専門家からの要請に応じて、最大2回の追加申請が許可される。3回目の追加申請は、2回目の申請中に追加の要件が提示された場合にのみ許可される。これらの制限は、医薬品登録諮問委員会(Advisory Council for Drug Registration)が発行する追加申請には適用されない。   見解 通達第12号は、ベトナムにおいて医薬品および医薬品原料を製造・取引する企業に影響を与える。これらの企業は、改正規定を適時に遵守できるよう、新しい規則を徹底的に検討することを提案する。   備考:本和文は英文記事を翻訳したものです。原文については、以下のリンクをご参照ください。 Vietnam Issues New Regulations on Drug Registration
June 6, 2025
As from July 1, 2025, as part of its ongoing efforts to digitalize and streamline the delivery of public services, the Vietnamese government will officially conduct administrative procedures, both online and offline, only via electronic identity (“e-ID”) accounts on the VNeID platform. In particular: Online administrative procedures carried out via the National Public Service Portal or via information systems for administrative procedures at the ministerial or provincial level are required to be implemented by using e-ID accounts only. When receiving dossiers, authorities will be required to check and verify the e-IDs of companies or individuals responsible for conducting administrative procedures. Further, it is worth noting that to complete the registration of an e-ID account for a company, the legal representative of the company must hold a level-2 e-ID account. Compliance Considerations Vietnam’s first regulation of e-ID accounts for individuals and organizations was issued in Decree No. 59/2022/ND-CP dated September 5, 2022, on electronic authentication and identification. This decree was subsequently replaced by Decree No. 69/2024/ND-CP dated June 25, 2024, which governs the same matters. Registration and operation of e-ID accounts are centralized through VNeID, a digital ID app developed by the National Population Data Center under the Ministry of Public Security of Vietnam. Although the registration of e-ID accounts for companies is not explicitly mandated by law, the absence of an e-ID account may hinder companies from completing administrative procedures, including licensing and reporting obligations. Such non-compliance could consequently result in administrative penalties. To mitigate unexpected non-compliance and administrative fines due to the lack of an e-ID account, companies should be well prepared for and implement the registration of a company e-ID account as soon as possible.
June 4, 2025
On April 2, 2024, the Cambodian Competition Commission (CCC) issued Decision No. 087 on Requirements and Procedures of Exemptions under the Law on Competition, outlining the requirements and procedures for requesting exemptions for agreements or activities that could prevent, restrict, or distort competition in Cambodia. Franchise agreements often include clauses such as price fixing, exclusive supply arrangements, or territorial restrictions, which could potentially raise concerns under the Law on Competition. Therefore, it is necessary for both franchisors and franchisees to understand how the law applies to their agreements and whether an exemption request may be required. Some arrangements under franchise agreements may fall within the scope of prohibited practices under the Law on Competition. These include horizontal and vertical agreements, abuse of dominant position, and anti-competitive business combination. If a business owner contemplates that their franchise agreement could be interpreted as anti-competitive, they must assess whether to apply for an exemption. Key Criteria for Exemption Under Decision No. 087, the CCC may grant an exemption if the applicant can demonstrate that the proposed agreement or activity meets all four of the following conditions: Significant and identifiable benefits: The agreement must provide clear technological, social, or economic benefits such as cost efficiencies, qualitative efficiencies, initiations of new technologies, or environmental and sustainable benefits. Necessity of the agreement/activities: These benefits must not be achievable without the proposed agreement or activity. The applicant must show that prevention, restriction, or distortion of competition are essential to realizing the benefits. Benefits outweigh harm: The positive impacts must significantly outweigh any adverse effects caused by the prevention, restriction, or distortion of competition, and the benefits should be likely to materialize within one year. No elimination of competition: The agreement must not eliminate competition in any substantial aspect of goods or services. Application and Supporting Documents Applicants must submit the application form and provide evidence to
June 4, 2025
The growth of Vietnam’s vibrant digital economy offers tremendous potential but is also a driver of the persistent problem of online intellectual property (IP) infringement. The spectrum of issues faced by IP rights holders runs from copyright piracy on digital services (such as streaming and torrent sites) to the sale of counterfeit goods via e-commerce sites and social platforms to the misuse of rights through misleading use of trademarks. These infringements do not only eat into profits; they damage brand reputation and mislead consumers. As a result, site blocking and keyword blocking have become increasingly important components of the enforcement toolkit available in Vietnam. Legal Framework for Blocking Actions Site and keyword blocking in Vietnam is supported by a growing legal framework, particularly following the 2022 amendment to the IP Law. Prior to this, the legal basis for blocking was scattered across various laws, and internet service providers (ISPs) were only obligated to block access to infringing content upon official requests from authorities. The introduction of Article 198b under the amended IP Law marked a significant shift, establishing a clearer mechanism for rights holders to request site blocking directly. This provision obliges them to act upon valid takedown or blocking requests. In addition to the IP Law, other key legislation includes the Law on Information Technology, the Law on Cybersecurity, the Law on Advertising, and various decrees. Together, these laws provide a more structured and enforceable basis for blocking actions in Vietnam, though practical enforcement still depends on ISP cooperation and the clarity of the infringement evidence. Competent Authorities Previously, rights holders could pursue administrative actions through specialized inspectorates under the Ministry of Science and Technology, the Ministry of Culture, Sports and Tourism, or the Vietnam E-Commerce and Digital Economy Agency (iDEA). However, due to a recent government restructuring, these bodies have been dissolved with
June 4, 2025
On June 1, 2025, Thailand’s Office of Central Company and Partnership Registration of the Department of Business Development opened a public hearing period on its draft notification regarding criteria and supporting documents for establishment of partnerships and limited companies in which foreign nationals are involved as investors or have signing authority. The draft notification requires applicants for registration of establishment of partnerships and limited companies to submit financial evidence of the capital contributions made by each Thai partner or shareholder in the following cases: When a partnership or limited company has partners or shareholders who are foreign nationals holding shares or equity amounting to less than 50% of the total capital contribution or registered capital in the partnership or company; or When a limited company has no foreign shareholders but has a non-Thai director who is an authorized or co-authorized signatory. The amounts shown in this financial evidence must be in accordance with the capital contribution or shareholding amount of each Thai partner or shareholder. Evidence can be provided in one of the following forms: Financial evidence issued by a bank to verify or demonstrate financial status. Copy of bank statement for the past six months. Copy of personal income tax or corporate income tax document (Form PorNgorDor.90 or PorNgorDor.91 for individuals; Form PorNgorDor.50 or PorNgorDor.51 for corporate shareholders). Any other supporting document showing the source of funds used for the capital contribution. The consultation period will be open until June 20, 2025, and the draft may be subject to additional revisions before it is finalized and made legally binding.