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

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.

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

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

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.

On March 12, 2025, Cambodia’s Ministry of Economy and Finance issued Prakas No. 192 on Tax Rules and Procedures for Trust to determine the tax rules and procedures for trust operations. With the exception of trusts whose legal form is a company or enterprise, all trustors, trustees, and beneficiaries engaged in trust operations in Cambodia are subject to this new regulation. Taxpayer Registration A trustee company must register as a medium or large taxpayer. An independent individual trustee must register as a small, medium, or large taxpayer depending on the amount of turnover or the value of the fixed assets of the business, as stipulated in the Prakas on the Clarification of Taxpayers under the Self-Assessment Regime. Independent individual trustees must register as taxpayers within 15 working days from the commencement of economic activity or from the receipt of a license or authorization from the Trust Regulator. Accounting Records Accounting records should follow the rules stipulated in Article 6 of the Law on Taxation., which requires small taxpayers to use simplified accounting, while medium and large taxpayers must adhere to the Cambodian International Financial Reporting Standards (CIFRS).The trustee must maintain separate accounting records between its own operations and the trust. If the trustee manages more than one trust, the trustee must prepare separate records for each trust. For all the records, the trustee must clearly identify the ownership of all assets, liabilities, expenses, and other transactions. Taxation of Trustee’s Income Trust property or funds that are transferred to a trustee for management are not considered income or property of the trustee. However, any allowances or commissions that the trustee receives from managing the trust are taxed as income. The trustee must follow the general rules on expenses outlined under Cambodian tax law to record all income and expenses related to managing the trust. The income tax

Tilleke & Gibbins attorneys in Vietnam have contributed the 2025 edition of Doing Business in Vietnam, a comprehensive Q&A-style resource from Thomson Reuters Practical Law that provides essential insights for companies navigating business operations in Vietnam. The guide presents a detailed overview of the country’s legal framework and regulatory environment, reflecting recent updates in Vietnamese legislation and practice. This annually updated guide offers key information on the following areas: Legal system: Structure of the Vietnamese judiciary and the role of codified law. Foreign investment: Conditions for market access, licensing requirements, foreign ownership restrictions, and investment incentives. Business vehicles: Formation and operation of legal entities, including limited liability companies, joint-stock companies, and representative offices. Employment: Employment contracts, social insurance, labor rights, and procedures for hiring foreign nationals. Tax: Overview of corporate income tax, personal income tax, value-added tax, and other tax obligations. Intellectual property: Procedures for protecting and enforcing patents, trademarks, copyrights, and other IP rights. Data protection: Compliance requirements under Vietnam’s data privacy laws, including the Personal Data Protection Decree. Competition law: Antitrust rules and regulatory oversight under the Law on Competition. Anti-bribery and corruption: Legal framework and enforcement practices aimed at curbing corrupt activities. E-commerce and digital business: Regulations governing online platforms, digital content, and cross-border services. Marketing and advertising: Laws and guidelines on advertising standards and consumer protection. Product regulation and liability: Safety requirements, product liability issues, and roles of relevant authorities. Doing Business in Vietnam is part of Practical Law’s global series of legal guides designed to support international practitioners and businesses. To access the most recent edition of the Vietnam guide, visit the Practical Law website and sign up for a free trial.

Thailand’s Food and Drug Administration (FDA) has launched a strategic collaboration with leading e-commerce platforms Lazada and Shopee to strengthen regulatory oversight of health-related products sold online. This partnership is part of a broader initiative to enhance consumer protection, enforce compliance with Thai health regulations, and foster a safer digital marketplace for health products. As part of this initiative, the Thai FDA is urging all sellers—particularly cross-border vendors—to secure proper FDA registration for their products before market entry. The objective is to ensure that only legally authorized, safe, and quality-assured healthcare products are available to Thai consumers. In pursuit of this goal, the FDA has been working closely with Lazada and Shopee to implement proactive surveillance mechanisms aimed at identifying and removing noncompliant, substandard, or unregistered products. This collaboration has already yielded measurable results. Between September 2023 and 2024, Lazada supported regulatory enforcement by removing 9,454 noncompliant listings and delisting 30 vendors. In addition, 134 sellers were subjected to legal proceedings for regulatory violations. Shopee has taken a similarly rigorous stance, committing to the immediate removal of products found to be in breach of FDA regulations. The platform has also provided educational materials for merchants and implemented consumer complaint mechanisms to enhance accountability. Looking ahead, the Thai FDA plans to roll out a data integration system utilizing API technology, enabling seamless and secure exchange of regulatory data between the agency and e-commerce platforms. This system will be supported by comprehensive training for both Thai FDA officials and e-commerce staff, with a particular focus on the use of the Thai government’s Law Enforcement Request Portal, a secure communication channel for coordinating enforcement actions between government agencies and platform operators. Additionally, a joint product inspection framework is currently under development in partnership with Lazada and Shopee. This framework will incorporate strict compliance standards and establish