On December 24, 2024, the government of Vietnam issued Decree No. 163/2024/ND-CP, providing guidelines for implementing the new Telecommunications Law that took effect on July 1, 2024 (“Decree 163”). This new decree replaces Decree No. 25/2011/ND-CP and its amendments (“Decree 25”) and took effect immediately upon issuance, with regulations on data center services, cloud computing services, and basic telecom services over the internet (“over-the-top” or OTT telecom services) having an official effective date of January 1, 2025. Decree 163 introduces substantial changes across the telecom sector, covering various aspects including service provision, licensing, standards and technical regulations, quality, passive infrastructure planning, dispute resolution, and more. Hence, it is necessary for enterprises to conduct a compliance review to identify gaps between the new decree and their business models, and take necessary steps to ensure lawful business operations in Vietnam. Below are some highlights of Decree 163. Expanded Scope of Services For basic telecom services, Decree 163 has introduced machine-to-machine (M2M) communication and classified it as a basic telecom service. This establishes a regulatory framework for IoT device communication, previously unregulated in Decree 25. For value-added telecom services, in light of the new Telecommunications Law, Decree 163 provides more detailed regulations for new telecom services such as data center services, cloud computing services, and OTT telecom services, which were not addressed in Decree 25. Regulation of Three New Telecom Services Expanding on the Telecommunications Law’s definitions of data center services, cloud computing services, and OTT telecom services, Decree 163 applies a light-touch management approach to regulate these three new services, as follows: Offshore providers: Cross-border service providers are exempt from signing commercial agreements with licensed local telecom companies. They only need to notify the Vietnam Telecommunications Authority (VNTA) using the prescribed procedures and forms before offering services. Onshore providers: The foreign

On November 30, 2024, the Data Law was officially promulgated after an accelerated preparation process that began in February 2024. The Data Law is set to take effect on July 1, 2025. Having extraterritorial effect, the Data Law will impact both local and foreign individuals and enterprises. As noted in our previous legal update, the Data Law governs digital data, the National Data Center, the National General Database, digital data products and services, digital data management, and the rights, obligations, and responsibilities of agencies, organizations, and individuals related to digital data activities. This legal update provides an overview of the Data Law, with a deep focus on the key provisions likely to impact businesses operating or offering services in Vietnam. New Data Definition and Classification The Data Law broadly defines “digital data” as data about objects, phenomena, and events, which can include one or a combination of audio, images, numbers, text, or symbols represented in digital format (hereinafter referred to as “data”). This definition is very broad and potentially covers any information recorded or represented in digital forms, including personal and nonpersonal data (such as business data, transactional data, trade secrets, etc.). Data is further categorized into different types that can be used by public bodies. However, the rights and obligations associated with each type of data are not clearly addressed. The data classification criteria include: The nature of data sharing (shared data, private data, open data); The importance of data (core data, important data, and other data); Any other criteria to meet the requirements of data administration, processing, and protection, as determined by the data owner. While the Data Law requires private organizations to categorize data based on its level of importance, it still grants these organizations the right to categorize data based on other criteria. Cross-Border Data

Experts from Tilleke & Gibbins have provided updates for the latest edition of The Pharma Legal Handbook: Vietnam, published by Pharma Boardroom. This comprehensive guide to the legal framework regulating the healthcare and life sciences industries in Vietnam was authored by by the Hanoi-based team of Hien Thi Thu Vu, head of regulatory affairs for Vietnam, and Mai Thi Le, regulatory affairs consultant, the handbook is a must-read for healthcare and life sciences companies that are interested in the Vietnam market. The guide includes eight sections on various important aspects of local regulations: Regulatory, Pricing, and Reimbursement Overview Preclinical & Clinical Trial Requirements Marketing, Manufacturing, Packaging & Labeling, and Advertising Traditional Medicines and Over-the-Counter Products Product Liability Patents and Trademarks Regulatory Reforms Orphan Drugs and Rare Diseases Tilleke & Gibbins has also authored The Pharma Legal Handbook: Thailand, which was updated at the same time as the Vietnam guide. The Pharma Legal Handbook: Vietnam, like all of the country guides from Pharma Boardroom, is available for purchase on the Pharma Boardroom website.

Attorneys from Tilleke & Gibbins in Bangkok have provided updates for the latest edition of The Pharma Legal Handbook: Thailand, published by Pharma Boardroom. This comprehensive guide to the legal framework regulating the healthcare and life sciences industries in Thailand was authored by Alan Adcock, partner and director, intellectual property, and head of the firm’s life sciences practice; Dr. Atthachai Homhuan, manager of regulatory affairs; and San Chaithiraphant, senior associate. The handbook is a must-read for healthcare and life sciences companies that are interested in exploring expansion into the Thai market.