Practitioners from Tilleke & Gibbins’ Vietnam offices contributed content for the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in Q&A format, of laws and regulations on pharmaceuticals, medical devices, and other life sciences products in dozens of jurisdictions around the world. The Life Sciences Global Guide is divided into two sections: Commercialization (see more details here) and Regulation, which covers the following topics: Pharmaceuticals: Laws and regulatory authorities Clinical trials: Legal, regulatory, and procedural requirements Manufacturing and distribution Marketing: Authorization for marketing medicinal products, monitoring compliance and penalties, pharmacovigilance and other commitments, foreign marketing authorizations Data privacy Packaging, labeling, and tracking Biological medicines Medical devices: Legislation and regulatory authorities, definition and classification Healthcare IT Combination products and borderlines Natural health products Recent developments and reform proposals Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Regulation in Vietnam” section can be found on the Practical Law website.

Thailand’s labeling requirements have new rules on product label font size and readability following the issuance of Announcement of the Label Committee Re: Characteristics of the Label for Label-Controlled Goods No. 3, which is a bylaw of the Consumer Protection Act (CPA). The announcement takes effect on June 18, 2023, and applies to all “label-controlled goods,” which are described under the CPA and its bylaws as goods either produced by factories in Thailand or imported into Thailand for sale. The labels of these goods must meet current labeling requirements, such as having information about the product name, quantity, intended use, cautions, and expiry date. Label readability—specifically in terms of the size of text on labels—is also a mandatory requirement, and is the focus of this latest announcement. Text size requirements are an important part of ensuring that consumers are fully aware of the details of a product before deciding to purchase the goods. According to the announcement, any statement or text displayed on a label must be easily visible and readable. The size of the text must be proportional to the label area. Specifically, the text height must not be less than 2 millimeters (or 1.5 millimeters for labels with an area of less than 35 square millimeters). The announcement does not clarify exactly how the height of the text will be determined. Some companies have expressed concern that these requirements are too strict and will be challenging to meet, especially for small businesses. The text size requirements may be expensive to implement, as the larger text requires more space on the label, potentially leading to larger labels or packages, higher production costs, or even expensive recalls to affix new labels. In some cases, text size requirements may even make it impossible to fit all the required information on

Life sciences specialists from Tilleke & Gibbins have supplied the Thailand and Vietnam contributions to the International Bar Association (IBA) Healthcare and Life Sciences Law Committee’s global telemedicine survey. The survey, spanning 54 jurisdictions worldwide, functions as a comparative legal guide on the provision of telemedicine and related products and services. It offers practitioners and industry users access to relevant rules and regulations, addressing key aspects such as regulation, data privacy, liability, and recent developments in telemedicine. Telemedicine has emerged as a transformative force in healthcare, revolutionizing the way medical services are accessed and delivered. As in many other jurisdictions, telemedicine has gained prevalence in Thailand and Vietnam, as it enables patients to remotely consult with healthcare professionals, access diagnostic services, and receive timely medical advice while minimizing physical contact. As the global healthcare landscape continues to evolve, understanding the legal and regulatory aspects of telemedicine becomes paramount, making initiatives like the IBA’s telemedicine survey vital for practitioners and industry stakeholders. The IBA is a globally recognized organization that brings together legal professionals and bar associations from around the world, and its Healthcare and Life Sciences Law Committee plays a crucial role in addressing legal issues and developments in the healthcare industry. The complete surveys for Thailand and Vietnam­—and the 52 other participating jurisdictions—are available on the IBA website.

Life sciences specialists at Tilleke & Gibbins’ office in Bangkok have contributed a new “Life Sciences Commercialization in Thailand” chapter to the Life Sciences Global Guide from Practical Law. The Q&A-style guide provides strategic information for companies active in the life sciences sector in Thailand. The chapter covers a number of key areas: Overview of the life sciences sector Pricing, government funding, and reimbursement: National health care system, price regulation and reimbursement Distribution and sale Cross-border trade and parallel imports Advertising and engagement with patient organizations Patents: Conditions for patentability, registration, length of protection, infringement, international treaties Trademarks: Requirements, registration Competition law issues: Authorities and legislation, commercial contracts and competition law, licensing approvals and formalities Product liability: Regulators, medicinal product liability law, liable partners, defenses, product liability claims, remedies Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Commercialization in Thailand” section can be found on the Practical Law website.