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.

On November 21, 2024, the National Assembly of Vietnam adopted a law amending and supplementing the 2016 Law on Pharmacy (“Amended Law on Pharmacy”). The Amended Law on Pharmacy simplifies some procedures for the pharmaceutical field, and will take effect on July 1, 2025, except for regulations on drug registration and rights and responsibilities of certain types of pharmaceutical business. Some outstanding points in the Amended Law on Pharmacy are presented below. E-commerce Distribution The Amended Law on Pharmacy allows trading in pharmaceutical products by the e-commerce channel, including e-commerce trading floors, e-commerce sales applications, and e-commerce sales websites with online ordering functions. Accordingly, e-commerce retail of non-prescription drugs is permitted if the drugs are neither specially controlled drugs nor drugs included in the list of drugs restricted for retail sale, and e-commerce wholesale of drugs and drug materials is permitted, as long as they are not specially controlled drugs. New Rights for Import FIEs The amendment provides some additional rights to foreign-invested enterprises (“FIEs”) that import drugs, including the rights to: Repurchase drugs and drug materials manufactured through the technology transfer of the FIE itself in Vietnam, and sell such products to wholesalers; Import drug materials to supply to drug manufacturers in Vietnam that are hired by or receive technology transfer from the FIE itself under a processing contract or technology transfer contract; Deliver and transport drugs and drug materials the FIE has imported, outsourced for processing, or transferred technology for in Vietnam, from the FIE’s warehouse to its wholesalers; Deliver and transport drugs used in aid, sponsorship, humanitarian, and disease prevention and control programs to medical facilities receiving funding; and Transport drug materials imported by the FIE from its warehouse to drug manufacturers that are hired by or receive technology transfer from the FIE itself under a

Cambodia’s Law on Seed Management and Plant Breeder’s Rights was enacted in 2008, but it was not until recently that new plant varieties could successfully be registered for protection in the country. Although the law has been in place for some time, recent developments confirmed the application process and a schedule of charges for the registration of new plant varieties. With these developments, breeders have been able to register their new plant varieties in Cambodia since March 1, 2024. Applicants for new plant variety protection must be Cambodian nationals, foreign nationals domiciled in Cambodia, or permanent residents of either a country that is a contracting party to the International Union for the Protection of New Varieties of Plants (UPOV) Convention or a country with which Cambodia has signed a memorandum of understanding on plant variety protection. Applicants can also claim a priority date from the first application for the same plant variety filed in any contracting party of the UPOV Convention within 12 months of the earliest application’s filing date. To be eligible for protection, new plant varieties must satisfy the following criteria: Novelty: A variety is considered “new” if, at the date of filing the application for new plant variety protection, it has not been sold, marketed, or otherwise disposed of others—by or with the consent of the breeder—for more than: One year for any plant variety in Cambodia; Six years for trees and vines or four years for all other plant varieties in countries besides Cambodia. Distinctiveness: A variety must be clearly distinguishable from any other existing varieties. Uniformity: A variety must be sufficiently uniform in its relevant characteristics. Stability: A variety must remain unchanged in its essential characteristics at the end of each cycle of propagation and in each generation. The last three criteria are often