On July 3, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 34/2025/TT-BYT amending some articles of Circular No. 06/2011/TT-BYT on the management of cosmetics products (Circular 34), which provides the current regulations on the product notification process for cosmetics (cosmetic notification). Circular 34 will come into effect on August 18, 2025. Changes to Cosmetic Notification Some of the key stipulations of Circular 34 are outlined below. Addition of submission route for notification Circular 34 officially adds online submission via the National Public Service Portal as an accepted type of cosmetic notification, in addition to direct submission and submission via post. Clearer regulations on preparing cosmetic notification form Circular 34 provides clarification on the signing requirements for cosmetic notification forms. For online submissions, both e-signatures and digital signatures are accepted. For offline submissions, the circular explicitly states that stamped/generated signatures are not acceptable. There are no substantive changes to existing requirements regarding grouping of products in a single declaration, ingredient listing, or language used in the notification form. Circular 34 only introduces formatting adjustments to these provisions. Updated administrative procedures Circular 34 updates requirements on digital procedures and authentication for online submission with references to new government decrees. In addition, processing timelines for cosmetic notification are further clarified, in particular, five working days for feedback on incomplete dossiers and five working days for approval after receiving complete supplemental dossiers. Revised requirements for import of samples for testing and research An updated Appendix 14-MP form is introduced with Circular 34, in which the receiving authority is updated from the Drug Administration of Vietnam to the specialized health agency under the provincial People’s Committee. Both online and direct submission of the request are allowed. The approval timeline is three working days from the date of reviewing the request. Transition clause Notifications

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.

Addressing technical barriers to trade is a key priority for the Association of Southeast Asian Nations (ASEAN) as part of trade facilitation in achieving the single market and production base under the ASEAN Economic Community directive agreed in 2015. The region has been undertaking positive steps toward standard harmonization in ASEAN priority sectors, integrating and bringing about regulatory convergence by taking into account the diversities that exist in the ten ASEAN member states. Health supplements in ASEAN are under the responsibility of the Traditional Medicine and Health Supplement Product Working Group (TMHS PWG). One of the TMHS PWG’s outputs is the ASEAN Agreement on a Regulatory Framework for Health Supplements, which includes various technical requirements for health supplements that participating member states must adopt by adjusting their domestic regulations. The key ingredients of these health supplements are vitamins and minerals. While all ASEAN countries allow the use of vitamins and minerals in health supplements, the amounts allowed for use vary, depending on the nutritional requirements deemed appropriate by each country. Partly in response to these efforts for regional harmonization, there have been important changes to vitamin and mineral limits in certain ASEAN countries that are worth monitoring. Some of these are outlined below. Thailand In January 2024, the Thai Food and Drug Administration (TFDA) updated the Thai Recommended Daily Intake (Thai RDI) guidelines for the Thai population. Subsequently, the TFDA adjusted the vitamin and mineral limits in order to comply with the updated Thai RDI and to follow the ASEAN Agreement on a Regulatory Framework for Health Supplements. The TFDA’s adjustment of vitamin and mineral limits for use in food supplements came in Notification of the Ministry of Public Health (No. 448) B.E. 2566 (2023) Re: Food Supplements (No. 5), which was published in the Government Gazette on January

Attorneys from Tilleke & Gibbins in Vietnam have provided an updated Vietnam chapter for Fashion Law 2024, a guide to law surrounding the business of fashion in jurisdictions around the world. The guide, which covers 20 key jurisdictions in the global fashion industry, offers insights into local legal frameworks for a range of issues, such as brand enforcement and protection, e-commerce and marketing, and sustainability. The Vietnam chapter of Fashion Law 2024 provides detailed information on the following topics: Main intellectual property rights for fashion products Contractual arrangements in manufacturing, distribution, and advertising Regulations and enforcement of online marketing Unfair competition rules and judicial interpretation Specific regulations on sustainability and ESG in fashion Special import and export rules for fashion products The full Vietnam chapter is available for free through the button below and on the Global Legal Post website. Tilleke & Gibbins also contributed the Thailand chapter to the guide.