With the tightening of budgets and increased scrutiny by the Ministry of Health, this article delves into the practicability of Vietnam’s regulatory framework governing the life sciences industry. Ranging from the quality of national healthcare, manufacturing authorization, marketing, and pricing of medicinal products, to the intellectual property surrounding each product and the scope of product liability law in this industry, this Q&A chapter provides a detailed overview of the effect of key legislation and the power of regulatory authorities. In particular, the chapter covers:

• Pricing Structure: Costs and state funding of medicinal products and national healthcare
• Manufacturing: Authorization, conditions, fees, and validity of licenses
• Marketing: Fees, conditions, authorization, packaging requirements, foreign marketing authorizations, parallel imports, and restrictions such as marketing on the internet
• Traditional Medicine: Manufacturing and marketing regulations
• Patent Law: Conditions, patentable products, scope of protection, validity, revocation, infringement, and remedies available
• Trademark Law: Conditions, scope of protection, duration of protection, revocation, infringement, remedies available, and relevant international conventions
• Product Liability Law: Key legislation, the substantive test, procedures of bringing a claim, defenses and remedies available, limitation periods, and parties liable under the Consumer Protection Law
• Proposals for Reform: The Draft Law on Advertisement, and further guidance through implementing circulars

This chapter was published by Practical Law Company, a leading provider of legal guidance, analysis, and market intelligence in up to 30 jurisdictions.