May 7, 2013

PLC Life Sciences Multi-Jurisdictional Guide 2013 – Vietnam Chapter

Practical Law Company

This Q&A chapter analyzes legal issues pertaining to Vietnam’s regulatory framework in 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 answers to the most important legal questions faced by life sciences companies. This detailed and succinctly written chapter discusses the impact of key legislation and regulatory powers. In particular, the following topics are covered:

  • Pricing and State Funding: Costs of medicinal products and national healthcare
  • Manufacturing: Authorization process, regulator’s powers, conditions, fees, and validity of licenses
  • Clinical Trials: Legislation and regulatory authorities, trial pre-conditions, and procedural requirements
  • Marketing: Authorization, conditions, fees, key stages and timing, packaging requirements, foreign marketing authorizations, post-marketing commitments, pharmacovigilance obligations, penalties, 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, registration process and timing, scope of protection, duration of protection, revocation, infringement, remedies available, license agreements, 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 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. To read the full article, please visit the PLC website.

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