Presented in a Q&A format, the PLC Life Sciences Multi-jurisdictional Guide provides a comprehensive overview of life sciences laws and regulations in jurisdictions around the world. Lawyers at Tilleke & Gibbins wrote the Vietnam chapter of the guide, which covers the following subjects in detail:
- Regulatory Overview: Legislation including the Law on Pharmacy No. 34/2005/QH11, regulatory authorities such as the Ministry of Health, biologicals and combination products, and medical devices and diagnostics.
- National Healthcare: Structure and medicinal product price regulation.
- Clinical Trials: Authorizations, consent, pre-conditions, and procedural requirements.
- Manufacturing: Key stages and timing, fees, monitoring compliance, and imposing penalties.
- Marketing: Circular No. 44/2014/TT-BYT on conditions and requirements to obtain marketing authorization, and restrictions on selling and advertising medicinal products.
- Data Protection: IT Law, Law on Telecommunications, Consumer Protection Law, Law on E-Transactions, Law on Medical Examination and Treatment, Law on Pharmacy, and Law on Internet Information Security.
- Packaging and Labeling: Information requirements such as medicine names and active ingredients.
- Product Liability: Medical product inspection agencies, mandatory requirements on medicinal product safety, limitation periods, and class actions.
- Intellectual Property: Competition law, conditions and legislation, process to obtain, and claims and remedies for infringement concerning trademarks and patents.
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