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July 4, 2023

Practical Law: Life Sciences Regulation in Vietnam 2023

Practical Law Company

Practitioners from Tilleke & Gibbins’ Vietnam offices contributed content for the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in Q&A format, of laws and regulations on pharmaceuticals, medical devices, and other life sciences products in dozens of jurisdictions around the world.

The Life Sciences Global Guide is divided into two sections: Commercialization (see more details here) and Regulation, which covers the following topics:

  • Pharmaceuticals: Laws and regulatory authorities
  • Clinical trials: Legal, regulatory, and procedural requirements
  • Manufacturing and distribution
  • Marketing: Authorization for marketing medicinal products, monitoring compliance and penalties, pharmacovigilance and other commitments, foreign marketing authorizations
  • Data privacy
  • Packaging, labeling, and tracking
  • Biological medicines
  • Medical devices: Legislation and regulatory authorities, definition and classification
  • Healthcare IT
  • Combination products and borderlines
  • Natural health products
  • Recent developments and reform proposals

Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas.

The full “Life Sciences Regulation in Vietnam” section can be found on the Practical Law website.

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June 9, 2021
The latest updates to Practical Law’s Life Sciences Global Guide feature two revised sections from Tilleke & Gibbins attorneys in the firm’s Jakarta office—“Medicinal Product Regulation and Product Liability in Indonesia,” and “Pharmaceutical IP and Competition Law in Indonesia.” “Medicinal Product Regulation and Product Liability in Indonesia” covers a range of regulatory issues related to the marketing and selling of pharmaceutical products, including the following: Regulatory overview, including relevant laws and authorities, scope, definitions, and general procedures for pharmaceuticals, biologicals, and medical devices and health care IT Pricing, government funding, and reimbursement: Structure of Indonesia’s health care system, price regulation, and reimbursement Clinical trials Manufacturing and distribution Marketing: Authorization for marketing medicinal products, parallel imports and cross-border trade in medicines Restrictions on dealings with health care professionals Selling restrictions Advertising and promotion Data privacy Packaging, labeling, and tracking Product safety, quality, and liability Local establishment, representation, and residency requirements Reform The full “Medicinal Product Regulation and Product Liability in Indonesia” section can be accessed on the Practical Law website. “Pharmaceutical IP and Competition Law in Indonesia” first goes over the country’s legal and regulatory environment for patents and trademarks in relation to pharmaceutical business operations in the jurisdiction. The section then turns to competition law issues, with the Q&A format focusing on how the country’s competition laws and regulations affect the pharmaceutical sector. Readers are also given information on how to properly comply with Indonesian competition law, including in the licensing of medicines and pharmaceutical technology. The full “Pharmaceutical Intellectual Property and Competition Law in Indonesia” section can be found on the Practical Law website. Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas.