Practical Law Life Sciences Global Guide 2021: Indonesia

June 9, 2021

Practical Law Life Sciences Global Guide 2021: Indonesia

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.

Related Professionals

Wongrat Ratanaprayul

Partner and Director, Indonesia

Thailand, Indonesia,

+6221 2971 8099

Email

Indah Handayani

IP Consultant

Indonesia

+6221 2971 8088

Email

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