Attorneys in Tilleke & Gibbins’ Jakarta office have contributed a new “Life Sciences Regulation in Indonesia” chapter to Practical Law’s updated Life Sciences Global Guide. The chapter covers a range of regulatory issues related to the development, manufacturing, and selling of pharmaceutical products and medical devices, including 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 Developments, reforms, and 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 Indonesia” chapter can be accessed on the Practical Law website

Tilleke & Gibbins’ life sciences specialists in Indonesia have contributed a new “Life Sciences Commercialization in Indonesia” chapter to the Life Sciences Global Guide from Practical Law. This Q&A guide to commercializing life sciences innovations in Indonesia provides important information that companies can use to shape their strategies for life sciences products and activities in the jurisdiction. Specifically, the chapter covers: Overview of the life sciences sector Pricing, government funding, and reimbursement: National health care system, price regulation and reimbursement Distribution and sale Cross-border trade and parallel imports Advertising and engagement with patient organizations Patents: Conditions for patentability, registration, length of protection, infringement, international treaties Trademarks: Requirements, registration Competition law issues: Authorities and legislation, commercial contracts and competition law, licensing approvals and formalities Product liability: Regulators, medicinal product liability law, liable partners, defenses, product liability claims, remedies 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 Commercialization in Indonesia” section can be found on the Practical Law website.

Attorneys from Tilleke & Gibbins have contributed the Cambodia, Laos, Myanmar, and Vietnam sections to DLA Piper’s Global Government Contracting Country by Country guide, which provides essential information for businesses in 75 jurisdictions on how to source and enter into government contracting opportunities. The guide provides procurement information for jurisdictions in Africa, the Americas, Asia-Pacific, Europe, and the Middle East, and includes information on how to find procurement opportunities, the structure of procurement laws, and in-country resources and relevant publications. Each jurisdictional section includes valuable information on procedures for government tenders, bidding, and contract execution, as well as an overview of the legal and regulatory framework governing government procurement. Businesses can refer to the guide to gain a better understanding of procurement processes and regulations in each jurisdiction, which can help them identify potential opportunities and make informed decisions when pursuing government contracts. The guide’s procurement information for Cambodia, Laos, Myanmar, and Vietnam, combined with the online platform’s comprehensive resources, provides businesses and governments with a valuable tool to navigate the complex regulatory landscape of government contracting in the region. The full Global Contracting Country-by-Country guide is available on the DLA Piper website.

On March 3, 2023, the government of Vietnam issued Decree No. 07/2023/ND-CP (Decree 07) amending Decree 98/2021/ND-CP on medical device management (Decree 98) to resolve many urgent problems in the healthcare sector in Vietnam. Decree 07 took effect on the same day and amends and supplements several articles in its predecessor, Decree 98, which originally took effect on January 1, 2022. Some outstanding points of Decree 07 are summarized below. 1. Registration of Medical Devices The compulsory implementation of the ASEAN Common Submission Dossier Template (CSDT) in registration applications for medical devices will be delayed until January 1, 2024, instead of the deadline of January 1, 2023 under Decree 98. In addition, if after three rounds of amendment/supplementation as requested by the authority, the registration dossiers still have not been approved, the applicants must submit new registration dossiers. 2. Withdrawal of Registration Number Decree 98 adds one case for withdrawing the registration number of a medical device, which is when the documents in the registration dossier are concluded by the authority to be noncompliant with the provisions of law. 3. Listing Price of Medical Devices It is required for establishments manufacturing or trading medical devices to list their prices in locations stipulated under Article 17 of Decree No. 177/2013/ND-CP implementing the Law on Prices (such as at transaction or selling locations of the trading establishments) or on the online portal of the Department of Medical Equipment and Construction’s (DMEC). 4. Price Declaration It is no longer required to declare prices of all medical devices circulating on the Vietnam market. Instead, the Ministry of Health will issue and adjust the list of medical devices subject to price declaration, depending on management requirements and the actual situation, especially when there are abnormal fluctuations in prices affecting the supply of medical devices,