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July 20, 2018

PLC Distribution and Marketing of Drugs 2018 – Vietnam Chapter

Practical Law Company

Practical Law has published the 2018 edition of its Distribution and Marketing of Drugs Global Guide, a easily accessible Q&A overview of the key legal issues involved in bringing drugs to market in 29 jurisdictions worldwide. Members of the Tilleke & Gibbins life sciences team wrote the Vietnam chapter of this year’s guide.

The Vietnam chapter provides a high-level overview of the regulatory regime for the distribution and marketing of pharmaceuticals in Vietnam. The distribution section of the guide covers pre-conditions for distribution, including marketing authorization and exceptions; licensing; distribution to consumers; and wholesale distribution. The marketing section summarizes the regulations on marketing to consumers and marketing to professionals, including the types of marketing activities that are permitted and prohibited; restrictions on advertising; and the permissibility of discounts, free samples, and sponsorships.

Tilleke & Gibbins also contributed the Thailand chapter of the guide. To read the Vietnam chapter, please click on the link below.

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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.