Understanding Regulatory Requirements for Exporting Drugs to Cambodia, Laos, and Myanmar
Language:
[Wednesday, 13th Dec 2023]
Understanding Regulatory Requirements for Exporting Drugs to Cambodia, Laos, and Myanmar
Aye Thuzar Hlaing / David Mol / Dino Santaniello
Tilleke & Gibbins
FREE
Background

Cambodia, Laos, and Myanmar are all heavily reliant on imported pharmaceutical products. A strong economic outlook in Cambodia and the introduction of universal healthcare coverage in Laos are both expected to drive growth in the pharmaceutical sector. While economic uncertainty continues to hamper growth in Myanmar, medicine shortages are giving rise to significantly increased demand.

In this webinar David Mol, a Senior Associate in Tilleke & Gibbins' Cambodia office, Dino Santaniello, Head of Tilleke & Gibbins' Laos office, and Aye Thuzar Hlaing, a Senior Associate in Tilleke & Gibbins' Myanmar office, will provide an overview of the regulatory framework for the importation of pharmaceutical products in their three countries, including the requirements for obtaining marketing authorization.

Other Sessions

Marketing Authorization and Regulatory Requirements for Exporting Drugs to ThailandMarketing Authorization and Regulatory Requirements for Exporting Drugs to Thailand

Understanding Regulatory Requirements for Exporting Drugs to Indonesia and VietnamUnderstanding Regulatory Requirements for Exporting Drugs to Indonesia and Vietnam

Contents

Cambodia

1. Cambodia Pharmaceutical Market Outlook

2. Regulatory Framework and Competent Authority

  • 2.1 Legislation update

  • 2.2 Competent authorities

3. Drug Product Requirements

  • 3.1 Definitions and classifications

  • 3.2 Good Manufacturing Practices (GMPs) and overseas manufacturing sites

  • 3.3 Obtaining a marketing authorization license 

Laos

1. Laos Pharmaceutical Market Outlook

2. Regulatory Framework and Competent Authority

  • 2.1 Legislation update

  • 2.2 Competent authorities

3. Drug Product Requirements

  • 3.1 Definitions and classifications

  • 3.2 Good Manufacturing Practices (GMPs) and overseas manufacturing sites

  • 3.3 Obtaining a marketing authorization license 

Myanmar

1. Myanmar Pharmaceutical Market Outlook

2. Regulatory Framework and Competent Authority

  • 2.1 Legislation update

  • 2.2 Competent authorities

3. Drug Product Requirements

  • 3.1 Definitions and classifications

  • 3.2 Good Manufacturing Practices (GMPs) and overseas manufacturing sites

  • 3.3 Obtaining a marketing authorization license

Speakers
Aye Thuzar Hlaing
Senior Associate at Tilleke & Gibbins Myanmar
Aye Thuzar Hlaing is a senior associate in Tilleke & Gibbins’ Myanmar office. Practicing primarily in the firm’s corporate and commercial group, she assists her clients on a range of corporate and commercial matters, including investment licensing and company establishment. With a deep and practical understanding of regulatory regimes in Myanmar, she is frequently sought for her advice on regulatory affairs such as licensing, regulatory compliance, wholesale/retail registration and import/export matters.
David Mol
Senior Associate at Tilleke & Gibbins Cambodia
David Mol, a senior associate in Tilleke & Gibbins’ Cambodia office with considerable experience handling legal matters in Cambodia, is regarded by his clients and peers as a trusted advisor for doing business in Cambodia. He assists both domestic and foreign clients on complex matters relating to intellectual property, regulatory affairs, licensing, and corporate operations in Cambodia. His clients are diverse, ranging across industries that include consumer goods, sports, energy, technology, automotive and life sciences.
Dino Santaniello
Consultant of Tilleke & Gibbins Laos
Dino Santaniello is a consultant in Tilleke & Gibbins’ Laos office. He has broad experience across many fields of law, including corporate establishment, intellectual property, privacy and data protection, licensing, and commercial transactions. Dino advises both domestic and international companies on legal matters in Laos and Thailand, and based on the strengths of his client service and legal expertise, is recognized as leading lawyer in Laos by Asialaw Leading Lawyers, Chambers Asia-Pacific, IFLR 1000, and The Legal 500 Asia Pacific.
Contact
If you have any question about this webinar, please contact us:
+86 (0)571 8710 3829
contact@chemlinked.com