Understanding Regulatory Requirements for Exporting Drugs to Cambodia, Laos, and Myanmar

Dec. 13th, 2023

Aye Thuzar Hlaing / David Mol / Dino Santaniello

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:

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

Schedule


Date Time (GMT+8) World Clock Language
2023-12-13 21:00 ~ 22:00 London: 14:00-15:00

New York: 9:00-10:00

English

Speaker


Aye Thuzar Hlaing

Senior Associate at Tilleke & Gibbins Myanmar

Aye Thuzar Hlaing is an 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.

David Mol

Senior Associate at Tilleke & Gibbins Cambodia

David Mol is an associate in Tilleke & Gibbins’ Phnom Penh office. He assists both domestic and foreign clients on matters relating to intellectual property, licensing, regulatory affairs, and doing business in Cambodia. Prior to working at Tilleke & Gibbins, David advised the prosecution in the high-profile Khmer Rouge case before the Extraordinary Chambers in the Courts of Cambodia. He has also advised NGOs and nonprofit organizations in Cambodia on a range of commercial transactions, including financial and funding matters, real estate, employment relations, and regulatory affairs.

Dino Santaniell

Head of Tilleke & Gibbins Laos

Dino Santaniello is the head of Tilleke & Gibbins’ office in Laos. He has broad experience across many fields of law, including patents and trademarks, privacy and data protection, corporate establishment, 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.

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