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

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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 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. She has extensive experience dealing with the Directorate of Investment and Company Administration as well as the Myanmar Investment Commission, and has developed a deep familiarity with the working procedures and requirements of these bodies. Through her experience acting for clients in matters related to various regulatory authorities, Aye has also gained insight into the workings of many regulatory bodies in Myanmar, including the country’s Food and Drug Administration, the Plant Protection Division, the Plant Variety Protection Section, the Department of Agricultural Research, the Livestock Breeding and Veterinary Department, the Posts and Telecommunications Department, the Central Bank of Myanmar, and the Department of Trade. Because of her deep 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. Aye previously worked at a leading commercial bank and the Myanmar office of a prominent international law firm, where she gained experience in a broad range of corporate and commercial law. She graduated with an LLB from the University of Dagon, and she holds diplomas in business law, international relations, and intellectual property law from the University of Yangon. She is a member of the Bar Council of Myanmar.
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. David also has extensive experience advising the private sector on intellectual property and related enforcement issues, with a particular focus on pharmaceuticals, cosmetics, and other life science focused products. He is an active member of the firm’s Life Sciences Industry Group, and a trusted advisor to life sciences clients seeking to do business, protect their intellectual assets, and protect the public from harmful counterfeit products in Cambodia. David has been recognized as a “Next Generation Lawyer” in The Legal 500’s guide to up-and-coming practitioners in the Asia Pacific. David received a bachelor’s degree in law and a master’s degree in public international law from the University of Amsterdam. With his international background and experience working in Cambodia, David has a strong local network of expats and Cambodians to facilitate the needs of his clients.
Dino Santaniello
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. Prior to joining Tilleke & Gibbins, Dino worked as an in-house counsel in the insurance and oil and gas industries. During this time, he advised on corporate and commercial issues, as well as intellectual property matters such as trade secrets and restrictive covenants. Dino has spent significant time in studying foreign languages with the aim of helping inbound investors entering into Asian markets. He is fluent in French, English, Lao, and Thai, and he is conversant in Korean.
Contact
If you have any question about this webinar, please contact us:
+86 (0)571 8710 3829
contact@chemlinked.com