The latest edition of Practical Law’s Life Sciences Global Guide features contributions from Tilleke & Gibbins attorneys in the firm’s Yangon office. One of the sections they have provided for the Myanmar chapter of this Q&A-style guide to life sciences regulatory frameworks worldwide is “Medicinal Product Regulation and Product Liability in Myanmar.”
The section includes discussion of a range of regulatory issues related to the marketing and selling of pharmaceutical products, including the following topics:
- Regulatory overview: Authorities, scope, and general procedures for pharmaceuticals, biologicals, and medical devices and health care IT
- Pricing, government funding, and reimbursement: National 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
The full “Medicinal Product Regulation and Product Liability in Myanmar” section can be accessed 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. Tilleke & Gibbins also supplied “Pharmaceutical IP and Competition Law in Myanmar,” which was published in the Life Sciences Global Guide at the same time.