MAH Registration in Bangladesh: What Foreign Manufacturers Must Know

The Marketing Authorization Holder (MAH) is the legal entity responsible for a pharmaceutical product in Bangladesh. For international manufacturers without a local entity, appointing an MAH partner is mandatory for registration, import, and distribution.

Core MAH responsibilities

• Product registration and renewal with DGDA
• Import permission and batch release coordination
• Pharmacovigilance reporting and adverse event management
• Labeling compliance and promotional material review
• Recall procedures and quality defect notifications

Inventa holds MAH registrations across specialty care, biosimilars, and critical-care injectables — absorbing regulatory and commercial risk so principals can focus on innovation.