Mynd Healthcare

Library / regulatory-reference

Bolivia: State Agency for Medicines and Health Technologies (AGEMED)

Audience: administrators-policy, researchers-scientists ยท Review state: published

The national authority

The State Agency for Medicines and Health Technologies, known by its Spanish initials AGEMED, is Bolivia's national regulator for medicines and health technologies, operating under the Ministry of Health.

Bolivia's medicine supply combines imports with a domestic generic sector oriented to the public system, and the agency's registration decisions shape both channels.

How products enter the market

Medicines require marketing authorization through the agency's commercialization-authorization department after evaluation of quality, safety and efficacy, and establishments are licensed and inspected by its surveillance and control functions.

The agency also runs a health-technology-assessment and rational-use department, linking registration decisions to how products are actually used in the health system.

Regional and international role

The agency participates in Andean and Latin American regulatory cooperation, where reliance and harmonization among mid-sized authorities are active themes.

Its explicit rational-use mandate is a distinguishing feature: few national regulators in the region carry technology assessment inside the same agency.

Using this profile

The agency publishes regulations and announcements in Spanish through its official portal, which is the primary source for current rules and listed in this profile's internal reference record.

For cross-country comparison: AGEMED illustrates the regulator with an embedded rational-use arm: registration, surveillance and technology assessment under one roof.

Limitations

Educational profile of a national regulatory system, current as of drafting. It simplifies routes and classes and is not legal, regulatory, or clinical advice. Filing and compliance decisions must be confirmed against the authority's current published rules and, where needed, professional regulatory counsel.