Bolivia

Regulation name

Ley N° 1737 (1996), Decreto Supremo N° 25235 (1998); no current decree on serialization or traceability

Serialization status

No serialization system

Country population

12 million

Alert requirement: Standard pharmacovigilance and market surveillance via AGEMED/DINAMED; no serialization-based alert system

Aggregation requirement: N/A

Track & Trace requirement: N/A

Official governing body: AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud) / Ministry of Health and Sports

Implementation deadline: Not scheduled

Serialization type / level: N/A

MAH / CMO responsibilities: N/A

Serialized product scope: N/A

Penalties for non-compliance: N/A

Repackaging rules: Regulated under standard GMP and labeling rules; repackaging allowed with AGEMED notification, not tied to serialization

Market coding requirements:

N/A