Paraguay

Regulation name

Decreto 2479/24 (Sep 2024) – actualiza Ley 1119/97 para registro y etiquetado; Decreto 2942/2024

Serialization status

In Process of Implementation - National Traceability System recently established. for medicines & medical devices; regulatory decree in effect (~May 2025) real-time implementation is pending. Practical adoption remains uneven, pending DINAVISA’s roll‑out of technical infrastructure in second half of 2025

Country population

7.3 million

Alert requirement: In progress - under DINAVISA; traceability supports alerts but the system is still being rolled out

Aggregation requirement: Planned for future

Track & Trace requirement: In progress - traceability mandatory for medicines & devices; real-time digital traceability system launched, not fully implemented

Official governing body: DINAVISA (Dirección Nacional de Vigilancia Sanitaria - National Health Surveillance Directorate)

Implementation deadline: Decree 2479/24 published Sep 5, 2024; system activation expected by mid-late 2025

Serialization type / level: En progreso

MAH / CMO responsibilities: In progress - MAH or their delegate (registered entity in Paraguay CMO/Distributor) legally responsible for transmitting serialized and aggregated event data into the DINAVISA national traceability system via GS1-compliant formats

Serialized product scope: In progress - planned Rx, OTC, biological products (Vaccines, Insulins, Immunoglobulins), medical devices

Penalties for non-compliance: Under Law 1119/97 non-compliance could lead to fines, suspension, or withdrawal of sanitary registration (enforcement expected post-implementation)