Uruguay

Pharmacovigilance in Uruguay is coordinated by the Pharmacovigilance Unit of the Ministry of Public Health (MSP). Under the updated Ministerial Order No. 23/025, each laboratory holding a product registration must appoint a pharmacovigilance responsible person and an alternate; both must reside in Uruguay and serve as the official links with the authority. Registration holders must maintain a database of received safety reports, implement methods for early signal detection and submit cases electronically through e-Reporting Industria using the required ICH E2B(R3), MedDRA and WHODrug standards. Events that may create a risk involving a large number of people must be communicated within 24 hours, followed by the electronic report within 15 working days; all other cases submitted by registration-holding laboratories are due within 15 working days of awareness. The order also supports spontaneous, additional and active pharmacovigilance, and the MSP may impose product-specific monitoring or risk-minimisation measures. A separate EU-format PSMF is not expressly established in the reviewed public rule. Where the cited public sources do not expressly define ICSR reporting route and timelines, periodic safety reporting, risk-management plan and audit and inspection arrangements, the MAH should confirm the current product-specific requirements with the competent authority and against the marketing-authorisation conditions. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.