Nicaragua

Pharmacovigilance in Nicaragua is overseen by the Ministerio de Salud (MINSA) through the Autoridad Nacional de Regulación Sanitaria (ANRS) and its Departamento de Farmacovigilancia. Resolución Administrativa No. 0009-2025 updates Normativa No. 063. MAHs must appoint a nationally responsible pharmacovigilance person with documented training and experience, maintain safety archives and a database, and operate an appropriate quality system with SOPs and trained personnel. The Normativa does not expressly require a separate PSMF. Through Noti-FACEDRA, serious suspected reactions are initially reportable within 24 hours and completed within seven days; non-serious cases are due within 15 days. Periodic safety reports are required every six months for the first two years, annually for the next three years and every five years thereafter, normally within 90 days of data lock. RMPs apply to specified new, biological, orphan or safety-concern products and when requested. ANRS may inspect the pharmacovigilance system and compliance with good practices. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.