Costa Rica

Pharmacovigilance in Costa Rica is regulated by the Ministry of Health through the National Pharmacovigilance Centre (CNFV), principally under Executive Decrees No. 35244-S and No. 39417-S. Marketing authorisation Holders must maintain a documented pharmacovigilance programme and designate a qualified healthcare professional responsible for pharmacovigilance and communication with the CNFV. Serious or unexpected suspected adverse reactions must be reported within 24 hours, while other non-serious suspected adverse reactions are reportable within 10 business days. Periodic Safety Reports (IPS/PSURs) are subject to mandatory routine submission for innovative medicines, biological medicines including biosimilars, and medicines required to demonstrate therapeutic equivalence; the CNFV may also request an IPS for any other medicine for safety reasons. The established frequency is every six months during the first two years from the International Birth Date, annually during years three to five, and every five years thereafter. Reports covering six or twelve months must generally be submitted within 70 calendar days after the data lock point, and reports covering more than twelve months within 90 calendar days. The Ministry of Health conducts Good Pharmacovigilance Practice inspections of the pharmaceutical industry. No standalone Costa Rican PSMF requirement or universal routine RMP submission requirement was identified in the current official requirements. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.