Portugal

Pharmacovigilance in Portugal is coordinated by the National Authority of Medicines and Health Products (INFARMED, I.P.) through the National Pharmacovigilance System, within the harmonized European Union pharmacovigilance framework. Under the consolidated Decree-Law No. 176/2006, each marketing authorisation Holder (MAH) must operate a pharmacovigilance system under an EU-based QPPV and appoint a national pharmacovigilance contact resident in Portugal who reports to that QPPV. The MAH must maintain the pharmacovigilance system master file, record and submit suspected adverse reactions through the applicable EU channels, monitor and evaluate signals, keep the benefit-risk balance under continuous review, submit PSURs according to the authorisation or EU reference dates, maintain and update risk-management plans, and implement required safety communications and risk-minimisation measures. INFARMED summarizes the legal responsibilities of authorization holders and operates the official Portal RAM for suspected adverse-reaction reporting. MAHs remain subject to pharmacovigilance inspection and EU good-pharmacovigilance-practice requirements. As an EU/EEA jurisdiction, the EU pharmacovigilance framework applies to the EU QPPV and Union PSMF, EudraVigilance ICSR reporting, applicable PSURs, RMPs, signal management, quality-system audits and competent-authority inspections. MAHs should also check current national submission channels, contact arrangements and language requirements. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Difference in QPPV Nomination Between EU and KSA; PSMF Maintenance: Concept and Importance in Pharmacovigilance.