Iraq

Pharmacovigilance in Iraq is overseen by the Iraqi Pharmacovigilance Center (IqPhvc) under the national Good Pharmacovigilance Practice framework. For a company/MAH branch in Iraq, the local safety responsible person must be Iraqi and resident in Iraq; representatives must also maintain an identified local PV responsibility. A local PSMF applies to the branch model, while representatives use the national Pharmacovigilance Sub-System File (PSSF) together with the global PSMF arrangement; the PSSF must be available to the authority within 14 days in the applicable request context. Serious ICSRs are reported within 15 calendar days and non-serious domestic ICSRs within 90 calendar days. PSUR/PBRER and risk-management obligations apply according to the national guideline and product status, together with applicable inspection requirements. Iraqi PSMF/PSSF terminology controls locally. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.