Iceland

Pharmacovigilance activities in Iceland are regulated by the Icelandic Medicines Agency (Lyfjastofnun) under Icelandic medicines legislation and the pharmacovigilance framework applicable within the European Economic Area (EEA). Marketing Authorisation Holders (MAHs) must operate a pharmacovigilance system and have a Qualified Person Responsible for Pharmacovigilance (QPPV) who resides and works within the EEA; the QPPV is not required to be based in Iceland. MAHs must maintain a Pharmacovigilance System Master File (PSMF) and make it available to Lyfjastofnun upon request. In addition, Lyfjastofnun may require an MAH to designate a pharmacovigilance contact person in Iceland who reports to the QPPV. Serious suspected adverse reactions must be submitted to EudraVigilance within 15 days, and non-serious suspected adverse reactions within 90 days. MAHs must also submit Periodic Safety Update Reports (PSURs) electronically in accordance with the applicable EEA requirements and maintain a risk-management system/Risk Management Plan as required. Lyfjastofnun supervises MAH compliance and may require relevant information and access to the MAH's premises for pharmacovigilance oversight. 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.