Liechtenstein

Pharmacovigilance in Liechtenstein is supervised by the Amt für Gesundheit (Office of Public Health) and operates within Liechtenstein’s EEA medicines framework, with additional cooperation arrangements relevant to Swiss-authorised products. The official German-language Arzneimittelüberwachung page confirms that medicines authorised under the EEA framework are incorporated into European safety surveillance and provides channels for adverse-reaction and quality-defect reporting. For EEA-authorised human medicines, the EU/EEA pharmacovigilance system therefore applies: the MAH must have a continuously available QPPV residing and operating in the EEA and maintain a PSMF at an appropriate location in the EEA; EMA’s GVP Module II expressly recognises Liechtenstein as an eligible EEA location for these functions. Valid EEA ICSRs follow the EU framework, including 15-day reporting for serious cases and 90-day reporting for non-serious cases, while PSUR/PBRER, RMP, signal-management and inspection obligations follow the applicable EU/EEA rules and product authorisation. The precise route can differ for products supplied under the Swiss–Liechtenstein framework, so the authorisation basis should be confirmed before applying a reporting pathway. 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.