Pharmacovigilance in Liechtenstein - Interesting Facts
Liechtenstein is a small country that is located between Austria and Switzerland. Liechtenstein is not a part of the European Union, but it is a part of the European Economic Area (EEA) and the European Free Trade Association (EFTA).
Switzerland is a part of EFTA, and not a part of EEA. On the other hand, Austria is a part of the European Union (EU), and not a part of the EFTA.
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As part of the customs contract, Liechtenstein is integrated into Swissmedic's Swiss surveillance network. The side effects of medicinal products that are authorized under the customs contract in Liechtenstein need to be reported to the responsible regional pharmacovigilance centre. For more information on the Pharmacovigilance requirements in Switzerland, please refer here.
Side effects of medicinal products manufactured in accordance with Art. 4 Therapeutic Products Act, LR 812.102 need to be reported to the Office of Health. These reports can be submitted using either the Austrian or the Swiss registration form.
One can appreciate that the adverse events associated with medicinal products authorized in the EEA are reported in Eudravigilance system. Adverse Events associated with the medicinal products authorized within the scope of the agreement with Austria need to be reported to the Office of Health. One can submit these reports using either the Austrian or the Swiss registration form.
Who can report Adverse Events in Liechtenstein?
Healthcare Professionals are obliged to report adverse drug effects or quality defects if they identify them in Liechtenstein.
Patients are also allowed to report adverse events. The reporting forms can be accessed here. The reports from patients need to be sent to the Office for Health. Medical confirmation is desirable but not mandatory.