Pharmacovigilance Requirements in Liechtenstein
Medicines are there to help alleviate, prevent or detect diseases. Medicines can also damage health, for example if they are not used correctly, if side effects occur, but also if they are defective. It is therefore important that the authorities continuously monitor the medicinal products from their manufacture to their disposal.
As part of the customs contract, the Liechtenstein market is integrated into Swissmedic's Swiss surveillance network. The side effects of medicinal products that are authorized under the customs contract in Liechtenstein must be reported to the responsible regional pharmacovigilance center. Further information on the reporting system in Switzerland can be found here .
Side effects of medicinal products manufactured in accordance with Art. 4 Therapeutic Products Act, LR 812.102 are to be reported to the Office of Health. These reports can be submitted using either the Austrian or the Swiss registration form.
Medicinal products authorized in the EEA are recorded in the European surveillance system. Undesired effects and quality defects of the medicinal products authorized within the scope of the agreement with Austria must be reported to the Office of Health. These reports can be submitted using either the Austrian or the Swiss registration form. In the EEA, all reports of side effects that are made after approval, but also in clinical trials in the EEA, are recorded in a common European database . The European Medicines Agency also publishes a list of medicinal products that are also monitored.
Important information on medicinal product safety can be found under "Swissmedic" (customs contract) as well as on the website of the European Medicines Agency and the Austrian Federal Office for Safety and Health Care .
Some EEA medicines are under additional surveillance. They are marked with a black triangle. The black triangle means that this EEA medicine is monitored even more closely than other medicines. Patients should report any suspicion of a side effect when using such a medicine: to their doctor or to the Office for Health. The list of these EEA medicines can be found here .
Who reports?
Anyone who uses or dispenses medicinal products on a commercial basis (pharmacists, drugstores, doctors, naturopaths) is obliged to report adverse drug effects or quality defects if they identify them in Liechtenstein.
Patients are also free to report adverse effects of drug therapy. Registration forms can be accessed here. The reports from patients are to be sent to the Office for Health. A consultation with the general practitioner. A joint notification has the advantage that precise information on relevant test results can be provided, but it is not mandatory.