Evaluating reports of suspected side effects is a key component in the continuous monitoring of drug safety. Healthcare professionals are obligated under the Therapeutic Products Act to report severe or previously unknown side effects to Swissmedic. To do so, they have been using the eGovernment portal “ElViS” (Electronic Vigilance System) for several years. Patients, relatives and interested third parties can also report side effects and incidents electronically to Swissmedic without the need for any medical expertise.
Reporting side effects electronically: new online reporting form for those affected or their relatives
Private individuals can now report suspected adverse drug reactions to Swissmedic via a web form
14.07.2022
The new online form for reporting of side effects by private individuals ensures secure transmission of data. The person reporting enters all necessary information for a valid, usable report themself in a structured way. Following submission, they receive an automatic confirmation of receipt for the form in the application – there is no additional e-mail notification. The information is entered directly in the Swiss database of reported suspected adverse drug reactions: Swissmedic's pharmacovigilance database.
Swissmedic reviews all reports received. The specialist medical evaluation is carried out in collaboration with the six regional pharmacovigilance centres in Basel, Bern, Geneva, Lausanne, Lugano and Zurich. If further information is needed, the reporting person is contacted by e-mail and receives a link to enter additional details online.
All reports received by Swissmedic are forwarded in anonymised form to the respective authorisation holder of the medicinal product and recorded in the WHO's global pharmacovigilance database in Uppsala (Sweden). This ensures that the reports are also available for international analysis.
Reporting of side effects or suspected cases makes an important contribution to safe medicinal products and vaccines but can never replace a medical examination or diagnosis. Patients must always consult their treating physician regarding health questions. Swissmedic is unable to answer individual treatment or health questions and cannot give any corresponding recommendations.
Important information on reports by private individuals
Please note that reporting a side effect does not replace either a medical examination or a diagnosis. Although there may be a temporal relationship between the administration of a medicinal product or vaccine and the onset of a symptom or illness in an individual case, this does not necessarily mean that the medicinal product or vaccine was actually the cause. Other possible causes, which may possibly require targeted therapeutic measures, can only be excluded with a medical diagnosis.
If you notice symptoms that could be a side effect, you should first contact the place that prescribed, dispensed or administered the medicinal product. Always consult your treating physician in the event of symptoms/ailments. Healthcare professionals can assess whether this involves a side effect that must be reported or symptoms that are more likely to be caused by something else. You can potentially ask your healthcare professional (doctor, pharmacist) to report the side effect.
By reporting side effects or suspected cases, you are making an important contribution to safe medicinal products and vaccines. However, please note that Swissmedic is unable to answer individual treatment or health questions and cannot give any corresponding recommendations.
Reports of side effects are often the first indication of an as-yet unknown or insufficiently described risk of medicinal products and vaccines. They can be the starting point for further investigations to confirm potential risks and analyse these in greater detail. In general, several reports are necessary to give an initial indication of a possible risk.