Notification of side effects
To identify side effects after the vaccination, information needs to be collected about them, this information analysed and compared to data that is already available (previous cases). Therefore, a doctor or nurse who has administered a vaccination injection should always be informed if there is a suspicion that the health problems experienced may have resulted from vaccination. The healthcare professional who performed this (for example, a family physician, a healthcare provider at school), in turn, has an obligation to inform the Agency of Medicines or the marketing authorization holder of the incident. The patient/parent can notify the Agency of Medicines of side effects of the vaccine by themselves as well.
Information is collected and analysed
All side effects notifications are recorded, analysed and stored at the State Agency of Medicines. This information will also be provided to the marketing authorization holder, the World Health Organization and the European Medicines Agency. Based on the information gathered from different countries into a single database, a comprehensive overview of the quality and safety of the medicine will be compiled. This will create a good foundation for further decisions.
Statistics on side effect notifications are made public
The State Agency of Medicines will annually disclose, on its website, an overview of notifications received on the side effects of medicines, including an overview of side effects of vaccines.
The precise procedure and requirements for the transmission of data on the safety of medicinal products are regulated by the Medicinal Products Act and the legislation established on the basis thereof. For more information and an overview of the side effects of medication received can be found on the website of the State Agency of Medicines.