If you suspect that a medicine or vaccine has caused side effects or damage to health, you can report this directly to the relevant authorities. Adverse reactions are, for example, harmful effects of a medicine, vaccine complications or health damage.
Any suspected adverse reaction reported in Europe is forwarded to the common European adverse reaction database EudraVigilance. Based on these reports and other scientific information, the national authorities responsible for drug safety in Europe and the European Medicines Agency (EMA) jointly and systematically assess the safety of:
- Tissue preparations, for example heart valves or corneas;
- Advanced therapy medicinal products.
Reporting by Individuals
As an individual, you may report a suspected adverse reaction for yourself. You may also submit the suspicion on behalf of someone you care for, such as your child or other dependents.
Physicians and pharmacists can help you fill out the report or submit suspected cases directly. In any case, you should contact a doctor to diagnose your symptoms and treat your symptoms.
As a patient, you can remain anonymous: Providing your name or personal contact information is voluntary. However, by providing a contact for queries, you will assist the authorities in following up suspected cases, which is important for drug safety.
Reporting by healthcare professionals
As a healthcare professional - such as a physician or pharmacist - you are legally required to report vaccine complications to the competent authorities. The obligation to report suspected adverse drug reactions is regulated by the respective professional regulations. Adverse drug reactions can also be reported to the relevant competent authority.
Reporting by manufacturers and other healthcare professionals
As a pharmaceutical company or commercial sponsor of a clinical trial, you report adverse drug reactions in accordance with the legal regulations and guidelines exclusively electronically using the EudraVigilance infrastructure to the respective competent European (EMA) or national authority. As a non-commercial sponsor of clinical trials, you report suspected cases directly to the national authorities, preferably also electronically using the EudraVigilance infrastructure.
As a marketing authorization holder of medicinal products, you are also obliged to immediately pass on safety-relevant information to physicians and pharmacies via so-called red-hand letters in consultation with the competent higher federal authority.
Information for reporting suspected cases
If possible, please provide the following information for tracking the suspected case:
- Information about the person in whom the adverse reaction or vaccine complication occurred, especially age and gender information;
- A description of the adverse reaction or vaccine complication;
- the dose and the name of the drug/vaccine (trade name and active ingredient name) which is suspected of having caused the adverse reaction or vaccination complication; including the chronological order of the adverse reaction or vaccination complication;
- the batch designation of the drug or vaccine, which is indicated on the packaging;
- any other drugs or vaccines taken or injected at about the same time; this includes non-prescription drugs, herbal medicines and contraceptives;
- any other health problems of the person who experienced the adverse reaction, such as pre-existing conditions, but also health risk factors such as obesity or smoking.