Drugs, vaccines, or tissue preparations; reporting suspected adverse reactions and adverse health effects.

By reporting suspected adverse events or vaccine complications to authorities, you help make medicines and vaccines safer.


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:

  • Medicines;
  • Vaccines;
  • 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.


You can report a suspected case at any time.


Reports from private individuals:

  • As a private individual, you can report a suspected adverse reaction, vaccine complication, or health impairment informally, preferably online or by e-mail, mail, fax, or telephone.
  • Online reporting: Go to the website "Online reporting of adverse reactions".
  • Select the type of adverse reaction you want to report.
  • The reporting form will guide you step-by-step through the necessary information for your suspected case.
  • You will receive an electronically generated report number at the end of the reporting process, as well as a report submission confirmation that summarizes your information.

Reports from healthcare professionals or non-commercial sponsors of clinical trials:

  • As a health professional, report a suspected adverse reaction, vaccine complication, or adverse health event preferably online or by email, mail, fax, or telephone.
  • Online reporting: access the online form "Reporting suspected adverse drug reactions and vaccine complications" of the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI).
  • Select which type of notification you want to submit.
  • The form will guide you step by step through the necessary information for your suspected case.
  • At the end of the notification, you will receive an electronically generated notification number as well as a confirmation of notification submission summarizing your information.
  • Offline notification for tissue preparations and advanced therapy medicinal products (ATMPs): Call up the notification form on the website of the Paul Ehrlich Institute (PEI).
  • Fill out the form as completely as possible.
  • Send the completed form by e-mail, mail or fax to the addresses or numbers provided.

Notifications from manufacturers and other professionals:

  • As a pharmaceutical company or commercial sponsor of a clinical trial, you report adverse events electronically only via the EudraVigilance infrastructure. This is also available to non-commercial sponsors of clinical trials.
  • To use EudraVigilance, you must register and obtain certification. For more information on how to use it, please visit the EMA website.

Process after submitting the notification:

  • Competent authority staff review your notification along with all other notifications and available scientific information about the drug or vaccine. If there are any queries, the authorities will contact you or the contact person you have provided.
  • For vaccines, biomedical medicinal products, tissue preparations and advanced therapy medicinal products, the Paul Ehrlich Institute is responsible. For medicinal products, the Federal Institute for Drugs and Medical Devices is responsible.
  • All valid notifications are entered into the European Adverse Reaction Database (EudraVigilance), which is operated by the European Medicines Agency (EMA).
  • After completion of the review of the available data at the European level, the competent authorities order further measures such as warnings, training material or recalls, if necessary.


You can report a suspected case at any time. Pharmaceutical companies such as sponsors of clinical trials must comply with the legal requirements.

Processing time

  • The suspected case of a serious adverse reaction as well as a vaccination incident will be processed within 15 days.
  • For non-serious suspected adverse reaction cases, the processing time can be up to 90 days.
  • You will not receive any feedback from the processing authority.

Required documents

  • Required document(s)

    You do not need to submit any documentation. You can send documents, such as laboratory results, to the authorities after your report. To do so, please quote the processing number that you will receive following your SAR.


Online procedures


  • There are no costs for you.


No legal remedies are given.


Responsible for editing:Bundesministerium für Gesundheit

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  • Form, Bavaria-wide
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  • Prefillable Form, Bavaria-wide
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