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.

Description

Prerequisites

You can report a suspected case at any time.

Procedure

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.

Deadlines

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.

Forms

Online procedures

Fees

  • There are no costs for you.

Remedy

No legal remedies are given.

Status:03.03.2023

Responsible for editing:Bundesministerium für Gesundheit

Contains machine translated content. Show the original content

  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Form, Bavaria-wide
  • Form, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
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