Report suspected side effects and damage to health caused by medicines, vaccines or tissue preparations
If you suspect that a medicine or vaccine has caused side effects or damage to your health, you can report it directly to the relevant authorities. Side effects include, for example, harmful effects of a drug, vaccination complications or damage to health.
Every suspected case of a side effect reported in Europe is forwarded to the common European side effect database EudraVigilance. On the basis of these notifications 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 cornea;
- Advanced Therapy Medicinal Products.
Reports from private individuals
As a private individual, you can report a suspected side effect for yourself. You can also submit the suspicion on behalf of someone you are caring for, such as your child or other relatives.
Doctors and pharmacists can help you fill out the report or transmit suspected cases directly. In order to diagnose your symptoms and treat your symptoms, you should always contact a doctor.
As a patient, you can remain anonymous: providing your name or personal contact details is voluntary. However, by providing a contact for queries, you support the authorities in the follow-up of suspected cases, which is important for drug safety.
Reports from health professionals
As a health professional – such as doctors and pharmacists – you are legally obliged to report vaccination complications to the competent authorities. The obligation to report suspected side effects of medicinal products is regulated by the respective professional code. Side effects caused by medicinal products can also be reported to the relevant competent authority.
Reports from manufacturers and other professional groups
As a pharmaceutical company or commercial sponsor of a clinical trial, you report side effect cases to the relevant European (EMA) or national authority in accordance with the legal regulations and guidelines, exclusively electronically using the EudraVigilance infrastructure. 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 authorisation holder of medicinal products, you are also obliged to immediately pass on safety-relevant information to doctors and pharmacies in consultation with the competent higher federal authority via so-called red hand letters.
Information for the reporting of suspected cases
If possible, please provide the following information to follow up on the suspected case:
- information about the person who has experienced the adverse reaction or vaccination complication, in particular information about age and gender;
- a description of the side effect or vaccine complication;
- the dose and the name of the drug/vaccine (trade name and active ingredient name) that is suspected of causing it; including the timing of the side effect or vaccination complication;
- the batch name of the medicinal product or vaccine indicated on the packaging;
- any other medicines or vaccines taken or injected around the same time; this includes non-prescription medicines, herbal medicines and contraceptives;
- any other health problems of the person who has experienced the side effect, such as pre-existing conditions, but also health risk factors such as obesity or smoking.
Process flow
Reports from private individuals:
- As a private individual, you can report a suspicion of side effects, vaccination complications or damage to health informally, preferably online or by e-mail, post, fax or telephone.
- Online reporting: Go to the "Online Reporting of Adverse Reactions" webpage.
- Select the type of side effect you want to report.
- The reporting form guides you step by step through the necessary information for your suspected case.
- At the end of the report, you will receive an electronically generated report number as well as a confirmation of the submission of the report, which summarizes your information.
Reports from healthcare professionals or non-commercial sponsors of clinical trials:
- As a healthcare professional, you should report a suspected side effect, vaccination complication or damage to your health, preferably online or by e-mail, post, fax or telephone.
- Online reporting: Call up the online form "Reporting of suspected cases of adverse drug reactions and vaccination complications" of the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI).
- Select the type of report you want to submit.
- The form guides you step by step through the necessary information for your suspected case.
- At the end of the report, you will receive an electronically generated report number as well as a confirmation of the submission of the report, which summarizes your information.
- Offline Notification for Tissue Preparations and Advanced Therapy Medicinal Products (ATMP): Access 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, post or fax to the addresses or numbers provided.
Reports from manufacturers and other professional circles:
- As a pharmaceutical company or commercial sponsor of a clinical trial, you can only report adverse reactions electronically via the EudraVigilance infrastructure. This is also available to non-commercial sponsors of clinical trials.
- To use EudraVigilance, you need to register and be certified. For more information on how to use it, please visit the EMA's website.
Procedure after submission of the report:
- The staff of the competent authorities will review your notification together with any other reports and available scientific information on the medicine or vaccine. If you have any questions, the authorities will contact you or the contact person you have specified.
- The Paul-Ehrlich-Institut is responsible for vaccines, biomedicines, tissue preparations and advanced therapy drugs. The Federal Institute for Drugs and Medical Devices is responsible for medicinal products.
- All valid reports are included in the European Adverse Reactions Database (EudraVigilance), which is operated by the European Medicines Agency (EMA).
- Once the examination of the available data at European level has been completed, the competent authorities will order further measures, such as warnings, training material or recalls, where appropriate.
Requirements
You can report a suspected case at any time.
Which documents are required?
You don't need to submit any documents. After your report, you can send documents such as laboratory results to the authorities. Please enter the processing number that you will receive after your suspicious transaction report.
What are the fees?
There are no costs for you.
What deadlines do I have to pay attention to?
You can report a suspected case at any time. Pharmaceutical companies, such as sponsors of clinical trials, must comply with the legal requirements.
Processing duration
- The suspected case of a serious side effect as well as a vaccination incident will be processed within 15 days.
- In the case of non-serious suspected side effects, the processing time can be up to 90 days.
- You will not receive any feedback from the processing authority.
Legal basis
Section 62 (2) to (3) of the German Medicinal Products Act (AMG)
Section 63c of the German Medicinal Products Act (AMG)
Article 28 Implementing Regulation EU 520/2012
Section 11 (4) of the Infection Protection Act (IfSG)
Section 6 (1) of the Infection Protection Act (IfSG)
Section 63j (1) to (2) of the German Medicinal Products Act (AMG)
Applications / forms
Forms: yes
Online procedure possible: yes
Written form required: no
Personal appearance required: no
Drug safety reporting forms on the website of the Paul-Ehrlich-Institut
Notification forms for adverse receptor reactions related to tissue preparations
Advanced Therapy Medicinal Products (ATMP) Adverse Receptor Response Notification Forms
Appeal
There are no legal remedies.
Flyer "How do you report side effects?" on the website of the European Medicines Agency
Information on drug safety on the website of the Paul-Ehrlich-Institut
Information on drug safety on the BfArM website
Information on vaccines for humans on the website of the Paul-Ehrlich-Institut
Overview of adverse reaction reports in the European Adverse Reaction Database (EudraVigilance)
Information on the use of the EudraVigilance infrastructure on the EMA's website
Technically approved by
Federal Ministry of Health (BMG)
Professionally released on
04.08.2021
Author
The text was automatically translated based on the German content.
