Report suspected adverse reactions and damage to health caused by medicinal products, vaccines or tissue preparations
If you suspect that a medicine or vaccine has caused side effects or damage to health, you can report this directly to the competent authorities. Adverse reactions are, for example, harmful effects of a medicinal product, vaccination complications or damage to health.
Every suspected case of an adverse reaction reported in Europe is forwarded to the common European adverse reaction database EudraVigilance. The national authorities responsible for drug safety in Europe and the European Medicines Agency (EMA) jointly and systematically assess the safety of medicines based on these reports and other scientific information:
- Medicinal products;
- vaccines;
- Tissue preparations, for example heart valves or corneas;
- advanced therapy medicinal products (ATMPs).
Reports from private individuals
As a private individual, you can report a suspected adverse reaction for yourself. You can also report on behalf of someone you care for, for example your child or other relatives.
Doctors and pharmacists can help you fill in the form or report suspected cases directly. You should always contact a doctor to diagnose your symptoms and treat your complaints.
As a patient, you can remain anonymous: Providing your name or personal contact details is voluntary. However, by providing a contact for queries, you will help the authorities to follow up on suspected cases, which is important for drug safety.
Reports from healthcare professionals
As a healthcare professional - such as a doctor or pharmacist - you are legally obliged to report vaccination complications to the relevant authorities. The obligation to report suspected adverse drug reactions is regulated by the respective professional code of conduct. Adverse drug reactions can also be reported to the relevant competent authority.
Reports from manufacturers and other healthcare professionals
As a pharmaceutical company or commercial sponsor of a clinical trial, you report adverse drug reaction cases exclusively electronically to the relevant European (EMA) or national authority using the EudraVigilance infrastructure in accordance with legal regulations and guidelines. 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 pass on safety-relevant information immediately to doctors and pharmacies in consultation with the competent higher federal authority via so-called red hand letters.
Information for reporting suspected cases
If possible, please provide the following information for tracing the suspected case:
- Information about the person in whom the adverse reaction or vaccination complication occurred, in particular details of age and gender;
- a description of the adverse reaction or vaccination complication;
- the dose and name of the medicinal product/vaccine (trade name and name of the active substance) suspected of having caused the adverse reaction or vaccination complication, including the timing of the adverse reaction or vaccination complication;
- the batch number 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 experiencing the side effect, such as pre-existing medical conditions, but also health risk factors such as obesity or smoking.
Reports from private individuals:
- As a private individual, you can report suspected adverse reactions, vaccination complications or damage to health informally, preferably online or by e-mail, post, fax or telephone.
- Online reporting: Go to the website "Online reporting of adverse reactions".
- Select the type of side effect you wish to report.
- The reporting form will guide 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 and a confirmation of submission summarizing your information.
Reports from healthcare professionals or non-commercial sponsors of clinical trials:
- As a healthcare professional, report a suspected adverse reaction, vaccination complication or adverse health event preferably online or by e-mail, mail, fax or telephone.
- Online reporting: Call up the online form "Reporting 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 wish 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 and a confirmation of notification submission summarizing your information.
- Offline notification for tissue preparations and advanced therapy medicinal products (ATMP): Call up the notification form on the website of the Paul-Ehrlich-Institut (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.
Notifications from manufacturers and other healthcare professionals:
- As a pharmaceutical company or commercial sponsor of a clinical trial, you only report adverse drug reactions electronically via the EudraVigilance infrastructure. This is also available to non-commercial sponsors of clinical trials.
- To use EudraVigilance, you must register and require certification. You can find further information on the EMA website.
Procedure after submitting the notification:
- The staff of the competent authorities will check your notification together with all other notifications and available scientific information on the medicinal product or vaccine. If there are any queries, the authorities will contact you or the contact person you have provided.
- The Paul-Ehrlich-Institut is responsible for vaccines, biomedical medicinal products, tissue preparations and advanced therapy medicinal products. The Federal Institute for Drugs and Medical Devices is responsible for medicinal products.
- All valid reports are entered into the European adverse drug reaction database (EudraVigilance), which is operated by the European Medicines Agency (EMA).
- Once the available data has been reviewed at European level, the competent authorities may order further measures such as warnings, training material or recalls.
You can report a suspected case at any time.
You do not have to submit any documents. You can send documents such as laboratory results to the authorities after your report. Please quote the processing number that you will receive following your SAR.
There are no costs for you.
You can report a suspected case at any time. Pharmaceutical companies and sponsors of clinical trials must comply with the legal requirements.
- Suspected cases of serious adverse reactions and vaccination incidents are processed within 15 days.
- For cases of suspected non-serious adverse reactions, the processing time can be up to 90 days.
- You will not receive any feedback from the processing authority.
- § 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
- Guideline on good pharmacovigilance practices (GVP) Module VI - Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2)
- § 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)
- § Section 13 (2) and (3) of the Ordinance on the Application of Good Clinical Practice in the Conduct of Clinical Trials with Medicinal Products for Human Use (GCP Ordinance)
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
- Reporting form on adverse drug reactions (including suspected cases) on the website of the Federal Institute for Drugs and Medical Devices (BfArM)
- Notification forms on adverse recipient reactions in connection with tissue preparations
- Reporting forms for an adverse reaction of a recipient in connection with advanced therapy medicinal products (ATMPs)
- Serious adverse reaction report forms for the use of an advanced therapy medicinal product (ATMP) that is not subject to authorization or approval in patients
There are no legal remedies.
- Flyer "How to 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 using the EudraVigilance infrastructure on the EMA website
Federal Ministry of Health (BMG)
04.08.2021
The text was automatically translated based on the German content.
