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 this directly to the competent authorities. Side effects include, for example, harmful effects of a drug, vaccine complications or damage to health.
Any suspected adverse reaction reported in Europe is forwarded to the common European adverse reaction database EudraVigilance. On the basis of these notifications and other scientific information, the national authorities responsible for pharmaceutical 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.
Notifications from private individuals
As a private individual, you can report a suspicion of a side effect for yourself. You can also report the suspicion on behalf of someone you are caring for, for example for your child or other relatives.
Doctors and pharmacists can help you fill out the report or report suspected cases directly. 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. By providing a contact for queries, however, you support the authorities in the follow-up of suspected cases, which is important for drug safety.
Notifications from healthcare professionals
As a healthcare 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.
Notifications from manufacturers and other experts
As a pharmaceutical company or commercial sponsor of a clinical trial, you report cases of side effects to the relevant European (EMA) or national authority exclusively electronically 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 authorisation holder for medicinal products, you are also obliged to pass on safety-relevant information immediately to doctors and pharmacies via so-called Dear Doctor Letters in consultation with the competent higher federal authority.
Information for reporting 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 vaccine complication, in particular information on age and gender;
- a description of the adverse reaction or vaccination complication;
- the dose and name of the medicinal product/vaccine (trade name and active ingredient name) suspected of having triggered it; including temporal classification for side effects or vaccination complication;
- the batch number of the medicinal product or vaccine indicated on the packaging;
- any other medicine or vaccine taken or injected around the same time; this includes non-prescription medicines, herbal medicines and contraceptives;
- any other health problems of the person who 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 Adverse Reaction Reporting" website.
- Select the type of side effect you want to report.
- The registration 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 notification 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 health, preferably online or by e-mail, post, fax or telephone.
- Online report: 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-Institut (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 notification 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 (ATMPs): Call up the registration 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.
Reports from manufacturers and other experts:
- As a pharmaceutical company or commercial sponsor of a clinical trial, you report adverse events exclusively electronically via the Eudravigilance infrastructure. This is also available to non-commercial sponsors of clinical trials.
- To use EudraVigilance, you must register and obtain certification. Further information on how to use it can be found on the EMA 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 medicinal product 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, biomedical drugs, tissue preparations and advanced therapy drugs. The Federal Institute for Drugs and Medical Devices is responsible for medicinal products.
- All valid notifications are included in the European Adverse Reactions Database (EudraVigilance), which is operated by the European Medicines Agency (EMA).
- After completion of the verification of the available data at European level, the competent authorities may order further measures such as warnings, training material or recalls.
Requirements
You can report a suspected case at any time.
Which documents are required?
You do not have 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 activity 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 legal requirements.
Processing duration
- The suspected case of a serious side effect and a vaccination incident will be processed within 15 days.
- In non-serious cases of 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 Medicines Act (AMG)
§ 63c of the German Medicines Act (AMG)
Article 28 Implementing Regulation EU 520/2012
§ 11 paragraph 4 Infection Protection Act (IfSG)
§ 6 paragraph 1 Infection Protection Act (IfSG)
Applications / forms
Forms: yes
Online procedure possible: yes
Written form required: no
Personal appearance required: no
Reporting forms for drug safety on the website of the Paul-Ehrlich-Institut
Recipient's adverse reaction reporting forms in relation to tissue preparations
Recipient adverse reaction notification forms for Advanced Therapy Medicinal Products (ATMPs)
Appeal
There are no legal remedies.
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.
