The Paul-Ehrlich-Institut and the Federal Institute for Drugs and Medical Devices as federal authorities are subjects to the regulations of the Datenschutzgrundverordnung (DSGVO, General Data Protection Regulation) and the Bundesdatenschutzgesetz (BDSG, Federal Data Protection Act (new)).
This Website is provided by
Federal Institute for Vaccines and Biomedicines
D- 63225 Langen, Germany
Phone: +49 6103 77 0
Fax: +49 6103 77 1234
Whenever our server is accessed, data are stored for statistical and security purposes. Date and time, as well as the web page you have visited are recorded on our server for a limited period of time. These data are used exclusively for improving our internet content. The data are not used in any other way or communicated to third parties.
Dealing with your personal information
All data of the online reporting is sent encrypted.
If you provide information on the reporting person in the report (summary, last step), you consent to the use of this data by the competent authority (PEI / BfArM). The data will only be used to contact reporters if questions are required. The data will not be shared with third parties. They are stored as long as the active substance or drug in question is authorized. Then the contact details will be blocked for 10 years in accordance with the law. This means that the authority may use the contact data without the consent of the reporter only in a few exceptional cases at all, and even in these cases, not further than before the blocking (see § 20 para 7 BDSG). This is followed by the final deletion of the data.
Reporters are free to revoke their consent to the processing and use of contact information at any time. To do this, it is necessary to specify the processing number given in the summary of the report. If the case data have already been transferred to the side effects database at this time, the notification of the suspected case is completely anonymized by the deletion of the contact data.
Anonymous reporting is possible
You can also submit a report of an adverse reaction anonymously. In the case of anonymous reports, any possibly necessary medical validation of the clinical information in the suspicious transaction report is not possible.
Contact form / email enquiries
For inquiries via the contact form the name and the email address are requested. The indication of the address is voluntary. This data is sent encrypted.
The data transmitted will be stored in conformity with the legal requirements electronically. The data will be destroyed or deleted when the legal retention period has expired. Your personal data will be treated as confidential.
The data will be used by the BfArM or PEI, but will not be disclosed to third parties outside of these higher federal authorities or used for purposes other than those stated in the response to your request.
Official data protection representative of the Paul-Ehrlich-Institut
Phone: +49 6103 77 1605
Date of issue: 2018.09.26