Reporting of suspected
adverse drug reactions

Why report adverse drug reactions?

At the time of market approval of a medicinal product knowledge about its safety is based on nonclinical experiments and clinical studies, carried out with calculated numbers of selected volunteers and patients. Thus, safety information of a just launched medicinal product requires further input which remains so in varying degrees even years after approval and continued administration to increasing numbers of patients. In most cases the knowledge gap concerning safety is getting smaller during the course of the application of a medicinal product due to reports from physicians, pharmacists and other health care professionals, as well as reports from patients. Of special interest are reports about adverse drug reactions that rarely occur, occur in specific patient groups (e.g. in children, elderly, etc.) or might be related to long-term use. Moreover, it is also very important to learn more about the medicinal product’s interactions with other medications.

Thus, in order to get comprehensive information about the safety of a medicinal product it is obligatory for Marketing Authorization Holders to systematically collect and update suspected adverse drug reactions, process and forward it to the local authorities.

Such information is then provided by most local authorities on their home page in local language. For those concerned it is advised to visit the respective homepage as required.

How can you report adverse drug reactions?

In order to report adverse drug reactions please download and fill in the form as indicated below:

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Reporting of suspected adverse drug reactions
PDF, 275 KB
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This report form corresponds to specifications provided by the Competent Authority responsible for Biotest products, the German Paul-Ehrlich-Institute (PEI). Alternatively you may report directly to your local authority in local language. Please check the home page of your local authority as appropriate.

Please fill out the provided report form providing the most complete information. Attachment of additional documents (e.g. doctor's records, laboratory results, etc.) are highly appreciated as they would support Biotest’s assessment of the event. According to the obligations stated in the European General Data Protection Regulation we keep all personal data provided strictly confidentially.

To avoid misuse we will not process anonymous reports. Persons reporting an adverse drug reaction are therefore asked to include their contact information.

What happens to adverse drug reaction reports at Biotest?

All data concerning an adverse drug reaction will be entered into Biotest’s electronic database and assessed by a medical or pharmaceutical staff member of the drug safety department with respect to that specific case and also in the context of similar cases.

According to obligations made by law, Biotest has to forward adverse drug reactions fulfilling specified criteria to the competent authority.

Data protection information on drug safety

This statement informs you how Biotest AG (hereinafter referred to as "Biotest") and its subsidiaries, including Biotest Pharma GmbH, collect, store, process, use and disclose your personal data.

Why we collect your personal data

Biotest processes your personal data for the purpose of monitoring drug safety by collecting, identifying, evaluating and preventing adverse reactions or other problems related to medicines.

Biotest processes your personal data on the following basis:

(1) If you report an adverse reaction affecting another person: on the basis that the processing is necessary to comply with our legal obligations regarding drug safety.

(2) If you report the adverse reaction yourself as a patient: on the basis that the processing is necessary for reasons of public interest in the field of public health.

Your personal information is provided on a voluntary basis (unless you are a healthcare professional who is required to report adverse events).

We will not use this information for any other purpose, and your personal information will not be shared with any third party unless required to do so by law (e.g., to regulatory authorities) or unless that third party is acting as a data processor on behalf of Biotest.

How long we keep your personal data

Your personal data will only be kept for as long as is reasonably considered necessary for the purposes described above for public health reasons and as required or permitted by applicable legislation, and for at least 10 years after the expiry of the product's authorisation.

To whom we pass on your personal data and to whom we pass on international data

For the purposes described above, Biotest may share your personal information with other Biotest Group companies and service providers acting on Biotest's behalf, such as IT system administration and user support service providers and service providers who process reports of adverse events.

Biotest is also obliged to report information relevant for pharmacovigilance to health authorities worldwide (including countries whose level of data protection differs from that of the EU). The notifications contain detailed information on the incident, but only limited personal data:

  • With regard to patients, the notification will contain only age and sex, depending on the information available, but never the name of the patient.
  • With regard to the notifier, the declaration will include the professional activity (e.g. doctor, pharmacist), depending on the information available.

The contact details are necessary to be able to follow up the reporting and thus obtain high-quality and complete information on adverse events. If your information is shared with other Biotest companies, business partners or service providers outside the EU, we will ensure appropriate protection of your personal information. To this end, we conclude suitable agreements on data transfer, for example.

You can request information about these third parties and copies of the agreements by e-mailing datenschutz@biotest.com

Further information with regards to data protection and your respective rights is contained in our Data Protection Notice. https://www.biotest.com/de/en/service_navigation/privacy_statement.cfm

Recording of adverse drug reactions of our products during their entire marketing cycle and analysis of these records might lead to further action, like change of content of the package leaflet to consider yet unknown side effects or change in frequency of side effects, which were already known.

Definitions / Explanations

Adverse Drug Reaction is a response to a medicinal product which is noxious and unintended. It may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure.

Serious Adverse Drug Reaction is a reaction which results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenial anomaly/birth defect.