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
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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 German Federal Data Protection Act we keep all personal data provided strictly confidentially and document all patient data in our safety data base in a pseudonymized[1] manner. Contact information provided will be only used for acknowledgement of receipt and, if necessary, for clarifying details. Personal data will not be transferred to third parties or other departments within Biotest.

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.

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.


[1] German Federal Data Protection Act, § 3(6a): Pseudonymization means replacing a person’s name and other identifying characteristics with a code, in order to exclude or substantially impede identification the person.