Data protection information
for medical inquiries

Medical Information – Further Legal Notices

Data Privacy statement

In order to respond to your query, we will store the personal data you send to us, including your question and our answer. This information will only be used for this purpose, for monitoring our product regarding product safety and to comply with the requirements of regulatory authorities. We might be required to send this information to regulatory authorities in your country and in other countries. We will not share this information with other third parties, however, the data will be stored and processed on secure servers which are maintained by our service provider, Veeva Systems Inc., 4280 Hacienda Drive, Pleasanton, CA 94588, USA on behalf of Biotest AG. Please be aware that that the level of data protection in the US is not comparable to the level within the EU. To protect your personal data, Biotest[1] agreed with Veeva Systems Inc. the EU model clauses for processors. For further information regarding your personal data stored by us in the context of medical inquiries, please see chapter "Information on data processing / European General Data Protection Regulation" further below.

Groups eligible to receive Medical Information from Biotest

The procedure for the granting of medical information ("MI") by the Biotest department of "Corporate Medical Affairs" via the medical information system ("MIS") is only available for healthcare professionals, patients and the general public. You are obliged to inform us in which function you approach Biotest. As the case may be, Biotest will be entitled to request confirmation that you belong to one of the aforementioned groups and/or for a verification of your authorization as a healthcare professional. Requests addressed by regulatory authorities, governmental organisations, non-governmental organisations, shareholders, journalists, lawyers, competitors and similar sources will not be answered via the MIS. Should members of the excluded groups gain MI from Biotest by fraudulent representation, we herewith explicitly forbid further usage and forwarding of the fraudulently gained MI.

Inquiries by those groups may be addressed to the following departments:

  1. Biotest Corporate Regulatory Affairs
  2. Biotest Legal
  3. Biotest Public or Investor Relations
  4. Biotest Marketing and Sales

Content of the Medical Information response

The medical or product-specific statements included in the response are intended only for the person who explicitly requested this medical information from Biotest. If you are not this person, please inform Biotest and discard the received information.

The included medical information is supplied as a professional service in response to your specific enquiry. This is independent of the commercial interests of Biotest and does not contain promotional statements. Accordingly, they are not advertising, and we will neither use your contact data nor the content of your inquiry for promotional purposes.

The literature and further references named and referred to in the included medical information may  sometimes not originate from Biotest, but represent external information. It is not possible for Biotest to examine all aspects of external information to ensure on its correctness, currency and completeness. For this reason, Biotest cannot accept any liability for the content of this literature and of those further references.

Pharmacovigilance data

Experiences with medicines are reported and compiled via several mechanisms. Biotest investigates, monitors and evaluates adverse events reported to the company in compliance with all applicable regulations. However, based on the spontaneous, voluntary nature of this system, not all adverse events coincident with the use of a medicinal product are reported to the manufacturer. Therefore, post-marketing report rates cannot be interpreted in isolation as true incident rates for a particular event with a specific medicinal product. Furthermore, clinical information (such as outcome, medical history, validation of diagnosis, time from drug use to onset of the event, dose, and use of concomitant drugs) may not be available for some reports.

Regulatory status of Biotest medicinal products

The regulatory status of the medicinal products marketed by Biotest is not the same in every country and not all Biotest medicines are licensed in all countries. In your country the Biotest medicinal product which is the subject of your query may not have a marketing authorisation (i.e. the medicine is unlicensed) or treatment of the particular disease stated in your query may not have been approved (a so-called "off-label" application). Biotest can answer those questions individually and from a medical point of view. However, an off-label use remains always the responsibility of the health care professional.

In principle, Biotest does not provide medical information regarding use of its products in countries where they are not licensed or for indications which are not approved, unless this information is necessary to answer your query. Therefore, the answer you receive from Biotest may contain medical statements on use of a Biotest product which does not hold a marketing authorisation in your country or may refer to an indication which is not approved (off-label), because your query specifically demands it. However, Biotest neither advocates such use, nor does it support it.

Biotest cannot provide personal medical advice

The current general medical information provided in response to a specific query is intended to give balanced, scientific and evidence-based answers to medical questions. It does however not constitute medical advice for the specific treatment of individual cases. The responsibility for the treatment of patients remains with the health care professionals based on their professional license, experience and knowledge of the patient. As a patient, please consult your physician and/or your pharmacist before starting or changing any therapy.

Information on data processing / European General Data Protection Regulation

In sharing medical information about our products, we work confidentially with numerous doctors, pharmacists and patients.

The entry into force of the European General Data Protection Regulation (GDPR) and the procedure for handling personal data specified in this Regulation have prompted us to inform you about the processing of your data and your associated rights according to the GDPR, and to assure you that the contact details that you send to us with your query will be used exclusively for answering medical queries. We will not actively write to you, but will only answer your query and any follow-up questions.

1.    Who is the responsible body?

The responsible body according to the German Federal Data Protection Act is:

Biotest AG, Department of Corporate Medical Affairs, Landsteinerstraße 5, 63303 Dreieich, Germany / Phone: +49 6103 801-0 / Email:

Contact details of our Medical Information Officer are:

Dr. Sandra Eiden, Biotest AG, Landsteinerstraße 5, 63303 Dreieich, Germany
Phone: +49 6103 801-7075 / Email:

Prof. Dr. Artur Bauhofer, Biotest AG, Landsteinerstraße 5, 63303 Dreieich, Germany
Phone: +49 6103 801-730 / Email:

You can contact our Data Protection Officer as follows:

2.    What data are recorded and processed?

In the context of your inquiry, we record your name, your practice or clinic address, your specialist work area as well as your telephone number and e-mail address (subsequently referred to as “personal data”).

3.    Where and how are the recorded data stored and used?

Your personal data will be stored only in a separate database that is specifically used for medical queries in order to ensure the reliable tracking of the answers.

Your personal data together with the content of your request and of our answer will usually be stored for 5 years and then deleted.

4.    Legal basis

Biotest must record your data in order to ensure the reliable tracking of answers to queries. Biotest therefore has a legitimate interest in processing your data in accordance with Art. 6. para. 1 f GDPR.

Feel free to contact us if you have any general questions on data protection:

You can find further information about the subject of data protection, and particularly about your rights, including your right to withdraw your consent, and contact details in our general data protection notes at


[1]    All references to "Biotest" relate to Biotest AG and their national affiliates. For an overview on Biotest global locations, see