The monitoring of adverse reactions, side effects and/or interactions with other medicinal products (“event”) associated with the use of medicinal products is known as pharmacovigilance. The legally defined pharmacovigilance obligations relate to our medicinal products and allow us and the competent regulatory authorities to record events and to collect, process or use personal data in this respect. Comparable regulations exist for our medical devices and cosmetics. In the following, we therefore use the term pharmacovigilance comprehensively for the above-mentioned products.
In order to fulfill our legal responsibilities in this respect, we must collect and process information that allows a natural person to be identified, directly or indirectly ("personal data"), from a patient brought to our attention and/or the person reporting such an event. Under certain conditions, we also must report these events to the relevant regulatory authorities. In case such an event occurs, we ensure that all personal data is processed exclusively for pharmacovigilance purposes and only where relevant and appropriate in order to document, assess and report the event properly in accordance with our respective pharmacovigilance obligations.
In order to safeguard this personal data, we have implemented appropriate state of the art technical and organizational measures.
The legal basis for the processing of your personal data is the fulfilment of our legal obligations regarding the applicable pharmacovigilance laws and regulations, respectively the safeguarding of the considerable public and our own legitimate interests, which consist in ensuring high safety and quality standards for our products (Art. 9 Para. 2 lit. i GDPR, Art. 6 Para. 1 lit. c GDPR / Art. 6 Para. 1 lit. f GDPR in conjunction with Section 22 para. 1 lit. c BDSG).
We may need to process the following personal data (including collection, storage and further use, hereinafter together “process”):
Where appropriate, we can process the following additional personal data related to health and medical history of the person experiencing such an event if and to the extent this is required to process the event for pharmacovigilance purposes:
With respect to the person which has reported the event to us we can process the following data, in order to allow further inquiries by the regulatory authorities and or to further investigate the event:
As part of meeting our pharmacovigilance obligations, we may process personal data in order to
As part of meeting our pharmacovigilance obligations, we may share and/or disclose personal data as follows:
Our pharmacovigilance databases are hosted in Germany. A transfer to third countries (outside the EU/EEA) may take place to the following recipients or categories of recipients due to compliance with the statutory reporting obligations:
We will use and store the personal data collected according to the aforementioned requirements in accordance with the respective mandatory and other legal requirements governing the storage and reporting of pharmacovigilance related information. Such mandatory requirements currently oblige us to archive the respective pharmacovigilance information, which may include personal data for the duration of the product life-cycle (i.e. until the respective product has been taken from the market) and for an additional ten years thereafter.
If we process personal data, the persons concerned are entitled to the following rights:
Please note, however, that these rights may be limited in order to fulfil our legal obligations. Your rights are not fully applicable if there is a legal basis for the processing of your personal data (e.g. information collected in the context of reporting an event cannot be deleted unless it is incorrect).
There is no automated decision-making including profiling according to Art. 22(1) and (4) GDPR.
Data subjects also have the right to file a complaint with a data protection authority.
For any questions you may have with respect to pharmacovigilance data protection or data protection in general please contact our data protection officer:
Aeonva Holding GmbH
Data Protection Officer
Berger Straße 8 - 10
82319 Starnberg (Percha)