Information on data protection according to Art. 13 of the GDPR (General Data Protection Regulation)
With the following information, we would like to inform you about the types of personal data we process in the context of pharmacovigilance and what purposes we use this data for.
The monitoring of adverse reactions or events (side effects) associated with the use of medicinal products is called pharmacovigilance. The statutory pharmacovigilance obligations relate to our medicinal products for human and animal use. Similar regulations exist for our medical devices and cosmetics. We therefore use the term pharmacovigilance hereinafter for the products stated above (Heel products).
In light of this, we need to process information that enables direct or indirect identification of a natural person ("personal data"), patient and/or the reporter of an adverse event that is brought to our attention.
Under certain circumstances, we must report these adverse events to the competent supervisory authorities.
Biologische Heilmittel Heel GmbH („Heel“)
Dr.-Reckeweg-Str. 2 - 4
Ralph Schmidt (Chairman), Marc Deschler
Biologische Heilmittel Heel GmbH
Data Protection Officer
Dr.-Reckeweg-Str. 2 - 4, 76532 Baden-Baden
We are required by law to collect, evaluate and, if necessary, report adverse events and other information relevant to pharmacovigilance to the corresponding authorities.
We use the data for the following purposes:
We process the following types of personal data for these purposes:
1. About patients:
2. About reporters:
The legal basis for processing your personal data is the fulfilment of our legal obligations or the safeguarding of our legitimate interests, which consist, in particular, of ensuring high safety and quality standards of our products (Art. 9 Para. 2 Letter i of the GDPR, Art. 6 Para. 1 Letter c of the GDPR/Art. 6 Para. 1 Letter f of the GDPR in conjunction with Art. 22 Para. 1 Letter c BDSG (FDPA [Federal Data Protection Act]).
The personal data we collect will only be stored for as long as is necessary to achieve the purpose for which the data was collected. Pharmacovigilance data and records for the medicinal products or medical devices concerned are kept based on legal obligations for as long as the product has marketing authorisation and for at least 10 years after the expiry of the marketing authorisation/registration/notification.
Your personal data are only forwarded if this is permitted based on the consideration of interests or we are legally obliged to forward these.
To fulfil our statutory pharmacovigilance obligations, we may forward personal data to the following recipients or categories of recipients:
If required, we publish information about adverse events (e.g. in case studies and summaries).
In such cases, we remove identifiers from any publication to keep the identity of individuals private.
Data may be transferred to third countries (outside of the EU/EEA) due to fulfilment of legal reporting obligations to the following recipients or categories of recipients:
If we process personal data, data subjects have the following rights:
Please note, however, that these rights may be limited to meet our legal obligations. Your rights may not apply in full if there is a legal basis for the processing of your personal data (for example, information collected as part of adverse event reporting cannot be erased unless it is incorrect).
There is no automated decision-making including profiling according to Art. 22 Para. 1 and 4 of the GDPR.
Furthermore, data subjects have the right to lodge a complaint with a supervisory authority.