Last update: April 2021
- the personal data we collect, store, process, block and erase (collectively referred to as ‘processing’),
- what we use these data for,
- how you can object or withdraw your consent to the use of these data and
- the other rights you have as a data subject and how you can assert them.
1. Who is responsible for data processing and who can I contact?
The responsible body for data processing (data controller) in the sense given in the GDPR is:
92318 Neumarkt, Germany
Phone: +49 (0) 9181 231-90
Fax: +49 (0) 9181 231-265
Our company data protection officer can be reached via email at firstname.lastname@example.org or by post at the above address (please include the line ‘ATTENTION: Data Protection Officer’).
As parent company of the Bionorica group we pursuant of a consistent corporate controlling provide different services for our subsidiaries (e.g. cross-company IT-, communication- and database-systems, central HR or financial accounting services as similar activities at our headquarter in Neumarkt) and also process personal data in this context.
In terms of data protection law, this processing is carried out under the joint responsibility of Bionorica SE and the respective subsidiary in accordance with Art. 26 GDPR. The following key points apply to joint processing:
- Bionorica SE and the respective subsidiary are equally responsible for the legality of the joint processing and take appropriate technical and organizational measures so that the rights of the data subjects are guaranteed at all times.
- Bionorica SE undertakes to make the information required by Art. 13 and 14 GDPR also publicly available with regard to joint processing.
- In order to ensure adequate transparency and reliable assertion of data subject rights, all data subject rights during joint processing can always be asserted against Bionorica SE as the parent company.
- Bionorica SE and the respective subsidiary are equally responsible for the information obligations resulting from Art. 33, 34 GDPR towards the supervisory authority or those affected by a violation of the protection of personal data.
- Both parties are jointly liable for the damage caused by processing that does not comply with the GDPR in the external relationship together towards the data subject.
We would be happy to provide you with an extract from our "Agreement on the joint processing of personal data in accordance with Art. 26 GDPR". For this purpose, please also contact the above-mentioned contact.
2. Am I obligated to provide data?
3. Which sources and data does Bionorica SE use?
We only process personal data which we receive from you personally (e.g. when reporting adverse drug reactions (ADRs)). An exception are ADR reports which we receive from members of the professional circles (e.g. doctors and pharmacists) if you provide them with personal data and declared your consent to their transmission to us.
The personal data which we process include in particular:
- personal particulars (name, address and other contact data),
- data pertaining to medicinal product safety (e.g. health data and information about adverse drug reactions),
- other data comparable to the categories mentioned above.
4. Processing purposes and legal basis
We process personal data in accordance with the provisions of the European General Data Protection Regulation (EU GDPR) and the German Federal Data Protection Act (BDSG) according to the following legal bases:
4.1. Based on legitimate interests (Art. 6 para. 1 cl. 1 lit. f GDPR)
As far as necessary, we process personal data beyond the scope of performance of the contract for protecting our legitimate interests.
This particularly covers the following activities and processes:
- assertion of legal rights and defence in legal disputes,
- ensuring of IT security and safeguarding of IT operations in our company,
4.2. Based on your consent (Art. 6 para. 1 cl. 1 lit. a GDPR)
If you granted us or a member of the professional circles consent to process personal data for specific purposes (e.g. within the scope of reporting adverse drug reactions), this processing is lawful based on this consent.
After granting your consent, you can withdraw it at any time. This also applies to the withdrawal of declarations of consent given to us before the GDPR came into effect. Please note that withdrawal of your consent does not affect the lawfulness of processing carried out up to the time of withdrawal.
You can withdraw consent free of charge by sending a formless statement to the contact given in Section 1. If you withdraw your consent by telephone, we may ask you to provide additional proof of your identity in another way.
5. When is automated individual decision-making used?
We do not use any processes for automated decision-making.
6. Who gets my data?
Within Bionorica SE, those offices and departments requiring your data for the fulfilment of the task covered by your consent receive your data. Carefully selected and controlled service providers employed by us may also receive data for these purposes, but within the scope of so-called contract data processing they are obligated to meet the data protection requirements that are also applicable to us. For example, companies in the fields of IT services or telecommunications.
A transfer to recipients outside of Bionorica only takes place if there is a legal basis (e.g. consent).
7. Are data transferred to companies in third countries or to international organisations?
Data are only transferred to locations in countries outside the European Union (so-called third countries) if, in addition to general requirements for data transfer, there is also an adequacy decision (Art. 45 GDPR) or appropriate safeguards (Art. 46 GDPR) and, if necessary, additional measures are taken or the requirements of Art. 49 are fulfilled (for example, the corresponding consent).
8. How long are my data stored?
We process your personal data only as long as necessary to fulfill the processing purposes described above. Once the data are no longer needed for this purpose, they are erased unless their further processing is necessary – for a limited period – for the following purposes:
- fulfilment of legal retention obligations: Commission Implementing Regulation (EU) No 520/2012 should be mentioned. The retention and documentation periods prescribed there are at least ten years following the expiration of approval of the product concerned.
- preservation of evidence in the context of the statute of limitations. Pursuant to Sections 195ff. of the German Civil Code (BGB) these statutory limitation periods can be up to 30 years, whereby the normal limitation period is three years.
9. What rights do I have as a data subject?
As a data subject you have the right to access pursuant to Art. 15 GDPR, the right to rectification pursuant to Art. 16 GDPR, the right to erasure pursuant to Art. GDPR, the right to restriction of processing pursuant to Art. 18 GDPR and the right to data portability according to Art. 20 GDPR. With respect to the right to access and the right to erasure, the limitations set forth in Sections 34 and 35 BDSG apply. You also have the right to lodge a complaint with a responsible data protection supervisory authority (Art. 77 in conjunction with Section 19 BDSG).
You also have the right to object under Art. 21 GDPR. You can object to the processing of personal data on the basis of Art. 6 para. 1 lit. e or f GDPR at any time without giving reasons.