Data Protection Statement | aenova-group.com

This Data Protection Statement informs you about the policy of Aenova Holding GmbH with regard to your data. The Data Protection Statement is based on the terminology used by the European regulators upon the adoption of the General Data Protection Regulation (GDPR).

This Data Protection Statement concerns the collection, processing and use of personal as well as non-personal data. Personal data are information about a given or identifiable natural person relating to them personally or their circumstances. Non-personal data are data which cannot be associated with a given or identifiable person, e.g. data about general usage of the website.

 

Name and address of the data controller

The data controller is, within the meaning of the General Data Protection Regulation, other data protection laws applicable in the member states of the European Union and other provisions relating to data protection:

Aenova Holding GmbH
Berger Straße 8 – 10
82319 Starnberg (Percha),
Germany

 

Data Protection Officer

Aenova Holding GmbH has decided to assign the role of data protection officer externally to INTARGIA Managementberatung GmbH, Max-Planck-Straße 20, 63303 Dreieich.

 

Access data

It is generally possible to use this website without disclosing any personal data. When accessing a page of our website and whenever you request a file, access data regarding this process will be saved in a log file. The log file contains: the page from which the file was requested, the name of the file, the date and time of the request, the volume of data transferred, the access status (file transferred, file not found, etc.), a description of the type of operating system and web browser used. The data saved cannot be used to deduce your identity and is analysed exclusively for statistical purposes.

 

Cookies

This website uses cookies. Cookies are small text files that are saved on your device. Your browser accesses these files. The use of cookies enhances the user’s experience and safety on this website.

Most browsers offer an option not to accept cookies. Please note: you may not be able to access all the features of this website if you select these settings.

 

Our website uses the open source software Piwik to conduct statistical analyses of its use by users.

Piwik uses cookies for this purpose. These text files are saved on the user's computer so that his or her use of the website can be analysed. The information and data generated by cookies are stored on a server in Germany. The IP address is anonymised prior to storage. You can disable the use of cookies in your brower's settings. However, you may then no longer be able to use all the features of our website.

Data is not shared with third parties. Piwik uses user data in an anonymous form so that we can optimise our website and offering. IP addresses are saved by Piwik with the last several digits omitted. This enables us to determine which network a request came from. It is impossible to associate an IP address with a computer in this way.

By using our website, you confirm that you agree to the processing of data by Piwik within the scope described above and for the purposes specified above.

 

Handling of personal data

We collect, use and share your personal data only if this is legally permissible or you have consented to the processing of your data.

 

Handling of contact information

If you contact us using any of the contact options we offer, your information will be saved so that it can be referred to for the purpose of processing and answering your query. This information is not shared with third parties.

 

Rights of the user: Information, correction and deletion

As a user, you can, upon request, receive information, free of charge, as to what personal information has been stored concerning you. If your request does not contradict any statutory obligation to store data (e.g. data retention), you are entitled to the correction of incorrect data and the blocking or deletion of your personal data.

 

Data protection regarding job applications and the application process

The data controller collects and processes personal data from job seekers in order to carry out the application process. Processing may also be done electronically. This is especially the case when an applicant sends the requisite application documents to the data controller electronically, e.g. by email or via an online form on the website. If the data controller concludes an employment contract with an applicant, the data transferred will be stored for the purpose of the employment relationship in accordance with the statutory requirements. If no employment contract is concluded by the data controller with the applicant, the application documents will be deleted within the legally stipulated time frame.

 

Data economy

We store personal data in accordance with the principles of data avoidance and data economy only for as long as necessary or as required by the law (statutory retention period). If the purpose for the collected information ceases to exist or the retention period ends, we will block or delete the data.

 

Changes to the Data Protection Statement

Aenova Holding GmbH will revise and amend this Data Protection Statement from time to time. We therefore recommend that you read the rules of this Data Protection Statement from time to time to ensure that you know how Aenova Holding GmbH collects, processes and uses data.

 

Additional information

If you have any questions regarding our Data Protection Statement, please write to datenschutz@aenova-group.com. For general questions, please use the contact form on our website.

 

 

Data Protection Statement Pharmacovigilance

As a pharmaceutical company, Aenova has a legal responsibility to monitor the safety of all products worldwide that we develop, produce or market. With the following information, we would like to inform you which personal data we process in the context of so-called pharmacovigilance and for which purposes we use this data. The scope of this statement is limited to the collection and processing of your personal data for pharmacovigilance and/or medical information inquiries. For general information about data processing at Aenova please visit: https://www.aenova-group.com/en/node/1506

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.

 

Legal basis

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 DS-GVO, Art. 6 Para. 1 lit. c DS-GVO / Art. 6 Para. 1 lit. f DS-GVO in conjunction with Section 22 para. 1 lit. c BDSG).

 

Categories of personal data

We may need to process the following personal data (including collection, storage and further use, hereinafter together “process”):

 

About the patient affected by the event

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:

  • Name and/or initials of the patient,
  • Date of birth/age group, sex, weight, height
  • Information on health, racial or ethnic origin and sexual life
  • Medical history and state of health, including, but not limited to, for example:
    • Details of the product suspected of having caused the event, including the dosage you have been taken or were prescribed, the reason for taking or prescribing the product, and any subsequent changes to your usual medical therapy;
    • Details of any other medicines or medications you are taking or were taking at the time of the event, including the dosage you have been taking or were prescribed, the period you were taking the medicine, the reason for taking the medicine and any subsequent changes to your medical therapy,
    • Details of the event that you suffered, the treatment you received for that event, the potential long-term effects of the event on your health, and any other information about your medical history that the reporter considered relevant, including documents such as laboratory reports, medication history and patient history.

 

About the person reporting the event to us:

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:

  • Name,
  • Contact details (e.g. which may include, but not limited to, your address, e-mail address, telephone or fax number),
  • Profession (this information may determine the questions you are asked about the event, depending on the assumed level of your medical knowledge about the event), and
  • Relationship to the subject of the report.

 

Purposes of the processing

As part of meeting our pharmacovigilance obligations, we may process personal data in order to

  • investigate the event,
  • contact you to obtain further information about the event you reported,
  • compare the information on the event with information on other events reported to us and, on this basis, analyse the safety of a production batch, product or active substance as a whole, and
  • to provide mandatory reports to national and/or regional competent regulatory authorities to enable them to analyse the safety of a production batch, product, generic ingredient or active substance as a whole, together with reports from other sources. These reports contain details about the reported incident but will only contain limited personal data of the patient (note that the name of the patient will never be provided).

 

Transfer of personal data

As part of meeting our pharmacovigilance obligations, we may share and/or disclose personal data as follows:

  • within the Aenova group to analyse and process a reported event.
  • with the competent regulatory authorities, with regard to a suspected event.
  • with third-party service providers of the Aenova group. Appropriate data protection security measures are implemented at our service providers to whom we pass on personal data and who are providing services on our behalf.
  • with other pharmaceutical companies acting as co-marketers, co-distributors or other licensing partners, where the pharmacovigilance obligations for such a product require such exchange of safety information. Please note that also in this case appropriate data protection security measures are implemented at these business partners.
  • with legal successors if the company, a therapeutic area or a specific product is sold, assigned, transferred or taken over by a third party. In this case we will require this third party to process personal data only in accordance with the applicable data protection law.
  • if information about events is published (for example, in the form of case studies and summaries); in these cases, all identifiers are removed from publications to keep your identity private.

 

Third countries

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:

  • Subsidiaries of the Aenova Group which are established in a third country,
  • Distributors and, where appropriate, other companies (established in a third country) acting as co-marketers, co-distributors or other licensing partners, where the pharmacovigilance obligations for a product require such exchange of safety information.
  • Competent authorities.

 

Retention periods

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.

 

Your rights as data subjects

If we process personal data, the persons concerned are entitled to the following rights:

  • Art. 15 DS-GVO Right to information
    Right to information about your personal data stored by us.
  • Art. 16 DS-GVO Right of rectification
    Right to rectification of incorrect or incomplete personal data concerning you.
  • Art. 17 DS-GVO Right to deletion
    Deletion of your personal data unless there is a legal obligation to keep records.
  • Art. 18 DS-GVO Right to restrict processing
    If certain conditions are met, you have the right to have your personal data blocked and not processed further.
  • Art. 20 DS-GVO Right to data transferability
    The right to data transferability of personal data concerning you that you have provided to us.

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) DS-GVO.

Data subjects also have the right to file a complaint with a data protection authority.

 

Contact details of the data protection officer

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)
E-Mail: datenschutz@aenova-group.com