Pharmacovigilance Privacy Statement

This notice provides you with information on how Baxter entity (hereinafter "Baxter", "we", "our", or "us") registered as the Marketing Authorisation Holder or its local representative for the concerned medicinal product and/or manufacturer, authorized representative in the EU, importer or distributor for the concerned medical device, together with its affiliates, successors, assignors and subcontractors as described in this Privacy Notice collects, stores, processes, uses and discloses your personal data.

Why we are collecting your personal data

Baxter will process your personal data for the purposes of monitoring of the safety and quality of the medicinal products and/or medical devices by collecting, detecting, assessing and preventing adverse events and medical incidents as well as quality complaints about those products.

Baxter will process your personal data on the following basis:

1. if you are reporter of the adverse event and/or medical incident or other type of complaint referring to the medical device and concerning other person – on the basis that this is necessary to comply with our legal obligations regarding the safety of medicinal products as well as because processing is necessary for reasons of public interest in the area of public health, such as ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy;
2. if you are a patient reporting the adverse event and/or medical incident or other type of complaint referring to the medical device – on the basis that it is necessary for reasons of public interest in the area of public health such as ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy.

The provision of your personal data is voluntary (unless you are a healthcare professional who is obliged to report adverse events or medical incidents), however if you do not provide your personal data we will not be able to address your query.

We will not use this information for any other purpose, and your personal data will not be shared with any other party unless we are legally obliged to do so (e.g. by regulatory authorities) or unless such third-party acts on behalf of Baxter as data processor.

How long we keep your personal data

Your personal data will only be kept for as long as we reasonably consider necessary for achieving the purposes set out above and as is required and/or permissible under applicable law.

With whom we may share your personal data and international data transfers

For the purposes outlined above, Baxter may transfer your personal data to other Baxter group companies and Baxter's service providers acting on behalf of Baxter, such as providers of IT system administration and user support services and providers of adverse events and/or quality assurance processing services.

Some of the third parties referred to above may process your personal data outside of your country. The level of data protection in another country may not be equivalent to that in your country. However, we only transfer your personal data either to countries where the EU Commission has decided that they have an adequate level of data protection, or we take measures to ensure that all recipients provide an adequate level of data protection. We do this, for example, by entering into appropriate data transfer agreements. You can request information about such third parties as well as access copies of the agreements which Baxter entered with them by writing to [email protected].

Your rights

You have the right to:

• check whether we hold personal data about you, and if so for what purposes and what kind of personal data we hold about you and to request copies of that data,
• request rectification or erasure of your personal data that is inaccurate or processed for purposes not stated above,
• request us to restrict the processing of your personal data,
• in certain circumstances, object to the processing of your personal data,
• request information on the identities or categories of third parties to which your personal data are transferred,
• lodge a complaint with the data protection authority in your country.

Data Controller

The controller responsible for processing your personal data is Baxter entity registered as the Marketing Authorisation Holder or its local representative for the concerned medicinal product and/or manufacturer, authorized representative in the EU, importer or distributor for the concerned medical device, indicated in the patient information leaflet and/or on the label or in the user manual of the medical device.

Please address your requests or questions concerning the processing of your personal data to: [email protected]