Pharmacovigilance Privacy Statement

This notice provides you with information about how Baxter RCS collects, stores, processes, uses and discloses your personal information for adverse event reporting.

In this notice we provide you with information about how the Baxter RCS entity (hereinafter, "Baxter RCS," "we," "our," "our(s)," or "us"), registered as the Marketing Authorization Holder for the subject medicinal product, together with its affiliates, successors, assigns and subcontractors, as described in this Privacy Notice, collects, stores, processes, uses and discloses your Personal Data.

Baxter RCS will process your Personal Data for the purposes of monitoring the safety of medicinal products by collecting, detecting, evaluating and preventing adverse events.

Baxter RCS will process your Personal Data according to the following criteria:

1. If you report the adverse event that affected another person, on the basis that it is necessary to comply with our legal obligations regarding the safety of medicinal products.
2. If you are a patient reporting an adverse event, on the basis that it is necessary for reasons of public interest in the area of public health.

Providing your personal data is voluntary (unless you are a healthcare professional who is required to report adverse events); however, if you do not provide us with your personal data, we will not be able to address your inquiry.

We will not use this information for any other purpose and your Personal Data will not be shared with any other person unless we are required by law to do so (e.g., by regulatory authorities) or unless that third party is acting on behalf of Baxter RCS as a data processor.

Your personal data will only be retained for as long as we deem reasonably necessary to achieve the purposes set out above and as required and/or permitted by applicable law.

With Whom We May Share Your Personal Data and International Data Transfers

For the purposes specified above, Baxter RCS may transfer your Personal Data to other Baxter RCS group companies and service providers acting on behalf of Baxter RCS, such as IT system administration providers, user support services and adverse event processing service providers.

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 the level in your country. However, we only transfer your personal data to countries where the European 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. To this end, for example, we enter into appropriate data transfer agreements. To request information about these third parties and to access copies of the agreements Baxter RCS has signed with them, please write to [email protected].

You have the right to:

• Verify whether we hold personal data about you, and if so, for what purposes and what type of personal data we hold about you, and to request copies of that information.
• Request rectification or erasure of your personal data which is inaccurate or which is processed for purposes other than those mentioned above.
• Ask us to restrict the processing of your personal data..
• In certain circumstances, object to the processing of your personal data.
• Request information about the identities or categories of third parties to whom your personal data is transferred.
• File a complaint with the data protection authority in your country.

The controller responsible for processing your personal data is the entity registered as the Marketing Authorization Holder for the medicinal product in question, as indicated in the patient information leaflet.

Please direct any questions regarding the processing of our personal data to Baxter RCS International Inc. or send an e-mail to [email protected]