Privacy Statement for Pharmacovigilance Data
Bayer takes product safety and your privacy seriously. Bayer Middle East FZE, Dubai, U.A.E (hereinafter “Bayer”, “us”, “our” and “we”) develops and markets prescription and over the counter medicines as well as medical devices and cosmetics, for human use (“Bayer Health Products”). The safety of all Bayer Health Products worldwide that are in development or are marketed in any country has to be monitored.
Humans and animals vary in their biological reactions to medicinal products or medical devices and not all adverse reactions or events (side effects) associated with the use of medicinal products and medical devices can be detected during clinical development, not even by the most comprehensive clinical trials. Capturing adverse events, however rare they may be in absolute terms, in the development and marketing phase from worldwide sources is of paramount importance.
Such monitoring of adverse events is called Pharmacovigilance (“PV”). PV requirements exist to allow us and competent regulatory authorities (such as the European Medicines Agency and other authorities) to manage adverse events and to protect public health and ensure high standards of quality and the safety of Bayer Health Products.
Our Pharmacovigilance obligations require us to process certain information, which allow to directly or indirectly identify a person, (“Personal Data”) of a patient and/or the reporter of an adverse event that we receive in order to comply with strict obligations to perform benefit-/risk assessments of Bayer Health Products continuously and report suspected adverse reactions or events to relevant regulatory authorities.
This Pharmacovigilance Privacy Statement (“Statement”) provides important information to you about how we process Personal Data for PV purposes, in line with our obligations under applicable data privacy laws and in particular the EU General Data Protection Regulation ((EU) 2016/679) (“GDPR”).
All Personal Data is processed exclusively for PV purposes and only where relevant and appropriate to document, assess and report your adverse event properly in accordance with our Pharmacovigilance obligations.
If you have any questions about this Statement or about how we use your Personal Data, please contact us via our contact details at the end of this Statement.