Pharmacovigilance and Adverse Event Reports
If you receive reports regarding adverse events, or concerning the safety and quality of a Bayer product, it is important to deal with them promptly and correctly. In many cases the relevant company, division or business unit will have standard operation procedures for the handling of such messages. Please note that such procedures apply not only to the directly related websites but to all Bayer websites which can be viewed by the general public.
Any relevant e-mails must immediately be forwarded to the local pharmacovigilance contact.
For Bayer Phamaceuticals and Consumer Health medicinal products for human use, such messages must be passed on to the department responsible within 24 hours of receipt. Please refer to the Bayer policy Product Safety and Quality: Reporting Obligations of Employees (available only on the Bayer intranet), chapters 2 and 3 for further information. In every case contact your local pharmacovigilance department to ensure that requirements described in the regulation are adequately covered on your website.
In addition, we recommend that as long as this complies with the law in their country, all Bayer websites add the following disclaimer, translated and adjusted as necessary, to the contact form. Please discuss any changes with your local pharmacovigilance officer.
Humans
vary in their biological reactions to medicinal products. This is why not all adverse reactions (side effects) associated with the use of medicinal products can be detected during clinical development, not even by the most comprehensive clinical trials. Capturing as many of these adverse reactions, however rare they may be in absolute terms, from worldwide sources is of paramount importance for continued patient and drug safety (pharmacovigilance).
For Bayer as a global pharmaceutical company, pharmacovigilance takes center stage, beyond mere compliance with worldwide regulations. To enable Bayer to provide up-to date safety information on Bayer products, your support is pivotal, whether you are a customer, patient or healthcare professional.
If you want to report a side effect or quality complaint, please contact your healthcare professional (e.g., physician or pharmacist) or your local health authority.
Reports can also be made on our Side Effect Reporting website.
Menschen reagieren unterschiedlich auf Medikamente und deren Wirkstoffe. Deswegen können nicht alle mögliche Nebenwirkungen eines Produktes während der Entwicklung, nicht mal in den umfassendsten klinischen Studien, festgestellt werden. Für die Patienten- und Medikamentensicherheit (Pharmakovigilanz) ist es jedoch von höchster Bedeutung, Nebenwirkungen aller Art zu erfassen, unabhängig davon wie oft diese in absoluten Zahlen vorkommen können.
Für Bayer als global tätiges Pharma-Unternehmen ist die Patienten – und Medikamentensicherheit von herausragender Bedeutung und geht weit über die einfache Einhaltung weltweiter Vorgaben hinaus. Damit Bayer aktuelle Informationen über die Sicherheit seiner Produkte bereitstellen kann, ist Ihre Unterstützung unerlässlich, egal ob Sie Kunde, Patient oder im Gesundheitsbereich tätig sind.
Wenn Sie Nebenwirkungen oder Qualitätsbeanstandungen melden wollen, wenden Sie sich bitte an Ihren Arzt oder Apotheker, die örtliche Gesundheitsbehörde oder nutzen Sie unsere Website zur Meldung von Nebenwirkungen.