Spontaneous Reporting in Germany

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Chapter: Pharmacovigilance: Spontaneous Reporting in Germany

Pharmacovigilance has now been established as a science that has some specific aspects.

Spontaneous Reporting in Germany


Pharmacovigilance has now been established as a science that has some specific aspects. On the one hand, it is a combination of research in basic life sciences, diagnostic procedures or biotechnological tools, clinical pharmacology and medical practice, biostatistics and epidemiology, and on the other hand, it includes development as well as implementation and use of procedures. This is well reflected in the World Health Organisation (WHO)1 definition of pharma-covigilance: The overall aim is to protect patients, or rather, users, taking medicinal products from harm. Activities in pharmacovigilance are not restricted to actual pharmacological treatments or diagnostic procedures but also have links to many areas in the overall healthcare systems established nationally, including communication.

Because pharmacovigilance has emerged as a science and its complexity – and uncertainties – have become more and more clear, much progress has been made to identify and describe the different fields and aspects in more detail and to further develop crite-ria and principles for activities in the field of pharma-covigilance. On the European Union (EU) level, this has resulted in a large body of regulations, directives, guidelines and many other documents setting stan-dards for pharmacovigilance practice. These rules have now been largely implemented into national legislation. Today, we are operating within a widely different pharmacovigilance system than 15 years ago. Nevertheless, there are, and will remain, differences in the national health and pharmacovigilance systems, and experiences from different countries should be shared to improve the system in general without neglecting national medical traditions.

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