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European Database on Adverse Drug Reaction Reports

The changes in the pharmaceutical legislation of the European Union which came into force in the year 2012 provide among others for an improved access to information on risks associated with the use of medicinal products. In order to implement these regulations, a transitional phase was required to establish the technical prerequisites at the European Medicines Agency (EMA). This also included a database for the collection of suspected adverse drug reactions associated with the use of medicinal products ("EudraVigilance Database") together with the corresponding accessing options for interested parties.

This transitional phase has now been concluded. It is accompanied by a number of further legislative amendments that are dependent on the successful completion of these developments and which will come into force on 22 November 2017. These include the pharmaceutical industry's obligations to notify the EMA of suspected cases of adverse reactions.

In the light of this framework, the BfArM's publicly accessible database with suspected cases of adverse drug reactions, which until then had been provided on a national level, was an interim solution. This offer as well as the future access to the EudraVigilance Database will allow all interested parties an overview of the existing suspected cases of adverse drug reactions. Based on the legal changes as of 22 November 2017, the BfArM will henceforth only receive a small share of all suspected cases reported from Germany directly and will itself use the EudraVigilance Database for research purposes. In the future, all suspected cases of adverse drug reactions that occurred in Germany will be merged in the EudraVigilance Database. This database is accessible via the website and the extent of data collected exceeds the suspected cases reported from Germany. The user interface with advanced search options for different user groups will be available starting 22 November 2017. As a result of these developments, a publicly accessible database at a national level provided by the BfArM is no longer required and will therefore be discontinued.

Thus, on 22 November 2017, the national portal was closed and replaced by the information provided by the EMA.