Guide to individual case safety reporting

26 June 2015

We have prepared a guide to pharmaceutical companies about the exchange of individual case safety reports to and from the Danish Health Authority.

The guide is in English and includes recommendations and examples of good practice as well as technical and legal requirements.

The purpose of the guide is to ensure a continued high quality and consistency in the electronic reporting of ICSRs from pharmaceutical companies.

Link

Guide to individual case safety reporting

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