Guide to individual case safety reporting

26 June 2015

We have prepared a guide to companies on the electronic reporting of adverse drug reactions (ADR) to the Danish Health and Medicines Authority.

The guide is in English and is a Best Practice guide to the electronic reporting of Individual Case Safety Reports (ICSRs) to the Danish Health and Medicines Authority.

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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