This detailed guidance document provides recommendations relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection, taking into account the Notice to stakeholders published by the European Commission, the guidance regarding COVID-19 related terms published by the MedDRA MSSO and the implementation on 04 May 2020 of the updated MedDRA 23.0 containing additional COVID-19 related terms.
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