Updated Detailed Guidance on ICSRs in the Context of COVID-19: Validity and Coding of ICSRs

On 4 May 2020 the EMA updated the detailed guidance on ICSRs with additional COVID-19 related terms.

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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