Tag: EMA guidance
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EMA detailed guidelines on validity and coding of ICSR in context of COVID 19
On 30-October-2020, EMA had released detailed guidance on ICSRs in the context of COVID 19 – validity and coding of ICSRs. 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:…