Revision 2: Detailed guidance updated to acknowledge that COVID-19 related terms are made available from the updated MedDRA version 23.0 onwards and to notify the release of a COVID-19 SMQ with MedDRA version 23.1.
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 terms2 published by the MedDRA MSSO; and
• the introduction of COVID-19 related terms since the updated MedDRA version 23.0.
Organisations are reminded to comply with their legal obligations to report suspect adverse drug reactions in line with applicable legislation Articles 107 and 107a of Directive 2001/83/EC and to adhere to the guidelines in GVP Module VI3 , ICH E2B Guidelines4 and the current version of MedDRA term selection: Points to Consider. In particular:
• GVP Module VI Chapter VI. C.6.2.2. Preparation of individual case safety reports…