The EMA Management Board announced in December 2019 that ISO standard for Individual Case Safety Reports (ICSRs) (ISO 27953-2:2011), and the ISO terminology on pharmaceutical dose forms and routes of administration maintained by EDQM (ISO 11239:2012), should be implemented by all the stakeholders by 30th June 2022 in relation to reporting obligations to EudraVigilance (pre-and post-authorisation) (see our News of 17/01/2020 and our News of 16/04/2021).
As a consequence of the mandatory use of the ISO ICSR standard (ISO 27953-2:2011) …
