ISO ICSR/ICH E2B(R3), Dosage Forms & RoA Updates

EU Mandatory use of ISO ICSR/ICH E2B(R3) and EDQM terminology for Dosage Forms (DF) and Routes of Administration (RoA) in 6 days!!!

By June 30th, 2022 these messages need to use this new format and terminology, otherwise they risk rejection by EudraVigilance. This will apply to all submissions including initial, follow-ups, and nullifications.

Any issues with upgrading your safety systems?

We are pharmacovigilance architects ready to help.

Further information on the EMA website can be found here:

https://www.ema.europa.eu/en/documents/other/mandatory-use-iso-icsr/ich-e2br3-edqm-terminology-dosage-forms-df-routes-administration-roa_en.pdf

EU Mandatory Use of ISO ICSR/ICH E2B(R3) and More News!

Any issues with upgrading your safety systems?

We are pharmacovigilance architects ready to help.

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