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Étiqueté : Personal data

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EMA – Publication of the Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)

This document gives general guidance to applicants/marketing authorisation holders (MAHs) on the retention/removal of personal data (PD) and identification of commercially confidential information (CCI) when drafting risk management plans (RMPs) in the pre-approval process, and...