FDA - Spanish Agency of Medicines and Medical Devices Confidentiality Commitment, Additional Requirement
In the rare event that AEMPS needs to share information with its regional authorities related to FDA-provided non-public information in reliance on this confidentiality commitment, AEMPS will provide the information in general terms and redact for any non-public information. AEMPS will share the information with FDA first for concurrence before they share with the regional authorities.
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