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.

Back to Confidentiality Commitments:

• FDA – Spanish Agency of Medicines and Medical Devices, Confidentiality Commitment
• Spanish Agency of Medicines and Medical Devices – FDA, Confidentiality Commitment