Agreement between AEMPS and the Valencian Community to report adverse drug reactions in the FEDRA database
17 Aug 2026Effective: 22 Jul 202670 views
Who is affected:
Valencian regional health authorities and healthcare professionals submitting reports
Summary
The AEMPS and the Generalitat Valenciana agree to connect their computer systems to automatically send notifications of suspected adverse drug reactions to the national FEDRA database.
Detailed analysis
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The agreement establishes technical integration between the Valencian Community's SIA-ABUCASIS system and the AEMPS FEDRA database through a secure REST API (HTTPS). The Generalitat commits to registering serious cases within a maximum of 10 calendar days and non-serious cases within 80 days from receipt. The system al…
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Resolución de 24 de julio de 2026, de la Agencia Española de Medicamentos y Productos Sanitarios, por el que se publica el Convenio con la Generalitat Valenciana, para el envío a la base de datos FEDRA de notificaciones de sospechas de reacciones adversas a medicamentos de uso humano.
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