The Spanish Agency of Medicines and Medical Devices (AEMPS) has announced an update to its instructions for reporting suspected counterfeit medicines. This update marks the end of the stabilization period in Spain, which will be on September 30, 2024.

From this date onwards, the supply and dispensing of any medicine that has not successfully undergone a verification and deactivation operation will not be allowed. Any alert generated in the system that cannot be dismissed as a suspicion of counterfeiting will prevent the distribution of the medicine, except for users connected through the SNSFarma node. For these users, an applicable date will be established once the stabilization of the generated alerts is achieved.

The end of the stabilization period could imply significant changes in the current operations for users regarding packages that eventually generate alerts. Therefore, it is recommended that all involved parties ensure that control software and scanners are properly configured, and everything functions correctly before the deadline.

This measure, framed in compliance with the Delegated Regulation (EU) 2016/161, aims to strengthen security in the medicine supply chain, ensuring that only authentic and safe products are dispensed.

SunSet Technologies has developed an application that verifies the dispensing of medicines in hospital and healthcare settings, ensuring compliance with the Spanish Medicines Verification System (SEVeM).

This application offers seamless integration thanks to its modular API, allowing any management system to connect without issues, effectively adapting to any technological infrastructure. Additionally, SunSet SEVeM features an intuitive interface that ensures accessibility for all users and complies with Delegated Regulation (EU) 2016/161.

For more information, contact SunSet Tecnologies.

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