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EBA response to the SoHO regulation proposal

September 9, 2022

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On 14 July the European Commission published its proposal for a SoHO regulation. EBA welcomes the general direction and ambition of the proposal but stresses that certain elements of the proposal can still be improved.

The current directives served European citizens well for the past 20 years, setting an important and solid foundation for the implementation of standardised methods and practices to achieve high quality and safety of Substances of Human Origin. The proposed regulation offers a framework that is flexible enough to adapt to new scientific evidence and trends and better equipped to deal with crisis, while continuing to impose appropriate safety and quality requirements.

EBA now calls on European legislators to listen to blood establishments as they consider changes to the proposal in the negotiating process ahead.

You can find EBA’s response here.

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