EU Standards for Human Substances (SoHO)

by name voted on 24.04.2024

Summary

A new EU regulation to standardize the quality and safety of human-origin substances like blood and tissues.

9 24.04.2024

Report

health

public safety

public sector

social policy

administrative law

public administration

Key points

Establishment of high-level safety and quality standards for all substances of human origin intended for medical use.
Protection of donors through the principle that donation must be voluntary and unpaid, preventing financial gain from the human body.
Creation of a SoHO Coordination Board to harmonize rules and oversight across all EU Member States.
Implementation of an EU-wide digital platform for data exchange, registration, and monitoring of supply shortages.

Vote

PPE

S&D

Renew

PfE

Verts/ALE

ECR

The Left

NI

ESN

Total

Speeches

29 Speeches in total

Pro

Contra

Nathalie COLIN-OESTERLÉ

Nathalie COLIN-OESTERLÉ

PPE

1:01 min

6.4. Standards of quality and safety for substances of human origin intended for human application ***I (vote)

Nathalie COLIN-OESTERLÉ

Nathalie COLIN-OESTERLÉ

PPE

0:23 min

6.4. Standards of quality and safety for substances of human origin intended for human application ***I (vote)

Documents (PDFs)

PROVISIONAL AGREEMENT RESULTING FROM INTERINSTITUTIONAL NEGOTIATIONS Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC DRAFT REPORT on the proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC REPORT on the proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC Standards of quality and safety for substances of human origin intended for human application Standards of quality and safety for substances of human origin intended for human application

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