European Parliament approved the new Regulation on standards of quality and safety for substances of human origin intended for human application and the abrogation of the 2002/98/EC and 2004/23/EC directives
The next steps
The new SoHO regulation was formally adopted by the Council of the European Union and will become operational from 2027, three years after its publication and entry into force, with the sole exception of some provisions whose application requires an additional year.
The objectives
The new legislation provides for greater protection of recipients and donors of substances of human origin, as well as children born through medically assisted procreation.
The new regulatory framework provides:
- Clear rules covering all substances of human origin except solid organs, such as fecal microbiota and human breast milk;
- Accreditation of all entities carrying out activities that could affect the quality and safety of SoHO
- Greater innovation, with a common procedure to evaluate and authorize the preparation of SoHOs, proportionate to the risks they entail;
- Strengthening national control and EU support to national authorities (in fields such as training and IT);
- New measures to support continuity of supply that will help Member States take action when the supply of critical SoHO is at risk;
- A SoHO Coordination Board (SCB) will be established, with the help and to help the Member States. It will support the implementation of the new regulation and provide clarifications on legal matters;
- Finally, the EU SoHO digital platform will be created, to collect all the necessary information, simplify reporting and increase visibility for citizens.
For information see:
The press release from the Health and Food Safety DG of the European Commission
The text of the new regulation
Factsheet
Questions&Answers