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Standards of Quality and Safety for Substances of Human Origin Intended for Human Application
The European Data Protection Supervisor (‘EDPS’) has recently released the Opinion on the Proposal for a Regulation 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.
Accordingly this Opinion;
On 14 July 2022, the European Commission issued a 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/EC2
(‘the Proposal’). The Proposal includes measures that aim to:
- ensure safety and quality for patients treated with Substances of Human Origin (‘SoHO’) therapies and fully protect them from avoidable risks linked to SoHOs;
- ensure safety and quality for SoHO donors and for children born from donated eggs, sperm, or embryos;
- strengthen and allow for harmonization of oversight practices among the Member States;
- facilitate the development of safe and effective innovative SoHO therapies;
- improve the resilience of the sector, mitigating the risk of shortages.
The present Opinion of the EDPS is issued in response to a consultation by the European Commission on 14 July 2022, pursuant to Article 42(1) EUDPR. The EDPS welcomes the reference to this consultation in Recital 51 of the Proposal. In this regard, the EDPS also positively notes that he was already previously informally consulted pursuant to recital 60 of EUDPR.
You can reach further information here.
Kind regards,
Zumbul Attorneys at Law