Directive 2004/23/EC

E617257

EU legislative act European Union directive

Directive 2004/23/EC is a key European Union law that sets quality and safety standards for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells for medical use.

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All labels observed (1)

Label	Occurrences
Directive 2004/23/EC canonical	8

How this entity was disambiguated

This entity first appeared as the object of triple T6769627 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.

NED1 Entity disambiguation (via context triple) gpt-5-mini-2025-08-07

Target entity: Directive 2004/23/EC
Context triple: [EU Tissues and Cells Directives, includes, Directive 2004/23/EC]

A. Directive 2004/24/EC
Directive 2004/24/EC is a European Union law that created a simplified registration and regulatory framework for traditional herbal medicinal products across EU member states.
B. Directive 2003/41/EC
Directive 2003/41/EC was the original EU framework setting prudential and supervision rules for institutions for occupational retirement provision (IORPs) before being updated and replaced by the IORP II Directive.
C. Directive 2009/147/EC
Directive 2009/147/EC is a key European Union law on the conservation of wild birds, forming one of the main legal pillars of the Natura 2000 protected areas network.
D. Directive 2001/82/EC
Directive 2001/82/EC is a key European Union law that sets out the rules for the authorization, supervision, and pharmacovigilance of veterinary medicinal products across EU member states.
E. Directive 2001/83/EC
Directive 2001/83/EC is a key European Union law that sets the framework for the authorization, manufacture, distribution, and pharmacovigilance of medicinal products for human use across EU member states.
F. None of above. chosen
G. Unsure - the case is ambiguous/there is not enough information to decide.

NED2 Entity disambiguation (via description) gpt-5-mini-2025-08-07

Target entity: Directive 2004/23/EC
Target entity description: Directive 2004/23/EC is a key European Union law that sets quality and safety standards for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells for medical use.

A. Directive 2004/24/EC
Directive 2004/24/EC is a European Union law that created a simplified registration and regulatory framework for traditional herbal medicinal products across EU member states.
B. Directive 2003/41/EC
Directive 2003/41/EC was the original EU framework setting prudential and supervision rules for institutions for occupational retirement provision (IORPs) before being updated and replaced by the IORP II Directive.
C. Directive 2009/147/EC
Directive 2009/147/EC is a key European Union law on the conservation of wild birds, forming one of the main legal pillars of the Natura 2000 protected areas network.
D. Directive 2001/82/EC
Directive 2001/82/EC is a key European Union law that sets out the rules for the authorization, supervision, and pharmacovigilance of veterinary medicinal products across EU member states.
E. Directive 2001/83/EC
Directive 2001/83/EC is a key European Union law that sets the framework for the authorization, manufacture, distribution, and pharmacovigilance of medicinal products for human use across EU member states.
F. None of above. chosen

Statements (47)

Predicate	Object
instanceOf	EU legislative act ⓘ European Union directive ⓘ
adoptedBy	Council of the European Union ⓘ European Parliament ⓘ
aimsTo	ensure a high level of human health protection in the use of human tissues and cells ⓘ
appliesIn	EU Member States ⓘ linked to: Member States of the European Union
appliesTo	distribution of human tissues and cells ⓘ donation of human tissues and cells ⓘ preservation of human tissues and cells ⓘ processing of human tissues and cells ⓘ procurement of human tissues and cells ⓘ storage of human tissues and cells ⓘ testing of human tissues and cells ⓘ
basedOn	internal market and health protection objectives ⓘ
citationInOJ	Official Journal of the European Union L 102, 7.4.2004, p. 48–58 ⓘ linked to: Official Journal of the European Union
dateAdopted	2004-03-31 ⓘ
enteredIntoForce	2004-04-07 ⓘ
excludes	blood and blood products covered by other EU legislation ⓘ organs or parts of organs if their function is to be used for the same purpose as the entire organ in the human body ⓘ tissues and cells used as an autologous graft within the same surgical procedure ⓘ
fullName	Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells ⓘ linked to: EU Tissues and Cells Directives
implementedBy	Commission Directive 2006/17/EC ⓘ linked to: Directive 2006/17/EC Commission Directive 2006/86/EC ⓘ linked to: Directive 2006/86/EC
jurisdiction	European Union ⓘ
language	all official languages of the European Union ⓘ
legalBasis	Article 152 of the EC Treaty ⓘ
obliges	Member States to designate competent authorities for tissues and cells ⓘ Member States to ensure regular inspections of tissue establishments ⓘ Member States to establish systems for accreditation, designation, authorization or licensing of tissue establishments ⓘ
policyArea	human tissues and cells ⓘ public health ⓘ
purpose	to set standards of quality and safety for human tissues and cells intended for human application ⓘ
referredToAs	Tissues and Cells Directive 2004/23/EC ⓘ linked to: EU Tissues and Cells Directives
requires	authorization of tissue establishments ⓘ data protection and confidentiality of donor and recipient information ⓘ donor selection criteria and evaluation ⓘ informed consent of donors or their representatives ⓘ inspection and control measures for tissue establishments ⓘ traceability of human tissues and cells from donor to recipient and vice versa ⓘ vigilance and reporting of serious adverse events and reactions ⓘ
sets	minimum standards for quality management systems in tissue establishments ⓘ requirements for coding, processing, packaging and distribution of tissues and cells ⓘ requirements for import and export of human tissues and cells with third countries ⓘ
shortName	EU Tissues and Cells Directive ⓘ linked to: EU Tissues and Cells Directives
subjectMatter	quality and safety of human tissues and cells ⓘ
typeOfMeasure	harmonisation of minimum standards ⓘ
yearAdopted	2004 ⓘ