Directive 2004/23/EC
E617257
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.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Directive 2004/23/EC canonical | 3 |
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.
Target entity: Directive 2004/23/EC Context triple: [EU Tissues and Cells Directives, includes, Directive 2004/23/EC]
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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.
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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setting prudential and supervision rules for institutions for occupational retirement provision (IORPs) before being updated and replaced by the IORP II Directive.
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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.
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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.
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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.
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
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| aimsTo | ensure a high level of human health protection in the use of human tissues and cells ⓘ |
| appliesIn | EU Member States NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| implementedBy |
Commission Directive 2006/17/EC
NERFINISHED
ⓘ
Commission Directive 2006/86/EC NERFINISHED ⓘ |
| jurisdiction | European Union ⓘ |
| language | all official languages of the European Union ⓘ |
| legalBasis | Article 152 of the EC Treaty NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| subjectMatter | quality and safety of human tissues and cells ⓘ |
| typeOfMeasure | harmonisation of minimum standards ⓘ |
| yearAdopted | 2004 ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Subject: Directive 2004/23/EC Description of subject: 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.
Referenced by (3)
Full triples — surface form annotated when it differs from this entity's canonical label.