EU Tissues and Cells Directives
E155010
The EU Tissues and Cells Directives are a set of European Union laws that harmonize standards for the donation, testing, processing, storage, and distribution of human tissues and cells to ensure high levels of quality and safety across member states.
All labels observed (5)
How this entity was disambiguated
This entity first appeared as the object of triple T1339573 — 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: EU Tissues and Cells Directives Context triple: [Human Tissue Authority, hasLegalBasis, EU Tissues and Cells Directives]
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A.
Human Tissue Authority
The Human Tissue Authority is a UK regulatory body responsible for licensing and overseeing the removal, storage, use, and disposal of human bodies, organs, and tissue for purposes such as research, transplantation, and education.
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B.
NHS Blood and Transplant
NHS Blood and Transplant is a UK special health authority responsible for providing a safe and reliable supply of blood, organs, and associated services to the National Health Service.
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C.
European Union medical device regulations
European Union medical device regulations are a comprehensive set of legal and technical requirements governing the safety, performance, quality management, and market approval of medical devices within EU member states.
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D.
Cambridge Blood and Stem Cell Biobank
The Cambridge Blood and Stem Cell Biobank is a major research facility that collects, processes, and stores human blood and stem cell samples to support biomedical and translational research.
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E.
Committee for Advanced Therapies
The Committee for Advanced Therapies is a scientific body within the European Medicines Agency responsible for evaluating and providing expert opinions on advanced therapy medicinal products such as gene, cell, and tissue-engineered therapies.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
Target entity: EU Tissues and Cells Directives Target entity description: The EU Tissues and Cells Directives are a set of European Union laws that harmonize standards for the donation, testing, processing, storage, and distribution of human tissues and cells to ensure high levels of quality and safety across member states.
-
A.
Human Tissue Authority
The Human Tissue Authority is a UK regulatory body responsible for licensing and overseeing the removal, storage, use, and disposal of human bodies, organs, and tissue for purposes such as research, transplantation, and education.
-
B.
NHS Blood and Transplant
NHS Blood and Transplant is a UK special health authority responsible for providing a safe and reliable supply of blood, organs, and associated services to the National Health Service.
-
C.
European Union medical device regulations
European Union medical device regulations are a comprehensive set of legal and technical requirements governing the safety, performance, quality management, and market approval of medical devices within EU member states.
-
D.
Cambridge Blood and Stem Cell Biobank
The Cambridge Blood and Stem Cell Biobank is a major research facility that collects, processes, and stores human blood and stem cell samples to support biomedical and translational research.
-
E.
Committee for Advanced Therapies
The Committee for Advanced Therapies is a scientific body within the European Medicines Agency responsible for evaluating and providing expert opinions on advanced therapy medicinal products such as gene, cell, and tissue-engineered therapies.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
EU health and safety legislation
ⓘ
European Commission directive ⓘ European Commission directive ⓘ European Union directive ⓘ European Union directive package ⓘ |
| adoptedOn |
2004-03-31
ⓘ
2006-02-08 ⓘ 2006-10-24 ⓘ |
| aimsTo |
ensure high level of quality of human tissues and cells
ⓘ
ensure high level of safety of human tissues and cells ⓘ |
| allow | Member States to maintain or introduce more stringent protective measures ⓘ |
| appliesTo |
Member States of the European Union
ⓘ
surface form:
European Union Member States
|
| covers |
notification of serious adverse reactions and events
ⓘ
technical requirements for coding of human tissues and cells ⓘ technical requirements for distribution of human tissues and cells ⓘ technical requirements for donation of human tissues and cells ⓘ technical requirements for preservation of human tissues and cells ⓘ technical requirements for processing of human tissues and cells ⓘ technical requirements for procurement of human tissues and cells ⓘ technical requirements for storage of human tissues and cells ⓘ technical requirements for testing of human tissues and cells ⓘ traceability requirements for human tissues and cells ⓘ |
| doNotApplyTo | research using human tissues and cells that are not intended for application to the human body ⓘ |
| enteredIntoForce | 2004-04-07 ⓘ |
| fullName |
EU Tissues and Cells Directives
self-linksurface differs
ⓘ
surface form:
Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
EU Tissues and Cells Directives self-linksurface differs ⓘ
surface form:
Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC as regards traceability requirements, notification of serious adverse reactions and events, and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
EU Tissues and Cells Directives self-linksurface differs ⓘ
surface form:
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
|
| geographicalScope | European Economic Area ⓘ |
| implements |
Directive 2004/23/EC
ⓘ
Directive 2004/23/EC ⓘ |
| includes |
Directive 2004/23/EC
ⓘ
Directive 2006/17/EC ⓘ Directive 2006/86/EC ⓘ |
| influenced | national legislation on tissues and cells in EU Member States ⓘ |
| legalBasis | Article 152 of the EC Treaty ⓘ |
| policyArea |
blood, tissues and cells regulation
ⓘ
public health ⓘ |
| regulates |
distribution of human tissues and cells
ⓘ
donation of human tissues and cells ⓘ preservation of human tissues and cells ⓘ processing of human tissues and cells ⓘ storage of human tissues and cells ⓘ testing of human tissues and cells ⓘ |
| require |
authorization of tissue establishments
ⓘ
quality management systems in tissue establishments ⓘ reporting of serious adverse reactions and events ⓘ traceability of tissues and cells from donor to recipient ⓘ |
| setsOut | general quality and safety standards for human tissues and cells ⓘ |
How these facts were elicited
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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: EU Tissues and Cells Directives Description of subject: The EU Tissues and Cells Directives are a set of European Union laws that harmonize standards for the donation, testing, processing, storage, and distribution of human tissues and cells to ensure high levels of quality and safety across member states.
Referenced by (5)
Full triples — surface form annotated when it differs from this entity's canonical label.