Directive 2006/86/EC

E617258

EU secondary legislation European Union directive

Directive 2006/86/EC is a European Union legal act that sets detailed technical requirements for the traceability, notification of serious adverse reactions and events, and quality and safety standards for human tissues and cells used in medical treatments.

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All labels observed (3)

Label	Occurrences
Commission Directive 2006/86/EC	1
Commission Directive 2006/86/EC of 24 October 2006	1
Directive 2006/86/EC canonical	1

How this entity was disambiguated

This entity first appeared as the object of triple T6769629 — 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 2006/86/EC
Context triple: [EU Tissues and Cells Directives, includes, Directive 2006/86/EC]

A. 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.
B. 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.
C. Council Directive 2001/86/EC
Council Directive 2001/86/EC is a European Union legal act that supplements the Statute for a European Company (Societas Europaea) by establishing rules on employee involvement in such companies.
D. 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.
E. 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setting prudential and supervision rules for institutions for occupational retirement provision (IORPs) before being updated and replaced by the IORP II Directive.
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 2006/86/EC
Target entity description: Directive 2006/86/EC is a European Union legal act that sets detailed technical requirements for the traceability, notification of serious adverse reactions and events, and quality and safety standards for human tissues and cells used in medical treatments.

A. 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.
B. 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.
C. Council Directive 2001/86/EC
Council Directive 2001/86/EC is a European Union legal act that supplements the Statute for a European Company (Societas Europaea) by establishing rules on employee involvement in such companies.
D. 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.
E. 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.
F. None of above. chosen

Statements (49)

Predicate	Object
instanceOf	EU secondary legislation ⓘ European Union directive ⓘ
adoptedBy	European Commission ⓘ
aimsTo	ensure a high level of human health protection ⓘ ensure full traceability of tissues and cells from donor to recipient ⓘ ensure full traceability of tissues and cells from recipient to donor ⓘ harmonise technical requirements in the EU for tissues and cells ⓘ
appliesTo	Member States of the European Union ⓘ
basedOn	Article 152 of the EC Treaty (public health) ⓘ linked to: Article 152 of the EC Treaty
complements	Directive 2004/23/EC ⓘ
concerns	protection of donors of human tissues and cells ⓘ safety of recipients of human tissues and cells ⓘ
contains	requirements for documentation and data protection ⓘ requirements for inspection and control measures ⓘ requirements for notification of serious adverse events ⓘ requirements for notification of serious adverse reactions ⓘ requirements for quality management systems in tissue establishments ⓘ
dateAdopted	24 October 2006 ⓘ
enteredIntoForce	20 days after its publication in the Official Journal of the European Union ⓘ
fullTitle	Commission Directive 2006/86/EC of 24 October 2006 ⓘ linked to: Directive 2006/86/EC
geographicalScope	European Union ⓘ
implements	Directive 2004/23/EC ⓘ
languageOfTitle	English ⓘ
legalBasis	Directive 2004/23/EC ⓘ
partOf	European Union law ⓘ
policyArea	health and consumer protection ⓘ
publishedIn	Official Journal of the European Union ⓘ
regulates	coding and labelling of human tissues and cells ⓘ import and export of human tissues and cells ⓘ record-keeping for human tissues and cells ⓘ storage and distribution of human tissues and cells ⓘ tissue establishments ⓘ
requires	Member States to designate competent authorities for tissues and cells ⓘ linked to: EU Tissues and Cells Directives Member States to establish systems for traceability of tissues and cells ⓘ linked to: EU Tissues and Cells Directives maintenance of records for at least 30 years ⓘ reporting of serious adverse reactions and events to competent authorities ⓘ
sector	medical treatments ⓘ public health ⓘ
sets	standards for distribution conditions of tissues and cells ⓘ standards for documentation accompanying tissues and cells ⓘ standards for donor identification and coding ⓘ standards for labelling of tissues and cells ⓘ standards for storage conditions of tissues and cells ⓘ
subject	donation, procurement and testing of human tissues and cells ⓘ human tissues and cells ⓘ notification of serious adverse reactions and events ⓘ quality and safety of human tissues and cells ⓘ traceability of human tissues and cells ⓘ
typeOfMeasure	technical implementing directive ⓘ

How these facts were elicited

Referenced by (3)

Full triples — surface form annotated when it differs from this entity's canonical label.

EU Tissues and Cells Directives → includes → Directive 2006/86/EC ⓘ

Directive 2004/23/EC → implementedBy → Commission Directive 2006/86/EC ⓘ

linked to: Directive 2006/86/EC

Directive 2006/86/EC → fullTitle → Commission Directive 2006/86/EC of 24 October 2006 ⓘ