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

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

Referenced by (5)

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

Human Tissue Authority hasLegalBasis EU Tissues and Cells Directives
EU Tissues and Cells Directives fullName EU Tissues and Cells Directives self-linksurface differs
subject surface form: Directive 2004/23/EC
this entity 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
EU Tissues and Cells Directives fullName EU Tissues and Cells Directives self-linksurface differs
subject surface form: Directive 2006/17/EC
this entity 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 fullName EU Tissues and Cells Directives self-linksurface differs
subject surface form: Directive 2006/86/EC
this entity 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 Organ Donation Directive relatedTo EU Tissues and Cells Directives
this entity surface form: Directive 2004/23/EC on human tissues and cells