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

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

Referenced by (3)

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

EU Tissues and Cells Directives includes Directive 2004/23/EC
EU Tissues and Cells Directives implements Directive 2004/23/EC
subject surface form: Directive 2006/17/EC
EU Tissues and Cells Directives implements Directive 2004/23/EC
subject surface form: Directive 2006/86/EC