Directive 2006/86/EC

E617258

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.

All labels observed (1)

Label Occurrences
Directive 2006/86/EC canonical 1

How this entity was disambiguated

Statements (49)

Predicate Object
instanceOf EU secondary legislation
European Union directive
adoptedBy European Commission NERFINISHED
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 NERFINISHED
basedOn Article 152 of the EC Treaty (public health) NERFINISHED
complements Directive 2004/23/EC NERFINISHED
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 NERFINISHED
geographicalScope European Union NERFINISHED
implements Directive 2004/23/EC NERFINISHED
languageOfTitle English
legalBasis Directive 2004/23/EC NERFINISHED
partOf European Union law
policyArea health and consumer protection
publishedIn Official Journal of the European Union NERFINISHED
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 NERFINISHED
Member States to establish systems for traceability of tissues and cells NERFINISHED
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 (1)

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

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