Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23... (32006L0086)
INHALT
Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council 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 (Text with EEA relevance)
- of 24 October 2006
- implementing Directive 2004/23/EC of the European Parliament and of the Council 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
- (Text with EEA relevance)
- Article 1
- Scope
- Article 2
- Definitions
- Article 3
- Requirements for the accreditation, designation, authorisation or licensing of tissue establishments
- Article 4
- Requirements for the accreditation, designation, authorisation, licensing of tissue and cell preparation processes
- Article 5
- Notification of serious adverse reactions
- Article 6
- Notification of serious adverse events
- Article 7
- Annual reports
- Article 8
- Communication of information between competent authorities and to the Commission
- Article 9
- Traceability
- Article 10
- European coding system
- Article 11
- Transposition
- Article 12
- Entry into force
- Article 13
- Addressees
- ANNEX I
- Requirements for accreditation, designation, authorisation or licensing of tissue establishments as referred to in Article 3
- A. ORGANISATION AND MANAGEMENT
- B. PERSONNEL
- C. EQUIPMENT AND MATERIALS
- D. FACILITIES/PREMISES
- E. DOCUMENTATION AND RECORDS
- F. QUALITY REVIEW
- ANNEX II
- Requirements for the authorisation of tissue and cell preparation processes at the tissue establishments as referred to in Article 4
- A. RECEPTION AT THE TISSUE ESTABLISHMENT
- B. PROCESSING
- C. STORAGE AND RELEASE OF PRODUCTS
- D. DISTRIBUTION AND RECALL
- E. FINAL LABELLING FOR DISTRIBUTION
- F. EXTERNAL LABELLING OF THE SHIPPING CONTAINER
- ANNEX III
- NOTIFICATION OF SERIOUS ADVERSE REACTIONS
- ANNEX IV
- NOTIFICATION OF SERIOUS ADVERSE EVENTS
- ANNEX V
- ANNUAL NOTIFICATION FORMAT
- ANNEX VI
- Information on the minimum donor/recipient data set to be kept as required in Article 9
- A. BY TISSUE ESTABLISHMENTS
- B. BY ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION
- ANNEX VII
- Information contained in the European Coding System
Feedback