Directive 2015/565 - Amendment of Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells - Main contents
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official title
Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells Text with EEA relevance| Legal instrument | Directive |
|---|---|
| Number legal act | Directive 2015/565 |
| CELEX number i | 32015L0565 |
| Document | 08-04-2015 |
|---|---|
| Publication in Official Journal | 09-04-2015; OJ L 93 p. 43-55 |
| Effect | 29-04-2015; Entry into force Date pub. +20 See Art 3 |
| End of validity | 31-12-9999 |
| Transposition | 29-10-2016; At the latest See Art 2 |
9.4.2015 |
EN |
Official Journal of the European Union |
L 93/43 |
COMMISSION DIRECTIVE (EU) 2015/565
of 8 April 2015
amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 (1) on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, and in particular Article 28 thereof,
Whereas:
(1) |
Directive 2004/23/EC requires that Member States ensure the traceability of human tissues and cells from the donor to the recipient and vice versa. |
(2) |
In order to facilitate traceability it is necessary to establish a unique identifier applied to tissues and cells distributed in the Union (Single European Code) providing information on the main characteristics and properties of those tissues and cells. |
(3) |
In order to ensure a uniform implementation of the Single European Code throughout the Union, obligations of the Member States competent authorities and of the tissue establishments for the application of the Single European Code should be set out. Only this approach will guarantee a consistent and coherent application of the code in the Union. |
(4) |
Traceability from donor to recipient and vice versa should be ensured through coding of tissues and cells and through accompanying documentation. At the recipient end, the Single European Code provides information on the donation and on the tissue establishment responsible for the procurement of tissues and cells. At the donor end, the tissue establishment responsible for the procurement of tissues and cells may track the tissues and cells distributed for human application by requesting the next operators in the chain to provide data related to the use of the tissues and cells based on the donation identification elements of the Single European Code as contained in the accompanying documentation. |
(5) |
The format of the Single European Code should be harmonised in order to facilitate its application by small and large establishments, whilst allowing some flexibility for establishments to continue using existing codes. |
(6) |
A Single European Code allowing for donation and product identification should be allocated to all tissues and cells distributed for human application, including those imported from third countries. Member States may allow certain exemptions from the application of the code. |
(7) |
Where tissues and cells are excluded or exempted from the application of the Single European Code, the Member States should ensure that appropriate traceability of these tissues and cells is guaranteed throughout the entire chain from donation and procurement to human application. |
(8) |
In situations where tissues and cells are released for circulation, other than for distribution (such as transfer to another operator for further processing with or without return), as a minimum the donation identification sequence should be applied at least in the accompanying documentation. Where tissues and cells are transferred from a tissue establishment to another operator just for storage and/or for further distribution, the tissue establishment may already apply the Single European Code on their final label in addition to the donation identification sequence which should be applied at least in the accompanying documentation. |
(9) |
In the case of tissues and cells retrieved from a deceased donor by procurement teams operating for two or more tissue establishments, Member States shall ensure... |
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