APPLICABLE REGULATIONS

 

Commission Directive 2004/23/CE  defining the standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

 

Commission Directive 2006/17/CE amending Directive 2004/23 / EC of the European Parliament and of the Council regarding certain technical requirements for the donation, procurement and testing of human tissues and cells.

 

Commission Directive 2006/86/CE  amending Directive 2004/23 / EC of the European Parliament and of the Council regarding traceability requirements, notification of serious adverse reactions and effects and certain technical requirements for coding, processing, preservation, storage and distribution of human tissues and cells.

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Commission Directive 2015/565/CE regards certain technical requirements for the coding of human tissues and cells.

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Commission Directive 2015/566/CE regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.