Decree No. 422/2008 Coll., on Detailed Requirements for the Safeguarding of the Quality and Safety of Human Tissues and Cells Intended for Use in Man, Annex No. 4

Main information

Contact details of the competent authorities and authorities responsible for supervising the implementation

Directive 2004/23/EC of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
Commission Directive 2006/17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
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
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
Directive (EU) 2015/566, of 8 April 2015. implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells

Law type

Specific national requirements (relating to non-harmonised aspects, or administrative procedures, where applicable), e.g. any language requirements or additional requirements relating to putting into service, installation or use

Direct link to rule

https://www.zakonyprolidi.cz/cs/2008-422

Scope

screening of human tissue and cell donors

Main requirements that the business user needs to know about

p24 antigen testing is required for HIV screening