Act No. 296/2008 Coll., on Provision of Quality and Safety of Human Tissues and Cells Designated for Use in Humans

Main information

Implemented directive

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/2008-296

Scope

For the distribution of human tissues and cells it is necessary to obtain a permit (LTB distribution shall be performed only by an entity with the permission of regulatory authorities of the Czech Republic), either as a tissue facility (Sec. 11 and Sec. 12 of Act No. 296/2008 Coll.) or as a distributor (Sec. 20a of the Act, Annex No. 9 to Decree No. 422/2008 Coll.) or, with the exception of the urgent need of the patient (Sec. 13 of Act No. 296/2008 Coll.).

Main requirements that the business user needs to know about

Any appplicant must fulfill followed requirements for obtaining the authorisation: (a) proof that it is a legal or entrepreneurial natural person; (b) procedures and conditions to ensure that the quality and safety of tissues and cells are maintained during distribution; (c) procedures and conditions for accurate, rapid and verifiable withdrawal of distributed tissues and cells from further use, (d) data and documentation documenting the applicant's assumptions in the distribution of tissues and cells to fulfill the obligations under this Act.

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