of February 29, 2024 No. 42
About biological bank of the person
The Parliament adopts this organic law.
This law shifts:
a) Items (a), (c), (g), (j) and (k) of Article 3, parts (1) and (2) Articles 4, Article 7, parts (2) and (4) Articles 8, Article 17, Article 18, Article 22-24 and part (1) Article 25 of the Directive 2004/23/EC of the Commission of October 24, 2006 about enforcement of the Directive 2004/23/EC of the European parliament and Council on requirements to traceability, the notification on serious undesirable reactions and the phenomena, and also about certain technical requirements to coding, processing, preservation, storage and distribution of fabrics and cells of the person (the text concerning EEP), with the last changes made by Regulations (EU) No. 596/2009 of the European parliament and Council of June 18, 2009;
b) Items (a) and (g) of Article 2 and appendix I to the Directive 2006/86/EC of the Commission of October 24, 2006 about enforcement of the Directive 2004/23/EC of the European parliament and Council regarding requirements to traceability, the notification on serious undesirable reactions and the phenomena, and also about certain technical requirements to coding, processing, preservation, storage and distribution of fabrics and cells of the person (the text concerning EEP), with the last changes made by the Directive (EU) 2015/565 Commissions of April 8, 2015.
(1) This law establishes the legal base of regulation of creation and maintenance of activities of biological bank of the person (further – biobank) provided by organized collections of biosamples/selections of biosamples of the person and the related data and is applied to their donorship, withdrawal, control, processing, preservation, storage, distribution and destruction.
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