NLBloodTissueSample object

Specific requirements

Yes

Applicable legal framework

Regarding clinical trials with cells tissues, considered as medicinal products, all legislation related to clinical trials with medicinal products applies.

Other applicable legislation:

• Royal decree 65/2006, regulating the import ad export process of biological samples.
• Royal decree 1301/2006, regulating the donation, management and therapeutic use of human cells and tissues (not considered as medicinal products)
• Law 14/2007 (Ley 14/2007 de Investigación Biomédica): regulates Biomedical Research and biological samples.
• Royal decree 178/2004 lays down the legal principles of the contained use, release and marketing of genetically modified organisms (GMO).
• Royal decree 664/1997 deals with the exposure to biological agents (including cell cultures used to amplify the gene therapy vectors).

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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