Regulation from Denmark
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Overview
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Theory (updated on 2009-07-31)
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- Danish Tissue Act, N°273 of 1st April 2006
- Act on a Biomedical Research Ethics Committee System and the Processing of Biomedical Research Projects n. 402 of 28 May 2003
“The purpose of this Act is to lay down the legal framework for the scientific ethical evaluation of biomedical research projects.”
“Biomedical research projects” shall mean a project that involves trials on liveborn human individuals, human germ cells intended to be used in fertilization, human fertilized eggs, embryos and foetuses, tissue, cells and genetic material from humans, foetuses and the like or deceased individuals. In addition, such projects shall also include any trial intended to discover or verify the clinical, pharmacological or other pharmacodynamic effects, identify any adverse reactions or study pharmacokinetics (absorption, distribution, metabolism and excretion) with the object of ascertaining the safety or efficacy of medicinal products.”
Practice to export
The Danish rules to export
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Issues
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