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Bioethics

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Both national and European legislation do not clearly define the use of genetic tests for commercial purposes. However Embiodiagnostic strictly conforms with the regulations of the National and European Legislation relating to the use of tissues, cells and genetic material and the related commercial law.Greek legislation on these issues has been harmonized with the European directives (for example EEL102/7.4.2004, EEL 38/9.2.2006 and EEL 294/25.10.2006)

In addition, Embiodiagnostics fully implements all the provisions of the “Authority for Personal Data Protection”. Authority's mission is the protection of individual rights and privacy of the individual in Greece, in accordance with the provisions of Law 2472/1997 and 3471/2006

 

Selected references

 EMEA / Committee for Medicinal Products for Human Use (CHMP)

http://www.emea.europa.eu/htms/general/contacts/CHMP/CHMP.html

EudraLex / The Rules Governing Medicinal Products in the European Union

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/index.htm

Tissue Rule

The tissues and cells directive (2004/23/EC)

Τhe Human Tissue Act (2004)

GCP Rules

The clinical trials directive (2001/20/EC、2005/28/EC)

UK Statutory Instrument 2004 No.1031(The Medicines for human use clinical trials regulations)

Authorization Rules

the medicinal products directive (2001/83/EC, 2003/63/EC)

the medical devices directive (93/42/EEC)

GMP Rules

GMP directives (2003/94/EC)

EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

The Code of Practice for the Production of Human-derived Therapeutic Products (MHRA, 2002)

Additional references

MHRA  http://www.mhra.gov.uk/index.htm

HTA (Human Tissue Authority) http://www.hta.gov.uk/

National Institute for Biological Standards and Control http://www.nibsc.ac.uk/

http://www.genewatch.org/sub-396520#External links

http://www.bioethics.gr/index.php/en/dikaio/nomothesia
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