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- Samples from Humans and/or Derivatives
Authorisation must be sought from the French Research Ministry to import and export human organs, cell tissues and their derivatives which are to be used for scientific purposes. The form is in French because it should be presented to French customs on request, but the sections which must be filled in by the Scientists have been translated into English (in blue). This regulation is related to Bioethics.
N.B. This dossier must be submitted, by the ESRF, to the Research Ministry at least 2 months before the experiment is due to take place at the ESRF.
This dossier must include :
It is recommended:
once completed and the green light given
The regulation also applies for commercial human cell lines. The supplier certificate should be send to the Safety Group before completing the dossier. ECACC has agreed to provide a testimony about Bioethical procedures for their cell lines. The ESRF Safety Officer will add this document to your dossier.
For other suppliers and cell collections bank, either you can get such document directly from the supplier administrative offices or you have to provide their commercial agreement number to supply Human cell lines on the French territory (BRN number).
Do not hesitate to contact the Biosafety officer rapidly to complete the Human Sample dossier and to get help if needed.
Several regulation textes came out in 2007 (décret 2007-1220 du 10 août 2007, chapter II) requesting that each French institute declare to the French Ministry of Research all human samples and or derivatives stored on their premises. Such a declaration, once completed on their specific website, provides a number such as …DC-200X-YZ. Please refer to this link (in French) for more details. This Declaration de Conservation number will be requested by the Safety Group in advance, with details about number of samples, nature, type and conditionning, before granting access to the beamlines.
Do not hesitate to contact the Biosafety officer rapidly for more details and to get help if needed.
Several regulation texts have been published in France for human samples and derivatives. These texts, in French, are all entered in a database from the link as follow:
http://www.legifrance.gouv.fr/
or can be viewed from the list below: