For the application of the provisions of this chapter, samples taken in the context of biomedical research as defined in Article L. 1121-1 shall be regarded as samples taken for therapeutic purposes.
The authorisation to take tissue samples for therapeutic purposes from a deceased person is issued, suspended or withdrawn under the same conditions as those laid down in article R. 1233-2 and articles R. 1233-4 to R. 1233-6 and R. 1233-11.
To be authorised to take tissue samples for therapeutic purposes from a deceased person, health establishments must : 1° Demonstrate that their organisation and operating conditions are such that retrieval operations can be carried out satisfactorily; 2° Appoint a medical coordinator for the retrieval activity, after consultation with the establishment’s medical advisory body, and one or, where appropriate, hospital coordinators, nurses; the list of these persons is communicated to the…
Health establishments authorised to carry out tissue sampling shall take the necessary steps to ensure that all documents relating to the sampling referred to in the rules of good tissue sampling practice provided for in article L. 1245-6 are kept.
Each year, health establishments authorised to carry out tissue retrieval send the Director General of the Regional Health Agency and the Director General of the Biomedicine Agency the information required to assess their activity, in accordance with the procedures specified by order of the Minister for Health, issued after consultation with the Director General of the Biomedicine Agency.
The health establishments mentioned in the third paragraph of article L. 1233-1, which are not authorised to retrieve tissues, define the terms and conditions of their participation in a retrieval network by means of an agreement with the establishments authorised to carry out such retrievals. These agreements are forwarded to the Director General of the Agence de la biomédecine.
Inspections carried out in application of articles L. 1421-1 and L. 5313-1 in establishments authorised to retrieve tissues are carried out at least every two years.
The authorisation to take cell samples for therapeutic purposes is issued, suspended or withdrawn under the same conditions as those laid down in article R. 1233-2 and articles R. 1233-4 to R. 1233-6.
To be authorised to carry out cell harvesting for therapeutic purposes, applicant establishments must : 1° Demonstrate that they have an organisation and operating conditions that allow the satisfactory performance of harvesting operations in accordance with the rules of good cell harvesting practice provided for in Article L. 1245-6, and in particular an organisation that allows harvesting for autologous administration and harvesting for allogeneic administration to be carried out separately;…
When the staff of a blood transfusion establishment take blood cell samples in an establishment to make cell therapy preparations for therapeutic purposes, an agreement between the blood transfusion establishment and the health establishment lays down the conditions for carrying out this activity.
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call us at +33 (0) 1 84 88 31 00 or send us an email.
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
Resources
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
Useful links
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call +33 (0) 1 84 88 31 00 or send us an email.
All information exchanged through this website will be communicated to lawyers registered with a French Bar and will remain confidential.
