French Public Health Code
In forceI.-No later than eight months before the planned date of opening of the medical biology laboratory, the legal representative of the laboratory shall send the declaration provided for in the first paragraph of Article L. 6222-1, by any means that can be reliably dated, to the regional health agency or agencies concerned with the creation of the laboratory or site.
This declaration includes the following documents or information
1° Identification of the health establishment or legal structure referred to in Articles L. 6223-1 and L. 6223-2 which is opening the laboratory or site concerned, and the memorandum of association of this structure;
2° The address of the site or sites concerned by the opening;
3° A description and plan of the laboratory and, where applicable, its sites;
4° The planned opening date of the laboratory or site;
5° Identification of the biologist-in-charge provided for in Article L. 6213-7 and, where applicable, identification of the biologist(s) in charge provided for in Article L. 6213-9 ;
6° Identification of the medical biologists;
7° The projected volume of activity for the first three years of operation of the laboratory, estimated in accordance with the provisions of Articles D. 6211-13 and D. 6211-14 ;
8° Where applicable, a copy of the cooperation agreement(s) provided for in Article L. 6212-6, entered into by the laboratory;
9° For laboratories operating in the form of a health cooperation group, a copy of the constituent agreement;
10° For private laboratories operating in the form of an association or foundation:
a) A copy of the internal regulations ;
b) A list of the members of the board of directors;
11° For private laboratories operating in the form of a company, the documents and information provided for in Article R. 6223-3.
II - Before any changes are made to the legal and financial structure of the medical biology laboratory and before the operations referred to in Article L. 6222-3 and Article L. 6223-4, the laboratory's legal representative shall send the declaration provided for in the last paragraph of Article L. 6222-1 to the Regional Health Agency, by any means that can be reliably dated.
This declaration includes only the elements mentioned in I affected by the change and, where applicable :
1° The proposed acquisition of shares and the distribution of capital resulting from the operation ;
2° The proposed acquisition of a medical biology laboratory, a laboratory site or all or part of the assets of a company operating a laboratory;
3° The proposed merger or universal transfer of assets;
4° A copy of the Commercial Court order appointing the merger commissioner.
