Section 4: Declaration of the opening of the laboratory and changes to its operation

I.-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…

Within one month of receipt, the Regional Health Agency will send the person filing the declaration provided for in Article D. 6222-6 an acknowledgement of receipt. The application is deemed to be complete, with regard to I of article D. 6222-6 or, where applicable, II of the same article, if the Regional Health Agency does not notify the applicant, by the same deadline, of the list of missing documents. The…

I.- Opposition to the opening of a medical biology laboratory or a new site or to the transfer of an existing site, pursuant to Article L. 6222-2, and opposition to the operations referred to in Article L. 6222-3 , shall be notified by reasoned decision of the General Director of the Regional Health Agency concerned, by any means capable of conferring a date certain on such notification, no later than…

No later than two months before any change relating to the general organisation of the laboratory other than one of the site opening or transfer operations mentioned in the first paragraph of I and II of Article D. 6222-6 and any change in the biologist-in-charge or biologist-co-ordinator of the medical biology laboratory mentioned in Articles L. 6213-7 to L. 6213-10, the legal representative of the laboratory shall send the declaration…

As soon as it is received, the laboratory’s legal representative shall forward to the regional health agency or agencies concerned the provisional attestation of satisfaction of the accreditation criteria referred to in the second paragraph of I of Article L. 6221-2, without which no medical biology laboratory may open to carry out examinations. The Regional Health Agency shall acknowledge receipt of this declaration within one month of receipt.