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Article R6222-5 of the French Public Health Code

I.-When one or more medical biology laboratory sites created before the revision of the regional health plan or before the change in the delimitation of the zones defined in b of 2° of Article L. 1434-9 no longer meet the location conditions set by Article L. 6222-5 or to the forecasts for the location of sites indicated by the regional health plan in application of 4° of I of Article…

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Article D6222-6 of the French Public Health Code

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…

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Article D6222-7 of the French Public Health Code

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…

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Article R6222-8 of the French Public Health Code

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…

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Article D6222-9 of the French Public Health Code

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…

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Article R6222-10 of the French Public Health Code

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.

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Article D6222-11 of the French Public Health Code

I.-When, in application of the provisions of the first paragraph of article L. 6222-4 and without prejudice to the application of the provisions of article D. 6222-6 relating to the opening of laboratories and their sites, the public health establishments of the Assistance publique-hôpitaux de Paris, the hospices civils de Lyon and the Assistance publique-hôpitaux de Marseille intend to operate more than one medical biology laboratory, the general director of…

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Article R6223-2 of the French Public Health Code

A company operating a medical biology laboratory is formed under the suspensive condition of its registration on the roll of the Order of Physicians, where at least one medical biologist holds a fraction of the share capital, and on the roll of the Order of Pharmacists, where at least one pharmacist biologist holds a fraction of the share capital.

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Article R6223-3 of the French Public Health Code

The application for registration shall be sent by a joint representative appointed, in the articles of association or in a separate deed, by the members of the company, to the Council of the Association, referred to in article R. 6223-2, in whose area of jurisdiction the company’s registered office is located, by any means that provides proof of the date of receipt. It must be accompanied by the following documents:…

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