Article D6221-40 of the French Public Health Code
October 30, 2023
Renewal applications follow the same procedure as initial applications.
Renewal applications follow the same procedure as initial applications.
The head of the laboratory holding the authorisation is required to declare without delay to the Minister responsible for health any change relating to the legal rules and technical operating standards of the laboratory included in the authorisation application file.
Where it is established that the operating conditions of the laboratory holding the authorisation are not or are no longer equivalent to those imposed, under the first paragraph of Article 7 of Order no. 2010-49 of 13 January 2010 as amended relating to medical biology, on medical biology laboratories established on French territory, the authorisation shall be suspended or withdrawn by the Minister responsible for health. However, the authorisation may…
The experts mentioned in articles D. 6221-30 and D. 6221-37 are appointed by order of the Minister for Health.
The biological samples sent by the medical biology laboratory established in France requesting the analytical phase must be subject to a monitoring procedure to establish the conformity of the biological samples accepted by the laboratory carrying out the analytical phase, their identification, the maintenance of their integrity and their traceability.
The Minister for Health shall maintain and make available to the public a register of laboratories that have made the declaration provided for in the second paragraph of Article L. 6211-2-1 as it stood prior to the entry into force of Order no. 2010-49 of 13 January 2010 as amended relating to medical biology, or that have obtained the administrative authorisation provided for in the third paragraph of the same…
The site of a medical biology laboratory is the geographical unit within which the laboratory carries out all or part of its medical biology activity.
A medical biologist present on each site in accordance with the provisions of the first sentence of Article L. 6222-6, or another biologist from the medical biology laboratory, is designated as responsible for this site within the meaning of this same article. He/she may not simultaneously assume this responsibility for several sites.
On all professional titles and documents, in particular on all reports issued by the medical biology laboratory, the following information must be clearly displayed: 1° The name or business name of the medical biology laboratory and its form of operation; 2° The name of the biologist in charge of the medical biology laboratory and, where applicable, the names of the biologists in charge; 3° The accreditation number where full accreditation…
When the Director General of a Regional Health Agency establishes that, in an area defined in b of 2° of Article L. 1434-9, the supply of medical biology does not meet the needs of the population, in particular because of geographical difficulties of access, he shall indicate in the regional health plan that, in this area, a medical biology laboratory established in a neighbouring area may open a site in…
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is a Registered Trademark of
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75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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