Article D6221-16
The head of the medical biology 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 op…
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Showing 1681–1690 of 54255 articles for “Art. D 321-1 s.”
The head of the medical biology 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 op…
The Minister for Health shall maintain and make available to the public a register of medical biology laboratories established in another Member State of the European Union or party to the Agreement o…
The competent authorities of the State in which the laboratory has its registered office are informed of the decision of the Minister for Health.
Renewal applications follow the same procedure as initial applications.
I.-The application for authorisation provided for in 3° of Article L. 6221-4 shall be sent by the medical biology laboratory established in another Member State of the European Union or party to the A…
The authorisation is issued for a period of five years. It specifies the medical biology tests or families of medical biology tests that the laboratory is authorised to perform at the request of a med…
Applications for authorisation may only be examined if they are accompanied by a complete file. The application is deemed to be complete if, within one month of receipt, the Minister for Health has no…
The application for authorisation must be accompanied, where appropriate, by a copy of the documents representing authorisation or approval issued by the competent authorities of the State in which th…
Biological samples transmitted by the medical biology laboratory established in France requesting the performance of the analytical phase are subject to a monitoring procedure making it possible to es…
When it is established that the operating conditions of the laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area holding the aut…
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