Title II: Organisation

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 the laboratory is established. The application for authorisation and the attached documents must be accompanied by a certified translation into French.

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 not informed the applicant, by registered letter with acknowledgement of receipt, of the list of missing or incomplete documents.

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 medical biology laboratory established on French territory.

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.

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 operating standards of the laboratory included in the authorisation file.

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 authorisation are not or are no longer equivalent to those imposed on medical biology laboratories established on French territory, the authorisation is suspended or withdrawn by the Minister for Health after obtaining the opinion of the Director General…

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 establish the conformity of the biological samples accepted by the laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area which performs the analytical phase, their identification, the maintenance of their integrity…

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 on the European Economic Area which have made the declaration provided for in 1° and 2° of Article L. 6221-4 or which have obtained the administrative authorisation provided for in 3° of the same article, as well as…