Subsection 2: Provisions relating to the conditions of transmission of samples to medical biology laboratories established in another Member State of the European Union or party to the Agreement on the European Economic Area

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biology, on medical biology laboratories established on French territory, the authorisation shall be suspended or withdrawn by the Minister responsible for health.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…