Subsection 1: Conditions for authorisation

Approval to carry out the analyses mentioned in article L. 3512-15 is granted for a maximum period of five years by the public establishment mentioned in this article. It is renewable under the same conditions. Approval is published on the website of the Ministry of Health and the list of approved laboratories is sent by the Ministry of Health to the European Commission.

Approval is granted on the basis of the following criteria: 1° To present and maintain all guarantees of confidentiality, impartiality, integrity and independence. In particular, the approved laboratory and its staff must not be involved in activities that are incompatible with their independence of judgement and their integrity with regard to the analysis activities for which the laboratory is approved. The approved laboratory must not be owned or controlled, directly…

I.-The approved laboratory shall immediately inform the public establishment referred to in Article L. 3512-15 of any situation that may no longer enable it to comply with one or more conditions of approval. Failure to comply with one or more conditions of approval, delay in transmitting this information to the aforementioned public establishment, and false declarations are grounds for suspension or withdrawal of approval. The decision to withdraw approval is…

I.-The application for approval, accompanied by the information and documents listed in Annex I to Decree No. 2016-1139 of 22 August 2016, shall be sent by the head of the laboratory to the public establishment mentioned in Article L. 3512-15. This application, together with the information and documents requested, must be submitted no later than 30 June of the calendar year preceding the year for which approval is sought. II-Any…

A laboratory with establishments on several separate geographical sites where different teams operate submits an application for approval for each of them.

For control purposes, the approved laboratory shall send the public establishment mentioned in Article L. 3512-15 the results of the analyses provided for in that Article, in accordance with the technical specifications for computer transmission and presentation of the analysis results specified by the latter. The laboratory shall inform the aforementioned public establishment without delay of any anomaly or non-conformity in the test results.