French Public Health Code
In forceI.-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 Agreement on the European Economic Area to the Minister responsible for health, by electronic means or by post with acknowledgement of receipt.
II - If the medical biology laboratory is accredited in its own country under the conditions laid down in I of Article L. 6221-2, the application for authorisation for accredited examinations shall be accompanied only by the certificate of accreditation by the competent authority of the State in which it is established. The authorisation is issued by the Minister for Health.
III - If the medical biology laboratory is not accredited in its country, under the conditions laid down in I of Article L. 6221-2, the application for authorisation must indicate :
1° The legal rules and technical operating standards of the medical biology laboratory in the Member State of the European Union or party to the Agreement on the European Economic Area in which it is located, and the list of medical biology tests that it is authorised to perform there and for which it is seeking authorisation;
2° The number of medical biology tests performed during the calendar year preceding the application;
3° The number of people working in the laboratory at the date of the application and their specialisation;
4° Copies of the diplomas, certificates or other qualifications of the professionals working in the laboratory;
5° The content of the studies, work placements or periods of professional practice carried out as part of their training by all the professionals working in the laboratory;
6° The timing and frequency of the inspections to which the laboratory is subject and the purpose of the inspections;
7° A description of the layout and organisation of the laboratory, the quality and safety procedures for the transport of biological samples, a list of the materials, equipment and in vitro diagnostic medical devices used in the laboratory and a description of the quality assurance processes, operating procedures and standards implemented;
8° The arrangements for verification of compliance with quality assurance procedures by a third party organisation;
9° Where applicable, the name and address of the laboratories with which the applicant laboratory collaborates.
The Minister for Health will decide on the application for authorisation after receiving the opinion of the Director General of the French Accreditation Committee.
IV - Failure by the Minister for Health to respond within four months of receipt of the application for authorisation shall be deemed to constitute rejection of the application.
