French Public Health Code
In forceI.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) determines an annual programme of controls carried out by the Agency, in the light of the annual reports referred to in Article L. 6221-9 which are sent to it by the external quality assessment bodies. This programme is communicated to the Minister for Health and the Minister for Defence for their information prior to its implementation. It forms part of a multiannual programme of inspections.
If necessary, the programme may be modified during the year. The Minister for Health is notified of any changes.
These controls cover :
1° Medical biology tests relating to the health plans, actions and programmes mentioned in Article L. 1411-1 ;
2° Medical biology examinations carried out using in vitro diagnostic devices whose performance is essential for medical practice and whose failure is likely to result in a serious risk to people's health;
3° Tests that are the subject of a request for registration or are newly registered in the nomenclature of medical biology procedures;
4° Medical biology examinations necessary for the development of national reference data involving the participation of all medical biology laboratories performing these examinations;
5° Medical biology tests not covered by a programme implemented by an external quality assessment body;
6° Medical biology examinations for which national quality control of the results of medical biology examinations is provided for by specific regulatory provisions.
This control also covers, for public health reasons, medical biology examinations determined by the Minister for Health or the Director General of the National Agency for the Safety of Medicines and Health Products.
II - The Agence nationale de sécurité du médicament et des produits de santé :
1° Transmit to each medical biology laboratory and to the regional health agency with territorial jurisdiction the results of the controls that it carries out as well as the overall results of all the laboratories that participated in the controls, with the exception of those medical biology laboratories under the authority of the Minister of Defence and not on the list provided for in II of Article L. 6147-7, in order to enable an assessment of the quality of the medical biology examinations carried out;
2° Immediately informs the competent regional health agency of the results of a laboratory's control which present an anomaly likely to have serious consequences for the health of individuals;
3° Analyse and adopt, if necessary, the appropriate safety measures concerning in vitro diagnostic devices, in the light of the results of the quality controls of medical biology examinations mentioned in Articles L. 6221-9 and L. 6221-10;
4° Publishes a summary of the reports sent to it each year by the external quality assessment bodies;
5° Provide the Minister for Health with an annual report on the operations carried out as part of the national quality control of medical biology test results. This report is presented to the National Medical Biology Commission mentioned in Article L. 6213-12. It is made public by the Agence nationale de sécurité du médicament et des produits de santé.
