French Public Health Code
In forceThe Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) carries out inspections on file or on site at least once every two years, under the conditions laid down in this chapter, in each establishment and organisation authorised in application of Article L. 1243-2 , including when they have an authorisation for import activity under Article R. 1245-7 and establishments holding the authorisation referred to in Article R. 1245-24.
Subject to any agreements concluded between the European Union and a country outside the European Union or the Agreement on the European Economic Area, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may ask a supplier established in a third country to submit to an inspection by the Agency's inspectors if the tissues, their derivatives and cells from the human body or the cell therapy preparations are intended to be imported into France.
When other Member States or the European Commission wish to obtain information on the results of inspections and control measures concerning establishments holding an authorisation for import activity under Article R. 1245-7 and their suppliers established in third countries, they submit a duly justified request to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. In the light of the justification for this request, the Director General of the Agence nationale de sécurité du médicament et des produits de santé assesses whether it can provide the information requested.
When the establishments mentioned in the previous paragraph supply another Member State of the European Union or party to the Agreement on the European Economic Area with tissues, their derivatives and cells derived from the human body or cell therapy preparations imported from a third State, these establishments and their suppliers established in a third State may be subject to an inspection or control measures by the Agence nationale de sécurité du médicament et des produits de santé, at the duly justified request of the competent authority of the Member State to this Agency. If the Director General of the National Agency for the Safety of Medicines and Health Products considers that this request is justified, he will inform the establishments concerned. Following this inspection and these controls, the Director General of the National Agency for the Safety of Medicines and Health Products decides on the measures to be taken after consulting the competent authority of the Member State which made the request.
Where an on-site inspection follows the request referred to in the previous paragraph, the Director General of the National Agency for the Safety of Medicines and Health Products and the competent authority of the requesting Member State shall agree on whether and how the requesting Member State shall participate in the inspection. The final decision on such participation rests with the Director General of the National Agency for the Safety of Medicines and Health Products. The reasons for any decision to refuse such participation shall be explained to the competent authority of the requesting Member State.
