Book III: National Agency for the Safety of Medicines and Health Products

The Agence nationale de sécurité du médicament et des produits de santé may impose special conditions on, restrict or suspend the testing, manufacture, preparation, import, use, export, wholesale distribution, packaging, storage, placing on the market free of charge or against payment, holding with a view to sale or free distribution, advertising, putting into service, use, prescription, supply or administration of a product or group of products mentioned in Article L….

Where it appears, on the occasion of a decision to suspend or prohibit an activity relating to a product or group of products taken by the National Agency for the Safety of Medicines and Health Products pursuant to Article L. 5312-1, that all or part of the activities of the natural or legal person concerned are being carried out under conditions presenting a proven risk to human health, the Agency…

Without prejudice to any criminal proceedings that may be brought, where a product or group of products referred to in Article L. 5311-1 is placed on the market, put into service or used without having obtained the prior authorisation, registration or certification required by the legislative or regulatory provisions applicable to this product or group of products, the Agency may suspend, until the product or group of products has been…

In the cases referred to in Articles L. 5312-1 and L. 5312-2, and in the event of suspension or withdrawal of authorisation or registration of a product or group of products referred to in Article L. 5311-1, the Agency may order the natural or legal person responsible for placing the product on the market, putting it into service, making it available on the market or using it to withdraw the…

In the cases mentioned in articles L. 5312-1, L. 5312-2 and L. 5312-3, and in all cases where the interests of public health so require, the health authorities shall, if necessary, inform the general public and health professionals by any means and in particular by disseminating health messages or product recall notices using any appropriate medium. The Agence nationale de sécurité du médicament et des produits de santé shall set…

The Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) imposes financial penalties on natural or legal persons producing or marketing products mentioned in Article L. 5311-1 or providing services associated with these products, which may be accompanied by daily fines, in the cases provided for by law and, where applicable, by decree of the Conseil d’Etat….

When, during an inspection, the Agence nationale de sécurité du médicament et des produits de santé finds that the laws and regulations applicable to the activities and products mentioned in Article L. 5311-1 have not been complied with, it may order the person concerned to rectify the situation within a period which it shall determine. This injunction is issued after the interested party has been given the opportunity to present…