Title I: Tasks and prerogatives

The Agency shall appoint inspectors from among its staff to monitor the application of laws and regulations, in particular the application of the rules of good practice defined by decision of the Agence nationale de sécurité du médicament et des produits de santé or by order of the Minister for Health pursuant to this code, as well as the common specifications or standards concerning the devices mentioned in Article 1…

The provisions of articles L. 1421-1 to L. 1421-3 and the first paragraph of article L. 5127-3 are applicable to the Agency’s inspectors. To carry out duties requiring pharmaceutical expertise, these inspectors must hold a diploma in pharmacy.

For the sole purpose of recording the offences provided for in articles L. 5421-2, L. 5421-3, L. 5421-13, L. 5432-1, L. 5432-2, L. 5438-4, L. 5461-3 and L. 5462-3 of the Public Health Code, when committed using electronic means of communication, the inspectors of the Agency mentioned in article L. 5412-1 authorised under conditions specified by order of the Ministers of Justice, the Interior and Health may, without being criminally…

In order to carry out its duties, the Agency may ask the ministers and regional health agencies concerned to call upon their agents authorised to monitor the application of legislative and regulatory provisions designed to protect human health. When they intervene at the Agency’s request, these agents shall act in accordance with the laws and regulations applicable to them and the good practices mentioned in Article L. 5313-1.

The procedures for applying the provisions of this chapter shall be determined by decree in the Conseil d’Etat.