Book I: Pharmaceutical products

For investigations and inspections carried out in premises, places, installations and vehicles used for professional purposes under the conditions set out in Article L. 1421-2 relating to decisions for which it is responsible by virtue of the provisions of this Title and for monitoring the application of and compliance with these decisions, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail shall…

An adaptation period of a maximum duration of one year is used to ensure the technical and administrative skills of the Agency’s inspectors, mentioned in 1° of articles L. 5146-1 and L. 5146-2, and to validate their professional experience in the field of the good practices mentioned in articles L. 5141-4 and L. 5142-3. At the end of this period, the Director General of the Agency takes a decision regarding…

For the application of article L. 5146-2, the inspectors mentioned in article L. 5146-4 are authorised to investigate and establish criminal offences, at the end of the adaptation period, by decision of the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. This decision specifies the names, positions and qualifications of the agents concerned. Authorisation lasts for four years. It is renewable on…

The agents authorised by the Director General of the agency to perform the duties of inspector shall take the following oath before the judicial court within whose jurisdiction the head office of the agency is located: “I swear and promise to perform my duties well and faithfully and to observe in everything the duties imposed upon me. I also swear not to reveal or use anything brought to my knowledge…

The Agency’s inspectors will carry out inspections as decided by the Agency’s Director General, who will issue a letter of assignment to the inspector in charge of the investigation. This letter specifies the establishment or location to be inspected and the name(s) of the inspector(s).

The provisions of Section 2 of Chapter VII of Title II of Book I of this Part are applicable to the inspectors of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail mentioned in 1° of Articles L. 5146-1 and L. 5146-2 and to the official veterinarians mentioned in 3° of the same Articles.

When the inspection concerns a veterinary pharmaceutical establishment mentioned in article R. 5142-1 or an establishment which carries out non-clinical trials mentioned in article R. 5141-2, the inspectors shall ensure in particular that this establishment complies with the good practices provided for in article L. 5142-3 or article L. 5141-4 which concern it. The establishments of the companies mentioned in article R. 5142-1 are inspected at intervals set by the…

Within ninety days of the inspection of an establishment referred to in 1° or 2° of article R. 5142-1, a certificate of compliance with good practice is issued to the pharmacist or veterinarian responsible if it appears that this establishment complies with the good manufacturing practice for veterinary medicinal products referred to in article L. 5142-3 . This certificate relates to the conditions under which the various pharmaceutical operations were…

The official veterinarians mentioned in 3° of article L. 5146-2, sworn in under the conditions defined in article R. 205-1 of the rural and maritime fishing code and authorised to investigate and record offences provided for and punished by the provisions of title III of book II of the same code, are also authorised to investigate and record offences under this title, without taking a further oath.