Book I: Pharmaceutical products

On the basis of the inspection reports drawn up in application of Chapter VI of this Title or the results of inspections carried out under Article R. 5141-79 which reveal breaches of the provisions of Articles L. 5145-5 and L. 5145-6, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may initiate a sanction procedure against companies holding marketing authorisations for veterinary…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail sends a warning to the company in question, together with the inspection report or the results of the checks or verifications, indicating the facts that are attributed to it and that may justify the initiation of a sanction procedure. This warning specifies the deadline for implementing corrective measures. If, despite the warning, the…

In the absence of observations or in the event of an inadequate response to the complaints within the time limit mentioned in the previous article, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail shall impose the financial penalty and notify the company by any means that enables the date of receipt to be determined. The decision shall indicate the deadline and…

The penalty decision may, where appropriate, be accompanied by a daily penalty payment. This penalty payment is notified in accordance with the same procedural rules as the main sanction. The amount of the daily penalty is calculated from the date of notification of the financial penalty until the date of fulfilment of the commitments required to put an end to the disputed situation, as determined by the Director General of…

The financial penalties and daily fines provided for in Article L. 5145-5 are recovered by the accounting officer of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail and paid to the State.