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Chapter V: National Veterinary Medicines Agency

Article R5145-1 of the French Public Health Code

The Director of the National Veterinary Medicines Agency is appointed by order of the Ministers for Agriculture and Health, on a proposal from the Director General of the National Agency for Food, Environmental and Occupational Health Safety. He may be delegated by the Director General to represent the Agency and, at the request of the Government, France, in European or international organisations competent in the field of veterinary medicinal products.

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Article R5145-2 of the French Public Health Code

I. – In the case provided for in article R. 5141-86, where the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail considers that the planned advertisement is contrary to the provisions of articles R. 5141-82 to R. 5141-88, he may make his authorisation subject to a change in the content of the advertisement, the running of the planned advertising campaign or a…

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Article R5145-3 of the French Public Health Code

In the event of non-compliance with the formal notice at the end of the period prescribed in application of II of Article R. 5145-2 and where the observations presented are not satisfactory, the Director General of the Agency may implement the measures provided for in Article L. 5145-3. These measures are made public on the website of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail.

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Article R5145-4 of the French Public Health Code

In an emergency, the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may suspend, for a maximum period of three months, the dissemination of advertising which is manifestly contrary to the provisions of articles R. 5141-82 to R. 5141-88.

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Article R5145-5 of the French Public Health Code

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…

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Article R5145-6 of the French Public Health Code

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…

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Article R5145-7 of the French Public Health Code

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…

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Article R5145-8 of the French Public Health Code

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…

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