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Article L5141-5-1 of the French Public Health Code

By way of derogation from the provisions of paragraph 1 of Article 5 of Regulation (EU) 2019/6 of 11 December 2018, the veterinary medicinal products referred to in paragraph 6 of the same Article shall be subject to a registration procedure. The application for registration shall be submitted to the Director General of the National Agency for Food, Environment and Work.

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Article L5141-5-2 of the French Public Health Code

The company holding the marketing authorisation shall inform the National Agency for Food, Environmental and Occupational Health Safety, beforehand or, in an emergency, at the same time, of any action it takes to suspend marketing, withdraw from the market or withdraw a specific batch, as well as any risk of a stock shortage of a veterinary medicinal product likely to pose a risk to human health, animal health or animal…

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Article L5141-8 of the French Public Health Code

I.-1. A fee relating to the veterinary medicinal products mentioned in this Title shall be levied by the National Agency for Food, Environmental and Occupational Health Safety, within the limit of the ceiling provided for in I of Article 46 of Law No 2011-1977 of 28 December 2011 on finance for 2012, on each: 1° Application for marketing authorisation for a veterinary medicinal product; 2° Application for modification of a…

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Article L5141-9 of the French Public Health Code

The registration of homeopathic veterinary medicinal products with the Director General of the National Agency for Food, Environmental and Occupational Health Safety is valid for an unlimited period. The registration of homeopathic veterinary medicinal products referred to in Article 86 of Regulation (EU) 2019/6 of 11 December 2018 may be amended, suspended or withdrawn if the conditions laid down in Articles 86 and 87 of the same Regulation are no…

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Article L5141-10 of the French Public Health Code

Pursuant to Articles 110 and 116 of Regulation (EU) 2019/6 of 11 December 2018 on veterinary medicinal products, the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may, where the health situation so requires, authorise the use of veterinary medicinal products that do not have the marketing authorisation referred to in Article 5 of the same Regulation.

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Article L5141-13 of the French Public Health Code

Without prejudice to the application of the provisions of article L. 613-16 of the Industrial Property Code, patents granted for veterinary medicinal products may also, when the economics of breeding so require, be subject to the ex officio licence system by order of the Minister responsible for industrial property, at the request of the Minister responsible for agriculture.

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Article L5141-13-1 of the French Public Health Code

Subject to the provisions of Article L. 1453-6, it is prohibited for the professionals mentioned in Article L. 5143-2, the groups mentioned in Article L. 5143-6 and for feed business operators approved for the manufacture of medicated feed within the meaning of Regulation (EU) 2019/4 of 11 December 2018, as well as for the associations representing them, to receive benefits in kind or in cash, in any form whatsoever, in…

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Article L5141-14-1 of the French Public Health Code

I.-The holders of marketing authorisations for veterinary medicinal products referred to in article L. 5141-1 and the companies involved in the manufacture and distribution of medicated feed declare to the competent administrative authority the veterinary medicinal products containing one or more antimicrobial substances which they sell or which are sold on their behalf on national territory. Manufacturers and distributors of medicated feed shall also mention the prescribing veterinarian and the…

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Article L5141-14-2 of the French Public Health Code

On the occasion of the sale of veterinary medicinal products containing one or more antibiotic substances, discounts, rebates, the differentiation of general and special conditions of sale within the meaning ofarticle L. 441-1 of the French Commercial Code or the provision of free units and all equivalent practices are prohibited. Any commercial practice aimed at circumventing, directly or indirectly, this prohibition by granting discounts, rebates or discounts on another range…

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