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Article L5143-10 of the French Public Health Code

The following are determined, as necessary, by decrees in the Council of State issued after obtaining the opinion of the National Agency for Food, Environmental and Occupational Health Safety: 1° The conditions of preparation, labelling and use of extemporaneous preparations ; 2° The conditions of acquisition, possession, supply and use of the medicinal products referred to in article L. 5143-6 ; 3° The procedures for applying the provisions of article…

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Article L5144-1 of the French Public Health Code

Without prejudice to the provisions of Articles 94 and 95 of Regulation (EU) 2019/6 of 11 December 2018, specific obligations shall be laid down by regulation for the import, manufacture, acquisition, possession, sale or transfer free of charge of substances which are not veterinary medicinal products but which may be used in their manufacture: a) Virulent substances and products of microbial origin intended for the diagnosis, prevention and treatment of…

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Article L5144-1-1 of the French Public Health Code

Critically important antimicrobial substances are those whose efficacy must be preserved as a matter of priority in the interests of human and animal health and whose list is established by order of the ministers responsible for agriculture and health, after consulting the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail and the Agence nationale de sécurité du médicament et des produits de santé.

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Article L5144-2 of the French Public Health Code

The specific obligations applicable to the manufacture, possession, sale or transfer free of charge of the substances listed in article L. 5144-1 are determined, where necessary, by decrees of the Conseil d’Etat, issued after consultation with the Agence nationale chargée de la sécurité sanitaire de l’alimentation, de l’environnement et du travail.

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Article L5144-3 of the French Public Health Code

Decrees issued after obtaining the opinion of the National Agency for Food, Environmental and Occupational Health Safety lay down the other procedures for applying this Title. Exemptions from the provisions of this Title may be granted by order of the Ministers of Agriculture and Health for the supply and use of products intended for the capture and restraint of domestic or wild animals by persons and public services authorised for…

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Article L5145-1 of the French Public Health Code

A department of the Agence nationale chargée de la sécurité sanitaire de l’alimentation, de l’environnement et du travail, called the “Agence nationale du médicament vétérinaire”, implements the Agency’s missions as defined in this Title.

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Article L5145-2-1 of the French Public Health Code

The Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may suspend the testing, manufacture, preparation, import, use, export, wholesale distribution, packaging and placing on the market, whether free of charge or in return for payment, the holding with a view to sale or distribution free of charge, advertising, prescription, dispensing, use or administration of a veterinary medicinal product or a category of veterinary medicinal products not…

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Article L5145-2-2 of the French Public Health Code

Without prejudice to any criminal proceedings that may be brought, where a veterinary medicinal product is placed on the market or used without having obtained the prior authorisation or registration required by the provisions of Regulation (EU) 2019/6 of 11 December 2018 or this Title, or is placed on the market or used in disregard of those provisions, the Agency may suspend, the testing, manufacture, preparation, import, use, export, wholesale…

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Article L5145-3 of the French Public Health Code

In the event of failure to comply with the rules laid down in application of 9° of article L. 5141-16 relating to advertising, the Agency may: 1° Order the suspension or prohibition of advertising ; 2° Order the inclusion in the advertisement of warnings and precautions for use necessary to inform the user or the distribution of a correction; 3° Withdraw authorisation to advertise medicinal products presented as favouring the…

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