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Article R5141-108 of the French Public Health Code

A company operating veterinary medicinal products has at its disposal, on a permanent basis, the services of a person, pharmacist or veterinarian, responsible for veterinary pharmacovigilance residing in the European Union. The name, position and contact details of this person are communicated to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. This person is responsible for : 1° Gathering, processing and…

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Article R5141-109 of the French Public Health Code

The principles of good veterinary pharmacovigilance practice to which veterinarians, pharmacists and members of the other health professions mentioned in 4° of article R. 5141-93 are subject are defined, on a proposal from the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, by order of the Ministers for Agriculture and Health.

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Article R5141-110 of the French Public Health Code

The poison control centres referred to in article L. 6141-4 and the regional pharmacovigilance centres referred to in article R. 5121-167 shall transmit, without delay, to the Agence nationale de sécurité sanitaire, de l’alimentation, de l’environnement et du travail any information they have on adverse reactions in humans which may be attributed to the use of these medicinal products.

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Article R5141-111 of the French Public Health Code

I.-Without prejudice to the provisions applicable to medicinal products classified as narcotics, any prescription for medicinal products mentioned in article L. 5143-5, as well as in II of article L. 234-2 of the Rural and Maritime Fishing Code, is written, after a veterinary diagnosis, on a prescription that legibly indicates : 1° The surname, first name and address of the veterinarian, his national registration number when he is required to…

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Article R5141-112 of the French Public Health Code

I.-When veterinary medicinal products prescribed in accordance with the provisions of article R. 5141-111 are dispensed, the pharmacist or veterinarian must immediately transcribe the dispensing in ink, without blanks or overwriting, onto a register or record it using any appropriate system which does not allow the data contained therein to be altered once the registration has been validated. The recording systems allow the information provided for in this article to…

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Article R5141-112-1 of the French Public Health Code

For the purposes of 2° of article L. 5143-2, the following definitions apply 1° “Prohibition on keeping a dispensary open”: The prohibition on any veterinarian from preparing extemporaneously, and dispensing by retail, a veterinary medicinal product, whether or not subject to compulsory prescription, when it is intended to be administered : a) To an animal or to several animals for which he does not personally provide care or for which…

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Article R5141-112-2 of the French Public Health Code

I. – 1° The farm health report establishes the reference health status of the farm based on qualitative and quantitative criteria. It includes a list of diseases to which the farm has already been exposed, in particular those requiring priority action. It is based on a methodical analysis of information specifically adapted to each species and, where applicable, to each type of production, including clinical, biological and necropsy data, as…

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Article R5141-112-3 of the French Public Health Code

I.- Medicinal products covered by the regulations on poisonous substances and containing substances mentioned in 7°, 8° or 9° of article L. 5132-2 are used in veterinary medicine in compliance with good practices defined by order of the ministers responsible for agriculture and health. These good practices set out : 1° The medicinal products concerned and their route of administration ; 2° The animal species concerned; 3° The conditions and…

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Article R5141-113 of the French Public Health Code

For animals whose flesh or products are intended for human consumption, no more than one month’s treatment may be given in medicated feed. The veterinarian prescribing a medicated feed must ensure that the medicated feed prescribed and the feed being used do not contain the same antibiotic or coccidiostat as those used as the active ingredient in the medicated premix.

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Article R5141-114 of the French Public Health Code

As stated in article D234-6 of the French Rural and Maritime Fishing Code, which reads as follows: “I. – Veterinary medicinal products containing substances or categories of substances with anabolic, anticatabolic or beta-agonist activity may only be administered to animals belonging to species whose flesh or products are intended for human consumption under the following conditions: 1° For therapeutic use: a) Testosterone, progesterone or derivatives which readily hydrolyse the initial…

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