Part five: Health products

I.-The prescription of a medicinal product used in veterinary medicine containing one or more critically important antibiotic substances mentioned in article L. 5144-1-1 is subject to : 1° The prior performance of a clinical examination carried out by the prescribing veterinarian or a necropsy examination carried out at his request, as well as an analysis of the epidemiological context ; 2° The prior performance of an additional examination to identify…

I.-The prescription of a medicinal product for human use in veterinary medicine containing one or more critically important antibiotic substances mentioned in article L. 5144-1-1 and not contained in a veterinary medicinal product is only authorised in the following cases: 1° The substance is on the list of essential substances for equidae and for one of the indications provided for in Regulation (EC) No 1950/2006; 2° The medicinal product contains…

Companies that produce substances mentioned in II of Article L. 234-2 of the Rural and Maritime Fishing Code, i.e. beta-agonists, oestrogens, androgens or gestagens, and those that trade in the said substances, as well as the establishments mentioned in Article L. 5142-1 shall record, in chronological order, using any appropriate recording system that allows immediate editing at the request of the control authorities and does not allow any modification of…

The establishments mentioned in article L. 5142-1 which distribute veterinary medicinal products containing substances with anabolic or anticatabolic activity, in particular beta-agonists, oestrogens, androgens or gestagens, must record, in chronological order, using any appropriate recording system which allows immediate publication at the request of the control authorities and which does not allow any modification of the data after validation of their recording: 1° The name and quantity of the medicinal…

A veterinary surgeon who prescribes medicinal products containing substances having an oestrogenic, androgenic or gestagenic action for farm animals shall record the following information in chronological order in a register or by any appropriate recording system: 1° Number of the prescription prescribing the medicinal product in question ; 2° Nature of the treatment ; 3° Nature of the medicinal product ; 4° Date of treatment ; 5° Identity of the…

The registers or records mentioned in articles R. 5141-118 to R. 5141-120 are kept for five years and must be produced whenever required by the competent authorities. The recording systems comply with the characteristics laid down by order of the ministers responsible for agriculture and health.

Veterinarians alone are authorised to administer, in the case provided for in a of 3° of article L. 5143-4, to animals whose flesh or products are not intended for human consumption, medicinal products for human use classified in one of the categories subject to restricted prescription by article R. 5121-77, benefiting from a marketing authorisation, necessary to avoid unacceptable suffering for these animals or to respond to specific health situations….

Veterinarians alone are authorised to administer, in the cases provided for in Article L. 5143-4, to equidae declared as being intended for slaughter for human consumption, medicinal products for human use classified in one of the categories subject to restricted prescription by Article R. 5121-77, benefiting from a marketing authorisation and containing the substances listed in the Annex to Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing a…

Any veterinary medicinal product other than those mentioned in 1° and 2° of article L. 5142-7 which does not have one of the marketing authorisations mentioned in article L. 5141-5, or the registration mentioned in article L. 5141-9, or the temporary authorisation for use mentioned in article L. 5141-10 must, prior to importation, be the subject of an import authorisation. The import authorisation is issued by the Director General of…

By way of derogation from article R. 5141-123, the importation of veterinary medicinal products intended exclusively for animals whose flesh or products are not intended for human consumption is not subject to import authorisation, provided that the following conditions are met: 1° Veterinary medicinal products are transported personally by the person responsible for the care of the animal or animals for which they are intended; 2° The person responsible for…