French Public Health Code
In forceI.-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 the bacterial strain responsible for the infection from a sample taken by the prescribing veterinarian or at his request, from one or more live or dead animals, provided that the location of the infection, the type of infection or the general condition of the animal(s) allow the sample to be taken;
3° The prior performance of an additional examination designed to demonstrate the sensitivity of the bacterial strain identified to this antibiotic by means of a sensitivity test carried out using one of the methods laid down by joint order of the Ministers of Health and Agriculture;
4° Compliance with the information given in the contra-indications and precautions for use sections of the summary of product characteristics mentioned in article R. 5141-15.
II - The results of the examinations and analyses mentioned in I justifying the prescription of a medicinal product containing one or more of the critically important antibiotic substances mentioned in I are kept by the prescribing veterinarian for five years.
III - By way of derogation from I, the veterinarian is not required to carry out the additional examinations mentioned in 2° and 3° if the results of additional examinations carried out less than three months previously on the same animal or animals of the same physiological stage present on the same site and for the same condition have been brought to his attention.
IV - By way of derogation from 2° and 3° of I, a medicinal product containing one or more of the critically important antibiotic substances mentioned in I may be prescribed before the results of the additional examinations are known in the case of an acute case of bacterial infection for which treatment with other families of antibiotics would not be sufficiently effective. Within four days of the prescription, the veterinarian must adapt the treatment according to the clinical and epidemiological context and the results of the additional examinations brought to his attention.
