Article R5141-105-1
The holder of an authorisation referred to in Article L. 5141-12 must report to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail,…
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Showing 12601–12610 of 15302 articles for “Art. 12 al. 2”
The holder of an authorisation referred to in Article L. 5141-12 must report to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail,…
…veterinary use is prohibited. However, holders of the authorisation referred to in article L. 5141-12 may distribute information about their activities to veterinarians only. This information must co…
I.- For the purposes of this article, the following definitions shall apply 1° "Preventive treatment": any individual or collective prophylactic treatment applied to healthy animals exposed to a risk…
…orage precautions, if any; 11° Special precautions for disposing of unused medicated feed or waste; 12° Any other information required by the decision granting marketing authorisation for the medicate…
…L. 234-1 of the Rural and Maritime Fishing Code and in the register provided for in article R. 5141-120 of the Public Health Code. However, veterinary medicinal products containing :hormones, with the…
As long as the information concerning each medicinal product reproduces in full the summary of product characteristics mentioned in article R. 5141-15, publications intended to reference veterinary me…
The dossiers provided in support of the authorisation of the veterinary medicinal products mentioned in articles R. 5141-16 and R. 5141-18 are considered to include all the data necessary and sufficie…
Amendments concerning the data mentioned in the application and dossier provided for in articles R. 5141-63 and R. 5141-64 are submitted for approval to the Director General of the Agence nationale de…
…ection system in place; 11° Any other information required by the marketing authorisation decision; 12° The words "for veterinary use". 13° Where applicable, the words "to be dispensed only on prescri…
…decentralised procedure for which France acts as the Member State concerned are set as follows: 1° €12,000 for an application relating to : a) A veterinary medicinal product which is the subject of a…
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