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Showing 11611–11620 of 38939 articles for “Art. al. 4”
…dosage, or per unit of weight or volume, including a mention of the common name of its components; 4° The animals of destination accompanied by an indication of the withdrawal period for veterinary m…
…e, the package leaflet of the homeopathic veterinary medicinal products referred to in article L. 5141-9 must bear the following information exclusively: 1° The very clear indication "homeopathic vete…
The registration of a homeopathic veterinary medicinal product mentioned in Article L. 5141-9 may be refused, suspended or withdrawn by the Director General of the Agency. Decisions to refuse, suspend…
The decision to suspend, revoke or vary the marketing authorisation must state the reasons on which it is based and indicate the appeal procedures and deadlines. Except in cases of urgency, the decisi…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail will make a decision within two hundred and ten days of the submission of a compl…
When informed by the holder of a marketing authorisation granted under 1°, 2° or 3° of Article R. 5141-20, before the marketing of the veterinary medicinal product concerned, of the fact that for all…
The registration includes the registration number and the data mentioned in Article R. 5141-63 as approved by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l…
In specific cases of Community interest, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail or the applicant shall refer the matter…
…ate file for the medicinal product concerned, or a copy, has been transferred to the future holder; 4° An undertaking by the pharmacist or veterinary surgeon responsible for the manufacturing company…
…ng the marketing authorisation application dossier; 3° Seek the opinion of experts appointed by it; 4° Appoint rapporteurs to ensure that applications comply with the provisions of this Code; 5° Submi…
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