Article R5141-123-4
…nale de sécurité sanitaire de l'alimentation, de l'environnement et du travail requests additional information from the applicant that may be necessary to examine the application, in particular to ass…
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Showing 3371–3380 of 8984 articles for “Art. n° 22-18436 · AFNOR NF K 12-500”
…nale de sécurité sanitaire de l'alimentation, de l'environnement et du travail requests additional information from the applicant that may be necessary to examine the application, in particular to ass…
…and address of the applicant ; 2° As regards the veterinary medicinal product which has obtained marketing authorisation in France, its name within the meaning of Article R. 5141-1, and the number of…
…ring the inspection by the customs officers. For imported veterinary medicinal products with the marketing authorisation referred to in article L. 5141-5 or the registration referred to in article L.…
…travail shall notify the interested party of his decision with regard to the proven or potential risk to human or animal health within sixty days from the date of receipt of the complete application r…
…tary veterinary medicinal product may be imported in parallel with a view to being placed on the market in France if it meets the following conditions: 1° It comes from another Member State of the Eur…
…charge of an experiment. III-This application also includes, depending on the case, the following information or documents: 1° For veterinary medicinal products imported with a view to a clinical tri…
…nvolving veterinary medicinal products which have undergone all stages of manufacture, including packaging. By way of derogation from the provisions of the previous paragraph, veterinary medicinal pro…
The holder of the parallel import authorisation is responsible for placing the product on the market and, in this capacity, ensures that the provisions of this Title are complied with, in particular t…
…does not allow any modification of the data after validation of the registration. These records are kept for five years and include the following information: -the name of the veterinary medicinal pro…
…parallel import authorisation for a proprietary veterinary medicinal product of a change to the marketing authorisation for the proprietary veterinary medicinal product authorised in France, this cha…
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