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Showing 11591–11600 of 38939 articles for “Art. al. 4”
Independently of decisions to suspend, modify or withdraw authorisations and as a precautionary measure, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'envi…
…ded 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 sufficient for the evaluat…
Any substantial amendment to the trial must be the subject of a prior additional declaration by the sponsor sent by registered post with acknowledgement of receipt to the Director General of the Agenc…
…endments 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 s…
…o become available at the sites of action; 3° Bioequivalence, the equivalence of bioavailabilities; 4° Primary packaging, the container or other form of packaging with which the medicinal product come…
…istration, for a given volume or weight, using the common names; 3° The manufacturing batch number; 4° The marketing authorisation number; 5° The name or corporate name and address of the marketing au…
…onnement et du travail. Registration decisions include the information provided for in Article R. 5141-63.
I.-The amount of the fee provided for in 8° of 1 of I of Article L. 5141-8 is set at €1,500 per veterinary medicinal product or per series of homeopathic veterinary medicinal products and forming the…
I.-The amounts of the fee provided for in 1° of 1 of I of Article L. 5141-8 for marketing authorisation applications under a national procedure, a mutual recognition procedure or a decentralised proce…
…en it appears : 1° Either, in particular following evaluation of the data mentioned in article R. 5141-90, that the medicinal product no longer satisfies the conditions mentioned in article L. 5141-6;…
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