Article R5141-123-11
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail shall notify the interested party of his decision with regard to the proven or po…
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Showing 6561–6570 of 59300 articles for “Art. 9° and 10°”
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail shall notify the interested party of his decision with regard to the proven or po…
…by the same company or by an associated company or working under licence with the same quantitative and qualitative composition in active ingredients and excipients and the same pharmaceutical form as…
I.- Medicinal products covered by the regulations on poisonous substances and containing substances mentioned in 7°, 8° or 9° of article L. 5132-2 are used in veterinary medicine in compliance with go…
…imentation, de l'environnement et du travail must indicate : 1° The name or corporate name, address and position of the natural or legal person responsible for the import ; 2° The country of origin an…
…ided for in this article to be printed out immediately at the request of any supervisory authority, and each printed page must include the name and address of the pharmacy or the professional domicile…
…d by an authorisation for a series of import operations envisaged over a maximum period of one year and for a given overall quantity. The same applies to veterinary medicinal products intended for sto…
…he 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 th…
…g any recording system that allows immediate presentation at the request of the control authorities and does not allow any modification of the data after validation of the registration. These records…
Any modification concerning the elements and documents mentioned in Article R. 5141-130 is submitted for authorisation to the Director General of the Agence nationale de sécurité sanitaire de l'alimen…
…the authorisation is granted under the conditions set out in articles R. 5141-123-7, R. 5141-123-11 and R. 5141-123-12.
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