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Showing 681–690 of 57777 articles for “Art. n° 12-16956 and n° 12-15505”
…nt section at the end of the financial year is made up of the outturn balance corrected by the outstanding commitments.The outturn balance of the investment section corresponds to the difference betwe…
Doors and gates are maintained and inspected regularly. If falling doors or gates may present a danger to workers, particularly due to their size, weight or fixing method, the frequency of inspections…
The parallel import authorisation is granted for a period of five years. It specifies the differences mentioned in articles R. 5121-117 to R. 5121-119 with the speciality that has obtained marketing a…
…eriod. Renewal of the authorisation is granted under the conditions set out in Articles R. 5121-116 and R. 5121-123. If the Director General of the Agence nationale de sécurité du médicament et des pr…
…e de sécurité du médicament et des produits de santé. It must state : 1° The name or corporate name and address of the applicant ; 2° Concerning the proprietary medicinal product which has obtained ma…
…A sample of the proprietary medicinal product which has obtained marketing authorisation in France and a sample of the proprietary medicinal product marketed in the country of origin, which is intend…
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
…remains silent for a period of forty-five days from the date of receipt of the complete application and dossier referred to in Articles R. 5121-120 and R. 5121-121, authorisation of the parallel impor…
The holder of a parallel import authorisation notifies the holder of the marketing authorisation for the proprietary medicinal product in the Member State of origin of the marketing in France of the p…
…the parallel import authorisation complies with the provisions of Articles R. 5121-118, R. 5121-119 and R. 5121-128.
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