Article R5141-129
…nsibility of a qualified person, who has obtained the authorisation provided for in article L. 5141-12, in facilities which may, where appropriate, be made available by an organisation or company in w…
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Showing 2961–2970 of 50455 articles for “Art. Cass. com. 10 February 1987 n° 85-13.262 · Cass. com. 12 June 2007 n° 06-14.872 · Cass. com. 16 May 1995 · Cass. com. 27 May 2015 n° 14-14.744 · Cass. com. 12 December 1995 · Cass. com. 21 May 1996 · BOI-ENR-DMTOM-10-10-10 et -10-20-10”
…nsibility of a qualified person, who has obtained the authorisation provided for in article L. 5141-12, in facilities which may, where appropriate, be made available by an organisation or company in w…
…irector General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, at the request of a veterinary pharmaceutical establishment exporting a veterinary me…
The authorisation provided for in Article L. 5141-10 is issued by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.
…ation 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 authorisation in France. It i…
…or during the authorisation period. 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 s…
…ort authorisation is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. It must state : 1° The name or corporate name and address of the applicant…
…r a parallel import authorisation is accompanied by a dossier comprising : 1° A sample of the proprietary medicinal product which has obtained marketing authorisation in France and a sample of the pro…
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent for a period of forty-five days from the date of receipt of the complete application a…
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…
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