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Showing 5531–5540 of 59015 articles for “Art. 10 and 11”
…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…
…benefiting from the parallel import authorisation complies with the provisions of Articles R. 5121-118, R. 5121-119 and R. 5121-128.
…icinal product being imported, stating the parallel import authorisation number, the name, strength and pharmaceutical form of the imported medicinal product and the country of origin.
…nce relating to:-the summary of product characteristics, with the exception of the stability period and special storage precautions, which are those provided for in the marketing authorisation obtaine…
I.- Articles R. 5121-133 to R. 5121-135 do not apply to gene therapy and xenogenic cell therapy preparations. II-Any gene therapy or xenogenic cell therapy preparation that does not have the authorisa…
The operation, as defined in the second paragraph of 3° of Article R. 5124-2, of a proprietary medicinal product benefiting from a parallel import authorisation is carried out by the holder of this au…
When, in application of the second paragraph of Article L. 5124-11, the Director General of the Agence nationale de sécurité du médicament et des produits de santé intends to prohibit the export of a…
…pliance by the persons referred to in Article L. 561-2 with the obligations laid down in Chapters I and II of this Title, with directly applicable European provisions relating to the fight against mon…
Notaries and bailiffs are required, on pain of dismissal, costs and damages to the parties, to leave an exact copy of the protests. Subject to the same penalties, they are also required to hand over t…
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