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Showing 10591–10600 of 36632 articles for “Art. al. 5”
The detailed rules for the application of sections 1 to 12 of this chapter are determined as necessary, after obtaining the opinion of the Director General of the Agence nationale de sécurité du médic…
…by reasoned decision, refuse to include a medicinal product on the list referred to in Article R. 5121-202 for any public health reason, in particular when the benefit/risk balance of the medicinal…
…r body mentioned in Article L. 4211-9-1 or the pharmaceutical establishment mentioned in Article L. 5124-1 or Article L. 5124-9-1 ; 3° The patient's surname, first name and date of birth; 4° The produ…
This article applies to the post-authorisation safety studies referred to in Article R. 5121-178 which are carried out either voluntarily by the holder of the marketing authorisation referred to in Ar…
…adverse reaction suspected to be due to a medicinal product or to a product mentioned in Article R. 5121-150, occurring in France, which has been reported or notified to it; 2° Report electronically t…
…he pictogram provided for in II or III which he uses, without applying the provisions of Article R. 5121-41. V.-In the event of non-compliance with the provisions of II, III and IV, the suspension of…
…parallel distribution in France of a proprietary medicinal product within the meaning of Article L. 5124-13-2, it shall inform the marketing authorisation holder of this intention and send the Directo…
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…
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…
The classification of a medicinal product in the category of medicinal products requiring special monitoring during treatment has the effect of making its prescription subject to periodic examinations…
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