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Showing 2631–2640 of 15668 articles for “Art. CJEU – Pierre Fabre – Case C-439/09 – 13 Oct. 2011”
For the purposes of issuing the certificate referred to in the seventh paragraph of Article L. 229-2, the European Company shall produce to the notary responsible for carrying out the legality control…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Records any adverse reaction suspected to be due to a medicinal product or to a product mentioned in…
…70 ; 3° Information transmitted by the regional pharmacovigilance centres mentioned in Article R. 1413-61-4;4° Reports sent in application of article R. 5121-175 by pharmaceutical establishments, incl…
Without prejudice to the obligations laid down in Articles R. 5121-138 to R. 5121-142, the packaging of a blood-derived medicinal product includes three detachable labels, separate from the informatio…
In the establishments referred to in Article R. 5121-187, the person administering the blood-derived medicinal product to the patient completes the dispensing and administration slip with the followin…
…drug dependence and addictovigilance assessment and information centres referred to in article R. 5132-112 and the poison control centres referred to in article L. 6141-4 to provide him with any info…
…This supply is managed in accordance with the provisions of the order provided for in article R. 5132-42. When a medicinal product is taken from the supply provided for in the previous paragraph, th…
…an Union's emergency procedure if it considers that an urgent measure is necessary. IV.When, in the cases provided for in II and III, the Director General of the Agence nationale de sécurité du médica…
In health establishments and health cooperation groups authorised under article L. 6133-7 to carry out the tasks of these establishments which do not have an in-house pharmacy which hold blood-derived…
The registers or records provided for in articles R. 5121-185 to R. 5121-193 are kept for a period of forty years. Where necessary for the purposes of pharmacovigilance, the regional pharmacovigilance…
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