Article R5121-154
…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…
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Showing 2261–2270 of 5384 articles for “Art. 13 juill. 2005”
…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…
I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, in…
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…
When the in-house pharmacy dispenses a blood-derived medicinal product directly to a patient, the information referred to in article R. 5121-187 is transcribed onto a special register marked and initi…
…for in this paragraph take the place of the transcriptions and recordings mentioned in article R. 5132-10.
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