Article R2681-1
…ISIONSAS THEY STANDIn Book IR. 2100-1In Title IR. 2111-1 to R. 2111-2R. 2111-4 to R. 2112-12R. 2112-13Resulting from Decree no. 2018-1225 of 24 December 2018R. 2112-14 to R. 2113-8In Title IIR. 2121-1…
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Showing 2251–2260 of 6154 articles for “Art. 13 Mar 2020”
…ISIONSAS THEY STANDIn Book IR. 2100-1In Title IR. 2111-1 to R. 2111-2R. 2111-4 to R. 2112-12R. 2112-13Resulting from Decree no. 2018-1225 of 24 December 2018R. 2112-14 to R. 2113-8In Title IIR. 2121-1…
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…
…European Union of one of the following situations: 1° It is considering suspending or withdrawing a marketing authorisation; 2° It is considering prohibiting the supply of a medicinal product or a pro…
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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