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Showing 2371–2380 of 6711 articles for “Art. CA Rouen 13 juin 2000 n° 1999/04931”
…required to report the following to the Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Any serious adverse reaction suspected to be due to the allergen…
…ation exploiting a medicinal product or a product referred to in Article R. 5121-150 may not communicate information relating to pharmacovigilance to the general public about this medicinal product or…
…registration; 2° At the request of the Director General of the Agence nationale de sécurité du médicament et des produits de santé: a) When the Director General has concerns regarding pharmacovigilan…
…uthorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de santé an application to vary his authorisation accordingly, in accordance…
…a medicinal product or a product mentioned in article R. 5121-150 is required to transmit electronically to the European Medicines Agency a periodic safety update report containing : 1° All informati…
…submission of periodic safety update reports, for reasons of public health, in order to avoid duplication of assessments or for the purposes of international harmonisation. Changes to the European Un…
Pharmaceutical establishments, including those managed by public health establishments mentioned in articles R. 5124-68 to R. 5124-73 for their production, hospital preparation and magistral preparati…
The declarations and the periodic safety update report referred to in Articles R. 5121-161, R. 5121-168 and R. 5121-170 are drawn up in accordance with the procedures and standard form laid down by th…
…dicinal product or a product mentioned in Article R. 5121-150 participates in the detection of duplicates in the reports of suspected adverse reactions, in particular by reporting to the Agence nation…
…Article L. 5126-1 shall forward to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, immediately upon request, a report summarising the information rela…
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