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Showing 2281–2290 of 6535 articles for “Art. CA Rennes – 17 Dec. 2024 – no. 23/05277”
…le L. 5121-12-1, the obligations set out in article R. 5121-161 and articles R. 5121-166 to R. 5121-170 are carried out in accordance with the procedures set out in the therapeutic use protocol.
…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…
…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…
…f Article R. 1121-2, which give rise to the collection of safety information from patients or healthcare professionals. These studies are carried out under the responsibility of the marketing authoris…
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…
…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 the European Commi…
…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…
The procedures and standard form for the declarations and report mentioned in Articles R. 5121-174 to R. 5121-176 are laid down by decision of the Director General of the Agence nationale de sécurité…
A decision by the Director General of the Agence nationale de sécurité du médicament et des produits de santé defines the principles of good pharmacovigilance practice. This decision also sets out the…
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