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Showing 9321–9330 of 20753 articles for “Art. CA Paris 13-6-2024 n° 22/08263”
…21-12-1, 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.
…tem in order to fulfil its pharmacovigilance obligations, and in particular to collect and scientifically evaluate all the information relating to the adverse reactions mentioned in Article R. 5121-15…
…which it is aware, whether these reactions have been reported spontaneously or on request by healthcare professionals or patients, or observed during a post-authorisation study; 2° To report, electro…
…party to the Agreement on the European Economic Area, and providing evidence of appropriate qualifications in pharmacovigilance. The identity, position and contact details of this person are communic…
…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…
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