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compendial
officinale
Last Update: 2015-05-14
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nhpd compendial monograph
tissus d’origine animale** oui non
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nhpd compendial monograph 77.
monographie officinale de la dpsn nom date 77.
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compendial name, if relevant:
nom officiel (nom propre), si pertinent :
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nhpd compendial monograph:_______________________________________________ date: _________________________________________
monographique officinale de la dpsn :_____________________________________________ date : _________________________________________
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if a non-compendial method
la méthode est « appropriée pour l’objectif » et peut être
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compendial name, if relevant; c.
dénomination officinale, s'il y a lieu; c.
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• table 1 - compendial applications:
• tableau 1 - demandes officinales :
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• table 2 - non-compendial applications:
• tableau 2 - demandes non-officinales :
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note for compendial product licence applications :
remarque concernant les demandes de mise en marchÉ de produit officinal :
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about the compendium 1.1 compendial applications
introduction au compendium 1.1 les demandes officinales
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example of a compendial application appendix 2:
exemple de formulaire de demande officinale annexe 2 :
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necessary for schedule b compendial potency methods.
la préparation pharmaceutique.
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more than one medicinal ingredient in compendial applications :
plus d'un ingrédient médicinal dans les demandes officinales :
Last Update: 2015-05-14
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nhpd compendial monograph not applicable to homeopathic medicines.
monographie officinale de la dpsn ne s'applique pas aux médicaments homéopathiques.
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additional resources for compendial product licence applicants:
ressources documentaires additionnelles pour les demandes de licence de mise en marché officinales :
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chemistry & manufacturing for non-compendial medicinal ingredient.
données sur la chimie et la fabrication à l’appui d’une forme posologique.
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these products were found to be within compendial limits.
ces produits respectaient les normes applicables.
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combinations must be assessed through the non-compendial stream.
les combinaisons doivent être évaluées par le processus relatif aux demandes non officinales.
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it is expected that the strictest compendial standard will be adopted.
santé canada s’attend à ce que normes officinales les plus strictes soient adoptées.
Last Update: 2015-05-14
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