translate English to French: However, under the existing Food and Drug Regulations, they are not considered "significantly different . It is anticipated that this gap in the existing Regulations will be addressed as part of the Progressive Licensing Project. The changes included in this reporting category should be filed, along with the recommended supporting data, to Health Canada as a Notifiable Change.
Les changements de type niveau I, ou supplémentaires, constituent les modifications apportées à une drogue nouvelle « qui diffèrent sensiblement » en ce qui a trait aux sujets visés au paragraphe C.08.003 (2) du Règlement sur les aliments et drogues, et qui risquent d’avoir une incidence sur l’innocuité, l’efficacité, la qualité et/ou l’utilisation efficace de la drogue.