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Submissions formerly under review: New drug submissions
Submissions currently under review: New drug submissions
Submissions formerly under review: Supplemental new drug submissions for new uses
The objective of this document is to ensure that sponsors of SRTDs have the necessary information to satisfy the regulatory …
This document provides guidance on how fees for the review of veterinary drug submissions and applications will be administered in …
When Health Canada issues certain negative decisions related to the submission review process for a human drug, including hard-surface disinfectants, …
To provide sponsors of an Abbreviated New Drug Submission or an Abbreviated Extraordinary Use New Drug Submission who are seeking …
The purpose of the guidance document is to outline the requirements when preparing submissions that rely on Certificates of Suitability …
For Drug Identification Number applications, a separate completed HC/SC 3011 must be provided for each formulation, strength and dosage form. …
Health Canada has recently updated the Guidance document on fees for the review of human and disinfectant drug submissions and …