Health Canada
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Drugs and Health Products
Templates
- A blank Foreign Review Attestation template is available in Microsoft™ Word® upon request. To receive a blank Foreign Review Attestation template, please contact the Use of Foreign Regulatory Information Steering Committee at UFRI_URRE@hc-sc.gc.ca.
- Notice to Manufacturers/Sponsors of Nonprescription Drug Products: Emerging Regulatory Requirement for Non-Medicinal Ingredient (NMI) Labelling [2011-07-25]
- Non-Medicinal Ingredients Labelling Attestation Letter Template [2011-07-25]
- Non-Medicinal Ingredient (NMI) Labelling Regulations: Frequently Asked Questions [2011-07-25]
- Notice - Protocol Safety and Efficacy Assessment Template - Clinical Trial Application (PSEAT-CTA) [2008-02-27]
- Notice - Request for Reconsideration Template [2006-03-11]
- Request for Reconsideration Template [2006-03-11]
- Notice - Draft Comprehensive Summary : Bioequivalence (CS-BE) [2004-05-18]
- Draft Comprehensive Summary - Bioequivalence (CS-BE) [2004-05-18]
- Quality Overall Summary Templates [2009-03-12]
- Quality Overall Summary - Chemical Entities (Clinical Trial Applications Phase I) (QOS-CE (CTA - Phase I)) [2008-11-12]
- Quality Overall Summary - Chemical Entities (Clinical Trial Applications - Phase II) (QOS-CE (CTA - Phase II)) [2008-11-12]
- Quality Overall Summary - Chemical Entities (Clinical Trial Applications - Phase III) (QOS-CE (CTA - Phase III)) [2008-11-12]
- Quality Overall Summary - Chemical Entities (Clinical Trial Applications - Bioavailability Studies) (QOS-CE (CTA - BA)) [2004-04-01]
- Quality Overall Summary - Chemical Entities (New Drug Submissions/Abbreviated New Drug Submissions) (QOS-CE (NDS/ANDS)) [2004-04-01]
- Quality Overall Summary - Chemical Entities (Applications for Drug Identification Number Submissions) (QOS-CE (DINA)) [2004-04-01]
