ARCHIVED - Product Monographs - Templates - Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies

The following electronic templates (in Wordperfect or MS Word format found within the zip file) should be used when preparing a Product Monograph. For further instructions on how to complete the templates and the information that should be provided, please refer to the Draft Guidance for Industry, Product Monograph.

• Notice: Transparency - Release of Product Monographs Directly to Requesters
  Date: 2006-05-29
• Appendix E - Product Monograph Template - Standard
  Date: 2003-10-01
• Appendix F - Product Monograph Template - Notice of Compliance with Conditions Product Monograph
  Date: 2003-10-01
• Appendix G - Product Monograph Template - Subsequent Entry Product (except for Schedule C and D products)
  Date: 2003-10-01
• Appendix H - Product Monograph Template - Schedule C
  Date: 2003-10-01
• Appendix I - Product Monograph Template - Schedule D
  Date: 2003-10-01