Guidance Document: Product Monograph and Templates [April 4, 2014 Version]

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• Guidance Document Product Monograph [2014-04-04]


• Notice - Product Monograph Template Revisions: a) New Boxed Message Insert for Overdose Management Information; b) New Address for Canada Vigilance Program [2010-02-17]


• Notice: Revised Implementation Procedures for Product Monograph Guidance [2006-05-29]


• Guidance for Industry: Product Monograph [2004-06-14]
  
  
  
  • Appendix E - Product Monograph Template - Standard [2010-02-17]
  
  
  • Appendix F - Product Monograph Template - Notice of Compliance with Conditions Product Monograph
  
  
  • Appendix G - Product Monograph Template - Subsequent Entry Product (except for Schedule C and D products) - Revised
  
  
  • Appendix H - Product Monograph Template - Schedule C
  
  
  • Appendix I - Product Monograph Template - Schedule D
  
  
  
  


• Project - Revision of the Product Monograph

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