Health Canada
www.hc-sc.gc.ca
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Drugs and Health Products
Drugs Currently Regulated as New Drugs
- 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
- 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
- Listing of drugs currently regulated as new drugs [1999-04-01]
- Preparation of Human New Drug Submissions [1991-07-17]
